chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm after first dose; extremely tired after taking 1st dose; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm after first dose) and FATIGUE (extremely tired after taking 1st dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K2DA) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm after first dose) and FATIGUE (extremely tired after taking 1st dose). On 05-Feb-2021, PAIN IN EXTREMITY (sore arm after first dose) and FATIGUE (extremely tired after taking 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received the vaccine at Pharmacy concomitant medications reported were OTC vitamins treatment included good sleep and hot water bottle to sore arm were taken   This case was linked to MOD-2021-350385, MOD-2021-350398 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow up received, contains non significant information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Animal bite
Clinical narrative: Bitten by a dog; This spontaneous case was reported by a consumer and describes the occurrence of ANIMAL BITE (Bitten by a dog) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (ZUBSOLV) for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANIMAL BITE (Bitten by a dog). The patient was treated with TETANUS VACCINE at a dose of booster. At the time of the report, ANIMAL BITE (Bitten by a dog) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included series of antibiotics and tetanus booster.   This case was linked to MOD-2021-350320 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered from a vial greater than 12 hours post-puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered from a vial greater than 12 hours post-puncture) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC) for Birth control.  On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered from a vial greater than 12 hours post-puncture). On 12-Oct-2021, PRODUCT STORAGE ERROR (Vaccine administered from a vial greater than 12 hours post-puncture) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Off label use, Pyrexia
Clinical narrative: pain in the whole body; fever; fatigue; got the 3rd dose thinking it was the booster for her age, because she is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in the whole body), PYREXIA (fever), FATIGUE (fatigue) and OFF LABEL USE (got the 3rd dose thinking it was the booster for her age, because she is not immunocompromised) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A, 023M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced MYALGIA (pain in the whole body), PYREXIA (fever), FATIGUE (fatigue) and OFF LABEL USE (got the 3rd dose thinking it was the booster for her age, because she is not immunocompromised). On 23-Sep-2021, OFF LABEL USE (got the 3rd dose thinking it was the booster for her age, because she is not immunocompromised) had resolved. At the time of the report, MYALGIA (pain in the whole body), PYREXIA (fever) and FATIGUE (fatigue) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter.  No Treatment Information was provided by the reporter.   This case was linked to MOD-2021-350396 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Severe itching on her left arm at injection site down to her elbow 24 hours a day. It had gotten worse.; Redness on her left arm at injection site down to her elbow 24 hours a day.  It had gotten worse.; 2nd dose-25 Feb 2021 and 3rd dose-09 oct 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose-25 Feb 2021 and 3rd dose-09 oct 2021), VACCINATION SITE PRURITUS (Severe itching on her left arm at injection site down to her elbow 24 hours a day. It had gotten worse.) and VACCINATION SITE ERYTHEMA (Redness on her left arm at injection site down to her elbow 24 hours a day.  It had gotten worse.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose-25 Feb 2021 and 3rd dose-09 oct 2021). On 10-Oct-2021, the patient experienced VACCINATION SITE PRURITUS (Severe itching on her left arm at injection site down to her elbow 24 hours a day. It had gotten worse.) and VACCINATION SITE ERYTHEMA (Redness on her left arm at injection site down to her elbow 24 hours a day.  It had gotten worse.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form; AVENA SATIVA FLUID EXTRACT  at a dose of 1 dosage form and CORTISONE at a dose of 1 dosage form. On 09-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose-25 Feb 2021 and 3rd dose-09 oct 2021) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Severe itching on her left arm at injection site down to her elbow 24 hours a day. It had gotten worse.) and VACCINATION SITE ERYTHEMA (Redness on her left arm at injection site down to her elbow 24 hours a day.  It had gotten worse.) outcome was unknown.            No concomitant medication was provided.      Treatment medication include  Non-drugs treatment Icepacks   This case was linked to MOD-2021-350376, MOD-2021-350425 .
