chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Heart rate, Hypersensitivity
Clinical narrative: felt shitty; histamine response; Chills for about 2 hours; fever of 100.1; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (felt shitty), HYPERSENSITIVITY (histamine response), CHILLS (Chills for about 2 hours) and PYREXIA (fever of 100.1) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    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 FEELING ABNORMAL (felt shitty), HYPERSENSITIVITY (histamine response), CHILLS (Chills for about 2 hours) and PYREXIA (fever of 100.1). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN CHILDREN) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt shitty), HYPERSENSITIVITY (histamine response), CHILLS (Chills for about 2 hours) and PYREXIA (fever of 100.1) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 100.1 (Inconclusive) 100.1. On 12-Feb-2021, Heart rate: 125 (High) resting heart rate was 125, it is normally 55.  On walking around and her heart 125 and went up as high as 140.  at 4am and still her heart rate was about 85. On 13-Feb-2021, Heart rate: 55 (Inconclusive) it went down to 55..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided Treatment information provided as Fluids
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: felt shitty; histamine response; Chills for about 2 hours; fever of 100.1; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (felt shitty), HYPERSENSITIVITY (histamine response), CHILLS (Chills for about 2 hours) and PYREXIA (fever of 100.1) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    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 FEELING ABNORMAL (felt shitty), HYPERSENSITIVITY (histamine response), CHILLS (Chills for about 2 hours) and PYREXIA (fever of 100.1). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN CHILDREN) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt shitty), HYPERSENSITIVITY (histamine response), CHILLS (Chills for about 2 hours) and PYREXIA (fever of 100.1) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 100.1 (Inconclusive) 100.1. On 12-Feb-2021, Heart rate: 125 (High) resting heart rate was 125, it is normally 55.  On walking around and her heart 125 and went up as high as 140.  at 4am and still her heart rate was about 85. On 13-Feb-2021, Heart rate: 55 (Inconclusive) it went down to 55..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided Treatment information provided as Fluids
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Severe side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Severe side effects). At the time of the report, VACCINATION COMPLICATION (Severe side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Vaccination site induration, Vaccination site warmth
Clinical narrative: blood pressure was elevated; warm to touch at injection site; hard at injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (blood pressure was elevated), VACCINATION SITE WARMTH (warm to touch at injection site) and VACCINATION SITE INDURATION (hard at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HYPERTENSION (blood pressure was elevated), VACCINATION SITE WARMTH (warm to touch at injection site) and VACCINATION SITE INDURATION (hard at injection site). At the time of the report, HYPERTENSION (blood pressure was elevated), VACCINATION SITE WARMTH (warm to touch at injection site) and VACCINATION SITE INDURATION (hard at injection site) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Blood pressure measurement: 152/81 mm/hg (Inconclusive) Elevated Blood pressure, 152/81 mm/Hg.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injected limb mobility decreased
Clinical narrative: unable to lift arm; severe joint pain right shoulder; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (unable to lift arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062620A) for an unknown indication.     The patient's past medical history included Capsulitis and Surgery (capsulitis).   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. 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 INJECTED LIMB MOBILITY DECREASED (unable to lift arm). At the time of the report, INJECTED LIMB MOBILITY DECREASED (unable to lift arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast, Breast pain, Burning sensation
