chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain lower, Fatigue, Feeling abnormal
Clinical narrative: Cramps; Severe lower stomach pain; Bloated; Didn't feel good; Pressure in lower abdomen; Injection site hurt to touch with pressure; Rash on chest; Headache; Nausea; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps), ABDOMINAL PAIN LOWER (Severe lower stomach pain), ABDOMINAL DISTENSION (Bloated), FEELING ABNORMAL (Didn't feel good) and ABDOMINAL DISCOMFORT (Pressure in lower abdomen) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 10-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 MUSCLE SPASMS (Cramps), ABDOMINAL PAIN LOWER (Severe lower stomach pain), ABDOMINAL DISTENSION (Bloated), FEELING ABNORMAL (Didn't feel good), ABDOMINAL DISCOMFORT (Pressure in lower abdomen), VACCINATION SITE PAIN (Injection site hurt to touch with pressure), RASH (Rash on chest), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Exhaustion). At the time of the report, MUSCLE SPASMS (Cramps), ABDOMINAL PAIN LOWER (Severe lower stomach pain), ABDOMINAL DISTENSION (Bloated), FEELING ABNORMAL (Didn't feel good), ABDOMINAL DISCOMFORT (Pressure in lower abdomen), VACCINATION SITE PAIN (Injection site hurt to touch with pressure), RASH (Rash on chest), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Exhaustion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter.  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received contains updated information on events outcome
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Nausea, Rash, Vaccination site pain
Clinical narrative: Cramps; Severe lower stomach pain; Bloated; Didn't feel good; Pressure in lower abdomen; Injection site hurt to touch with pressure; Rash on chest; Headache; Nausea; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps), ABDOMINAL PAIN LOWER (Severe lower stomach pain), ABDOMINAL DISTENSION (Bloated), FEELING ABNORMAL (Didn't feel good) and ABDOMINAL DISCOMFORT (Pressure in lower abdomen) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 10-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 MUSCLE SPASMS (Cramps), ABDOMINAL PAIN LOWER (Severe lower stomach pain), ABDOMINAL DISTENSION (Bloated), FEELING ABNORMAL (Didn't feel good), ABDOMINAL DISCOMFORT (Pressure in lower abdomen), VACCINATION SITE PAIN (Injection site hurt to touch with pressure), RASH (Rash on chest), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Exhaustion). At the time of the report, MUSCLE SPASMS (Cramps), ABDOMINAL PAIN LOWER (Severe lower stomach pain), ABDOMINAL DISTENSION (Bloated), FEELING ABNORMAL (Didn't feel good), ABDOMINAL DISCOMFORT (Pressure in lower abdomen), VACCINATION SITE PAIN (Injection site hurt to touch with pressure), RASH (Rash on chest), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Exhaustion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter.  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received contains updated information on events outcome
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Headache; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (chills) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-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 (Headache), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, HEADACHE (Headache), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Dizziness
Clinical narrative: stomach issues; Dizziness; weakness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issues), DIZZINESS (Dizziness) and ASTHENIA (weakness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Stomach ache.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach issues), DIZZINESS (Dizziness) and ASTHENIA (weakness). At the time of the report, ABDOMINAL DISCOMFORT (stomach issues), DIZZINESS (Dizziness) and ASTHENIA (weakness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site reaction
Clinical narrative: Developed COVID arm; Red area at injection site that grew bigger for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Developed COVID arm) and VACCINATION SITE ERYTHEMA (Red area at injection site that grew bigger for 3 days) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M2CA and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (codeine). Concomitant products included MILK THISTLE [SILYBUM MARIANUM], SPIRONOLACTONE and IRON for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE REACTION (Developed COVID arm) and VACCINATION SITE ERYTHEMA (Red area at injection site that grew bigger for 3 days). On 20-Mar-2021, VACCINATION SITE ERYTHEMA (Red area at injection site that grew bigger for 3 days) had resolved. At the time of the report, VACCINATION SITE REACTION (Developed COVID arm) had not resolved.            The patient reported there was still a shadow at the infection site.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Updated patient demographics, medical history, added concomitant medicines, added new event -vaccination site erythema.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: nausea; vomiting; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting) and DIARRHOEA (diarrhea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 NAUSEA (nausea), VOMITING (vomiting) and DIARRHOEA (diarrhea). At the time of the report, NAUSEA (nausea), VOMITING (vomiting) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided  No treatment medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: attached : Initiative
