chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess, Furuncle, Vaccination site pruritus
Clinical narrative: boil on the left side of vagina; Abscess; Boil on the rectum; itching in the vaccinated arm (left arm); This spontaneous case was reported by a consumer and describes the occurrence of FURUNCLE (Boil on the rectum), FURUNCLE (boil on the left side of vagina), ABSCESS (Abscess) and VACCINATION SITE PRURITUS (itching in the vaccinated arm (left arm)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high and Hypercholesteraemia. Concomitant products included GLIMEPIRIDE, VITAMIN D NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) and EZETIMIBE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching in the vaccinated arm (left arm)). On 09-Feb-2021, the patient experienced FURUNCLE (Boil on the rectum) and ABSCESS (Abscess). On 23-Feb-2021, the patient experienced FURUNCLE (boil on the left side of vagina). The patient was treated with DOXYCYCLINE for Abscess, at an unspecified dose and frequency. At the time of the report, FURUNCLE (Boil on the rectum), FURUNCLE (boil on the left side of vagina), ABSCESS (Abscess) and VACCINATION SITE PRURITUS (itching in the vaccinated arm (left arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Ear infection, SARS-CoV-2 test
Clinical narrative: Ear infection; COVID-19 Positive; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (Ear infection) and COVID-19 (COVID-19 Positive) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced COVID-19 (COVID-19 Positive). On an unknown date, the patient experienced EAR INFECTION (Ear infection). The patient was treated with AMOXICILLIN for Ear infection, at an unspecified dose and frequency. At the time of the report, EAR INFECTION (Ear infection) outcome was unknown and COVID-19 (COVID-19 Positive) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore arm) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Sore arm). At the time of the report, PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood count, Blood count abnormal
Clinical narrative: Blood count dropped to 7 or 8; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD COUNT ABNORMAL (Blood count dropped to 7 or 8) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030l20a) for COVID-19 vaccination.     The patient's past medical history included Knee replacement on 12-Feb-2021. Concomitant products included VITAMINS NOS for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced BLOOD COUNT ABNORMAL (Blood count dropped to 7 or 8). The patient was treated with Transplant (blood transfusion) for Blood count abnormal. At the time of the report, BLOOD COUNT ABNORMAL (Blood count dropped to 7 or 8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: decrease (Low) dropped to 7 or 8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product include unspecified  inhaler and stomach medications.  Treatment information was not reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE, ROSUVASTATIN, MELOXICAM, AMLODIPINE and DULOXETINE for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced RASH PRURITIC (itchy rash). At the time of the report, RASH PRURITIC (itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included I put some Anti itch cream just before I called you.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash erythematous, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Rash red; Hardness injection site; Redness circle; Pain at injection site; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (Rash red), VACCINATION SITE INDURATION (Hardness injection site), VACCINATION SITE ERYTHEMA (Redness circle), VACCINATION SITE PAIN (Pain at injection site) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site) and HEADACHE (Headache). On 18-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Rash red), VACCINATION SITE INDURATION (Hardness injection site) and VACCINATION SITE ERYTHEMA (Redness circle). The patient was treated with HYDROCORTISONE at a dose of bid. On 11-Feb-2021, VACCINATION SITE PAIN (Pain at injection site) and HEADACHE (Headache) had resolved. On 19-Feb-2021, VACCINATION SITE INDURATION (Hardness injection site) had resolved. At the time of the report, RASH ERYTHEMATOUS (Rash red) and VACCINATION SITE ERYTHEMA (Redness circle) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information also included Ice.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up was received on 26 May 2021 included outcome of the event was updated and patient denied follow up.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Hypersomnia, Illness