Clinical narrative: extreme pain and burning at the site of breast biopsy; extreme pain and burning at the site of breast biopsy; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of BREAST PAIN (extreme pain and burning at the site of breast biopsy) and BURNING SENSATION (extreme pain and burning at the site of breast biopsy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 12220A) for COVID-19 vaccination.     The patient's past medical history included Breast biopsy on 18-Nov-2020.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced BREAST PAIN (extreme pain and burning at the site of breast biopsy) and BURNING SENSATION (extreme pain and burning at the site of breast biopsy). At the time of the report, BREAST PAIN (extreme pain and burning at the site of breast biopsy) and BURNING SENSATION (extreme pain and burning at the site of breast biopsy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2020, Biopsy breast: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on the Injection Site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on the Injection Site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness on the Injection Site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Rash pruritic, Vaccination site rash
Clinical narrative: stiff neck; a rash on the vaccine arm, that spread rapidly over next few days. It is red, 6 inches by 4 inches; a rash on the vaccine arm, that spread rapidly over next few days. It is red, 6 inches by 4 inches; headache; felt tired and exhausted; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), RASH PRURITIC (a rash on the vaccine arm, that spread rapidly over next few days. It is red, 6 inches by 4 inches), VACCINATION SITE RASH (a rash on the vaccine arm, that spread rapidly over next few days. It is red, 6 inches by 4 inches), FATIGUE (felt tired and exhausted) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease, Diabetes and Hair loss. Concomitant products included METFORMIN for Diabetes, SPIRONOLACTONE for Hair loss, LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease, ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    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 FATIGUE (felt tired and exhausted). On 05-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), RASH PRURITIC (a rash on the vaccine arm, that spread rapidly over next few days. It is red, 6 inches by 4 inches), VACCINATION SITE RASH (a rash on the vaccine arm, that spread rapidly over next few days. It is red, 6 inches by 4 inches) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Muscle pain, at an unspecified dose and frequency and HYDROCORTISONE for Rash, at an unspecified dose and frequency. On 30-Jan-2021, FATIGUE (felt tired and exhausted) had resolved. On 16-Feb-2021, HEADACHE (headache) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck), RASH PRURITIC (a rash on the vaccine arm, that spread rapidly over next few days. It is red, 6 inches by 4 inches) and VACCINATION SITE RASH (a rash on the vaccine arm, that spread rapidly over next few days. It is red, 6 inches by 4 inches) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Treatment information include an antihistamine cream for the rash.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: really hurt from injection site to wrist, and swollen; arm really hurt; Itchy around the injection site; Red 2-3 inch itchy circle around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy around the injection site), VACCINATION SITE ERYTHEMA (Red 2-3 inch itchy circle around the injection site), VACCINATION SITE PAIN (arm really hurt) and VACCINATION SITE SWELLING (really hurt from injection site to wrist, and swollen) in a 78-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 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy around the injection site) and VACCINATION SITE ERYTHEMA (Red 2-3 inch itchy circle around the injection site). On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm really hurt). On 12-Feb-2021, the patient experienced VACCINATION SITE SWELLING (really hurt from injection site to wrist, and swollen). The patient was treated with HYDROCORTISONE ACETATE (CORTIZONE [HYDROCORTISONE ACETATE]) at an unspecified dose and frequency and MENTHOL, METHYL SALICYLATE (BEN GAY) at an unspecified dose and frequency. On 26-Jan-2021, VACCINATION SITE PRURITUS (Itchy around the injection site) and VACCINATION SITE ERYTHEMA (Red 2-3 inch itchy circle around the injection site) had resolved. At the time of the report, VACCINATION SITE PAIN (arm really hurt) and VACCINATION SITE SWELLING (really hurt from injection site to wrist, and swollen) outcome was unknown.            No Concomitant medications were provided Treatment information provided skin moisturizer   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: Follow up received
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest pain
Clinical narrative: upper abdominal pressure; weird chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (weird chest pain) and ABDOMINAL DISCOMFORT (upper abdominal pressure) in a 28-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 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced CHEST PAIN (weird chest pain). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upper abdominal pressure). At the time of the report, CHEST PAIN (weird chest pain) and ABDOMINAL DISCOMFORT (upper abdominal pressure) 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.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site mass, Vaccination site swelling