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: itching; pink in color; slightly puffy; mild rash on legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching), ERYTHEMA (pink in color), SWELLING (slightly puffy) and RASH (mild rash on legs) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (itching), ERYTHEMA (pink in color), SWELLING (slightly puffy) and RASH (mild rash on legs). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 25 mg. At the time of the report, PRURITUS (itching), ERYTHEMA (pink in color), SWELLING (slightly puffy) and RASH (mild rash on legs) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: event outcome updated.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: delayed AE; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (delayed AE) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (delayed AE). At the time of the report, ADVERSE EVENT (delayed AE) 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 relevant concomitant medications were reported.  No treatment information was provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slight tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight tenderness) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ubknown) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (slight tenderness). At the time of the report, VACCINATION SITE PAIN (slight tenderness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Headache
Clinical narrative: Headache; Fatigue; Chest pressure; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue) and CHEST DISCOMFORT (Chest pressure) 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 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and CHEST DISCOMFORT (Chest pressure). On 01-Feb-2021, HEADACHE (Headache), FATIGUE (Fatigue) and CHEST DISCOMFORT (Chest pressure) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with the mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable. symptoms  got resolved after 4 days later for both doses after 14 - 15 days later of 2nd dose patient experiencing same symptoms again.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymoh node; 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 LYMPHADENOPATHY (Swollen lymoh node) 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 11-Feb-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 LYMPHADENOPATHY (Swollen lymoh node). At the time of the report, LYMPHADENOPATHY (Swollen lymoh node) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment medication was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dry mouth, Hordeolum, Nausea, Pain
Clinical narrative: STYE IN EYE; NAUSEA; NEEDLES IN SKIN; ACHY; FEVER; CHILLS; DRY MOUTH; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Feb-2021 and was forwarded to Moderna on 15-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (NAUSEA), PARAESTHESIA (NEEDLES IN SKIN), PAIN (ACHY), PYREXIA (FEVER) and CHILLS (CHILLS) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced NAUSEA (NAUSEA), PARAESTHESIA (NEEDLES IN SKIN), PAIN (ACHY), PYREXIA (FEVER), CHILLS (CHILLS) and DRY MOUTH (DRY MOUTH). On 13-Feb-2021, the patient experienced HORDEOLUM (STYE IN EYE). On 14-Feb-2021, NAUSEA (NAUSEA), PARAESTHESIA (NEEDLES IN SKIN), PAIN (ACHY), PYREXIA (FEVER), CHILLS (CHILLS), DRY MOUTH (DRY MOUTH) and HORDEOLUM (STYE IN EYE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: STYE IN EYE; NAUSEA; NEEDLES IN SKIN; ACHY; FEVER; CHILLS; DRY MOUTH; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Feb-2021 and was forwarded to Moderna on 15-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (NAUSEA), PARAESTHESIA (NEEDLES IN SKIN), PAIN (ACHY), PYREXIA (FEVER) and CHILLS (CHILLS) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced NAUSEA (NAUSEA), PARAESTHESIA (NEEDLES IN SKIN), PAIN (ACHY), PYREXIA (FEVER), CHILLS (CHILLS) and DRY MOUTH (DRY MOUTH). On 13-Feb-2021, the patient experienced HORDEOLUM (STYE IN EYE). On 14-Feb-2021, NAUSEA (NAUSEA), PARAESTHESIA (NEEDLES IN SKIN), PAIN (ACHY), PYREXIA (FEVER), CHILLS (CHILLS), DRY MOUTH (DRY MOUTH) and HORDEOLUM (STYE IN EYE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to the touch; Rash; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swelling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment provided include diphenhydramine tablet and cream.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Report
