chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Skin rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (5 rashes on my behind - started as "little bumps like a pimple) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced RASH (5 rashes on my behind - started as "little bumps like a pimple). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (5 rashes on my behind - started as "little bumps like a pimple) 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 included Benadryl; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the event, a causal relationship cannot be excluded. The reported event is consistent with the product safety profile
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) 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 No adverse event (No reported medical history.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site mass
Clinical narrative: knot midway down the arm; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (knot midway down the arm) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m23aa) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 09-Feb-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 INJECTION SITE MASS (knot midway down the arm) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INJECTION SITE MASS (knot midway down the arm) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Hypertension
Clinical narrative: Today my blood pressure was 144/82; i am  having nose bleeds; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Today my blood pressure was 144/82) and EPISTAXIS (i am  having nose bleeds) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol.    On 20-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 HYPERTENSION (Today my blood pressure was 144/82) and EPISTAXIS (i am  having nose bleeds). At the time of the report, HYPERTENSION (Today my blood pressure was 144/82) and EPISTAXIS (i am  having nose bleeds) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hypertension: 144/82 (Inconclusive) 144/82.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: pain at the back of her neck that shoots to her head; neck was stiff at the right side; pain was sharp at times and kind of radiates to her ears; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain at the back of her neck that shoots to her head), MUSCULOSKELETAL STIFFNESS (neck was stiff at the right side) and EAR PAIN (pain was sharp at times and kind of radiates to her ears) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event (No reported medical history). Concomitant products included METOPROLOL, IBUPROFEN, GABAPENTIN, MELATONIN, SERTRALINE, ATORVASTATIN, AMLODIPINE, LOSARTAN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and CEFIXIME (FLEXERIL [CEFIXIME]) for an unknown indication.    On 19-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 NECK PAIN (pain at the back of her neck that shoots to her head), MUSCULOSKELETAL STIFFNESS (neck was stiff at the right side) and EAR PAIN (pain was sharp at times and kind of radiates to her ears). At the time of the report, NECK PAIN (pain at the back of her neck that shoots to her head), MUSCULOSKELETAL STIFFNESS (neck was stiff at the right side) and EAR PAIN (pain was sharp at times and kind of radiates to her ears) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Vitamins are used as a Concomitant medication also. Ibuprofen used as a Treatment Medication.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Candida infection
Clinical narrative: Side effect; thrush; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ADVERSE DRUG REACTION (Side effect) and CANDIDA INFECTION (thrush) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 15-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 ADVERSE DRUG REACTION (Side effect) and CANDIDA INFECTION (thrush). At the time of the report, ADVERSE DRUG REACTION (Side effect) and CANDIDA INFECTION (thrush) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Oral medication used in treatment
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate, Lymphadenopathy, Pyrexia
Clinical narrative: Lymph nodes under the right arm are swollen; fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes under the right arm are swollen), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes under the right arm are swollen), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form and IBUPROFEN at a dose of UNK dosage form. At the time of the report, LYMPHADENOPATHY (Lymph nodes under the right arm are swollen), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Heart rate: increased (High) fast heart beat that persisted for a couple days.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       concomitant medications  were not reported   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: event was updated (Heart beat increase), withdrawn the 2nd dose
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Rash, Sciatica
Clinical narrative: patient could not walk due to back pain; rash all around trunk of body; severe sciatica pain; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of   in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patients medical history was not reported.  Previously administered products included for an unreported indication: HYDROXYZINE (25 mg P.O 3 times a day).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment included shot for pain, hydrocodone, oral steroids for 10 days.   Reporter did not allow further contact
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Confusional state, Headache, Pain
