chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypotension, Presyncope
Clinical narrative: diagnosis was near syncope; Sweats; Dizziness; He took his blood pressure and it was 85/49; Low potassium; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (diagnosis was near syncope), HYPERHIDROSIS (Sweats), DIZZINESS (Dizziness), HYPOTENSION (He took his blood pressure and it was 85/49) and BLOOD POTASSIUM DECREASED (Low potassium) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PRESYNCOPE (diagnosis was near syncope), HYPERHIDROSIS (Sweats), DIZZINESS (Dizziness), HYPOTENSION (He took his blood pressure and it was 85/49) and BLOOD POTASSIUM DECREASED (Low potassium). On 11-Mar-2021, HYPERHIDROSIS (Sweats), DIZZINESS (Dizziness) and HYPOTENSION (He took his blood pressure and it was 85/49) had resolved. At the time of the report, PRESYNCOPE (diagnosis was near syncope) and BLOOD POTASSIUM DECREASED (Low potassium) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood potassium: low (Low) low. On 11-Mar-2021, Blood pressure measurement: 85/49 mmhg, after 30 minutes was normal (Low) 85/49 mmHg, after 30 minutes was normal. On 11-Mar-2021, Electrocardiogram: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. The patient went to ER and was observed for 3 hours. No treatment information was provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: the injection site is red; The injection site is hot; The injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (the injection site is red), INJECTION SITE WARMTH (The injection site is hot) and INJECTION SITE SWELLING (The injection site is swollen) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for an unknown indication.     The patient's past medical history included No adverse event.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (the injection site is red), INJECTION SITE WARMTH (The injection site is hot) and INJECTION SITE SWELLING (The injection site is swollen). At the time of the report, INJECTION SITE ERYTHEMA (the injection site is red), INJECTION SITE WARMTH (The injection site is hot) and INJECTION SITE SWELLING (The injection site is swollen) outcome was unknown.            Concomitant medication provided was blood thinner. No treatment medications Tylenol and ice pack.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscular weakness, Paraesthesia, Vaccination site bruising
Clinical narrative: bruise; muscle weakness; tingling on her arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruise), MUSCULAR WEAKNESS (muscle weakness), PARAESTHESIA (tingling on her arm) and HEADACHE (headache) 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 12-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 VACCINATION SITE BRUISING (bruise), MUSCULAR WEAKNESS (muscle weakness), PARAESTHESIA (tingling on her arm) and HEADACHE (headache). At the time of the report, VACCINATION SITE BRUISING (bruise), MUSCULAR WEAKNESS (muscle weakness), PARAESTHESIA (tingling on her arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Neck pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: very debilitated; Pain is also going up her neck; vaccine site would swell, de-swell and swell again; pain was more intense/has not been to work; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very debilitated), NECK PAIN (Pain is also going up her neck), VACCINATION SITE SWELLING (vaccine site would swell, de-swell and swell again) and VACCINATION SITE PAIN (pain was more intense/has not been to work) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced ASTHENIA (very debilitated), NECK PAIN (Pain is also going up her neck), VACCINATION SITE SWELLING (vaccine site would swell, de-swell and swell again) and VACCINATION SITE PAIN (pain was more intense/has not been to work). At the time of the report, ASTHENIA (very debilitated), NECK PAIN (Pain is also going up her neck), VACCINATION SITE SWELLING (vaccine site would swell, de-swell and swell again) and VACCINATION SITE PAIN (pain was more intense/has not been to work) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications reported.  No treatment information was provided.    This case was linked to MOD-2021-027254 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Myalgia
Clinical narrative: back pain; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), CHILLS (chills) and MYALGIA (body aches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced CHILLS (chills) and MYALGIA (body aches). On an unknown date, the patient experienced BACK PAIN (back pain). At the time of the report, BACK PAIN (back pain), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Reportedly, the patient hasn't taken anything for treatment of his symptoms.   The patient's back pain is not constant but only when he rides or sits down.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: hard to bend the left knee; Left knee pain burning in nature " similar to arthritic pain"; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (hard to bend the left knee) and ARTHRALGIA (Left knee pain burning in nature " similar to arthritic pain") in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0101921A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced MOBILITY DECREASED (hard to bend the left knee) and ARTHRALGIA (Left knee pain burning in nature " similar to arthritic pain"). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (hard to bend the left knee) and ARTHRALGIA (Left knee pain burning in nature " similar to arthritic pain") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: elevated sugar levels: 380mg/dL; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (elevated sugar levels: 380mg/dL) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (elevated sugar levels: 380mg/dL). At the time of the report, BLOOD GLUCOSE INCREASED (elevated sugar levels: 380mg/dL) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Blood glucose: 380 mg/dl (High) 380.         Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Myalgia, Paraesthesia, Peripheral swelling
