chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Cough, Wheezing
Clinical narrative: coughing through out the night/coughing up mucus; wheezing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing through out the night/coughing up mucus) and WHEEZING (wheezing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-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 COUGH (coughing through out the night/coughing up mucus) and WHEEZING (wheezing). At the time of the report, COUGH (coughing through out the night/coughing up mucus) and WHEEZING (wheezing) 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.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-162342 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162342:Linked to wife case
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Noticed my covid arm yesterday, had swelling and itching; Noticed my covid arm yesterday, had swelling and itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Noticed my covid arm yesterday, had swelling and itching) and VACCINATION SITE SWELLING (Noticed my covid arm yesterday, had swelling and itching) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002331) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced VACCINATION SITE PRURITUS (Noticed my covid arm yesterday, had swelling and itching) and VACCINATION SITE SWELLING (Noticed my covid arm yesterday, had swelling and itching). At the time of the report, VACCINATION SITE PRURITUS (Noticed my covid arm yesterday, had swelling and itching) and VACCINATION SITE SWELLING (Noticed my covid arm yesterday, had swelling and itching) 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 concomitant medication were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: woke up with a bad headache.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (woke up with a bad headache.) 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 HEADACHE (woke up with a bad headache.). At the time of the report, HEADACHE (woke up with a bad headache.) outcome was unknown.            No concomitant medications and treatment information were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Getting the shot hurts; 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 VACCINATION SITE PAIN (Getting the shot hurts) 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 VACCINATION SITE PAIN (Getting the shot hurts). At the time of the report, VACCINATION SITE PAIN (Getting the shot hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Cancelling 2nd dose appointment today due to stomach pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Medical history not provided by the reporter.  Concomitant products included IBUPROFEN for Pain, COLECALCIFEROL (VITAMIN D3) and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Cancelling 2nd dose appointment today due to stomach pain). The patient was treated with DICYCLOVERINE HYDROCHLORIDE (BENTYL) for Irritable bowel syndrome, at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Cancelling 2nd dose appointment today due to stomach pain) outcome was unknown.            Patient called 21May2021 stating she has chronic stomach pain but states she does not think it is from vaccine 1st dose because she has had this problem for years prior and is calling because she needs to cancel 2nd dose appointment originally scheduled that day  due to the stomach pain.  Concomitant medications include blood pressure pill, anti-depressant pill, heart burn pill   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore shoulder near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore shoulder near injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Injection site pain (Sore shoulder near injection site).    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 VACCINATION SITE PAIN (Sore shoulder near injection site). At the time of the report, VACCINATION SITE PAIN (Sore shoulder near injection site) outcome was unknown.            Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of a bad headache in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# unknown) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date,  patient had a bad headache. At the time of the report, bad headache outcome: unknown. No concomitant medication provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Pain in extremity, Paraesthesia, Vaccination site pain
