chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19; The injection site was very sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (The injection site was very sore) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced INJECTION SITE PAIN (The injection site was very sore). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Pain in arm, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (The injection site was very sore) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event(Vaccination site pain).a causal relationship cannot be excluded. However, The event SARS CoV-19 Positive is unlikely related to mRNA.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: pain away from injection site; tiny bump that raised at injection site; arm was a little swollen; arm was red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain away from injection site), VACCINATION SITE URTICARIA (tiny bump that raised at injection site), VACCINATION SITE SWELLING (arm was a little swollen) and VACCINATION SITE ERYTHEMA (arm was red) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no adverse event reported).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN (pain away from injection site), VACCINATION SITE URTICARIA (tiny bump that raised at injection site), VACCINATION SITE SWELLING (arm was a little swollen) and VACCINATION SITE ERYTHEMA (arm was red). At the time of the report, PAIN (pain away from injection site), VACCINATION SITE URTICARIA (tiny bump that raised at injection site), VACCINATION SITE SWELLING (arm was a little swollen) and VACCINATION SITE ERYTHEMA (arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        No treatment information was provided.   No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever; Aching; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Aching) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced PYREXIA (Fever), MYALGIA (Aching) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Fever), MYALGIA (Aching) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itching at the injection site; muscle pain in the legs; redness at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), MYALGIA (muscle pain in the legs), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a female patient of an unknown age 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).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site), MYALGIA (muscle pain in the legs), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site), MYALGIA (muscle pain in the legs), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  concomitant medication were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: injection site was red, raised, hard, and itching; injection site was red, raised, hard, and itching; injection site was red, raised, hard, and itching; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (injection site was red, raised, hard, and itching), VACCINATION SITE PRURITUS (injection site was red, raised, hard, and itching), VACCINATION SITE ERYTHEMA (injection site was red, raised, hard, and itching) and PYREXIA (fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Jan-2021, the patient experienced PYREXIA (fever). On 20-Jan-2021, the patient experienced VACCINATION SITE INDURATION (injection site was red, raised, hard, and itching), VACCINATION SITE PRURITUS (injection site was red, raised, hard, and itching) and VACCINATION SITE ERYTHEMA (injection site was red, raised, hard, and itching). On 15-Jan-2021, PYREXIA (fever) had resolved. At the time of the report, VACCINATION SITE INDURATION (injection site was red, raised, hard, and itching), VACCINATION SITE PRURITUS (injection site was red, raised, hard, and itching) and VACCINATION SITE ERYTHEMA (injection site was red, raised, hard, and itching) 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 product use was unknown by the reporter.   Treatment information was not provided/unknown.
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Myalgia
Clinical narrative: feel like going trough a cold or flu; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feel like going trough a cold or flu) and MYALGIA (sore left arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was  reported.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 19-Jan-2021, the patient experienced FEELING COLD (feel like going trough a cold or flu) and MYALGIA (sore left arm). At the time of the report, FEELING COLD (feel like going trough a cold or flu) and MYALGIA (sore left arm) 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.    Blood pressure medication, diabetes medication, arthritis medication were the Concomitant Products.  Treatment information was not provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site joint swelling, Vaccination site pain, Vaccination site swelling