Clinical narrative: legs have swelled up; burning sensations in legs and feet; tingling sensations in legs and feet; knees were hurting, joint pain in knees; Muscle pain in her legs; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (legs have swelled up), BURNING SENSATION (burning sensations in legs and feet), PARAESTHESIA (tingling sensations in legs and feet), ARTHRALGIA (knees were hurting, joint pain in knees) and MYALGIA (Muscle pain in her legs) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 immunization.     Concurrent medical conditions included Arthritis (At baseline). Concomitant products included FISH OIL, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D3 for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PERIPHERAL SWELLING (legs have swelled up), BURNING SENSATION (burning sensations in legs and feet), PARAESTHESIA (tingling sensations in legs and feet), ARTHRALGIA (knees were hurting, joint pain in knees) and MYALGIA (Muscle pain in her legs). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at a dose of UNK dosage form and IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, PERIPHERAL SWELLING (legs have swelled up), BURNING SENSATION (burning sensations in legs and feet), PARAESTHESIA (tingling sensations in legs and feet), ARTHRALGIA (knees were hurting, joint pain in knees) and MYALGIA (Muscle pain in her legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy arm). At the time of the report, PRURITUS (itchy arm) 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 by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Very red arm in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Very red arm in the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood disorder (Vonwillibrands type1 - a platelet disorder, cannot take aspirin).    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Very red arm in the injection site). On 09-Feb-2021, VACCINATION SITE ERYTHEMA (Very red arm in the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  pharmacist said to just put warm compresses, and then ice   This case was linked to MOD21-051822 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: 2inch by 2 inch red circle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (2inch by 2 inch red circle) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029LZ0A and 030A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, VITAMIN D2, BUPROPION and LEVOTHYROXINE for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (2inch by 2 inch red circle). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, VACCINATION SITE ERYTHEMA (2inch by 2 inch red circle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain
Clinical narrative: Red spot in her arm; felt like a be pinch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red spot in her arm) and PAIN (felt like a be pinch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Dental implantation (post in her mouth, two implants).   On 04-Mar-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 ERYTHEMA (Red spot in her arm) and PAIN (felt like a be pinch). At the time of the report, ERYTHEMA (Red spot in her arm) and PAIN (felt like a be pinch) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.   ?No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse event). At the time of the report, VACCINATION COMPLICATION (Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient hasn't received 2nd dose because of vaccine site shut-down; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose because of vaccine site shut-down) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose because of vaccine site shut-down). On 19-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose because of vaccine site shut-down) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported.   This case was linked to MOD-2021-229317 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Follow up received on 20-06-2021 and contains no significant information.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: extreme soreness started again; arms were sore; arm where the vaccine was received is extremely sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extreme soreness started again), PAIN IN EXTREMITY (arms were sore) and VACCINATION SITE PAIN (arm where the vaccine was received is extremely sore) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (arms were sore) and VACCINATION SITE PAIN (arm where the vaccine was received is extremely sore). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (extreme soreness started again). On 11-Mar-2021, PAIN IN EXTREMITY (arms were sore) had resolved. At the time of the report, PAIN IN EXTREMITY (extreme soreness started again) and VACCINATION SITE PAIN (arm where the vaccine was received is extremely sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: insufficient dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (insufficient dose) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 ACCIDENTAL UNDERDOSE (insufficient dose). At the time of the report, ACCIDENTAL UNDERDOSE (insufficient dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment medication provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Severe Muscle pain,Excruciating pain on the Left hand side; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Severe Muscle pain,Excruciating pain on the Left hand side) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (Severe Muscle pain,Excruciating pain on the Left hand side). The patient was treated with FLUCONAZOLE (SOLONA) at an unspecified dose and frequency. At the time of the report, MYALGIA (Severe Muscle pain,Excruciating pain on the Left hand side) outcome was unknown. Not Provided    No relevant concomitant medications reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Night sweats, Vaccination site swelling
Clinical narrative: night "sweating like crazy"; swelling of injection site; headache; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night "sweating like crazy"), VACCINATION SITE SWELLING (swelling of injection site), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZIDE) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced NIGHT SWEATS (night "sweating like crazy"), VACCINATION SITE SWELLING (swelling of injection site), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, NIGHT SWEATS (night "sweating like crazy"), VACCINATION SITE SWELLING (swelling of injection site), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: diarrhea; Nausea; Vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038321A) 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 11-Mar-2021, the patient experienced DIARRHOEA (diarrhea), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache). At the time of the report, DIARRHOEA (diarrhea), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-074920 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Lot number updated for first dose. Information regarding patient's second dose and events provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscular weakness
