chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.  Date the vial was initially stored in the refrigerator on 10-Sep and freezer were taken out this morning 08-Sep-2021 at 8:00am   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up received contain NNI
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Vaccination complication
Clinical narrative: AE to the Moderna Booster; experienced tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (AE to the Moderna Booster) and TACHYCARDIA (experienced tachycardia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 032L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TACHYCARDIA (experienced tachycardia). On an unknown date, the patient experienced VACCINATION COMPLICATION (AE to the Moderna Booster). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. On 30-Oct-2021, TACHYCARDIA (experienced tachycardia) had resolved. At the time of the report, VACCINATION COMPLICATION (AE to the Moderna Booster) outcome was unknown.            No concomitant medications were provided.  Patient had reported that the tachycardia came on at 2 PM on 30 Oct 2021 and lasted until 7 PM in the evening. She stated she went to a clinic for evaluation but should have went to the emergency room.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: The recent follow-up contains significant information due to additional event and patient gender updated. Reporter were also updated.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow-up information received on 09-NOV-2021 contains non-significant information.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: we had a few patients that were vaccinated with a vaccinethat was 40 days in the refrigerator; 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 PRODUCT STORAGE ERROR (we had a few patients that were vaccinated with a vaccinethat was 40 days in the refrigerator) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (we had a few patients that were vaccinated with a vaccinethat was 40 days in the refrigerator). At the time of the report, PRODUCT STORAGE ERROR (we had a few patients that were vaccinated with a vaccinethat was 40 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported.  It was reported that there were no adverse events reported with this event.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow up information received contains non significant information.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: Hospitalized after receiving the Moderna vaccine booster dose.; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (Hospitalized after receiving the Moderna vaccine booster dose.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalized after receiving the Moderna vaccine booster dose.) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (Hospitalized after receiving the Moderna vaccine booster dose.) outcome was unknown.     The patient is hospitalized after receiving the Moderna vaccine booster dose.  Company Comment - This is a spontaneous case concerning a 80-year-old female patient with no relevant medical history reported, who experienced serious, unexpected event of Hospitalization. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. It was reported that patient was hospitalized after receiving the Moderna vaccine booster dose. No other information provided. Consent to follow up denied. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 80-year-old female patient with no relevant medical history reported, who experienced serious, unexpected event of Hospitalization. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. It was reported that patient was hospitalized after receiving the Moderna vaccine booster dose. No other information provided. Consent to follow up denied. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Genital blister
Clinical narrative: Painful blisters in the genital area; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL BLISTER (Painful blisters in the genital area) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 046B21A and 037A21B) for COVID-19 vaccination.     The patient's past medical history included Herpes infection (Patient had herpes 45 or 50 years ago). Concomitant products included MULTIVITAMIN [VITAMINS NOS] and COLLAGEN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GENITAL BLISTER (Painful blisters in the genital area). At the time of the report, GENITAL BLISTER (Painful blisters in the genital area) had not resolved.            Concomitant medications include Blood pressure pills.  No treatment details were reported.  It was reported that patient will visit ER  09-NOV-2021 to consult doctor.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up report received on 12-Nov-2021 contains Non Significant Follow-Up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 2.5mL dose of booster shot was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (2.5mL dose of booster shot was administered) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (2.5mL dose of booster shot was administered). On 09-Nov-2021, ACCIDENTAL OVERDOSE (2.5mL dose of booster shot was administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On 09-Nov-2021 during administration of booster Moderna shot, Patient was  administered with 2.5mL instead of 0.25mL dose.No concomitant medication  were reported.No Treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: They discovered after they had given him the booster dose that he had not had either dose of the primary series; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (They discovered after they had given him the booster dose that he had not had either dose of the primary series) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced INCORRECT DOSE ADMINISTERED (They discovered after they had given him the booster dose that he had not had either dose of the primary series). On 05-Nov-2021, INCORRECT DOSE ADMINISTERED (They discovered after they had given him the booster dose that he had not had either dose of the primary series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  It was reported that the patient had a recent case of COVID-19 and thought that he just needed the booster.