chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Sinus disorder
Clinical narrative: Really bad issues with sinuses; headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (Really bad issues with sinuses), HEADACHE (headache), PYREXIA (Fever) and CHILLS (Chills) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUS DISORDER (Really bad issues with sinuses), HEADACHE (headache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, SINUS DISORDER (Really bad issues with sinuses), HEADACHE (headache), PYREXIA (Fever) and CHILLS (Chills) had not resolved.            Action taken with mRNA-1273 Moderna COVID-19 Vaccination was Not applicable.  No Concomitant medication was provided.  No Treatment medication was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: TCR received on 18-june-2021 contains NNI
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Hypersensitivity, Hypoaesthesia oral
Clinical narrative: Mild allergic reaction; Tightness in chest; Shortness of breath; Numb tongue; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERSENSITIVITY (Mild allergic reaction), CHEST DISCOMFORT (Tightness in chest), DYSPNOEA (Shortness of breath) and HYPOAESTHESIA ORAL (Numb tongue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Allergy (polysorbate 80) since an unknown date.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced HYPERSENSITIVITY (Mild allergic reaction), CHEST DISCOMFORT (Tightness in chest), DYSPNOEA (Shortness of breath) and HYPOAESTHESIA ORAL (Numb tongue). At the time of the report, HYPERSENSITIVITY (Mild allergic reaction), CHEST DISCOMFORT (Tightness in chest), DYSPNOEA (Shortness of breath) and HYPOAESTHESIA ORAL (Numb tongue) 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.   Concomitant medications were not provided. Treatment details were not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Asthenia, Chills, Diarrhoea
Clinical narrative: weakness; leg pain; diarrhea; burn when urinate; vision blurred; my arm got a little sore; leg pain; everything looks kind of fussy; joint pain; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), the first episode of PAIN IN EXTREMITY (leg pain), DIARRHOEA (diarrhea), DYSURIA (burn when urinate) and VISION BLURRED (vision blurred) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 02-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 ASTHENIA (weakness), the first episode of PAIN IN EXTREMITY (leg pain), DIARRHOEA (diarrhea), DYSURIA (burn when urinate), VISION BLURRED (vision blurred), PAIN IN EXTREMITY (my arm got a little sore), the second episode of PAIN IN EXTREMITY (leg pain), ANXIETY (everything looks kind of fussy), ARTHRALGIA (joint pain), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), DIARRHOEA (diarrhea), DYSURIA (burn when urinate), VISION BLURRED (vision blurred), PAIN IN EXTREMITY (my arm got a little sore), the last episode of PAIN IN EXTREMITY (leg pain), ANXIETY (everything looks kind of fussy), ARTHRALGIA (joint pain), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Concomitant medication included heart medication.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Headache, Pain in extremity, Pyrexia, Vision blurred
Clinical narrative: weakness; leg pain; diarrhea; burn when urinate; vision blurred; my arm got a little sore; leg pain; everything looks kind of fussy; joint pain; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), the first episode of PAIN IN EXTREMITY (leg pain), DIARRHOEA (diarrhea), DYSURIA (burn when urinate) and VISION BLURRED (vision blurred) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 02-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 ASTHENIA (weakness), the first episode of PAIN IN EXTREMITY (leg pain), DIARRHOEA (diarrhea), DYSURIA (burn when urinate), VISION BLURRED (vision blurred), PAIN IN EXTREMITY (my arm got a little sore), the second episode of PAIN IN EXTREMITY (leg pain), ANXIETY (everything looks kind of fussy), ARTHRALGIA (joint pain), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), DIARRHOEA (diarrhea), DYSURIA (burn when urinate), VISION BLURRED (vision blurred), PAIN IN EXTREMITY (my arm got a little sore), the last episode of PAIN IN EXTREMITY (leg pain), ANXIETY (everything looks kind of fussy), ARTHRALGIA (joint pain), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Concomitant medication included heart medication.