chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over his trunk area; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over his trunk area) 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 13-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 RASH (rash all over his trunk area). At the time of the report, RASH (rash all over his trunk area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal
Clinical narrative: Had Chills 2 months later; Felt off; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Felt off) and CHILLS (Had Chills 2 months later) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, POTASSIUM CHLORIDE, AMLODIPINE, METOPROLOL, TRIAMTERENE, LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN D3, ASCORBIC ACID (VITAMIN C ACID), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), THIAMINE DISULFIDE (BIOGEN [THIAMINE DISULFIDE]) and OMEPRAZOLE for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced FEELING ABNORMAL (Felt off). In May 2021, the patient experienced CHILLS (Had Chills 2 months later). At the time of the report, FEELING ABNORMAL (Felt off) and CHILLS (Had Chills 2 months later) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were unknown.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.   This case was linked to MOD-2021-132132 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Second dose vaccine information (Start date, Lot number and Route of administration) updated. On 18-MAR-2021 new event "Felt off" added. New event "Chills" added.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Pain in extremity
Clinical narrative: sore arm; dizzy; headache; muscle ache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DIZZINESS (dizzy), HEADACHE (headache) and MYALGIA (muscle ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 PAIN IN EXTREMITY (sore arm), DIZZINESS (dizzy), HEADACHE (headache) and MYALGIA (muscle ache). At the time of the report, PAIN IN EXTREMITY (sore arm), DIZZINESS (dizzy), HEADACHE (headache) and MYALGIA (muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Body ache; Fever; chills; exhaustion; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Body ache), PYREXIA (Fever), CHILLS (chills) and FATIGUE (exhaustion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body ache), PYREXIA (Fever), CHILLS (chills) and FATIGUE (exhaustion). At the time of the report, MYALGIA (Body ache), PYREXIA (Fever), CHILLS (chills) and FATIGUE (exhaustion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Plaque Psoriasis flare up; A spontaneous report was received from a Healthcare Professional concerning about his son in law a 37-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events as plaque psoriasis flare up.  The patient's medical history was not provided.   Concomitant medications reported were Otezla oral solid, Prednisolone oral solid for drug use for unknown indication.  On 12 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 for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the events plaque psoriasis flare up.  Treatment details included Prescription Medications:, Otzela-chronic psoriasis, Prednisolone 15mg daily.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, plaque psoriasis flare up was not reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sick relative
Clinical narrative: very very lil sore on her right arm; neighbors got sick; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very very lil sore on her right arm) and SICK RELATIVE (neighbors got sick) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2010, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (very very lil sore on her right arm) and SICK RELATIVE (neighbors got sick). At the time of the report, PAIN IN EXTREMITY (very very lil sore on her right arm) and SICK RELATIVE (neighbors got sick) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Foreign body sensation in eyes, Formication, Headache, Paraesthesia oral
Clinical narrative: headache; redness is coming back; it's warm to the touch; face started getting blotches; lips were tingling; welt on their arm; skin was crawling; blured vision; Eyes felt gritty; fogginess; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (fogginess), VISION BLURRED (blured vision), FOREIGN BODY SENSATION IN EYES (Eyes felt gritty), URTICARIA (welt on their arm) and FORMICATION (skin was crawling) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product HYDROXYZINE for an unknown indication.    The patient's past medical history included Hashimoto's disease since an unknown date and Asthma since an unknown date. Concomitant products included MONTELUKAST for Asthma, LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started HYDROXYZINE (unknown route) at an unspecified dose. On 01-Feb-2021, the patient experienced VISION BLURRED (fogginess). On 02-Feb-2021, the patient experienced VISION BLURRED (blured vision), FOREIGN BODY SENSATION IN EYES (Eyes felt gritty) and FORMICATION (skin was crawling). On 06-Feb-2021, the patient experienced URTICARIA (welt on their arm), RASH MACULAR (face started getting blotches) and PARAESTHESIA ORAL (lips were tingling). On 15-Feb-2021, the patient experienced ERYTHEMA (redness is coming back) and VACCINATION SITE WARMTH (it's warm to the touch). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with CLINDAMYCIN for Infection, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VISION BLURRED (fogginess), VISION BLURRED (blured vision), FOREIGN BODY SENSATION IN EYES (Eyes felt gritty), URTICARIA (welt on their arm), FORMICATION (skin was crawling), RASH MACULAR (face started getting blotches), PARAESTHESIA ORAL (lips were tingling), ERYTHEMA (redness is coming back), VACCINATION SITE WARMTH (it's warm to the touch) and HEADACHE (headache) 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Urticaria, Vaccination site warmth, Vision blurred
