chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Pain in extremity
Clinical narrative: same tested positive for COVID; took the test because, that morning learned that was exposed to someone positive; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (same tested positive for COVID), EXPOSURE TO SARS-COV-2 (took the test because, that morning learned that was exposed to someone positive) and PAIN IN EXTREMITY (sore arm) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concomitant products included DILTIAZEM, RIVAROXABAN (XARELTO), POTASSIUM, RIVASTIGMINE, METFORMIN, HYDROCHLOROTHIAZIDE, PAROXETINE, ATORVASTATIN, VITAMIN D3, DOXYCYCLINE HYCLATE, DEXAMETHASONE and FAMOTIDINE for an unknown indication.    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 COVID-19 (same tested positive for COVID), EXPOSURE TO SARS-COV-2 (took the test because, that morning learned that was exposed to someone positive) and PAIN IN EXTREMITY (sore arm). At the time of the report, COVID-19 (same tested positive for COVID), EXPOSURE TO SARS-COV-2 (took the test because, that morning learned that was exposed to someone positive) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Nausea, Pain, Pyrexia
Clinical narrative: fatigue; Little achy; Little nausea; Low grade fever; feeling abnormal; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PAIN (Little achy), NAUSEA (Little nausea), PYREXIA (Low grade fever) and FEELING ABNORMAL (feeling abnormal) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 031A21A) 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 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (fatigue), PAIN (Little achy), NAUSEA (Little nausea), PYREXIA (Low grade fever) and FEELING ABNORMAL (feeling abnormal). On 10-Mar-2021, FATIGUE (fatigue), PAIN (Little achy), NAUSEA (Little nausea), PYREXIA (Low grade fever) and FEELING ABNORMAL (feeling abnormal) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events  a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: developed herpes like cold sores within hours of both the first and second vaccine; This spontaneous case was reported by a  and describes the occurrence of ORAL HERPES (developed herpes like cold sores within hours of both the first and second vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20 and 029K20A) 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. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On an unknown date, the patient experienced ORAL HERPES (developed herpes like cold sores within hours of both the first and second vaccine). At the time of the report, ORAL HERPES (developed herpes like cold sores within hours of both the first and second vaccine) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2021: No specific follow-up information recorded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Muscle tightness
Clinical narrative: Diarrhea; Tight neck and shoulders; Splitting headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MUSCLE TIGHTNESS (Tight neck and shoulders) and HEADACHE (Splitting headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-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 DIARRHOEA (Diarrhea), MUSCLE TIGHTNESS (Tight neck and shoulders) and HEADACHE (Splitting headache). At the time of the report, DIARRHOEA (Diarrhea), MUSCLE TIGHTNESS (Tight neck and shoulders) and HEADACHE (Splitting headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Myalgia, Vaccination site discolouration
Clinical narrative: she can't sleep; Discolored; Injection site sore; swelled up; Headache; Fatigue; Muscle sore; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (she can't sleep), VACCINATION SITE DISCOLOURATION (Discolored), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE SWELLING (swelled up) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 842L28A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced INSOMNIA (she can't sleep), VACCINATION SITE DISCOLOURATION (Discolored), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE SWELLING (swelled up), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Muscle sore). At the time of the report, INSOMNIA (she can't sleep), VACCINATION SITE DISCOLOURATION (Discolored), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE SWELLING (swelled up), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Muscle sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: she can't sleep; Discolored; Injection site sore; swelled up; Headache; Fatigue; Muscle sore; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (she can't sleep), VACCINATION SITE DISCOLOURATION (Discolored), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE SWELLING (swelled up) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 842L28A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced INSOMNIA (she can't sleep), VACCINATION SITE DISCOLOURATION (Discolored), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE SWELLING (swelled up), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Muscle sore). At the time of the report, INSOMNIA (she can't sleep), VACCINATION SITE DISCOLOURATION (Discolored), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE SWELLING (swelled up), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Muscle sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea
Clinical narrative: "been in bed all day"; nausea; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE ("been in bed all day"), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body ache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Blood pressure management, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    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 MALAISE ("been in bed all day"), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body ache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MALAISE ("been in bed all day"), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test positive
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, SARS-CoV-2 antibody test: positive (Positive) positive. 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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Formication, Myalgia, Pruritus
Clinical narrative: itching feeling all over; crawling skin; pin-poking skin; drowsy; body rash; aches; chills; 100.8 F. fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching feeling all over), FORMICATION (crawling skin), SKIN DISCOMFORT (pin-poking skin), SOMNOLENCE (drowsy) and RASH (body rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A221B and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced RASH (body rash), CHILLS (chills) and PYREXIA (100.8 F. fever). 27-Mar-2021, the patient experienced MYALGIA (aches). On 01-Apr-2021, the patient experienced PRURITUS (itching feeling all over), FORMICATION (crawling skin), SKIN DISCOMFORT (pin-poking skin) and SOMNOLENCE (drowsy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. On 28-Mar-2021, MYALGIA (aches), CHILLS (chills) and PYREXIA (100.8 F. fever) had resolved. At the time of the report, PRURITUS (itching feeling all over), FORMICATION (crawling skin), SKIN DISCOMFORT (pin-poking skin) and SOMNOLENCE (drowsy) outcome was unknown and RASH (body rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Body temperature: 100.8 (High) 100.8.         No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: No new information was received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Skin discomfort, Somnolence
Clinical narrative: itching feeling all over; crawling skin; pin-poking skin; drowsy; body rash; aches; chills; 100.8 F. fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching feeling all over), FORMICATION (crawling skin), SKIN DISCOMFORT (pin-poking skin), SOMNOLENCE (drowsy) and RASH (body rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A221B and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced RASH (body rash), CHILLS (chills) and PYREXIA (100.8 F. fever). 27-Mar-2021, the patient experienced MYALGIA (aches). On 01-Apr-2021, the patient experienced PRURITUS (itching feeling all over), FORMICATION (crawling skin), SKIN DISCOMFORT (pin-poking skin) and SOMNOLENCE (drowsy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. On 28-Mar-2021, MYALGIA (aches), CHILLS (chills) and PYREXIA (100.8 F. fever) had resolved. At the time of the report, PRURITUS (itching feeling all over), FORMICATION (crawling skin), SKIN DISCOMFORT (pin-poking skin) and SOMNOLENCE (drowsy) outcome was unknown and RASH (body rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Body temperature: 100.8 (High) 100.8.         No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: No new information was received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Papule
Clinical narrative: red, swollen, tight, hot to touch bump as big as size of a hand; This spontaneous case was reported by a consumer and describes the occurrence of PAPULE (red, swollen, tight, hot to touch bump as big as size of a hand) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAPULE (red, swollen, tight, hot to touch bump as big as size of a hand). At the time of the report, PAPULE (red, swollen, tight, hot to touch bump as big as size of a hand) outcome was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Nausea
