chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia, Pain in extremity
Clinical narrative: sore arm; body aches; headache; severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea), PAIN IN EXTREMITY (sore arm), MYALGIA (body aches) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced DIARRHOEA (severe diarrhea). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, DIARRHOEA (severe diarrhea), PAIN IN EXTREMITY (sore arm), MYALGIA (body aches) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She said she'll go out to the store today to get Pepto- Bismol or something. When referred to her HCP, she said she has a VA doctor and you can't just call up a VA doctor. She would have to go to the emergency room. No concomitant medication were reported No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Additional information was received on 14-May-2021. Outcome of the events was updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Hypersensitivity reaction; This spontaneous case was reported by a dentist and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 041L20A) for COVID-19 vaccination.     Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]) for Bladder disorder NOS, ROSUVASTATIN CALCIUM (CRESTOR) for Hypercholesterolaemia, GABAPENTIN for Spinal disorder NOS, OMEGA-3-ACID ETHYL ESTER (LOVAZA), PANTOPRAZOLE, FISH OIL and VITAMIN D NOS for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021 at 11:00 AM, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) from 14-Jan-2021 to January 2021 for Adverse event, at a dose of 1 dosage form; METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) 03-Feb-2021 for Adverse event, at an unspecified dose and frequency; IBUPROFEN at a dose of 2 dosage form and NAPROXEN (MOTRIN [NAPROXEN]) at a dose of 2 dosage form. On 16-Jan-2021, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient informed that her arm started to itch and when she scratched it, it was very warm and red. She experienced symptoms of hypersensitivity reaction including itching/pruritis, rashes, arm was warm (hot localized), indurated hive at injection site, photo sensitivity to sun, hot pink look on the skin/red. The side effects of sensitivity was stronger at time of first dose but caused no skin damage, just a quick dark pink button color to skin exposed to sun. Patient's vitals including body temperature, heart rate, respiratory rate and blood pressure on 14-Jan-2021, were reported within limits. She reported that her symptoms of 'itchy red, warm to touch, elevated hive' were eliminated two days after taking Medrol pack.  The Medrol pack was taken at the time of second vaccine and there were no side effects at all. Also, she reported that the sun sensitivity was not as strong with the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 08-Aug-2021: Additional reporter details, action taken and concomitant medication details were updated. Final diagnosis of 'hypersensitivity reaction' was captured as the only event.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: she cannot attend for the second dose (first dose 19FEB2021, second dose 19MAR2021); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (she cannot attend for the second dose (first dose 19FEB2021, second dose 19MAR2021)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (she cannot attend for the second dose (first dose 19FEB2021, second dose 19MAR2021)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (she cannot attend for the second dose (first dose 19FEB2021, second dose 19MAR2021)) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: received 2nd dose
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Rash
Clinical narrative: Rash over while body; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of RASH and DIZZINESS in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH and DIZZINESS. At the time of the report, RASH  and DIZZINESS outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Neck pain
Clinical narrative: Sweats; Neck pain ("shooting up my spine"); Headache; Body aches; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), NECK PAIN (Neck pain ("shooting up my spine")), HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Chills) in a female 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 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced HYPERHIDROSIS (Sweats), NECK PAIN (Neck pain ("shooting up my spine")), HEADACHE (Headache), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweats), NECK PAIN (Neck pain ("shooting up my spine")), HEADACHE (Headache), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sweats; Neck pain ("shooting up my spine"); Headache; Body aches; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), NECK PAIN (Neck pain ("shooting up my spine")), HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Chills) in a female 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 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced HYPERHIDROSIS (Sweats), NECK PAIN (Neck pain ("shooting up my spine")), HEADACHE (Headache), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweats), NECK PAIN (Neck pain ("shooting up my spine")), HEADACHE (Headache), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Under 18 years old received first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years old received first dose) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years old received first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years old received first dose) had 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.   This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown,  with no associated AEs.   This case was linked to US-MODERNATX, INC.-MOD-2021-066855  (Linked Report).; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown,  with no associated AEs. US-MODERNATX, INC.-MOD-2021-066855:Crossed linked
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Polydipsia, Pyrexia