Clinical narrative: Body pain; confusion; weakness; Mild fever; chills; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Body pain), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), PYREXIA (Mild fever) and CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (Body pain), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), PYREXIA (Mild fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, PAIN (Body pain), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), PYREXIA (Mild fever), CHILLS (chills) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body pain; confusion; weakness; Mild fever; chills; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Body pain), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), PYREXIA (Mild fever) and CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (Body pain), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), PYREXIA (Mild fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, PAIN (Body pain), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), PYREXIA (Mild fever), CHILLS (chills) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Muscle pain; Joint pain; Fatigue; Headache; Nausea; Chills; Vaccination site pain; A spontaneous report was received from a Consumer concerning a  73 Years-old female patient who received Moderna's   COVID-19 vaccine (mRNA-1273) and experienced events vaccination site pain, fatigue, headache, muscle pain, joint pain, chills, nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 20-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:028L20A ) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20-JAN-2021, The patient experienced the events vaccination site pain, fatigue, headache, muscle pain, joint pain, chills, nausea.  Treatment details Tylenol was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events vaccination site pain, fatigue, headache, muscle pain, joint pain, chills, nausea, which events are being referenced here were unknown.  The reporter assessed the events vaccination site pain, fatigue, headache, muscle pain, joint pain, chills, nausea as related to study drug.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Muscle pain; Joint pain; Fatigue; Headache; Nausea; Chills; Vaccination site pain; A spontaneous report was received from a Consumer concerning a  73 Years-old female patient who received Moderna's   COVID-19 vaccine (mRNA-1273) and experienced events vaccination site pain, fatigue, headache, muscle pain, joint pain, chills, nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 20-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:028L20A ) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20-JAN-2021, The patient experienced the events vaccination site pain, fatigue, headache, muscle pain, joint pain, chills, nausea.  Treatment details Tylenol was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events vaccination site pain, fatigue, headache, muscle pain, joint pain, chills, nausea, which events are being referenced here were unknown.  The reporter assessed the events vaccination site pain, fatigue, headache, muscle pain, joint pain, chills, nausea as related to study drug.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Red rash that is a 1 inch 1/2 wide; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Red rash that is a 1 inch 1/2 wide) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (Red rash that is a 1 inch 1/2 wide). At the time of the report, INJECTION SITE RASH (Red rash that is a 1 inch 1/2 wide) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: bodyache; FEVER; chills; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (bodyache), PYREXIA (FEVER), CHILLS (chills) and HEADACHE (Head ache) in a 22-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 Calf pain.   On 02-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 02-Feb-2021, the patient experienced MYALGIA (bodyache), PYREXIA (FEVER), CHILLS (chills) and HEADACHE (Head ache). At the time of the report, MYALGIA (bodyache), PYREXIA (FEVER), CHILLS (chills) and HEADACHE (Head ache) had not resolved.            No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Rash, Urticaria
Clinical narrative: Swollen lips; Welts on back; Hives; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of LIP SWELLING (Swollen lips), RASH (Welts on back) and URTICARIA (Hives) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included LEVOTHYROXINE 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 22-Jan-2021, the patient experienced LIP SWELLING (Swollen lips), RASH (Welts on back) and URTICARIA (Hives). On 03-Feb-2021, LIP SWELLING (Swollen lips) and URTICARIA (Hives) had resolved. At the time of the report, RASH (Welts on back) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of LIP SWELLING (Swollen lips), RASH (Welts on back) and URTICARIA (Hives) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included LEVOTHYROXINE 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 22-Jan-2021, the patient experienced LIP SWELLING (Swollen lips), RASH (Welts on back) and URTICARIA (Hives). On 03-Feb-2021, LIP SWELLING (Swollen lips) and URTICARIA (Hives) had resolved. At the time of the report, RASH (Welts on back) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: No specific follow-up information recorded.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Injection site pruritus, Myalgia, Pyrexia
Clinical narrative: joint pain/knees and feet; Muscle pain belowknees to feet; fever in the arm; injection site redness; injection site itching; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever,redness and itching around the injection site,joint pain in both knees down to her feet and muscle pain below both knees to her feet.  The patient's medical history was not reported. Concomitant medication was not reported.  18-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) for prophylaxis of COVID-19 infection.  On 22-JAN-2021, The patient experienced fever,redness and itching around the injection site On 29-Jan-2021,she had joint pain in both knees down to her feet and muscle pain below both knees to her feet. Her arm was not as red or itchy at the time of the report. No Laboratory details provided.  Treatment information o f cold pack,zyrtec,cortizone 10 was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events fever,injection site redness,injection site itchiness,arthralgia,myalgia are Unknown
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site redness; injection site swelling; delayed injection site warm; delayed injection site itching; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE WARMTH (delayed injection site warm) and INJECTION SITE PRURITUS (delayed injection site itching) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical history was provided by reporter.     On 26-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 INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE WARMTH (delayed injection site warm) and INJECTION SITE PRURITUS (delayed injection site itching). At the time of the report, INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE WARMTH (delayed injection site warm) and INJECTION SITE PRURITUS (delayed injection site itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by reporter   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: Arm and hand swollen; Joints, knuckles hurt a little bit; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm and hand swollen) and ARTHRALGIA (Joints, knuckles hurt a little bit) in a 66-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 04-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 PERIPHERAL SWELLING (Arm and hand swollen) and ARTHRALGIA (Joints, knuckles hurt a little bit). At the time of the report, PERIPHERAL SWELLING (Arm and hand swollen) had not resolved and ARTHRALGIA (Joints, knuckles hurt a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication was not provided   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received and significant information, outcome of the event swollen from unknown to not recovered/not resolved
