chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Diarrhoea, Fatigue, Myalgia
Clinical narrative: Little pain in the arm of the injection; Nausea; Diarrhea; Loss of appetite; Stomach upset; Body aches; Very fatigued; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Stomach upset), PAIN (Body aches) and NAUSEA (Nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and High cholesterol. Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN (Body aches), FATIGUE (Very fatigued) and MYALGIA (Muscle pain). On 09-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Stomach upset) and NAUSEA (Nausea). On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Little pain in the arm of the injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Feb-2021, ABDOMINAL DISCOMFORT (Stomach upset), PAIN (Body aches), FATIGUE (Very fatigued) and MYALGIA (Muscle pain) had resolved. On 10-Feb-2021, DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite) and NAUSEA (Nausea) had resolved. At the time of the report, VACCINATION SITE PAIN (Little pain in the arm of the injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include high blood pressure and high cholesterol medications.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vaccination site pain
Clinical narrative: Little pain in the arm of the injection; Nausea; Diarrhea; Loss of appetite; Stomach upset; Body aches; Very fatigued; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Stomach upset), PAIN (Body aches) and NAUSEA (Nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and High cholesterol. Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN (Body aches), FATIGUE (Very fatigued) and MYALGIA (Muscle pain). On 09-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Stomach upset) and NAUSEA (Nausea). On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Little pain in the arm of the injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Feb-2021, ABDOMINAL DISCOMFORT (Stomach upset), PAIN (Body aches), FATIGUE (Very fatigued) and MYALGIA (Muscle pain) had resolved. On 10-Feb-2021, DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite) and NAUSEA (Nausea) had resolved. At the time of the report, VACCINATION SITE PAIN (Little pain in the arm of the injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include high blood pressure and high cholesterol medications.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, Pruritus
Clinical narrative: right-side pain from her back to her front; soreness in her left arm; left arm itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her left arm), PRURITUS (left arm itching) and BACK PAIN (right-side pain from her back to her front) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Diabetes, Reflux esophagitis, Anxiety disorder, Bipolar disorder, Cardiovascular disease, unspecified, Blood pressure high, Cholesterol high and Drug allergy (Gemfibrozil and Zoloft). Concomitant products included GABAPENTIN, AMLODIPINE BESYLATE, DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID, TOCOPHEROL (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]), LOSARTAN POTASSIUM, MONTELUKAST, SIMVASTATIN, PROPRANOLOL, PANTOPRAZOLE, MAGNESIUM, BIOTIN, MELATONIN, INSULIN GLARGINE, INSULIN LISPRO and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in her left arm) and PRURITUS (left arm itching). On 14-Feb-2021, the patient experienced BACK PAIN (right-side pain from her back to her front). At the time of the report, PAIN IN EXTREMITY (soreness in her left arm) and PRURITUS (left arm itching) outcome was unknown and BACK PAIN (right-side pain from her back to her front) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: left arm aching 3-4 inches from site of inyection; left arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm sore) and MYALGIA (left arm aching 3-4 inches from site of inyection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029LZ0A) for COVID-19 vaccination.     Concomitant products included VALSARTAN, OMEPRAZOLE, MELOXICAM, METOPROLOL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HCTZ) and DICLOFENAC SODIUM for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm sore). On 20-Jan-2021, the patient experienced MYALGIA (left arm aching 3-4 inches from site of inyection). At the time of the report, PAIN IN EXTREMITY (left arm sore) and MYALGIA (left arm aching 3-4 inches from site of inyection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she suspended the meloxicam.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Loose stool; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose stool) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Loose stool). The patient was treated with LOPERAMIDE at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Loose stool) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that he received both vaccines, and he had for five weeks loose stool.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: POSSIBLE REACTION; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (POSSIBLE REACTION) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-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 ADVERSE EVENT (POSSIBLE REACTION). At the time of the report, ADVERSE EVENT (POSSIBLE REACTION) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Product administered at inappropriate site, Vaccination site erythema, Vaccination site mass, Vaccination site rash
