chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for an unknown indication.    No Medical History information was reported.   On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received first dose of INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (Intramuscular) 1 dosage form. On 30-Oct-2021, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported. This case concerns a  62-year-old, female patient with relevant medical history of concomitant Influenza vaccination, who experienced the unexpected non-serious event of Malasie and the expected non-serious event of Headache. The events occurred approximately 1 day after the second dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The patient's medical history of concomitant Influenza vaccination remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-370266 (Patient Link).; Sender's Comments: This case concerns a  62-year-old, female patient with relevant medical history of concomitant Influenza vaccination, who experienced the unexpected non-serious event of Malasie and the expected non-serious event of Headache. The events occurred approximately 1 day after the second dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The patient's medical history of concomitant Influenza vaccination remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Pain in jaw
Clinical narrative: Pain in her left jaw in the hinge area; she opens her mouth too wide, she gets a sharp pain almost like it's tearing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Pain in her left jaw in the hinge area) and ORAL PAIN (she opens her mouth too wide, she gets a sharp pain almost like it's tearing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A, 117B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-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 PAIN IN JAW (Pain in her left jaw in the hinge area) and ORAL PAIN (she opens her mouth too wide, she gets a sharp pain almost like it's tearing). At the time of the report, PAIN IN JAW (Pain in her left jaw in the hinge area) and ORAL PAIN (she opens her mouth too wide, she gets a sharp pain almost like it's tearing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received her first dose (lot 011A21A) of Moderna COVID19 Vaccine on 02Mar2021 and second dose (lot 117B21A) on 30Mar2021. All doses were given in her left deltoid. She did not have this jaw pain after the first two doses.   No concomitant medications or treatment details were reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine past beyond use date administered to a patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine past beyond use date administered to a patient) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine past beyond use date administered to a patient). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine past beyond use date administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter. The reporter stated that a vaccine that expired on 09-NOV-2021 12 hours after it had been punctured and at room temperature. The expired dose was administered at 8:34PM on 10NOV2021 .
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for Vaccination.    No Medical History information was reported.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and first dose of INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (Intramuscular) 1 dosage form. On 30-Oct-2021, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MALAISE (Malaise) and HEADACHE (Headache) to be possibly related.    No treatment medications were provided.   This case was linked to MOD-2021-370320 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLUARIX (GSK, Lot number 379TF, Intramuscular route. Right Deltoid and First dose.).    On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Oct-2021, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MALAISE (Malaise) and HEADACHE (Headache) to be possibly related.    No concomitant and treatment medications were provided   This case was linked to MOD-2021-370174 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was reported.  No treatment medications details were provided.   This case was linked to MOD-2021-370236 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Nov-2021 and was forwarded to Moderna on 09-Nov-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Oct-2021 at 8:00 AM, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MALAISE (Malaise) and HEADACHE (Headache) to be possibly related.    No concomitant products were reported.  No treatment drugs were reported.   This case was linked to MOD-2021-370370 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLUARIX (Route: IM Body Site: Right Deltoid Lot No:379TF).   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable. This case concerns a 42-year-old, female patient, with no relevant medical history, who experienced the non-serious unexpected event of malaise and non-serious expected event of headache. The events occurred  1 day after booster dose of mRNA 1273 vaccine. The rechallenge for third dose is not applicable as no additional dose is expected. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report   This case was linked to MOD-2021-370222 (Patient Link).; Sender's Comments: This case concerns a 42-year-old, female patient, with no relevant medical history, who experienced the non-serious unexpected event of malaise and non-serious expected event of headache. The events occurred  1 day after booster dose of mRNA 1273 vaccine. The rechallenge for third dose is not applicable as no additional dose is expected. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA and FATIGUE in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 028L20A, and 025J02A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN and OCUPLUS for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced PYREXIA and FATIGUE. On 30-Oct-2021, PYREXIA and FATIGUE had resolved. Not Provided          Concomitant medication includes Vitamin, throne ployresveratrol. No treatment medication reported.  Fever and fatigue started on 30-Oct-2021 at 04:30 am.  This case concerns a  73-year-old, female patient with no relevant medical history, who experienced the expected non-serious events of Pyrexia and Fatigue. The events occurred approximately 1 day after the third dose of mRNA-1273 Vaccine. The rechallenge was positive for Pyrexia as this event also occurred after the second dose. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-313006, MOD-2021-313029 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Headache, Vaccination complication