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue; uncontrollable chills; Minor internal body aches (ex: when they took a deep breath they felt body ache internally); Headache; fever 101.3 (at its highest); Body aches; Tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (uncontrollable chills), VISCERAL PAIN (Minor internal body aches (ex: when they took a deep breath they felt body ache internally)), HEADACHE (Headache) and PYREXIA (fever 101.3 (at its highest)) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20 and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid-19). On 18-Feb-2021, the patient experienced FATIGUE (Fatigue), CHILLS (uncontrollable chills), VISCERAL PAIN (Minor internal body aches (ex: when they took a deep breath they felt body ache internally)), HEADACHE (Headache), PYREXIA (fever 101.3 (at its highest)) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and UBROGEPANT (UBRELVY) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, FATIGUE (Fatigue), CHILLS (uncontrollable chills), VISCERAL PAIN (Minor internal body aches (ex: when they took a deep breath they felt body ache internally)), HEADACHE (Headache), PYREXIA (fever 101.3 (at its highest)), MYALGIA (Body aches) and SARS-COV-2 TEST POSITIVE (Tested positive for covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive. On 18-Feb-2021, Body temperature: 101.3 (High) 101.3. On 19-Feb-2021, Body temperature: 99f (Low) 99F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications lisinopril, crestor.   This case was linked to MOD-2021-022090 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive, Visceral pain
Clinical narrative: Fatigue; uncontrollable chills; Minor internal body aches (ex: when they took a deep breath they felt body ache internally); Headache; fever 101.3 (at its highest); Body aches; Tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (uncontrollable chills), VISCERAL PAIN (Minor internal body aches (ex: when they took a deep breath they felt body ache internally)), HEADACHE (Headache) and PYREXIA (fever 101.3 (at its highest)) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20 and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid-19). On 18-Feb-2021, the patient experienced FATIGUE (Fatigue), CHILLS (uncontrollable chills), VISCERAL PAIN (Minor internal body aches (ex: when they took a deep breath they felt body ache internally)), HEADACHE (Headache), PYREXIA (fever 101.3 (at its highest)) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and UBROGEPANT (UBRELVY) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, FATIGUE (Fatigue), CHILLS (uncontrollable chills), VISCERAL PAIN (Minor internal body aches (ex: when they took a deep breath they felt body ache internally)), HEADACHE (Headache), PYREXIA (fever 101.3 (at its highest)), MYALGIA (Body aches) and SARS-COV-2 TEST POSITIVE (Tested positive for covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive. On 18-Feb-2021, Body temperature: 101.3 (High) 101.3. On 19-Feb-2021, Body temperature: 99f (Low) 99F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications lisinopril, crestor.   This case was linked to MOD-2021-022090 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site rash
Clinical narrative: Mildly itchy rash from neck to ankles; Fine rash at injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH PRURITIC (Mildly itchy rash from neck to ankles) and VACCINATION SITE RASH (Fine rash at injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Mildly itchy rash from neck to ankles) and VACCINATION SITE RASH (Fine rash at injection site). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Mildly itchy rash from neck to ankles) and VACCINATION SITE RASH (Fine rash at injection site) 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.   Concomitant medications were not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity, Pruritus, Rash
Clinical narrative: very severe cramp in my upper right leg; rash all over my body, on my legs and my arms, hands, back, chest and feet; itching; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MUSCLE SPASMS (very severe cramp in my upper right leg), PRURITUS (itching) and RASH (rash all over my body, on my legs and my arms, hands, back, chest and feet) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 28-Jan-2021, the patient experienced PRURITUS (itching). On 03-Feb-2021, the patient experienced RASH (rash all over my body, on my legs and my arms, hands, back, chest and feet). On an unknown date, the patient experienced MUSCLE SPASMS (very severe cramp in my upper right leg). At the time of the report, PAIN IN EXTREMITY (sore arm), MUSCLE SPASMS (very severe cramp in my upper right leg), PRURITUS (itching) and RASH (rash all over my body, on my legs and my arms, hands, back, chest and feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nosebleeds and went to the hospital for 7 to 8 hours; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nosebleeds and went to the hospital for 7 to 8 hours) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced EPISTAXIS (nosebleeds and went to the hospital for 7 to 8 hours). At the time of the report, EPISTAXIS (nosebleeds and went to the hospital for 7 to 8 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided.  Concomitant drug details not provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchiness; A spontaneous report was received from a healthcare professional concerning a 88 years old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pruritus/itchiness.  