Clinical narrative: hard golf ball size lump; red; itchy; little swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (little swelling), VACCINATION SITE MASS (hard golf ball size lump), ERYTHEMA (red) and PRURITUS (itchy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) 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 11-Feb-2021, the patient experienced VACCINATION SITE SWELLING (little swelling). On 15-Feb-2021, the patient experienced VACCINATION SITE MASS (hard golf ball size lump), ERYTHEMA (red) and PRURITUS (itchy). At the time of the report, VACCINATION SITE SWELLING (little swelling), VACCINATION SITE MASS (hard golf ball size lump), ERYTHEMA (red) and PRURITUS (itchy) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No relevant concomitant medications were reported.  No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Myalgia
Clinical narrative: Is hard for her to get around (more than usual); Feeling achy; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Is hard for her to get around (more than usual)) and MYALGIA (Feeling achy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced GAIT DISTURBANCE (Is hard for her to get around (more than usual)) and MYALGIA (Feeling achy). At the time of the report, GAIT DISTURBANCE (Is hard for her to get around (more than usual)) and MYALGIA (Feeling achy) outcome was unknown.     No relevant concomitant medications were reported.  Treatment information for the events was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Sore arm; Vomiting; A spontaneous report  was received from a consumer concerning a 77-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, vomiting.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 0316204) intramuscularly for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the event(s) sore arm. vomiting.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, vomiting was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Heart rate increased, Hypertension
Clinical narrative: VERY FATIGUED; sharp pain in her head like in the back of her eye; HEART WAS BEATING FAST; BLOOD PRESSURE WAS GOING UP; COULD HARDLY OPEN HER EYES; COULD HARDLY SPEAK; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (VERY FATIGUED), HEADACHE (sharp pain in her head like in the back of her eye), HEART RATE INCREASED (HEART WAS BEATING FAST), HYPERTENSION (BLOOD PRESSURE WAS GOING UP) and SOMNOLENCE (COULD HARDLY OPEN HER EYES) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROXYZINE, AMITRIPTYLINE, CAFFEINE, MAGNESIUM SALICYLATE (DIUREX WATER PILLS), OMEPRAZOLE and PROBIOTICS NOS 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 FATIGUE (VERY FATIGUED), HEADACHE (sharp pain in her head like in the back of her eye), HEART RATE INCREASED (HEART WAS BEATING FAST), HYPERTENSION (BLOOD PRESSURE WAS GOING UP), SOMNOLENCE (COULD HARDLY OPEN HER EYES) and ASTHENIA (COULD HARDLY SPEAK). On 12-Feb-2021, FATIGUE (VERY FATIGUED), HEART RATE INCREASED (HEART WAS BEATING FAST) and SOMNOLENCE (COULD HARDLY OPEN HER EYES) had resolved, HYPERTENSION (BLOOD PRESSURE WAS GOING UP) outcome was unknown. At the time of the report, HEADACHE (sharp pain in her head like in the back of her eye) and ASTHENIA (COULD HARDLY SPEAK) 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 is on concomitant medicine for her blood pressure, thyroid and pain.  Treatment medicines was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Patient denied further follow up stating they are fine now
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: VERY FATIGUED; sharp pain in her head like in the back of her eye; HEART WAS BEATING FAST; BLOOD PRESSURE WAS GOING UP; COULD HARDLY OPEN HER EYES; COULD HARDLY SPEAK; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (VERY FATIGUED), HEADACHE (sharp pain in her head like in the back of her eye), HEART RATE INCREASED (HEART WAS BEATING FAST), HYPERTENSION (BLOOD PRESSURE WAS GOING UP) and SOMNOLENCE (COULD HARDLY OPEN HER EYES) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROXYZINE, AMITRIPTYLINE, CAFFEINE, MAGNESIUM SALICYLATE (DIUREX WATER PILLS), OMEPRAZOLE and PROBIOTICS NOS 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 FATIGUE (VERY FATIGUED), HEADACHE (sharp pain in her head like in the back of her eye), HEART RATE INCREASED (HEART WAS BEATING FAST), HYPERTENSION (BLOOD PRESSURE WAS GOING UP), SOMNOLENCE (COULD HARDLY OPEN HER EYES) and ASTHENIA (COULD HARDLY SPEAK). On 12-Feb-2021, FATIGUE (VERY FATIGUED), HEART RATE INCREASED (HEART WAS BEATING FAST) and SOMNOLENCE (COULD HARDLY OPEN HER EYES) had resolved, HYPERTENSION (BLOOD PRESSURE WAS GOING UP) outcome was unknown. At the time of the report, HEADACHE (sharp pain in her head like in the back of her eye) and ASTHENIA (COULD HARDLY SPEAK) 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 is on concomitant medicine for her blood pressure, thyroid and pain.  Treatment medicines was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Patient denied further follow up stating they are fine now
