chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Malaise, Myalgia, Neck pain, Vaccination complication
Clinical narrative: neck pain was quite severe for three months after the vaccine; couldn't even get out of bed and function properly; General body aches; Neck pain left side and I got my shot in my left arm; General sick feeling; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain left side and I got my shot in my left arm), MALAISE (General sick feeling), CONDITION AGGRAVATED (neck pain was quite severe for three months after the vaccine), VACCINATION COMPLICATION (couldn't even get out of bed and function properly) and MYALGIA (General body aches) in a 31-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.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced NECK PAIN (Neck pain left side and I got my shot in my left arm), MALAISE (General sick feeling) and MYALGIA (General body aches). On an unknown date, the patient experienced CONDITION AGGRAVATED (neck pain was quite severe for three months after the vaccine) and VACCINATION COMPLICATION (couldn't even get out of bed and function properly). On 25-Feb-2021, MALAISE (General sick feeling) and MYALGIA (General body aches) had resolved. At the time of the report, NECK PAIN (Neck pain left side and I got my shot in my left arm) had not resolved and CONDITION AGGRAVATED (neck pain was quite severe for three months after the vaccine) and VACCINATION COMPLICATION (couldn't even get out of bed and function properly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information  provided. The patient's neck pain began the same day but didn't reach its worst severity until the third day after the first shot.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received as new events aggravation of existing disorder, vaccination related malaise was added.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Heart rate, Heart rate increased, Malaise
Clinical narrative: Feeling pretty swamp; Went to 90-95 bpm; Body aches; Body temperature was raised over two degrees; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling pretty swamp), HEART RATE INCREASED (Went to 90-95 bpm), MYALGIA (Body aches), PYREXIA (Body temperature was raised over two degrees) and CHILLS (chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced MALAISE (Feeling pretty swamp), HEART RATE INCREASED (Went to 90-95 bpm), MYALGIA (Body aches), PYREXIA (Body temperature was raised over two degrees) and CHILLS (chills). On 25-Feb-2021, MALAISE (Feeling pretty swamp), HEART RATE INCREASED (Went to 90-95 bpm), MYALGIA (Body aches), PYREXIA (Body temperature was raised over two degrees) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 99.5 (High) 99.5°F. On 23-Feb-2021, Heart rate: 90-95 (High) Went to 90-95 bpm.         No Concomitant information  provided. No Treatment information  provided   This case was linked to MOD-2021-026064 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up information received on 15 Jul 2021 and Patient intials were changed from JS to GS. Laboratory data Body temperature was added. Chills deleted as additional event.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Feeling pretty swamp; Went to 90-95 bpm; Body aches; Body temperature was raised over two degrees; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling pretty swamp), HEART RATE INCREASED (Went to 90-95 bpm), MYALGIA (Body aches), PYREXIA (Body temperature was raised over two degrees) and CHILLS (chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced MALAISE (Feeling pretty swamp), HEART RATE INCREASED (Went to 90-95 bpm), MYALGIA (Body aches), PYREXIA (Body temperature was raised over two degrees) and CHILLS (chills). On 25-Feb-2021, MALAISE (Feeling pretty swamp), HEART RATE INCREASED (Went to 90-95 bpm), MYALGIA (Body aches), PYREXIA (Body temperature was raised over two degrees) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 99.5 (High) 99.5°F. On 23-Feb-2021, Heart rate: 90-95 (High) Went to 90-95 bpm.         No Concomitant information  provided. No Treatment information  provided   This case was linked to MOD-2021-026064 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up information received on 15 Jul 2021 and Patient intials were changed from JS to GS. Laboratory data Body temperature was added. Chills deleted as additional event.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (Fever) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, ATORVASTATIN, METOPROLOL and METFORMIN for an unknown indication, FAMOTIDINE (PEPCID AC).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 1. On 05-Feb-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature (100-102.5): 100 and 102.5 Temperature was running between 100 and 102.5, yesterday it was below 98 and today it is mild 98.9.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non significant follow up received on 05-MAY-2021, no new information
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Influenza like illness, Muscular weakness, Pyrexia
