chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site pain
Clinical narrative: Began waking up and unable to get back to sleep; Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site) and INSOMNIA (Began waking up and unable to get back to sleep) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN (LIPTOR [ATORVASTATIN]), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). On 09-Feb-2021, the patient experienced INSOMNIA (Began waking up and unable to get back to sleep). On 18-Jan-2021, VACCINATION SITE PAIN (Sore arm at injection site) had resolved. At the time of the report, INSOMNIA (Began waking up and unable to get back to sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Additional information provided: Reporter Address, contact(Email) updated
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Induration, Malaise, Musculoskeletal discomfort
Clinical narrative: dizziness; headache; not feeling great; Arm was hard; Arm was sore; both shoulders were heavy; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (both shoulders were heavy), PAIN IN EXTREMITY (Arm was sore), DIZZINESS (dizziness), HEADACHE (headache) and MALAISE (not feeling great) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (both shoulders were heavy). On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and INDURATION (Arm was hard). On 01-Mar-2021, the patient experienced DIZZINESS (dizziness), HEADACHE (headache) and MALAISE (not feeling great). On 15-Feb-2021, MUSCULOSKELETAL DISCOMFORT (both shoulders were heavy) had resolved. On 19-Feb-2021, PAIN IN EXTREMITY (Arm was sore) and INDURATION (Arm was hard) had resolved. At the time of the report, DIZZINESS (dizziness), HEADACHE (headache) and MALAISE (not feeling great) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-033822.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: dizziness; headache; not feeling great; Arm was hard; Arm was sore; both shoulders were heavy; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (both shoulders were heavy), PAIN IN EXTREMITY (Arm was sore), DIZZINESS (dizziness), HEADACHE (headache) and MALAISE (not feeling great) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (both shoulders were heavy). On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and INDURATION (Arm was hard). On 01-Mar-2021, the patient experienced DIZZINESS (dizziness), HEADACHE (headache) and MALAISE (not feeling great). On 15-Feb-2021, MUSCULOSKELETAL DISCOMFORT (both shoulders were heavy) had resolved. On 19-Feb-2021, PAIN IN EXTREMITY (Arm was sore) and INDURATION (Arm was hard) had resolved. At the time of the report, DIZZINESS (dizziness), HEADACHE (headache) and MALAISE (not feeling great) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-033822.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Terrible cramps in all the left side of her body/After go to left side of her head, to her left calf and the left foot. And continued moving from left to right; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (Terrible cramps in all the left side of her body/After go to left side of her head, to her left calf and the left foot. And continued moving from left to right) and PAIN IN EXTREMITY (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 02-Mar-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 02-Mar-2021 at 2:30 PM, the patient experienced MUSCLE SPASMS (Terrible cramps in all the left side of her body/After go to left side of her head, to her left calf and the left foot. And continued moving from left to right). At the time of the report, MUSCLE SPASMS (Terrible cramps in all the left side of her body/After go to left side of her head, to her left calf and the left foot. And continued moving from left to right) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Migraine, Pyrexia, Rash
Clinical narrative: migraine; severe abdominal pain; diarrhea; Skin rash; 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 MIGRAINE (migraine), ABDOMINAL PAIN (severe abdominal pain), DIARRHOEA (diarrhea), RASH (Skin rash) and PYREXIA (Fever) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraine), ABDOMINAL PAIN (severe abdominal pain), DIARRHOEA (diarrhea), RASH (Skin rash) and PYREXIA (Fever). At the time of the report, MIGRAINE (migraine), ABDOMINAL PAIN (severe abdominal pain), DIARRHOEA (diarrhea), RASH (Skin rash) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-034252 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypertension, Pain, Peripheral swelling, Pyrexia
Clinical narrative: swollen arm; Soreness; severe chills; severe shakes; high blood pressure; fever of 100.9 F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (severe chills), TREMOR (severe shakes), HYPERTENSION (high blood pressure), PYREXIA (fever of 100.9 F) and PERIPHERAL SWELLING (swollen arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (severe chills), TREMOR (severe shakes), HYPERTENSION (high blood pressure) and PYREXIA (fever of 100.9 F). On 04-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arm) and PAIN (Soreness). On 04-Mar-2021, CHILLS (severe chills), TREMOR (severe shakes), HYPERTENSION (high blood pressure) and PYREXIA (fever of 100.9 F) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen arm) and PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: swollen arm; Soreness; severe chills; severe shakes; high blood pressure; fever of 100.9 F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (severe chills), TREMOR (severe shakes), HYPERTENSION (high blood pressure), PYREXIA (fever of 100.9 F) and PERIPHERAL SWELLING (swollen arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (severe chills), TREMOR (severe shakes), HYPERTENSION (high blood pressure) and PYREXIA (fever of 100.9 F). On 04-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arm) and PAIN (Soreness). On 04-Mar-2021, CHILLS (severe chills), TREMOR (severe shakes), HYPERTENSION (high blood pressure) and PYREXIA (fever of 100.9 F) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen arm) and PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; 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 VACCINATION COMPLICATION (side effects) 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 VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) 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 and treatment medications were reported.; Reporter's Comments: vvdvbdbdbdjbfbbfn f jgkkl./
