chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Vaccination site pain
Clinical narrative: cramps when moving the fingers; she began having left hand pain & cramps when moving the fingers; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramps when moving the fingers) and VACCINATION SITE PAIN (she began having left hand pain & cramps when moving the fingers) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 013M2VA or 013M2UA and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced MUSCLE SPASMS (cramps when moving the fingers) and VACCINATION SITE PAIN (she began having left hand pain & cramps when moving the fingers). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (cramps when moving the fingers) and VACCINATION SITE PAIN (she began having left hand pain & cramps when moving the fingers) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered to unknownumber of patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to unknownumber of patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) 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 EXPIRED PRODUCT ADMINISTERED (Expired doses administered to unknownumber of patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to unknownumber of patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown. Not Provided          No treatment  was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired Moderna COVID-19 vaccines were administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna COVID-19 vaccines were administered to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) 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 EXPIRED PRODUCT ADMINISTERED (expired Moderna COVID-19 vaccines were administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna COVID-19 vaccines were administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP reported that there were 55 patients who received expired vaccine. He stated that most of the people were elderly.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Second shot was worse than first and took longer to go away.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE and LEVOTHYROXINE for an unknown indication.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION COMPLICATION. At the time of the report, VACCINATION COMPLICATION had resolved.        No treatment medications were reported.   This case was linked to MOD-2021-403775 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My arm was hurting 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was hurting 1st dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A, 040A21A and 939909) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis and Arthritis (arthritis in left thumb. basil joint issues in left hand).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (My arm was hurting 1st dose). At the time of the report, VACCINATION SITE PAIN (My arm was hurting 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2021-403846, MOD-2021-403805, MOD-2021-403805 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered  beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.   This case was linked to MOD-2021-403910 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered  beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction) 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 VACCINATION COMPLICATION (Reaction). At the time of the report, VACCINATION COMPLICATION (Reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia, Sluggishness
Clinical narrative: Mild arm pain; sluggish; Could not stop shaking; tenderness; Feverish; Severe, heavy chills; he felt a little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild arm pain), SLUGGISHNESS (sluggish), TREMOR (Could not stop shaking), TENDERNESS (tenderness) and PYREXIA (Feverish) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (Mild arm pain), SLUGGISHNESS (sluggish), TREMOR (Could not stop shaking), TENDERNESS (tenderness), PYREXIA (Feverish), CHILLS (Severe, heavy chills) and FATIGUE (he felt a little tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Mild arm pain), SLUGGISHNESS (sluggish), TREMOR (Could not stop shaking), TENDERNESS (tenderness), PYREXIA (Feverish), CHILLS (Severe, heavy chills) and FATIGUE (he felt a little tired) outcome was unknown.            No concomitant medication was provided.  IT was reported that  about 8 hours after the injection the caller patient  was feverish and he had mild arm pain and tenderness.  Patient reported that Benadryl helped some, also the symptoms tapered off and the next day he felt a little tired and sluggish.   This case was linked to MOD-2021-403975 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Tremor
Clinical narrative: Mild arm pain; sluggish; Could not stop shaking; tenderness; Feverish; Severe, heavy chills; he felt a little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild arm pain), SLUGGISHNESS (sluggish), TREMOR (Could not stop shaking), TENDERNESS (tenderness) and PYREXIA (Feverish) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (Mild arm pain), SLUGGISHNESS (sluggish), TREMOR (Could not stop shaking), TENDERNESS (tenderness), PYREXIA (Feverish), CHILLS (Severe, heavy chills) and FATIGUE (he felt a little tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Mild arm pain), SLUGGISHNESS (sluggish), TREMOR (Could not stop shaking), TENDERNESS (tenderness), PYREXIA (Feverish), CHILLS (Severe, heavy chills) and FATIGUE (he felt a little tired) outcome was unknown.            No concomitant medication was provided.  IT was reported that  about 8 hours after the injection the caller patient  was feverish and he had mild arm pain and tenderness.  Patient reported that Benadryl helped some, also the symptoms tapered off and the next day he felt a little tired and sluggish.   This case was linked to MOD-2021-403975 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: did not feel great" the day afterwards.; soreness in his left arm.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (did not feel great" the day afterwards.) and VACCINATION SITE PAIN (soreness in his left arm.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced FEELING ABNORMAL (did not feel great" the day afterwards.) and VACCINATION SITE PAIN (soreness in his left arm.). At the time of the report, FEELING ABNORMAL (did not feel great" the day afterwards.) and VACCINATION SITE PAIN (soreness in his left arm.) outcome was unknown.        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-2021-404030, MOD-2021-404031 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm soreness in her vaccination arm after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness in her vaccination arm after the 2nd dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L22A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (Arm soreness in her vaccination arm after the 2nd dose). At the time of the report, VACCINATION SITE PAIN (Arm soreness in her vaccination arm after the 2nd dose) outcome was unknown.            No concomitant medications reported. No treatment medications reported.   This case was linked to MOD-2021-403991 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Treponema test positive