Clinical narrative: Very bad headache; Chills; Wants to vomit; First dose was administered on 06Feb2021 and second dose was on 31Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 06Feb2021 and second dose was on 31Mar2021), HEADACHE (Very bad headache), CHILLS (Chills) and NAUSEA (Wants to vomit) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Headache. Concomitant products included IBUPROFEN for an unknown indication.   On 06-Feb-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 06Feb2021 and second dose was on 31Mar2021). On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Very bad headache), CHILLS (Chills) and NAUSEA (Wants to vomit). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 06Feb2021 and second dose was on 31Mar2021) had resolved and HEADACHE (Very bad headache), CHILLS (Chills) and NAUSEA (Wants to vomit) outcome was unknown.            No treatment information was provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site erythema, Vaccination site inflammation, Vaccination site pain, Vaccination site rash
Clinical narrative: COVID Arm; Inflamed Injection Site; Red Rash on the Injection Site; Tender to the touch Injection Site; Red Rash on the Injection Site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (COVID Arm), VACCINATION SITE INFLAMMATION (Inflamed Injection Site), VACCINATION SITE ERYTHEMA (Red Rash on the Injection Site), VACCINATION SITE PAIN (Tender to the touch Injection Site) and VACCINATION SITE RASH (Red Rash on the Injection Site) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION COMPLICATION (COVID Arm), VACCINATION SITE INFLAMMATION (Inflamed Injection Site), VACCINATION SITE ERYTHEMA (Red Rash on the Injection Site), VACCINATION SITE PAIN (Tender to the touch Injection Site) and VACCINATION SITE RASH (Red Rash on the Injection Site). At the time of the report, VACCINATION COMPLICATION (COVID Arm), VACCINATION SITE INFLAMMATION (Inflamed Injection Site), VACCINATION SITE ERYTHEMA (Red Rash on the Injection Site), VACCINATION SITE PAIN (Tender to the touch Injection Site) and VACCINATION SITE RASH (Red Rash on the Injection Site) 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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site induration, Injection site warmth, Pain in extremity, Phlebitis
Clinical narrative: soreness of upper arm; Looks like phlebitis; upper arm Warm to touch; redness of upper arm; itching of upper arm; hardness of upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of upper arm), PHLEBITIS (Looks like phlebitis), INJECTION SITE WARMTH (upper arm Warm to touch), ERYTHEMA (redness of upper arm) and PRURITUS (itching of upper arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DEXLANSOPRAZOLE (DEXILANT), AMLODIPINE, EZETIMIBE, LEVOTHYROXINE, BACLOFEN, DULOXETINE, BISOPROLOL, PANTOPRAZOLE and LISINOPRIL for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness of upper arm), PHLEBITIS (Looks like phlebitis), INJECTION SITE WARMTH (upper arm Warm to touch), ERYTHEMA (redness of upper arm), PRURITUS (itching of upper arm) and INJECTION SITE INDURATION (hardness of upper arm). At the time of the report, PAIN IN EXTREMITY (soreness of upper arm), PHLEBITIS (Looks like phlebitis), INJECTION SITE WARMTH (upper arm Warm to touch), ERYTHEMA (redness of upper arm), PRURITUS (itching of upper arm) and INJECTION SITE INDURATION (hardness of upper arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: soreness of upper arm; Looks like phlebitis; upper arm Warm to touch; redness of upper arm; itching of upper arm; hardness of upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of upper arm), PHLEBITIS (Looks like phlebitis), INJECTION SITE WARMTH (upper arm Warm to touch), ERYTHEMA (redness of upper arm) and PRURITUS (itching of upper arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DEXLANSOPRAZOLE (DEXILANT), AMLODIPINE, EZETIMIBE, LEVOTHYROXINE, BACLOFEN, DULOXETINE, BISOPROLOL, PANTOPRAZOLE and LISINOPRIL for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness of upper arm), PHLEBITIS (Looks like phlebitis), INJECTION SITE WARMTH (upper arm Warm to touch), ERYTHEMA (redness of upper arm), PRURITUS (itching of upper arm) and INJECTION SITE INDURATION (hardness of upper arm). At the time of the report, PAIN IN EXTREMITY (soreness of upper arm), PHLEBITIS (Looks like phlebitis), INJECTION SITE WARMTH (upper arm Warm to touch), ERYTHEMA (redness of upper arm), PRURITUS (itching of upper arm) and INJECTION SITE INDURATION (hardness of upper arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Swollen tongue, Vomiting