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow-up received contains no new information. On 13-Nov-2021: Follow-up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: non-immunocompromised patient received third full dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (non-immunocompromised patient received third full dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (non-immunocompromised patient received third full dose). At the time of the report, INCORRECT DOSE ADMINISTERED (non-immunocompromised patient received third full dose) had resolved.            No concomitant medication was provided.       No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder
Clinical narrative: Eye surgery/Did not know that she was going to have the eye surgery/She is in such a "big ole" mess here; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (Eye surgery/Did not know that she was going to have the eye surgery/She is in such a "big ole" mess here) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011120A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE DISORDER (Eye surgery/Did not know that she was going to have the eye surgery/She is in such a "big ole" mess here). At the time of the report, EYE DISORDER (Eye surgery/Did not know that she was going to have the eye surgery/She is in such a "big ole" mess here) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and medication information provided. The patient also stated that in July, she had an eye surgery which was after she received the first dose of the moderna vaccine and stated that she did not know that she was going to have the eye surgery the time she took the first dose of the moderna vaccine. While searching for the vaccination card, the patient said she is in such a "big ole" mess here. On 13-Feb-2021, the patient received second dose of moderna vaccine in left arm, intramuscular injection, lot: 028L20A. No treatment information provided.   This case was linked to MOD-2021-380931 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 6 doses administered beyond the expiration date (2 days Expired Moderna Vaccine); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 doses administered beyond the expiration date (2 days Expired Moderna Vaccine)) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021 at 3:10 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 doses administered beyond the expiration date (2 days Expired Moderna Vaccine)). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (6 doses administered beyond the expiration date (2 days Expired Moderna Vaccine)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No side effects reported by the patient from the date the expired vaccine received.  No treatment medications were reported.     This case was linked to MOD-2021-381144 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up information received contains non significant information. On 12-Nov-2021: significant follow up appended
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: they found that 6 patients received expired vaccine of Moderna COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they found that 6 patients received expired vaccine of Moderna COVID-19) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (they found that 6 patients received expired vaccine of Moderna COVID-19). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (they found that 6 patients received expired vaccine of Moderna COVID-19) had resolved. Not Provided      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 provided   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow up received.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: Nose is stuffy; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nose is stuffy) 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, the patient experienced NASAL CONGESTION (Nose is stuffy). At the time of the report, NASAL CONGESTION (Nose is stuffy) outcome was unknown.            No concomitant product reported by reporter. No treatment medication reported by reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient passed away; This spontaneous case was reported by a nurse and describes the occurrence of DEATH (Patient passed away) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 07-Nov-2021 The patient died on 07-Nov-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        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 was not provided by the reporter.  Reporter reported that patient passed away on 07 Nov 2021 and it could be due to age and comorbidities.  Company comment: This case concerns a 83-year-old, female patient with no reported medical history, who experienced the unexpected fatal event of death. Death occurred on 07-NOV-2021, 5 days after receiving the first dose of mRNA-1273. The rechallenge is not applicable considering the outcome of the event. No autopsy results were provided; the cause of death was not reported. Patient´s age could be a confounding factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 83-year-old, female patient with no reported medical history, who experienced the unexpected fatal event of death. Death occurred on 07-NOV-2021, 5 days after receiving the first dose of mRNA-1273. The rechallenge is not applicable considering the outcome of the event. No autopsy results were provided; the cause of death was not reported. Patient´s age could be a confounding factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: bad case of diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (bad case of diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.  