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Stenosis, Vein disorder
Clinical narrative: Noticed a complete change in the veins in her hands; Blood vessels have shrunk,she can barely see them; Ice cold hands; This spontaneous case was reported by a consumer and describes the occurrence of VEIN DISORDER (Noticed a complete change in the veins in her hands), STENOSIS (Blood vessels have shrunk,she can barely see them) and FEELING COLD (Ice cold hands) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN and AMLODIPINE for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VEIN DISORDER (Noticed a complete change in the veins in her hands), STENOSIS (Blood vessels have shrunk,she can barely see them) and FEELING COLD (Ice cold hands). At the time of the report, VEIN DISORDER (Noticed a complete change in the veins in her hands), STENOSIS (Blood vessels have shrunk,she can barely see them) and FEELING COLD (Ice cold hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-043635 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: no new information; Sender's Comments:  MOD21-043635:Non-significant follow up contact information updated
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Diarhhea; injection site swollen; injection site red; injection site itchy; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarhhea), VACCINATION SITE SWELLING (injection site swollen), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PRURITUS (injection site itchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE SWELLING (injection site swollen), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PRURITUS (injection site itchy). On 10-Feb-2021, the patient experienced DIARRHOEA (Diarhhea). On 11-Feb-2021, DIARRHOEA (Diarhhea) had resolved. At the time of the report, VACCINATION SITE SWELLING (injection site swollen), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PRURITUS (injection site itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included over the counter anti itch cream, Pepto Bismol.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Shingles. Concomitant products included APIXABAN (ELIQUIS), CLOPIDOGREL, ATORVASTATIN, METOPROLOL, LISINOPRIL, OMEPRAZOLE, ACYCLOVIR [ACICLOVIR], MULTIVITAMINS [VITAMINS NOS], DILTIAZEM HYDROCHLORIDE (TIADYLT ER) and PROBIOTICS NOS for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She did get a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She did get a sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Swollen glands (The patient reports she had swollen gland on her throat.).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (She did get a sore arm). At the time of the report, PAIN IN EXTREMITY (She did get a sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Outcome of the event is updated to recovered or resolved.  Reporter said she was feeling fine and declined further follow-up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Sore at the injection site, Big area that was tender; Subcutaneous reaction; Big area that was tender and warm; itching; Hardness; Redness; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (Subcutaneous reaction), VACCINATION SITE WARMTH (Big area that was tender and warm), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (Sore at the injection site, Big area that was tender) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness ). On 03-Mar-2021, the patient experienced SKIN REACTION (Subcutaneous reaction), VACCINATION SITE WARMTH (Big area that was tender and warm) and VACCINATION SITE PRURITUS (itching). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore at the injection site, Big area that was tender). On 26-Feb-2021, VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness ) had resolved. At the time of the report, SKIN REACTION (Subcutaneous reaction), VACCINATION SITE WARMTH (Big area that was tender and warm), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (Sore at the injection site, Big area that was tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Sore at the injection site, Big area that was tender; Subcutaneous reaction; Big area that was tender and warm; itching; Hardness; Redness; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (Subcutaneous reaction), VACCINATION SITE WARMTH (Big area that was tender and warm), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (Sore at the injection site, Big area that was tender) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness ). On 03-Mar-2021, the patient experienced SKIN REACTION (Subcutaneous reaction), VACCINATION SITE WARMTH (Big area that was tender and warm) and VACCINATION SITE PRURITUS (itching). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore at the injection site, Big area that was tender). On 26-Feb-2021, VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness ) had resolved. At the time of the report, SKIN REACTION (Subcutaneous reaction), VACCINATION SITE WARMTH (Big area that was tender and warm), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (Sore at the injection site, Big area that was tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: site of injection is itching; site of injection developed a red mark; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (site of injection is itching) and VACCINATION SITE ERYTHEMA (site of injection developed a red mark) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (site of injection is itching) and VACCINATION SITE ERYTHEMA (site of injection developed a red mark). At the time of the report, VACCINATION SITE PRURITUS (site of injection is itching) and VACCINATION SITE ERYTHEMA (site of injection developed a red mark) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural, Fatigue, Head discomfort, Headache, Malaise
Clinical narrative: Head feels very heavy; Dizzy on standing; Sleeping on and off; feels sick; head feels very heavy, head is pounding; Body feels achy; slight nausea; Feels tired; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Head feels very heavy), DIZZINESS POSTURAL (Dizzy on standing), SOMNOLENCE (Sleeping on and off), MALAISE (feels sick) and HEADACHE (head feels very heavy, head is pounding) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001AZ1A and 041LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced HEAD DISCOMFORT (Head feels very heavy), DIZZINESS POSTURAL (Dizzy on standing), SOMNOLENCE (Sleeping on and off), MALAISE (feels sick), HEADACHE (head feels very heavy, head is pounding), MYALGIA (Body feels achy), NAUSEA (slight nausea) and FATIGUE (Feels tired). At the time of the report, HEAD DISCOMFORT (Head feels very heavy), DIZZINESS POSTURAL (Dizzy on standing), SOMNOLENCE (Sleeping on and off), MALAISE (feels sick), HEADACHE (head feels very heavy, head is pounding), MYALGIA (Body feels achy), NAUSEA (slight nausea) and FATIGUE (Feels tired) had not resolved.            Concomitant product use was not provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Somnolence
Clinical narrative: Head feels very heavy; Dizzy on standing; Sleeping on and off; feels sick; head feels very heavy, head is pounding; Body feels achy; slight nausea; Feels tired; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Head feels very heavy), DIZZINESS POSTURAL (Dizzy on standing), SOMNOLENCE (Sleeping on and off), MALAISE (feels sick) and HEADACHE (head feels very heavy, head is pounding) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001AZ1A and 041LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced HEAD DISCOMFORT (Head feels very heavy), DIZZINESS POSTURAL (Dizzy on standing), SOMNOLENCE (Sleeping on and off), MALAISE (feels sick), HEADACHE (head feels very heavy, head is pounding), MYALGIA (Body feels achy), NAUSEA (slight nausea) and FATIGUE (Feels tired). At the time of the report, HEAD DISCOMFORT (Head feels very heavy), DIZZINESS POSTURAL (Dizzy on standing), SOMNOLENCE (Sleeping on and off), MALAISE (feels sick), HEADACHE (head feels very heavy, head is pounding), MYALGIA (Body feels achy), NAUSEA (slight nausea) and FATIGUE (Feels tired) had not resolved.            Concomitant product use was not provided. No treatment information was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: Sore arm; Bled a little bit after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bled a little bit after the first shot) and VACCINATION SITE PAIN (Sore arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroiditis NOS.    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 VACCINATION SITE HAEMORRHAGE (Bled a little bit after the first shot). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). On 18-Jan-2021, VACCINATION SITE HAEMORRHAGE (Bled a little bit after the first shot) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood thinner, thyroid Medication. No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches, some strong ones; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HEADACHE (headaches, some strong ones) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches, some strong ones). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of UNK dosage form. At the time of the report, HEADACHE (headaches, some strong ones) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Palpitations, Presyncope, Pyrexia
Clinical narrative: Patient had fever; Heart palpitations; Arm sore; Nauseas; felt like she was going to faint; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Patient had fever), PALPITATIONS (Heart palpitations), PAIN IN EXTREMITY (Arm sore), NAUSEA (Nauseas) and PRESYNCOPE (felt like she was going to faint) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Patient had fever), PALPITATIONS (Heart palpitations), PAIN IN EXTREMITY (Arm sore), NAUSEA (Nauseas) and PRESYNCOPE (felt like she was going to faint). At the time of the report, PYREXIA (Patient had fever), PALPITATIONS (Heart palpitations), PAIN IN EXTREMITY (Arm sore), NAUSEA (Nauseas) and PRESYNCOPE (felt like she was going to faint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Hypoaesthesia, Lacrimation increased