Clinical narrative: aches in my arms and legs; tongue got a little bit swollen; VOMITING; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (aches in my arms and legs), SWOLLEN TONGUE (tongue got a little bit swollen), VOMITING (VOMITING) and CHILLS (CHILLS) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (aches in my arms and legs), SWOLLEN TONGUE (tongue got a little bit swollen), VOMITING (VOMITING) and CHILLS (CHILLS). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Feb-2021, SWOLLEN TONGUE (tongue got a little bit swollen), VOMITING (VOMITING) and CHILLS (CHILLS) had resolved. On 04-Mar-2021, PAIN IN EXTREMITY (aches in my arms and legs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Felt like crap; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like crap) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CEFALEXIN (CEPHALEXINE), TRAMADOL, FENTANYL, LOVASTATIN, CYCLOBENZAPRINE, CLONAZEPAM and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced FEELING ABNORMAL (Felt like crap). At the time of the report, FEELING ABNORMAL (Felt like crap) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-025545 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up information received on 22-jun-2021 , contains no new information
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Oropharyngeal pain, Pain in extremity, Rhinitis
Clinical narrative: sore throat; running nose; fatigue; chills; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat), RHINITIS (running nose), FATIGUE (fatigue) and CHILLS (chills) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history not included . relevant concomitant products usage were not reported by the reporter    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 01-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINITIS (running nose), FATIGUE (fatigue) and CHILLS (chills).  At the time of the report, PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat), RHINITIS (running nose), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiac disorder, Dyspnoea, Heart rate, Hypertension
Clinical narrative: Cardiac issues; thinks that his symptoms were Moderna arm; Itching; blood pressure was 157/102; left arm was red; left arm was swollen; left arm was painful; was not able to breathe; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA, CARDIAC DISORDER, VACCINATION SITE REACTION, PRURITUS, and HYPERTENSION in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011520) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus since 01-Jan-1985 and Hypertension since 01-Jan-2002. Concomitant products included INSULIN, CRESTOR, ZETIA, OMEPRAZOLE, and VALSARTAN for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced DYSPNOEA. On an unknown date, the patient experienced CARDIAC DISORDER, VACCINATION SITE REACTION, PRURITUS, HYPERTENSION, VACCINATION SITE ERYTHEMA, VACCINATION SITE SWELLING, and VACCINATION SITE PAIN. The patient was treated with LOPRESSOR for Hypertension, at an unspecified dose and frequency and KEFLEX for Adverse event, at a dose of Arm. At the time of the report, DYSPNOEA, CARDIAC DISORDER, VACCINATION SITE REACTION, PRURITUS, HYPERTENSION, VACCINATION SITE ERYTHEMA, VACCINATION SITE SWELLING, and VACCINATION SITE PAIN had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 157/102 (High) blood pressure. On an unknown date, Heart rate: 148 bpm (High).         Treatment included steroids and antibiotic.  Patient took second dose on 08-AUG-2021 into the left arm.   This case was linked to MOD-2021-280200.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Additional information received and includes Reporter details updated and events Moderna arm, Cardiac issues were added. On 06-Aug-2021: Follow-up received and other relevant history was updated, lab data was updated, concomitants was updated, treatment information was updated, patient demographic details was updated and event missed dose deleted as the patient took second dose and outcome of the events changed from unknown to resolved.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Cardiac issues; thinks that his symptoms were Moderna arm; Itching; blood pressure was 157/102; left arm was red; left arm was swollen; left arm was painful; was not able to breathe; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA, CARDIAC DISORDER, VACCINATION SITE REACTION, PRURITUS, and HYPERTENSION in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011520) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus since 01-Jan-1985 and Hypertension since 01-Jan-2002. Concomitant products included INSULIN, CRESTOR, ZETIA, OMEPRAZOLE, and VALSARTAN for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced DYSPNOEA. On an unknown date, the patient experienced CARDIAC DISORDER, VACCINATION SITE REACTION, PRURITUS, HYPERTENSION, VACCINATION SITE ERYTHEMA, VACCINATION SITE SWELLING, and VACCINATION SITE PAIN. The patient was treated with LOPRESSOR for Hypertension, at an unspecified dose and frequency and KEFLEX for Adverse event, at a dose of Arm. At the time of the report, DYSPNOEA, CARDIAC DISORDER, VACCINATION SITE REACTION, PRURITUS, HYPERTENSION, VACCINATION SITE ERYTHEMA, VACCINATION SITE SWELLING, and VACCINATION SITE PAIN had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 157/102 (High) blood pressure. On an unknown date, Heart rate: 148 bpm (High).         