Clinical narrative: she has felt thirsty for 6 days; fever for 1 day; This spontaneous case was reported by a consumer and describes the occurrence of POLYDIPSIA (she has felt thirsty for 6 days) and PYREXIA (fever for 1 day) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced POLYDIPSIA (she has felt thirsty for 6 days) and PYREXIA (fever for 1 day). On 27-Mar-2021, PYREXIA (fever for 1 day) had resolved. At the time of the report, POLYDIPSIA (she has felt thirsty for 6 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Chills, Insomnia, Lethargy, Myalgia
Clinical narrative: has a bad hip which has gotten seriously inflamed; really intense muscular pain; Chills; trouble sleeping; Lethargic; achy; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (has a bad hip which has gotten seriously inflamed), INSOMNIA (trouble sleeping), LETHARGY (Lethargic), PAIN (achy) and MYALGIA (really intense muscular pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hip discomfort.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced INSOMNIA (trouble sleeping), LETHARGY (Lethargic), PAIN (achy) and CHILLS (Chills). On 31-Mar-2021, the patient experienced ARTHRITIS (has a bad hip which has gotten seriously inflamed) and MYALGIA (really intense muscular pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form and TRAMADOL at a dose of 1 dosage form. At the time of the report, ARTHRITIS (has a bad hip which has gotten seriously inflamed), INSOMNIA (trouble sleeping), LETHARGY (Lethargic), PAIN (achy), MYALGIA (really intense muscular pain) and CHILLS (Chills) outcome was unknown.            Concomitant medications were not provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: has a bad hip which has gotten seriously inflamed; really intense muscular pain; Chills; trouble sleeping; Lethargic; achy; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (has a bad hip which has gotten seriously inflamed), INSOMNIA (trouble sleeping), LETHARGY (Lethargic), PAIN (achy) and MYALGIA (really intense muscular pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hip discomfort.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced INSOMNIA (trouble sleeping), LETHARGY (Lethargic), PAIN (achy) and CHILLS (Chills). On 31-Mar-2021, the patient experienced ARTHRITIS (has a bad hip which has gotten seriously inflamed) and MYALGIA (really intense muscular pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form and TRAMADOL at a dose of 1 dosage form. At the time of the report, ARTHRITIS (has a bad hip which has gotten seriously inflamed), INSOMNIA (trouble sleeping), LETHARGY (Lethargic), PAIN (achy), MYALGIA (really intense muscular pain) and CHILLS (Chills) outcome was unknown.            Concomitant medications were not provided by reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Fatigue, Feeling abnormal, Gait inability
Clinical narrative: has been feeling really bad, ¨i have never felt this bad before; my body hurts really bad; bone pain; chills; have been tired all day, can´t wake up from bed; Legs hurt a lot; is not able to walk due to the pain; think she has fever; terrible headache; arm is really sore and hurts; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (has been feeling really bad, ¨i have never felt this bad before), MYALGIA (my body hurts really bad), BONE PAIN (bone pain), CHILLS (chills) and FATIGUE (have been tired all day, can´t wake up from bed) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 01-Apr-2021, the patient experienced FEELING ABNORMAL (has been feeling really bad, ¨i have never felt this bad before), MYALGIA (my body hurts really bad), BONE PAIN (bone pain), CHILLS (chills), FATIGUE (have been tired all day, can´t wake up from bed), PAIN IN EXTREMITY (Legs hurt a lot), GAIT INABILITY (is not able to walk due to the pain), PYREXIA (think she has fever), HEADACHE (terrible headache) and MYALGIA (arm is really sore and hurts). At the time of the report, FEELING ABNORMAL (has been feeling really bad, ¨i have never felt this bad before), MYALGIA (my body hurts really bad), BONE PAIN (bone pain), CHILLS (chills), FATIGUE (have been tired all day, can´t wake up from bed), PAIN IN EXTREMITY (Legs hurt a lot), GAIT INABILITY (is not able to walk due to the pain), PYREXIA (think she has fever), HEADACHE (terrible headache) and MYALGIA (arm is really sore and hurts) outcome was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: has been feeling really bad, ¨i have never felt this bad before; my body hurts really bad; bone pain; chills; have been tired all day, can´t wake up from bed; Legs hurt a lot; is not able to walk due to the pain; think she has fever; terrible headache; arm is really sore and hurts; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (has been feeling really bad, ¨i have never felt this bad before), MYALGIA (my body hurts really bad), BONE PAIN (bone pain), CHILLS (chills) and FATIGUE (have been tired all day, can´t wake up from bed) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 01-Apr-2021, the patient experienced FEELING ABNORMAL (has been feeling really bad, ¨i have never felt this bad before), MYALGIA (my body hurts really bad), BONE PAIN (bone pain), CHILLS (chills), FATIGUE (have been tired all day, can´t wake up from bed), PAIN IN EXTREMITY (Legs hurt a lot), GAIT INABILITY (is not able to walk due to the pain), PYREXIA (think she has fever), HEADACHE (terrible headache) and MYALGIA (arm is really sore and hurts). At the time of the report, FEELING ABNORMAL (has been feeling really bad, ¨i have never felt this bad before), MYALGIA (my body hurts really bad), BONE PAIN (bone pain), CHILLS (chills), FATIGUE (have been tired all day, can´t wake up from bed), PAIN IN EXTREMITY (Legs hurt a lot), GAIT INABILITY (is not able to walk due to the pain), PYREXIA (think she has fever), HEADACHE (terrible headache) and MYALGIA (arm is really sore and hurts) outcome was unknown.