No Medical History information was reported.On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced DIARRHOEA (bad case of diarrhea). At the time of the report, DIARRHOEA (bad case of diarrhea) outcome was unknown.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No Concomitant medications were provided by the reporter. No Treatment information was reported. Patient received the first dose of the Moderna COVID-19 vaccine on 21Feb2021 (Lot 007M20A), the second dose on 21Mar2021 (Lot  007B21A) and the booster dose on 04Nov2021 (Lot # 007B219), all 3 as injections into left arm. Two days after her first dose patient had a bad case of diarrhea. Then with the second shot she had no problems. Two days after the booster shot she had a bad case of diarrhea again   This case was linked to MOD-2021-381361 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: bad case of diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B219, 007B21A, and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced DIARRHOEA. At the time of the report, DIARRHOEA outcome was unknown.            The concomitant medication was unknown. The treatment information was not provided by the reporter.   This case was linked to MOD-2021-381347 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pain in extremity, Vaccination complication
Clinical narrative: Basic Symptoms; Ache; Sore arm; Didn't feel good for a week; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Basic Symptoms), PAIN (Ache), PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (Didn't feel good for a week) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION COMPLICATION (Basic Symptoms), PAIN (Ache), PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (Didn't feel good for a week), CHILLS (Chills) and NAUSEA (Nausea). On 24-Mar-2021, VACCINATION COMPLICATION (Didn't feel good for a week) had resolved. At the time of the report, VACCINATION COMPLICATION (Basic Symptoms), PAIN (Ache), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications reported. No Treatment medications reported.  Reporter reported that patient experienced the "basic symptoms" and a sore arm after the vaccination. Patient confirmed what her husband (reporter) had reported and added aches, chills and nausea that began the day after receiving the second dose. She states she didn't feel good for a week.   This case was linked to MOD-2021-381515 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: a terrible reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION. At the time of the report, VACCINATION COMPLICATION outcome was unknown.            No concomitant medication was provided. No treatment medication was provided.   Reporter did not allow further contact.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Fatigue, Malaise
Clinical narrative: Didn't feel good; Stayed in bed all day; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Didn't feel good), BEDRIDDEN (Stayed in bed all day) and FATIGUE (Very tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 048A21A and 030MZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced MALAISE (Didn't feel good), BEDRIDDEN (Stayed in bed all day) and FATIGUE (Very tired). At the time of the report, MALAISE (Didn't feel good), BEDRIDDEN (Stayed in bed all day) and FATIGUE (Very tired) outcome was unknown.            Concomitant medication not reported.  Treatment medication not reported.   This case was linked to MOD-2021-381452 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 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 (received expired doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received expired doses) 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 provided.  Nurse reported three patients were given doses from an expired vial (doses administered >12 hours post puncture).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoacusis, Insomnia, Tinnitus
Clinical narrative: other people with the same problem in her support group,tinnitus,swoshing sound in ear; hardly sleep; she is freaking out really bad; can barely hear out of the ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (other people with the same problem in her support group,tinnitus,swoshing sound in ear), INSOMNIA (hardly sleep), FEELING ABNORMAL (she is freaking out really bad) and HYPOACUSIS (can barely hear out of the ear) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Nov-2021, the patient experienced TINNITUS (other people with the same problem in her support group,tinnitus,swoshing sound in ear), INSOMNIA (hardly sleep), FEELING ABNORMAL (she is freaking out really bad) and HYPOACUSIS (can barely hear out of the ear). At the time of the report, TINNITUS (other people with the same problem in her support group,tinnitus,swoshing sound in ear) had not resolved and INSOMNIA (hardly sleep), FEELING ABNORMAL (she is freaking out really bad) and HYPOACUSIS (can barely hear out of the ear) 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 provided by the reporter. No Treatment information was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lack of efficacy; COVID positive; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (COVID positive) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (COVID positive). At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown and COVID-19 (COVID positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) tested negative, a few days earlier. On 09-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive (taken swab test sample).         No treatment medications were reported.  