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Headache, Muscular weakness, Vaccination complication
Clinical narrative: I could hardly stand; my body didn't feel right; legs were wobbly; head was achy; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (I could hardly stand), VACCINATION COMPLICATION (my body didn't feel right), MUSCULAR WEAKNESS (legs were wobbly) and HEADACHE (head was achy) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced DYSSTASIA (I could hardly stand), VACCINATION COMPLICATION (my body didn't feel right), MUSCULAR WEAKNESS (legs were wobbly) and HEADACHE (head was achy). On 28-Feb-2021, DYSSTASIA (I could hardly stand), VACCINATION COMPLICATION (my body didn't feel right), MUSCULAR WEAKNESS (legs were wobbly) and HEADACHE (head was achy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included vitamins, minerals and eye drops.  Patient reported losing her hair and eyesight. However, she said all that has been happening since before receiving the vaccine, and due to her old age.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve prolapse. Concurrent medical conditions included Blood pressure high.    On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication used were Beta Blocker For HBP and another medicine for Mitral valve prolapse  No treatment details were reported.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Had received their second dose of the Moderna covid-19 vaccine after the dose had passed the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Had received their second dose of the Moderna covid-19 vaccine after the dose had passed the published expiration date) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 (Had received their second dose of the Moderna covid-19 vaccine after the dose had passed the published expiration date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Had received their second dose of the Moderna covid-19 vaccine after the dose had passed the published expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 12 hours out of expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 hours out of expiration) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 hours out of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 hours out of expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-350532 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: expired dose; Inappropriate schedule of vaccine administered/ He received his second dose on 03-Feb-2021 and third dose on 12-Oct-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered/ He received his second dose on 03-Feb-2021 and third dose on 12-Oct-2021) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A, 013M20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered/ He received his second dose on 03-Feb-2021 and third dose on 12-Oct-2021). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered/ He received his second dose on 03-Feb-2021 and third dose on 12-Oct-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-350294, MOD-2021-350297, MOD-2021-350305, MOD-2021-350432, MOD-2021-350584 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Headache, Hot flush
Clinical narrative: hot flashes; body aches,; nausea at work; little bit of chills (no fever); stomach ache; she had an in and out headache; felt half decent,; she felt dizzy; her arm hurt a little bit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt half decent,), DIZZINESS (she felt dizzy), PAIN IN EXTREMITY (her arm hurt a little bit), HOT FLUSH (hot flashes) and ABDOMINAL PAIN UPPER (stomach ache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE, PANTOPRAZOLE and IBUPROFEN for an unknown indication.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced VACCINATION COMPLICATION (felt half decent,), DIZZINESS (she felt dizzy) and PAIN IN EXTREMITY (her arm hurt a little bit). On 10-Oct-2021, the patient experienced HEADACHE (she had an in and out headache). On 11-Oct-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), NAUSEA (nausea at work) and CHILLS (little bit of chills (no fever)). On 12-Oct-2021, the patient experienced HOT FLUSH (hot flashes) and MYALGIA (body aches,). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (felt half decent,), DIZZINESS (she felt dizzy), PAIN IN EXTREMITY (her arm hurt a little bit), HOT FLUSH (hot flashes), ABDOMINAL PAIN UPPER (stomach ache), HEADACHE (she had an in and out headache), NAUSEA (nausea at work), CHILLS (little bit of chills (no fever)) and MYALGIA (body aches,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Vaccination complication