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Paraesthesia
Clinical narrative: full body sweats; Fingers tingly; High heart rate; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (full body sweats), PARAESTHESIA (Fingers tingly) and HEART RATE INCREASED (High heart rate) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Sweating from 16-Jan-2021 to 17-Jan-2021, Paraesthesia from 16-Feb-2021 to 17-Feb-2021 and Heart rate increased from 16-Feb-2021 to 17-Feb-2021.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HYPERHIDROSIS (full body sweats), PARAESTHESIA (Fingers tingly) and HEART RATE INCREASED (High heart rate). On 17-Feb-2021, HYPERHIDROSIS (full body sweats), PARAESTHESIA (Fingers tingly) and HEART RATE INCREASED (High heart rate) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by reporter  No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain, Pyrexia
Clinical narrative: Had soreness for a few hours but it went away the same day; Achiness; Malaise; She also had some chills; Low grade fever that went up and down that night around 17:00; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Had soreness for a few hours but it went away the same day), PAIN (Achiness), MALAISE (Malaise) and CHILLS (She also had some chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphatic leukemia (Oncologist said she got it because she was not taking any cancer medications.). Concomitant products included FAMOTIDINE (PEPCID AC) for Esophagitis and Gastritis, LEVOTHYROXINE for an unknown indication.    On 29-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 PAIN (Had soreness for a few hours but it went away the same day), PAIN (Achiness), MALAISE (Malaise) and CHILLS (She also had some chills). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of UNK dosage form. On 29-Jan-2021, PAIN (Had soreness for a few hours but it went away the same day) had resolved. On 31-Jan-2021, PAIN (Achiness), MALAISE (Malaise) and CHILLS (She also had some chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives in her forearm, knee and feet; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives in her forearm, knee and feet) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021 at 2:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021 at 6:00 AM, the patient experienced URTICARIA (hives in her forearm, knee and feet). At the time of the report, URTICARIA (hives in her forearm, knee and feet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter  Treatment for the event included Benadryl.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Ten minutes post vaccine, I developed pulsitile tinnitus. The pounding was very harsh and frequent for months, and has slowly been decreasing. However, I still have pressure in my ears and periods of the pounding as well as ringing tinnitus.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram ST segment abnormal, Myocarditis, Painful respiration, Troponin increased
Clinical narrative: Patient received his second dose of Pfeizer's COVID-19  vaccine on 8/12/2021; on 8/14/2021, the patient developed chest pain.  On 8/15/2021, the patient had recurrence and worsening of his chest pain.  He was admitted to the hospital and was found to have elevated troponins, electrocardiogram with nonspecific ST changes.  His chest pain also worsens with deep inspirations. There was suspicion for Myopericarditis.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Cardiac imaging procedure abnormal, Chest pain, Myocarditis, Troponin increased
Clinical narrative: Patient received his second dose of Pfeizer's COVID-19  vaccine on 8/12/2021; on 8/14/2021, the patient developed chest pain.  On 8/15/2021, the patient had recurrence and worsening of his chest pain.  He was admitted to the hospital and was found to have elevated troponins, electrocardiogram with nonspecific ST changes.  His chest pain also worsens with deep inspirations. There was suspicion for Myopericarditis.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Injection site pain, Nausea, Vomiting
Clinical narrative: chills; where I got the injection was sore; nausea; vomited; diarrhea; Case reference number MOD-2021-016040 is a spontaneous case report sent by a Other on 04-FEB-2021 00:00:00 , which refers to a Female aged 71 Years The following drugs are known to have been taken by the patient prior to the event: CYCLOSPORINE[] ,CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE][] ,AMLODIPINE[] ,ENALAPRIL[] ,GLIMEPIRIDE[] ,TAMOXIFEN[] ,CLARITINE[] ,BACTRIM[] ,FAMOTIDINE[] ,POLY-IRON [IRON POLYSACCHARIDE COMPLEX][]  .  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  1 day later,  the patient developed chills. Over a period of the next <ENTER DURATION OF EVENT> days, the patient also developed where I got the injection was sore,nausea,vomited,diarrhea. Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:. The eventual diagnosis made on was Chills . .  The patient was treated for the event with   . <ENTER ANY PROCEDURES> An autopsy was performed on  . The Other did not declare any relatedness between chills and Moderna COVID-19 Vaccine In their opinion, other possible etiological factors included  <STATE OTHER FACTORS> and the patients age/ history or other factors <LIST OTHER RELEVANT  FACTORS> .  The company believes the following facts are also relevant in this case: <LIST OTHER RELEVANT FACTORS HERE> OR  <THERE IS NO KNOWN PLAUSIBLE MECHANISM BY WHICH THE DRUG WOULD CAUSE THE PRIMARY EVENT>.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .   Terse Narrative (for narratives and signal review) Brief 3 line summary of above for Agency listing: Report Source- Other,  Age- 71 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome-  .