Clinical narrative: spot has now grown in size to about 5 inches; spot was about an inch in diameter around the injection site; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT SWELLING (spot was about an inch in diameter around the injection site), VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (spot has now grown in size to about 5 inches) in a 33-year-old female patient 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) (Intramuscular) at an unspecified dose. On 06-Jan-2021, the patient experienced VACCINATION SITE JOINT SWELLING (spot was about an inch in diameter around the injection site) and VACCINATION SITE PAIN (pain at the injection site). On an unknown date, the patient experienced VACCINATION SITE SWELLING (spot has now grown in size to about 5 inches). At the time of the report, VACCINATION SITE JOINT SWELLING (spot was about an inch in diameter around the injection site), VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (spot has now grown in size to about 5 inches) outcome was unknown. Not Provided      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 include Corticosteroid injection and azithromycin.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Itchiness at injection site; little bit of a knot at injection site; 1-1.5 inch red circle around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE INDURATION (little bit of a knot at injection site) and VACCINATION SITE ERYTHEMA (1-1.5 inch red circle around injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not provided).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (1-1.5 inch red circle around injection site). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE INDURATION (little bit of a knot at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE INDURATION (little bit of a knot at injection site) and VACCINATION SITE ERYTHEMA (1-1.5 inch red circle around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Treatment for the event included Tylenol, Benadryl, topical ice pack intermittently.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 08-Aug-2020 and the estimated date of delivery was 06-Jun-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma exercise induced (more of a problem in childhood). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 26-Jun-2021. On 29-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 29-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.  The patient's previous pregnancy included a full term birth on an unknown date.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Swelling face
Clinical narrative: Face swelling; Chills; 99.0 degree fever; A spontaneous report was received from a consumer, concerning his mother, a 91-year- old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, 99.0-degree fever and face swelling.  The patient medical history included high blood pressure. The concomitant medications reported included lisinopril, metoprolol 50 mg and diltiazem hydrochloride for high blood pressure.  On 15-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013620A) via unknown route for prophylaxis of COVID-19 infection.  On 15-Jan-2021, after the vaccination, the patient experienced events chills and a 99.0-degree fever that night and the next day on 16-Jan-2021, the patient experienced face swelling. Treatment for the events included loratadine.  Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the events chills, pyrexia and swelling of face was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: hypersensitivity reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of   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.        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 product use was not provided.  Treatment information was not provided.  Very limited information regarding the event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding the event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breast feeding) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Breast feeding). At the time of the report, EXPOSURE VIA BREAST MILK (Breast feeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Eye pain, Headache, Myalgia
Clinical narrative: experienced som e dizziness; eyes ache; body aches; vomiting; diarrhea; arm was sore; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore), HEADACHE (headache), VOMITING (vomiting), DIARRHOEA (diarrhea) and DIZZINESS (experienced som e dizziness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Irritable stomach (Felt bad on stomach after taking Tylenol as treatment drug.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was sore) and HEADACHE (headache). On 17-Jan-2021, the patient experienced VOMITING (vomiting) and DIARRHOEA (diarrhea). On an unknown date, the patient experienced DIZZINESS (experienced som e dizziness), EYE PAIN (eyes ache) and MYALGIA (body aches). At the time of the report, VACCINATION SITE PAIN (arm was sore), HEADACHE (headache), VOMITING (vomiting), DIARRHOEA (diarrhea), DIZZINESS (experienced som e dizziness), EYE PAIN (eyes ache) and MYALGIA (body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: experienced som e dizziness; eyes ache; body aches; vomiting; diarrhea; arm was sore; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore), HEADACHE (headache), VOMITING (vomiting), DIARRHOEA (diarrhea) and DIZZINESS (experienced som e dizziness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Irritable stomach (Felt bad on stomach after taking Tylenol as treatment drug.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was sore) and HEADACHE (headache). On 17-Jan-2021, the patient experienced VOMITING (vomiting) and DIARRHOEA (diarrhea). On an unknown date, the patient experienced DIZZINESS (experienced som e dizziness), EYE PAIN (eyes ache) and MYALGIA (body aches). At the time of the report, VACCINATION SITE PAIN (arm was sore), HEADACHE (headache), VOMITING (vomiting), DIARRHOEA (diarrhea), DIZZINESS (experienced som e dizziness), EYE PAIN (eyes ache) and MYALGIA (body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia, Tinnitus
