chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site erythema, Vaccination site pain
Clinical narrative: where she got vaccinated is still red and it hurts/ still has redness in her upper arm where she got third dose; where she got vaccinated is still red and it hurts; headaches; feel tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (where she got vaccinated is still red and it hurts/ still has redness in her upper arm where she got third dose), VACCINATION SITE PAIN (where she got vaccinated is still red and it hurts), HEADACHE (headaches) and FATIGUE (feel tired) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A., 037K20A and 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.   On 26-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) (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 an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (where she got vaccinated is still red and it hurts/ still has redness in her upper arm where she got third dose), VACCINATION SITE PAIN (where she got vaccinated is still red and it hurts), HEADACHE (headaches) and FATIGUE (feel tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (where she got vaccinated is still red and it hurts/ still has redness in her upper arm where she got third dose), VACCINATION SITE PAIN (where she got vaccinated is still red and it hurts), HEADACHE (headaches) and FATIGUE (feel tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional information provided includes that the vaccination site arm is red and hurts. Patient also reported that he had Headache for first two days and then kind of went away.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used/Expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/Expired dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0321B21A, 101M20 and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/Expired dose). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/Expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient received expired vaccines (past manufacture expiration date); Extra dose administered; Inappropriate schedule of vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccines (past manufacture expiration date)), EXTRA DOSE ADMINISTERED (Extra dose administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A, 027A21A and 209K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccines (past manufacture expiration date)), EXTRA DOSE ADMINISTERED (Extra dose administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccines (past manufacture expiration date)), EXTRA DOSE ADMINISTERED (Extra dose administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (fever). At the time of the report, pyrexia (fever) outcome: unknown. No concomitant medication or treatment information reported. Patient experienced no event after first dose. Patient wanted to make very clear the issue was with the third dose, not the second or first ones. This case linked to MOD-2021-324782 (patient link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain, SARS-CoV-2 test
Clinical narrative: pain; chills; aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), CHILLS (chills) and MYALGIA (aches) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No medical history for patient was reported.  Concomitant products included AMLODIPINE BESILATE (NORVASC), SIMVASTATIN, IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (DUONEB), ACETYLSALICYLIC ACID (ASPIRIN) and NAPROXEN for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain), CHILLS (chills) and MYALGIA (aches). At the time of the report, PAIN (pain), CHILLS (chills) and MYALGIA (aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   Treatment information was not provided.  The caller want's to know when he can get the 2nd shot as he got positive COVID result on 1Sep2021 after received the 1st shot on 5Aug2021.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Myalgia, Pain, SARS-CoV-2 test
Clinical narrative: pain; chills; aches; got positive COVID result; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got positive COVID result), CHILLS (chills), MYALGIA (aches) and PAIN (pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included POTASSIUM, COLECALCIFEROL (VIT D3), DICLOFENAC, LETROZOLE, LOSARTAN, GLYBURIDE, SITAGLIPTIN PHOSPHATE (JANUVIA), METFORMIN, CARVEDILOL, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), SUCRALFATE (CARAFATE), ACETYLSALICYLIC ACID (ASPIRIN 81), AMLODIPINE, PROMETHAZINE, FISH OIL, CYANOCOBALAMIN (VITAMIN B12 AAA) and CALCIUM, MAGNESIUM, ZINC (CALCIUM MAGNESIUM ZINC [CALCIUM;MAGNESIUM;ZINC]) for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced COVID-19 (got positive COVID result). On an unknown date, the patient experienced CHILLS (chills), MYALGIA (aches) and PAIN (pain). At the time of the report, COVID-19 (got positive COVID result) had resolved and CHILLS (chills), MYALGIA (aches) and PAIN (pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.; Sender's Comments: This case concerns a 70 year-old, female patient with no relevant medical history, who experienced the non serious unexpected adverse event of special interest of COVID-19. The event occurred approximately 28 days after the first dose of Moderna COVID-19 vaccine. The rechallenge was unknown since the event occurred after the first dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Nausea, Peripheral swelling, Vaccination site pain
Clinical narrative: 3 inch circle at injection site; entire left arm got red; feel hot and has a temp; arm is a little swollen; feels nauseated; sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (3 inch circle at injection site), ERYTHEMA (entire left arm got red), FEELING HOT (feel hot and has a temp), PERIPHERAL SWELLING (arm is a little swollen) and NAUSEA (feels nauseated) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (3 inch circle at injection site), ERYTHEMA (entire left arm got red), FEELING HOT (feel hot and has a temp), PERIPHERAL SWELLING (arm is a little swollen), NAUSEA (feels nauseated) and VACCINATION SITE PAIN (sore at injection site). At the time of the report, VACCINATION SITE REACTION (3 inch circle at injection site), ERYTHEMA (entire left arm got red), FEELING HOT (feel hot and has a temp), PERIPHERAL SWELLING (arm is a little swollen), NAUSEA (feels nauseated) and VACCINATION SITE PAIN (sore at injection site) outcome was unknown.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: 3 inch circle at injection site; entire left arm got red; feel hot and has a temp; arm is a little swollen; feels nauseated; sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (3 inch circle at injection site), ERYTHEMA (entire left arm got red), FEELING HOT (feel hot and has a temp), PERIPHERAL SWELLING (arm is a little swollen) and NAUSEA (feels nauseated) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (3 inch circle at injection site), ERYTHEMA (entire left arm got red), FEELING HOT (feel hot and has a temp), PERIPHERAL SWELLING (arm is a little swollen), NAUSEA (feels nauseated) and VACCINATION SITE PAIN (sore at injection site). At the time of the report, VACCINATION SITE REACTION (3 inch circle at injection site), ERYTHEMA (entire left arm got red), FEELING HOT (feel hot and has a temp), PERIPHERAL SWELLING (arm is a little swollen), NAUSEA (feels nauseated) and VACCINATION SITE PAIN (sore at injection site) outcome was unknown.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Toothache, Vaccination site pain