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: Itching; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and SWELLING (Swelling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) 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) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PRURITUS (Itching) and SWELLING (Swelling). At the time of the report, PRURITUS (Itching) and SWELLING (Swelling) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Soreness of arm; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) and FATIGUE (Tiredness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm) and FATIGUE (Tiredness). At the time of the report, PAIN IN EXTREMITY (Soreness of arm) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: woke up with chest hot; red spot on arm; delayed reaction arm pain; delayed reaction arm swollen; delayed reaction rash injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (woke up with chest hot), VACCINATION SITE RASH (delayed reaction rash injection site), VACCINATION SITE ERYTHEMA (red spot on arm), VACCINATION SITE PAIN (delayed reaction arm pain) and VACCINATION SITE SWELLING (delayed reaction arm swollen) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE RASH (delayed reaction rash injection site). On an unknown date, the patient experienced CHEST DISCOMFORT (woke up with chest hot), VACCINATION SITE ERYTHEMA (red spot on arm), VACCINATION SITE PAIN (delayed reaction arm pain) and VACCINATION SITE SWELLING (delayed reaction arm swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site pain and Vaccination site swelling, at an unspecified dose and frequency and HYDROCORTISONE for Vaccination site pain and Vaccination site swelling, at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (woke up with chest hot), VACCINATION SITE RASH (delayed reaction rash injection site), VACCINATION SITE ERYTHEMA (red spot on arm), VACCINATION SITE PAIN (delayed reaction arm pain) and VACCINATION SITE SWELLING (delayed reaction arm swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Sweating; Fever; Sore muscles; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Sore muscles) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L2OA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 13-Jul-2020.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced CHILLS (Chills). On 22-Jan-2021, the patient experienced HYPERHIDROSIS (Sweating), PYREXIA (Fever) and MYALGIA (Sore muscles). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Sore muscles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus
Clinical narrative: Generalize itching; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Generalize itching) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PRURITUS (Generalize itching) and HEADACHE (Headache). At the time of the report, PRURITUS (Generalize itching) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever 108C; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 108C) 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 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PYREXIA (fever 108C). At the time of the report, PYREXIA (fever 108C) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Body temperature: 108c (High) 108C.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Chills; Nausea; Diarrhea; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Injection site pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 09-Dec-2020.    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 VACCINATION SITE PAIN (Injection site pain). On 13-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Injection site pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information were provided
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Lymphadenopathy, Peripheral swelling, Pruritus, Rash macular
Clinical narrative: Underarm itched; bruise spots; red spots on left breast; Swelling of lymh node under left arm; underneath her left arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (underneath her left arm is swollen), PRURITUS (Underarm itched), CONTUSION (bruise spots), RASH MACULAR (red spots on left breast) and LYMPHADENOPATHY (Swelling of lymh node under left arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 12-Feb-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (underneath her left arm is swollen). On 13-Feb-2021 at 7:00 PM, the patient experienced PRURITUS (Underarm itched), CONTUSION (bruise spots), RASH MACULAR (red spots on left breast) and LYMPHADENOPATHY (Swelling of lymh node under left arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 02-Mar-2021, PRURITUS (Underarm itched), CONTUSION (bruise spots), RASH MACULAR (red spots on left breast) and LYMPHADENOPATHY (Swelling of lymh node under left arm) had resolved. At the time of the report, PERIPHERAL SWELLING (underneath her left arm is swollen) outcome was unknown. Not Provided          No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Non significant follow up. Updated Email address was added. On 05-Aug-2021: Follow up received, information about Patient demographic, added events, added event outcome and added event assessment were updated.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Sinus disorder