Clinical narrative: headache; redness is coming back; it's warm to the touch; face started getting blotches; lips were tingling; welt on their arm; skin was crawling; blured vision; Eyes felt gritty; fogginess; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (fogginess), VISION BLURRED (blured vision), FOREIGN BODY SENSATION IN EYES (Eyes felt gritty), URTICARIA (welt on their arm) and FORMICATION (skin was crawling) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product HYDROXYZINE for an unknown indication.    The patient's past medical history included Hashimoto's disease since an unknown date and Asthma since an unknown date. Concomitant products included MONTELUKAST for Asthma, LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started HYDROXYZINE (unknown route) at an unspecified dose. On 01-Feb-2021, the patient experienced VISION BLURRED (fogginess). On 02-Feb-2021, the patient experienced VISION BLURRED (blured vision), FOREIGN BODY SENSATION IN EYES (Eyes felt gritty) and FORMICATION (skin was crawling). On 06-Feb-2021, the patient experienced URTICARIA (welt on their arm), RASH MACULAR (face started getting blotches) and PARAESTHESIA ORAL (lips were tingling). On 15-Feb-2021, the patient experienced ERYTHEMA (redness is coming back) and VACCINATION SITE WARMTH (it's warm to the touch). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with CLINDAMYCIN for Infection, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VISION BLURRED (fogginess), VISION BLURRED (blured vision), FOREIGN BODY SENSATION IN EYES (Eyes felt gritty), URTICARIA (welt on their arm), FORMICATION (skin was crawling), RASH MACULAR (face started getting blotches), PARAESTHESIA ORAL (lips were tingling), ERYTHEMA (redness is coming back), VACCINATION SITE WARMTH (it's warm to the touch) and HEADACHE (headache) 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: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Acne, Burning sensation, Rash, Vaccination site erythema, Vaccination site pain
Clinical narrative: sole of feet burning; rash on knee up both legs; pimple on legs; Pain in injection site; Red ring near injection; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (pimple on legs), BURNING SENSATION (sole of feet burning), RASH (rash on knee up both legs), VACCINATION SITE PAIN (Pain in injection site) and VACCINATION SITE ERYTHEMA (Red ring near injection) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Insect bite allergy.    On 04-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 VACCINATION SITE PAIN (Pain in injection site) and VACCINATION SITE ERYTHEMA (Red ring near injection). On 14-Feb-2021, the patient experienced ACNE (pimple on legs) and RASH (rash on knee up both legs). On an unknown date, the patient experienced BURNING SENSATION (sole of feet burning). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, ACNE (pimple on legs), BURNING SENSATION (sole of feet burning), RASH (rash on knee up both legs), VACCINATION SITE PAIN (Pain in injection site) and VACCINATION SITE ERYTHEMA (Red ring near injection) 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.   Patient took Ice on sole of feet.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pain in extremity
Clinical narrative: sore arm; a fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEART RATE INCREASED (a fast heart beat) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation since an unknown date. Concomitant products included FLECAINIDE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and HEART RATE INCREASED (a fast heart beat). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Covid like symptoms; This spontaneous case was reported by a pharmacist and describes the occurrence of SUSPECTED COVID-19 (Covid like symptoms) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced SUSPECTED COVID-19 (Covid like symptoms). At the time of the report, SUSPECTED COVID-19 (Covid like symptoms) outcome was unknown.        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.   This case was linked to MOD-2021-030810 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Erythema, Fatigue, Headache, Pyrexia
Clinical narrative: tested positive for COVID-19; swelling; redness; fever; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19), SWELLING (swelling), ERYTHEMA (redness), PYREXIA (fever) and HEADACHE (headache) in a 61-year-old male 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.     No Medical History information was reported.    On 11-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 SWELLING (swelling), ERYTHEMA (redness), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue). On 14-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (ROBITUSSIN DM) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for COVID-19), SWELLING (swelling), ERYTHEMA (redness), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, SARS-CoV-2 test positive: positive (Positive) Tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Swelling
