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 (Two patients received vaccine past it's beyond use date) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Two patients received vaccine past it's beyond use date). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Two patients received vaccine past it's beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This vaccine was removed from freezer on 8/31/21 and stored in a monitored refrigerator.  By manufacturer guidelines, refrigerator thawed vaccine has a storage life of 30 days (9/29/21).  Concomitant medications was not reported. Treatment medications was not reported.   This case was linked to MOD-2021-374545 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Significant follow up received Patient demographics, Past history and suspect expiry date updated.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Emotional disorder, Fatigue, Pyrexia, Somnolence
Clinical narrative: anxiety; sleeping; emotional; fatigue; high fever of 102 degrees; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxiety), SOMNOLENCE (sleeping), EMOTIONAL DISORDER (emotional), FATIGUE (fatigue) and PYREXIA (high fever of 102 degrees) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 006B21A and 007M20A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, SERTRALINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ANXIETY (anxiety), SOMNOLENCE (sleeping), EMOTIONAL DISORDER (emotional), FATIGUE (fatigue) and PYREXIA (high fever of 102 degrees). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 28-Oct-2021 for Adverse event, at a dose of 5 or 6 Tylenol. At the time of the report, ANXIETY (anxiety), SOMNOLENCE (sleeping), EMOTIONAL DISORDER (emotional), FATIGUE (fatigue) and PYREXIA (high fever of 102 degrees) outcome was unknown.            Patient's concomitant medication includes rheumatoid arthritis weekly shot.   This case was linked to MOD-2021-374981 (Patient Link).   Reporter did not allow further contact
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  It was reported that the patient received Moderna COVID-19 vaccine that was given after the expiration date. The date of administration of vaccine was between 24-Oct-2021 to 27-Oct-2021.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Fatigue, Headache, Hypertension
Clinical narrative: dizziness; blood pressure was still high and always over 90; tiredness; discomfort on the arm; really bad headaches on the back of the head; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HYPERTENSION (blood pressure was still high and always over 90), FATIGUE (tiredness), VACCINATION SITE DISCOMFORT (discomfort on the arm) and HEADACHE (really bad headaches on the back of the head) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003f21a and 014f21a) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced DIZZINESS (dizziness), HYPERTENSION (blood pressure was still high and always over 90), FATIGUE (tiredness), VACCINATION SITE DISCOMFORT (discomfort on the arm) and HEADACHE (really bad headaches on the back of the head). The patient was treated with CLONIDINE HYDROCHLORIDE for Blood pressure high, at a dose of 0.1 mg and PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), HYPERTENSION (blood pressure was still high and always over 90), FATIGUE (tiredness), VACCINATION SITE DISCOMFORT (discomfort on the arm) and HEADACHE (really bad headaches on the back of the head) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 140 (High) Result: Patient mentioned that the blood pressure was still high on the following values 140-150-160 waiving and always over 90, 150 (High) Result: Patient mentioned that the blood pressure was still high on the following values 140-150-160 waiving and always over 90, 160 (High) Result: Patient mentioned that the blood pressure was still high on the following values 140-150-160 waiving and always over 90 and 168/105 (High) High.         Tylenol painkillers helped the patient.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: dizziness; blood pressure was still high and always over 90; tiredness; discomfort on the arm; really bad headaches on the back of the head; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HYPERTENSION (blood pressure was still high and always over 90), FATIGUE (tiredness), VACCINATION SITE DISCOMFORT (discomfort on the arm) and HEADACHE (really bad headaches on the back of the head) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003f21a and 014f21a) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced DIZZINESS (dizziness), HYPERTENSION (blood pressure was still high and always over 90), FATIGUE (tiredness), VACCINATION SITE DISCOMFORT (discomfort on the arm) and HEADACHE (really bad headaches on the back of the head). The patient was treated with CLONIDINE HYDROCHLORIDE for Blood pressure high, at a dose of 0.1 mg and PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), HYPERTENSION (blood pressure was still high and always over 90), FATIGUE (tiredness), VACCINATION SITE DISCOMFORT (discomfort on the arm) and HEADACHE (really bad headaches on the back of the head) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 140 (High) Result: Patient mentioned that the blood pressure was still high on the following values 140-150-160 waiving and always over 90, 150 (High) Result: Patient mentioned that the blood pressure was still high on the following values 140-150-160 waiving and always over 90, 160 (High) Result: Patient mentioned that the blood pressure was still high on the following values 140-150-160 waiving and always over 90 and 168/105 (High) High.         Tylenol painkillers helped the patient.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Head discomfort, Headache, Myalgia, Pain in extremity