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: horrible headache kept getting worse; fever; vomiting every hour; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEADACHE (horrible headache kept getting worse), VOMITING (vomiting every hour) and PYREXIA (fever) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (horrible headache kept getting worse) and PYREXIA (fever). On an unknown date, the patient experienced VOMITING (vomiting every hour). At the time of the report, HEADACHE (horrible headache kept getting worse), VOMITING (vomiting every hour) and PYREXIA (fever) outcome was unknown.            No concomitant medication were provided by reporter  No Treatment was included.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chest pain, Dysgeusia, Exploding head syndrome, Heart rate abnormal
Clinical narrative: Woke up with an alarm in my head; Strong metallic taste in my mouth; Off balance; Heart started pounding really hard at normal rate; Chest hurts; This spontaneous case was reported by a patient and describes the occurrence of EXPLODING HEAD SYNDROME (Woke up with an alarm in my head), DYSGEUSIA (Strong metallic taste in my mouth), BALANCE DISORDER (Off balance), HEART RATE ABNORMAL (Heart started pounding really hard at normal rate) and CHEST PAIN (Chest hurts) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced EXPLODING HEAD SYNDROME (Woke up with an alarm in my head), DYSGEUSIA (Strong metallic taste in my mouth), BALANCE DISORDER (Off balance), HEART RATE ABNORMAL (Heart started pounding really hard at normal rate) and CHEST PAIN (Chest hurts). On 02-Feb-2021, EXPLODING HEAD SYNDROME (Woke up with an alarm in my head), DYSGEUSIA (Strong metallic taste in my mouth), BALANCE DISORDER (Off balance), HEART RATE ABNORMAL (Heart started pounding really hard at normal rate) and CHEST PAIN (Chest hurts) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not reported. No treatment information was provided   Reporter did not allow further contact
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Ocular hyperaemia, Pyrexia
Clinical narrative: eye and eyebrow area turned red; fever; chills; headache; body aches; This spontaneous case was reported by a patient and describes the occurrence of OCULAR HYPERAEMIA (eye and eyebrow area turned red), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (body aches) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced OCULAR HYPERAEMIA (eye and eyebrow area turned red), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, OCULAR HYPERAEMIA (eye and eyebrow area turned red), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown. Not Provided          No concomitant medication were provided  No treatment was reported   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Vaccination site discomfort, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: red spot at area of vaccination; itching at injection  site; the area generates discomfort; The area is warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red spot at area of vaccination), VACCINATION SITE PRURITUS (itching at injection  site), VACCINATION SITE DISCOMFORT (the area generates discomfort) and INJECTION SITE WARMTH (The area is warm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On 03-Feb-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red spot at area of vaccination), VACCINATION SITE PRURITUS (itching at injection  site), VACCINATION SITE DISCOMFORT (the area generates discomfort) and INJECTION SITE WARMTH (The area is warm). At the time of the report, VACCINATION SITE ERYTHEMA (red spot at area of vaccination), VACCINATION SITE PRURITUS (itching at injection  site), VACCINATION SITE DISCOMFORT (the area generates discomfort) and INJECTION SITE WARMTH (The area is warm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided/unknown by the reporter
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Injection site urticaria; Injection site is hot; Injection site is itchy; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE URTICARIA (Injection site urticaria), VACCINATION SITE WARMTH (Injection site is hot) and VACCINATION SITE PRURITUS (Injection site is itchy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L30A) for an unknown indication.     No Medical history was provided by reporter.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Injection site urticaria), VACCINATION SITE WARMTH (Injection site is hot) and VACCINATION SITE PRURITUS (Injection site is itchy). At the time of the report, VACCINATION SITE URTICARIA (Injection site urticaria), VACCINATION SITE WARMTH (Injection site is hot) and VACCINATION SITE PRURITUS (Injection site is itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported  No treatment information was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Skin exfoliation, Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: injection site almost exploded with skin peeling; Vaccination site bleeding; Vaccination site bruising; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (injection site almost exploded with skin peeling), VACCINATION SITE HAEMORRHAGE (Vaccination site bleeding) and VACCINATION SITE BRUISING (Vaccination site bruising) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026LJ01) for COVID-19 vaccination.     