chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0251.20A) for COVID-19 vaccination.     Concomitant products included TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash on the injection site). At the time of the report, VACCINATION SITE RASH (Rash on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Patient declined to be contacted anymore.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: Tested positive COVID-19; pain at injection (L); Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive COVID-19), VACCINATION SITE PAIN (pain at injection (L)) and FATIGUE (Fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at injection (L)) and FATIGUE (Fatigue). On 14-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive COVID-19). The patient was treated with AZITHROMYCIN (Z-PAK) on 14-Jan-2021 for COVID-19, at an unspecified dose and frequency; steroid pack on 14-Jan-2021 for COVID-19, at an unspecified dose and frequency and Cough syrup OTC on 14-Jan-2021 for COVID-19, at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive COVID-19), VACCINATION SITE PAIN (pain at injection (L)) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-2 test: positive (Positive) contracted Covid-19.         No relevant concomitant medications were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Mass, Rash
Clinical narrative: Had a knot on it; splotches that ran about 8 inches on my arm; allergic reaction; rash; A spontaneous report was received from a consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced had a knot on it, rash, and splotches that ran about 8 inches on my arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events had a knot on it . On 13 Jan 2021, the patient experienced the events rash. splotches that ran about 8 inches on my arm.  Treatment details included Patient put Benadryl cream and ice and took Zyrtec.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events had a knot on it, rash, splotches that ran about 8 inches on my arm was not reported.; Reporter's Comments: This case concerns a 80-year-old female who experienced NS unexpected events of "had a knot in it" (mass) and NS expected events of allergic reaction, rash and erythema.  Event onset occurred XX as / after the first dose of mRNA-1273. Treatment included Benadryl cream and Zyrtec. Events resolved/ongoing. Based on 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: M
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Myalgia, Nasal congestion, Somnolence
Clinical narrative: Slept for 11 hrs; Malaise general state of fatigue; Experienced high fatigue/tired; Experienced nasal congestion; Irritation of the throat from the post nasal drip; Lymph glands were a bit swollen; Minor body ache for the first 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Experienced nasal congestion), THROAT IRRITATION (Irritation of the throat from the post nasal drip), SOMNOLENCE (Slept for 11 hrs), VACCINATION COMPLICATION (Malaise general state of fatigue) and LYMPHADENOPATHY (Lymph glands were a bit swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced NASAL CONGESTION (Experienced nasal congestion), THROAT IRRITATION (Irritation of the throat from the post nasal drip), LYMPHADENOPATHY (Lymph glands were a bit swollen) and MYALGIA (Minor body ache for the first 2-3 days). On 02-Feb-2021, the patient experienced VACCINATION COMPLICATION (Malaise general state of fatigue) and FATIGUE (Experienced high fatigue/tired). On 07-Feb-2021, the patient experienced SOMNOLENCE (Slept for 11 hrs). On 31-Jan-2021, MYALGIA (Minor body ache for the first 2-3 days) had resolved. On 07-Feb-2021, SOMNOLENCE (Slept for 11 hrs) had resolved. At the time of the report, NASAL CONGESTION (Experienced nasal congestion), VACCINATION COMPLICATION (Malaise general state of fatigue) and FATIGUE (Experienced high fatigue/tired) had not resolved and THROAT IRRITATION (Irritation of the throat from the post nasal drip) and LYMPHADENOPATHY (Lymph glands were a bit swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation, Vaccination complication
Clinical narrative: Slept for 11 hrs; Malaise general state of fatigue; Experienced high fatigue/tired; Experienced nasal congestion; Irritation of the throat from the post nasal drip; Lymph glands were a bit swollen; Minor body ache for the first 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Experienced nasal congestion), THROAT IRRITATION (Irritation of the throat from the post nasal drip), SOMNOLENCE (Slept for 11 hrs), VACCINATION COMPLICATION (Malaise general state of fatigue) and LYMPHADENOPATHY (Lymph glands were a bit swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced NASAL CONGESTION (Experienced nasal congestion), THROAT IRRITATION (Irritation of the throat from the post nasal drip), LYMPHADENOPATHY (Lymph glands were a bit swollen) and MYALGIA (Minor body ache for the first 2-3 days). On 02-Feb-2021, the patient experienced VACCINATION COMPLICATION (Malaise general state of fatigue) and FATIGUE (Experienced high fatigue/tired). On 07-Feb-2021, the patient experienced SOMNOLENCE (Slept for 11 hrs). On 31-Jan-2021, MYALGIA (Minor body ache for the first 2-3 days) had resolved. On 07-Feb-2021, SOMNOLENCE (Slept for 11 hrs) had resolved. At the time of the report, NASAL CONGESTION (Experienced nasal congestion), VACCINATION COMPLICATION (Malaise general state of fatigue) and FATIGUE (Experienced high fatigue/tired) had not resolved and THROAT IRRITATION (Irritation of the throat from the post nasal drip) and LYMPHADENOPATHY (Lymph glands were a bit swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Faeces discoloured