Clinical narrative: pain in the tooth; swollen face; pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (pain in the tooth), SWELLING FACE (swollen face) and VACCINATION SITE PAIN (pain in the arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A1) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TOOTHACHE (pain in the tooth), SWELLING FACE (swollen face) and VACCINATION SITE PAIN (pain in the arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, TOOTHACHE (pain in the tooth) and SWELLING FACE (swollen face) outcome was unknown and VACCINATION SITE PAIN (pain in the arm) was resolving.        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.   Patient also has problems with a tooth. It hurts; but stated that tooth has been bothering patient from before vaccination and after first dose ate something hard which caused pain and swollen face.Patient took Tylenol to treat symptoms and pain started to fade away Patient was taking  antibiotics for the tooth situation
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of Moderna vaccine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Medical history was not provided.     On 27-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non-significant follow-up On 28-Sep-2021: Significant follow-up-Expiry date updated
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Rash; High Fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and PYREXIA (High Fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and PYREXIA (High Fever). At the time of the report, RASH (Rash) and PYREXIA (High Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No Treatment medications were provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Incorrect dose administered
Clinical narrative: patient was administered an expired dose of Moderna vaccine; second dose received on day 40; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of Moderna vaccine) and INCORRECT DOSE ADMINISTERED (second dose received on day 40) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of Moderna vaccine) and INCORRECT DOSE ADMINISTERED (second dose received on day 40). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of Moderna vaccine) and INCORRECT DOSE ADMINISTERED (second dose received on day 40) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   There are no treatment or concomitant medications. There is no previous history given   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: fallow up received  contains New event updated
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) 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 and Treatment medications are not provided.   This case was linked to MOD-2021-334628, MOD-2021-334629.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: fast heart beat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Sep-2021 and was forwarded to Moderna on 28-Sep-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of HEART RATE INCREASED (fast heart beat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21) for COVID-19 vaccination.     Concurrent medical conditions included Tetanus allergy. Concomitant products included CLONIDINE, CARVEDILOL and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, the patient experienced HEART RATE INCREASED (fast heart beat). At the time of the report, HEART RATE INCREASED (fast heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Thrombosis after both doses of Moderna COVID-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS (Thrombosis after both doses of Moderna COVID-19 vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hyperlipidemia.    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 THROMBOSIS (Thrombosis after both doses of Moderna COVID-19 vaccine) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Thrombosis after both doses of Moderna COVID-19 vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided.  Company comment -This case concerns a 65 year old male patient with medical history of Hypertension and Hyperlipidemia, who experienced the unexpected serious event of THROMBOSIS (Thrombosis after both doses of Moderna COVID-19 vaccine), within unknown days after the dose of mRNA-1273 vaccine.  Limited information regarding the event have been provided at this time.  Rechallenge is not applicable. The benefit-risk relationship of the vaccine is not affected by this report.   This case was linked to MOD-2021-334636 (Patient Link).; Sender's Comments: This case concerns a 65 year old male patient with medical history of Hypertension and Hyperlipidemia, who experienced the unexpected serious event of THROMBOSIS (Thrombosis after both doses of Moderna COVID-19 vaccine), within unknown days after the dose of mRNA-1273 vaccine.  Limited information regarding the event have been provided at this time.  Rechallenge is not applicable. The benefit-risk relationship of the vaccine is not affected by this report.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very little sore arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very little sore arm after first dose) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Very little sore arm after first dose). At the time of the report, PAIN IN EXTREMITY (Very little sore arm after first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was not on concomitant medication.  Treatment information was not provided by reporter.   This case was linked to MOD-2021-328618 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A, 020M21A and LOT 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: Swollen lymph node under the armpit of the same arm of the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node under the armpit of the same arm of the shot) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 023M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node under the armpit of the same arm of the shot). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node under the armpit of the same arm of the shot) outcome was unknown.            Patient received third dose due to underlying issues. Patient spoke with doctor and he advised to give it two weeks. Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-334583, MOD-2021-334629 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-334628, MOD-2021-334583 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Three (3) people drying after receiving the second dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Three (3) people drying after receiving the second dose of the Moderna vaccine) 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.     Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment - This case concerns a female patient of an unknown age  with no relevant medical history reported, who experienced serious unexpected event of death. The patient died on an unknown date after the second dose of mRNA-1273 (vaccination date was not reported). The cause of death was not reported. It is unknown if an autopsy was performed. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age  with no relevant medical history reported, who experienced serious unexpected event of death. The patient died on an unknown date after the second dose of mRNA-1273 (vaccination date was not reported). The cause of death was not reported. It is unknown if an autopsy was performed. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: thrombosis after both doses of Moderna COVID-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS (thrombosis after both doses of Moderna COVID-19 vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hyperlipidemia.   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 2021, the patient experienced THROMBOSIS (thrombosis after both doses of Moderna COVID-19 vaccine) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (thrombosis after both doses of Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Physician stated that she did a literature search and found one case report from June from 29-Jun-2021 where the patient developed thrombosis after receiving both doses of the Moderna COVID-19 vaccine.  No treatment information provided.  Company Comment: This case concerns a 65-year-old male patient with relevant medical history of Hypertension and Hyperlipidemia , who experienced the unexpected serious event of Thrombosis.The event occurred unknown days after the first and second dose of Spikevax. The rechallenge is unknown since there's no information about the doses.  The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-334622 (Patient Link).; Sender's Comments: This case concerns a 65-year-old male patient with relevant medical history of Hypertension and Hyperlipidemia , who experienced the unexpected serious event of Thrombosis.The event occurred unknown days after the first and second dose of Spikevax. The rechallenge is unknown since there's no information about the doses.  The benefit-risk relationship of Spikevax is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Vaccination site bruising, Vaccination site pain
Clinical narrative: Felt foggy in the head; Vaccintation site pain; Vaccination site bruising; tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt foggy in the head), VACCINATION SITE PAIN (Vaccintation site pain), VACCINATION SITE BRUISING (Vaccination site bruising) and FATIGUE (tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt foggy in the head), VACCINATION SITE PAIN (Vaccintation site pain), VACCINATION SITE BRUISING (Vaccination site bruising) and FATIGUE (tired). At the time of the report, FEELING ABNORMAL (Felt foggy in the head) and FATIGUE (tired) outcome was unknown and VACCINATION SITE PAIN (Vaccintation site pain) and VACCINATION SITE BRUISING (Vaccination site bruising) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: The follow up document contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: I think I injected some people today with some moderna vaccines that were from a vial that was punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I think I injected some people today with some moderna vaccines that were from a vial that was punctured more than 12 hours ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (I think I injected some people today with some moderna vaccines that were from a vial that was punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I think I injected some people today with some moderna vaccines that were from a vial that was punctured more than 12 hours ago) 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 provided
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 013A21A and 030M20A) for COVID-19 vaccination. Concurrent medical conditions included HIV infection since 1996. On Feb 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 25, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 27, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (sore arm). At the time of the report, pain in extremity (sore arm) outcome: unknown. No concomitant drug details or treatment information reported. This case linked to MOD-2021-073142, MOD-2021-073169 (patient link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Fatigue, Feeling abnormal, Impaired work ability
Clinical narrative: Has not been able to work; Extreme brain fog; Extreme hair loss, Hair loss is continuing through today; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (Has not been able to work), FEELING ABNORMAL (Extreme brain fog), ALOPECIA (Extreme hair loss, Hair loss is continuing through today) and FATIGUE (Extreme fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMPAIRED WORK ABILITY (Has not been able to work), FEELING ABNORMAL (Extreme brain fog), ALOPECIA (Extreme hair loss, Hair loss is continuing through today) and FATIGUE (Extreme fatigue). At the time of the report, IMPAIRED WORK ABILITY (Has not been able to work), FEELING ABNORMAL (Extreme brain fog) and FATIGUE (Extreme fatigue) outcome was unknown and ALOPECIA (Extreme hair loss, Hair loss is continuing through today) had not resolved.            No Concomitant medication was reported. No treatment medications were reported. Patient reported that after second dose she felt extreme fatigue, extreme brain fog, extreme hair loss, reactions were so bad she had to drop out of her studies at school, her doctor may have thought she had a stroke but was not sure. Brought in an ambulance to the ER but not hospitalized.   This case was linked to MOD-2021-334639 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Third dose  24Sep2021; expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose  24Sep2021) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received twelfth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose  24Sep2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose  24Sep2021) outcome was unknown.        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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Feeling abnormal