Clinical narrative: tested positive for COVID-19; swelling; redness; fever; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19), SWELLING (swelling), ERYTHEMA (redness), PYREXIA (fever) and HEADACHE (headache) in a 61-year-old male 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.     No Medical History information was reported.    On 11-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 SWELLING (swelling), ERYTHEMA (redness), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue). On 14-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (ROBITUSSIN DM) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for COVID-19), SWELLING (swelling), ERYTHEMA (redness), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, SARS-CoV-2 test positive: positive (Positive) Tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Feeling abnormal, Pyrexia
Clinical narrative: Fever; felt bad overall; A spontaneous report was received from a consumer concerning a 66-year-old,patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed pyrexia and feeling abnormal.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included losartan, otc allergy medicine,b12 supplement, multivitamin.  On 08 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot 043L70A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 09 Feb 2021, the patient developed feeling abnormal. On 10 Feb 2021,the patient developed pyrexia. Treatment for the event included Tylenol.  Action taken with mRNA-1273 in response to the event was not applicable.   The outcome of the event, pyrexia and feeling bad, was considered unknown
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; Mild headache; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Mild headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Mild headache). The patient was treated with ACETAMINOPHEN ongoing since an unknown date for Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Mild headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was  not reported.    Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: No specific follow-up information recorded.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Pain
Clinical narrative: lymph swelling right side of neck; headache; Pain body; Fatigue; A spontaneous report was received from a healthcare professional concerning a 20-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events lymphadenopathy, headache, general body pain, fatigue.  The patient's medical history included OVID-19 positive prior to receivingvaccine and autoimmune disease lupus kidney disease. was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced the event(s) lymph swelling right side of neck . On 16 Jan 2021, the patient experienced the event(s) headache. pain body, fatigue.  Treatment details included medical center: 2 ultra sounds and CAT scan preformed February 2021.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s) headache was considered resolved on 17 Jan 2021.The outcome of event(s) pain body was considered resolved on 17 Jan 2021.The outcome of event(s) fatigue was considered resolved on 17 Jan 2021. The outcome of event(s), lymph swelling right side of neck,  was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes
Clinical narrative: Genital herpes sores; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL HERPES (Genital herpes sores) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 022M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included FAMOTIDINE, CITALOPRAM, LEVOTHYROXINE and ATORVASTATIN for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GENITAL HERPES (Genital herpes sores). At the time of the report, GENITAL HERPES (Genital herpes sores) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event was none. Caller reported that they presented with genital herpes sores 2 days after receiving dose 1 and dose 2 in the left arm of the Moderna vaccine. With dose 1, it cleared after 2 days and with dose 2 it cleared after 1 day. It's been 20 years since their last outbreak.   This case was linked to MOD-2021-031963, MOD-2021-031963 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (fever) 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 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (Chills). On 04-Mar-2021, the patient experienced PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) on 03-Mar-2021 for Chills and Fever, at a dose of 1 dosage form. At the time of the report, CHILLS (Chills) and PYREXIA (fever) outcome was unknown.            No concomitant medications reported.   This case was linked to MOD-2021-225584 (Parent-Child Link).   See case MOD-2021-225584 for details regarding the child case.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Food aversion, Gait disturbance
