chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: slowed down; Tested positive; headache; muscle aches; body aches; chills; weakness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches), PAIN (body aches), CHILLS (chills), ASTHENIA (weakness) and FEELING ABNORMAL (slowed down) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced MYALGIA (muscle aches), PAIN (body aches), CHILLS (chills), ASTHENIA (weakness) and HEADACHE (headache). On 17-Feb-2021, the patient experienced FEELING ABNORMAL (slowed down) and COVID-19 (Tested positive). On 17-Feb-2021, MYALGIA (muscle aches), PAIN (body aches), CHILLS (chills), ASTHENIA (weakness) and HEADACHE (headache) had resolved. At the time of the report, FEELING ABNORMAL (slowed down) and COVID-19 (Tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, COVID-19: positive positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: Little tired; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little tired) and HEADACHE (Slight headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Allergy: Vaccines (every 2 weeks which she did not take for 1 month before Moderna vaccine).    On 24-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 FATIGUE (Little tired) and HEADACHE (Slight headache). At the time of the report, FATIGUE (Little tired) and HEADACHE (Slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: negative (Negative) No antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not reported. Treatment information were not provided.   This case was linked to MOD-2021-034236 (E2B Linked Report).; Sender's Comments:  MOD-2021-034236:Same reporter
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling abnormal, Injection site discolouration, Injection site pain
Clinical narrative: skin is discolored; skin is red; rash about 2-3 inches at injection site; itching; burning; arm was slightly sore; didnt feel real good; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm was slightly sore), FEELING ABNORMAL (didnt feel real good), PRURITUS (itching), INJECTION SITE DISCOLOURATION (skin is discolored) and ERYTHEMA (skin is red) in a 66-year-old female 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.     The patient's past medical history included COVID-19 (she had covid back in October and received convalescent plasma. She had antibodies for covid in December.) in October 2020. Concomitant products included VITAMIN C [ASCORBIC ACID], ZINC, VITAMIN D NOS, UBIDECARENONE (COQ10 [UBIDECARENONE]), AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR), METFORMIN, ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN B12 [VITAMIN B12 NOS], VITAMIN B6, FOLIC ACID (FOLATE) and TAGETES SPP. (LUTEIN [TAGETES SPP.]) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was slightly sore), FEELING ABNORMAL (didnt feel real good) and FATIGUE (fatigue). On 20-Feb-2021, the patient experienced PRURITUS (itching), INJECTION SITE RASH (rash about 2-3 inches at injection site) and INJECTION SITE PAIN (burning). On 03-Mar-2021, the patient experienced INJECTION SITE DISCOLOURATION (skin is discolored) and ERYTHEMA (skin is red). On 27-Feb-2021, INJECTION SITE RASH (rash about 2-3 inches at injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was slightly sore), FEELING ABNORMAL (didnt feel real good), PRURITUS (itching), INJECTION SITE DISCOLOURATION (skin is discolored), ERYTHEMA (skin is red), FATIGUE (fatigue) and INJECTION SITE PAIN (burning) 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 treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pain in extremity, Pruritus
Clinical narrative: skin is discolored; skin is red; rash about 2-3 inches at injection site; itching; burning; arm was slightly sore; didnt feel real good; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm was slightly sore), FEELING ABNORMAL (didnt feel real good), PRURITUS (itching), INJECTION SITE DISCOLOURATION (skin is discolored) and ERYTHEMA (skin is red) in a 66-year-old female 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.     The patient's past medical history included COVID-19 (she had covid back in October and received convalescent plasma. She had antibodies for covid in December.) in October 2020. Concomitant products included VITAMIN C [ASCORBIC ACID], ZINC, VITAMIN D NOS, UBIDECARENONE (COQ10 [UBIDECARENONE]), AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR), METFORMIN, ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN B12 [VITAMIN B12 NOS], VITAMIN B6, FOLIC ACID (FOLATE) and TAGETES SPP. (LUTEIN [TAGETES SPP.]) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was slightly sore), FEELING ABNORMAL (didnt feel real good) and FATIGUE (fatigue). On 20-Feb-2021, the patient experienced PRURITUS (itching), INJECTION SITE RASH (rash about 2-3 inches at injection site) and INJECTION SITE PAIN (burning). On 03-Mar-2021, the patient experienced INJECTION SITE DISCOLOURATION (skin is discolored) and ERYTHEMA (skin is red). On 27-Feb-2021, INJECTION SITE RASH (rash about 2-3 inches at injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was slightly sore), FEELING ABNORMAL (didnt feel real good), PRURITUS (itching), INJECTION SITE DISCOLOURATION (skin is discolored), ERYTHEMA (skin is red), FATIGUE (fatigue) and INJECTION SITE PAIN (burning) 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 treatment information was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient has hives that started 1 week after vaccine and has not resolved.  patient has taken allergy antihistamines
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Continued pain after 28 days, no mobility issues
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted shortly after vaccine was administered. Was feeling better after 15 minutes, gave him some water and coke to drink.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chest discomfort, Chest pain, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: pteint complianed of radiating pain around neck area to back and blurry vision-Medium, Systemic: Weakness-Medium
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Vision blurred
