chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itching at injection site; Red rash at injection site 10 days after vaccination and increasing in size; Red rash at injection site 10 days after vaccination and increasing in size; pain at injection site; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021. The most recent information was received on 07-May-2021 and was forwarded to Moderna on 07-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE RASH (Red rash at injection site 10 days after vaccination and increasing in size) and VACCINATION SITE ERYTHEMA (Red rash at injection site 10 days after vaccination and increasing in size) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). On 14-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE RASH (Red rash at injection site 10 days after vaccination and increasing in size) and VACCINATION SITE ERYTHEMA (Red rash at injection site 10 days after vaccination and increasing in size). At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE RASH (Red rash at injection site 10 days after vaccination and increasing in size) and VACCINATION SITE ERYTHEMA (Red rash at injection site 10 days after vaccination and increasing in size) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment medication included antihistamine for itching.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up information received on 07-May-2021 included second dose details, events outcome and action taken updated.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Swelling
Clinical narrative: Swelling around the collar bone; bad headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling around the collar bone), HEADACHE (bad headache) and NAUSEA (Nausea) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced HEADACHE (bad headache) and NAUSEA (Nausea). On 16-Mar-2021, the patient experienced SWELLING (Swelling around the collar bone). On 14-Mar-2021, HEADACHE (bad headache) and NAUSEA (Nausea) had resolved. At the time of the report, SWELLING (Swelling around the collar bone) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: redness; itching; swelling; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (redness), PRURITUS (itching) and SWELLING (swelling) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), PRURITUS (itching) and SWELLING (swelling). At the time of the report, ERYTHEMA (redness), PRURITUS (itching) and SWELLING (swelling) 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.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Feeling hot, Headache
Clinical narrative: diarrhea; body and muscle aches; a sudden feeling of hotness; lightheadedness; rash from the injection site that was red, hot, and swollen; rash from the injection site but closer to the elbow; rash from the injection site that was red, hot, and swollen; rash from the injection site that was red, hot, and swollen; chills; body and muscle aches; throwing up; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN (body and muscle aches), FEELING HOT (a sudden feeling of hotness), DIZZINESS (lightheadedness) and INJECTION SITE WARMTH (rash from the injection site that was red, hot, and swollen) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Right arm surgery). Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROID) for Thyroid disorder.    On 13-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 DIARRHOEA (diarrhea), PAIN (body and muscle aches), FEELING HOT (a sudden feeling of hotness), DIZZINESS (lightheadedness), INJECTION SITE WARMTH (rash from the injection site that was red, hot, and swollen), VACCINATION SITE RASH (rash from the injection site but closer to the elbow), INJECTION SITE ERYTHEMA (rash from the injection site that was red, hot, and swollen), INJECTION SITE SWELLING (rash from the injection site that was red, hot, and swollen), CHILLS (chills), MYALGIA (body and muscle aches), VOMITING (throwing up) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), PAIN (body and muscle aches), FEELING HOT (a sudden feeling of hotness), DIZZINESS (lightheadedness), INJECTION SITE WARMTH (rash from the injection site that was red, hot, and swollen), VACCINATION SITE RASH (rash from the injection site but closer to the elbow), INJECTION SITE ERYTHEMA (rash from the injection site that was red, hot, and swollen), INJECTION SITE SWELLING (rash from the injection site that was red, hot, and swollen), CHILLS (chills), MYALGIA (body and muscle aches), VOMITING (throwing up) and HEADACHE (headache) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   This case was linked to MOD-2021-049558 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Myalgia, Pain