Clinical narrative: Black stool; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED (Black stool) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M(Z/2)01) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced FAECES DISCOLOURED (Black stool). At the time of the report, FAECES DISCOLOURED (Black stool) 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.; 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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: very severe pain down to her left leg and back; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (very severe pain down to her left leg and back) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fractured pelvis NOS. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HCTZ) for Hypertension, IBUPROFEN and PARACETAMOL (TYLENOL) for Pelvic fracture, OXYBUTYNIN, COLECALCIFEROL (VITAMIN D 3) and CANNABIDIOL (CBD OIL) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (very severe pain down to her left leg and back). At the time of the report, PAIN IN EXTREMITY (very severe pain down to her left leg and back) 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.   In addition to above mentioned patient also takes Acubite concomitantly. No treatment medications were provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Symptom recurrence, Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: reaction came back; hot and covering a sizable area; very itchy; swelling; very red; large local reaction; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE REACTION (large local reaction), SYMPTOM RECURRENCE (reaction came back), VACCINATION SITE WARMTH (hot and covering a sizable area), VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE SWELLING (swelling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergies to some medications.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE REACTION (large local reaction). On 21-Jan-2021, the patient experienced SYMPTOM RECURRENCE (reaction came back), VACCINATION SITE WARMTH (hot and covering a sizable area), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (very red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event following immunisation, at an unspecified dose and frequency. On 23-Jan-2021, SYMPTOM RECURRENCE (reaction came back), VACCINATION SITE WARMTH (hot and covering a sizable area), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (very red) had resolved. At the time of the report, VACCINATION SITE REACTION (large local reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: reaction came back; hot and covering a sizable area; very itchy; swelling; very red; large local reaction; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE REACTION (large local reaction), SYMPTOM RECURRENCE (reaction came back), VACCINATION SITE WARMTH (hot and covering a sizable area), VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE SWELLING (swelling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergies to some medications.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE REACTION (large local reaction). On 21-Jan-2021, the patient experienced SYMPTOM RECURRENCE (reaction came back), VACCINATION SITE WARMTH (hot and covering a sizable area), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (very red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event following immunisation, at an unspecified dose and frequency. On 23-Jan-2021, SYMPTOM RECURRENCE (reaction came back), VACCINATION SITE WARMTH (hot and covering a sizable area), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (very red) had resolved. At the time of the report, VACCINATION SITE REACTION (large local reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: got the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a physician assistant and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (got the vaccine while pregnant) in a 31-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-Jul-2020 and the estimated date of delivery was 09-Apr-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (got the vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (got the vaccine while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's last menstrual period was recorded as 7-3-2020 with a positive pregnancy test on 7-29-2020.The estimated date of conception is recorded as 7-17-2020.  Before the patient was administered MDRNA COVID Vaccine, the patient had undergone 4 pregnancy ultrasounds each one at 6 w,15w,20w and 26w and a glucose tolerance test as part of her pre-natal care regime.  Patient has no history of sub-fertility.  Patient reported prior use of alcohol.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Irritable bowel syndrome
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (Irritable bowel like symptoms that resembled something similar to a stomach bug), DIARRHOEA (Diarrhea where she was going to the bathroom repeatedly but it wasn't runny), ABDOMINAL PAIN UPPER (Few stomach pains) and HEADACHE (slight dull headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and 041620A) for COVID-19 vaccination. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced IRRITABLE BOWEL SYNDROME (Irritable bowel like symptoms that resembled something similar to a stomach bug), DIARRHOEA (Diarrhea where she was going to the bathroom repeatedly but it wasn't runny), ABDOMINAL PAIN UPPER (Few stomach pains) and HEADACHE (slight dull headache). The patient was treated with IBUPROFEN for Headache dull, at an unspecified dose and frequency. At the time of the report, IRRITABLE BOWEL SYNDROME (Irritable bowel like symptoms that resembled something similar to a stomach bug), DIARRHOEA (Diarrhea where she was going to the bathroom repeatedly but it wasn't runny), ABDOMINAL PAIN UPPER (Few stomach pains) and HEADACHE (slight dull headache) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The concomitant medication information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Second dose details of Moderna vaccine were updated.