chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (Body ache), NAUSEA (Nausea) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included VITAMIN D NOS, VITAMIN C [ASCORBIC ACID], ATENOLOL, ZINC and THYROID 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 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN (Body ache), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), PAIN (Body ache), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash at injection site; A spontaneous report was received from a 73-years-old  female patient  concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash at injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the event rash at injection site.  Treatment details included not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, rash at injection site was unknown.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086228:1st dose
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in calf muscle; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in calf muscle) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM (XANAX) and FAMOTIDINE for an unknown indication.    On 11-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 PAIN IN EXTREMITY (Pain in calf muscle). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and GABAPENTIN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pain in calf muscle) had not 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 assessment.    Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: Follow up received on 03 MAY 2021: Updated reporter's address. On 15-Jul-2021: TCR form received on 15 JUL 2021: No new information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain, Vaccination site rash
Clinical narrative: a little bruise; a little sore; Ball shaped rash on left arm just below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (a little bruise), PAIN (a little sore) and VACCINATION SITE RASH (Ball shaped rash on left arm just below the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (a little bruise), PAIN (a little sore) and VACCINATION SITE RASH (Ball shaped rash on left arm just below the injection site). At the time of the report, CONTUSION (a little bruise) and PAIN (a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: significant live follow up
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient tested positive for COVID-19; A spontaneous report was received from a healthcare professional concerning a 59-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events patient tested positive for covid-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On Dec 2020, prior to the onset of the events the patient received first of two planned doses of mRNA-1273  via unknown route for prophylaxis of COVID-19 infection.  On 7 Jan 2021, the patient experienced the event(s) patient tested positive for covid-19.  Treatment details included not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), patient tested positive for covid-19 was .
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Myalgia, Pyrexia
Clinical narrative: Loss of appetite; High fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (High fever), CHILLS (Chills) and MYALGIA (Body aches) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) 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 24-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite), PYREXIA (High fever), CHILLS (Chills) and MYALGIA (Body aches). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. On 25-Feb-2021, DECREASED APPETITE (Loss of appetite), PYREXIA (High fever), CHILLS (Chills) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication included.  No treatment medication included.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: TCR received on 28 -APR-2021 , Containing No new Information On 15-Jul-2021: TCR Received on 15 - JUL -2021 , Containing non significant information added
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: spotting : menstrual period; heaviness: menstrual period; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (spotting : menstrual period) and HEAVY MENSTRUAL BLEEDING (heaviness: menstrual period) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced INTERMENSTRUAL BLEEDING (spotting : menstrual period) and HEAVY MENSTRUAL BLEEDING (heaviness: menstrual period). At the time of the report, INTERMENSTRUAL BLEEDING (spotting : menstrual period) and HEAVY MENSTRUAL BLEEDING (heaviness: menstrual period) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: follow up added
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Pyrexia, Tremor
Clinical narrative: fever; headache; shaking; diarrhea; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), DIARRHOEA (diarrhea), VOMITING (vomiting), CHILLS (chills) and PYREXIA (fever) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced TREMOR (shaking), DIARRHOEA (diarrhea), VOMITING (vomiting) and CHILLS (chills). On 10-Feb-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) on 10-Feb-2021 at an unspecified dose and frequency. On 09-Feb-2021, VOMITING (vomiting) had resolved. On 10-Feb-2021, TREMOR (shaking), DIARRHOEA (diarrhea) and CHILLS (chills) had resolved. On 11-Feb-2021, PYREXIA (fever) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: fever; headache; shaking; diarrhea; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), DIARRHOEA (diarrhea), VOMITING (vomiting), CHILLS (chills) and PYREXIA (fever) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced TREMOR (shaking), DIARRHOEA (diarrhea), VOMITING (vomiting) and CHILLS (chills). On 10-Feb-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) on 10-Feb-2021 at an unspecified dose and frequency. On 09-Feb-2021, VOMITING (vomiting) had resolved. On 10-Feb-2021, TREMOR (shaking), DIARRHOEA (diarrhea) and CHILLS (chills) had resolved. On 11-Feb-2021, PYREXIA (fever) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Headache, Herpes zoster, Lymphadenopathy
Clinical narrative: headache; Chills; Rash; Pain; Shingles; Swollen lymph nodes; Pain on left hand side near ribs where she thought it was possibly the spleen; Stiffness in left side of neck; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Pain on left hand side near ribs where she thought it was possibly the spleen), MUSCULOSKELETAL STIFFNESS (Stiffness in left side of neck), PAIN (Pain), HERPES ZOSTER (Shingles) and LYMPHADENOPATHY (Swollen lymph nodes) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced ABDOMINAL PAIN (Pain on left hand side near ribs where she thought it was possibly the spleen), MUSCULOSKELETAL STIFFNESS (Stiffness in left side of neck) and LYMPHADENOPATHY (Swollen lymph nodes). On 09-Feb-2021, the patient experienced PAIN (Pain), HERPES ZOSTER (Shingles) and RASH (Rash). On 10-Feb-2021, the patient experienced HEADACHE (headache) and CHILLS (Chills). At the time of the report, ABDOMINAL PAIN (Pain on left hand side near ribs where she thought it was possibly the spleen), MUSCULOSKELETAL STIFFNESS (Stiffness in left side of neck), PAIN (Pain), HERPES ZOSTER (Shingles), LYMPHADENOPATHY (Swollen lymph nodes), RASH (Rash), HEADACHE (headache) and CHILLS (Chills) had not resolved. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: No specific follow-up information recorded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Rash