Treatment included steroids and antibiotic.  Patient took second dose on 08-AUG-2021 into the left arm.   This case was linked to MOD-2021-280200.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Additional information received and includes Reporter details updated and events Moderna arm, Cardiac issues were added. On 06-Aug-2021: Follow-up received and other relevant history was updated, lab data was updated, concomitants was updated, treatment information was updated, patient demographic details was updated and event missed dose deleted as the patient took second dose and outcome of the events changed from unknown to resolved.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Pruritus, Rash, Swollen tongue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching really bad), SWOLLEN TONGUE (her tongue was swollen), GLOSSODYNIA (sore on left side of tongue) and RASH (rash under arms and around where the elastic on the bra goes around the back) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PRURITUS (itching really bad) and RASH (rash under arms and around where the elastic on the bra goes around the back). On 31-Mar-2021, the patient experienced SWOLLEN TONGUE (her tongue was swollen). On 01-Apr-2021, the patient experienced GLOSSODYNIA (sore on left side of tongue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itching really bad), SWOLLEN TONGUE (her tongue was swollen), GLOSSODYNIA (sore on left side of tongue) and RASH (rash under arms and around where the elastic on the bra goes around the back) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eye irritation, Eye pruritus, Headache, Myalgia
Clinical narrative: Her lungs hurt to inhale and exhale for a couple of days; The left upper eyelid swell up slightly; Is very irritated; Is very itchy; Muscle pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Her lungs hurt to inhale and exhale for a couple of days), SWELLING OF EYELID (The left upper eyelid swell up slightly), EYE IRRITATION (Is very irritated), EYE PRURITUS (Is very itchy) and MYALGIA (Muscle pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE, CHROMIC CHLORIDE, CINNAMOMUM SPP., GYMNEMA SYLVESTRE, THIOCTIC ACID (DIABETES), VITAMIN D;VITAMIN E and BIOTIN for an unknown indication.    On 26-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 DYSPNOEA (Her lungs hurt to inhale and exhale for a couple of days), SWELLING OF EYELID (The left upper eyelid swell up slightly), EYE IRRITATION (Is very irritated), EYE PRURITUS (Is very itchy), MYALGIA (Muscle pain) and HEADACHE (Headache). At the time of the report, DYSPNOEA (Her lungs hurt to inhale and exhale for a couple of days) had resolved and SWELLING OF EYELID (The left upper eyelid swell up slightly), EYE IRRITATION (Is very irritated), EYE PRURITUS (Is very itchy), MYALGIA (Muscle pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Her lungs hurt to inhale and exhale for a couple of days; The left upper eyelid swell up slightly; Is very irritated; Is very itchy; Muscle pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Her lungs hurt to inhale and exhale for a couple of days), SWELLING OF EYELID (The left upper eyelid swell up slightly), EYE IRRITATION (Is very irritated), EYE PRURITUS (Is very itchy) and MYALGIA (Muscle pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE, CHROMIC CHLORIDE, CINNAMOMUM SPP., GYMNEMA SYLVESTRE, THIOCTIC ACID (DIABETES), VITAMIN D;VITAMIN E and BIOTIN for an unknown indication.    On 26-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 DYSPNOEA (Her lungs hurt to inhale and exhale for a couple of days), SWELLING OF EYELID (The left upper eyelid swell up slightly), EYE IRRITATION (Is very irritated), EYE PRURITUS (Is very itchy), MYALGIA (Muscle pain) and HEADACHE (Headache). At the time of the report, DYSPNOEA (Her lungs hurt to inhale and exhale for a couple of days) had resolved and SWELLING OF EYELID (The left upper eyelid swell up slightly), EYE IRRITATION (Is very irritated), EYE PRURITUS (Is very itchy), MYALGIA (Muscle pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm is hurting and sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm is hurting and sore) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm is hurting and sore). At the time of the report, PAIN IN EXTREMITY (Left arm is hurting and sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Doesn't feel good), PAIN (Aching), CHILLS (Chills) and PYREXIA (fever) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Doesn't feel good), PAIN (Aching), CHILLS (Chills) and PYREXIA (fever). At the time of the report, FEELING ABNORMAL (Doesn't feel good), PAIN (Aching), CHILLS (Chills) and PYREXIA (fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.9 - 99.5 (Inconclusive) 98.9 - 99.5. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up information received on 28-JUN-2021 and contains significant information. Outcome of events updated.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in a 40-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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination site pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Event updated sore arm to arm pain. No new information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Limb discomfort