Clinical narrative: could not eat/walk; right knee swollen; could not eat/walk; diarrhea 2.5 weeks; fatigue; nausea; Headache; severe arthritis joint pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FOOD AVERSION (could not eat/walk), JOINT SWELLING (right knee swollen), GAIT DISTURBANCE (could not eat/walk), DIARRHOEA (diarrhea 2.5 weeks) and FATIGUE (fatigue) in a 74-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 reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS], KCL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), DICYCLOMINE [DICYCLOVERINE], FENOFIBRATE, LEVOTHYROXINE, liothiorinine, METOPROLOL, AMLODIPINE BESILATE (NORVASC), ROSUVASTATIN and GLICLAZIDE (DIAZIDE [GLICLAZIDE]) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced FOOD AVERSION (could not eat/walk), JOINT SWELLING (right knee swollen), GAIT DISTURBANCE (could not eat/walk), DIARRHOEA (diarrhea 2.5 weeks), FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (Headache) and ARTHRALGIA (severe arthritis joint pain). The patient was treated with DOMPERIDONE (EMETROL [DOMPERIDONE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Feb-2021, JOINT SWELLING (right knee swollen) had resolved. On 20-Feb-2021, DIARRHOEA (diarrhea 2.5 weeks) had resolved. At the time of the report, FOOD AVERSION (could not eat/walk), GAIT DISTURBANCE (could not eat/walk), FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (Headache) and ARTHRALGIA (severe arthritis joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Joint swelling, Nausea
Clinical narrative: could not eat/walk; right knee swollen; could not eat/walk; diarrhea 2.5 weeks; fatigue; nausea; Headache; severe arthritis joint pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FOOD AVERSION (could not eat/walk), JOINT SWELLING (right knee swollen), GAIT DISTURBANCE (could not eat/walk), DIARRHOEA (diarrhea 2.5 weeks) and FATIGUE (fatigue) in a 74-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 reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS], KCL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), DICYCLOMINE [DICYCLOVERINE], FENOFIBRATE, LEVOTHYROXINE, liothiorinine, METOPROLOL, AMLODIPINE BESILATE (NORVASC), ROSUVASTATIN and GLICLAZIDE (DIAZIDE [GLICLAZIDE]) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced FOOD AVERSION (could not eat/walk), JOINT SWELLING (right knee swollen), GAIT DISTURBANCE (could not eat/walk), DIARRHOEA (diarrhea 2.5 weeks), FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (Headache) and ARTHRALGIA (severe arthritis joint pain). The patient was treated with DOMPERIDONE (EMETROL [DOMPERIDONE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Feb-2021, JOINT SWELLING (right knee swollen) had resolved. On 20-Feb-2021, DIARRHOEA (diarrhea 2.5 weeks) had resolved. At the time of the report, FOOD AVERSION (could not eat/walk), GAIT DISTURBANCE (could not eat/walk), FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (Headache) and ARTHRALGIA (severe arthritis joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Injection site erythema, Injection site pruritus, Injection site warmth, Sensitive skin
Clinical narrative: Sensitive skin, can break out even when putting sanitizer; Big red spot and the next day it was larger and it was hot; Red spot and the next day it was larger and it was hot; It was uncomfortable and very hot to the touch and it itched; Very uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Big red spot and the next day it was larger and it was hot), INJECTION SITE WARMTH (Red spot and the next day it was larger and it was hot), INJECTION SITE PRURITUS (It was uncomfortable and very hot to the touch and it itched), DISCOMFORT (Very uncomfortable) and SENSITIVE SKIN (Sensitive skin, can break out even when putting sanitizer) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Big red spot and the next day it was larger and it was hot), INJECTION SITE WARMTH (Red spot and the next day it was larger and it was hot), INJECTION SITE PRURITUS (It was uncomfortable and very hot to the touch and it itched) and DISCOMFORT (Very uncomfortable). On an unknown date, the patient experienced SENSITIVE SKIN (Sensitive skin, can break out even when putting sanitizer). At the time of the report, INJECTION SITE ERYTHEMA (Big red spot and the next day it was larger and it was hot), INJECTION SITE WARMTH (Red spot and the next day it was larger and it was hot), INJECTION SITE PRURITUS (It was uncomfortable and very hot to the touch and it itched) and DISCOMFORT (Very uncomfortable) had resolved and SENSITIVE SKIN (Sensitive skin, can break out even when putting sanitizer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: When I got shot hurt extremely/left arm got sore; Hadache; Joints started hurting/right shoulder and back hurt; Fatigue/really tired; Nauseous; Dry heaves; No appetite; whole body shaking; chills/ teeth chattering; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (When I got shot hurt extremely/left arm got sore), HEADACHE (Hadache), ARTHRALGIA (Joints started hurting/right shoulder and back hurt), FATIGUE (Fatigue/really tired) and NAUSEA (Nauseous) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not reported.). Concomitant products included SERTRALINE, ATORVASTATIN, AMLODIPINE, LISINOPRIL and NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (When I got shot hurt extremely/left arm got sore), HEADACHE (Hadache), ARTHRALGIA (Joints started hurting/right shoulder and back hurt), FATIGUE (Fatigue/really tired), NAUSEA (Nauseous), RETCHING (Dry heaves), DECREASED APPETITE (No appetite), TREMOR (whole body shaking) and CHILLS (chills/ teeth chattering). At the time of the report, VACCINATION SITE PAIN (When I got shot hurt extremely/left arm got sore), HEADACHE (Hadache), ARTHRALGIA (Joints started hurting/right shoulder and back hurt), FATIGUE (Fatigue/really tired), NAUSEA (Nauseous), RETCHING (Dry heaves), DECREASED APPETITE (No appetite), TREMOR (whole body shaking) and CHILLS (chills/ teeth chattering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for headache and pain  included tylenol.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Retching, Tremor, Vaccination site pain
Clinical narrative: When I got shot hurt extremely/left arm got sore; Hadache; Joints started hurting/right shoulder and back hurt; Fatigue/really tired; Nauseous; Dry heaves; No appetite; whole body shaking; chills/ teeth chattering; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (When I got shot hurt extremely/left arm got sore), HEADACHE (Hadache), ARTHRALGIA (Joints started hurting/right shoulder and back hurt), FATIGUE (Fatigue/really tired) and NAUSEA (Nauseous) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not reported.). Concomitant products included SERTRALINE, ATORVASTATIN, AMLODIPINE, LISINOPRIL and NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (When I got shot hurt extremely/left arm got sore), HEADACHE (Hadache), ARTHRALGIA (Joints started hurting/right shoulder and back hurt), FATIGUE (Fatigue/really tired), NAUSEA (Nauseous), RETCHING (Dry heaves), DECREASED APPETITE (No appetite), TREMOR (whole body shaking) and CHILLS (chills/ teeth chattering). At the time of the report, VACCINATION SITE PAIN (When I got shot hurt extremely/left arm got sore), HEADACHE (Hadache), ARTHRALGIA (Joints started hurting/right shoulder and back hurt), FATIGUE (Fatigue/really tired), NAUSEA (Nauseous), RETCHING (Dry heaves), DECREASED APPETITE (No appetite), TREMOR (whole body shaking) and CHILLS (chills/ teeth chattering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for headache and pain  included tylenol.
Sex: M
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: red stripes around the chest; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red stripes around the chest) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red stripes around the chest). At the time of the report, ERYTHEMA (red stripes around the chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug was taken. No treatment drug was taken.   Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Pallor, Rash pruritic
Clinical narrative: Itchy rash; Pressure on her chest; Very pale; Joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Itchy rash), CHEST PAIN (Pressure on her chest), PALLOR (Very pale) and ARTHRALGIA (Joint pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Non-Hodgkin's lymphoma and Drug allergy (Allergic to a certain chemotherapy during treatment).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced RASH PRURITIC (Itchy rash), CHEST PAIN (Pressure on her chest), PALLOR (Very pale) and ARTHRALGIA (Joint pain). On 25-Feb-2021, CHEST PAIN (Pressure on her chest) and PALLOR (Very pale) had resolved. At the time of the report, RASH PRURITIC (Itchy rash) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include chemotherapy Treatment medications included loratadine, diphenhydramine and calamine lotion
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: my arm was changing colors; my arm swelled up pretty bad; my arm was really painful; A spontaneous report was received from a healthcare professional concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events my arm swelled up pretty bad, my arm was really painful, my arm was changing colors.  The patient's medical history was not provided. Concomitant medications reported were gabapentin 100 mg tabs 1 tab PO QHS for drug use for unknown indication.  On 26 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 002A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Feb 2021, the patient experienced the event(s) my arm swelled up pretty bad. my arm was really painful. On 27 Feb 2021, the patient experienced the event(s) my arm was changing colors.  Treatment details included None..  Action taken with mRNA-1273 in response to the events were  not reported.  The outcome of event, my arm swelled up pretty bad was considered resolved on 2 Mar 2021.The outcome of events, my arm was really painful was considered resolved on 2 Mar 2021.The outcome of event, my arm was changing colors was considered resolved on 2 Mar 2021.  was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash erythematous, Urticaria