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: covid-19 test came out positive; felt very tired right after the shot; cold symptoms progressed for the next week after shot; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold symptoms progressed for the next week after shot), COVID-19 (covid-19 test came out positive) and FATIGUE (felt very tired right after the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (I felt like I might be having, like an allergy, a slight, runny, stuffy nose feeling, and I did mention it to the provider who said it was fine to get the shot.) since 06-Jan-2021.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced NASOPHARYNGITIS (cold symptoms progressed for the next week after shot) and FATIGUE (felt very tired right after the shot). On 18-Jan-2021, the patient experienced COVID-19 (covid-19 test came out positive). At the time of the report, NASOPHARYNGITIS (cold symptoms progressed for the next week after shot), COVID-19 (covid-19 test came out positive) and FATIGUE (felt very tired right after the shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: negative (Negative) I went in for a COVID test on 08Jan2021, it turned out negative. On 18-Jan-2021, SARS-CoV-2 test: positive (Positive) got another test on the 18th, which came out positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment details were provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Hyperglycaemia
Clinical narrative: Blood sugar has been running high; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (Blood sugar has been running high) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HYPERGLYCAEMIA (Blood sugar has been running high). At the time of the report, HYPERGLYCAEMIA (Blood sugar has been running high) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Blood glucose: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up received on 25-JUN-2021 included no new information.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and FATIGUE (Fatigue) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced HEADACHE (headache) and FATIGUE (Fatigue). At the time of the report, HEADACHE (headache) and FATIGUE (Fatigue) 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.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Fatigue, Headache, Vaccination site erythema, Vaccination site pain
Clinical narrative: Increased Blood Pressure; Fatigue; Swelling - Near Injection Site; Arm Pain; Headache; Redness - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Increased Blood Pressure), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE PAIN (Arm Pain) and HEADACHE (Headache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Increased Blood Pressure), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE PAIN (Arm Pain), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site). The patient was treated with PARACETAMOL (TYLENOL) on 29-Jan-2021 for Adverse event following immunisation, at an unspecified dose and frequency. On 04-Feb-2021, BLOOD PRESSURE INCREASED (Increased Blood Pressure), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE PAIN (Arm Pain), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported using High blood pressure medications (not specified) concomitantly to manage Blood Pressure.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Increased Blood Pressure; Fatigue; Swelling - Near Injection Site; Arm Pain; Headache; Redness - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Increased Blood Pressure), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE PAIN (Arm Pain) and HEADACHE (Headache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Increased Blood Pressure), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE PAIN (Arm Pain), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site). The patient was treated with PARACETAMOL (TYLENOL) on 29-Jan-2021 for Adverse event following immunisation, at an unspecified dose and frequency. On 04-Feb-2021, BLOOD PRESSURE INCREASED (Increased Blood Pressure), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE PAIN (Arm Pain), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported using High blood pressure medications (not specified) concomitantly to manage Blood Pressure.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itching at the injection site; Pain at the injection site; Redness at the injection site; Swollen at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swollen at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swollen at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swollen at the injection site) had resolved.    No treatment information was provided.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; 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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: a stiff neck; During the week it was itchy; The area where I got the shot is red, a big circle that was red; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (a stiff neck), VACCINATION SITE PRURITUS (During the week it was itchy), VACCINATION SITE ERYTHEMA (The area where I got the shot is red, a big circle that was red) and HEADACHE (headaches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMINS NOS and Cholesterol Medication for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (a stiff neck), VACCINATION SITE PRURITUS (During the week it was itchy), VACCINATION SITE ERYTHEMA (The area where I got the shot is red, a big circle that was red) and HEADACHE (headaches). At the time of the report, MUSCULOSKELETAL STIFFNESS (a stiff neck), VACCINATION SITE PRURITUS (During the week it was itchy), VACCINATION SITE ERYTHEMA (The area where I got the shot is red, a big circle that was red) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she stopped taking aspirin 2 days ago as she read somewhere that it is better not to be taking painkillers.