Clinical narrative: Flu like symptoms; fever; muscles non responsive; wheezing huffing and puffing; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever), MUSCULAR WEAKNESS (muscles non responsive) and DYSPNOEA (wheezing huffing and puffing) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 immunization.     The patient's past medical history included No adverse event.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever), MUSCULAR WEAKNESS (muscles non responsive) and DYSPNOEA (wheezing huffing and puffing).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: sore arm; Chills; Headache; Fever  99.9 temp; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever  99.9 temp) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Migraine.    On 04-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 PAIN IN EXTREMITY (sore arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever  99.9 temp). At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever  99.9 temp) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: (Borderline) Body temperature 99.9 F.     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 Concomitant information  provided. No Treatment information  provided
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Hives; Face red; Rash; This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (Hives), ERYTHEMA (Face red) and RASH (Rash) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Obesity.    On 09-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 1:00 AM, the patient experienced URTICARIA (Hives), ERYTHEMA (Face red) and RASH (Rash). On 09-Feb-2021 at 6:00 AM, RASH (Rash) had resolved. At the time of the report, URTICARIA (Hives) and ERYTHEMA (Face red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient was advised to take Benadryl but did not.   This case was linked to MOD-2021-026058, US-MODERNATX, INC.-MOD-2021-026058 (E2B Linked Report).; Sender's Comments:  MOD-2021-026058:Same reporter US-MODERNATX, INC.-MOD-2021-026058:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: not comforting; This spontaneous case was reported by an other and describes the occurrence of DISCOMFORT (not comforting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (not comforting). At the time of the report, DISCOMFORT (not comforting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Tongue discomfort
Clinical narrative: Ear hurting; Tongue "on fire"; A spontaneous report was received from a consumer concerning a 85-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events ear pain, tongue discomfort.  The patient's medical history was not provided. Concomitant medications reported were amoxycillin Antibiotic, Loratadine Antihistamine for drug use for unknown indication.  On 6 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced the events ear pain, tongue discomfort.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, ear pain, tongue discomfort was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Facial pain, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: swelling; Slightly painful in temple area; Black, bluish, purplish discoloration below left eye; sweat; flu kind of symptoms; body ache; Chills, Shivering; myalgia; headache; This spontaneous case was reported by a physician and describes the occurrence of SKIN DISCOLOURATION (Black, bluish, purplish discoloration below left eye), HYPERHIDROSIS (sweat), INFLUENZA LIKE ILLNESS (flu kind of symptoms), SWELLING (swelling) and FACIAL PAIN (Slightly painful in temple area) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dental implantation. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HYPERHIDROSIS (sweat), INFLUENZA LIKE ILLNESS (flu kind of symptoms), PAIN (body ache), CHILLS (Chills, Shivering), MYALGIA (myalgia) and HEADACHE (headache). On 06-Feb-2021, the patient experienced SKIN DISCOLOURATION (Black, bluish, purplish discoloration below left eye), SWELLING (swelling) and FACIAL PAIN (Slightly painful in temple area). On 05-Feb-2021, HYPERHIDROSIS (sweat), INFLUENZA LIKE ILLNESS (flu kind of symptoms), PAIN (body ache), CHILLS (Chills, Shivering), MYALGIA (myalgia) and HEADACHE (headache) had resolved. On 09-Feb-2021, SWELLING (swelling) and FACIAL PAIN (Slightly painful in temple area) had resolved. At the time of the report, SKIN DISCOLOURATION (Black, bluish, purplish discoloration below left eye) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient used for ice pack and unspecified pain killer as treatment medication.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Skin discolouration, Swelling