Clinical narrative: Muscle weakness; Severe Fatigue; pretty bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness), FATIGUE (Severe Fatigue) and HEADACHE (pretty bad headache) in a 73-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 10-Mar-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) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness), FATIGUE (Severe Fatigue) and HEADACHE (pretty bad headache). At the time of the report, MUSCULAR WEAKNESS (Muscle weakness), FATIGUE (Severe Fatigue) and HEADACHE (pretty bad headache) had resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received on 25-jun-2021 included outcome of the events.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash starts from day 2-9 post vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash starts from day 2-9 post vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced RASH (Rash starts from day 2-9 post vaccination). At the time of the report, RASH (Rash starts from day 2-9 post vaccination) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: tenderness at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (tenderness at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (tenderness at injection site). At the time of the report, VACCINATION SITE PAIN (tenderness at injection site) outcome was unknown.      Concomitant medications were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-037020 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Non-significant follow-up received.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site erythema, Vaccination site pain
Clinical narrative: She noticed big red circle on left arm at ivaccination site after 8 days; 17 year old daughter received 1st dose of vaccine; Patient had a sore arm on the same day; A spontaneous report was received from a consumer concerning a 17-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and patient had a sore arm on the same day and she noticed big red circle on left arm at injection site after 8 days.    The patient's medical history, was not provided by the reporter. Concomitant medications were not reported.  On 4 Mar 2021, approximately same day prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number:027A21A)  intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 4 Mar 2021, the patient had a sore arm on the same day and she noticed big red circle on left arm at injection site after 8 days. Treatment for the events included diphenhydramine HCL.   Action taken with mRNA-1273 in response to the events was not reported.   The events,17 year old daughter received 1st dose of vaccine was considered resolved on 4 Mar 2021. On 4 Mar 2021, the outcome of patient had a sore arm on the same day and she noticed big red circle on left arm at injection site after 8 days, were unknown.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 027A21A) with associated AEs reported of vaccination site pain and injection site erythema.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: a haziness in the eyes, as if the sun is glaring into them; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (a haziness in the eyes, as if the sun is glaring into them) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VISION BLURRED (a haziness in the eyes, as if the sun is glaring into them). At the time of the report, VISION BLURRED (a haziness in the eyes, as if the sun is glaring into them) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: fast heartrate ever since, especially when she starts to move herself; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heartrate ever since, especially when she starts to move herself) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history information provided.  Concomitant products included ALPRAZOLAM, ATENOLOL, HYDROCHLOROTHIAZIDE, AMLODIPINE and METFORMIN for an unknown indication.   On 10-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 HEART RATE INCREASED (fast heartrate ever since, especially when she starts to move herself). At the time of the report, HEART RATE INCREASED (fast heartrate ever since, especially when she starts to move herself) outcome was unknown.            No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up received on 02-AUG-2021 and contains no significant information. Reporters contact details updated, Address and email address. Patient identifier in initial source document was LEM and in FU document LM were updated.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Nausea, Vomiting
Clinical narrative: Weakness; Chills; Vomiting; Severe nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), CHILLS (Chills), VOMITING (Vomiting) and NAUSEA (Severe nausea) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced ASTHENIA (Weakness), CHILLS (Chills), VOMITING (Vomiting) and NAUSEA (Severe nausea). At the time of the report, ASTHENIA (Weakness), CHILLS (Chills), VOMITING (Vomiting) and NAUSEA (Severe nausea) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications include birth control Treatment medications were not provided
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity, Pruritus
Clinical narrative: migraine; arm sore; itching; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), PAIN IN EXTREMITY (arm sore) and PRURITUS (itching) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (migraine), PAIN IN EXTREMITY (arm sore) and PRURITUS (itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine), PAIN IN EXTREMITY (arm sore) and PRURITUS (itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching both arm, hands and above her knees), HYPOAESTHESIA ORAL (Lips feel a bit numb) and PARAESTHESIA ORAL (Tongue feels different) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Acid reflux (oesophageal). Concomitant products included MACROGOL 3350 (MIRALAX) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PRURITUS (Itching both arm, hands and above her knees). On 12-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (Lips feel a bit numb) and PARAESTHESIA ORAL (Tongue feels different). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching both arm, hands and above her knees) had not resolved and HYPOAESTHESIA ORAL (Lips feel a bit numb) and PARAESTHESIA ORAL (Tongue feels different) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant product used included hypertension medication and acid reflux medication (unspecified).  Additional treatment included unspecified ointment on hands and legs to alleviate the itching.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Headache
Clinical narrative: Patient 1 received 3 doses; Headache; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient 1 received 3 doses) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Patient 1 received 3 doses) and HEADACHE (Headache). At the time of the report, EXTRA DOSE ADMINISTERED (Patient 1 received 3 doses) had resolved and HEADACHE (Headache) outcome 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.  Treatment information was not provided.  The patient went to the hospital and was advised Tylenol (acetaminophen) if the event persists. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-043192 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-043192:Case for patient 2
