chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: lip sore; knot; itchy; red; felt warm on the Left arm,just below the injection site; rash; soreness of the Left arm the day of injection; This spontaneous case was reported by a consumer and describes the occurrence of LIP PAIN (lip sore), MASS EXCISION (knot), PRURITUS (itchy), ERYTHEMA (red) and FEELING HOT (felt warm on the Left arm,just below the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness of the Left arm the day of injection). On 26-Jan-2021, the patient experienced LIP PAIN (lip sore), MASS EXCISION (knot), PRURITUS (itchy), ERYTHEMA (red), FEELING HOT (felt warm on the Left arm,just below the injection site) and RASH (rash). At the time of the report, LIP PAIN (lip sore), MASS EXCISION (knot), PRURITUS (itchy), ERYTHEMA (red), FEELING HOT (felt warm on the Left arm,just below the injection site) and RASH (rash) outcome was unknown and PAIN IN EXTREMITY (soreness of the Left arm the day of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not provided. No relevant concomitant medications were reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Rash; Redness about 3 in long x 2 in wide; Slightly itchy injection site; Swollen lymph nodes right above her clavicle; This spontaneous case was reported by a dentist (subsequently medically confirmed) and describes the occurrence of RASH (Rash), VACCINATION SITE ERYTHEMA (Redness about 3 in long x 2 in wide), VACCINATION SITE PRURITUS (Slightly itchy injection site) and LYMPHADENOPATHY (Swollen lymph nodes right above her clavicle) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Anxiety. Concomitant products included CETIRIZINE for Allergy, SERTRALINE for Anxiety.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced RASH (Rash), VACCINATION SITE ERYTHEMA (Redness about 3 in long x 2 in wide), VACCINATION SITE PRURITUS (Slightly itchy injection site) and LYMPHADENOPATHY (Swollen lymph nodes right above her clavicle). In January 2021, RASH (Rash), VACCINATION SITE ERYTHEMA (Redness about 3 in long x 2 in wide) and LYMPHADENOPATHY (Swollen lymph nodes right above her clavicle) had resolved and VACCINATION SITE PRURITUS (Slightly itchy 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.   Treatment details included Cortisone cream and Benadryl for 1 day.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Toothache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of toothache (pain inside jaw and mouth like a toothache/pain in lower teeth) and lymphadenopathy (she also has swelling in lymph nodes in her throat) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 27, 2021, patient experienced toothache (pain inside jaw and mouth like a toothache/pain in lower teeth) and lymphadenopathy (she also has swelling in lymph nodes in her throat). At the time of the report, toothache (pain inside jaw and mouth like a toothache/pain in lower teeth) and lymphadenopathy (she also has swelling in lymph nodes in her throat) outcome: unknown. Treatment information and concomitant medications not provided.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of asthenia (very weak), pyrexia (101+ fever) and fatigue (very tired) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced asthenia (very weak), pyrexia (101+ fever) and fatigue (very tired). At the time of the report, asthenia (very weak), pyrexia (101+ fever) and fatigue (very tired): resolving. No concomitant medications  provided. Reportedly, patient experienced fever of 101+ most of the day following the second dose of Moderna COVID-19 vaccine. The patient felt better after lots of rest and water. Sender's comments: Very limited information regarding these events has been provided at this time. No further information expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity, Product storage error
Clinical narrative: cold few days later more so flu like symptom; 1st dose may not be effective as vial used was opened a day before and refrigerated probably; arm pain; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (cold few days later more so flu like symptom), PRODUCT STORAGE ERROR (1st dose may not be effective as vial used was opened a day before and refrigerated probably) and PAIN IN EXTREMITY (arm pain) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-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 INFLUENZA LIKE ILLNESS (cold few days later more so flu like symptom), PRODUCT STORAGE ERROR (1st dose may not be effective as vial used was opened a day before and refrigerated probably) and PAIN IN EXTREMITY (arm pain). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at a dose of 1 dosage form; DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at a dose of 1 dosage form and GUAIFENESIN (MUCINEX) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (cold few days later more so flu like symptom), PRODUCT STORAGE ERROR (1st dose may not be effective as vial used was opened a day before and refrigerated probably) and PAIN IN EXTREMITY (arm pain) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Pain in extremity