Clinical narrative: swelling; Slightly painful in temple area; Black, bluish, purplish discoloration below left eye; sweat; flu kind of symptoms; body ache; Chills, Shivering; myalgia; headache; This spontaneous case was reported by a physician and describes the occurrence of SKIN DISCOLOURATION (Black, bluish, purplish discoloration below left eye), HYPERHIDROSIS (sweat), INFLUENZA LIKE ILLNESS (flu kind of symptoms), SWELLING (swelling) and FACIAL PAIN (Slightly painful in temple area) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dental implantation. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HYPERHIDROSIS (sweat), INFLUENZA LIKE ILLNESS (flu kind of symptoms), PAIN (body ache), CHILLS (Chills, Shivering), MYALGIA (myalgia) and HEADACHE (headache). On 06-Feb-2021, the patient experienced SKIN DISCOLOURATION (Black, bluish, purplish discoloration below left eye), SWELLING (swelling) and FACIAL PAIN (Slightly painful in temple area). On 05-Feb-2021, HYPERHIDROSIS (sweat), INFLUENZA LIKE ILLNESS (flu kind of symptoms), PAIN (body ache), CHILLS (Chills, Shivering), MYALGIA (myalgia) and HEADACHE (headache) had resolved. On 09-Feb-2021, SWELLING (swelling) and FACIAL PAIN (Slightly painful in temple area) had resolved. At the time of the report, SKIN DISCOLOURATION (Black, bluish, purplish discoloration below left eye) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient used for ice pack and unspecified pain killer as treatment medication.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea
Clinical narrative: Diarrhea; Stomach Pain; Chills; A spontaneous report was received from a consumer, concerning a 81-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea, chills and stomach pain.  The patient's medical history included cholesterol and stomach. concomitant medications reported included ascorbic acid, betacarotene, biotin, calcium carbonate, calcium phosphate, chlorine, colecalciferol, cupric oxide, ferrous fumarate, folic acid, iodine, magnesium oxide, manganese sulfate, molybdenum, nickel sulfate, nicotinamide, pantothenic acid, phosphorus, potassium chloride, pyridoxine hydrochloride, retinol acetate, riboflavin, selenium, silicon, thiamine, tin, tocopherol, vanadium, vitamin b12 nos, zinc oxide; acetylsalicylic acid; diltiazem hydrochloride and aluminium hydroxide, dicycloverine hydrochloride, magnesium oxidum leve.  On 22 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) via unknown route for prophylaxis of COVID-19 infection.  On 25 Feb 2021 evening, the patient experienced some side effects includes diarrhea, chills, stomach pain. But however, currently, patient was not having fever. The patient took some medication to help with the symptoms.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of event(s), diarrhea, chills and stomach pain were unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Sluggishness
Clinical narrative: Sore Arm; Sluggish; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and SLUGGISHNESS (Sluggish) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Emphysema and COPD.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm) and SLUGGISHNESS (Sluggish). At the time of the report, PAIN IN EXTREMITY (Sore Arm) and SLUGGISHNESS (Sluggish) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm sore) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm sore). At the time of the report, VACCINATION SITE PAIN (Arm sore) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication history not provided. Treatment information was unknown. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Outcome of the event changed unknown to recovered/ resolved
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Head discomfort, Nausea, Throat irritation, Tinnitus
Clinical narrative: Nausea; sea breeze/ buzzing; ears covered; heard everything deep inside her head/ discomfort in her head on the left side; burning (not sore) throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (burning (not sore) throat), EAR DISCOMFORT (ears covered), HEAD DISCOMFORT (heard everything deep inside her head/ discomfort in her head on the left side), NAUSEA (Nausea) and TINNITUS (sea breeze/ buzzing) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol and Vertigo. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 20-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 THROAT IRRITATION (burning (not sore) throat). On 22-Feb-2021, the patient experienced EAR DISCOMFORT (ears covered) and HEAD DISCOMFORT (heard everything deep inside her head/ discomfort in her head on the left side). On 24-Feb-2021, the patient experienced NAUSEA (Nausea) and TINNITUS (sea breeze/ buzzing). At the time of the report, THROAT IRRITATION (burning (not sore) throat), EAR DISCOMFORT (ears covered), HEAD DISCOMFORT (heard everything deep inside her head/ discomfort in her head on the left side), NAUSEA (Nausea) and TINNITUS (sea breeze/ buzzing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient uses matricin 20 mg for vertigo and some unspecified high cholesterol tablets of 10 mg as concomitant medication.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain, Pain in extremity