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pruritus, Vaccination site discolouration
Clinical narrative: pinky looking arm at the injection site; itching; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (pinky looking arm at the injection site), PRURITUS (itching) and OROPHARYNGEAL PAIN (sore throat) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN, HYDROCHLOROTHIAZIDE, PRAVASTATIN, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), PAROXETINE and RESTIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE;THIAMINE;VALERIANA OFFICINALIS] for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (pinky looking arm at the injection site), PRURITUS (itching) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, VACCINATION SITE DISCOLOURATION (pinky looking arm at the injection site), PRURITUS (itching) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was given antihistamine in response to events. Her symptoms were not relieved by the antihistamine.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Pyrexia
Clinical narrative: Diarrhea; temp 102 F; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and PYREXIA (temp 102 F) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's medical history information was not provided.  Concomitant products included LORATADINE (CLARITIN [LORATADINE]) from 10-Mar-2021 to an unknown date for Prevention.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and PYREXIA (temp 102 F). At the time of the report, DIARRHOEA (Diarrhea) and PYREXIA (temp 102 F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 102°f (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot at the injection site; itching, is red and hot at the injection site; hot at the injection site and little swollen; red and hot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (itching, is red and hot at the injection site), VACCINATION SITE SWELLING (hot at the injection site and little swollen) and VACCINATION SITE ERYTHEMA (red and hot at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 immunisation.     Concurrent medical conditions included COPD, Thyroid disorder, Rheumatoid arthritis and Osteoporosis.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (itching, is red and hot at the injection site), VACCINATION SITE SWELLING (hot at the injection site and little swollen) and VACCINATION SITE ERYTHEMA (red and hot at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (itching, is red and hot at the injection site), VACCINATION SITE SWELLING (hot at the injection site and little swollen) and VACCINATION SITE ERYTHEMA (red and hot at the injection site) outcome was unknown.            Concomitantly the patient was receiving chronic obstructive pulmonary disease pills, thyroid pills, Rheumatoid arthritis pills and osteoporosis pills (all unspecified). Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: COVID like symptoms 3 weeks after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (COVID like symptoms 3 weeks after vaccine) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was provided.  Concomitant products included INSULIN, LISINOPRIL and ATORVASTATIN 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 10-Mar-2021, the patient experienced SUSPECTED COVID-19 (COVID like symptoms 3 weeks after vaccine). At the time of the report, SUSPECTED COVID-19 (COVID like symptoms 3 weeks after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has taken covid test after 10MAR2021 as he was having covid like symptoms. At the time of reporting he has not yet received the results and want to know if he can take his 2nd shot which is scheduled on 15MAR2021.  In the follow up letter consumer states that they did not report side effects, but his wife had side effects & reported them to Moderna personnel. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Follow-up has no new information
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: very hot; arm was itchy; a golf ball sized swelling at the injection site; issues; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (issues), VACCINATION SITE WARMTH (very hot), VACCINATION SITE PRURITUS (arm was itchy) and VACCINATION SITE SWELLING (a golf ball sized swelling at the injection site) in a 66-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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE REACTION (issues). On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (very hot), VACCINATION SITE PRURITUS (arm was itchy) and VACCINATION SITE SWELLING (a golf ball sized swelling at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; HYDROCORTISONE at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (issues), VACCINATION SITE WARMTH (very hot), VACCINATION SITE PRURITUS (arm was itchy) and VACCINATION SITE SWELLING (a golf ball sized swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in the knees; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in the knees) in a 75-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (pain in the knees). At the time of the report, ARTHRALGIA (pain in the knees) outcome was unknown.            Concomitant product use was not provided.  Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Warm to touch.; Red hot circle around injection site; Low a fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch.), VACCINATION SITE ERYTHEMA (Red hot circle around injection site) and PYREXIA (Low a fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) for Diabetes.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm to touch.), VACCINATION SITE ERYTHEMA (Red hot circle around injection site) and PYREXIA (Low a fever). At the time of the report, VACCINATION SITE WARMTH (Warm to touch.), VACCINATION SITE ERYTHEMA (Red hot circle around injection site) and PYREXIA (Low a fever) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  The patient received their second dose and developed a low fever in the morning and a red hot circle around injection site which was warm to touch.   Concomitant medication also included Globoside to treat diabetes.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Arm is red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm is red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 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 ERYTHEMA (Arm is red). At the time of the report, ERYTHEMA (Arm is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Fup-Report not scheduled for Follow up as initial report is pending for submission