Clinical narrative: blood pressure was up, at 2 o'clock her BP was 140/98, was down to 123/87 and 124/88; Didn't feel good/felt fuzzy; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (blood pressure was up, at 2 o'clock her BP was 140/98, was down to 123/87 and 124/88) and FEELING ABNORMAL (Didn't feel good/felt fuzzy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051E21A and 020F21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high.   On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (blood pressure was up, at 2 o'clock her BP was 140/98, was down to 123/87 and 124/88) and FEELING ABNORMAL (Didn't feel good/felt fuzzy). At the time of the report, BLOOD PRESSURE FLUCTUATION (blood pressure was up, at 2 o'clock her BP was 140/98, was down to 123/87 and 124/88) and FEELING ABNORMAL (Didn't feel good/felt fuzzy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, Blood pressure measurement: high (High) was up (could not remember the numbers).. On 28-Sep-2021, Blood pressure measurement: 140/98 (High) at 2 o'clock BP was 140/98, 123/87 (High) a little while ago it was down to 123/87 and 124/88 (High) a little while ago it was down to 124/88.         No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Got the third shot and felt the same way: It gave him energy too; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Got the third shot and felt the same way: It gave him energy too) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Got the third shot and felt the same way: It gave him energy too). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Got the third shot and felt the same way: It gave him energy too) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Cough, Dyspnoea, Pulmonary congestion, Vaccination site erythema
Clinical narrative: lungs started filling up; cough; started having trouble breathing; she might be allergic to it; red arm; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (lungs started filling up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD.    On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY CONGESTION (lungs started filling up) (seriousness criterion medically significant), COUGH (cough), DYSPNOEA (started having trouble breathing), ALLERGY TO VACCINE (she might be allergic to it), VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE PAIN (sore arm). At the time of the report, PULMONARY CONGESTION (lungs started filling up), COUGH (cough), DYSPNOEA (started having trouble breathing), ALLERGY TO VACCINE (she might be allergic to it), VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE PAIN (sore arm) 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 considered PULMONARY CONGESTION (lungs started filling up), COUGH (cough), DYSPNOEA (started having trouble breathing), ALLERGY TO VACCINE (she might be allergic to it), VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE PAIN (sore arm) to be possibly related.    No treatment drug information provided.  No concomitant drug information provided.  Company Comment: This case concerns a 66 years old female patient, with reported relevant medical history of Chronic Obstructive Pulmonary Disease, who experienced the serious unexpected event of Pulmonary congestion.The event occurred after the first dose of Spikevax vaccination. The rechallenge was unknown for the events, as only the first dose was administered. The medical history of Chronic Obstructive Pulmonary Disease remains a confounders to the event of Pulmonary congestion. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 66 years old female patient, with reported relevant medical history of Chronic Obstructive Pulmonary Disease, who experienced the serious unexpected event of Pulmonary congestion.The event occurred after the first dose of Spikevax vaccination. The rechallenge was unknown for the events, as only the first dose was administered. The medical history of Chronic Obstructive Pulmonary Disease remains a confounders to the event of Pulmonary congestion. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: lungs started filling up; cough; started having trouble breathing; she might be allergic to it; red arm; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (lungs started filling up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD.    On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY CONGESTION (lungs started filling up) (seriousness criterion medically significant), COUGH (cough), DYSPNOEA (started having trouble breathing), ALLERGY TO VACCINE (she might be allergic to it), VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE PAIN (sore arm). At the time of the report, PULMONARY CONGESTION (lungs started filling up), COUGH (cough), DYSPNOEA (started having trouble breathing), ALLERGY TO VACCINE (she might be allergic to it), VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE PAIN (sore arm) 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 considered PULMONARY CONGESTION (lungs started filling up), COUGH (cough), DYSPNOEA (started having trouble breathing), ALLERGY TO VACCINE (she might be allergic to it), VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE PAIN (sore arm) to be possibly related.    No treatment drug information provided.  No concomitant drug information provided.  Company Comment: This case concerns a 66 years old female patient, with reported relevant medical history of Chronic Obstructive Pulmonary Disease, who experienced the serious unexpected event of Pulmonary congestion.The event occurred after the first dose of Spikevax vaccination. The rechallenge was unknown for the events, as only the first dose was administered. The medical history of Chronic Obstructive Pulmonary Disease remains a confounders to the event of Pulmonary congestion. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 66 years old female patient, with reported relevant medical history of Chronic Obstructive Pulmonary Disease, who experienced the serious unexpected event of Pulmonary congestion.The event occurred after the first dose of Spikevax vaccination. The rechallenge was unknown for the events, as only the first dose was administered. The medical history of Chronic Obstructive Pulmonary Disease remains a confounders to the event of Pulmonary congestion. The benefit-risk relationship of Spikevax is not affected by this report.