Clinical narrative: Pain in upper arm; Warm to touch; Pain become severe; Pain in left arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm), FEELING HOT (Warm to touch), PAIN (Pain become severe) and PAIN IN EXTREMITY (Pain in upper arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in left arm). On 15-Feb-2021, the patient experienced FEELING HOT (Warm to touch) and PAIN (Pain become severe). On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in upper arm). At the time of the report, PAIN IN EXTREMITY (Pain in left arm), FEELING HOT (Warm to touch), PAIN (Pain become severe) and PAIN IN EXTREMITY (Pain in upper arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up information was received on 24 Apr 2021, outcome of the events updated from unknown to recovered. Second dose information updated.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: leg pain; fatigue; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg pain), FATIGUE (fatigue) and MYALGIA (body aches) 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 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain), FATIGUE (fatigue) and MYALGIA (body aches). At the time of the report, PAIN IN EXTREMITY (leg pain), FATIGUE (fatigue) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: terrible soreness after vaccine; A spontaneous report was received from a consumer concerning a 65-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pain (terrible soreness after vaccine).  The patient's medical history included arthritis. No relevant concomitant medications were reported.  On 1 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 1 Feb 2021, the patient experienced terrible soreness after vaccine and on the day of reporting it was still there.  Treatment details included tylenol, ibuprofen and heating pad.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event  was reported to be unknown.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: a fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (a fever) and CHILLS (chills) in an 81-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (a fever) and CHILLS (chills). At the time of the report, PYREXIA (a fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Tremor
Clinical narrative: very tired; hands are shaking; A spontaneous report was received from a consumer concerning a 68-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue (very tired) and tremor (hands are shaking).  The patient's medical history includes Parkinson's disease. No relevant concomitant medications was provided by the reporter.  On 24 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) through unknown route in the right arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient stated he was feeling very tired and his hands were shaking.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had some side effects on the moderna vaccine; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events side effects on Moderna vaccine/vaccination adverse reaction  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their one of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event side effects on Moderna vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 8 Feb 2021 the outcome of event side effects on Moderna vaccine was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Diffused rash; A spontaneous report (United States) was received from a consumer (patient's wife), concerning an 83 years old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and patient experienced diffused rash.   The patient's medical history was not reported. Concomitant medications were not reported.  On 09 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot number: 024M20A), intramuscularly in the left deltoid for the prophylaxis of COVID-19 infection.  On 24 Feb 2021, the patient experienced adverse reaction which looks like measles. The rash just showed on his body, on his trunks, quite a bit on his back, scattered on his chest and tummy and on the anterior portion of both thighs. The patient hasn't had a fever, and it doesn't itch. The patient's wife was checking to see if this was possible late reaction to the vaccine. He has diffused rash on his back that looks like measles. The patient's wife gave her husband the treatment medication cetirizine on 25 Feb 2021. She also applied aspercreme with lidocaine on his left shoulder.   Action taken with second dose of mRNA-1273 in response to the event was unknown.  The outcome of the event, diffused rash was unknown.; Reporter's Comments: This case concerns a 83 years old, male patient, who experienced diffused rash on his body. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Oropharyngeal pain, Pain in extremity
Clinical narrative: Arm soreness; Extreme tiredness; Sore throat; achy joints; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme tiredness), ARTHRALGIA (achy joints), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Arm soreness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ARTHRALGIA (achy joints). On 09-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On an unknown date, the patient experienced FATIGUE (Extreme tiredness) and PAIN IN EXTREMITY (Arm soreness). At the time of the report, FATIGUE (Extreme tiredness), ARTHRALGIA (achy joints), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Arm soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications reported.    Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: No specific follow-up information recorded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: headache; chills; A spontaneous report was received from a consumer concerning a 66 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On 25 Feb 2021, approximately 1 day prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 015M20A) via unknown route for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the event(s) headache, chills.