Clinical narrative: right side of face was "nummy; my eye was watering a bit; I felt warm and cold; This spontaneous case was reported by a health care professional and describes the occurrence of HYPOAESTHESIA (right side of face was "nummy), LACRIMATION INCREASED (my eye was watering a bit) and FEELING OF BODY TEMPERATURE CHANGE (I felt warm and cold) 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 was not provided. Concomitant product use was not provided.  On an unknown date, approximately 3 weeks prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced HYPOAESTHESIA (right side of face was "nummy), LACRIMATION INCREASED (my eye was watering a bit) and FEELING OF BODY TEMPERATURE CHANGE (I felt warm and cold). Treatment information was not provided.  At the time of the report, HYPOAESTHESIA (right side of face was "nummy), LACRIMATION INCREASED (my eye was watering a bit) and FEELING OF BODY TEMPERATURE CHANGE (I felt warm and cold) outcome was unknown.    The outcome of the events, HYPOAESTHESIA (right side of face was "nummy), LACRIMATION INCREASED (my eye was watering a bit) and FEELING OF BODY TEMPERATURE CHANGE (I felt warm and cold) were unknown.   Action taken with mRNA-1273 in response to the events was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysstasia
Clinical narrative: Dizziness; Patient could not stand up; Patient had no energy for 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DYSSTASIA (Patient could not stand up) and ASTHENIA (Patient had no energy for 3 weeks) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced DIZZINESS (Dizziness), DYSSTASIA (Patient could not stand up) and ASTHENIA (Patient had no energy for 3 weeks). At the time of the report, DIZZINESS (Dizziness), DYSSTASIA (Patient could not stand up) and ASTHENIA (Patient had no energy for 3 weeks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided. Patient stated that he is fine and got his 2 dose of vaccine and no longer needs a follow up.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Event outcome updated from unknown to recovered/resolved.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Induration, Peripheral swelling, Vaccination site warmth
Clinical narrative: black and blue the whole width of the arm; bruising the  size of 2 x 3 inches.; swelling felt hard; arm was swollen; arm was warm; redness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen), VACCINATION SITE WARMTH (arm was warm), ERYTHEMA (redness), CONTUSION (black and blue the whole width of the arm) and INDURATION (swelling felt hard) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included RISEDRONATE SODIUM, CARBIDOPA, LEVODOPA (CARBIDOPA-LEVODOPA-B), LOVASTATIN and METHIMAZOLE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 26-Feb-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen), VACCINATION SITE WARMTH (arm was warm), ERYTHEMA (redness) and INDURATION (swelling felt hard). On 02-Mar-2021, the patient experienced CONTUSION (black and blue the whole width of the arm) and CONTUSION (bruising the  size of 2 x 3 inches.). At the time of the report, PERIPHERAL SWELLING (arm was swollen), VACCINATION SITE WARMTH (arm was warm), ERYTHEMA (redness), CONTUSION (black and blue the whole width of the arm), INDURATION (swelling felt hard) and CONTUSION (bruising the  size of 2 x 3 inches.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: NNI
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Headache
Clinical narrative: memory loss; Headache and pain on right side of head; A Spontaneous report was sent by consumer concerning a 71 years female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced Headache and pain on right side of head/headache and memory loss/amnesia.  The patient's medical history is unknown. Concomitant medications were not reported.  17 Feb 2021, prior to the onset of the events, the patient received the first dose of mRNA-1273 (Lot number not available) intramuscular in her left upper arm for prophylaxis of COVID-19 infection.   On 18 Feb 2021, the patient experienced headache and pain on the right side of her head near ear and also memory loss. She could not  remember where she laid things down and she is not sure if she will take the 2nd shot.  The patient was treated with acetaminophen. Laboratory details are not provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome is headache and memory loss were reported as unknown..  The causality was not provided by the reporter.; 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: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Nausea; couldn't get out of bed for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and FATIGUE (couldn't get out of bed for 3 days) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and FATIGUE (couldn't get out of bed for 3 days). At the time of the report, NAUSEA (Nausea) and FATIGUE (couldn't get out of bed for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.  The report on 17-May-2021 clarified that the original reported events were those she read about in the paper; she did not experience any of those events. The patient did experience nausea and that she "had no power" and thus couldn't get out of bed for 3 days.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-138795 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Additional information added on 17-MAY-2021 provided clarification on the events experienced by the patient and provided outcome.; 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. US-MODERNATX, INC.-MOD-2021-138795:2nd dose case
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, Vomiting