Clinical narrative: Felt like being shot; sharp shooting pain in the leg and head; Could barely lift head from bed; hurt all over/ body was hurting all over/everything hurt/felt like muscle pain; hurt all over/ body was hurting all over/everything hurt/felt like muscle pain; Running a fever; Sharp shooting pain in leg and head; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like being shot), PAIN IN EXTREMITY (sharp shooting pain in the leg and head), HEAD DISCOMFORT (Could barely lift head from bed), the first episode of MYALGIA (hurt all over/ body was hurting all over/everything hurt/felt like muscle pain) and the second episode of MYALGIA (hurt all over/ body was hurting all over/everything hurt/felt like muscle pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A and 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021 at 12:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced FEELING ABNORMAL (Felt like being shot), PAIN IN EXTREMITY (sharp shooting pain in the leg and head), HEAD DISCOMFORT (Could barely lift head from bed), the first episode of MYALGIA (hurt all over/ body was hurting all over/everything hurt/felt like muscle pain), the second episode of MYALGIA (hurt all over/ body was hurting all over/everything hurt/felt like muscle pain), PYREXIA (Running a fever) and HEADACHE (Sharp shooting pain in leg and head). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Felt like being shot), PAIN IN EXTREMITY (sharp shooting pain in the leg and head), HEAD DISCOMFORT (Could barely lift head from bed), the last episode of MYALGIA (hurt all over/ body was hurting all over/everything hurt/felt like muscle pain), PYREXIA (Running a fever) and HEADACHE (Sharp shooting pain in leg and head) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. Motrin did not help the patient.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Felt like being shot; sharp shooting pain in the leg and head; Could barely lift head from bed; hurt all over/ body was hurting all over/everything hurt/felt like muscle pain; hurt all over/ body was hurting all over/everything hurt/felt like muscle pain; Running a fever; Sharp shooting pain in leg and head; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like being shot), PAIN IN EXTREMITY (sharp shooting pain in the leg and head), HEAD DISCOMFORT (Could barely lift head from bed), the first episode of MYALGIA (hurt all over/ body was hurting all over/everything hurt/felt like muscle pain) and the second episode of MYALGIA (hurt all over/ body was hurting all over/everything hurt/felt like muscle pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A and 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021 at 12:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced FEELING ABNORMAL (Felt like being shot), PAIN IN EXTREMITY (sharp shooting pain in the leg and head), HEAD DISCOMFORT (Could barely lift head from bed), the first episode of MYALGIA (hurt all over/ body was hurting all over/everything hurt/felt like muscle pain), the second episode of MYALGIA (hurt all over/ body was hurting all over/everything hurt/felt like muscle pain), PYREXIA (Running a fever) and HEADACHE (Sharp shooting pain in leg and head). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Felt like being shot), PAIN IN EXTREMITY (sharp shooting pain in the leg and head), HEAD DISCOMFORT (Could barely lift head from bed), the last episode of MYALGIA (hurt all over/ body was hurting all over/everything hurt/felt like muscle pain), PYREXIA (Running a fever) and HEADACHE (Sharp shooting pain in leg and head) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. Motrin did not help the patient.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. No Treatment medications were not reported
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) 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 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment drugs were provided. Date the vial was initially stored in the refrigerator: 24Sept2021 o*Date(s) of administration of vaccine: 24Oct2021 - 27Oct2021   This case was linked to MOD-2021-374935 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired booster dose given; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired booster dose given) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired booster dose given). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired booster dose given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: Feeling  hot spots on the legs after booster; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling  hot spots on the legs after booster) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 029L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING HOT (Feeling  hot spots on the legs after booster). At the time of the report, FEELING HOT (Feeling  hot spots on the legs after booster) outcome was unknown.            No concomitant medications was reported. No treatment was reported.   This case was linked to MOD-2021-007799, MOD-2021-002376 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache,head hurting really bad, the patient said that has a blinging headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache,head hurting really bad, the patient said that has a blinging headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE (Primary series was Pfizer's with batch number EL9264 Second dose:Lot EN6200) on 04-Feb-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE. Concurrent medical conditions included Migraine (from before the vaccine).    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache,head hurting really bad, the patient said that has a blinging headache). At the time of the report, HEADACHE (headache,head hurting really bad, the patient said that has a blinging headache) outcome was unknown.            No concomitant medications were provided by reporter. No treatment medications were reported.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported. Date of administration of vaccine was 24-Oct-2021 to 27-Oct-2021.