The COVID symptoms started about 5 days prior to the patient's husband's onset and manifested as extreme painful nausea, stomach pain, dry breathing, dry cough, headache, exhaustion, diarrhea, cold sore in the mouth and terrible taste in the mouth (like blood, rubber) in the patient. The patient was having a difficult time. This is a Spontaneous case concerning a -year-old, male/female patient with unknown medical history,  who experienced the unexpected non serious (AESI) events of COVID 19 and Drug ineffective. The event occurred approximately 9 months and 13 days after the first dose and 8 months and 16 days after the second dose of Moderna COVID 19 vaccine. The rechallenge is not applicable.  The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a -year-old, male/female patient with unknown medical history,  who experienced the unexpected non serious (AESI) events of COVID 19 and Drug ineffective. The event occurred approximately 9 months and 13 days after the first dose and 8 months and 16 days after the second dose of Moderna COVID 19 vaccine. The rechallenge is not applicable.  The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Pain
Clinical narrative: Body started hurting; chills; pain in joints; pain in muscles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body started hurting), CHILLS (chills), ARTHRALGIA (pain in joints) and MYALGIA (pain in muscles) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced PAIN (Body started hurting), CHILLS (chills), ARTHRALGIA (pain in joints) and MYALGIA (pain in muscles). At the time of the report, PAIN (Body started hurting), CHILLS (chills), ARTHRALGIA (pain in joints) and MYALGIA (pain in muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 10 Nov 2021, patient felt chills, pain in joints and muscles.  No concomitants and treatment drugs are provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Dyspnoea, Peripheral swelling, Presyncope
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like he was going to pass out/Felt like  had gotten over something), DYSPNOEA (Short of breath/Like not getting enough air coming in/Gasping/Starving for air), COUGH (Cough) and PERIPHERAL SWELLING (Right leg started swelling/Foot was really swollen, especially on top/Toes were like balloons) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030MZ0A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (Cardiac history significant for bypass surgery 20-30 years ago.).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced FEELING ABNORMAL (Felt like he was going to pass out/Felt like  had gotten over something), DYSPNOEA (Short of breath/Like not getting enough air coming in/Gasping/Starving for air), COUGH (Cough) and PERIPHERAL SWELLING (Right leg started swelling/Foot was really swollen, especially on top/Toes were like balloons). At the time of the report, FEELING ABNORMAL (Felt like he was going to pass out/Felt like  had gotten over something), DYSPNOEA (Short of breath/Like not getting enough air coming in/Gasping/Starving for air), COUGH (Cough) and PERIPHERAL SWELLING (Right leg started swelling/Foot was really swollen, especially on top/Toes were like balloons) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) normal. On an unknown date, Swallow study: normal (normal) normal. On an unknown date, Viral test: negative (Negative) negative..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that he actually thought he had the virus, but he tested and his test was negative. Treatment medication was Decongestant/Cough Medicine that may have had codeine in it. No concomitant medication reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Swallow study, Viral test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like he was going to pass out/Felt like  had gotten over something), DYSPNOEA (Short of breath/Like not getting enough air coming in/Gasping/Starving for air), COUGH (Cough) and PERIPHERAL SWELLING (Right leg started swelling/Foot was really swollen, especially on top/Toes were like balloons) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030MZ0A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (Cardiac history significant for bypass surgery 20-30 years ago.).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced FEELING ABNORMAL (Felt like he was going to pass out/Felt like  had gotten over something), DYSPNOEA (Short of breath/Like not getting enough air coming in/Gasping/Starving for air), COUGH (Cough) and PERIPHERAL SWELLING (Right leg started swelling/Foot was really swollen, especially on top/Toes were like balloons). At the time of the report, FEELING ABNORMAL (Felt like he was going to pass out/Felt like  had gotten over something), DYSPNOEA (Short of breath/Like not getting enough air coming in/Gasping/Starving for air), COUGH (Cough) and PERIPHERAL SWELLING (Right leg started swelling/Foot was really swollen, especially on top/Toes were like balloons) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) normal. On an unknown date, Swallow study: normal (normal) normal. On an unknown date, Viral test: negative (Negative) negative..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that he actually thought he had the virus, but he tested and his test was negative. Treatment medication was Decongestant/Cough Medicine that may have had codeine in it. No concomitant medication reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chilling; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chilling) and PYREXIA (fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII in September 2021.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced CHILLS (chilling) and PYREXIA (fever). At the time of the report, CHILLS (chilling) and PYREXIA (fever) outcome was unknown.            No concomitant medication was provided.  No treatment information was provided.   This case was linked to MOD-2021-382275 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: ongoing injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (ongoing injection site pain) 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 VACCINATION SITE PAIN (ongoing injection site pain). At the time of the report, VACCINATION SITE PAIN (ongoing injection site pain) had not resolved.            The patient had ongoing injection site pain since receiving the 2nd dose. The patient had both doses of the Moderna. No concomitant and treatment medications were provided