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: under 18 years old got first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old got first dose) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old got first dose). On 18-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old got first dose) 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.   No concomitant medications were reported. Patient did not receive any treatment drug.  This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: Not Provided) with no associated AEs. Patient received his second dose on 15 april  2021 with the batch number 041B21A through intramuscular route. Patient received his second dose 28 days apart from the first dose.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up was received on 19 may 2021significant case  included no new information- reporter talking about 17 year old patient not for this case.added second dose information; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: Not Provided) with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Feeling hot, Gait disturbance, Muscular weakness, Myalgia
Clinical narrative: Weakness when walking; Unusually unstable gait when she walks; Legs feel warm; Rest of her body feels cold; Not sure if she has a fever; Muscles are achy in her shoulder; Pain in the arm specifically around the injection point; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness when walking), GAIT DISTURBANCE (Unusually unstable gait when she walks), FEELING HOT (Legs feel warm), FEELING COLD (Rest of her body feels cold) and PYREXIA (Not sure if she has a fever) in a female 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.     Concurrent medical conditions included Parkinson's disease. Concomitant products included CARBIDOPA, LEVODOPA (SINEMET) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain in the arm specifically around the injection point). On 01-Apr-2021, the patient experienced MUSCULAR WEAKNESS (Weakness when walking), GAIT DISTURBANCE (Unusually unstable gait when she walks), FEELING HOT (Legs feel warm), FEELING COLD (Rest of her body feels cold), PYREXIA (Not sure if she has a fever) and MYALGIA (Muscles are achy in her shoulder). The patient was treated with IBUPROFEN (ADVIL 12HOUR) for Pain and Fever, at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (Weakness when walking), GAIT DISTURBANCE (Unusually unstable gait when she walks), FEELING HOT (Legs feel warm), FEELING COLD (Rest of her body feels cold), PYREXIA (Not sure if she has a fever), MYALGIA (Muscles are achy in her shoulder) and VACCINATION SITE PAIN (Pain in the arm specifically around the injection point) outcome was unknown.  Action taken with mRNA-1273 in response to the events was not applicable
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Weakness when walking; Unusually unstable gait when she walks; Legs feel warm; Rest of her body feels cold; Not sure if she has a fever; Muscles are achy in her shoulder; Pain in the arm specifically around the injection point; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness when walking), GAIT DISTURBANCE (Unusually unstable gait when she walks), FEELING HOT (Legs feel warm), FEELING COLD (Rest of her body feels cold) and PYREXIA (Not sure if she has a fever) in a female 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.     Concurrent medical conditions included Parkinson's disease. Concomitant products included CARBIDOPA, LEVODOPA (SINEMET) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain in the arm specifically around the injection point). On 01-Apr-2021, the patient experienced MUSCULAR WEAKNESS (Weakness when walking), GAIT DISTURBANCE (Unusually unstable gait when she walks), FEELING HOT (Legs feel warm), FEELING COLD (Rest of her body feels cold), PYREXIA (Not sure if she has a fever) and MYALGIA (Muscles are achy in her shoulder). The patient was treated with IBUPROFEN (ADVIL 12HOUR) for Pain and Fever, at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (Weakness when walking), GAIT DISTURBANCE (Unusually unstable gait when she walks), FEELING HOT (Legs feel warm), FEELING COLD (Rest of her body feels cold), PYREXIA (Not sure if she has a fever), MYALGIA (Muscles are achy in her shoulder) and VACCINATION SITE PAIN (Pain in the arm specifically around the injection point) outcome was unknown.  Action taken with mRNA-1273 in response to the events was not applicable
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache every single day which worsens at night), PAIN IN EXTREMITY (sore arm) and PAIN (throbbing pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced HEADACHE (headache every single day which worsens at night) and PAIN (throbbing pain). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 19-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, HEADACHE (headache every single day which worsens at night) and PAIN (throbbing pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product used was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching). At the time of the report, PRURITUS (itching) outcome was unknown.            Concomitant and Treatment medications were not provided by reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: Blood in urine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in urine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced BLOOD URINE PRESENT (Blood in urine). At the time of the report, BLOOD URINE PRESENT (Blood in urine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: diarrhea; soreness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (soreness in the injection site) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (soreness in the injection site). At the time of the report, DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (soreness in the injection site) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Feeling abnormal, Headache, Illness