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd Dose administered beyond 30-day use; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  It was reported that the date taken out of freezer 08-Sep-2021.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) 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 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Developed alopecia/a lot of hair loss; This spontaneous case was reported by a health care professional and describes the occurrence of ALOPECIA (Developed alopecia/a lot of hair loss) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Diabetes. Concomitant products included METFORMIN and GLIPIZIDE for Diabetes, INFLIXIMAB (REMICADE) and METHOTREXATE for Rheumatoid arthritis.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-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 ALOPECIA (Developed alopecia/a lot of hair loss). At the time of the report, ALOPECIA (Developed alopecia/a lot of hair loss) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that a month after the second dose he began notice a lot of hair loss. Patient  reported the only difference was he had the Moderna vaccine 5-6 months ago. Patient reported not taking any medication as treatment.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Not immunocompromised was administered a third full dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (Not immunocompromised was administered a third full dose of the Moderna COVID-19 vaccine) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 001A20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Not immunocompromised was administered a third full dose of the Moderna COVID-19 vaccine). On 02-Nov-2021, OFF LABEL USE (Not immunocompromised was administered a third full dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.  Till the time of reporting patient did not experience any adverse event.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow-up received on 08 Nov 2021 contains reporter details and route  and time of administration of second dose updated.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Gave 0.5ml third full dose instead of half shot booster.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Nov-2021 and was forwarded to Moderna on 03-Nov-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.). On 02-Nov-2021, ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), 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-2021-374517 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd Dose administered beyond 30-day use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported. No concomitant medication reported. The vail Date taken out of freezer: 9/8/2021
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-19 vaccine that was given after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that was given after the expiration date) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that was given after the expiration date). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that was given after the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   4 vials with 44 doses were initially stored in the refrigerator on 24-Sep-2021 and did not undergo any temperature excursion.  Dosing was done between 24-Oct-2021 - 27-Oct-2021.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment medications were not provided.  It was reported that there were 4 vials (15 dose) 44 doses. The vial was initially stored in the refrigerator on 24-Sep-2021. Vaccine was administered between 24Oct2021 - 27Oct2021. The vials did not undergo any temperature excursions.   This case was linked to MOD-2021-374648, MOD-2021-374935, MOD-2021-374432 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site rash
Clinical narrative: Sore arm; Red rash that lasted one week after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) and VACCINATION SITE RASH (Red rash that lasted one week after 2nd dose) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-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 MYALGIA (Sore arm) and VACCINATION SITE RASH (Red rash that lasted one week after 2nd dose). At the time of the report, MYALGIA (Sore arm) and VACCINATION SITE RASH (Red rash that lasted one week after 2nd dose) outcome was unknown.        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.   This case was linked to MOD-2021-374585 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash in the lower extremity; This spontaneous case was reported by a health care professional and describes the occurrence of RASH (Rash in the lower extremity) 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 RASH (Rash in the lower extremity). At the time of the report, RASH (Rash in the lower extremity) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant or treatment medication reported.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Injection site joint pain, Insomnia, Pain in extremity, Vaccination site mass
Clinical narrative: Right leg pain from foot to hip; He couldn't sleep because of the pain.; He states there's a bump there, but it has gone down some today.; He couldn't stand; He still has pain in the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, INSOMNIA, VACCINATION SITE MASS, DYSSTASIA, and INJECTION SITE JOINT PAIN in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 027L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced PAIN IN EXTREMITY, INSOMNIA, DYSTASIA, and INJECTION SITE JOINT PAIN. 03-Nov-2021, the patient experienced VACCINATION SITE MASS. On 03-Nov-2021, PAIN IN EXTREMITY, INSOMNIA, and VACCINATION SITE MASS had resolved. At the time of the report, DYSTASIA was resolving and INJECTION SITE JOINT PAIN had not resolved.            No concomitant information was reported. No treatment information was reported. Patient date of birth was mentioned like this in source document 20210320 (20-MAR-2021).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported. On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with GABAPENTIN for Shingles, at a dose of 1 dosage form; PREDNISONE for Shingles, at a dose of 1 dosage form and VALACYCLOVIR [VALACICLOVIR] for Shingles, at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.            No concomitant medications were reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Vaccination site pain