Clinical narrative: sick; vomiting; diarrhea; couldn't eat; dizzy; slept most of the time; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), VOMITING (vomiting), DIARRHOEA (diarrhea), DECREASED APPETITE (couldn't eat) and DIZZINESS (dizzy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Congestive heart failure and COPD.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ILLNESS (sick), VOMITING (vomiting), DIARRHOEA (diarrhea), DECREASED APPETITE (couldn't eat), DIZZINESS (dizzy) and HYPERSOMNIA (slept most of the time). On 10-Feb-2021, ILLNESS (sick), VOMITING (vomiting), DIARRHOEA (diarrhea), DECREASED APPETITE (couldn't eat), DIZZINESS (dizzy) and HYPERSOMNIA (slept most of the time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were Medications for congestive heart failure, Medications for COPD. No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: sick; vomiting; diarrhea; couldn't eat; dizzy; slept most of the time; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), VOMITING (vomiting), DIARRHOEA (diarrhea), DECREASED APPETITE (couldn't eat) and DIZZINESS (dizzy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Congestive heart failure and COPD.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ILLNESS (sick), VOMITING (vomiting), DIARRHOEA (diarrhea), DECREASED APPETITE (couldn't eat), DIZZINESS (dizzy) and HYPERSOMNIA (slept most of the time). On 10-Feb-2021, ILLNESS (sick), VOMITING (vomiting), DIARRHOEA (diarrhea), DECREASED APPETITE (couldn't eat), DIZZINESS (dizzy) and HYPERSOMNIA (slept most of the time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were Medications for congestive heart failure, Medications for COPD. No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: Fever 100.2°F; Chills; several aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.2°F), CHILLS (Chills) and MYALGIA (several aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (Fever 100.2°F), CHILLS (Chills) and MYALGIA (several aches). At the time of the report, PYREXIA (Fever 100.2°F), CHILLS (Chills) and MYALGIA (several aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: 100.2°f degree (plane angle) (High) 100.2°F.         Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site swelling, Pruritus, Rash, Vaccination site warmth
Clinical narrative: hot sensation near injection site; Itchy feeling; rash bigger than the palm of the hand on back of leg; redness, bumps on back of leg; Swollen under injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot sensation near injection site), PRURITUS (Itchy feeling), RASH (rash bigger than the palm of the hand on back of leg), ERYTHEMA (redness, bumps on back of leg) and INJECTION SITE SWELLING (Swollen under injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot sensation near injection site), PRURITUS (Itchy feeling), RASH (rash bigger than the palm of the hand on back of leg), ERYTHEMA (redness, bumps on back of leg) and INJECTION SITE SWELLING (Swollen under injection site). At the time of the report, VACCINATION SITE WARMTH (hot sensation near injection site), PRURITUS (Itchy feeling), RASH (rash bigger than the palm of the hand on back of leg), ERYTHEMA (redness, bumps on back of leg) and INJECTION SITE SWELLING (Swollen under injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Severe anxiety), INFLUENZA LIKE ILLNESS (Felt like flu), INSOMNIA (No sleep), FEELING ABNORMAL (Felt like he was about to die) and INJECTION SITE PRURITUS (Itchy area at injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Severe anxiety), INFLUENZA LIKE ILLNESS (Felt like flu), INSOMNIA (No sleep), FEELING ABNORMAL (Felt like he was about to die), INJECTION SITE PRURITUS (Itchy area at injection site), INJECTION SITE SWELLING (Raised area at injection site), VOMITING (Vomiting), CHILLS (Chills), HEADACHE (Headaches) and MYALGIA (Muscle pains). At the time of the report, ANXIETY (Severe anxiety), INFLUENZA LIKE ILLNESS (Felt like flu), INSOMNIA (No sleep), FEELING ABNORMAL (Felt like he was about to die), INJECTION SITE PRURITUS (Itchy area at injection site), INJECTION SITE SWELLING (Raised area at injection site), VOMITING (Vomiting), CHILLS (Chills), HEADACHE (Headaches) and MYALGIA (Muscle pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Insomnia, Myalgia, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Severe anxiety), INFLUENZA LIKE ILLNESS (Felt like flu), INSOMNIA (No sleep), FEELING ABNORMAL (Felt like he was about to die) and INJECTION SITE PRURITUS (Itchy area at injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Severe anxiety), INFLUENZA LIKE ILLNESS (Felt like flu), INSOMNIA (No sleep), FEELING ABNORMAL (Felt like he was about to die), INJECTION SITE PRURITUS (Itchy area at injection site), INJECTION SITE SWELLING (Raised area at injection site), VOMITING (Vomiting), CHILLS (Chills), HEADACHE (Headaches) and MYALGIA (Muscle pains). At the time of the report, ANXIETY (Severe anxiety), INFLUENZA LIKE ILLNESS (Felt like flu), INSOMNIA (No sleep), FEELING ABNORMAL (Felt like he was about to die), INJECTION SITE PRURITUS (Itchy area at injection site), INJECTION SITE SWELLING (Raised area at injection site), VOMITING (Vomiting), CHILLS (Chills), HEADACHE (Headaches) and MYALGIA (Muscle pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Nausea, Pain, Pain in extremity
