chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: I been not feeling good  Since I got vaccines the first time; I felt so tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I been not feeling good  Since I got vaccines the first time) and FATIGUE (I felt so tired) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I been not feeling good  Since I got vaccines the first time) and FATIGUE (I felt so tired). At the time of the report, FEELING ABNORMAL (I been not feeling good  Since I got vaccines the first time) and FATIGUE (I felt so tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: got so bad of the pain that didn't wanted to receive the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (got so bad of the pain that didn't wanted to receive the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (got so bad of the pain that didn't wanted to receive the second dose). At the time of the report, PAIN (got so bad of the pain that didn't wanted to receive the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Her temperature keeps rising over 105 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Her temperature keeps rising over 105 degrees) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Her temperature keeps rising over 105 degrees). At the time of the report, PYREXIA (Her temperature keeps rising over 105 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 105 (High) Fever.         No concomitant medication information given. No treatment information given. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headaches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 82916100) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METHYLPREDNISOLONE (MEDROL DOSEPAK) and BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches) and NAUSEA (nausea). At the time of the report, HEADACHE (headaches) and NAUSEA (nausea) 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.   Treatment information was not provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) in a 26-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered vaccine after 12 hrs of 1st puncture of vial; Then it was put back to refrigerator and then next day on 16JUN2021 it was taken out of refrigerator; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) and PRODUCT STORAGE ERROR (Then it was put back to refrigerator and then next day on 16JUN2021 it was taken out of refrigerator) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) and PRODUCT STORAGE ERROR (Then it was put back to refrigerator and then next day on 16JUN2021 it was taken out of refrigerator). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) and PRODUCT STORAGE ERROR (Then it was put back to refrigerator and then next day on 16JUN2021 it was taken out of refrigerator) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to event was not applicable.  Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Poor quality sleep, Sputum discoloured
Clinical narrative: Started coughing/Felt like an upper respiratory cough/Cough is like a tickle; Woken up out of sleep by the cough; Notice tiny amount of green sputum; This spontaneous case was reported by a nurse and describes the occurrence of COUGH (Started coughing/Felt like an upper respiratory cough/Cough is like a tickle), POOR QUALITY SLEEP (Woken up out of sleep by the cough) and SPUTUM DISCOLOURED (Notice tiny amount of green sputum) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 045821A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN C [ASCORBIC ACID] and ZINC for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced COUGH (Started coughing/Felt like an upper respiratory cough/Cough is like a tickle), POOR QUALITY SLEEP (Woken up out of sleep by the cough) and SPUTUM DISCOLOURED (Notice tiny amount of green sputum). The patient was treated with PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, COUGH (Started coughing/Felt like an upper respiratory cough/Cough is like a tickle), POOR QUALITY SLEEP (Woken up out of sleep by the cough) and SPUTUM DISCOLOURED (Notice tiny amount of green sputum) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA 1273 in response to event was not applicable.  The patient's cough was like a tickle. It comes and goes. She was often woken up out of her sleep by the cough. Patient noticed a tiny amount of green sputum and also stated that she was able to do normal activities such as paddle boarding.  No treatment information was reported.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received pfizer vaccine as the second dose instead of Moderna; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received pfizer vaccine as the second dose instead of Moderna) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received pfizer vaccine as the second dose instead of Moderna). On 17-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient received pfizer vaccine as the second dose instead of Moderna) 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.   Concomitant product details was not reported.  Treatment details was not reported .