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Warmth at the site of injection; Reddness expanding to inner arm; Redness at the injection site; Itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE WARMTH (Warmth at the site of injection), VACCINATION SITE PRURITUS (Itching at the injection site) and ERYTHEMA (Reddness expanding to inner arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included RA (medication taken every week of Tuesday 26JAN2021) and Diabetes. Concomitant products included METFORMIN and GLYBURIDE for Diabetes, METHOTREXATE from 26-Jan-2021 to an unknown date for RA.  On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PRURITUS (Itching at the injection site). On 21-Jan-2021, the patient experienced ERYTHEMA (Reddness expanding to inner arm). On 24-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warmth at the site of injection). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE WARMTH (Warmth at the site of injection), VACCINATION SITE PRURITUS (Itching at the injection site) and ERYTHEMA (Reddness expanding to inner arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment details were not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Oral pain
Clinical narrative: His mouth and inside of the mouth was tender; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (His mouth and inside of the mouth was tender) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Periodontitis, High cholesterol and Heart valvular prosthesis user (artificial valve). Concomitant products included AMLODIPINE for Heart valvular prosthesis user, SPECTINOMYCIN HYDROCHLORIDE (TROBICIN [SPECTINOMYCIN HYDROCHLORIDE]) for High cholesterol.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced ORAL PAIN (His mouth and inside of the mouth was tender). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 25-Jan-2021 for Mouth pain, at a dose of 1 dosage form. On 25-Jan-2021, ORAL PAIN (His mouth and inside of the mouth was tender) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported, a month ago he started using a new antiseptic mouth medicine (unspecified) and a nurse said that may be what caused the side effects.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2021: Start date of suspect product was amended.  Patient demographics were updated.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection areas starting hurting; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (injection areas starting hurting) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection areas starting hurting). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (injection areas starting hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Large red, swollen patch (4 x 6")  at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Large red, swollen patch (4 x 6")  at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Stent placement on 19-Mar-2019. Previously administered products included for Vitamin B12 deficiency: Vitamin B12 on 02-Dec-2020. Concurrent medical conditions included Allergy to vaccine (Tetanus toxoid), Milk allergy, Allergy to chemicals (Off insect spray (dry formula only)), Blood pressure high since 15-Mar-2019 and Vitamin B12 deficiency since 30-Nov-2020. Concomitant products included LOSARTAN from 19-Mar-2019 to an unknown date and METOPROLOL from 19-Mar-2019 to an unknown date for Blood pressure high, ACETYLSALICYLIC ACID (BABY ASPIRIN) from 19-Mar-2019 to an unknown date for an unknown indication.    On 30-Dec-2020 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021 at 9:00 AM, the patient experienced VACCINATION SITE ERYTHEMA (Large red, swollen patch (4 x 6")  at the injection site). On 25-Jan-2021, VACCINATION SITE ERYTHEMA (Large red, swollen patch (4 x 6")  at the injection site) had resolved.            Large, red swollen patch (4 x 6 inches) on left arm. It resolved over time, but the skin looked different in that area for awhile (kind of burnt looking). It eventually faded away. No treatment medication us was reported/Provided   This case was linked to MOD-2021-025544 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Follow-up received on 05-Apr-2021 included no new information. On 07-Apr-2021: Follow-up information indicated patient's prior vaccine, allergies, medical history, concomitant medications and  event resolved date were provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash pruritic
Clinical narrative: Itchy rash; Both arms had little circular spots that were red that spread around the elbow; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Both arms had little circular spots that were red that spread around the elbow) and RASH PRURITIC (Itchy rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (amoxicillin) and Drug allergy (Norco). Concomitant products included INDAPAMIDE, SERTRALINE and ATORVASTATIN for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced ERYTHEMA (Both arms had little circular spots that were red that spread around the elbow). On 26-Jan-2021, the patient experienced RASH PRURITIC (Itchy rash). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) on 25-Jan-2021 for Erythema, at an unspecified dose and frequency; TRIAMCINOLONE (topical) on 25-Jan-2021 for Erythema and Itchy rash, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 25-Jan-2021 for Redness and Itchy rash, at an unspecified dose and frequency. On 28-Jan-2021, ERYTHEMA (Both arms had little circular spots that were red that spread around the elbow) and RASH PRURITIC (Itchy rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Additional info