Clinical narrative: RPR positive; This spontaneous case was reported by a consumer and describes the occurrence of TREPONEMA TEST POSITIVE (RPR positive) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A, 032B21A and 067F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced TREPONEMA TEST POSITIVE (RPR positive). At the time of the report, TREPONEMA TEST POSITIVE (RPR positive) outcome was unknown.            No concomitant medications was provided by the reporter.  No treatment was provided by the reporter.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: gave a booster dose to a patient instead of a full 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (gave a booster dose to a patient instead of a full 1st dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.  On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (gave a booster dose to a patient instead of a full 1st dose). On 02-Dec-2021, ACCIDENTAL UNDERDOSE (gave a booster dose to a patient instead of a full 1st dose) 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.   Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired booster doses given; Product storage error; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired booster doses given) and PRODUCT STORAGE ERROR (Product storage error) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 18-Nov-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 EXPIRED PRODUCT ADMINISTERED (expired booster doses given) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired booster doses given) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: after more than 12 hours at room temperature and after puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (after more than 12 hours at room temperature and after puncture) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066F21A, 039A21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (after more than 12 hours at room temperature and after puncture). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (after more than 12 hours at room temperature and after puncture) had resolved.        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. Patient received a booster dose which had been administered more than 12 hours after the initial vial puncture. Reporter stated that there are no known symptoms, though the patient left before monitoring time had elapsed.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache
Clinical narrative: felt a little hot after the first vaccine but did not have a fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt a little hot after the first vaccine but did not have a fever) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 645A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced FEELING HOT (felt a little hot after the first vaccine but did not have a fever) and HEADACHE (headache). At the time of the report, FEELING HOT (felt a little hot after the first vaccine but did not have a fever) and HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant medications were reported. No Treatment mediations were reported.   This case was linked to MOD-2021-404090 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Nausea
Clinical narrative: Felt weak after booster; Not hungry at all  after booster/Forced herself to eat after booster; Nauseous every time she stood up after booster, Feels nauseous constantly 3 days after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak after booster), DECREASED APPETITE (Not hungry at all  after booster/Forced herself to eat after booster) and NAUSEA (Nauseous every time she stood up after booster, Feels nauseous constantly 3 days after booster dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 009C21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced ASTHENIA (Felt weak after booster), DECREASED APPETITE (Not hungry at all  after booster/Forced herself to eat after booster) and NAUSEA (Nauseous every time she stood up after booster, Feels nauseous constantly 3 days after booster dose). On 02-Dec-2021, ASTHENIA (Felt weak after booster), DECREASED APPETITE (Not hungry at all  after booster/Forced herself to eat after booster) and NAUSEA (Nauseous every time she stood up after booster, Feels nauseous constantly 3 days after booster dose) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: just contracted COVID as of Sunday December 5th, 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (just contracted COVID as of Sunday December 5th, 2021) 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 29-Mar-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. On 05-Dec-2021, the patient experienced COVID-19 (just contracted COVID as of Sunday December 5th, 2021). At the time of the report, COVID-19 (just contracted COVID as of Sunday December 5th, 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Dec-2021, SARS-CoV-2 test: positive (Positive) contracted COVID as of Sunday December 5th, 2021.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. It was reported that patient wanted to know when the patient can take booster dose.  Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19, 8 months after patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19, 8 months after patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This week I tested positive for Covid/symptoms are mild; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (This week I tested positive for Covid/symptoms are mild) in a 71-year-old female patient 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 November 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 COVID-19 (This week I tested positive for Covid/symptoms are mild). At the time of the report, COVID-19 (This week I tested positive for Covid/symptoms are mild) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) Patient tested positive for Covid and so far the symptoms are mild..         Concomitant medication information was not provided by the reporter.                             Treatment information was not provided by the reporter.  The patient had reasonably good health with no major underlying conditions.  I received the Moderna Covid vaccines in January and February, 2021 and the booster shot at the beginning of November. I'm a 71 year old woman in reasonably good health with no major underlying conditions. This week I tested positive for Covid and so far the symptoms are mild.  Company comment: This case concerns a 71-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected  event of Covid-19 on unknown date after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient had mild symptoms and tested positive for Covid. The patient's age may have increased her risk of getting infected with Covid-19. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 71-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected  event of Covid-19 on unknown date after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient had mild symptoms and tested positive for Covid. The patient's age may have increased her risk of getting infected with Covid-19. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Mild case of covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Mild case of covid) in a 79-year-old female patient 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 2021, the patient experienced COVID-19 (Mild case of covid). At the time of the report, COVID-19 (Mild case of covid) outcome was unknown. Not Provided          No concomitant medication and treatment information was reported. Reporter stated that he and his wife both were vaccinated against COVID-19 in January and February 2021 and during Thanksgiving they both got a mild case of COVID, very mild case. He stated that he received Pfizer for his vaccinations ad his wife has got Moderna COVID-19 vaccine. He does not have her vaccination card and wanted to know how soon can they take the booster dose.  Company comment: This case concerns a 79-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19 on unknown date after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient had a very mild case of Covid as well as her husband. The patient's age may have increased her risk of getting Covid.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 79-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19 on unknown date after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient had a very mild case of Covid as well as her husband. The patient's age may have increased her risk of getting Covid.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Developed COVID after Moderna series; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Developed COVID after Moderna series) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Illness (Health issue hat makes patient eligible for the booster dose.).   In 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 November 2021, the patient experienced COVID-19 (Developed COVID after Moderna series). At the time of the report, COVID-19 (Developed COVID after Moderna series) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, COVID-19: positive (Positive) POSITIVE.         No concomitant medication information provided.  No treatment medication information provided.  The patient had a breakthrough case in the beginning of November i.e. 6 months  after the vaccine series. The reporter stated that his son had health issues that make him eligible for the booster dose  Company comment: This case concerns a 27-year-old male patient, with medical history of illness, who experienced the non-serious, unexpected AESI event of Covid-19, 6 months after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient's medical history of illness may have increased his risk of getting infected with Covid-19.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 27-year-old male patient, with medical history of illness, who experienced the non-serious, unexpected AESI event of Covid-19, 6 months after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient's medical history of illness may have increased his risk of getting infected with Covid-19.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got covid; This spontaneous case was reported by another health care professional and describes the occurrence of COVID-19 (Got covid) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2020, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got covid). In November 2021, COVID-19 (Got covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Patient got Covid.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.  Company comment: This case concerns a 46-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19 on unknown date after second dose of mRNA-1273 (Moderna COVID-19 Vaccine).  Onset latency was unknown as the specific dates of the vaccine and the event was not given. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 46-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19 on unknown date after second dose of mRNA-1273 (Moderna COVID-19 Vaccine).  Onset latency was unknown as the specific dates of the vaccine and the event was not given. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I was double vaccinated had Covid; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (I was double vaccinated had Covid) 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 COVID-19 (I was double vaccinated had Covid). At the time of the report, COVID-19 (I was double vaccinated had Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) patient had had Covid.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided Patient was received monoclonal antibodies in September 23.  