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Malaise) and HEADACHE (Headache) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) injection for an unknown indication.    No Medical History information was reported.   On 29-Oct-2021, the patient started INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (Intramuscular) 1 dosage form. On 29-Oct-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Oct-2021 at 8:00 AM, the patient experienced VACCINATION COMPLICATION (Malaise) and HEADACHE (Headache). At the time of the report, VACCINATION COMPLICATION (Malaise) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION COMPLICATION (Malaise) and HEADACHE (Headache) to be possibly related.    No treatment drugs were reported. No concomitants were reported.   This case was linked to MOD-2021-370379 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2021-370462 (Patient Link).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment medications are provided   This case was linked to MOD-2021-370324 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-370123 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Oct-2021 at 8:00 AM, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MALAISE (Malaise) and HEADACHE (Headache) to be possibly related.    No concomitant medications were provided. No treatment medication were provided.   This case was linked to MOD-2021-370221 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided by the reporter. No treatment information provided.     This case was linked to MOD-2021-370455 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications was reported.   This case was linked to MOD-2021-370033 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE and HEADACHE in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced MALAISE and HEADACHE. At the time of the report, MALAISE  and HEADACHE outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medication was provided. No treatment was provided.   This case was linked to MOD-2021-370195 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes on 09-Nov-2021 the follow up received on 09-NOV-2021 contains No new information.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hyposmia, Pain, Taste disorder, Vaccination complication
Clinical narrative: adverse reactions consistent with both doses; Painful; smell dulled; Sense of taste altered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reactions consistent with both doses), PAIN (Painful), HYPOSMIA (smell dulled) and TASTE DISORDER (Sense of taste altered) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis since 01-Jan-2010, Hay fever, Grass allergy (Itchiness, redness, swelling at exposure site.) since 10-Nov-1961, Diabetes (Pre Diabetes) since 01-Jan-2019, Depression since 01-Dec-2020 and Allergy since 01-Jan-2010. Concomitant products included LORATADINE (CLARITINE) for Allergy, SERTRALINE HYDROCHLORIDE (ZOLOFT) from 01-Dec-2020 to an unknown date for Depression, METFORMIN from 01-Jan-2010 to an unknown date for Diabetes, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) from 02-Feb-2019 to an unknown date for Psoriasis.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-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 VACCINATION COMPLICATION (adverse reactions consistent with both doses), PAIN (Painful), HYPOSMIA (smell dulled) and TASTE DISORDER (Sense of taste altered). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 10-Sep-2021, HYPOSMIA (smell dulled) and TASTE DISORDER (Sense of taste altered) had resolved with sequelae. At the time of the report, VACCINATION COMPLICATION (adverse reactions consistent with both doses) and PAIN (Painful) outcome was unknown.            Treatment information include lot's of fluids and chicken soup. Patient had stated that he never had a reaction to the vaccine before and pharmacist has suggested to go to the ER, but did not seen physician.   This case was linked to MOD-2021-278767 (Patient Link).
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: pain/sore at the injection site; Chill at night; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (pain/sore at the injection site) and CHILLS (Chill at night) in a 96-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced VACCINATION SITE PAIN (pain/sore at the injection site) and CHILLS (Chill at night). On 30-Oct-2021, VACCINATION SITE PAIN (pain/sore at the injection site) and CHILLS (Chill at night) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.  The patient received COVID-19 Vaccine on an unknown deltoid.   Patient had no fever or no fatigue.; Sender's Comments: This case concerns a 96-year-old, male patient, with no relevant medical history, who experienced the non-serious expected events of vaccination site pain and chills which resolved the next day. The events occurred  on the same day after booster dose of mRNA 1273 vaccine. The rechallenge is not applicable as no additional dose is expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain/sore at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (pain/sore at the injection site) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F214) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cholesterol high.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced VACCINATION SITE PAIN (pain/sore at the injection site). On 30-Oct-2021, VACCINATION SITE PAIN (pain/sore at the injection site) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (pain/sore at the injection site) to be possibly related.    Patient received vaccination on Deltoid muscle.  No concomitant and treatment medication was reported.  Company Comment : This case concerns a  94-year-old, male patient with no relevant medical history, who experienced the expected non-serious event of Vaccination site pain. The event occurred on the day of the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the earlier doses were disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a  94-year-old, male patient with no relevant medical history, who experienced the expected non-serious event of Vaccination site pain. The event occurred on the day of the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the earlier doses were disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: pain/sore at the injection site; Fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (pain/sore at the injection site) and FATIGUE (Fatigue) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concurrent medical conditions included Blood pressure increased and High cholesterol.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced VACCINATION SITE PAIN (pain/sore at the injection site) and FATIGUE (Fatigue). On 30-Oct-2021, VACCINATION SITE PAIN (pain/sore at the injection site) and FATIGUE (Fatigue) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (pain/sore at the injection site) and FATIGUE (Fatigue) to be possibly related.    Patient race mentioned,  and anatomical location given as Deltoid. No concomitant medications were provided. No treatment medications were provided