Clinical narrative: headache; Chills; Rash; Pain; Shingles; Swollen lymph nodes; Pain on left hand side near ribs where she thought it was possibly the spleen; Stiffness in left side of neck; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Pain on left hand side near ribs where she thought it was possibly the spleen), MUSCULOSKELETAL STIFFNESS (Stiffness in left side of neck), PAIN (Pain), HERPES ZOSTER (Shingles) and LYMPHADENOPATHY (Swollen lymph nodes) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced ABDOMINAL PAIN (Pain on left hand side near ribs where she thought it was possibly the spleen), MUSCULOSKELETAL STIFFNESS (Stiffness in left side of neck) and LYMPHADENOPATHY (Swollen lymph nodes). On 09-Feb-2021, the patient experienced PAIN (Pain), HERPES ZOSTER (Shingles) and RASH (Rash). On 10-Feb-2021, the patient experienced HEADACHE (headache) and CHILLS (Chills). At the time of the report, ABDOMINAL PAIN (Pain on left hand side near ribs where she thought it was possibly the spleen), MUSCULOSKELETAL STIFFNESS (Stiffness in left side of neck), PAIN (Pain), HERPES ZOSTER (Shingles), LYMPHADENOPATHY (Swollen lymph nodes), RASH (Rash), HEADACHE (headache) and CHILLS (Chills) had not resolved. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: No specific follow-up information recorded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breastfeeding; A spontaneous report was received from a consumer concerning a 37-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events breastfeeding.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Feb 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: Unavailable) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) breastfeeding.  Treatment details included Not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), breastfeeding was unknown.; Reporter's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-107095:Wife's case
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: feels like she has covid again; arm is sore; body aches; nausea; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feels like she has covid again), PAIN IN EXTREMITY (arm is sore), PAIN (body aches), NAUSEA (nausea) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023MZ) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to sulfa drug). Concomitant products included HYDROXYCHLOROQUINE and LEVOTHYROXINE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (feels like she has covid again), PAIN IN EXTREMITY (arm is sore), PAIN (body aches), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (feels like she has covid again), PAIN IN EXTREMITY (arm is sore), PAIN (body aches), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: feels like she has covid again; arm is sore; body aches; nausea; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feels like she has covid again), PAIN IN EXTREMITY (arm is sore), PAIN (body aches), NAUSEA (nausea) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023MZ) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to sulfa drug). Concomitant products included HYDROXYCHLOROQUINE and LEVOTHYROXINE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (feels like she has covid again), PAIN IN EXTREMITY (arm is sore), PAIN (body aches), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (feels like she has covid again), PAIN IN EXTREMITY (arm is sore), PAIN (body aches), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Pain in extremity, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), INJECTION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE RASH (Vaccination site rash) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included CLONAZEPAM, METOPROLOL SUCCINATE (TOPROL XL), ESCITALOPRAM OXALATE (LEXAPRO), ATORVASTATIN CALCIUM (LIPITOR), AZELASTINE HCL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 15-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 (Pain in arm), INJECTION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE RASH (Vaccination site rash). At the time of the report, PAIN IN EXTREMITY (Pain in arm), INJECTION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE RASH (Vaccination site rash) 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 25-Feb-2021: follow up added
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nasal congestion, Pain
Clinical narrative: little congestion; body ache so bad; chills; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (little congestion), PAIN (body ache so bad), CHILLS (chills) and HEADACHE (severe headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Migraine.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced NASAL CONGESTION (little congestion), PAIN (body ache so bad), CHILLS (chills) and HEADACHE (severe headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 06-Feb-2021, NASAL CONGESTION (little congestion), PAIN (body ache so bad), CHILLS (chills) and HEADACHE (severe headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 101 (High) 101°F fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15 july 2021.Patient contact details were updated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body Aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.  No Medical History information was reported. On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body Aches). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body Aches) outcome was unknown. No treatment information was provided. No relevant concomitant medications reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Dizziness; Injection site itching; Injection site swelling; Injection site redness; Headache; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), DIZZINESS (Dizziness), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (Injection site redness) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 24-Feb-2021, the patient experienced DIZZINESS (Dizziness), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Injection site redness) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain in arm), DIZZINESS (Dizziness), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Injection site redness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient have a event like injection site sore.   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: follow up added