Clinical narrative: she was still not doing well; joints hurt; bad headache; Evening she began to not feel well; Feels sick; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Evening she began to not feel well), ILLNESS (Feels sick), MALAISE (she was still not doing well), ARTHRALGIA (joints hurt) and HEADACHE (bad headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced FEELING ABNORMAL (Evening she began to not feel well), ILLNESS (Feels sick), ARTHRALGIA (joints hurt) and HEADACHE (bad headache). On an unknown date, the patient experienced MALAISE (she was still not doing well). At the time of the report, FEELING ABNORMAL (Evening she began to not feel well), ILLNESS (Feels sick), MALAISE (she was still not doing well), ARTHRALGIA (joints hurt) and HEADACHE (bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 10 (High) 101, 102 degrees Fahrenheit, today it's a 99.         No Concomitant medications were provided by the reporter. Treatment medications included Tylenol was noted   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Additional Information received on 14-MAY-2021 Included no new significant information and Patient stated that she was still not doing well.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: she was still not doing well; joints hurt; bad headache; Evening she began to not feel well; Feels sick; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Evening she began to not feel well), ILLNESS (Feels sick), MALAISE (she was still not doing well), ARTHRALGIA (joints hurt) and HEADACHE (bad headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced FEELING ABNORMAL (Evening she began to not feel well), ILLNESS (Feels sick), ARTHRALGIA (joints hurt) and HEADACHE (bad headache). On an unknown date, the patient experienced MALAISE (she was still not doing well). At the time of the report, FEELING ABNORMAL (Evening she began to not feel well), ILLNESS (Feels sick), MALAISE (she was still not doing well), ARTHRALGIA (joints hurt) and HEADACHE (bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 10 (High) 101, 102 degrees Fahrenheit, today it's a 99.         No Concomitant medications were provided by the reporter. Treatment medications included Tylenol was noted   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Additional Information received on 14-MAY-2021 Included no new significant information and Patient stated that she was still not doing well.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Peripheral swelling
Clinical narrative: Diarhhea; Swollen arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarhhea), PERIPHERAL SWELLING (Swollen arm) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported. .     On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced DIARRHOEA (Diarhhea), PERIPHERAL SWELLING (Swollen arm) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarhhea), PERIPHERAL SWELLING (Swollen arm) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received; event outcomes updated
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Really bad headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Really bad headache). At the time of the report, HEADACHE (Really bad headache) outcome was unknown. Not Provided           The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal discomfort, Pyrexia, Tinnitus
Clinical narrative: tinnitus; headache; fever; scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (scratchy throat), TINNITUS (tinnitus), HEADACHE (headache) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 028A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE for Diuresis, LOSARTAN for Hypertension.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (scratchy throat), HEADACHE (headache) and PYREXIA (fever). On 01-Apr-2021, the patient experienced TINNITUS (tinnitus). On 04-Mar-2021, OROPHARYNGEAL DISCOMFORT (scratchy throat), HEADACHE (headache) and PYREXIA (fever) outcome was unknown. At the time of the report, TINNITUS (tinnitus) outcome was unknown.            No treatment information were reported. Action taken with mRNA-1273 in response to the event was not applicable
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: sore throat; COVID-19 positive after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and SARS-COV-2 TEST POSITIVE (COVID-19 positive after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and SARS-COV-2 TEST POSITIVE (COVID-19 positive after 1st dose). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and SARS-COV-2 TEST POSITIVE (COVID-19 positive after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Pyrexia, SARS-CoV-1 test