Clinical narrative: hot flashes; body aches,; nausea at work; little bit of chills (no fever); stomach ache; she had an in and out headache; felt half decent,; she felt dizzy; her arm hurt a little bit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt half decent,), DIZZINESS (she felt dizzy), PAIN IN EXTREMITY (her arm hurt a little bit), HOT FLUSH (hot flashes) and ABDOMINAL PAIN UPPER (stomach ache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE, PANTOPRAZOLE and IBUPROFEN for an unknown indication.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced VACCINATION COMPLICATION (felt half decent,), DIZZINESS (she felt dizzy) and PAIN IN EXTREMITY (her arm hurt a little bit). On 10-Oct-2021, the patient experienced HEADACHE (she had an in and out headache). On 11-Oct-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), NAUSEA (nausea at work) and CHILLS (little bit of chills (no fever)). On 12-Oct-2021, the patient experienced HOT FLUSH (hot flashes) and MYALGIA (body aches,). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (felt half decent,), DIZZINESS (she felt dizzy), PAIN IN EXTREMITY (her arm hurt a little bit), HOT FLUSH (hot flashes), ABDOMINAL PAIN UPPER (stomach ache), HEADACHE (she had an in and out headache), NAUSEA (nausea at work), CHILLS (little bit of chills (no fever)) and MYALGIA (body aches,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Impaired driving ability, Somnolence
Clinical narrative: Even more confused; Very drowzy,patient is falling asleep while driving; Patient is having trouble with driving; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Even more confused), SOMNOLENCE (Very drowzy,patient is falling asleep while driving) and IMPAIRED DRIVING ABILITY (Patient is having trouble with driving) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 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 CONFUSIONAL STATE (Even more confused), SOMNOLENCE (Very drowzy,patient is falling asleep while driving) and IMPAIRED DRIVING ABILITY (Patient is having trouble with driving). At the time of the report, CONFUSIONAL STATE (Even more confused), SOMNOLENCE (Very drowsy, patient is falling asleep while driving) and IMPAIRED DRIVING ABILITY (Patient is having trouble with driving) outcome was unknown.            No treatment medication was reported.   This case was linked to MOD-2021-340945 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: developed a severe adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (developed a severe adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced VACCINATION COMPLICATION (developed a severe adverse reaction). At the time of the report, VACCINATION COMPLICATION (developed a severe adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.  On October 07 2021, Patient received the first shot of the Moderna COVID-19 vaccination series. After 10 to 15 minutes, patient developed a severe adverse reaction and was transferred to the Emergency department  via ambulance.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: burning sensation in his arm and shooting up his neck; This spontaneous case was reported by a pharmacist and describes the occurrence of BURNING SENSATION (burning sensation in his arm and shooting up his neck) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (burning sensation in his arm and shooting up his neck). At the time of the report, BURNING SENSATION (burning sensation in his arm and shooting up his neck) 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.   Concomitant medications were not provided.  Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included AMLODIPINE, ATORVASTATIN, BACLOFEN, CITALOPRAM, CLONAZEPAM, MAGNESIUM, PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (MIRAPEX), LOPERAMIDE HYDROCHLORIDE (IMODIUM) and VITAMIN D NOS for an unknown indication.    On 12-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  Symptoms: The patient did not experienced any symptoms, The medical assistant confirmed that only one patient received expired dose and the vial was initially stored in the refrigerator on 13-Sep-2021 and it did not went under any temperature excursions.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        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: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported.  On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant drug details were reported. No treatment details were reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date.). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was unknown. It was reported that the vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna COVID-19 vaccine was administered to patients past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.  The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Treatment information was not provided
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna COVID-19 vaccine was administered to patients past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) in a 98-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.  The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna COVID-19 vaccine was administered to patients past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions  Concomitant medication use was unknown Treatment information was unknown
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.   The vials were stored in the freezer and taken out of the freezer and placed on the date of administration.   The vials did not undergo any temperature excursions.  No treatment medications were provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications are provided by the reporter.  The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Intermenstrual bleeding, Menstrual disorder, Menstruation delayed, Myalgia