The patient's medical history was not provided.  Products known to have been used by the patient were blood pressure meds and tramadol.   On 20 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 022M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced  itchiness all over the body starting from the right shoulder.  Treatment details included Benadryl. No relevant laboratory details were included.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, itchiness was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm of the injection got warm, itchy, swollen and there's a puffy area; arm of the injection got warm, itchy, swollen and there's a puffy area; arm of the injection got warm, itchy, swollen and there's a puffy area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm of the injection got warm, itchy, swollen and there's a puffy area), VACCINATION SITE PRURITUS (arm of the injection got warm, itchy, swollen and there's a puffy area) and VACCINATION SITE SWELLING (arm of the injection got warm, itchy, swollen and there's a puffy area) in a 62-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 12-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 VACCINATION SITE WARMTH (arm of the injection got warm, itchy, swollen and there's a puffy area), VACCINATION SITE PRURITUS (arm of the injection got warm, itchy, swollen and there's a puffy area) and VACCINATION SITE SWELLING (arm of the injection got warm, itchy, swollen and there's a puffy area). At the time of the report, VACCINATION SITE WARMTH (arm of the injection got warm, itchy, swollen and there's a puffy area), VACCINATION SITE PRURITUS (arm of the injection got warm, itchy, swollen and there's a puffy area) and VACCINATION SITE SWELLING (arm of the injection got warm, itchy, swollen and there's a puffy area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Scan
Clinical narrative: severe pain in her left shoulder; Arm discomfort; This spontaneous case was reported by a health care professional and describes the occurrence of LIMB DISCOMFORT (Arm discomfort) and ARTHRALGIA (severe pain in her left shoulder) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm discomfort). On 10-Feb-2021, the patient experienced ARTHRALGIA (severe pain in her left shoulder). On 29-Jan-2021, LIMB DISCOMFORT (Arm discomfort) outcome was unknown. At the time of the report, ARTHRALGIA (severe pain in her left shoulder) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan: normal (normal) normal.     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: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 1st dose sore arm lasted one day; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (1st dose sore arm lasted one day) in a 32-year-old male patient who received the first dose of mRNA-1273 (Moderna COVID-19 Vaccine)  on 06 Jan 2021 for COVID-19 vaccination.     No Medical History information was reported.  Concomitant medication of was not treatment.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) via Intramuscular route of administration(batch no. 025L20A). On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (1st dose sore arm lasted one day). On 06-Jan-2021, PAIN IN EXTREMITY (1st dose sore arm lasted one day) had resolved.      The treatment medication included-Meclizine 25mg Ativan 1mg (only one time) Sertraline 25mg  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   This case was linked to MOD-2021-022173 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Diarrhoea, Nausea, Pain in extremity
Clinical narrative: cold sweats; diarrhea; nauseous; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), COLD SWEAT (cold sweats), DIARRHOEA (diarrhea) and NAUSEA (nauseous) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). On 13-Feb-2021, the patient experienced NAUSEA (nauseous). On 21-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 22-Feb-2021, the patient experienced COLD SWEAT (cold sweats). On 13-Feb-2021, NAUSEA (nauseous) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in arm), COLD SWEAT (cold sweats) and DIARRHOEA (diarrhea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details not provided.  concomitant details not provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache
Clinical narrative: weakness; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness) and HEADACHE (Bad headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TAMOXIFEN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced ASTHENIA (weakness) and HEADACHE (Bad headache). At the time of the report, ASTHENIA (weakness) and HEADACHE (Bad headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment information was provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Fever of 102.2F; Fatigue; Pain at the injection site; Lightheadedness; A spontaneous report was received from a consumer concerning a 44-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue, pain at the injection site / vaccination site pain, lightheadedness / dizziness and fever of 102.2F / pyrexia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 022M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 21 Feb 2021, the patient experienced fatigue, pain at the injection site and lightheadedness. On 22 Feb 2021, the patient had fever of 102.2F.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, fatigue, pain at the injection site, lightheadedness and fever of 102.2F was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Pain, Pyrexia