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of event(s), headache, chills was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Fever 101.4 F; Exhaustion; Fatigue; Headache; Pain Injection Site; Redness Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 101.4 F), FATIGUE (Exhaustion), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain Injection Site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac arrest (patient had Cardiac issues.).    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (Fever 101.4 F), FATIGUE (Exhaustion), FATIGUE (Fatigue), HEADACHE (Headache), VACCINATION SITE PAIN (Pain Injection Site) and VACCINATION SITE ERYTHEMA (Redness Injection Site). At the time of the report, PYREXIA (Fever 101.4 F), FATIGUE (Exhaustion), FATIGUE (Fatigue), HEADACHE (Headache), VACCINATION SITE PAIN (Pain Injection Site) and VACCINATION SITE ERYTHEMA (Redness Injection Site) outcome was unknown.            This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 101.4 F), FATIGUE (Exhaustion), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain Injection Site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac arrest (patient had Cardiac issues.).    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (Fever 101.4 F), FATIGUE (Exhaustion), FATIGUE (Fatigue), HEADACHE (Headache), VACCINATION SITE PAIN (Pain Injection Site) and VACCINATION SITE ERYTHEMA (Redness Injection Site). At the time of the report, PYREXIA (Fever 101.4 F), FATIGUE (Exhaustion), FATIGUE (Fatigue), HEADACHE (Headache), VACCINATION SITE PAIN (Pain Injection Site) and VACCINATION SITE ERYTHEMA (Redness Injection Site) outcome was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Cough, Oropharyngeal pain
Clinical narrative: covid-19; sore throat; cough; loss of taste and smell; A spontaneous report was received from a nurse concerning a female patient who received Moderna Covid 19 vaccine and experienced sore throat, cough, loss of taste and smell and tested positive for Covid 19. The patient's medical history shows allergic to medications and also is on OTC medication. No relevant concomitant medication were reported. On 26 Dec 2021, patient received first of two two unplanned doses of mRNA-1273 ,Batch number:37K20A for prophylaxis of covid 19 infection.  Patient was tested positive for COVID on 25Jan 2021. She had a sore throat, cough, and loss of taste and smell. She was prescribed azithromycin medication 250mg 5 tablets total for 2tablets the first day and 1 tablet a day afterwards which was ordered on 01FEB2021 Lab parameters were not provided. No other reactions observed. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Disorientation, Dizziness, Gait inability
Clinical narrative: couldn't walk for 3 days; dizziness; loss of balance; I was disoriented; A Spontaneous was received from a Consumer concerning a 68 years old Male patient  who experienced I was disoriented, Couldn't walk for 3 days, Dizziness and Loss of balance.    The patient's medical history was not provided. Concomitant medications was not provided.    On 12 FEB 2021 , prior to the onset of the events, the patient received their First of two planned doses of mRNA-1273 Batch no: 007M20A Intramuscularly in the Left Arm for prophylaxis of COVID-19 infection.  It was reported that the patient experienced I was disoriented, Couldn't walk for 3 days, Dizziness and Loss of balance.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was included, I was disoriented, Couldn't walk for 3 days, Dizziness and Loss of balance was considered unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light Headed; A spontaneous report was received from a consumer, concerning himself, a 69-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lightheaded.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Feb 2021, one hour prior to the onset of the event the patient received first of two planned doses of mRNA-1273 (lot/batch: 014M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, one hour after vaccination,  the patient felt lightheaded. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event lightheaded was unknown.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Soreness in Injection Arm; Slight Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in Injection Arm) and CHILLS (Slight Chills) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in Injection Arm) and CHILLS (Slight Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness in Injection Arm) and CHILLS (Slight Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment for the event included Ibuprofen
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: patient got half dose; A spontaneous report was received from a pharmacist for a female patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient received half dose.  The patient's medical history was not provided. No concomitant product use was reported.  On 24 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. It was known that the needle used to administered vaccine was loose hence the patient received half of the dose.  Treatment information was not applicable.  Action taken with mRNA-1273 was not applicable.  The outcome of the event was not applicable.; Reporter's Comments: This report refers to a case of underdose and syringe issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site erythema