Clinical narrative: hard at injection site; Headache; itchy rash at injection site; swelling at injection site; purple, reddish mottling at injection site; received shot in buttocks; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received shot in buttocks), VACCINATION SITE MASS (hard at injection site), HEADACHE (Headache), VACCINATION SITE RASH (itchy rash at injection site) and VACCINATION SITE SWELLING (swelling at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 UNK. On 06-Feb-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received shot in buttocks). On 08-Feb-2021, the patient experienced VACCINATION SITE MASS (hard at injection site), HEADACHE (Headache), VACCINATION SITE RASH (itchy rash at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE ERYTHEMA (purple, reddish mottling at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at a dose of 50 mg; IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received shot in buttocks) and HEADACHE (Headache) had resolved, VACCINATION SITE MASS (hard at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE ERYTHEMA (purple, reddish mottling at injection site) outcome was unknown and VACCINATION SITE RASH (itchy rash at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported she had an allergic reaction to a tetanus shot in 1970  No concomitant medications were reported
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: hard at injection site; Headache; itchy rash at injection site; swelling at injection site; purple, reddish mottling at injection site; received shot in buttocks; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received shot in buttocks), VACCINATION SITE MASS (hard at injection site), HEADACHE (Headache), VACCINATION SITE RASH (itchy rash at injection site) and VACCINATION SITE SWELLING (swelling at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 UNK. On 06-Feb-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received shot in buttocks). On 08-Feb-2021, the patient experienced VACCINATION SITE MASS (hard at injection site), HEADACHE (Headache), VACCINATION SITE RASH (itchy rash at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE ERYTHEMA (purple, reddish mottling at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at a dose of 50 mg; IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received shot in buttocks) and HEADACHE (Headache) had resolved, VACCINATION SITE MASS (hard at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE ERYTHEMA (purple, reddish mottling at injection site) outcome was unknown and VACCINATION SITE RASH (itchy rash at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported she had an allergic reaction to a tetanus shot in 1970  No concomitant medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: Ache in her legs; Not much appetite; Feels like she's been hit by a truck; Chills; Steady headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Steady headaches), PAIN IN EXTREMITY (Ache in her legs), DECREASED APPETITE (Not much appetite), CHILLS (Chills) and FEELING ABNORMAL (Feels like she's been hit by a truck) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and VITAMINS NOS for an unknown indication.   On 16-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) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (Steady headaches), PAIN IN EXTREMITY (Ache in her legs), DECREASED APPETITE (Not much appetite), CHILLS (Chills) and FEELING ABNORMAL (Feels like she's been hit by a truck). At the time of the report, HEADACHE (Steady headaches), PAIN IN EXTREMITY (Ache in her legs), DECREASED APPETITE (Not much appetite), CHILLS (Chills) and FEELING ABNORMAL (Feels like she's been hit by a truck) outcome was unknown.            No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pruritus, Vaccination site erythema
Clinical narrative: Redness below injection site; 2 inches wide and 3 inches long; Itchy shoulder; Shoulder soreness; 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 shoulder soreness/ arthralgia, itchy shoulder/ pruritus, redness belowinjection site/ vaccination site erythema.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 28 Jan 2021, prior to the onset of the events ,the patient received first of two planned doses of mRNA-1273 (Batch number: 038K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 29 Jan 2021, approximately 1 day after vaccination, the patient experienced shoulder soreness that lasted for few days and subsided. On 03 Feb 2021, the patient experienced itchy shoulder and 2 days later, on 5 Feb 2021, the patient discovered that area was itchy and red. The affected area was below the injection site and it was 2 inches wide and 3 inches long. The patient reported that the itchiness was subsided and redness was still there.   Treatment for the events included Hydrocortisone, OTC Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, shoulder soreness, itchy shoulder, were considered to be resolving at the time of report. the outcome of the event, redness below injection site, was considered not resolved at the time of report.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Vaccination site erythema, Vaccination site warmth
Clinical narrative: fast heartbeat//1st dose; warmth at injection site//1st dose; redness at injection site//1st dose; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heartbeat//1st dose), VACCINATION SITE WARMTH (warmth at injection site//1st dose) and VACCINATION SITE ERYTHEMA (redness at injection site//1st dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HEART RATE INCREASED (fast heartbeat//1st dose), VACCINATION SITE WARMTH (warmth at injection site//1st dose) and VACCINATION SITE ERYTHEMA (redness at injection site//1st dose). On 17-Jan-2021, HEART RATE INCREASED (fast heartbeat//1st dose), VACCINATION SITE WARMTH (warmth at injection site//1st dose) and VACCINATION SITE ERYTHEMA (redness at injection site//1st dose) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to MOD21-031476.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Lymph node pain, Mass, Pain