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.            No concomitant medications were provided. No treatment details were provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea
Clinical narrative: cough; runny nose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (cough) and RHINORRHOEA (runny nose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cough and Sneezing. Concomitant products included CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE WITH CODEINE) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced COUGH (cough) and RHINORRHOEA (runny nose). The patient was treated with CODEINE PHOSPHATE, GUAIFENESIN, PHENIRAMINE MALEATE (ROBITUSSIN WITH CODEINE) at an unspecified dose and frequency. At the time of the report, COUGH (cough) and RHINORRHOEA (runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic reaction). At the time of the report, ALLERGY TO VACCINE (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No Treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Throat tightness, Vaccination complication
Clinical narrative: Patient is feeling as she puts it very heavy after the 2nd dose; Patient's throat is tightening after the 2nd dose; Patient feels like she's dying after the 2nd dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (Patient is feeling as she puts it very heavy after the 2nd dose), THROAT TIGHTNESS (Patient's throat is tightening after the 2nd dose) and FEELING ABNORMAL (Patient feels like she's dying after the 2nd dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient is feeling as she puts it very heavy after the 2nd dose), THROAT TIGHTNESS (Patient's throat is tightening after the 2nd dose) and FEELING ABNORMAL (Patient feels like she's dying after the 2nd dose). At the time of the report, VACCINATION COMPLICATION (Patient is feeling as she puts it very heavy after the 2nd dose), THROAT TIGHTNESS (Patient's throat is tightening after the 2nd dose) and FEELING ABNORMAL (Patient feels like she's dying after the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna COVID-19 vaccine was administered to a 17 years old female; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine was administered to a 17 years old female) in a 17-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine was administered to a 17 years old female). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine was administered to a 17 years old female) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Nurse asked if this should be reported to a manufacturer as an adverse event, and also stated that she does not have all the information available at this time about patient and the vaccine administration. Consent given for Safety follow-up. Preferred contact method is email  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional dose omission, SARS-CoV-2 antibody test
Clinical narrative: Patient missed her 2nd dose, more than 42 days; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jun-2021 and was forwarded to Moderna on 17-Jun-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of INTENTIONAL DOSE OMISSION (Patient missed her 2nd dose, more than 42 days) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Crohn's disease. Concomitant products included DILTIAZEM (CARDIZEM [DILTIAZEM]), PROBIOTICS NOS, VITAMIN B COMPLEX, TOCOPHEROL (VITAMIN E NATURAL [TOCOPHEROL]) and ADALIMUMAB (HUMIRA) for an unknown indication.    On 11-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 INTENTIONAL DOSE OMISSION (Patient missed her 2nd dose, more than 42 days). At the time of the report, INTENTIONAL DOSE OMISSION (Patient missed her 2nd dose, more than 42 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 antibody 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.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Product dose omission issue, Viral infection, Vomiting
Clinical narrative: only first dose was received; exposed by virus (non COVID) after first shot; Could not drive; dizzy; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only first dose was received), VIRAL INFECTION (exposed by virus (non COVID) after first shot), FEELING ABNORMAL (Could not drive), DIZZINESS (dizzy) and VOMITING (throwing up) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced FEELING ABNORMAL (Could not drive), DIZZINESS (dizzy) and VOMITING (throwing up). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (only first dose was received) and VIRAL INFECTION (exposed by virus (non COVID) after first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only first dose was received), VIRAL INFECTION (exposed by virus (non COVID) after first shot), FEELING ABNORMAL (Could not drive), DIZZINESS (dizzy) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hyperhidrosis, Palpitations, Pyrexia, Vomiting
Clinical narrative: chest pain; breaking out in sweats so bad it looked like water pouring off her face; heart beating out of chest; fever; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), HYPERHIDROSIS (breaking out in sweats so bad it looked like water pouring off her face), PALPITATIONS (heart beating out of chest), PYREXIA (fever) and VOMITING (throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bipolar disorder, Smoker (smokes cigarettes) and Alcoholism.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced CHEST PAIN (chest pain), HYPERHIDROSIS (breaking out in sweats so bad it looked like water pouring off her face), PALPITATIONS (heart beating out of chest), PYREXIA (fever) and VOMITING (throwing up). At the time of the report, CHEST PAIN (chest pain), HYPERHIDROSIS (breaking out in sweats so bad it looked like water pouring off her face), PALPITATIONS (heart beating out of chest), PYREXIA (fever) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received on 20-Jul-2021 and the event heart beating out of chest was added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swollen feet / 2 weeks after the shot, both of her feet started swelling.; Her heels hurt a lot, rated pain as 8 out of 10, 10 being the highest/ sore feet; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen feet / 2 weeks after the shot, both of her feet started swelling.) and PAIN IN EXTREMITY (Her heels hurt a lot, rated pain as 8 out of 10, 10 being the highest/ sore feet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen feet / 2 weeks after the shot, both of her feet started swelling.) and PAIN IN EXTREMITY (Her heels hurt a lot, rated pain as 8 out of 10, 10 being the highest/ sore feet). At the time of the report, PERIPHERAL SWELLING (Swollen feet / 2 weeks after the shot, both of her feet started swelling.) and PAIN IN EXTREMITY (Her heels hurt a lot, rated pain as 8 out of 10, 10 being the highest/ sore feet) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.    This case was linked to MOD-2021-226507 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: No specific follow-up information recorded. On 18-Jun-2021: Significant follow up appended to AER