Clinical narrative: I have been having two weeks of persistent abnormal bleeding, This abnormal bleeding began September 14, stopped after 3 days then began again; itchiness; I skipped a cycle in August; Clotty kind of blood, which is abnormal than my regular period; I had fever after both shots, 102 degrees fahrenheit at first dose, and 101fahrenheit after second dose; I had chills; muscle ache; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (I have been having two weeks of persistent abnormal bleeding, This abnormal bleeding began September 14, stopped after 3 days then began again), PRURITUS (itchiness), MENSTRUATION DELAYED (I skipped a cycle in August), INTERMENSTRUAL BLEEDING (Clotty kind of blood, which is abnormal than my regular period) and PYREXIA (I had fever after both shots, 102 degrees fahrenheit at first dose, and 101fahrenheit after second dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (I have been having two weeks of persistent abnormal bleeding, This abnormal bleeding began September 14, stopped after 3 days then began again), PRURITUS (itchiness), MENSTRUATION DELAYED (I skipped a cycle in August), INTERMENSTRUAL BLEEDING (Clotty kind of blood, which is abnormal than my regular period), PYREXIA (I had fever after both shots, 102 degrees fahrenheit at first dose, and 101fahrenheit after second dose), CHILLS (I had chills), MYALGIA (muscle ache) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, MENSTRUAL DISORDER (I have been having two weeks of persistent abnormal bleeding, This abnormal bleeding began September 14, stopped after 3 days then began again), MENSTRUATION DELAYED (I skipped a cycle in August) and INTERMENSTRUAL BLEEDING (Clotty kind of blood, which is abnormal than my regular period) had not resolved and PRURITUS (itchiness), PYREXIA (I had fever after both shots, 102 degrees fahrenheit at first dose, and 101fahrenheit after second dose), CHILLS (I had chills), MYALGIA (muscle ache) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.            No concomitant product was reported. Treatment information was not provided.   This case was linked to MOD-2021-351211 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Vaccination site pain
Clinical narrative: I have been having two weeks of persistent abnormal bleeding, This abnormal bleeding began September 14, stopped after 3 days then began again; itchiness; I skipped a cycle in August; Clotty kind of blood, which is abnormal than my regular period; I had fever after both shots, 102 degrees fahrenheit at first dose, and 101fahrenheit after second dose; I had chills; muscle ache; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (I have been having two weeks of persistent abnormal bleeding, This abnormal bleeding began September 14, stopped after 3 days then began again), PRURITUS (itchiness), MENSTRUATION DELAYED (I skipped a cycle in August), INTERMENSTRUAL BLEEDING (Clotty kind of blood, which is abnormal than my regular period) and PYREXIA (I had fever after both shots, 102 degrees fahrenheit at first dose, and 101fahrenheit after second dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (I have been having two weeks of persistent abnormal bleeding, This abnormal bleeding began September 14, stopped after 3 days then began again), PRURITUS (itchiness), MENSTRUATION DELAYED (I skipped a cycle in August), INTERMENSTRUAL BLEEDING (Clotty kind of blood, which is abnormal than my regular period), PYREXIA (I had fever after both shots, 102 degrees fahrenheit at first dose, and 101fahrenheit after second dose), CHILLS (I had chills), MYALGIA (muscle ache) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, MENSTRUAL DISORDER (I have been having two weeks of persistent abnormal bleeding, This abnormal bleeding began September 14, stopped after 3 days then began again), MENSTRUATION DELAYED (I skipped a cycle in August) and INTERMENSTRUAL BLEEDING (Clotty kind of blood, which is abnormal than my regular period) had not resolved and PRURITUS (itchiness), PYREXIA (I had fever after both shots, 102 degrees fahrenheit at first dose, and 101fahrenheit after second dose), CHILLS (I had chills), MYALGIA (muscle ache) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.            No concomitant product was reported. Treatment information was not provided.   This case was linked to MOD-2021-351211 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) 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 reported. No treatment reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) 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.   Reporter stated that, It was unknown if the doses were first, second or third doses for the patients. 10 patients were administered the dose on 09Sep2021, 20 patients on 16Sep2021, 11 patients on 30Sep2021, 9 patients on 07Oct2021, 10 patients on 08Oct2021 and 20 patients on 11Oct2021.  No concomitant medications were reported. No treatment medications were provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) 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