Clinical narrative: Pain in the whole upper left arm that she couldn't lay on her left side after the 1st dose; Circle of pain around the injection site in her left arm after the 1st dose; Whole face and tongue numb and tingly after the 1st dose; Whole face and tongue numb and tingly after the 1st dose; Whole face and tongue numb and tingly after the 1st dose; whole face tingly; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Circle of pain around the injection site in her left arm after the 1st dose), HYPOAESTHESIA (Whole face and tongue numb and tingly after the 1st dose), HYPOAESTHESIA ORAL (Whole face and tongue numb and tingly after the 1st dose), PARAESTHESIA (Whole face and tongue numb and tingly after the 1st dose) and PARAESTHESIA (whole face tingly) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONAZEPAM, RIVAROXABAN (XARELTO), LITHIUM CARBONATE, PRAZOSIN, LOPERAMIDE, BUPROPION HYDROCHLORIDE (BUPROPION HCL), ATORVASTATIN, ROPINIROLE HYDROCHLORIDE (ROPINIROLE HCL), LISINOPRIL, GABAPENTIN, BACLOFEN, METOPROLOL SUCCINATE and GLYCERYL TRINITRATE (NITROGLYCERIN) for an unknown indication.    On 24-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE PAIN (Circle of pain around the injection site in her left arm after the 1st dose), HYPOAESTHESIA (Whole face and tongue numb and tingly after the 1st dose), HYPOAESTHESIA ORAL (Whole face and tongue numb and tingly after the 1st dose), PARAESTHESIA (Whole face and tongue numb and tingly after the 1st dose) and PARAESTHESIA (whole face tingly). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the whole upper left arm that she couldn't lay on her left side after the 1st dose). On 24-Apr-2021, HYPOAESTHESIA (Whole face and tongue numb and tingly after the 1st dose), HYPOAESTHESIA ORAL (Whole face and tongue numb and tingly after the 1st dose), PARAESTHESIA (Whole face and tongue numb and tingly after the 1st dose) and PARAESTHESIA (whole face tingly) had resolved. On 01-May-2021, VACCINATION SITE PAIN (Circle of pain around the injection site in her left arm after the 1st dose) and PAIN IN EXTREMITY (Pain in the whole upper left arm that she couldn't lay on her left side after the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication has been provided by the reporter. No lab data has been provided by the reporter.   This case was linked to MOD-2021-162400 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Menstruation irregular, Peripheral swelling, Vaccination complication
Clinical narrative: side effects; Five days after the first shot, my arm swelled pretty bad; warm to touch; little bit bruised; week after, my period came early and it lasted for 11 days; large red area; fatigue for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects), PERIPHERAL SWELLING (Five days after the first shot, my arm swelled pretty bad), VACCINATION SITE WARMTH (warm to touch), CONTUSION (little bit bruised) and MENSTRUATION IRREGULAR (week after, my period came early and it lasted for 11 days) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects), PERIPHERAL SWELLING (Five days after the first shot, my arm swelled pretty bad), VACCINATION SITE WARMTH (warm to touch), CONTUSION (little bit bruised), MENSTRUATION IRREGULAR (week after, my period came early and it lasted for 11 days), VACCINATION SITE ERYTHEMA (large red area) and FATIGUE (fatigue for a day or two). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (side effects), PERIPHERAL SWELLING (Five days after the first shot, my arm swelled pretty bad), VACCINATION SITE WARMTH (warm to touch), CONTUSION (little bit bruised), MENSTRUATION IRREGULAR (week after, my period came early and it lasted for 11 days), VACCINATION SITE ERYTHEMA (large red area) and FATIGUE (fatigue for a day or two) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.Treatment medication was not provided
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: side effects; Five days after the first shot, my arm swelled pretty bad; warm to touch; little bit bruised; week after, my period came early and it lasted for 11 days; large red area; fatigue for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects), PERIPHERAL SWELLING (Five days after the first shot, my arm swelled pretty bad), VACCINATION SITE WARMTH (warm to touch), CONTUSION (little bit bruised) and MENSTRUATION IRREGULAR (week after, my period came early and it lasted for 11 days) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects), PERIPHERAL SWELLING (Five days after the first shot, my arm swelled pretty bad), VACCINATION SITE WARMTH (warm to touch), CONTUSION (little bit bruised), MENSTRUATION IRREGULAR (week after, my period came early and it lasted for 11 days), VACCINATION SITE ERYTHEMA (large red area) and FATIGUE (fatigue for a day or two). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (side effects), PERIPHERAL SWELLING (Five days after the first shot, my arm swelled pretty bad), VACCINATION SITE WARMTH (warm to touch), CONTUSION (little bit bruised), MENSTRUATION IRREGULAR (week after, my period came early and it lasted for 11 days), VACCINATION SITE ERYTHEMA (large red area) and FATIGUE (fatigue for a day or two) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.Treatment medication was not provided
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Fatigue