Clinical narrative: stabbing pains; ringing noise in her ears; chills; Nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (stabbing pains), TINNITUS (ringing noise in her ears), CHILLS (chills), NAUSEA (Nausea) and PYREXIA (fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 702195-013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN (stabbing pains), TINNITUS (ringing noise in her ears), CHILLS (chills), NAUSEA (Nausea) and PYREXIA (fever). On 17-Jan-2021, PAIN (stabbing pains), TINNITUS (ringing noise in her ears), CHILLS (chills), NAUSEA (Nausea) and PYREXIA (fever) 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.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swelling) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (no historical condition was reported.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swelling). At the time of the report, INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Diarrhea; Extreme Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and FATIGUE (Extreme Tiredness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and FATIGUE (Extreme Tiredness). On 21-Jan-2021, FATIGUE (Extreme Tiredness) had resolved. At the time of the report, DIARRHOEA (Diarrhea) had not 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: arm pain; Felling achy and her body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felling achy and her body aches) and VACCINATION SITE PAIN (arm pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and MULTIVITAMINS, PLAIN for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN (Felling achy and her body aches). On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm pain). At the time of the report, PAIN (Felling achy and her body aches) and VACCINATION SITE PAIN (arm pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) 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 and treatment medications were not reported.   Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Neck pain
Clinical narrative: neck pain; shoulder pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), ARTHRALGIA (shoulder pain) and HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B120-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced NECK PAIN (neck pain), ARTHRALGIA (shoulder pain) and HEADACHE (headache). On 18-Jan-2021, NECK PAIN (neck pain), ARTHRALGIA (shoulder pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash
Clinical narrative: tired; mild rash under chin and right side of neck; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) and RASH (mild rash under chin and right side of neck) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced FATIGUE (tired) and RASH (mild rash under chin and right side of neck). At the time of the report, FATIGUE (tired) and RASH (mild rash under chin and right side of neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Vaccine given to 1 breastfeeding woman; This spontaneous case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Vaccine given to 1 breastfeeding woman) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Vaccine given to 1 breastfeeding woman). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Vaccine given to 1 breastfeeding woman) 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.   N concomitant medications and treatment medications reported.   This case was linked to MOD-2021-009950 (Patient Link).; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Rash, Throat tightness
Clinical narrative: tightness of throat; Rash on her chest; This spontaneous case was reported by a health care professional and describes the occurrence of THROAT TIGHTNESS (tightness of throat) and RASH (Rash on her chest) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergies with anaphylaxis to Bee), Drug allergy (sodium nitrate) and Drug allergy (sulfa).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced THROAT TIGHTNESS (tightness of throat) and RASH (Rash on her chest). At the time of the report, THROAT TIGHTNESS (tightness of throat) and RASH (Rash on her chest) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 157 Blood pressure 157 sats 97. On an unknown date, Heart rate: 104.     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.
Sex: F
Vaccine: COVID19
Symptoms: Eyelid sensory disorder, Hypoaesthesia
Clinical narrative: slight numbness at her hairline between one ear and the other; moved down to her eyebrow and eyelids; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (slight numbness at her hairline between one ear and the other) and EYELID SENSORY DISORDER (moved down to her eyebrow and eyelids) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L020A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (it's under control).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (slight numbness at her hairline between one ear and the other) and EYELID SENSORY DISORDER (moved down to her eyebrow and eyelids). At the time of the report, HYPOAESTHESIA (slight numbness at her hairline between one ear and the other) and EYELID SENSORY DISORDER (moved down to her eyebrow and eyelids) 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.
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Hypoacusis
Clinical narrative: some pressure in her unspecified ear; partial loss of hearing; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (some pressure in her unspecified ear) and HYPOACUSIS (partial loss of hearing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced EAR DISCOMFORT (some pressure in her unspecified ear) and HYPOACUSIS (partial loss of hearing). In January 2021, EAR DISCOMFORT (some pressure in her unspecified ear) and HYPOACUSIS (partial loss of hearing) 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.   Acetaminophen (TYLENOL) was reported as treatment medication.