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus, Vaccination site rash
Clinical narrative: vaccination site mass; vaccination site pruritus; vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (vaccination site mass), VACCINATION SITE PRURITUS (vaccination site pruritus) and VACCINATION SITE RASH (vaccination site rash) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027/A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE MASS (vaccination site mass), VACCINATION SITE PRURITUS (vaccination site pruritus) and VACCINATION SITE RASH (vaccination site rash). At the time of the report, VACCINATION SITE MASS (vaccination site mass), VACCINATION SITE PRURITUS (vaccination site pruritus) and VACCINATION SITE RASH (vaccination site rash) outcome was unknown.            No relevant concomitant medications were reported. Treatment details included rubbing alcohol and cortisone cream..   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Patient's race added. Dose 1 details updated. Dose 2 details added. Vaccination facility information added.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Nausea, Vaccination site pain, Vomiting
Clinical narrative: Felt weak; Diarrhea, loose stools; Sore left arm; Nausea; Vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Felt weak), DIARRHOEA (Diarrhea, loose stools), VACCINATION SITE PAIN (Sore left arm), NAUSEA (Nausea) and VOMITING (Vomiting) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hyperlipidemia and Hypothyroidism. Concomitant products included LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID), HCTZ and ATORVASTATIN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-Jan-2021, the patient experienced ASTHENIA (Felt weak), DIARRHOEA (Diarrhea, loose stools), VACCINATION SITE PAIN (Sore left arm), NAUSEA (Nausea) and VOMITING (Vomiting). On 28-Jan-2021, ASTHENIA (Felt weak), DIARRHOEA (Diarrhea, loose stools), VACCINATION SITE PAIN (Sore left arm), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 03 MAY 2021 contains non-significant information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Palpitations, Seasonal allergy
Clinical narrative: seasonal allergies; Pain-soreness at the injection site; shortness of breath - after walking, once I sit down for 20 minutes then I am fine; heart palpitations; severe headache; total fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (seasonal allergies), DYSPNOEA (shortness of breath - after walking, once I sit down for 20 minutes then I am fine), PALPITATIONS (heart palpitations), HEADACHE (severe headache) and FATIGUE (total fatigue) in a 71-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 was reported by the reporter.  Concomitant products included AMLODIPINE BESILATE, VALSARTAN (EXFORGE), HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HCTZ) and VITAMINS NOS for an unknown indication.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (severe headache) and FATIGUE (total fatigue). On 08-Feb-2021, the patient experienced DYSPNOEA (shortness of breath - after walking, once I sit down for 20 minutes then I am fine) and PALPITATIONS (heart palpitations). On an unknown date, the patient experienced SEASONAL ALLERGY (seasonal allergies) and VACCINATION SITE PAIN (Pain-soreness at the injection site). The patient was treated with LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) ongoing since an unknown date at a dose of UNK dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, SEASONAL ALLERGY (seasonal allergies), DYSPNOEA (shortness of breath - after walking, once I sit down for 20 minutes then I am fine), PALPITATIONS (heart palpitations), HEADACHE (severe headache), FATIGUE (total fatigue) and VACCINATION SITE PAIN (Pain-soreness at the injection site) outcome was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: seasonal allergies; Pain-soreness at the injection site; shortness of breath - after walking, once I sit down for 20 minutes then I am fine; heart palpitations; severe headache; total fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (seasonal allergies), DYSPNOEA (shortness of breath - after walking, once I sit down for 20 minutes then I am fine), PALPITATIONS (heart palpitations), HEADACHE (severe headache) and FATIGUE (total fatigue) in a 71-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 was reported by the reporter.  Concomitant products included AMLODIPINE BESILATE, VALSARTAN (EXFORGE), HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HCTZ) and VITAMINS NOS for an unknown indication.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (severe headache) and FATIGUE (total fatigue). On 08-Feb-2021, the patient experienced DYSPNOEA (shortness of breath - after walking, once I sit down for 20 minutes then I am fine) and PALPITATIONS (heart palpitations). On an unknown date, the patient experienced SEASONAL ALLERGY (seasonal allergies) and VACCINATION SITE PAIN (Pain-soreness at the injection site). The patient was treated with LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) ongoing since an unknown date at a dose of UNK dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, SEASONAL ALLERGY (seasonal allergies), DYSPNOEA (shortness of breath - after walking, once I sit down for 20 minutes then I am fine), PALPITATIONS (heart palpitations), HEADACHE (severe headache), FATIGUE (total fatigue) and VACCINATION SITE PAIN (Pain-soreness at the injection site) outcome was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Chills, Disorientation, Dizziness