Clinical narrative: Sinus issues; Runny nose; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (Sinus issues), RHINORRHOEA (Runny nose) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUS DISORDER (Sinus issues), RHINORRHOEA (Runny nose) and PYREXIA (Fever). At the time of the report, SINUS DISORDER (Sinus issues), RHINORRHOEA (Runny nose) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Updated the second dose details and updated the action taken as not applicable from unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Discomfort, Pyrexia
Clinical narrative: Weight on my head; chills; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (chills), PYREXIA (Fever) and DISCOMFORT (Weight on my head) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (Fever) and DISCOMFORT (Weight on my head). At the time of the report, CHILLS (chills), PYREXIA (Fever) and DISCOMFORT (Weight on my head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter considered CHILLS (chills), PYREXIA (Fever) and DISCOMFORT (Weight on my head) to be related.    Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Vitamin D
Clinical narrative: Blood pressure increase; UTI; Elevated hct and hgb; Presence of huge lymph nodes - LEFT; Dizziness; Weakness; Hard; Palpitation; Left arm soreness; Left arm hurts when raised especially the elbow; Swollen on the left forearm; Swollen on the elbow; Joint ache; Muscle ache; A spontaneous report was received from a healthcare professional concerning a 51-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscle ache, joint ache, left arm soreness, left arm hurts when raised especially the elbow, swollen on the left upper arm, swollen on the left forearm, swollen on the elbow, hard, palpitation, dizziness, weakness, presence of huge lymph nodes - left, multiple lymph nodes in the clavicle and armpit, uti , swollen lymph nodes on her left axilla.  The patient's medical history was not provided. Concomitant medications reported were Multivitamins for supplemental purposes, Vitamin D3 for drug use for unknown indication.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced the events muscle ache. joint ache, left arm soreness, left arm hurts when raised especially the elbow, swollen on the left upper arm, swollen on the left forearm, swollen on the elbow, hard. On 22 Jan 2021, the patient experienced the event(s) palpitation. elevated heart rate, dizziness, weakness. On 24 Jan 2021, the patient experienced the event(s) presence of huge lymph nodes - left . On 28 Jan 2021, the patient experienced the event(s) bp 199 133. multiple lymph nodes in the clavicle and armpit, elevated hct and hgb. On 29 Jan 2021, the patient experienced the event(s) elevated ferritin level. decreased vitamin d, uti, sinus rhythm abnormality in her t-wave. On 2 Feb 2021, the patient experienced the event(s) swollen lymph nodes on her left axilla. laboratory exams performed to further diagnose the event were blood pressure 199/133, CT scan lung multiple lymph nodes on the clavicle and armpit area, electrocardiogram Sinus Rhythm abnormality in her T-Wave, elevated hematocrit ,hemoglobin, heart rate, ultrasound and mammogram, elevated serum ferritin , urinalysis, decreased vitamin D. Treatment details included Was under Amlodipine and Antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event muscle ache, joint ache was considered resolved on 23 Jan 2021.The outcome of events, left arm soreness, left arm hurts when raised especially the elbow,swollen on the left upper arm,swollen on the left forearm,swollen on the elbow, hard, palpitation, dizziness, weakness, presence of huge lymph nodes - left,multiple lymph nodes in the clavicle and armpit, uti, swollen lymph nodes on her left axilla was considered not resolved.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Menstrual disorder, Nausea, Vertigo
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MENSTRUAL DISORDER (Menstrual period), VERTIGO (Extreme vertigo where she couldn't walk), NAUSEA (Nausea) and FATIGUE (Feeling a little soggy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical conditions reported.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced HEADACHE (Headache). On 21-Jan-2021, the patient experienced MENSTRUAL DISORDER (Menstrual period). On an unknown date, the patient experienced VERTIGO (Extreme vertigo where she couldn't walk), NAUSEA (Nausea) and FATIGUE (Feeling a little soggy). At the time of the report, HEADACHE (Headache), MENSTRUAL DISORDER (Menstrual period), VERTIGO (Extreme vertigo where she couldn't walk), NAUSEA (Nausea) and FATIGUE (Feeling a little soggy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included,Augmentin antivertigo medication and an antinausea medication.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity, Pruritus