Clinical narrative: diarrhea; body and muscle aches; a sudden feeling of hotness; lightheadedness; rash from the injection site that was red, hot, and swollen; rash from the injection site but closer to the elbow; rash from the injection site that was red, hot, and swollen; rash from the injection site that was red, hot, and swollen; chills; body and muscle aches; throwing up; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN (body and muscle aches), FEELING HOT (a sudden feeling of hotness), DIZZINESS (lightheadedness) and INJECTION SITE WARMTH (rash from the injection site that was red, hot, and swollen) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Right arm surgery). Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROID) for Thyroid disorder.    On 13-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 DIARRHOEA (diarrhea), PAIN (body and muscle aches), FEELING HOT (a sudden feeling of hotness), DIZZINESS (lightheadedness), INJECTION SITE WARMTH (rash from the injection site that was red, hot, and swollen), VACCINATION SITE RASH (rash from the injection site but closer to the elbow), INJECTION SITE ERYTHEMA (rash from the injection site that was red, hot, and swollen), INJECTION SITE SWELLING (rash from the injection site that was red, hot, and swollen), CHILLS (chills), MYALGIA (body and muscle aches), VOMITING (throwing up) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), PAIN (body and muscle aches), FEELING HOT (a sudden feeling of hotness), DIZZINESS (lightheadedness), INJECTION SITE WARMTH (rash from the injection site that was red, hot, and swollen), VACCINATION SITE RASH (rash from the injection site but closer to the elbow), INJECTION SITE ERYTHEMA (rash from the injection site that was red, hot, and swollen), INJECTION SITE SWELLING (rash from the injection site that was red, hot, and swollen), CHILLS (chills), MYALGIA (body and muscle aches), VOMITING (throwing up) and HEADACHE (headache) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   This case was linked to MOD-2021-049558 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vomiting
Clinical narrative: diarrhea; body and muscle aches; a sudden feeling of hotness; lightheadedness; rash from the injection site that was red, hot, and swollen; rash from the injection site but closer to the elbow; rash from the injection site that was red, hot, and swollen; rash from the injection site that was red, hot, and swollen; chills; body and muscle aches; throwing up; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN (body and muscle aches), FEELING HOT (a sudden feeling of hotness), DIZZINESS (lightheadedness) and INJECTION SITE WARMTH (rash from the injection site that was red, hot, and swollen) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Right arm surgery). Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROID) for Thyroid disorder.    On 13-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 DIARRHOEA (diarrhea), PAIN (body and muscle aches), FEELING HOT (a sudden feeling of hotness), DIZZINESS (lightheadedness), INJECTION SITE WARMTH (rash from the injection site that was red, hot, and swollen), VACCINATION SITE RASH (rash from the injection site but closer to the elbow), INJECTION SITE ERYTHEMA (rash from the injection site that was red, hot, and swollen), INJECTION SITE SWELLING (rash from the injection site that was red, hot, and swollen), CHILLS (chills), MYALGIA (body and muscle aches), VOMITING (throwing up) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), PAIN (body and muscle aches), FEELING HOT (a sudden feeling of hotness), DIZZINESS (lightheadedness), INJECTION SITE WARMTH (rash from the injection site that was red, hot, and swollen), VACCINATION SITE RASH (rash from the injection site but closer to the elbow), INJECTION SITE ERYTHEMA (rash from the injection site that was red, hot, and swollen), INJECTION SITE SWELLING (rash from the injection site that was red, hot, and swollen), CHILLS (chills), MYALGIA (body and muscle aches), VOMITING (throwing up) and HEADACHE (headache) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   This case was linked to MOD-2021-049558 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Leukoplakia oral, Vaccination site erythema, Vaccination site pain
Clinical narrative: Leukoplakia on her gums; sore after receiving vaccination; left arm  got red; This spontaneous case was reported by a consumer and describes the occurrence of LEUKOPLAKIA ORAL (Leukoplakia on her gums), VACCINATION SITE PAIN (sore after receiving vaccination) and VACCINATION SITE ERYTHEMA (left arm  got red) 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 Biopsy (Gum biopsy).    On 07-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 LEUKOPLAKIA ORAL (Leukoplakia on her gums), VACCINATION SITE PAIN (sore after receiving vaccination) and VACCINATION SITE ERYTHEMA (left arm  got red). At the time of the report, LEUKOPLAKIA ORAL (Leukoplakia on her gums), VACCINATION SITE PAIN (sore after receiving vaccination) and VACCINATION SITE ERYTHEMA (left arm  got red) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Event updated, Reporter contact information updated
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypersensitivity, Insomnia, Muscle spasms