Clinical narrative: headache; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and LIMB DISCOMFORT (arm hurt) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-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 HEADACHE (headache) and LIMB DISCOMFORT (arm hurt). At the time of the report, HEADACHE (headache) and LIMB DISCOMFORT (arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: back pain; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) and PAIN IN EXTREMITY (arm pain) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 BACK PAIN (back pain) and PAIN IN EXTREMITY (arm pain). At the time of the report, BACK PAIN (back pain) and PAIN IN EXTREMITY (arm pain) outcome was unknown.        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.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient doesnt believe she received full vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient doesnt believe she received full vaccine) 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 reported medical history.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient doesnt believe she received full vaccine). At the time of the report, ACCIDENTAL UNDERDOSE (Patient doesnt believe she received full vaccine) had resolved.        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.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of accidental underdose for mRNA-1273 with no associated AEs.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Taste disorder
Clinical narrative: dry taste in his mouth; metallic taste in his mouth; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (dry taste in his mouth) and DYSGEUSIA (metallic taste in his mouth) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced TASTE DISORDER (dry taste in his mouth) and DYSGEUSIA (metallic taste in his mouth). On 03-Feb-2021, TASTE DISORDER (dry taste in his mouth) and DYSGEUSIA (metallic taste in his mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was reported.   No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: Lymph nodes of the left arm are swollen/ major swelling; Chills; Soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Lymph nodes of the left arm are swollen/ major swelling), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness in the left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION SITE LYMPHADENOPATHY (Lymph nodes of the left arm are swollen/ major swelling), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness in the left arm). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Lymph nodes of the left arm are swollen/ major swelling) had not resolved and CHILLS (Chills) and VACCINATION SITE PAIN (Soreness in the left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported by the reporter.  As of 14-May-2021, the patient was doing fine and she took her second dose on an unknown date and confirmed that there were no events after her second dose. On 29-Jun-2021, the patient reported that it had been close to 2 months and she still had major swelling in her left arm lymph nodes.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up report received on 14-May-2021 included information about outcome of events and information of second dose was added. On 29-Jun-2021: Follow up report received on 29-June-2021 included reporter's email address and event outcome was updated to not recovered.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rashes are itchy; Rashes on both arms - upper arm and forearm, in medium to large patches; Rashes are sore; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rashes are itchy), RASH (Rashes on both arms - upper arm and forearm, in medium to large patches) and RASH (Rashes are sore) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash and Rash pruritic.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced RASH PRURITIC (Rashes are itchy), RASH (Rashes on both arms - upper arm and forearm, in medium to large patches) and RASH (Rashes are sore). At the time of the report, RASH PRURITIC (Rashes are itchy), RASH (Rashes on both arms - upper arm and forearm, in medium to large patches) and RASH (Rashes are sore) 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.