Clinical narrative: dizziness; he had "a hard a time walking"; develop a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (develop a sore arm), DIZZINESS (dizziness) and GAIT DISTURBANCE (he had "a hard a time walking") in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012o20a) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included MECLIZINE HCL for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (develop a sore arm) and GAIT DISTURBANCE (he had "a hard a time walking"). On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, PAIN IN EXTREMITY (develop a sore arm), DIZZINESS (dizziness) and GAIT DISTURBANCE (he had "a hard a time walking") was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included Blood pressure medication. Treatment details was not provided by reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Burning sensation
Clinical narrative: lower back pain; hip pain; burning; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), ARTHRALGIA (hip pain) and BURNING SENSATION (burning) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced BACK PAIN (lower back pain), ARTHRALGIA (hip pain) and BURNING SENSATION (burning). The patient was treated with IBUPROFEN at a dose of 800 mg, 1 tablet. On 06-Jan-2021, BACK PAIN (lower back pain), ARTHRALGIA (hip pain) and BURNING SENSATION (burning) 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.   No concomitant medications were reported.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral coldness, Pyrexia, Vomiting
Clinical narrative: Ice Cold Extremities - Hands and Feet; Nausea; Vomiting; Fever (101.8F); This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Ice Cold Extremities - Hands and Feet), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever (101.8F)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PERIPHERAL COLDNESS (Ice Cold Extremities - Hands and Feet), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever (101.8F)). At the time of the report, PERIPHERAL COLDNESS (Ice Cold Extremities - Hands and Feet), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever (101.8F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Pyrexia: 101.8 (High) 101.8F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: tender lymph node; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (tender lymph node) and FATIGUE (fatigue) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced FATIGUE (fatigue). On 28-Jan-2021, the patient experienced LYMPHADENOPATHY (tender lymph node). At the time of the report, LYMPHADENOPATHY (tender lymph node) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling cold, Influenza like illness, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: cough; very unwell; feeling unwell with the flu; feeling cold; nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feeling unwell with the flu), FEELING COLD (feeling cold), NASAL CONGESTION (nasal congestion), COUGH (cough) and VACCINATION COMPLICATION (very unwell) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (Patient takes pills to maintain blood pressure.). Concomitant products included blood pressure medicines for Blood pressure management, VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.    On 16-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 INFLUENZA LIKE ILLNESS (feeling unwell with the flu), FEELING COLD (feeling cold) and NASAL CONGESTION (nasal congestion). On 28-Jan-2021, the patient experienced COUGH (cough) and VACCINATION COMPLICATION (very unwell). At the time of the report, INFLUENZA LIKE ILLNESS (feeling unwell with the flu), FEELING COLD (feeling cold), NASAL CONGESTION (nasal congestion), COUGH (cough) and VACCINATION COMPLICATION (very unwell) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, SARS-CoV-2 test positive: positive rapid test for covid-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment included use of ibuprofen and intake of cinnamon water with lemon and ginger
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: cough; very unwell; feeling unwell with the flu; feeling cold; nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feeling unwell with the flu), FEELING COLD (feeling cold), NASAL CONGESTION (nasal congestion), COUGH (cough) and VACCINATION COMPLICATION (very unwell) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (Patient takes pills to maintain blood pressure.). Concomitant products included blood pressure medicines for Blood pressure management, VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.    On 16-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 INFLUENZA LIKE ILLNESS (feeling unwell with the flu), FEELING COLD (feeling cold) and NASAL CONGESTION (nasal congestion). On 28-Jan-2021, the patient experienced COUGH (cough) and VACCINATION COMPLICATION (very unwell). At the time of the report, INFLUENZA LIKE ILLNESS (feeling unwell with the flu), FEELING COLD (feeling cold), NASAL CONGESTION (nasal congestion), COUGH (cough) and VACCINATION COMPLICATION (very unwell) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, SARS-CoV-2 test positive: positive rapid test for covid-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment included use of ibuprofen and intake of cinnamon water with lemon and ginger
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Dermatitis, Dyspnoea, Hypertension