Clinical narrative: little pinches of aches here and there on his arms and legs; little body aches; Joint pain in my knees; nauseated/nauseated a little bit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little pinches of aches here and there on his arms and legs), PAIN (little body aches), ARTHRALGIA (Joint pain in my knees) and NAUSEA (nauseated/nauseated a little bit) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (little pinches of aches here and there on his arms and legs), PAIN (little body aches), ARTHRALGIA (Joint pain in my knees) and NAUSEA (nauseated/nauseated a little bit). At the time of the report, PAIN IN EXTREMITY (little pinches of aches here and there on his arms and legs), PAIN (little body aches), ARTHRALGIA (Joint pain in my knees) and NAUSEA (nauseated/nauseated a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Pain in extremity, Pruritus, Rash, Vaccination site erythema
Clinical narrative: COVID R arm; Sore R arm; Itchy R arm; Redness R arm; Rash over R arm; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (COVID R arm), PAIN IN EXTREMITY (Sore R arm), PRURITUS (Itchy R arm), VACCINATION SITE ERYTHEMA (Redness R arm) and RASH (Rash over R arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to atropine). Concomitant products included ATENOLOL, CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and AMPICILLIN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DERMATITIS ALLERGIC (COVID R arm), PAIN IN EXTREMITY (Sore R arm), PRURITUS (Itchy R arm), VACCINATION SITE ERYTHEMA (Redness R arm) and RASH (Rash over R arm). At the time of the report, DERMATITIS ALLERGIC (COVID R arm), PAIN IN EXTREMITY (Sore R arm), PRURITUS (Itchy R arm), VACCINATION SITE ERYTHEMA (Redness R arm) and RASH (Rash over R arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Swelling face, Tinnitus
Clinical narrative: Right ear unable to hear; Right ear loud ringing; Right side of face swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOACUSIS (Right ear unable to hear), TINNITUS (Right ear loud ringing) and SWELLING FACE (Right side of face swollen) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Urinary tract infection. Concomitant products included CIPROFLOXACIN (CIPRO CARE) from 23-Feb-2021 to an unknown date for Urinary tract infection.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HYPOACUSIS (Right ear unable to hear), TINNITUS (Right ear loud ringing) and SWELLING FACE (Right side of face swollen). In February 2021, HYPOACUSIS (Right ear unable to hear), TINNITUS (Right ear loud ringing) and SWELLING FACE (Right side of face swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site warmth, Pruritus, Skin warm, Vaccination site rash
Clinical narrative: warm left arm rash; Right arm is also slightly warm; sometimes itches ("comes and goes"); Swollen left arm; A little pink left arm rash; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm left arm rash), SKIN WARM (Right arm is also slightly warm), PRURITUS (sometimes itches ("comes and goes")), VACCINATION SITE SWELLING (Swollen left arm) and VACCINATION SITE RASH (A little pink left arm rash) in a 72-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 Eye injury (she has,one eye, due to injury years ago). Concurrent medical conditions included Hypertension, Hypothyroidism and Allergy to antibiotic (Certain antibiotics). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), ACETYLSALICYLIC ACID (BABY ASPIRIN) and FOLIC ACID for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 12-Feb-2021, the patient experienced INJECTION SITE WARMTH (warm left arm rash), SKIN WARM (Right arm is also slightly warm), PRURITUS (sometimes itches ("comes and goes")), VACCINATION SITE SWELLING (Swollen left arm), VACCINATION SITE RASH (A little pink left arm rash) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (warm left arm rash), SKIN WARM (Right arm is also slightly warm), PRURITUS (sometimes itches ("comes and goes")), VACCINATION SITE SWELLING (Swollen left arm), VACCINATION SITE RASH (A little pink left arm rash) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: warm left arm rash; Right arm is also slightly warm; sometimes itches ("comes and goes"); Swollen left arm; A little pink left arm rash; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm left arm rash), SKIN WARM (Right arm is also slightly warm), PRURITUS (sometimes itches ("comes and goes")), VACCINATION SITE SWELLING (Swollen left arm) and VACCINATION SITE RASH (A little pink left arm rash) in a 72-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 Eye injury (she has,one eye, due to injury years ago). Concurrent medical conditions included Hypertension, Hypothyroidism and Allergy to antibiotic (Certain antibiotics). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), ACETYLSALICYLIC ACID (BABY ASPIRIN) and FOLIC ACID for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 12-Feb-2021, the patient experienced INJECTION SITE WARMTH (warm left arm rash), SKIN WARM (Right arm is also slightly warm), PRURITUS (sometimes itches ("comes and goes")), VACCINATION SITE SWELLING (Swollen left arm), VACCINATION SITE RASH (A little pink left arm rash) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (warm left arm rash), SKIN WARM (Right arm is also slightly warm), PRURITUS (sometimes itches ("comes and goes")), VACCINATION SITE SWELLING (Swollen left arm), VACCINATION SITE RASH (A little pink left arm rash) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness, Pain, Vaccination site pain
Clinical narrative: Diagnosed with COVID; Aches/pains; flu like symptoms; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID), PAIN (Aches/pains), INFLUENZA LIKE ILLNESS (flu like symptoms) and VACCINATION SITE PAIN (sore arm) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0391L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL, MONTELUKAST SODIUM (SINGULAIR) and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 22-Jan-2021, the patient experienced PAIN (Aches/pains) and INFLUENZA LIKE ILLNESS (flu like symptoms). On 29-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 22-Jan-2021, VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, COVID-19 (Diagnosed with COVID), PAIN (Aches/pains) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, COVID-19: covid (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that his AE lasted for about 18 hours.  Treatment included Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: fallow up received on 29-jun-2021 - outcome  of the events was updated  form unknown to recovered resolved
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Headache, Pyrexia
Clinical narrative: Weakness; Headaches; Low grade fever - Temp 100, normally ~97.6; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), HEADACHE (Headaches) and PYREXIA (Low grade fever - Temp 100, normally ~97.6) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 ASTHENIA (Weakness), HEADACHE (Headaches) and PYREXIA (Low grade fever - Temp 100, normally ~97.6). At the time of the report, ASTHENIA (Weakness), HEADACHE (Headaches) and PYREXIA (Low grade fever - Temp 100, normally ~97.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 100 (Inconclusive) 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Gait disturbance, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: trouble walking.; arm at the injection site was sore and swollen; arm at the injection site was sore and swollen; fever of 100.0; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (trouble walking.), VACCINATION SITE SWELLING (arm at the injection site was sore and swollen), VACCINATION SITE PAIN (arm at the injection site was sore and swollen) and PYREXIA (fever of 100.0) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced GAIT DISTURBANCE (trouble walking.), VACCINATION SITE SWELLING (arm at the injection site was sore and swollen), VACCINATION SITE PAIN (arm at the injection site was sore and swollen) and PYREXIA (fever of 100.0). At the time of the report, GAIT DISTURBANCE (trouble walking.), VACCINATION SITE SWELLING (arm at the injection site was sore and swollen), VACCINATION SITE PAIN (arm at the injection site was sore and swollen) and PYREXIA (fever of 100.0) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Body temperature: high (High) 100.         No concomitant medication details was reported. No treatment medication details was reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: he had temperature; slight fever; chills; body ache/muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE (he had temperature), PYREXIA (slight fever), CHILLS (chills) and MYALGIA (body ache/muscle ache) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE (he had temperature), PYREXIA (slight fever), CHILLS (chills) and MYALGIA (body ache/muscle ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BODY TEMPERATURE (he had temperature), PYREXIA (slight fever), CHILLS (chills) and MYALGIA (body ache/muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant drug was given to patient no treatment was received by the patient   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Followup received on 12-JUL-2021. It provides no new information.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vomiting