Clinical narrative: slightly itchy; still very red and large; injection site was raised; injection site redness; injection site hard and hot to touch; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), INJECTION SITE WARMTH (injection site hard and hot to touch), PRURITUS (slightly itchy), INJECTION SITE SWELLING (injection site was raised) and INJECTION SITE ERYTHEMA (injection site redness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 29L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 12-Feb-2021, the patient experienced INJECTION SITE WARMTH (injection site hard and hot to touch), INJECTION SITE SWELLING (injection site was raised) and INJECTION SITE ERYTHEMA (injection site redness). On 13-Feb-2021, the patient experienced PRURITUS (slightly itchy) and INJECTION SITE ERYTHEMA (still very red and large). At the time of the report, PAIN IN EXTREMITY (arm soreness), INJECTION SITE WARMTH (injection site hard and hot to touch), PRURITUS (slightly itchy), INJECTION SITE SWELLING (injection site was raised), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE ERYTHEMA (still very red and large) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: give 13 doses from single vial; A spontaneous report was received from a healthcare professional concerning 13 unidentified patients who were administered 13 doses from a single vial of Moderna COVID-19 vaccine.  No medical history was reporter. Concomitant product use was not provided.   On an unknown date, the patients received planned dose of mRNA-1273 (lot # 016M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, a staff member gave 13 doses from a single vial of Moderna COVID-19 vaccine. The reporter inquired if lot was overfilled or if staff performed error in administration of vaccine.  Action taken with mRNA-1273 was not reported.  The outcome of event was unknown.; Reporter's Comments: This report refers to a case of Accidental underdose for mRNA-1273, lot # Unknown, with no associated AEs.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Arm has a lump; Arm itches; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Arm has a lump), VACCINATION SITE PRURITUS (Arm itches) and VACCINATION SITE PAIN (Arm was sore) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037L20a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE MASS (Arm has a lump), VACCINATION SITE PRURITUS (Arm itches) and VACCINATION SITE PAIN (Arm was sore). At the time of the report, VACCINATION SITE MASS (Arm has a lump), VACCINATION SITE PRURITUS (Arm itches) and VACCINATION SITE PAIN (Arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Lung disorder, SARS-CoV-2 test, X-ray
Clinical narrative: Covid + after the 1th shot; Lungs burning; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid + after the 1th shot) and LUNG DISORDER (Lungs burning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy and Blood pressure. Concomitant products included LISINOPRIL for Blood pressure management.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced LUNG DISORDER (Lungs burning). On 29-Jan-2021, the patient experienced COVID-19 (Covid + after the 1th shot). At the time of the report, COVID-19 (Covid + after the 1th shot) and LUNG DISORDER (Lungs burning) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, SARS-CoV-2 test: positive (Positive) tested Covid + on Jan 29. On an unknown date, X-ray: normal (normal) patient received clear x-ray.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Patient was scheduled to get second dose of vaccine on 15-Feb-2021.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site pain, Vaccination site pruritus
Clinical narrative: felt Itchy all over the body; Rash all over the body; Itching Injection Site; Tender/Sore Injection Site; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (felt Itchy all over the body), RASH (Rash all over the body), VACCINATION SITE PRURITUS (Itching Injection Site) and VACCINATION SITE PAIN (Tender/Sore Injection Site) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching Injection Site) and VACCINATION SITE PAIN (Tender/Sore Injection Site). On 11-Feb-2021, the patient experienced PRURITUS (felt Itchy all over the body) and RASH (Rash all over the body). On 11-Feb-2021, VACCINATION SITE PAIN (Tender/Sore Injection Site) outcome was unknown. At the time of the report, PRURITUS (felt Itchy all over the body), RASH (Rash all over the body) and VACCINATION SITE PRURITUS (Itching Injection Site) outcome was unknown.            No concomitants or treatment medications were reported.