Clinical narrative: Injection arm sore; chills; fever of 101.3; lethargic; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection arm sore), CHILLS (chills), PYREXIA (fever of 101.3), LETHARGY (lethargic) and HEADACHE (bad headache) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia (tested positive for covid in 2020 and did develop pneumonia).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Injection arm sore), CHILLS (chills), PYREXIA (fever of 101.3), LETHARGY (lethargic) and HEADACHE (bad headache). At the time of the report, VACCINATION SITE PAIN (Injection arm sore), CHILLS (chills), PYREXIA (fever of 101.3), LETHARGY (lethargic) and HEADACHE (bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-1 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection arm sore; chills; fever of 101.3; lethargic; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection arm sore), CHILLS (chills), PYREXIA (fever of 101.3), LETHARGY (lethargic) and HEADACHE (bad headache) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia (tested positive for covid in 2020 and did develop pneumonia).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Injection arm sore), CHILLS (chills), PYREXIA (fever of 101.3), LETHARGY (lethargic) and HEADACHE (bad headache). At the time of the report, VACCINATION SITE PAIN (Injection arm sore), CHILLS (chills), PYREXIA (fever of 101.3), LETHARGY (lethargic) and HEADACHE (bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-1 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling of body temperature change, Headache, Pain in extremity, Vomiting
Clinical narrative: Sore arm; dizziness; hot and cold phases; Vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (dizziness), FEELING OF BODY TEMPERATURE CHANGE (hot and cold phases), VOMITING (Vomiting) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01932A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIZZINESS (dizziness), FEELING OF BODY TEMPERATURE CHANGE (hot and cold phases), VOMITING (Vomiting) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIZZINESS (dizziness), FEELING OF BODY TEMPERATURE CHANGE (hot and cold phases), VOMITING (Vomiting) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Cough, Illness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of coughing, COVID-19 (had COVID-19), illness (sick) and chest pain (sore on chest and body) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. On Mar 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 26, 2021, patient experienced coughing, COVID-19 (had COVID-19), illness (sick) and chest pain (sore on his chest and body). The patient treated with Mucinex (guaifenesin) at an unspecified dose; and frequency and Aspirin EC (acetylsalicylic acid), at an unspecified dose and frequency. At the time of the report, coughing, COVID-19 (had COVID-19), illness (sick) and chest pain (sore on chest and body) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Treatment medications include Mucinex and Aspirin.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site erythema, Vaccination site rash
Clinical narrative: chills; high temperature; red rash; Red rash; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (high temperature), VACCINATION SITE RASH (red rash) and VACCINATION SITE ERYTHEMA (Red rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (high temperature), VACCINATION SITE RASH (red rash) and VACCINATION SITE ERYTHEMA (Red rash). At the time of the report, CHILLS (chills), PYREXIA (high temperature), VACCINATION SITE RASH (red rash) and VACCINATION SITE ERYTHEMA (Red rash) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No concomitant medications were provided. Treatment medications was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: The email address updated.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymph node pain, Myalgia
Clinical narrative: Muscle pain; Joint pain; Lymph node pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and LYMPH NODE PAIN (Lymph node pain) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and LYMPH NODE PAIN (Lymph node pain). At the time of the report, MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and LYMPH NODE PAIN (Lymph node pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: a week later, it was in both the eyes; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (a week later, it was in both the eyes) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (a week later, it was in both the eyes). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VISUAL IMPAIRMENT (a week later, it was in both the eyes) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient reported that he had an effect of aurora borealis between 15-30 minutes in the left eye after the second dose and his peripheral vision was wavy and could not focus on the vision. After the first vaccine, patient had this in both the eyes.  Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-066830 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Rash
Clinical narrative: started feeling very itchy around the shot area; some rash; a little area of redness; some soreness of my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (some soreness of my arm), PRURITUS (started feeling very itchy around the shot area), RASH (some rash) and ERYTHEMA (a little area of redness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (some soreness of my arm). On 28-Mar-2021, the patient experienced PRURITUS (started feeling very itchy around the shot area), RASH (some rash) and ERYTHEMA (a little area of redness). The patient was treated with ALOE VERA (ALOE 99) at an unspecified dose and frequency. On 22-Mar-2021, PAIN IN EXTREMITY (some soreness of my arm) outcome was unknown. At the time of the report, PRURITUS (started feeling very itchy around the shot area), RASH (some rash) and ERYTHEMA (a little area of redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications includes OTC vitamins.