Clinical narrative: blood pressure had shot up; inflammation around the chest; swelling around chest; could not breathe; woke up arm hurting real bad; arm was swollen; redness; fever; back shoulder blade hurting real bad; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (could not breathe), HYPERTENSION (blood pressure had shot up), DERMATITIS (inflammation around the chest), SWELLING (swelling around chest) and VACCINATION SITE PAIN (woke up arm hurting real bad) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PANTOPRAZOLE, LEVOTHYROXINE, METOPROLOL SUCCINATE and AZITHROMYCIN for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (woke up arm hurting real bad), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE ERYTHEMA (redness), PYREXIA (fever) and ARTHRALGIA (back shoulder blade hurting real bad). On 22-Jan-2021, the patient experienced DYSPNOEA (could not breathe). On 26-Jan-2021, the patient experienced HYPERTENSION (blood pressure had shot up), DERMATITIS (inflammation around the chest) and SWELLING (swelling around chest). The patient was treated with PARACETAMOL (TYLENOL) on 22-Jan-2021 for Pain, at an unspecified dose and frequency and PREDNISONE (intravenous) on 26-Jan-2021 for Inflammation and Swelling, at a dose of IV bag. At the time of the report, DYSPNOEA (could not breathe), HYPERTENSION (blood pressure had shot up), DERMATITIS (inflammation around the chest), SWELLING (swelling around chest), VACCINATION SITE PAIN (woke up arm hurting real bad), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE ERYTHEMA (redness), PYREXIA (fever) and ARTHRALGIA (back shoulder blade hurting real bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Blood pressure measurement: 200 (High) shot up to 200, patient forgot the bottom number.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: blood pressure had shot up; inflammation around the chest; swelling around chest; could not breathe; woke up arm hurting real bad; arm was swollen; redness; fever; back shoulder blade hurting real bad; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (could not breathe), HYPERTENSION (blood pressure had shot up), DERMATITIS (inflammation around the chest), SWELLING (swelling around chest) and VACCINATION SITE PAIN (woke up arm hurting real bad) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PANTOPRAZOLE, LEVOTHYROXINE, METOPROLOL SUCCINATE and AZITHROMYCIN for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (woke up arm hurting real bad), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE ERYTHEMA (redness), PYREXIA (fever) and ARTHRALGIA (back shoulder blade hurting real bad). On 22-Jan-2021, the patient experienced DYSPNOEA (could not breathe). On 26-Jan-2021, the patient experienced HYPERTENSION (blood pressure had shot up), DERMATITIS (inflammation around the chest) and SWELLING (swelling around chest). The patient was treated with PARACETAMOL (TYLENOL) on 22-Jan-2021 for Pain, at an unspecified dose and frequency and PREDNISONE (intravenous) on 26-Jan-2021 for Inflammation and Swelling, at a dose of IV bag. At the time of the report, DYSPNOEA (could not breathe), HYPERTENSION (blood pressure had shot up), DERMATITIS (inflammation around the chest), SWELLING (swelling around chest), VACCINATION SITE PAIN (woke up arm hurting real bad), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE ERYTHEMA (redness), PYREXIA (fever) and ARTHRALGIA (back shoulder blade hurting real bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Blood pressure measurement: 200 (High) shot up to 200, patient forgot the bottom number.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swollen tongue, Vaccination site pain
Clinical narrative: Swollen tongue; Tingling tongue; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swollen tongue), PARAESTHESIA ORAL (Tingling tongue) and VACCINATION SITE PAIN (Pain in the arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced SWOLLEN TONGUE (Swollen tongue), PARAESTHESIA ORAL (Tingling tongue) and VACCINATION SITE PAIN (Pain in the arm). At the time of the report, SWOLLEN TONGUE (Swollen tongue), PARAESTHESIA ORAL (Tingling tongue) and VACCINATION SITE PAIN (Pain in the arm) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm local to injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore arm local to injection site) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm local to injection site). At the time of the report, VACCINATION SITE PAIN (sore arm local to injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Blood pressure.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Swollen between shoulder and neck; Lymph node swollen; A spontaneous report was received from a Consumer concerning a 45-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen between shoulder and neck and lymph node swollen.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021, 1 day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient reported to experience swelling between shoulder and neck. She also reported it was like lymph node was swollen.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis
Clinical narrative: Perspiring; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Perspiring) and HEADACHE (headache) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Perspiring) and HEADACHE (headache). At the time of the report, HYPERHIDROSIS (Perspiring) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; 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.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pyrexia