Clinical narrative: Day 3, I had high fever of 101degF for 24 hours; Low grade fever; My headaches were really bad. They're getting better now; really bad nausea; Then I felt tired; chills; body aches; very weak in the evening; had stomach aches every time I eat; got my period again on the 7th day; diarrhea on and off; overall not feeling well.; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (very weak in the evening), ABDOMINAL PAIN UPPER (had stomach aches every time I eat), HEAVY MENSTRUAL BLEEDING (got my period again on the 7th day), DIARRHOEA (diarrhea on and off) and MALAISE (overall not feeling well.) in a 44-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.     No Medical History information was reported.    On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (very weak in the evening), ABDOMINAL PAIN UPPER (had stomach aches every time I eat), HEAVY MENSTRUAL BLEEDING (got my period again on the 7th day), DIARRHOEA (diarrhea on and off), MALAISE (overall not feeling well.), PYREXIA (Day 3, I had high fever of 101degF for 24 hours), NAUSEA (really bad nausea), FATIGUE (Then I felt tired), CHILLS (chills), MYALGIA (body aches), PYREXIA (Low grade fever) and HEADACHE (My headaches were really bad. They're getting better now). At the time of the report, ASTHENIA (very weak in the evening), ABDOMINAL PAIN UPPER (had stomach aches every time I eat), HEAVY MENSTRUAL BLEEDING (got my period again on the 7th day), DIARRHOEA (diarrhea on and off), MALAISE (overall not feeling well.), PYREXIA (Day 3, I had high fever of 101degF for 24 hours), NAUSEA (really bad nausea), FATIGUE (Then I felt tired), CHILLS (chills), MYALGIA (body aches), PYREXIA (Low grade fever) and HEADACHE (My headaches were really bad. They're getting better now) outcome was unknown.            Treatment includes Tylenol. Patient had intestinal issues everytime she had virus. Patient also felt like she was going to pass out.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Malaise, Myalgia, Nausea
Clinical narrative: Day 3, I had high fever of 101degF for 24 hours; Low grade fever; My headaches were really bad. They're getting better now; really bad nausea; Then I felt tired; chills; body aches; very weak in the evening; had stomach aches every time I eat; got my period again on the 7th day; diarrhea on and off; overall not feeling well.; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (very weak in the evening), ABDOMINAL PAIN UPPER (had stomach aches every time I eat), HEAVY MENSTRUAL BLEEDING (got my period again on the 7th day), DIARRHOEA (diarrhea on and off) and MALAISE (overall not feeling well.) in a 44-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.     No Medical History information was reported.    On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (very weak in the evening), ABDOMINAL PAIN UPPER (had stomach aches every time I eat), HEAVY MENSTRUAL BLEEDING (got my period again on the 7th day), DIARRHOEA (diarrhea on and off), MALAISE (overall not feeling well.), PYREXIA (Day 3, I had high fever of 101degF for 24 hours), NAUSEA (really bad nausea), FATIGUE (Then I felt tired), CHILLS (chills), MYALGIA (body aches), PYREXIA (Low grade fever) and HEADACHE (My headaches were really bad. They're getting better now). At the time of the report, ASTHENIA (very weak in the evening), ABDOMINAL PAIN UPPER (had stomach aches every time I eat), HEAVY MENSTRUAL BLEEDING (got my period again on the 7th day), DIARRHOEA (diarrhea on and off), MALAISE (overall not feeling well.), PYREXIA (Day 3, I had high fever of 101degF for 24 hours), NAUSEA (really bad nausea), FATIGUE (Then I felt tired), CHILLS (chills), MYALGIA (body aches), PYREXIA (Low grade fever) and HEADACHE (My headaches were really bad. They're getting better now) outcome was unknown.            Treatment includes Tylenol. Patient had intestinal issues everytime she had virus. Patient also felt like she was going to pass out.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Day 3, I had high fever of 101degF for 24 hours; Low grade fever; My headaches were really bad. They're getting better now; really bad nausea; Then I felt tired; chills; body aches; very weak in the evening; had stomach aches every time I eat; got my period again on the 7th day; diarrhea on and off; overall not feeling well.; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (very weak in the evening), ABDOMINAL PAIN UPPER (had stomach aches every time I eat), HEAVY MENSTRUAL BLEEDING (got my period again on the 7th day), DIARRHOEA (diarrhea on and off) and MALAISE (overall not feeling well.) in a 44-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.     No Medical History information was reported.    On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (very weak in the evening), ABDOMINAL PAIN UPPER (had stomach aches every time I eat), HEAVY MENSTRUAL BLEEDING (got my period again on the 7th day), DIARRHOEA (diarrhea on and off), MALAISE (overall not feeling well.), PYREXIA (Day 3, I had high fever of 101degF for 24 hours), NAUSEA (really bad nausea), FATIGUE (Then I felt tired), CHILLS (chills), MYALGIA (body aches), PYREXIA (Low grade fever) and HEADACHE (My headaches were really bad. They're getting better now). At the time of the report, ASTHENIA (very weak in the evening), ABDOMINAL PAIN UPPER (had stomach aches every time I eat), HEAVY MENSTRUAL BLEEDING (got my period again on the 7th day), DIARRHOEA (diarrhea on and off), MALAISE (overall not feeling well.), PYREXIA (Day 3, I had high fever of 101degF for 24 hours), NAUSEA (really bad nausea), FATIGUE (Then I felt tired), CHILLS (chills), MYALGIA (body aches), PYREXIA (Low grade fever) and HEADACHE (My headaches were really bad. They're getting better now) outcome was unknown.            