Clinical narrative: red raised rash; sore arm for three days; hives; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red raised rash), PAIN IN EXTREMITY (sore arm for three days) and URTICARIA (hives) in a 75-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. Concomitant products included HYDROCHLOROTHIAZIDE and APIXABAN (ELIQUIS) for an unknown indication.    On 18-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 RASH ERYTHEMATOUS (red raised rash), PAIN IN EXTREMITY (sore arm for three days) and URTICARIA (hives). At the time of the report, RASH ERYTHEMATOUS (red raised rash), PAIN IN EXTREMITY (sore arm for three days) and URTICARIA (hives) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching on the area of injection; Red spot about the size of a nickle; A spontaneous report was received from a consumer concerning a 73-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itching on the area of injection/ vaccination site pruritus, red spot about the size of a nickle/ vaccination site erythema.  The patient's medical history included hypertension. Concomitant medications reported were Apixaban, Ticagrelor, blood pressure medicine.  On 22 Feb 2021, nine days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the events itching on the area of injection, red spot about the size of a nickle.  The patient did not receive any treatment.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, itching on the area of injection, red spot about the size of a nickle was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a not specif 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles).   At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.      Reporter did not allow further contact
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fatigue, Influenza like illness, Pain
Clinical narrative: fatigue; fever; flu like symptoms; aches; dizziness; shaking; out of balance; swollen both arms; like internal tremors; A spontaneous report was received from a consumer concerning a 80-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever, flu like symptoms, aches, fatigue, dizziness, out of balance, shaking, like internal tremors, swollen both arms.  The patient's medical history was not provided. Concomitant medications reported were Rosuvastatin, Omeprazole, Vitamin D3, Vitamin C, COQ10, Aspirin for drug use for unknown indication.  On 4 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012A21A)  unknown route for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the events,fever, flu like symptoms, aches, fatigue, dizziness, out of balance, shaking, like internal tremors, swollen both arms.  Treatment details  was not included.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, fever, flu like symptoms, aches, fatigue, dizziness, out of balance, shaking, like internal tremors, swollen both arms was unknown.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Tremor
Clinical narrative: fatigue; fever; flu like symptoms; aches; dizziness; shaking; out of balance; swollen both arms; like internal tremors; A spontaneous report was received from a consumer concerning a 80-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever, flu like symptoms, aches, fatigue, dizziness, out of balance, shaking, like internal tremors, swollen both arms.  The patient's medical history was not provided. Concomitant medications reported were Rosuvastatin, Omeprazole, Vitamin D3, Vitamin C, COQ10, Aspirin for drug use for unknown indication.  On 4 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012A21A)  unknown route for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the events,fever, flu like symptoms, aches, fatigue, dizziness, out of balance, shaking, like internal tremors, swollen both arms.  Treatment details  was not included.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, fever, flu like symptoms, aches, fatigue, dizziness, out of balance, shaking, like internal tremors, swollen both arms was unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Myalgia, Vaccination site pruritus
Clinical narrative: Swelling at site of injection; Hardness at site of injection; Redness at site of injection; Severe itching at site of injection; Headache; Bilateral arm muscle pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Bilateral arm muscle pain), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling at site of injection) and VACCINATION SITE REACTION (Hardness at site of injection) in an 84-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.     Concurrent medical conditions included Blood pressure high and Hyperlipidemia.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (Headache), MYALGIA (Bilateral arm muscle pain) and FATIGUE (Fatigue). On 27-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at site of injection), VACCINATION SITE REACTION (Hardness at site of injection), INJECTION SITE ERYTHEMA (Redness at site of injection) and VACCINATION SITE PRURITUS (Severe itching at site of injection). At the time of the report, HEADACHE (Headache), MYALGIA (Bilateral arm muscle pain), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling at site of injection), VACCINATION SITE REACTION (Hardness at site of injection), INJECTION SITE ERYTHEMA (Redness at site of injection) and VACCINATION SITE PRURITUS (Severe itching at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant Medications includes High Blood Pressure Medication ,Antihyperlipidemic Medication. Treatment Medications were not provided by the reporter.