No medical history was provided by reporter.     On 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Vaccination site bleeding) and VACCINATION SITE BRUISING (Vaccination site bruising). On an unknown date, the patient experienced SKIN EXFOLIATION (injection site almost exploded with skin peeling). At the time of the report, SKIN EXFOLIATION (injection site almost exploded with skin peeling), VACCINATION SITE HAEMORRHAGE (Vaccination site bleeding) and VACCINATION SITE BRUISING (Vaccination site bruising) outcome was unknown. Not Provided          No concomitant medication were provided by reporter  The events were treated with atopical creams and ointments on the injection site.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Chills, Cough, Headache
Clinical narrative: Headache; Muscle pain; FEVER; chills; joint pain; Belly pain; Felt nauseas; Runny nose; Cough; Bruise on injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of INJECTION SITE INJURY (Bruise on injection site), RHINORRHOEA (Runny nose), COUGH (Cough), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.     On 22-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 INJECTION SITE INJURY (Bruise on injection site). On 26-Jan-2021, the patient experienced RHINORRHOEA (Runny nose) and COUGH (Cough). On 27-Jan-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle pain), PYREXIA (FEVER), CHILLS (chills), ARTHRALGIA (joint pain), ABDOMINAL PAIN (Belly pain) and NAUSEA (Felt nauseas). At the time of the report, INJECTION SITE INJURY (Bruise on injection site), RHINORRHOEA (Runny nose), COUGH (Cough), HEADACHE (Headache), MYALGIA (Muscle pain), PYREXIA (FEVER), CHILLS (chills), ARTHRALGIA (joint pain), ABDOMINAL PAIN (Belly pain) and NAUSEA (Felt nauseas) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: process together
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site injury, Myalgia, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: Headache; Muscle pain; FEVER; chills; joint pain; Belly pain; Felt nauseas; Runny nose; Cough; Bruise on injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of INJECTION SITE INJURY (Bruise on injection site), RHINORRHOEA (Runny nose), COUGH (Cough), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.     On 22-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 INJECTION SITE INJURY (Bruise on injection site). On 26-Jan-2021, the patient experienced RHINORRHOEA (Runny nose) and COUGH (Cough). On 27-Jan-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle pain), PYREXIA (FEVER), CHILLS (chills), ARTHRALGIA (joint pain), ABDOMINAL PAIN (Belly pain) and NAUSEA (Felt nauseas). At the time of the report, INJECTION SITE INJURY (Bruise on injection site), RHINORRHOEA (Runny nose), COUGH (Cough), HEADACHE (Headache), MYALGIA (Muscle pain), PYREXIA (FEVER), CHILLS (chills), ARTHRALGIA (joint pain), ABDOMINAL PAIN (Belly pain) and NAUSEA (Felt nauseas) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: process together
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: felt nauseated; Headache; chills; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (felt nauseated), HEADACHE (Headache) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19.     No medical History was provided by reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced NAUSEA (felt nauseated), HEADACHE (Headache) and CHILLS (chills). At the time of the report, NAUSEA (felt nauseated), HEADACHE (Headache) and CHILLS (chills) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I am covered in a rash over my body; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RASH (I am covered in a rash over my body) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), LISINOPRIL, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and MULTIVITAMIN [VITAMINS NOS].    On 03-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 (I am covered in a rash over my body). At the time of the report, RASH (I am covered in a rash over my body) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information for the event was provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20/2A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), LOSARTAN, MELOXICAM and MONTELUKAST for an unknown indication.   On 02-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 03-Feb-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 101 (High) fever- 101.         Treatment was not specified   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19-APR-2021 contain no new information; 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.