Treatment includes Tylenol. Patient had intestinal issues everytime she had virus. Patient also felt like she was going to pass out.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives, red spots apppeared; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives, red spots apppeared) in an 86-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives, red spots apppeared). At the time of the report, URTICARIA (Hives, red spots apppeared) outcome was unknown.            Concomitant product details not provided.  Treatment product details not provided.   This case was linked to MOD-2021-162466 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) 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) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) 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 drug was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effect from vaccine; 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 VACCINATION COMPLICATION (Side effect from vaccine) 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 VACCINATION COMPLICATION (Side effect from vaccine). At the time of the report, VACCINATION COMPLICATION (Side effect from vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effect) 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) dosage form. On an unknown date, the patient experienced ADVERSE EVENT (side effect). At the time of the report, ADVERSE EVENT (side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment medications are provided.   Reporter did not allow further contact
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: Hives all over the body; Swollen lips; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (Hives all over the body) and LIP SWELLING (Swollen lips) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced URTICARIA (Hives all over the body) and LIP SWELLING (Swollen lips). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives all over the body) and LIP SWELLING (Swollen lips) 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 concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Updated reporter name and email address.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission in error
Clinical narrative: Only received one shot of vaccine; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION IN ERROR (Only received one shot of vaccine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PRODUCT DOSE OMISSION IN ERROR (Only received one shot of vaccine). At the time of the report, PRODUCT DOSE OMISSION IN ERROR (Only received one shot of vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Fatigue, Neuralgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENOPIA (eye on the opposite side of her body feels weak), NEURALGIA (Nerve pain in the opposite arm) and FATIGUE (fatigue after the vaccine) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced NEURALGIA (Nerve pain in the opposite arm) and FATIGUE (fatigue after the vaccine). On an unknown date, the patient experienced ASTHENOPIA (eye on the opposite side of her body feels weak). At the time of the report, ASTHENOPIA (eye on the opposite side of her body feels weak), NEURALGIA (Nerve pain in the opposite arm) and FATIGUE (fatigue after the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. No treatment medications were reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Illness, Renal pain, Vaccination error, Vomiting
Clinical narrative: I think the vaccine was destroyed by my body, so I'm not vaccinated; I had pain in my kidney two or three weeks after being vaccinated; Dizzy; He was really sick for about three weeks; He was throwing up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION ERROR (I think the vaccine was destroyed by my body, so I'm not vaccinated), RENAL PAIN (I had pain in my kidney two or three weeks after being vaccinated), DIZZINESS (Dizzy), ILLNESS (He was really sick for about three weeks) and VOMITING (He was throwing up) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Accident (In 1995 he was in an accident.) in 1995, Cancer (Cancer for 6 years and has been cured of it 2 years ago.), Broken bones (Fingers were broken.), Fracture of pelvis (Pelvis was broken.), Skull fracture (Head was split open.), Dialysis (He was getting dialysis for four years.) since an unknown date, Spinal fusion (Five spinal fusions and can still walk.) and Kidney transplant. Concurrent medical conditions included Blood pressure management. Concomitant products included TACROLIMUS for an unknown indication.   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 an unknown date, the patient experienced VACCINATION ERROR (I think the vaccine was destroyed by my body, so I'm not vaccinated), RENAL PAIN (I had pain in my kidney two or three weeks after being vaccinated), DIZZINESS (Dizzy), ILLNESS (He was really sick for about three weeks) and VOMITING (He was throwing up). At the time of the report, VACCINATION ERROR (I think the vaccine was destroyed by my body, so I'm not vaccinated), RENAL PAIN (I had pain in my kidney two or three weeks after being vaccinated), DIZZINESS (Dizzy), ILLNESS (He was really sick for about three weeks) and VOMITING (He was throwing up) outcome was unknown.            Patient received first dose of vaccine on January 2021 and second dose on February 2021.  Treatment medications were not reported.   This case was linked to MOD-2021-010275 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received on 02-JUL-2021, contains reporters demographic details, new events added. On 02-Jul-2021: Follow-up information received  contains non-significant information