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: Jaw is hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Jaw is hurting) in a male patient of an unknown age 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 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 IN JAW (Jaw is hurting). At the time of the report, PAIN IN JAW (Jaw is hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site urticaria
Clinical narrative: red. with a lump/ welt, warm and itchy at injection site; injection site pain; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE URTICARIA (red. with a lump/ welt, warm and itchy at injection site) and INJECTION SITE PAIN (injection site pain) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025j20-2a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included PRAMIPEXOLE DIHYDROCHLORIDE (MIRAPEX), GABAPENTIN, METFORMIN and VITAMIN B12 [VITAMIN B12 NOS] (VITAMIN B12) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021 at 8:00 AM, the patient experienced INJECTION SITE URTICARIA (red. with a lump/ welt, warm and itchy at injection site) and INJECTION SITE PAIN (injection site pain). At the time of the report, INJECTION SITE URTICARIA (red. with a lump/ welt, warm and itchy at injection site) and INJECTION SITE PAIN (injection site 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.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (Diarrhea) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Traumatic brain injury. Concurrent medical conditions included Dementia and Type 2 diabetes mellitus.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) ongoing since an unknown date for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) 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 relevant concomitant medications were reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history provided).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced ARTHRALGIA (sore arm). On 12-Jan-2021, ARTHRALGIA (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Oropharyngeal pain, Pain
Clinical narrative: Tested positive for COVID-19; sweating; headache; sore throat; fever; sore arm; body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and HYPERHIDROSIS (sweating) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced HYPERHIDROSIS (sweating). On 18-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) outcome was unknown and HYPERHIDROSIS (sweating) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19; sweating; headache; sore throat; fever; sore arm; body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and HYPERHIDROSIS (sweating) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced HYPERHIDROSIS (sweating). On 18-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) outcome was unknown and HYPERHIDROSIS (sweating) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Joint contracture
Clinical narrative: high blood pressure; both hands were contracting; both feet were contracting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure) and JOINT CONTRACTURE (both feet were contracting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported).    On 20-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (high blood pressure) and JOINT CONTRACTURE (both feet were contracting). At the time of the report, HYPERTENSION (high blood pressure) and JOINT CONTRACTURE (both feet were contracting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 188 mmHg high blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Hypotonia, Oxygen saturation, Periorbital swelling
Clinical narrative: periorbital swelling; somnolence; flaccidity; swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIORBITAL SWELLING (periorbital swelling), SOMNOLENCE (somnolence), HYPOTONIA (flaccidity) and SWELLING (swelling) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Food allergy to soy).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PERIORBITAL SWELLING (periorbital swelling), SOMNOLENCE (somnolence), HYPOTONIA (flaccidity) and SWELLING (swelling). At the time of the report, PERIORBITAL SWELLING (periorbital swelling), SOMNOLENCE (somnolence), HYPOTONIA (flaccidity) and SWELLING (swelling) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Blood pressure measurement: 146/91 at 9:50am high, 139/97 at 9:51 am got down from high with the treatment. and 135/88 at 10:03am. On 13-Jan-2021, Heart rate: 115, 128 and 116. On 13-Jan-2021, Oxygen saturation: 100%, 100% and 100%. On 13-Jan-2021, Respiratory rate: 16, 16 and 16.     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 medications were reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate, Somnolence, Swelling
Clinical narrative: periorbital swelling; somnolence; flaccidity; swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIORBITAL SWELLING (periorbital swelling), SOMNOLENCE (somnolence), HYPOTONIA (flaccidity) and SWELLING (swelling) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Food allergy to soy).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PERIORBITAL SWELLING (periorbital swelling), SOMNOLENCE (somnolence), HYPOTONIA (flaccidity) and SWELLING (swelling). At the time of the report, PERIORBITAL SWELLING (periorbital swelling), SOMNOLENCE (somnolence), HYPOTONIA (flaccidity) and SWELLING (swelling) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Blood pressure measurement: 146/91 at 9:50am high, 139/97 at 9:51 am got down from high with the treatment. and 135/88 at 10:03am. On 13-Jan-2021, Heart rate: 115, 128 and 116. On 13-Jan-2021, Oxygen saturation: 100%, 100% and 100%. On 13-Jan-2021, Respiratory rate: 16, 16 and 16.     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 medications were reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Tremor
Clinical narrative: Uncontrolled shaking; Malaise; Extremely tired; Chills; This spontaneous case was reported by a nurse and describes the occurrence of TREMOR (Uncontrolled shaking), MALAISE (Malaise), FATIGUE (Extremely tired) and CHILLS (Chills) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy, Type 2 diabetes mellitus and Dyslipidemia. Concomitant products included METFORMIN, ROSUVASTATIN CALCIUM (CRESTOR OD) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 19-Jan-2021 at 10:50 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced TREMOR (Uncontrolled shaking), MALAISE (Malaise), FATIGUE (Extremely tired) and CHILLS (Chills). At the time of the report, TREMOR (Uncontrolled shaking), MALAISE (Malaise), FATIGUE (Extremely tired) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.