Clinical narrative: Allergic reaction; High heart beat; Couldn't sleep; Spasm in her arms and chest on her front and back on the left side of her body; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), HEART RATE INCREASED (High heart beat), INSOMNIA (Couldn't sleep) and MUSCLE SPASMS (Spasm in her arms and chest on her front and back on the left side of her body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0225A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Steroids).   On 14-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 HYPERSENSITIVITY (Allergic reaction), HEART RATE INCREASED (High heart beat), INSOMNIA (Couldn't sleep) and MUSCLE SPASMS (Spasm in her arms and chest on her front and back on the left side of her body). At the time of the report, HYPERSENSITIVITY (Allergic reaction), HEART RATE INCREASED (High heart beat), INSOMNIA (Couldn't sleep) and MUSCLE SPASMS (Spasm in her arms and chest on her front and back on the left side of her body) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications reported. No treatment information reported.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Dyspnoea, Echocardiogram, Erythema, Hypersensitivity
Clinical narrative: Allergic reaction to the shot; Shortness of breath; Right leg looked like COVID-19 arm; Both legs started getting more red/real red and blotchy; Both legs swelled up/There are bumps on his legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Allergic reaction to the shot), DYSPNOEA (Shortness of breath), PERIPHERAL SWELLING (Both legs swelled up/There are bumps on his legs), VACCINATION COMPLICATION (Right leg looked like COVID-19 arm) and ERYTHEMA (Both legs started getting more red/real red and blotchy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011V20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PERIPHERAL SWELLING (Both legs swelled up/There are bumps on his legs) and ERYTHEMA (Both legs started getting more red/real red and blotchy). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction to the shot), DYSPNOEA (Shortness of breath) and VACCINATION COMPLICATION (Right leg looked like COVID-19 arm). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (SMZ-TMP) at a dose of 800-160mg. At the time of the report, HYPERSENSITIVITY (Allergic reaction to the shot), DYSPNOEA (Shortness of breath), PERIPHERAL SWELLING (Both legs swelled up/There are bumps on his legs) and VACCINATION COMPLICATION (Right leg looked like COVID-19 arm) outcome was unknown and ERYTHEMA (Both legs started getting more red/real red and blotchy) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: no change (normal) No change from 10 years ago when he had those tests. On an unknown date, Echocardiogram: no change (normal) No change from 10 years ago when he had those tests. On an unknown date, Ultrasound Doppler: negative (Negative) Negative.         No concomitant medications were provided. Treatment medications included steroid, 20mg of water pill, inhaler. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-049470 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Ultrasound Doppler, Vaccination complication
Clinical narrative: Allergic reaction to the shot; Shortness of breath; Right leg looked like COVID-19 arm; Both legs started getting more red/real red and blotchy; Both legs swelled up/There are bumps on his legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Allergic reaction to the shot), DYSPNOEA (Shortness of breath), PERIPHERAL SWELLING (Both legs swelled up/There are bumps on his legs), VACCINATION COMPLICATION (Right leg looked like COVID-19 arm) and ERYTHEMA (Both legs started getting more red/real red and blotchy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011V20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PERIPHERAL SWELLING (Both legs swelled up/There are bumps on his legs) and ERYTHEMA (Both legs started getting more red/real red and blotchy). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction to the shot), DYSPNOEA (Shortness of breath) and VACCINATION COMPLICATION (Right leg looked like COVID-19 arm). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (SMZ-TMP) at a dose of 800-160mg. At the time of the report, HYPERSENSITIVITY (Allergic reaction to the shot), DYSPNOEA (Shortness of breath), PERIPHERAL SWELLING (Both legs swelled up/There are bumps on his legs) and VACCINATION COMPLICATION (Right leg looked like COVID-19 arm) outcome was unknown and ERYTHEMA (Both legs started getting more red/real red and blotchy) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: no change (normal) No change from 10 years ago when he had those tests. On an unknown date, Echocardiogram: no change (normal) No change from 10 years ago when he had those tests. On an unknown date, Ultrasound Doppler: negative (Negative) Negative.         No concomitant medications were provided. Treatment medications included steroid, 20mg of water pill, inhaler. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-049470 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Headache, Hyperhidrosis, Myalgia