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Fatigue, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: sleepy; sore arm; fever; fatigue; 1 mL was administered to four patients; This spontaneous case was reported by a medical assistant and describes the occurrence of ACCIDENTAL OVERDOSE (1 mL was administered to four patients), SOMNOLENCE (sleepy), PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and FATIGUE (fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 21-May-2021, the patient experienced ACCIDENTAL OVERDOSE (1 mL was administered to four patients). On 22-May-2021, the patient experienced SOMNOLENCE (sleepy), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). 22-May-2021, the patient experienced PYREXIA (fever). On 24-May-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 25-May-2021, SOMNOLENCE (sleepy), PYREXIA (fever) and FATIGUE (fatigue) had resolved. At the time of the report, ACCIDENTAL OVERDOSE (1 mL was administered to four patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.     Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Reporter information, patient demographics and additional events were provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Respiration abnormal
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitation (pulse went up above 100)) and RESPIRATION ABNORMAL (breathing symptom) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PALPITATIONS (palpitation (pulse went up above 100)) and RESPIRATION ABNORMAL (breathing symptom). At the time of the report, PALPITATIONS (palpitation (pulse went up above 100)) and RESPIRATION ABNORMAL (breathing symptom) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication was provided. Concomitant medications includes taking medication for Asthma. This case was linked to MOD-2021-162412.
Sex: U
Vaccine: COVID19
Symptoms: Viral infection
Clinical narrative: currently have a viral infection; 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 VIRAL INFECTION (currently have a viral infection) 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 VIRAL INFECTION (currently have a viral infection). At the time of the report, VIRAL INFECTION (currently have a viral infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication history not provided. Treatment information was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hyperhidrosis, Pain in extremity
Clinical narrative: Sore arm; Hot and sweaty; Hot and sweaty; Headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING HOT (Hot and sweaty), HYPERHIDROSIS (Hot and sweaty) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna 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 21-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FEELING HOT (Hot and sweaty), HYPERHIDROSIS (Hot and sweaty) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING HOT (Hot and sweaty), HYPERHIDROSIS (Hot and sweaty) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; 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 PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.    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 an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.            Treatment medications were not reported.                                             Concomitant medications were not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine from 2 vials which are moved from freezer to refrigerator 30 days ago are administered to 12 patients on 31st day; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine from 2 vials which are moved from freezer to refrigerator 30 days ago are administered to 12 patients on 31st day) 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 PRODUCT STORAGE ERROR (Vaccine from 2 vials which are moved from freezer to refrigerator 30 days ago are administered to 12 patients on 31st day). At the time of the report, PRODUCT STORAGE ERROR (Vaccine from 2 vials which are moved from freezer to refrigerator 30 days ago are administered to 12 patients on 31st day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and treatment information were reported.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: vaccine negatively effect someone who is nursing; 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 EXPOSURE VIA BREAST MILK (vaccine negatively effect someone who is nursing) 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 EXPOSURE VIA BREAST MILK (vaccine negatively effect someone who is nursing). At the time of the report, EXPOSURE VIA BREAST MILK (vaccine negatively effect someone who is nursing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations, Respiration abnormal