Clinical narrative: I started driving home 30 minutes after I received the Moderna Covid-19 vaccine and then I felt disoriented and dizzy; dizziness; chills; muscle pain; loss of taste; tingling of tongue; low grade fever; joint pain; blurred vision; overall malaise; thought I was going to pass out/nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (I started driving home 30 minutes after I received the Moderna Covid-19 vaccine and then I felt disoriented and dizzy), DIZZINESS (dizziness), CHILLS (chills), MYALGIA (muscle pain) and AGEUSIA (loss of taste) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (Food allergies: Dairy, Egg Plants, Macadamia Nuts.), Allergy to antibiotic (Allergic to Clindamycin, Tetracycline, Erythromycin) and Drug allergy (Drug allergies-Latex, Lanolin, PCN,Bromocriptine, Dilantin, Flagyl, Biaxin, Reclast, Prolea, Omega-3,). Concomitant products included PARACETAMOL (TYLENOL), DIPHENHYDRAMINE, LEVOTHYROXINE, PANTOPRAZOLE, Famotidine                                                     As needed, ESTRADIOL, OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) and LORAZEPAM for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DISORIENTATION (I started driving home 30 minutes after I received the Moderna Covid-19 vaccine and then I felt disoriented and dizzy), DIZZINESS (dizziness), CHILLS (chills), MYALGIA (muscle pain), AGEUSIA (loss of taste), PARAESTHESIA ORAL (tingling of tongue), PYREXIA (low grade fever), ARTHRALGIA (joint pain), VISION BLURRED (blurred vision), MALAISE (overall malaise), NAUSEA (thought I was going to pass out/nausea) and HEADACHE (headache). On 12-Feb-2021, DISORIENTATION (I started driving home 30 minutes after I received the Moderna Covid-19 vaccine and then I felt disoriented and dizzy) had resolved. At the time of the report, DIZZINESS (dizziness), CHILLS (chills), MYALGIA (muscle pain), AGEUSIA (loss of taste), PARAESTHESIA ORAL (tingling of tongue), PYREXIA (low grade fever), ARTHRALGIA (joint pain), VISION BLURRED (blurred vision), MALAISE (overall malaise), NAUSEA (thought I was going to pass out/nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Paraesthesia oral
Clinical narrative: I started driving home 30 minutes after I received the Moderna Covid-19 vaccine and then I felt disoriented and dizzy; dizziness; chills; muscle pain; loss of taste; tingling of tongue; low grade fever; joint pain; blurred vision; overall malaise; thought I was going to pass out/nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (I started driving home 30 minutes after I received the Moderna Covid-19 vaccine and then I felt disoriented and dizzy), DIZZINESS (dizziness), CHILLS (chills), MYALGIA (muscle pain) and AGEUSIA (loss of taste) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (Food allergies: Dairy, Egg Plants, Macadamia Nuts.), Allergy to antibiotic (Allergic to Clindamycin, Tetracycline, Erythromycin) and Drug allergy (Drug allergies-Latex, Lanolin, PCN,Bromocriptine, Dilantin, Flagyl, Biaxin, Reclast, Prolea, Omega-3,). Concomitant products included PARACETAMOL (TYLENOL), DIPHENHYDRAMINE, LEVOTHYROXINE, PANTOPRAZOLE, Famotidine                                                     As needed, ESTRADIOL, OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) and LORAZEPAM for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DISORIENTATION (I started driving home 30 minutes after I received the Moderna Covid-19 vaccine and then I felt disoriented and dizzy), DIZZINESS (dizziness), CHILLS (chills), MYALGIA (muscle pain), AGEUSIA (loss of taste), PARAESTHESIA ORAL (tingling of tongue), PYREXIA (low grade fever), ARTHRALGIA (joint pain), VISION BLURRED (blurred vision), MALAISE (overall malaise), NAUSEA (thought I was going to pass out/nausea) and HEADACHE (headache). On 12-Feb-2021, DISORIENTATION (I started driving home 30 minutes after I received the Moderna Covid-19 vaccine and then I felt disoriented and dizzy) had resolved. At the time of the report, DIZZINESS (dizziness), CHILLS (chills), MYALGIA (muscle pain), AGEUSIA (loss of taste), PARAESTHESIA ORAL (tingling of tongue), PYREXIA (low grade fever), ARTHRALGIA (joint pain), VISION BLURRED (blurred vision), MALAISE (overall malaise), NAUSEA (thought I was going to pass out/nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vision blurred