Clinical narrative: low grade fevers to 100 F; diffuse myalgia; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fevers to 100 F), MYALGIA (diffuse myalgia) and FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PYREXIA (low grade fevers to 100 F), MYALGIA (diffuse myalgia) and FATIGUE (fatigue). On 22-Jan-2021, PYREXIA (low grade fevers to 100 F), MYALGIA (diffuse myalgia) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hypoaesthesia, Myalgia, Neck pain
Clinical narrative: left arm was cold and numb; left arm was cold; pain on the right side of the neck; had headache; right and left shoulders sore; Left foot and left knee are sore; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (left arm was cold and numb), PERIPHERAL COLDNESS (left arm was cold), NECK PAIN (pain on the right side of the neck), HEADACHE (had headache) and ARTHRALGIA (right and left shoulders sore) in an 80-year-old male 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 was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced HYPOAESTHESIA (left arm was cold and numb), PERIPHERAL COLDNESS (left arm was cold), NECK PAIN (pain on the right side of the neck), HEADACHE (had headache), ARTHRALGIA (right and left shoulders sore) and MYALGIA (Left foot and left knee are sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (left arm was cold and numb), PERIPHERAL COLDNESS (left arm was cold), NECK PAIN (pain on the right side of the neck), HEADACHE (had headache), ARTHRALGIA (right and left shoulders sore) and MYALGIA (Left foot and left knee are sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: left arm was cold and numb; left arm was cold; pain on the right side of the neck; had headache; right and left shoulders sore; Left foot and left knee are sore; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (left arm was cold and numb), PERIPHERAL COLDNESS (left arm was cold), NECK PAIN (pain on the right side of the neck), HEADACHE (had headache) and ARTHRALGIA (right and left shoulders sore) in an 80-year-old male 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 was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced HYPOAESTHESIA (left arm was cold and numb), PERIPHERAL COLDNESS (left arm was cold), NECK PAIN (pain on the right side of the neck), HEADACHE (had headache), ARTHRALGIA (right and left shoulders sore) and MYALGIA (Left foot and left knee are sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (left arm was cold and numb), PERIPHERAL COLDNESS (left arm was cold), NECK PAIN (pain on the right side of the neck), HEADACHE (had headache), ARTHRALGIA (right and left shoulders sore) and MYALGIA (Left foot and left knee are sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Soreness; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), FATIGUE (Fatigue) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Soreness), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, PAIN (Soreness) outcome was unknown and FATIGUE (Fatigue) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was eager for her second dose and stated she never wanted to go through or her family go through Covid again. Concomitant medications were not provided. Treatment information was not reported.   Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: arm pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm pain) and HEADACHE (headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 MYALGIA (arm pain) and HEADACHE (headache). At the time of the report, MYALGIA (arm pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Headache, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; loss of taste; runny nose; bad headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid), AGEUSIA (loss of taste), RHINORRHOEA (runny nose), HEADACHE (bad headache) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid), AGEUSIA (loss of taste), RHINORRHOEA (runny nose), HEADACHE (bad headache) and CHILLS (Chills). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid), AGEUSIA (loss of taste), RHINORRHOEA (runny nose), HEADACHE (bad headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hot flush
Clinical narrative: hot circle; red, hot circle; This spontaneous case was reported by a patient and describes the occurrence of HOT FLUSH (hot circle) and ERYTHEMA (red, hot circle) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    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 HOT FLUSH (hot circle) and ERYTHEMA (red, hot circle). At the time of the report, HOT FLUSH (hot circle) and ERYTHEMA (red, hot circle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL HEADACHE & MIGRAINE) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: red; warm; splotchy; itchy; sorenes; raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red), INJECTION SITE WARMTH (warm), VACCINATION SITE RASH (splotchy), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE PAIN (sorenes) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, LUTEIN [XANTOFYL] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red), INJECTION SITE WARMTH (warm), VACCINATION SITE RASH (splotchy), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (sorenes) and VACCINATION SITE INDURATION (raised). At the time of the report, VACCINATION SITE ERYTHEMA (red), INJECTION SITE WARMTH (warm), VACCINATION SITE RASH (splotchy), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (sorenes) and VACCINATION SITE INDURATION (raised) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: red; warm; splotchy; itchy; sorenes; raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red), INJECTION SITE WARMTH (warm), VACCINATION SITE RASH (splotchy), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE PAIN (sorenes) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, LUTEIN [XANTOFYL] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red), INJECTION SITE WARMTH (warm), VACCINATION SITE RASH (splotchy), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (sorenes) and VACCINATION SITE INDURATION (raised). At the time of the report, VACCINATION SITE ERYTHEMA (red), INJECTION SITE WARMTH (warm), VACCINATION SITE RASH (splotchy), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (sorenes) and VACCINATION SITE INDURATION (raised) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Infection, Injection site warmth, Pruritus, Rash
Clinical narrative: very red; hot to the touch; swollen; itchy; angry looking, infection like; rash came back; developed rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (very red), INJECTION SITE WARMTH (hot to the touch), SWELLING (swollen), PRURITUS (itchy) and INFECTION (angry looking, infection like) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), FLUTICASONE PROPIONATE (FLOVENT) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE RASH (developed rash at injection site). On 15-Jan-2021, the patient experienced ERYTHEMA (very red), INJECTION SITE WARMTH (hot to the touch), SWELLING (swollen), PRURITUS (itchy), INFECTION (angry looking, infection like) and RASH (rash came back). The patient was treated with TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) at an unspecified dose and frequency. On 08-Jan-2021, VACCINATION SITE RASH (developed rash at injection site) had resolved. At the time of the report, ERYTHEMA (very red), INJECTION SITE WARMTH (hot to the touch), SWELLING (swollen), PRURITUS (itchy), INFECTION (angry looking, infection like) and RASH (rash came back) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site rash
Clinical narrative: very red; hot to the touch; swollen; itchy; angry looking, infection like; rash came back; developed rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (very red), INJECTION SITE WARMTH (hot to the touch), SWELLING (swollen), PRURITUS (itchy) and INFECTION (angry looking, infection like) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), FLUTICASONE PROPIONATE (FLOVENT) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE RASH (developed rash at injection site). On 15-Jan-2021, the patient experienced ERYTHEMA (very red), INJECTION SITE WARMTH (hot to the touch), SWELLING (swollen), PRURITUS (itchy), INFECTION (angry looking, infection like) and RASH (rash came back). The patient was treated with TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) at an unspecified dose and frequency. On 08-Jan-2021, VACCINATION SITE RASH (developed rash at injection site) had resolved. At the time of the report, ERYTHEMA (very red), INJECTION SITE WARMTH (hot to the touch), SWELLING (swollen), PRURITUS (itchy), INFECTION (angry looking, infection like) and RASH (rash came back) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; Fever; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: negative (Negative) Negative. On 02-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative.   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 product use was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Textured (bumpy) Injection Site; Painful Injection Site; Hot to the touch Injection Site; Red Injection Site; Raised Injection Site/Swollen about a Quarter size; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE SWELLING (Raised Injection Site/Swollen about a Quarter size), VACCINATION SITE PAIN (Painful Injection Site) and INJECTION SITE MASS (Textured (bumpy) Injection Site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reportd).    On 19-Jan-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red Injection Site) and VACCINATION SITE SWELLING (Raised Injection Site/Swollen about a Quarter size). On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch Injection Site) and VACCINATION SITE PAIN (Painful Injection Site). On 28-Jan-2021, the patient experienced INJECTION SITE MASS (Textured (bumpy) Injection Site). On 25-Jan-2021, VACCINATION SITE WARMTH (Hot to the touch Injection Site) and VACCINATION SITE PAIN (Painful Injection Site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red Injection Site) and VACCINATION SITE SWELLING (Raised Injection Site/Swollen about a Quarter size) had not resolved and INJECTION SITE MASS (Textured (bumpy) Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Anosmia, Injection site pain, Rash
Clinical narrative: Lost my sense of smell; Arm is a burning; Hot rash; 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 ANOSMIA (Lost my sense of smell), INJECTION SITE PAIN (Arm is a burning) and RASH (Hot rash) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced ANOSMIA (Lost my sense of smell), INJECTION SITE PAIN (Arm is a burning) and RASH (Hot rash).   At the time of the report, ANOSMIA (Lost my sense of smell), INJECTION SITE PAIN (Arm is a burning) and RASH (Hot rash) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication provided. No treatment information provided. Case is from social media page with no further information as such.   Reporter did not allow further contact.