Clinical narrative: chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and VOMITING (vomiting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and VOMITING (vomiting). At the time of the report, CHILLS (chills) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Blood potassium increased, High density lipoprotein increased, Low density lipoprotein increased
Clinical narrative: Potassium level came back high; LDL came back high; HDL came back high; Total cholesterol came back high; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD POTASSIUM INCREASED (Potassium level came back high), LOW DENSITY LIPOPROTEIN INCREASED (LDL came back high), HIGH DENSITY LIPOPROTEIN INCREASED (HDL came back high) and BLOOD CHOLESTEROL INCREASED (Total cholesterol came back high) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN, DILTIAZEM, APIXABAN (ELIQUIS), LEVOTHYROXINE and LANSOPRAZOLE (PREVACID) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD POTASSIUM INCREASED (Potassium level came back high), LOW DENSITY LIPOPROTEIN INCREASED (LDL came back high), HIGH DENSITY LIPOPROTEIN INCREASED (HDL came back high) and BLOOD CHOLESTEROL INCREASED (Total cholesterol came back high). At the time of the report, BLOOD POTASSIUM INCREASED (Potassium level came back high), LOW DENSITY LIPOPROTEIN INCREASED (LDL came back high), HIGH DENSITY LIPOPROTEIN INCREASED (HDL came back high) and BLOOD CHOLESTEROL INCREASED (Total cholesterol came back high) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up information received on 12 Jul 2021 contains non significant information
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard, bump,bigger ball, without heat,), VACCINATION SITE PRURITUS (itchy left arm), VACCINATION SITE ERYTHEMA (Red ball), VACCINATION SITE SWELLING (Swollen left arm) and PYREXIA (Fever (100.8F)) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy left arm). On 02-Feb-2021, the patient experienced VACCINATION SITE INDURATION (hard, bump,bigger ball, without heat,). On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red ball). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swollen left arm) and PYREXIA (Fever (100.8F)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (hard, bump,bigger ball, without heat,), VACCINATION SITE PRURITUS (itchy left arm), VACCINATION SITE ERYTHEMA (Red ball), VACCINATION SITE SWELLING (Swollen left arm) and PYREXIA (Fever (100.8F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8 f (High) fever (100.8F).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard, bump,bigger ball, without heat,), VACCINATION SITE PRURITUS (itchy left arm), VACCINATION SITE ERYTHEMA (Red ball), VACCINATION SITE SWELLING (Swollen left arm) and PYREXIA (Fever (100.8F)) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy left arm). On 02-Feb-2021, the patient experienced VACCINATION SITE INDURATION (hard, bump,bigger ball, without heat,). On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red ball). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swollen left arm) and PYREXIA (Fever (100.8F)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (hard, bump,bigger ball, without heat,), VACCINATION SITE PRURITUS (itchy left arm), VACCINATION SITE ERYTHEMA (Red ball), VACCINATION SITE SWELLING (Swollen left arm) and PYREXIA (Fever (100.8F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8 f (High) fever (100.8F).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Lymph node pain, Neck pain, Vaccination site pain
Clinical narrative: Lingering numbness behind her left ear and left side of the neck; Feels like something is off; Soreness in the lymph node in her left arm pit; Soreness in her neck; Numbness on left side of her face from the eyebrow down to her jaw and around her lip; Tenderness where she had the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on left side of her face from the eyebrow down to her jaw and around her lip), HYPOAESTHESIA (Lingering numbness behind her left ear and left side of the neck), NECK PAIN (Soreness in her neck), FEELING ABNORMAL (Feels like something is off) and LYMPH NODE PAIN (Soreness in the lymph node in her left arm pit) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fracture bone (Permanent fractured sesamoid bone in left foot.) since 2009. Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL FE 1/20) for Birth control.    