Clinical narrative: I started driving home 30 minutes after I received the Moderna Covid-19 vaccine and then I felt disoriented and dizzy; dizziness; chills; muscle pain; loss of taste; tingling of tongue; low grade fever; joint pain; blurred vision; overall malaise; thought I was going to pass out/nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (I started driving home 30 minutes after I received the Moderna Covid-19 vaccine and then I felt disoriented and dizzy), DIZZINESS (dizziness), CHILLS (chills), MYALGIA (muscle pain) and AGEUSIA (loss of taste) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (Food allergies: Dairy, Egg Plants, Macadamia Nuts.), Allergy to antibiotic (Allergic to Clindamycin, Tetracycline, Erythromycin) and Drug allergy (Drug allergies-Latex, Lanolin, PCN,Bromocriptine, Dilantin, Flagyl, Biaxin, Reclast, Prolea, Omega-3,). Concomitant products included PARACETAMOL (TYLENOL), DIPHENHYDRAMINE, LEVOTHYROXINE, PANTOPRAZOLE, Famotidine                                                     As needed, ESTRADIOL, OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) and LORAZEPAM for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DISORIENTATION (I started driving home 30 minutes after I received the Moderna Covid-19 vaccine and then I felt disoriented and dizzy), DIZZINESS (dizziness), CHILLS (chills), MYALGIA (muscle pain), AGEUSIA (loss of taste), PARAESTHESIA ORAL (tingling of tongue), PYREXIA (low grade fever), ARTHRALGIA (joint pain), VISION BLURRED (blurred vision), MALAISE (overall malaise), NAUSEA (thought I was going to pass out/nausea) and HEADACHE (headache). On 12-Feb-2021, DISORIENTATION (I started driving home 30 minutes after I received the Moderna Covid-19 vaccine and then I felt disoriented and dizzy) had resolved. At the time of the report, DIZZINESS (dizziness), CHILLS (chills), MYALGIA (muscle pain), AGEUSIA (loss of taste), PARAESTHESIA ORAL (tingling of tongue), PYREXIA (low grade fever), ARTHRALGIA (joint pain), VISION BLURRED (blurred vision), MALAISE (overall malaise), NAUSEA (thought I was going to pass out/nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Urinary tract infection, Vaccination site inflammation, Vaccination site warmth
Clinical narrative: pain in her back; UTI infection; a little patch on her arm that got larger every day/inflammation; Lot of heat; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in her back), URINARY TRACT INFECTION (UTI infection), VACCINATION SITE INFLAMMATION (a little patch on her arm that got larger every day/inflammation) and VACCINATION SITE WARMTH (Lot of heat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METHOTREXATE for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (pain in her back), URINARY TRACT INFECTION (UTI infection), VACCINATION SITE INFLAMMATION (a little patch on her arm that got larger every day/inflammation) and VACCINATION SITE WARMTH (Lot of heat). The patient was treated with HYDROXYZINE for Vaccination site inflammation, at an unspecified dose and frequency and CHLORAMPHENICOL (ANTIBIOTIC [CHLORAMPHENICOL]) for UTI, at an unspecified dose and frequency. At the time of the report, BACK PAIN (pain in her back), URINARY TRACT INFECTION (UTI infection), VACCINATION SITE INFLAMMATION (a little patch on her arm that got larger every day/inflammation) and VACCINATION SITE WARMTH (Lot of heat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Higher sugar levels in blood; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BLOOD GLUCOSE INCREASED (Higher sugar levels in blood) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, METFORMIN and GLIMEPIRIDE for Diabetes, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (Higher sugar levels in blood). At the time of the report, BLOOD GLUCOSE INCREASED (Higher sugar levels in blood) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: pain, lump, itchiness, swelling (left arm) injection site; pain, lump, itchiness, swelling (left arm) injection site; pain, lump, itchiness, swelling (left arm) injection site; pain, lump, itchiness, swelling (left arm) injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (pain, lump, itchiness, swelling (left arm) injection site), INJECTION SITE PRURITUS (pain, lump, itchiness, swelling (left arm) injection site), INJECTION SITE PAIN (pain, lump, itchiness, swelling (left arm) injection site) and INJECTION SITE SWELLING (pain, lump, itchiness, swelling (left arm) injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced INJECTION SITE MASS (pain, lump, itchiness, swelling (left arm) injection site), INJECTION SITE PRURITUS (pain, lump, itchiness, swelling (left arm) injection site), INJECTION SITE PAIN (pain, lump, itchiness, swelling (left arm) injection site) and INJECTION SITE SWELLING (pain, lump, itchiness, swelling (left arm) injection site). The patient was treated with LOSARTAN at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, INJECTION SITE MASS (pain, lump, itchiness, swelling (left arm) injection site), INJECTION SITE PRURITUS (pain, lump, itchiness, swelling (left arm) injection site), INJECTION SITE PAIN (pain, lump, itchiness, swelling (left arm) injection site) and INJECTION SITE SWELLING (pain, lump, itchiness, swelling (left arm) injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter. Patient had used cold cloth for swelling. Patient had applied cold pack and alcohol on injection site but it was not getting better.