Clinical narrative: Itchy Arm; Sore Arm; Red Arm  (injection Site); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy Arm), PAIN IN EXTREMITY (Sore Arm) and VACCINATION SITE ERYTHEMA (Red Arm  (injection Site)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (Itchy Arm), PAIN IN EXTREMITY (Sore Arm) and VACCINATION SITE ERYTHEMA (Red Arm  (injection Site)). At the time of the report, PRURITUS (Itchy Arm), PAIN IN EXTREMITY (Sore Arm) and VACCINATION SITE ERYTHEMA (Red Arm  (injection Site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Headache; Fatigue; Achy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue) and PAIN (Achy) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and PAIN (Achy). At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue) and PAIN (Achy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: has a little round, pink circle roughly 3 inches in diameter; a little swollen; warm to the touch; had a little discomfort in her arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced limb discomfort (had a little discomfort in her arm), vaccination site erythema (a little, round, pink circle, roughly 3 inches in diameter), vaccination site swelling (a little swollen) and vaccination site warmth ( warm to the touch).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced a little, round, pink circle, roughly 3 inches in diameter and that was little swollen and was warm to the touch. On 24 Feb 2021, the patient also stated experiencing a little discomfort in her arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Paraesthesia, Paraesthesia oral, Pruritus, Swelling face
Clinical narrative: Tingling in the left jaw; Left side of her face felt weird; Swelling of The Face; Itching in her Face; Tingling in the Tongue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the left jaw), FEELING ABNORMAL (Left side of her face felt weird), SWELLING FACE (Swelling of The Face), PRURITUS (Itching in her Face) and PARAESTHESIA ORAL (Tingling in the Tongue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PARAESTHESIA (Tingling in the left jaw), FEELING ABNORMAL (Left side of her face felt weird), SWELLING FACE (Swelling of The Face), PRURITUS (Itching in her Face) and PARAESTHESIA ORAL (Tingling in the Tongue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. On 08-Feb-2021, PARAESTHESIA (Tingling in the left jaw), FEELING ABNORMAL (Left side of her face felt weird), SWELLING FACE (Swelling of The Face), PRURITUS (Itching in her Face) and PARAESTHESIA ORAL (Tingling in the Tongue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Steroid. The patient indicates that had never used Dermal Fillers in face.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cold sweat, Nausea, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Back started hurting; Clammy; Started getting nauseous; Rash has become much bigger, red, and itchy.; Rash has become much bigger, red, and itchy; She developed a rash at the injection site/rash is bigger; Rash got bigger and hot to the touch; Swelling at the injection site which has gotten bigger\ump at injection site is getting bigger; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (She developed a rash at the injection site/rash is bigger), VACCINATION SITE WARMTH (Rash got bigger and hot to the touch), BACK PAIN (Back started hurting), COLD SWEAT (Clammy) and NAUSEA (Started getting nauseous) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included Armidex, METFORMIN, LISINOPRIL, LAMOTRIGINE (LAMICTAL), DULOXETINE HYDROCHLORIDE (CYMBALTA) and PROPRANOLOL for an unknown indication.   On 06-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 06-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site which has gotten bigger\ump at injection site is getting bigger). On 07-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Rash got bigger and hot to the touch). On 08-Feb-2021, the patient experienced VACCINATION SITE RASH (She developed a rash at the injection site/rash is bigger), BACK PAIN (Back started hurting), COLD SWEAT (Clammy), NAUSEA (Started getting nauseous), VACCINATION SITE ERYTHEMA (Rash has become much bigger, red, and itchy.) and VACCINATION SITE PRURITUS (Rash has become much bigger, red, and itchy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of 1 dosage form and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE RASH (She developed a rash at the injection site/rash is bigger), VACCINATION SITE WARMTH (Rash got bigger and hot to the touch), BACK PAIN (Back started hurting), COLD SWEAT (Clammy), NAUSEA (Started getting nauseous), VACCINATION SITE ERYTHEMA (Rash has become much bigger, red, and itchy.), VACCINATION SITE PRURITUS (Rash has become much bigger, red, and itchy) and VACCINATION SITE SWELLING (Swelling at the injection site which has gotten bigger\ump at injection site is getting bigger) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.