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Dizziness; Injection site itching; Injection site swelling; Injection site redness; Headache; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), DIZZINESS (Dizziness), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (Injection site redness) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 24-Feb-2021, the patient experienced DIZZINESS (Dizziness), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Injection site redness) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain in arm), DIZZINESS (Dizziness), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Injection site redness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient have a event like injection site sore.   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: follow up added
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Minor reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Minor reaction) 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 19-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Minor reaction). At the time of the report, VACCINATION COMPLICATION (Minor reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported  No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Flatulence, Vaccination complication
Clinical narrative: side effects that she might be having; Bloating; Excessive gases; A spontaneous report was received from a consumer concerning herself, female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced side effects/vaccination complications, bloating/abdominal distension, excessive gas/flatulence.  The patient's medical history was not included. Concomitant products use was not provided.  On 30 Jan 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch N0:unknown) intramuscularly for prophylaxis of covid 19 infection.  On an unknown date, the patient experienced vaccination side effects, on 12 Feb 2021 patient experienced bloating and excessive gases.  Treatment information was not included.  Action taken with mRNA-1273 in response to the events was unknown.   A follow up was received on 12 Feb 2021, and information about events bloating and flatulence were provided.  The outcome of the events, side effects/vaccination complications, bloating/abdominal distension, excessive gas/flatulence were unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness
Clinical narrative: Headache; Flu-like symptoms; A spontaneous report was received from a consumer concerning a 75-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache and flu-like symptoms.  The patient's medical history was not provided. Concomitant medications included warfarin as blood thinner.  On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced real bad headache and flu-like symptoms, treated with Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events real bad headache and flu-like symptoms was not recovered (ongoing).; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid on 03Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid on 03Feb2021) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Leukemia, Blood pressure high and Diabetes. Concomitant products included chemo therapy medication, OLMESARTAN, METFORMIN, FENOFIBRATE and ROSUVASTATIN for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid on 03Feb2021). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid on 03Feb2021) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: Did not get a complete dose; something happened with the syringe; vaccine hit his face; A spontaneous report was received from a spouse concerning their husband, a 78- year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the events did not get a complete dose/vaccine under dose, something happened with the syringe/syringe connection issue and vaccine hit his face/exposure via skin contact.   The patient's medical condition included neurological issues. Concomitant product use was not provided by the reporter.   On 23 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On date 23 Feb 2021, while administering the vaccine something happened with the syringe and a sprinkle came up which was enough to hit his face. The patient did not get a complete dose.Treatment information was not provided.    The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The events something happened with the syringe and did not get a complete dose were considered resolved on 23 Feb 2021. The outcome of the event vaccine hit his face was considered unknown.; Reporter's Comments: This report refers to a case of vaccine underdose, syringe connection issue and exposure via skin for mRNA-1273 (Batch number not provided) with no associated AEs.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: High Blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High Blood pressure) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History Information was reported.  Concurrent medical conditions included Lactose intolerance, Gluten intolerance, Allergy to metals, Allergy to antibiotic (Allergic to Bactrim.) and Drug allergy (Allergic to Macrobid.). Concomitant products included IRBESARTAN and VERAPAMIL for an unknown indication.    On 23-Feb-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced HYPERTENSION (High Blood pressure). On 24-Feb-2021, HYPERTENSION (High Blood pressure) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Blood pressure measurement: 188 (High) 188.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information for the event was provided.   This case was linked to MOD-2021-259147 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: NON-SIGNIFICANT FU On 16-Jul-2021: Follow-up information received on 17 Jul 2021: second reporter information added and checked medically confirm and Other Relevant History and lab data result added and anatomical location of suspect drug, vaccine facility information concomitant drugs added.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Fatigue, Headache