Clinical narrative: Body aches; No appetite; Feeling unsteady/dizzy; Fever (100.8° after taking Tylenol); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), DECREASED APPETITE (No appetite), DIZZINESS (Feeling unsteady/dizzy) and PYREXIA (Fever (100.8° after taking Tylenol)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Cholesterol high. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Body aches), DECREASED APPETITE (No appetite), DIZZINESS (Feeling unsteady/dizzy) and PYREXIA (Fever (100.8° after taking Tylenol)). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown. At the time of the report, PAIN (Body aches), DECREASED APPETITE (No appetite), DIZZINESS (Feeling unsteady/dizzy) and PYREXIA (Fever (100.8° after taking Tylenol)) had not resolved.            patient uses unspecified blood pressure and cholesterol medications as concomitants.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Only felt tired from her first vaccine; A spontaneous report was received from a consumer concerning a 74-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt tired from first vaccine/fatigue.  The patient's medical history provided included diabetes. Concomitant medications reported were insulin.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, after receiving the first dose of vaccine the patient felt tired. On 19 Feb 2021, the patient experienced the events, aches, fever, headaches, chills, felt tired, blood sugar has been almost at 300. No treatment information was provided.  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.  At the time of this report, the outcome of event felt tired from her first vaccine was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported). Concomitant products included THYROID for Thyroid dysfunction in pregnancy, BETA GLUCAN (CHOLESTEROL BALANCE [BETA GLUCAN]) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced ARTHRALGIA (sore arm). At the time of the report, ARTHRALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Pyrexia
Clinical narrative: Extremely bad headache; 3.5 days of 101F fever; Upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Extremely bad headache), PYREXIA (3.5 days of 101F fever) and ABDOMINAL DISCOMFORT (Upset stomach) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (He still has not regained his taste or smell.) in October 2020.    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 HEADACHE (Extremely bad headache), PYREXIA (3.5 days of 101F fever) and ABDOMINAL DISCOMFORT (Upset stomach). At the time of the report, HEADACHE (Extremely bad headache) had not resolved and PYREXIA (3.5 days of 101F fever) and ABDOMINAL DISCOMFORT (Upset stomach) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Heart rate decreased, Hyperhidrosis, Vision blurred
Clinical narrative: Sweating; Blurred vision; Pulse was low; Anxiety; Chills; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERHIDROSIS (Sweating), VISION BLURRED (Blurred vision), HEART RATE DECREASED (Pulse was low), ANXIETY (Anxiety) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 immunization.     The patient's past medical history included No adverse event.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPERHIDROSIS (Sweating), VISION BLURRED (Blurred vision), HEART RATE DECREASED (Pulse was low), ANXIETY (Anxiety) and CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Sweating), VISION BLURRED (Blurred vision), HEART RATE DECREASED (Pulse was low), ANXIETY (Anxiety) and CHILLS (Chills) 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.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: 2x4 inch red area around the injection site (like a rectangle); A spontaneous report was received from a consumer, a 89-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 2x4 inch red area around the injection site (like a rectangle)/ injection site erythema.  The patient's medical history included removal of lymph node in the 1980's and swollen arms. Concomitant products used was metolazone.  On 11 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: [030MZ0A] in the right arm for prophylaxis of COVID-19 infection.   On 22 Feb 2021, after 11 days of vaccine administration the patient developed a 2x4 inch red area around the injection site (like a rectangle) not itchy, no pain, not freckled. Treatment for the event was not reported.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, 2x4 inch red area around the injection site (like a rectangle) was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Laziness, Malaise, Pain in extremity, Vaccination site erythema