Clinical narrative: sweaty wet and hot; redness; itching; fever; headache; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty wet and hot), ERYTHEMA (redness), PRURITUS (itching), PYREXIA (fever) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 HYPERHIDROSIS (sweaty wet and hot), ERYTHEMA (redness), PRURITUS (itching), PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle ache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweaty wet and hot), ERYTHEMA (redness), PRURITUS (itching), PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 (Inconclusive) developed fever temperature 100.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: sweaty wet and hot; redness; itching; fever; headache; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty wet and hot), ERYTHEMA (redness), PRURITUS (itching), PYREXIA (fever) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 HYPERHIDROSIS (sweaty wet and hot), ERYTHEMA (redness), PRURITUS (itching), PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle ache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweaty wet and hot), ERYTHEMA (redness), PRURITUS (itching), PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 (Inconclusive) developed fever temperature 100.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0482A1) 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 an unknown date, the patient experienced DYSGEUSIA (metallic taste). At the time of the report, DYSGEUSIA (metallic taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Patient had a swelling; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Patient had a swelling) 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 23-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 VACCINATION SITE SWELLING (Patient had a swelling). At the time of the report, VACCINATION SITE SWELLING (Patient had a swelling) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not reported.  It was reported that the patient had a swelling, a week later had more swelling and it grew
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination complication, Weight decreased
Clinical narrative: Diarrhea; massive loss of weight (15lbs) in less than 2 weeks; after shot not constipated anymore; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), WEIGHT DECREASED (massive loss of weight (15lbs) in less than 2 weeks) and VACCINATION COMPLICATION (after shot not constipated anymore) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced WEIGHT DECREASED (massive loss of weight (15lbs) in less than 2 weeks) and VACCINATION COMPLICATION (after shot not constipated anymore). On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved and WEIGHT DECREASED (massive loss of weight (15lbs) in less than 2 weeks) and VACCINATION COMPLICATION (after shot not constipated anymore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 19-Mar-2021: Follow up received on 19-MAR-2021 Contains new events added, reporter information was added. On 07-May-2021: Addition information document received on 07-MAY-2021 Contains Outcome of the events added, information about second dose added.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchiness at injection site; Spot quite red at injection site; Spot at injection site a little swollen; Arm little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm little sore), VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE ERYTHEMA (Spot quite red at injection site) and VACCINATION SITE SWELLING (Spot at injection site a little swollen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm little sore). On 17-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE ERYTHEMA (Spot quite red at injection site) and VACCINATION SITE SWELLING (Spot at injection site a little swollen). At the time of the report, PAIN IN EXTREMITY (Arm little sore), VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE ERYTHEMA (Spot quite red at injection site) and VACCINATION SITE SWELLING (Spot at injection site a little swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information includes High Blood Pressure, Cholesterol medication. Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Slightly raised and itchy rash on neck and chest; Extreme arm pain that went into shoulders; Couldn't lift arm arm and having mobility issues at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't lift arm arm and having mobility issues at injection site), RASH (Slightly raised and itchy rash on neck and chest) and VACCINATION SITE PAIN (Extreme arm pain that went into shoulders) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not provided.).    On 22-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 VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't lift arm arm and having mobility issues at injection site) and VACCINATION SITE PAIN (Extreme arm pain that went into shoulders). On 14-Mar-2021, the patient experienced RASH (Slightly raised and itchy rash on neck and chest). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't lift arm arm and having mobility issues at injection site) had resolved and RASH (Slightly raised and itchy rash on neck and chest) and VACCINATION SITE PAIN (Extreme arm pain that went into shoulders) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment included ibuprofen and a hot water bottle on the affected arm.   This case was linked to MOD21-056849 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Rash pruritic, Swelling