Clinical narrative: Body aches; Joint pain; fatigue; Tickling in the throat; Dry cough; Headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), THROAT TIGHTNESS (Tickling in the throat) and COUGH (Dry cough) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.     On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced MYALGIA (Body aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), THROAT TIGHTNESS (Tickling in the throat), COUGH (Dry cough), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with DICLOFENAC for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (Body aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), THROAT TIGHTNESS (Tickling in the throat), COUGH (Dry cough), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), THROAT TIGHTNESS (Tickling in the throat) and COUGH (Dry cough) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.     On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced MYALGIA (Body aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), THROAT TIGHTNESS (Tickling in the throat), COUGH (Dry cough), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with DICLOFENAC for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (Body aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), THROAT TIGHTNESS (Tickling in the throat), COUGH (Dry cough), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Throat tightness
Clinical narrative: Body aches; Joint pain; fatigue; Tickling in the throat; Dry cough; Headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), THROAT TIGHTNESS (Tickling in the throat) and COUGH (Dry cough) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.     On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced MYALGIA (Body aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), THROAT TIGHTNESS (Tickling in the throat), COUGH (Dry cough), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with DICLOFENAC for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (Body aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), THROAT TIGHTNESS (Tickling in the throat), COUGH (Dry cough), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), THROAT TIGHTNESS (Tickling in the throat) and COUGH (Dry cough) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.     On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced MYALGIA (Body aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), THROAT TIGHTNESS (Tickling in the throat), COUGH (Dry cough), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with DICLOFENAC for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (Body aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), THROAT TIGHTNESS (Tickling in the throat), COUGH (Dry cough), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Gait inability, Somnolence
Clinical narrative: unable to walk; back aching; slept all day; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (unable to walk), BACK PAIN (back aching) and SOMNOLENCE (slept all day) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Walking difficulty (can't walk without a walker) since an unknown date.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (unable to walk), BACK PAIN (back aching) and SOMNOLENCE (slept all day). At the time of the report, GAIT INABILITY (unable to walk), BACK PAIN (back aching) and SOMNOLENCE (slept all day) outcome was unknown.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Consumer feels fine. No problem at all This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (unable to walk), BACK PAIN (back aching) and SOMNOLENCE (slept all day) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Walking difficulty (can't walk without a walker) since an unknown date.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (unable to walk), BACK PAIN (back aching) and SOMNOLENCE (slept all day). At the time of the report, GAIT INABILITY (unable to walk), BACK PAIN (back aching) and SOMNOLENCE (slept all day) outcome was unknown.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Consumer feels fine. No problem at all
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included WARFARIN for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE ERYTHEMA (Redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included INSULIN and METFORMIN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm soreness). On 24-Feb-2021, VACCINATION SITE PAIN (arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient have concomitant drug like cpap machine.   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: follow up added
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site lymphadenopathy, Vaccination site mass
Clinical narrative: lump; swollen lymph nodes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (lump) and INJECTION SITE LYMPHADENOPATHY (swollen lymph nodes) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History was reported.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), LAMOTRIGINE (LAMICTAL) and ALPRAZOLAM (XANAX) for an unknown indication.    On 07-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 VACCINATION SITE MASS (lump) and INJECTION SITE LYMPHADENOPATHY (swollen lymph nodes). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (lump) and INJECTION SITE LYMPHADENOPATHY (swollen lymph nodes) 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 28-Apr-2021: NNI
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Injection site rash, Pain in extremity, Peripheral swelling
Clinical narrative: sore arm from elbow to shoulder; red arm from elbow to shoulder; hard, swollen, sore arm; hard, swollen, sore arm; red, itchy rash; raised white pimple-like; red, itchy rash; giant rash on arm; rash under bandage; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm from elbow to shoulder), ERYTHEMA (red arm from elbow to shoulder), PERIPHERAL SWELLING (hard, swollen, sore arm), INDURATION (hard, swollen, sore arm) and ERYTHEMA (red, itchy rash) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma since an unknown date and Allergy since an unknown date.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm from elbow to shoulder), ERYTHEMA (red arm from elbow to shoulder), PERIPHERAL SWELLING (hard, swollen, sore arm), INDURATION (hard, swollen, sore arm), ERYTHEMA (red, itchy rash), RASH PAPULAR (raised white pimple-like), RASH PRURITIC (red, itchy rash), INJECTION SITE RASH (giant rash on arm) and RASH (rash under bandage). The patient was treated with BETAMETHASONE (topical) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm from elbow to shoulder), ERYTHEMA (red arm from elbow to shoulder), PERIPHERAL SWELLING (hard, swollen, sore arm), INDURATION (hard, swollen, sore arm), ERYTHEMA (red, itchy rash), RASH PAPULAR (raised white pimple-like), RASH PRURITIC (red, itchy rash), INJECTION SITE RASH (giant rash on arm) and RASH (rash under bandage) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include asthma medications, allergy medications and immunosupressants. Additional treatment medications include steroid cream and cold pack.