Clinical narrative: ed patch about the size of his palm around the injection site; Mildly unwell; Did not feel like doing anything; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MALAISE (Mildly unwell), LAZINESS (Did not feel like doing anything) and VACCINATION SITE ERYTHEMA (ed patch about the size of his palm around the injection site) in a 67-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 PAIN IN EXTREMITY (Sore arm). On 13-Feb-2021, the patient experienced MALAISE (Mildly unwell) and LAZINESS (Did not feel like doing anything). On 22-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (ed patch about the size of his palm around the injection site). The patient was treated with IBUPROFEN for Pain in extremity, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), MALAISE (Mildly unwell), LAZINESS (Did not feel like doing anything) and VACCINATION SITE ERYTHEMA (ed patch about the size of his palm around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure systolic, Blood pressure systolic increased, Heart rate, Palpitations
Clinical narrative: systolic blood pressure which has risen to 130s from usual (113); felt like heart was going to burst out of chest; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (felt like heart was going to burst out of chest) and BLOOD PRESSURE SYSTOLIC INCREASED (systolic blood pressure which has risen to 130s from usual (113)) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, CALCIUM, CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, METHYLSULFONYLMETHANE (TRIPLE FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE;METHYLSULFONYLMETHANE]), CARVEDILOL, MONTELUKAST, AMLODIPINE, IRBESARTAN, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), UBIDECARENONE (CO Q 10 [UBIDECARENONE]), LYSINE (L LYSINE [LYSINE]) and MULTIVITAMIN [VITAMINS NOS] 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 19-Feb-2021, the patient experienced PALPITATIONS (felt like heart was going to burst out of chest). On an unknown date, the patient experienced BLOOD PRESSURE SYSTOLIC INCREASED (systolic blood pressure which has risen to 130s from usual (113)). At the time of the report, PALPITATIONS (felt like heart was going to burst out of chest) and BLOOD PRESSURE SYSTOLIC INCREASED (systolic blood pressure which has risen to 130s from usual (113)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure systolic: 130 (High) 130. On an unknown date, Heart rate: 88 (normal) 88.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Bedridden, Feeling cold, Malaise
Clinical narrative: Felt sicker than hell; Back hurt like someone dropped a box on it; Shaking/Felt like he had a vibrator; Stayed in bed for day and half; Feels weak; Arm is still tender; Felt so cold; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sicker than hell), BACK PAIN (Back hurt like someone dropped a box on it), TREMOR (Shaking/Felt like he had a vibrator), BEDRIDDEN (Stayed in bed for day and half) and ASTHENIA (Feels weak) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack, COVID-19 on 26-Dec-2020 and Pacemaker complication. Concurrent medical conditions included Heart disorder.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced MALAISE (Felt sicker than hell), BACK PAIN (Back hurt like someone dropped a box on it), TREMOR (Shaking/Felt like he had a vibrator), BEDRIDDEN (Stayed in bed for day and half), ASTHENIA (Feels weak), TENDERNESS (Arm is still tender) and FEELING COLD (Felt so cold). At the time of the report, MALAISE (Felt sicker than hell) and BEDRIDDEN (Stayed in bed for day and half) had resolved and BACK PAIN (Back hurt like someone dropped a box on it), TREMOR (Shaking/Felt like he had a vibrator), ASTHENIA (Feels weak), TENDERNESS (Arm is still tender) and FEELING COLD (Felt so cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included heart pills.  Treatment information was not provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Tremor
Clinical narrative: Felt sicker than hell; Back hurt like someone dropped a box on it; Shaking/Felt like he had a vibrator; Stayed in bed for day and half; Feels weak; Arm is still tender; Felt so cold; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sicker than hell), BACK PAIN (Back hurt like someone dropped a box on it), TREMOR (Shaking/Felt like he had a vibrator), BEDRIDDEN (Stayed in bed for day and half) and ASTHENIA (Feels weak) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack, COVID-19 on 26-Dec-2020 and Pacemaker complication. Concurrent medical conditions included Heart disorder.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced MALAISE (Felt sicker than hell), BACK PAIN (Back hurt like someone dropped a box on it), TREMOR (Shaking/Felt like he had a vibrator), BEDRIDDEN (Stayed in bed for day and half), ASTHENIA (Feels weak), TENDERNESS (Arm is still tender) and FEELING COLD (Felt so cold). At the time of the report, MALAISE (Felt sicker than hell) and BEDRIDDEN (Stayed in bed for day and half) had resolved and BACK PAIN (Back hurt like someone dropped a box on it), TREMOR (Shaking/Felt like he had a vibrator), ASTHENIA (Feels weak), TENDERNESS (Arm is still tender) and FEELING COLD (Felt so cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included heart pills.  Treatment information was not provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Pain in extremity, Vertigo