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dysphonia, Inappropriate schedule of product administration, Malaise
Clinical narrative: not feeling well; shakes; felt weak; raspy voice; sore throat; chills; 2nd dose after more than 36 days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), TREMOR (shakes), ASTHENIA (felt weak), DYSPHONIA (raspy voice) and OROPHARYNGEAL PAIN (sore throat) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after more than 36 days). On an unknown date, the patient experienced MALAISE (not feeling well), TREMOR (shakes), ASTHENIA (felt weak), DYSPHONIA (raspy voice), OROPHARYNGEAL PAIN (sore throat) and CHILLS (chills). On 08-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after more than 36 days) had resolved. At the time of the report, MALAISE (not feeling well), TREMOR (shakes), ASTHENIA (felt weak), DYSPHONIA (raspy voice), OROPHARYNGEAL PAIN (sore throat) and CHILLS (chills) outcome was unknown.            No concomitant medication was reported. The treatment information was not reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Tremor
Clinical narrative: not feeling well; shakes; felt weak; raspy voice; sore throat; chills; 2nd dose after more than 36 days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), TREMOR (shakes), ASTHENIA (felt weak), DYSPHONIA (raspy voice) and OROPHARYNGEAL PAIN (sore throat) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after more than 36 days). On an unknown date, the patient experienced MALAISE (not feeling well), TREMOR (shakes), ASTHENIA (felt weak), DYSPHONIA (raspy voice), OROPHARYNGEAL PAIN (sore throat) and CHILLS (chills). On 08-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after more than 36 days) had resolved. At the time of the report, MALAISE (not feeling well), TREMOR (shakes), ASTHENIA (felt weak), DYSPHONIA (raspy voice), OROPHARYNGEAL PAIN (sore throat) and CHILLS (chills) outcome was unknown.            No concomitant medication was reported. The treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment details were provided. The vial was initially stored in the refrigerator on 14Oct2021.  No adverse event was reported by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up received on 12-NOV-2021 contains significant information and updated in the narrative.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test
Clinical narrative: 14 patients administered expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. List of concomitant medication were not given.   This case was linked to MOD-2021-385976 (Patient Link).
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED. At the time of the report, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided.       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 provided by the reporter.   This case was linked to MOD-2021-385972, MOD-2021-385984 (Patient Link).
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test
Clinical narrative: 14 patients administered expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant were reported.  No treatment were reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered to 14 patients; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020. Previously administered products included for an unreported indication: INFLUENZA in September 2021. Concurrent medical conditions included Allergy to antibiotic (Allergy to Sulfa).    On 12-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.; Sender's Comments: This is a spontaneous case of expired product administered for this 83-year-old, male patient with no relevant medical history. No adverse event was reported after administration of the second dose of the Moderna mRNA-1273. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 14 patients) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 14 patients). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 14 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment : This case concerns a 20-year-old, male patient, with no relevant medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after second dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report. No concomitant medication was reported by reporter. No treatment medication was reported by reporter.; Sender's Comments: This case concerns a 20-year-old, male patient, with no relevant medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after second dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered past the 30 use by date expiration; 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 (Dose administered past the 30 use by date expiration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30 use by date expiration). In November 2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30 use by date expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was stated that 3 doses were administered past the 30 day use by date and the number of doses/vials: 2 vials total, 3 doses administered On 04-Oct-2021 at 09.28 am, the vial was initially stored in the refrigerator and on 04-Nov-2021 and 05-Nov-2021, the 3 doses of vaccine were administered. The vaccine did not undergo any temperature excursions.  No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-386462, MOD-2021-378185 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 doses administered past the 30 use by date expiration; 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 (3 doses administered past the 30 use by date expiration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 doses administered past the 30 use by date expiration). In November 2021, EXPIRED PRODUCT ADMINISTERED (3 doses administered past the 30 use by date expiration) 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.   This case was linked to MOD-2021-378185, MOD-2021-386455 (Patient Link).