Clinical narrative: lump by chavicol/mass; he has a node on her thyroid; swelling on the neck; Itchiness in both arms; stinging pain; Lymph node; Headache; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), PRURITUS (Itchiness in both arms), AXILLARY PAIN (stinging pain), LYMPH NODE PAIN (Lymph node) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included METFORMIN, LEVOTHYROXINE SODIUM (LEVOTIROXIN), LOVASTATIN, ATENOLOL and LOSARTAN for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 04-Feb-2021, the patient experienced PAIN (Soreness) and HEADACHE (Headache). On 08-Feb-2021, the patient experienced PRURITUS (Itchiness in both arms), AXILLARY PAIN (stinging pain) and LYMPH NODE PAIN (Lymph node). At the time of the report, PAIN (Soreness), PRURITUS (Itchiness in both arms), AXILLARY PAIN (stinging pain), LYMPH NODE PAIN (Lymph node) and HEADACHE (Headache) outcome was unknown.            Treatment included Advil and concomitant medication.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Thyroid mass
Clinical narrative: lump by chavicol/mass; he has a node on her thyroid; swelling on the neck; Itchiness in both arms; stinging pain; Lymph node; Headache; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), PRURITUS (Itchiness in both arms), AXILLARY PAIN (stinging pain), LYMPH NODE PAIN (Lymph node) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included METFORMIN, LEVOTHYROXINE SODIUM (LEVOTIROXIN), LOVASTATIN, ATENOLOL and LOSARTAN for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 04-Feb-2021, the patient experienced PAIN (Soreness) and HEADACHE (Headache). On 08-Feb-2021, the patient experienced PRURITUS (Itchiness in both arms), AXILLARY PAIN (stinging pain) and LYMPH NODE PAIN (Lymph node). At the time of the report, PAIN (Soreness), PRURITUS (Itchiness in both arms), AXILLARY PAIN (stinging pain), LYMPH NODE PAIN (Lymph node) and HEADACHE (Headache) outcome was unknown.            Treatment included Advil and concomitant medication.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: lightheadedness; soreness; itching; redness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness), PAIN (soreness), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced DIZZINESS (lightheadedness), PAIN (soreness), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, DIZZINESS (lightheadedness), PAIN (soreness), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo, Vomiting
Clinical narrative: lightheadedness; vertigo; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting), DIZZINESS (lightheadedness) and VERTIGO (vertigo) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting), DIZZINESS (lightheadedness) and VERTIGO (vertigo). The patient was treated with MECLIZINE [MECLOZINE] for Nausea, Vomiting, Lightheadedness and Vertigo, at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), VOMITING (vomiting), DIZZINESS (lightheadedness) and VERTIGO (vertigo) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient does not take concomitant medicines.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Paraesthesia
Clinical narrative: Lower Limb Cramps; Neurological Tingles in Legs and scalp; Scalp Tingling; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Lower Limb Cramps), PARAESTHESIA (Neurological Tingles in Legs and scalp) and PARAESTHESIA (Scalp Tingling) 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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced MUSCLE SPASMS (Lower Limb Cramps), PARAESTHESIA (Neurological Tingles in Legs and scalp) and PARAESTHESIA (Scalp Tingling). At the time of the report, MUSCLE SPASMS (Lower Limb Cramps), PARAESTHESIA (Neurological Tingles in Legs and scalp) and PARAESTHESIA (Scalp Tingling) 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.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021 at 9:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: A spontaneous report was received from a consumer concerning a female patient  of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced insomnia.  The patient's medical history was not reported. Concomitant products information was not reported.  On unspecified date, prior to the onset of event, the patient received their second of two planned doses of mRNA-1273 (batch number: unknown) for prophylaxis of COVID-19 infection.   On unspecified date after receiving vaccine she experienced insomnia. She also reported that she could not sleep more than three hours, maybe a total of 5 hours. She was not tired, wanted to fall asleep but could not. The insomnia started after she got the second dose of the COVID-19 Moderna vaccine. She has never had insomnia before.  Action taken with mRNA-1273 in response to the event was not applicable.   Treatment information was not provided.  On 17 Feb 2021 the outcome of the event insomnia was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Lymphadenopathy, Tongue discolouration, Vaccination site pruritus