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Chills, Cold sweat, Headache, Myalgia
Clinical narrative: Losing her voice; Fever now 99.8; Cold sweats; Sweating during the night; Cold; Body aches; Muscle pain; Feverish, fever 100.2; Chills; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Cold sweats), NIGHT SWEATS (Sweating during the night), NASOPHARYNGITIS (Cold), APHONIA (Losing her voice) and PAIN (Body aches) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 COLD SWEAT (Cold sweats), NIGHT SWEATS (Sweating during the night), NASOPHARYNGITIS (Cold), PAIN (Body aches), MYALGIA (Muscle pain), PYREXIA (Feverish, fever 100.2), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). On 08-Feb-2021, the patient experienced PYREXIA (Fever now 99.8). On an unknown date, the patient experienced APHONIA (Losing her voice). At the time of the report, COLD SWEAT (Cold sweats), NIGHT SWEATS (Sweating during the night), NASOPHARYNGITIS (Cold), APHONIA (Losing her voice), PAIN (Body aches), MYALGIA (Muscle pain), PYREXIA (Feverish, fever 100.2), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever now 99.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Pyrexia: 100.2 fever 100.2. On 08-Feb-2021, Pyrexia: 99.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by the reporter. No concomitant medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: TCR form was attached
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea, Night sweats, Pain, Pyrexia
Clinical narrative: Losing her voice; Fever now 99.8; Cold sweats; Sweating during the night; Cold; Body aches; Muscle pain; Feverish, fever 100.2; Chills; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Cold sweats), NIGHT SWEATS (Sweating during the night), NASOPHARYNGITIS (Cold), APHONIA (Losing her voice) and PAIN (Body aches) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 COLD SWEAT (Cold sweats), NIGHT SWEATS (Sweating during the night), NASOPHARYNGITIS (Cold), PAIN (Body aches), MYALGIA (Muscle pain), PYREXIA (Feverish, fever 100.2), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). On 08-Feb-2021, the patient experienced PYREXIA (Fever now 99.8). On an unknown date, the patient experienced APHONIA (Losing her voice). At the time of the report, COLD SWEAT (Cold sweats), NIGHT SWEATS (Sweating during the night), NASOPHARYNGITIS (Cold), APHONIA (Losing her voice), PAIN (Body aches), MYALGIA (Muscle pain), PYREXIA (Feverish, fever 100.2), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever now 99.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Pyrexia: 100.2 fever 100.2. On 08-Feb-2021, Pyrexia: 99.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by the reporter. No concomitant medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: TCR form was attached
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Pain in extremity, Peripheral coldness
Clinical narrative: I was very sick; so cold, couldn't get my body warm; My arm was very sore both days; fatigue like I never had before, tired; Terrible terrible headaches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was very sick), PERIPHERAL COLDNESS (so cold, couldn't get my body warm), PAIN IN EXTREMITY (My arm was very sore both days), FATIGUE (fatigue like I never had before, tired) and HEADACHE (Terrible terrible headaches) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ILLNESS (I was very sick), PERIPHERAL COLDNESS (so cold, couldn't get my body warm), PAIN IN EXTREMITY (My arm was very sore both days), FATIGUE (fatigue like I never had before, tired) and HEADACHE (Terrible terrible headaches). At the time of the report, ILLNESS (I was very sick), PERIPHERAL COLDNESS (so cold, couldn't get my body warm), PAIN IN EXTREMITY (My arm was very sore both days), FATIGUE (fatigue like I never had before, tired) and HEADACHE (Terrible terrible headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient reported she did not take any medications for treatment, just moved her arms around.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Feels run down - can't get out of bed; barely can talk; Arm was hurting; Fever; Headache; A spontaneous report (United States) was received from a consumer concerning a 40-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever, pain in arm, headache, felt run down - can't get out of bed and could barely talk.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced  fever, pain in arm and headache. On 28 Jan 2021, the patient experienced the events feels run down - can't get out of bed and could barely talk. No lab data was provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, fever, pain in arm, headache, felt run down - can't get out of bed and could barely talk was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Chills, Headache, Hyperhidrosis, Myalgia
Clinical narrative: sweating; Body temperature goes from very cold to very hot; Chills; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), BODY TEMPERATURE FLUCTUATION (Body temperature goes from very cold to very hot), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body ache) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HYPERHIDROSIS (sweating), BODY TEMPERATURE FLUCTUATION (Body temperature goes from very cold to very hot), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body ache). At the time of the report, HYPERHIDROSIS (sweating), BODY TEMPERATURE FLUCTUATION (Body temperature goes from very cold to very hot), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.