Clinical narrative: Itchy rash on her forehead which developed a couple days after the first injection; Blisters; Swelling; Its red; This spontaneous case was reported by a nurse and describes the occurrence of RASH PRURITIC (Itchy rash on her forehead which developed a couple days after the first injection), BLISTER (Blisters), SWELLING (Swelling) and ERYTHEMA (Its red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Biopsy (right eye) on 09-Mar-2021.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash on her forehead which developed a couple days after the first injection), BLISTER (Blisters), SWELLING (Swelling) and ERYTHEMA (Its red). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) on 16-Mar-2021 for Rash, at an unspecified dose and frequency. In March 2021, RASH PRURITIC (Itchy rash on her forehead which developed a couple days after the first injection) had resolved. At the time of the report, BLISTER (Blisters), SWELLING (Swelling) and ERYTHEMA (Its red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up included updated information of patient demographics and outcome of event.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Hypersensitivity
Clinical narrative: Allergies; nose is stuffy; scratchy throat; sinus drainage; sinus infection; felt tired, stayed in and out of bed for two weeks; bad headaches; felt like she had the flu; the injection made her sick; had weakness; had dizziness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu), ILLNESS (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness) and SINUSITIS (sinus infection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy, Hypertension, Migraine, Heart disease, unspecified and Palpitations.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), ASTHENIA (had weakness), DIZZINESS (had dizziness) and FATIGUE (felt tired, stayed in and out of bed for two weeks). 20-Feb-2021, the patient experienced ILLNESS (the injection made her sick) and HEADACHE (bad headaches). On 11-Mar-2021, the patient experienced SINUSITIS (sinus infection). On 18-Mar-2021, the patient experienced HYPERSENSITIVITY (Allergies), NASAL CONGESTION (nose is stuffy), THROAT IRRITATION (scratchy throat) and SINUS DISORDER (sinus drainage). At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had the flu), ILLNESS (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness), SINUSITIS (sinus infection), HYPERSENSITIVITY (Allergies), NASAL CONGESTION (nose is stuffy), THROAT IRRITATION (scratchy throat), SINUS DISORDER (sinus drainage), FATIGUE (felt tired, stayed in and out of bed for two weeks) and HEADACHE (bad headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 24-Feb-2021 patient was given allergy shots by her HCP.  Patient was taking concomitant medications, but could not recall the names of the medications. Second dose scheduled on 18-May-2021 was noted.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Nasal congestion, Sinus disorder, Sinusitis
Clinical narrative: Allergies; nose is stuffy; scratchy throat; sinus drainage; sinus infection; felt tired, stayed in and out of bed for two weeks; bad headaches; felt like she had the flu; the injection made her sick; had weakness; had dizziness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu), ILLNESS (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness) and SINUSITIS (sinus infection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy, Hypertension, Migraine, Heart disease, unspecified and Palpitations.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), ASTHENIA (had weakness), DIZZINESS (had dizziness) and FATIGUE (felt tired, stayed in and out of bed for two weeks). 20-Feb-2021, the patient experienced ILLNESS (the injection made her sick) and HEADACHE (bad headaches). On 11-Mar-2021, the patient experienced SINUSITIS (sinus infection). On 18-Mar-2021, the patient experienced HYPERSENSITIVITY (Allergies), NASAL CONGESTION (nose is stuffy), THROAT IRRITATION (scratchy throat) and SINUS DISORDER (sinus drainage). At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had the flu), ILLNESS (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness), SINUSITIS (sinus infection), HYPERSENSITIVITY (Allergies), NASAL CONGESTION (nose is stuffy), THROAT IRRITATION (scratchy throat), SINUS DISORDER (sinus drainage), FATIGUE (felt tired, stayed in and out of bed for two weeks) and HEADACHE (bad headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 24-Feb-2021 patient was given allergy shots by her HCP.  Patient was taking concomitant medications, but could not recall the names of the medications. Second dose scheduled on 18-May-2021 was noted.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Allergies; nose is stuffy; scratchy throat; sinus drainage; sinus infection; felt tired, stayed in and out of bed for two weeks; bad headaches; felt like she had the flu; the injection made her sick; had weakness; had dizziness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu), ILLNESS (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness) and SINUSITIS (sinus infection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy, Hypertension, Migraine, Heart disease, unspecified and Palpitations.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), ASTHENIA (had weakness), DIZZINESS (had dizziness) and FATIGUE (felt tired, stayed in and out of bed for two weeks). 