Clinical narrative: enlarged lymph nodes; left ear pain; white patches on tongue; itching on arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (enlarged lymph nodes), EAR PAIN (left ear pain), TONGUE DISCOLOURATION (white patches on tongue) and INJECTION SITE PRURITUS (itching on arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Keflex, sulfa and cipro.).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itching on arm). On 09-Feb-2021, the patient experienced LYMPHADENOPATHY (enlarged lymph nodes), EAR PAIN (left ear pain) and TONGUE DISCOLOURATION (white patches on tongue). On 29-Jan-2021, INJECTION SITE PRURITUS (itching on arm) had resolved. At the time of the report, LYMPHADENOPATHY (enlarged lymph nodes), EAR PAIN (left ear pain) and TONGUE DISCOLOURATION (white patches on tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medications were reported. Treatment medication taken was Tylenol.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: cold sore appeared in nose, lower lip; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sore appeared in nose, lower lip) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (cold sore appeared in nose, lower lip). The patient was treated with DOCOSANOL (ABREVA) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ORAL HERPES (cold sore appeared in nose, lower lip) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Local reaction
Clinical narrative: localize reaction; This spontaneous case was reported by a nurse and describes the occurrence of LOCAL REACTION (localize reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 LOCAL REACTION (localize reaction). At the time of the report, LOCAL REACTION (localize reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Diagnosed with COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19) 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 No adverse event.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Diagnosed with COVID-19). At the time of the report, COVID-19 (Diagnosed with COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pruritus
Clinical narrative: "Covid arm" 7 inches down and 3 0r 4 inches across redness; itchiness at the injection site; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA ("Covid arm" 7 inches down and 3 0r 4 inches across redness), INJECTION SITE PRURITUS (itchiness at the injection site) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL for Hypertension.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA ("Covid arm" 7 inches down and 3 0r 4 inches across redness), INJECTION SITE PRURITUS (itchiness at the injection site) and CHILLS (Chills). At the time of the report, INJECTION SITE ERYTHEMA ("Covid arm" 7 inches down and 3 0r 4 inches across redness), INJECTION SITE PRURITUS (itchiness at the injection site) and CHILLS (Chills) outcome was unknown.            Patient put ice on the area where the injection site
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PROPRANOLOL, ROSUVASTATIN and MINERALS for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE PAIN (sore arm). At the time of the report, INJECTION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment reported for this event.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Rash
Clinical narrative: Bit of reaction on second night; rash on left body side; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Bit of reaction on second night) and RASH (rash on left body side) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029120A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced ADVERSE REACTION (Bit of reaction on second night) and RASH (rash on left body side). At the time of the report, ADVERSE REACTION (Bit of reaction on second night) and RASH (rash on left body side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Itching at injection site; Injection site redness; Swelling at injection site; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itching at injection site), INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (Swelling at injection site) and INJECTION SITE RASH (Rash at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (Itching at injection site), INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (Swelling at injection site) and INJECTION SITE RASH (Rash at injection site). At the time of the report, INJECTION SITE PRURITUS (Itching at injection site), INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (Swelling at injection site) and INJECTION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided by the reporter.  The treatment information was not provided by the reporter.  Upon internal review on 04-AUG-2021, the age was corrected to 73 years.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching near injection site; Arm turned red near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching near injection site) and VACCINATION SITE ERYTHEMA (Arm turned red near injection site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching near injection site) and VACCINATION SITE ERYTHEMA (Arm turned red near injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching near injection site) and VACCINATION SITE ERYTHEMA (Arm turned red near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported.  The patient reported treatment included ice.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received:No New Information. Confirmed patient information, event details and vaccine inforamtion.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Welts all over body; Rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welts all over body) and RASH (Rash all over body) in a 71-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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced URTICARIA (Welts all over body) and RASH (Rash all over body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and CORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, URTICARIA (Welts all over body) and RASH (Rash all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: upper left arm red; rash on upper left arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (upper left arm red) and RASH (rash on upper left arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-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 ERYTHEMA (upper left arm red) and RASH (rash on upper left arm). At the time of the report, ERYTHEMA (upper left arm red) and RASH (rash on upper left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: she had an rash on her throat; This spontaneous case was reported by a consumer and describes the occurrence of RASH (she had an rash on her throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (she had an rash on her throat). At the time of the report, RASH (she had an rash on her throat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.  