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigued) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigued). At the time of the report, FATIGUE (Fatigued) outcome was unknown.            No concomitant medications were provided. No treatment details were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: I may have had a reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I may have had a reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (I may have had a reaction). At the time of the report, VACCINATION SITE REACTION (I may have had a reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Testicular pain, Testicular swelling
Clinical narrative: testicular pain; testicular swelling; This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR PAIN (testicular pain) and TESTICULAR SWELLING (testicular swelling) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TESTICULAR PAIN (testicular pain) and TESTICULAR SWELLING (testicular swelling). At the time of the report, TESTICULAR PAIN (testicular pain) and TESTICULAR SWELLING (testicular swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired after the first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jun-2021 and was forwarded to Moderna on 17-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired after the first dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired after the first dose). At the time of the report, FATIGUE (Tired after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported  Treatment details were not provided.   This case was linked to US-irms-MOD21-112442 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm hurt) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031M20A) for COVID-19 immunization. No medical history reported. Concomitant products included Copaxone (glatiramer acetate) for an unknown indication. On Mar 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pain in extremity (arm hurt). At the time of the report, pain in extremity (arm hurt) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No treatment information provided. This case linked to MOD-2021-080162 (patient link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Headache, Paraesthesia, Pyrexia
Clinical narrative: Mucus discharge; Tingling in the arm; Diarrhea; Runny nose; Headache; Throwed up; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (Mucus discharge), PARAESTHESIA (Tingling in the arm), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and BOHD) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-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 SECRETION DISCHARGE (Mucus discharge), PARAESTHESIA (Tingling in the arm), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), HEADACHE (Headache), VOMITING (Throwed up) and PYREXIA (Low grade fever ). At the time of the report, SECRETION DISCHARGE (Mucus discharge), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), HEADACHE (Headache), VOMITING (Throwed up) and PYREXIA (Low grade fever ) outcome was unknown and PARAESTHESIA (Tingling in the arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.2 Fahrenheit.         No concomitant medication was provided by reporter.   No treatment information was provided by reporter.   This case was linked to MOD-2021-090550 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up information received on 10-AUG-2021 contains no significant information. Second dosage regimen added, event outcome updated for tingling and the events were re-arranged from the previous version.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Secretion discharge, Vomiting
Clinical narrative: Mucus discharge; Tingling in the arm; Diarrhea; Runny nose; Headache; Throwed up; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (Mucus discharge), PARAESTHESIA (Tingling in the arm), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and BOHD) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-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 SECRETION DISCHARGE (Mucus discharge), PARAESTHESIA (Tingling in the arm), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), HEADACHE (Headache), VOMITING (Throwed up) and PYREXIA (Low grade fever ). At the time of the report, SECRETION DISCHARGE (Mucus discharge), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), HEADACHE (Headache), VOMITING (Throwed up) and PYREXIA (Low grade fever ) outcome was unknown and PARAESTHESIA (Tingling in the arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.2 Fahrenheit.         No concomitant medication was provided by reporter.   No treatment information was provided by reporter.   This case was linked to MOD-2021-090550 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up information received on 10-AUG-2021 contains no significant information. Second dosage regimen added, event outcome updated for tingling and the events were re-arranged from the previous version.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Viral infection
Clinical narrative: exposed by virus (non COVID) after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (exposed by virus (non COVID) after first shot) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VIRAL INFECTION (exposed by virus (non COVID) after first shot). At the time of the report, VIRAL INFECTION (exposed by virus (non COVID) after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was reported No treatment medications was reported No concomitant medications was reported
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 patients were given vaccine  after 24 hours in a prefilled syringe & 2 other patients given 0.5ml of the vaccine after 26 hours in a prefilled syringe.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients were given vaccine  after 24 hours in a prefilled syringe & 2 other patients given 0.5ml of the vaccine after 26 hours in a prefilled syringe.) 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 (4 patients were given vaccine  after 24 hours in a prefilled syringe & 2 other patients given 0.5ml of the vaccine after 26 hours in a prefilled syringe.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients were given vaccine  after 24 hours in a prefilled syringe & 2 other patients given 0.5ml of the vaccine after 26 hours in a prefilled syringe.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatic pain, Hepatomegaly