Clinical narrative: pulse went high up; breathing symptom; palpitation; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (pulse went high up), DYSPNOEA (breathing symptom) and PALPITATIONS (palpitation) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (pulse went high up), DYSPNOEA (breathing symptom) and PALPITATIONS (palpitation). At the time of the report, HEART RATE INCREASED (pulse went high up), DYSPNOEA (breathing symptom) and PALPITATIONS (palpitation) outcome was unknown.            Concomitant medications includes taking medication for Asthma. No treatment information were reported.   This case was linked to MOD-2021-162401, MOD-2021-162401 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain lower
Clinical narrative: Feeling crampy in my lower abdomen; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN LOWER (Feeling crampy in my lower abdomen) 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 ABDOMINAL PAIN LOWER (Feeling crampy in my lower abdomen). At the time of the report, ABDOMINAL PAIN LOWER (Feeling crampy in my lower abdomen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided by the reporter. Concomitant information was not provide by the reporter.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Oropharyngeal pain, Vaccination site pruritus
Clinical narrative: sore throat; really bad stomach pain for 7 days; nauseous; itchiness at injection site for 20mins; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), ABDOMINAL PAIN UPPER (really bad stomach pain for 7 days), NAUSEA (nauseous) and VACCINATION SITE PRURITUS (itchiness at injection site for 20mins) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergic to iodine contrast).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at injection site for 20mins). On 27-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), ABDOMINAL PAIN UPPER (really bad stomach pain for 7 days) and NAUSEA (nauseous). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Stomach ache, at an unspecified dose and frequency. On 26-Apr-2021, VACCINATION SITE PRURITUS (itchiness at injection site for 20mins) had resolved. On 04-May-2021, OROPHARYNGEAL PAIN (sore throat), ABDOMINAL PAIN UPPER (really bad stomach pain for 7 days) and NAUSEA (nauseous) had resolved.            Concomitant medications:Over the counter Vitamin once daily,Birth Control Sprintec. Action taken with mRNA-1273 in response to the event/s was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: got my second shot of an why are the affects stronger; 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 VACCINATION COMPLICATION (got my second shot of an why are the affects stronger) 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) (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 an unknown date, the patient experienced VACCINATION COMPLICATION (got my second shot of an why are the affects stronger). At the time of the report, VACCINATION COMPLICATION (got my second shot of an why are the affects stronger) outcome was unknown.            Concomitant medication and treatment information were not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Inappropriate schedule of product administration
Clinical narrative: severe stomach cramps; diarrhea; She did get it eventually on Thursday, 20May2021; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (severe stomach cramps), DIARRHEA (diarrhea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did get it eventually on Thursday, 20May2021) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 038AZ1A) for COVID-19 vaccination.     Concomitant products included VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did get it eventually on Thursday, 20May2021). On 22-May-2021, the patient experienced ABDOMINAL PAIN UPPER (severe stomach cramps) and DIARRHEA (diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (severe stomach cramps), DIARRHEA (diarrhea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did get it eventually on Thursday, 20May2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information  included hydrated with Water and Gatorade.
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Leg pain from the knee down; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain from the knee down) and NECK PAIN (Neck pain) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Leg pain from the knee down) and NECK PAIN (Neck pain). At the time of the report, PAIN IN EXTREMITY (Leg pain from the knee down) and NECK PAIN (Neck pain) outcome was unknown.            The reporter  stated  that his mom takes Tylenol and the pain goes away.
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Toothache; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Toothache) 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 TOOTHACHE (Toothache). At the time of the report, TOOTHACHE (Toothache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.