No treatment medication were provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Minor soreness on arm/Pain on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Minor soreness on arm/Pain on the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (Minor soreness on arm/Pain on the arm). At the time of the report, PAIN IN EXTREMITY (Minor soreness on arm/Pain on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Nasopharyngitis, Pain in extremity
Clinical narrative: Cold; Chest congestion; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (Cold) and CHEST DISCOMFORT (Chest congestion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 immunization.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 10-Feb-2021, the patient experienced NASOPHARYNGITIS (Cold) and CHEST DISCOMFORT (Chest congestion). On 19-Jan-2021, PAIN IN EXTREMITY (Sore arm) outcome was unknown. At the time of the report, NASOPHARYNGITIS (Cold) and CHEST DISCOMFORT (Chest congestion) 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.   The patient had taken Zinc, Aspirin, Vitamin C, OTC decongestant.   Reporter did not allow further contact
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; A spontaneous report was received from a consumer concerning a 74-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event diarrhea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   24 hours after the vaccination patient developed diarrhea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, diarrhea was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: Blurry Vision; Loss of Taste; Threw up; Weak; Fever; Achy; Shaking; Cold; Everything Hurt; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Threw up), ASTHENIA (Weak), PYREXIA (Fever), PAIN (Achy) and TREMOR (Shaking) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESLICARBAZEPINE ACETATE (APTIOM).    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VOMITING (Threw up), ASTHENIA (Weak), PYREXIA (Fever), PAIN (Achy), TREMOR (Shaking), NASOPHARYNGITIS (Cold) and PAIN (Everything Hurt). On 12-Feb-2021, the patient experienced AGEUSIA (Loss of Taste). On 15-Feb-2021, the patient experienced VISION BLURRED (Blurry Vision). At the time of the report, VOMITING (Threw up), ASTHENIA (Weak), PYREXIA (Fever), PAIN (Achy), TREMOR (Shaking), NASOPHARYNGITIS (Cold), PAIN (Everything Hurt), AGEUSIA (Loss of Taste) and VISION BLURRED (Blurry Vision) outcome was unknown.            No treatment information provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vision blurred, Vomiting
Clinical narrative: Blurry Vision; Loss of Taste; Threw up; Weak; Fever; Achy; Shaking; Cold; Everything Hurt; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Threw up), ASTHENIA (Weak), PYREXIA (Fever), PAIN (Achy) and TREMOR (Shaking) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESLICARBAZEPINE ACETATE (APTIOM).    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VOMITING (Threw up), ASTHENIA (Weak), PYREXIA (Fever), PAIN (Achy), TREMOR (Shaking), NASOPHARYNGITIS (Cold) and PAIN (Everything Hurt). On 12-Feb-2021, the patient experienced AGEUSIA (Loss of Taste). On 15-Feb-2021, the patient experienced VISION BLURRED (Blurry Vision). At the time of the report, VOMITING (Threw up), ASTHENIA (Weak), PYREXIA (Fever), PAIN (Achy), TREMOR (Shaking), NASOPHARYNGITIS (Cold), PAIN (Everything Hurt), AGEUSIA (Loss of Taste) and VISION BLURRED (Blurry Vision) outcome was unknown.            No treatment information provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: Sore arm; Red rash; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH ERYTHEMATOUS (Red rash) and PRURITUS (Itching) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) 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 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), RASH ERYTHEMATOUS (Red rash) and PRURITUS (Itching). At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH ERYTHEMATOUS (Red rash) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: very high fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (very high fever) in a 35-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 (No reported medical history).    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 PYREXIA (very high fever). At the time of the report, PYREXIA (very high fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment details included Tylenol   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No New Information.
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: arm swell; injection site is black; warm to touch at injection site; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swell), INJECTION SITE REACTION (injection site is black), INJECTION SITE WARMTH (warm to touch at injection site) and PAIN IN EXTREMITY (soreness in arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm swell), INJECTION SITE REACTION (injection site is black), INJECTION SITE WARMTH (warm to touch at injection site) and PAIN IN EXTREMITY (soreness in arm). At the time of the report, PERIPHERAL SWELLING (arm swell), INJECTION SITE REACTION (injection site is black), INJECTION SITE WARMTH (warm to touch at injection site) and PAIN IN EXTREMITY (soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were reported. No treatment was reported