Clinical narrative: 30 minutes after 3rd dose felt chest constriction lasting 4 hours, "Like an elephant on chest when you have COVID; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (30 minutes after 3rd dose felt chest constriction lasting 4 hours, "Like an elephant on chest when you have COVID) and VACCINATION SITE PAIN (soreness at injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Anxiety, CYCLOBENZAPRINE for Muscle relaxant, LEVOTHYROXINE and MIRABEGRON (MYRBETRIQ) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 03-Nov-2021, the patient experienced CHEST PAIN (30 minutes after 3rd dose felt chest constriction lasting 4 hours, "Like an elephant on chest when you have COVID) and VACCINATION SITE PAIN (soreness at injection site). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. On 03-Nov-2021, CHEST PAIN (30 minutes after 3rd dose felt chest constriction lasting 4 hours, "Like an elephant on chest when you have COVID) had resolved. At the time of the report, VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.            This case was linked to MOD-2021-374850 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Gave 0.5ml third full dose instead of half shot booster.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.). On 02-Nov-2021, ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported   This case was linked to MOD-2021-374517 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 49 expired doses administered; 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 (49 expired doses administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) 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 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (49 expired doses administered). On 17-Oct-2021, EXPIRED PRODUCT ADMINISTERED (49 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication was provided.  The nurse states that one of their providers continued to use the Moderna COVID-19 Vaccine after  one month beyond-use-date. They wanted to see if they need to re-vaccinate their patients. Forty-nine doses were administered. The lot number was 048F21A. The provider received the vaccine on 17-Sep-2021, so they determined that the expiration date was 17-Oct-2021. They kept administering Moderna COVID19 Vaccine since 17-Oct-2021 through 02-Nov-2021. The patient information is not available.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that Number of doses vials were 4 vials (15 dose) given for 44 patients. and date the vial was initially stored in the refrigerator was 24Sept2021. No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Facility they doesn't swirl the vial after every withdrawal; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Facility they doesn't swirl the vial after every withdrawal) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Facility they doesn't swirl the vial after every withdrawal). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Facility they doesn't swirl the vial after every withdrawal) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided No treatment medication provided   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2021: Follow-up received on 08-NOV-2021 contains no new information
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Fatigue, Headache, Hypokinesia
Clinical narrative: a very big reaction to second shot; loss of balance; brain not operating correctly, the patient couldn't think straight; had trouble getting up and getting to the bathroom  and back and when the patient laid down, the patient might never get up; really extreme fatigue; headache; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a very big reaction to second shot), BALANCE DISORDER (loss of balance), THINKING ABNORMAL (brain not operating correctly, the patient couldn't think straight), HYPOKINESIA (had trouble getting up and getting to the bathroom  and back and when the patient laid down, the patient might never get up) and FATIGUE (really extreme fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Overweight and Blood pressure high.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (a very big reaction to second shot), BALANCE DISORDER (loss of balance), THINKING ABNORMAL (brain not operating correctly, the patient couldn't think straight), HYPOKINESIA (had trouble getting up and getting to the bathroom  and back and when the patient laid down, the patient might never get up), FATIGUE (really extreme fatigue), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills). At the time of the report, VACCINATION COMPLICATION (a very big reaction to second shot), BALANCE DISORDER (loss of balance), THINKING ABNORMAL (brain not operating correctly, the patient couldn't think straight), HYPOKINESIA (had trouble getting up and getting to the bathroom  and back and when the patient laid down, the patient might never get up), FATIGUE (really extreme fatigue), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.            No Concomitant Medications were provided by the reporter.  No Treatment Information were provided by the reporter.  The patient had all the symptoms to the extreme for about 30 hours.   This case was linked to MOD-2021-374058 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Significant Followup received contains updated reporter's Information, updated patient's demographics and new events are added