Clinical narrative: ongoing dizziness or vertigo; fatigue (for 2 days); chills (for 2 days); 2nd dose sore arm (for 3 days); dizziness (since 2nd dose and still going on); This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (2nd dose sore arm (for 3 days)), DIZZINESS (dizziness (since 2nd dose and still going on)), VERTIGO (ongoing dizziness or vertigo), FATIGUE (fatigue (for 2 days)) and CHILLS (chills (for 2 days)) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (2nd dose sore arm (for 3 days)), DIZZINESS (dizziness (since 2nd dose and still going on)), FATIGUE (fatigue (for 2 days)) and CHILLS (chills (for 2 days)). On an unknown date, the patient experienced VERTIGO (ongoing dizziness or vertigo). The patient was treated with MECLIZINE HCL (oral) at a dose of 25 mg; LORAZEPAM (ATIVAN) (oral) at a dose of 1 mg once a day and SERTRALINE (oral) at a dose of 25 mg. On 07-Feb-2021, FATIGUE (fatigue (for 2 days)) and CHILLS (chills (for 2 days)) had resolved. On 08-Feb-2021, PAIN IN EXTREMITY (2nd dose sore arm (for 3 days)) had resolved. At the time of the report, DIZZINESS (dizziness (since 2nd dose and still going on)) and VERTIGO (ongoing dizziness or vertigo) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product details not provided.   This case was linked to MOD-2021-022145.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Myalgia
Clinical narrative: Dizziness; Headache; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizziness), HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Additional information include no new information.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling abnormal, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Pain in arm; got worse; Swelling; looked awful; felt like needle when touched; very bad; Itching/3 x 4 inches on upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), CONDITION AGGRAVATED (got worse), PERIPHERAL SWELLING (Swelling), CONDITION AGGRAVATED (looked awful) and PARAESTHESIA (felt like needle when touched) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), CONDITION AGGRAVATED (got worse), PERIPHERAL SWELLING (Swelling), CONDITION AGGRAVATED (looked awful), PARAESTHESIA (felt like needle when touched), FEELING ABNORMAL (very bad) and PRURITUS (Itching/3 x 4 inches on upper arm). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arm), CONDITION AGGRAVATED (got worse), PERIPHERAL SWELLING (Swelling), CONDITION AGGRAVATED (looked awful), PARAESTHESIA (felt like needle when touched), FEELING ABNORMAL (very bad) and PRURITUS (Itching/3 x 4 inches on upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment as Allegra, cold Compress was given. No concomitant medication was given.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up received as dose 2 details were updated, events for dose 2 added.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Pain in arm; got worse; Swelling; looked awful; felt like needle when touched; very bad; Itching/3 x 4 inches on upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), CONDITION AGGRAVATED (got worse), PERIPHERAL SWELLING (Swelling), CONDITION AGGRAVATED (looked awful) and PARAESTHESIA (felt like needle when touched) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), CONDITION AGGRAVATED (got worse), PERIPHERAL SWELLING (Swelling), CONDITION AGGRAVATED (looked awful), PARAESTHESIA (felt like needle when touched), FEELING ABNORMAL (very bad) and PRURITUS (Itching/3 x 4 inches on upper arm). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arm), CONDITION AGGRAVATED (got worse), PERIPHERAL SWELLING (Swelling), CONDITION AGGRAVATED (looked awful), PARAESTHESIA (felt like needle when touched), FEELING ABNORMAL (very bad) and PRURITUS (Itching/3 x 4 inches on upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment as Allegra, cold Compress was given. No concomitant medication was given.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up received as dose 2 details were updated, events for dose 2 added.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: Hearing problem; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOACUSIS (Hearing problem) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 HYPOACUSIS (Hearing problem). The patient was treated with PREDNISONE for Hypoacusis, at a dose of 2 weeks. At the time of the report, HYPOACUSIS (Hearing problem) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs details not provided.