20-Feb-2021, the patient experienced ILLNESS (the injection made her sick) and HEADACHE (bad headaches). On 11-Mar-2021, the patient experienced SINUSITIS (sinus infection). On 18-Mar-2021, the patient experienced HYPERSENSITIVITY (Allergies), NASAL CONGESTION (nose is stuffy), THROAT IRRITATION (scratchy throat) and SINUS DISORDER (sinus drainage). At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had the flu), ILLNESS (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness), SINUSITIS (sinus infection), HYPERSENSITIVITY (Allergies), NASAL CONGESTION (nose is stuffy), THROAT IRRITATION (scratchy throat), SINUS DISORDER (sinus drainage), FATIGUE (felt tired, stayed in and out of bed for two weeks) and HEADACHE (bad headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 24-Feb-2021 patient was given allergy shots by her HCP.  Patient was taking concomitant medications, but could not recall the names of the medications. Second dose scheduled on 18-May-2021 was noted.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash pruritic
Clinical narrative: rash reappeared and is itchy; Red and sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Red and sore arm) and RASH PRURITIC (rash reappeared and is itchy) in a 48-year-old male patient 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. Concomitant products included INTERFERON from 18-Mar-2021 to an unknown date for Multiple sclerosis, CALCIUM PANTOTHENATE, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (B VITAMIN COMP [CALCIUM PANTOTHENATE;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) from 18-Mar-2021 to an unknown date and COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) from 18-Mar-2021 to an unknown date for Stress.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Red and sore arm). On 18-Mar-2021, the patient experienced RASH PRURITIC (rash reappeared and is itchy). On 12-Mar-2021, PAIN IN EXTREMITY (Red and sore arm) outcome was unknown. At the time of the report, RASH PRURITIC (rash reappeared and is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Added FUP email from patient
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Rash pruritic
Clinical narrative: raised bump 1/4-half dollar in size on forehead and scalp/ rash was on scalp and forehead; Rash itched bad; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PAPULAR (raised bump 1/4-half dollar in size on forehead and scalp/ rash was on scalp and forehead) and RASH PRURITIC (Rash itched bad) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced RASH PAPULAR (raised bump 1/4-half dollar in size on forehead and scalp/ rash was on scalp and forehead) and RASH PRURITIC (Rash itched bad). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH PAPULAR (raised bump 1/4-half dollar in size on forehead and scalp/ rash was on scalp and forehead) and RASH PRURITIC (Rash itched bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included a topical corticosteroid, and to use a cold rag for rash. No concomitant medications were reported. Patient visited dermatologist. She received her second shot on 09-Mar-2021 (batch lot 006M20A) in right arm.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17-year-old patient administered his first Moderna vaccine dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient administered his first Moderna vaccine dose) in a 17-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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient administered his first Moderna vaccine dose). On 22-Jan-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient administered his first Moderna vaccine dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Left facial numbness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Left facial numbness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced HYPOAESTHESIA (Left facial numbness). On 21-Jan-2021, HYPOAESTHESIA (Left facial numbness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant or treatment information was provided.   This case was linked to MOD-2021-049556 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site rash, Vaccination site warmth
Clinical narrative: heat coming out from her injection site; itchy; rash around her belly button area had striations going from the belly button; big rash around the site of injection; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE WARMTH (heat coming out from her injection site), PRURITUS (itchy), RASH (rash around her belly button area had striations going from the belly button) and VACCINATION SITE RASH (big rash around the site of injection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE WARMTH (heat coming out from her injection site), PRURITUS (itchy), RASH (rash around her belly button area had striations going from the belly button) and VACCINATION SITE RASH (big rash around the site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (heat coming out from her injection site), PRURITUS (itchy), RASH (rash around her belly button area had striations going from the belly button) and VACCINATION SITE RASH (big rash around the site of injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information use was not reported.  Treatment information was not provided.