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itchy bump) and VACCINATION SITE RASH (Full blown rash around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No medical history was reported by the reporter. Concomitant products included DIPHENHYDRAMINE, PARACETAMOL (TYLENOL), Diphenhydramine cream and arnica gel for an unknown indication. On Nov-1950, 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 PRURITUS (injection site itchy bump) and VACCINATION SITE RASH (Full blown rash around the injection site). At the time of the report, VACCINATION SITE PRURITUS (injection site itchy bump) and VACCINATION SITE RASH (Full blown rash around the injection site) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenopia, Pain, Pain in extremity
Clinical narrative: Sore right arm; Pain in arm travels to shoulder blade; Eyes felt like they was in his skull; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore right arm), PAIN (Pain in arm travels to shoulder blade) and ASTHENOPIA (Eyes felt like they was in his skull) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 PAIN IN EXTREMITY (Sore right arm), PAIN (Pain in arm travels to shoulder blade) and ASTHENOPIA (Eyes felt like they was in his skull). At the time of the report, PAIN IN EXTREMITY (Sore right arm), PAIN (Pain in arm travels to shoulder blade) and ASTHENOPIA (Eyes felt like they was in his skull) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick in bed for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick in bed for 5 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick in bed for 5 days). At the time of the report, ILLNESS (sick in bed for 5 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment was provided. No concomitants were provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: follow up received on 10-jun-2021, AE contact information updated.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pain, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PAIN IN EXTREMITY (sore arm), PYREXIA (fever(102F)) and COUGH (coughing) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. 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 PAIN (body aches), PAIN IN EXTREMITY (sore arm), PYREXIA (fever(102F)) and COUGH (coughing). At the time of the report, PAIN (body aches), PAIN IN EXTREMITY (sore arm), PYREXIA (fever(102F)) and COUGH (coughing) had not resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications provided by the reporter.
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Tenderness, Urticaria
Clinical narrative: Arm was a little tender after injection; Hives; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Arm was a little tender after injection) and URTICARIA (Hives) in an 86-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Arm was a little tender after injection) and URTICARIA (Hives). At the time of the report, TENDERNESS (Arm was a little tender after injection) and URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: dizziness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and FATIGUE (fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIZZINESS (dizziness) and FATIGUE (fatigue). At the time of the report, DIZZINESS (dizziness) and FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator. No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Adverse reactions; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reactions) 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 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reactions). At the time of the report, ADVERSE REACTION (Adverse reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter was calling on behalf of the patient who received their Moderna vaccine on 01-Feb-2021 and had very adverse reactions.  No Concomitant product use was reported. No treatment information was provided..   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: TCR Received and contains non-significant information.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Myalgia, Nausea
Clinical narrative: Stomach pain; Fever; Nausea; Body ache; Headache; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach pain), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Body ache) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and HEADACHE (Headache). On 25-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach pain), PYREXIA (Fever), NAUSEA (Nausea), MYALGIA (Body ache) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.