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Nasopharyngitis, Nausea
Clinical narrative: just felt like having the flu; Cold; Throbbing headache; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA, NASOPHARYNGITIS, HEADACHE, and NAUSEA in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced INFLUENZA, NASOPHARYNGITIS, HEADACHE, and NAUSEA. The patient was treated with TYLENOL at an unspecified dose and frequency. On 10-Nov-2021, INFLUENZA, NASOPHARYNGITIS, HEADACHE, and NAUSEA had resolved.            No concomitant medications were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Pain, Pyrexia
Clinical narrative: Body aches; Chills; Little fever; quite a bit discomfort; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), DISCOMFORT (quite a bit discomfort), CHILLS (Chills) and PYREXIA (Little fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer vaccine (Patient the first dose of the Pfizer vaccine on 15Feb2021 Lot EL9266.) on 15-Feb-2021 and Pfizer vaccine (Patient the second dose of the Pfizer vaccine on 18Mar 2021 Lot EN6204) on 18-Mar-2021. Concurrent medical conditions included Cholesterol.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced DISCOMFORT (quite a bit discomfort). On 10-Nov-2021, the patient experienced PAIN (Body aches), CHILLS (Chills) and PYREXIA (Little fever). At the time of the report, PAIN (Body aches), DISCOMFORT (quite a bit discomfort), CHILLS (Chills) and PYREXIA (Little fever) outcome was unknown.            No Concomitant medications were reported.  No Treatment information was reported.  This case was created for booster dose. Patient wanted to know if she could take any Aspirin product or Excedrin   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Significant followup received on 10-NOV-2021 contains historical vaccine added, event coding updated. On 10-Nov-2021: Followup received on 10-NOV-2021 contains Non-Significant  information.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Moderna has damaged me with a bad product; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (Moderna has damaged me with a bad product) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Moderna has damaged me with a bad product). At the time of the report, VACCINATION COMPLICATION (Moderna has damaged me with a bad product) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications, Lab data details and Treatment information were not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Mobility decreased, Oropharyngeal pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN, ASTHENIA, MOBILITY DECREASED, PERIPHERAL SWELLING, and PAIN IN EXTREMITY in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 045A21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Knee operation (on her right leg) on 01-Aug-2021. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included HUMIRA from 13-May-2021 to an unknown date for Rheumatoid arthritis.  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 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced OROPHARYNGEAL PAIN and PAIN IN EXTREMITY. On 08-Nov-2021, the patient experienced VACCINATION SITE PAIN. On an unknown date, the patient experienced ASTHENIA, MOBILITY DECREASED, PERIPHERAL SWELLING and FATIGUE. At the time of the report, OROPHARYNGEAL PAIN, PERIPHERAL SWELLING, PAIN IN EXTREMITY, FATIGUE, and VACCINATION SITE PAIN outcome was unknown, ASTHENIA was resolving and MOBILITY DECREASED had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Humira was paused between 24-Jun-2021 and 23-Sep-2021 and had a dose of on 28-Oct-2021. No treatment information was provided. She had knee surgery on her right leg and went to therapy for her right knee on Tuesday & Thursday of last week from the reporting day. She had taken oxycodone & Tylenol over the last 2 days every 6 hours that was left over from her knee surgery.   This case was linked to MOD-2021-382082, MOD-2021-382083 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN, ASTHENIA, MOBILITY DECREASED, PERIPHERAL SWELLING, and PAIN IN EXTREMITY in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 045A21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Knee operation (on her right leg) on 01-Aug-2021. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included HUMIRA from 13-May-2021 to an unknown date for Rheumatoid arthritis.  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 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced OROPHARYNGEAL PAIN and PAIN IN EXTREMITY. On 08-Nov-2021, the patient experienced VACCINATION SITE PAIN. On an unknown date, the patient experienced ASTHENIA, MOBILITY DECREASED, PERIPHERAL SWELLING and FATIGUE. At the time of the report, OROPHARYNGEAL PAIN, PERIPHERAL SWELLING, PAIN IN EXTREMITY, FATIGUE, and VACCINATION SITE PAIN outcome was unknown, ASTHENIA was resolving and MOBILITY DECREASED had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Humira was paused between 24-Jun-2021 and 23-Sep-2021 and had a dose of on 28-Oct-2021. No treatment information was provided. She had knee surgery on her right leg and went to therapy for her right knee on Tuesday & Thursday of last week from the reporting day. She had taken oxycodone & Tylenol over the last 2 days every 6 hours that was left over from her knee surgery.   This case was linked to MOD-2021-382082, MOD-2021-382083 (Patient Link).