Company comment: This case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19, on unknown date after second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The onset latency was unknown as the specific dates of the vaccine and event was not provided.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19, on unknown date after second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The onset latency was unknown as the specific dates of the vaccine and event was not provided.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with COVID; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (diagnosed with COVID) 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 COVID-19 (diagnosed with COVID). At the time of the report, COVID-19 (diagnosed with COVID) 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 provided. No treatment medications provided. The patient had her first two doses of Moderna COVID19 Vaccine on unknown dates, but theywere over 6 months ago.  Company comment: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19, more than 6 months after second dose of mRNA-1273 (Moderna COVID-19 Vaccine).  No further information was given. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19, more than 6 months after second dose of mRNA-1273 (Moderna COVID-19 Vaccine).  No further information was given. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Contracted Covid-19 in mid-October (tested positive); lack of drug efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted Covid-19 in mid-October (tested positive)) and DRUG INEFFECTIVE (lack of drug efficacy) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced COVID-19 (Contracted Covid-19 in mid-October (tested positive)) and DRUG INEFFECTIVE (lack of drug efficacy). At the time of the report, COVID-19 (Contracted Covid-19 in mid-October (tested positive)) had resolved and DRUG INEFFECTIVE (lack of drug efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, SARS-CoV-2 test: negative (Negative) tested negative two weeks later.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported,. No treatment drug details was reported. Company comment: This case concerns a 66-years-old male patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19. Additionally, Drug ineffective was also reported.  The events were reported to occur approximately 8 months after the administration of a proper schedule of vaccination with the mRNA-1273 vaccine (29 days between doses) and, at the time of the report, the outcome was reported as Recovered/Resolved.  The causality is not applicable as per the nature of the event.  No further information on clinical course, diagnosis or treatment was provided.  The rechallenge is not applicable as the events occurred after the administration of the second dose of the mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 66-years-old male patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19. Additionally, Drug ineffective was also reported.  The events were reported to occur approximately 8 months after the administration of a proper schedule of vaccination with the mRNA-1273 vaccine (29 days between doses) and, at the time of the report, the outcome was reported as Recovered/Resolved.  The causality is not applicable as per the nature of the event.  No further information on clinical course, diagnosis or treatment was provided.  The rechallenge is not applicable as the events occurred after the administration of the second dose of the mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BELL'S PALSY (Bells Palsy). At the time of the report, BELL'S PALSY (Bells Palsy) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that patient experienced Bell's Palsy after 2 days of dose 2 and wanted to know if patient can take booster dose as one internist said not to take it because there was a possibility to develop Gillian barre syndrome.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Malaise, Nervousness, Panic attack, Vomiting
Clinical narrative: having a heart attack; having a panic attack; nervous person; Feeling sick; might throw up; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (having a heart attack), PANIC ATTACK (having a panic attack), NERVOUSNESS (nervous person), MALAISE (Feeling sick) and VOMITING (might throw up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904 and 017Moderna) for COVID-19 vaccination.     Concurrent medical conditions included Disability.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-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 ANGINA PECTORIS (having a heart attack), PANIC ATTACK (having a panic attack), NERVOUSNESS (nervous person), MALAISE (Feeling sick) and VOMITING (might throw up). At the time of the report, ANGINA PECTORIS (having a heart attack), PANIC ATTACK (having a panic attack), NERVOUSNESS (nervous person), MALAISE (Feeling sick) and VOMITING (might throw up) outcome was unknown.            No concomitant medication reported.  No treatment information was provided.  Patient states that all these symptoms are being triggered by the stressful situation of having lost the information of her second dose   Company Comment: This case concerns an adult female patient of unknown age, with no medical history, who experienced the unexpected events of Angina pectoris, Panic attack, Nervousness, malaise and the expected event of Vomiting. The events occurred on an unknown date after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns an adult female patient of unknown age, with no medical history, who experienced the unexpected events of Angina pectoris, Panic attack, Nervousness, malaise and the expected event of Vomiting. The events occurred on an unknown date after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement
Clinical narrative: The Moderna vaccine seemed to lower her blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (The Moderna vaccine seemed to lower her blood pressure) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, 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 experienced BLOOD PRESSURE DECREASED (The Moderna vaccine seemed to lower her blood pressure). At the time of the report, BLOOD PRESSURE DECREASED (The Moderna vaccine seemed to lower her blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: lowered Lowered blood pressure.         No concomitant medications was reported. No treatment drug details was reported.