On 28-Jan-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (Tenderness where she had the vaccine). On 28-Jan-2021 at 12:20 PM, the patient experienced HYPOAESTHESIA (Numbness on left side of her face from the eyebrow down to her jaw and around her lip). On 31-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NECK PAIN (Soreness in her neck). On 03-Feb-2021, the patient experienced LYMPH NODE PAIN (Soreness in the lymph node in her left arm pit). On an unknown date, the patient experienced HYPOAESTHESIA (Lingering numbness behind her left ear and left side of the neck) and FEELING ABNORMAL (Feels like something is off). On 01-Feb-2021, HYPOAESTHESIA (Numbness on left side of her face from the eyebrow down to her jaw and around her lip) had resolved. On 18-Feb-2021, NECK PAIN (Soreness in her neck) and LYMPH NODE PAIN (Soreness in the lymph node in her left arm pit) had resolved. At the time of the report, HYPOAESTHESIA (Lingering numbness behind her left ear and left side of the neck), FEELING ABNORMAL (Feels like something is off) and VACCINATION SITE PAIN (Tenderness where she had the vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No Concomitant information  provided. Treatment included Advil and warm compresses   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional information was received on 28 Apr 2021. Additional information on patient details, medical history, concomitant medication, event details, action taken were added. On 25-May-2021: Follow up received on 25-may-2021 contains no new information.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Overdose
Clinical narrative: Fatigue; Muscle ache; Headache; Fever; Chills; Given 1ml dose instead of .5ml; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2021 and was forwarded to Moderna on 29-Jan-2021.    This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (Given 1ml dose instead of .5ml), FATIGUE (Fatigue), MYALGIA (Muscle ache), HEADACHE (Headache) and PYREXIA (Fever) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Dec-2020 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021 at 8:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 ml. On 28-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (Given 1ml dose instead of .5ml). On an unknown date, the patient experienced FATIGUE (Fatigue), MYALGIA (Muscle ache), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On 28-Jan-2021, OVERDOSE (Given 1ml dose instead of .5ml) had resolved. At the time of the report, FATIGUE (Fatigue), MYALGIA (Muscle ache), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter stated that on 28-Jan-2021, one of the vaccinators reported potentially overdosing 2 individuals while giving the moderna covid vaccine. They possibly received 1ml of dosage instead of 0.5ml.  The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-022427 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up information received on 26-Apr-2021 contains information regarding patient demographics, dosing details, and additional events.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-022427:Same reporter
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fatigue; Muscle ache; Headache; Fever; Chills; Given 1ml dose instead of .5ml; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2021 and was forwarded to Moderna on 29-Jan-2021.    This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (Given 1ml dose instead of .5ml), FATIGUE (Fatigue), MYALGIA (Muscle ache), HEADACHE (Headache) and PYREXIA (Fever) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Dec-2020 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021 at 8:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 ml. On 28-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (Given 1ml dose instead of .5ml). On an unknown date, the patient experienced FATIGUE (Fatigue), MYALGIA (Muscle ache), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On 28-Jan-2021, OVERDOSE (Given 1ml dose instead of .5ml) had resolved. At the time of the report, FATIGUE (Fatigue), MYALGIA (Muscle ache), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter stated that on 28-Jan-2021, one of the vaccinators reported potentially overdosing 2 individuals while giving the moderna covid vaccine. They possibly received 1ml of dosage instead of 0.5ml.  The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-022427 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up information received on 26-Apr-2021 contains information regarding patient demographics, dosing details, and additional events.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-022427:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: raised bubble in the rash; itchiness; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itchiness, raised bubbles in the rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced itchiness, raised bubbles in the rash..  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events  itchiness, raised bubbles in the rash was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.