Clinical narrative: fatigue; vomiting (cramping in stomach that caused pain; chills; feverish; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), VOMITING (vomiting (cramping in stomach that caused pain), CHILLS (chills), PYREXIA (feverish) and PAIN (body aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FATIGUE (fatigue), VOMITING (vomiting (cramping in stomach that caused pain), CHILLS (chills), PYREXIA (feverish) and PAIN (body aches). At the time of the report, FATIGUE (fatigue), VOMITING (vomiting (cramping in stomach that caused pain), CHILLS (chills), PYREXIA (feverish) and PAIN (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 03-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swelling in right side of neck lymph node; Tenderness in neck lymph node; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in right side of neck lymph node) and LYMPH NODE PAIN (Tenderness in neck lymph node) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced LYMPHADENOPATHY (Swelling in right side of neck lymph node) and LYMPH NODE PAIN (Tenderness in neck lymph node). At the time of the report, LYMPHADENOPATHY (Swelling in right side of neck lymph node) and LYMPH NODE PAIN (Tenderness in neck lymph node) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Developed a raised rash patch that was a 2 inch patch across around the injection site; Developed a slightly raised rash patch that was itchy around the injection site; Developed a slightly reddish raised rash patch around the injection site; Just had a minor sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Just had a minor sore shoulder), VACCINATION SITE RASH (Developed a raised rash patch that was a 2 inch patch across around the injection site), VACCINATION SITE PRURITUS (Developed a slightly raised rash patch that was itchy around the injection site) and VACCINATION SITE ERYTHEMA (Developed a slightly reddish raised rash patch around the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced ARTHRALGIA (Just had a minor sore shoulder). On 24-Feb-2021, the patient experienced VACCINATION SITE RASH (Developed a raised rash patch that was a 2 inch patch across around the injection site), VACCINATION SITE PRURITUS (Developed a slightly raised rash patch that was itchy around the injection site) and VACCINATION SITE ERYTHEMA (Developed a slightly reddish raised rash patch around the injection site). On 27-Feb-2021, VACCINATION SITE RASH (Developed a raised rash patch that was a 2 inch patch across around the injection site), VACCINATION SITE PRURITUS (Developed a slightly raised rash patch that was itchy around the injection site) and VACCINATION SITE ERYTHEMA (Developed a slightly reddish raised rash patch around the injection site) had resolved. At the time of the report, ARTHRALGIA (Just had a minor sore shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list also included blood pressure med combined lisinopril and statin 20 mg. Treatment information was not provided. The patient reported that she refrained from itching, applied lotion and took short showers to relieve the symptoms.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Having the side effects of Covid-19 all over again; Fever; Muscle aches; Fatigue; Joint pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Having the side effects of Covid-19 all over again), PYREXIA (Fever), MYALGIA (Muscle aches), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced ADVERSE REACTION (Having the side effects of Covid-19 all over again), PYREXIA (Fever), MYALGIA (Muscle aches), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and HEADACHE (Headache). On 24-Feb-2021, ADVERSE REACTION (Having the side effects of Covid-19 all over again), PYREXIA (Fever), MYALGIA (Muscle aches), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Having the side effects of Covid-19 all over again; Fever; Muscle aches; Fatigue; Joint pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Having the side effects of Covid-19 all over again), PYREXIA (Fever), MYALGIA (Muscle aches), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced ADVERSE REACTION (Having the side effects of Covid-19 all over again), PYREXIA (Fever), MYALGIA (Muscle aches), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and HEADACHE (Headache). On 24-Feb-2021, ADVERSE REACTION (Having the side effects of Covid-19 all over again), PYREXIA (Fever), MYALGIA (Muscle aches), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Fatigue
Clinical narrative: elevated blood pressure 150/90; Light headed; dizzy; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (elevated blood pressure 150/90), DIZZINESS (Light headed), DIZZINESS (dizzy) and FATIGUE (fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included METHOCARBAMOL, PARACETAMOL (EXTRA STRENGTH TYLENOL BACK PAIN) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (elevated blood pressure 150/90), DIZZINESS (Light headed), DIZZINESS (dizzy) and FATIGUE (fatigue). At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressure 150/90), DIZZINESS (Light headed), DIZZINESS (dizzy) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Headache, Intentional dose omission, Nausea
Clinical narrative: Will not take second dose due to side effects; Backaches; Headaches; Nausea; Bad upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Bad upset stomach), INTENTIONAL DOSE OMISSION (Will not take second dose due to side effects), BACK PAIN (Backaches), HEADACHE (Headaches) and NAUSEA (Nausea) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Bad upset stomach), BACK PAIN (Backaches), HEADACHE (Headaches) and NAUSEA (Nausea). On 03-Mar-2021, the patient experienced INTENTIONAL DOSE OMISSION (Will not take second dose due to side effects). On 03-Mar-2021, ABDOMINAL DISCOMFORT (Bad upset stomach), INTENTIONAL DOSE OMISSION (Will not take second dose due to side effects), BACK PAIN (Backaches), HEADACHE (Headaches) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.