Clinical narrative: swollen liver/his liver was swelled up; his liver swelled up and was in pain; This spontaneous case was reported by a consumer and describes the occurrence of HEPATOMEGALY (swollen liver/his liver was swelled up) and HEPATIC PAIN (his liver swelled up and was in pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. W2621A) for COVID-19 vaccination.     Concurrent medical conditions included Hepatitis C. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and SALBUTAMOL (VENTOLINE [SALBUTAMOL]) for COPD and Asthma, GABAPENTIN for Nerve pain, MILK THISTLE [SILYBUM MARIANUM], SIMVASTATIN, DUTASTERIDE, TAMSULOSIN, FERROUS GLUCONATE, BACLOFEN, CETIRIZINE and MONTELUKAST for an unknown indication.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced HEPATOMEGALY (swollen liver/his liver was swelled up) and HEPATIC PAIN (his liver swelled up and was in pain). At the time of the report, HEPATOMEGALY (swollen liver/his liver was swelled up) and HEPATIC PAIN (his liver swelled up and was in pain) 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.   The patient reported that 2 hours after receiving the vaccine, his liver was swollen and he was in pain for 4-5 days. The patient  reported that the symptoms stopped around the 07JUN2021- 08JUN2021.  The patient  reported that he had liver problems for 10-12 years and  he was diagnosed with Hepatitis C. The patient  was told to quit drinking and had to start taking Milk Thistle.    The patient reported that he had couple of biopsies done and the last one was good. He  reported that his liver function was fine.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose > 35 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose > 35 days ago) 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 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose > 35 days ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose > 35 days ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication information was reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Myalgia, Pyrexia
Clinical narrative: chills; headache; myalgia; fever; Vaccine 2- 102 days Post BAM protocol; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine 2- 102 days Post BAM protocol), CHILLS (chills), HEADACHE (headache), MYALGIA (myalgia) and PYREXIA (fever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014c21a and 037k20a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 27-Jan-2021.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine 2- 102 days Post BAM protocol). On an unknown date, the patient experienced CHILLS (chills), HEADACHE (headache), MYALGIA (myalgia) and PYREXIA (fever). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine 2- 102 days Post BAM protocol) had resolved and CHILLS (chills), HEADACHE (headache), MYALGIA (myalgia) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not reported.  Treatment information was not reported.   This case was linked to MOD-2021-220827 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Head discomfort, Musculoskeletal discomfort
Clinical narrative: like something stuck in the back of my neck on right side; something stuck in the back of my neck on right side and push through now that side of my head; face feel funny I happen two times 30 seconds apart; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (like something stuck in the back of my neck on right side), HEAD DISCOMFORT (something stuck in the back of my neck on right side and push through now that side of my head) and FEELING ABNORMAL (face feel funny I happen two times 30 seconds apart) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (like something stuck in the back of my neck on right side), HEAD DISCOMFORT (something stuck in the back of my neck on right side and push through now that side of my head) and FEELING ABNORMAL (face feel funny I happen two times 30 seconds apart). At the time of the report, MUSCULOSKELETAL DISCOMFORT (like something stuck in the back of my neck on right side), HEAD DISCOMFORT (something stuck in the back of my neck on right side and push through now that side of my head) and FEELING ABNORMAL (face feel funny I happen two times 30 seconds apart) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the second dose 3 weeks after the first dose instead of 4 weeks; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 3 weeks after the first dose instead of 4 weeks) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 3 weeks after the first dose instead of 4 weeks). On 17-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 3 weeks after the first dose instead of 4 weeks) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Tenderness under the armpits area 4 months later after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness under the armpits area 4 months later after the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Tenderness under the armpits area 4 months later after the second shot). At the time of the report, TENDERNESS (Tenderness under the armpits area 4 months later after the second shot) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dyspepsia, Gastrooesophageal reflux disease, Productive cough
Clinical narrative: heartburn; Productive cough; GERD; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jun-2021 and was forwarded to Moderna on 17-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (heartburn), PRODUCTIVE COUGH (Productive cough) and GASTROOESOPHAGEAL REFLUX DISEASE (GERD) 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-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (heartburn), PRODUCTIVE COUGH (Productive cough) and GASTROOESOPHAGEAL REFLUX DISEASE (GERD). At the time of the report, DYSPEPSIA (heartburn), PRODUCTIVE COUGH (Productive cough) and GASTROOESOPHAGEAL REFLUX DISEASE (GERD) outcome was unknown. Not Provided          No concomitant medications was reported by the reporter.  No treatment medications was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Gingival pain, Taste disorder
Clinical narrative: gums hurt after second shot; tastes blood in the mouth; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (gums hurt after second shot) and TASTE DISORDER (tastes blood in the mouth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GINGIVAL PAIN (gums hurt after second shot) and TASTE DISORDER (tastes blood in the mouth). At the time of the report, GINGIVAL PAIN (gums hurt after second shot) and TASTE DISORDER (tastes blood in the mouth) outcome was unknown.            No concomitant medications were reported. No treatment information was provided by the reporter.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: My whole arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (My whole arm is swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History information 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 PERIPHERAL SWELLING (My whole arm is swollen). At the time of the report, PERIPHERAL SWELLING (My whole arm is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not provided by the reporter. Treatment medication were not provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Felt like I had the worst flu; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jun-2021 and was forwarded to Moderna on 18-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like I had the worst flu) 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 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Felt like I had the worst flu). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like I had the worst flu) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.