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: pteint complianed of radiating pain around neck area to back and blurry vision-Medium, Systemic: Weakness-Medium
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Bradyphrenia, Computerised tomogram head normal, Hypoaesthesia, Hypotonia, Magnetic resonance imaging
Clinical narrative: She went to ER due to one sided numbness/tingling, one arm became flaccid, half of face was numb, and she could not get her thoughts out.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Transient ischaemic attack
Clinical narrative: She went to ER due to one sided numbness/tingling, one arm became flaccid, half of face was numb, and she could not get her thoughts out.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Vision blurred, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: blurry vision (resolved)-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle spasms, Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Diarrhea-Mild, Systemic: cramps-Mild
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Pain in extremity
Clinical narrative: Soreness in arms; Very little reactions; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arms) and ADVERSE REACTION (Very little reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in arms) and ADVERSE REACTION (Very little reactions). At the time of the report, PAIN IN EXTREMITY (Soreness in arms) and ADVERSE REACTION (Very little reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-033403 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant follow up received on 20-JUL-2021. patient demographics were updated.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: 2 days after my first shot, "Covid Arm" developed.  A large spot, about the size of 1 and 1/2 tennis balls developed.  It was red, hard, hot and was extremely itchy.  These side effects lasted for 10 days to 2 weeks.  I treated my arm by using Advil, hydrocortizone and neosporin with ice packs.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Headache, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Additional Details: unresponsive for 1 minute
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Additional Details: unresponsive for 1 minute
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Error: Infection / Cellulitis (diagnosed by MD)-
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dysphagia, Dyspnoea, Fatigue, Lethargy
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Mild, Additional Details: patient expereineced diffuculty breathing, gave epinephrine, breathing got better, patient was very lethargic and confused, border line fainting but still responsive, called ems they arrived and took her to hospital
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Mild, Additional Details: patient expereineced diffuculty breathing, gave epinephrine, breathing got better, patient was very lethargic and confused, border line fainting but still responsive, called ems they arrived and took her to hospital
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Diarrhoea, Dizziness, Hypotension
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Tachycardia-Medium, Additional Details: family called pharmacy and stated reaction from covid vaccine, patient smoked a cigarette one hour after and passed out, pt is alert but informed family to seek medical attention since patient refuses, and does not have medical insurance
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Loss of consciousness, Tachycardia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Tachycardia-Medium, Additional Details: family called pharmacy and stated reaction from covid vaccine, patient smoked a cigarette one hour after and passed out, pt is alert but informed family to seek medical attention since patient refuses, and does not have medical insurance
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Hyperhidrosis
Clinical narrative: Hot flash with intense sweating for about 30 min at 11:00pm Intense right temple headache, sharp stabbing and throbbing for an hour. Went away after taking two Advil
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Very very bad pain in her injection arm and it was hard to move; Pain in the arm of the injection was getting better and then it has gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm of the injection was getting better and then it has gotten worse) and INJECTION SITE PAIN (Very very bad pain in her injection arm and it was hard to move) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 immunisation.  Concomitant products included VITAMINS NOS and CALCIUM for an unknown indication.  On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced INJECTION SITE PAIN (Very very bad pain in her injection arm and it was hard to move). On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm of the injection was getting better and then it has gotten worse). The patient was treated with IBUPROFEN for Adverse event NOS, at an unspecified dose and frequency. On 20-Feb-2021, INJECTION SITE PAIN (Very very bad pain in her injection arm and it was hard to move) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in the arm of the injection was getting better and then it has gotten worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included: cold and hot packs.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Dizziness, Fatigue, Injection site pain
Clinical narrative: Fever 99.5 - 102.7 Nausea Dizziness/Vertigo Tiredness (slept most of the day) slight sore throat  joint pain, especially neck, back and wrists injection site swollen, hot  injection site/arm sore for 3 days
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Nausea, Neck pain, Oropharyngeal pain
Clinical narrative: Fever 99.5 - 102.7 Nausea Dizziness/Vertigo Tiredness (slept most of the day) slight sore throat  joint pain, especially neck, back and wrists injection site swollen, hot  injection site/arm sore for 3 days
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vertigo
Clinical narrative: Fever 99.5 - 102.7 Nausea Dizziness/Vertigo Tiredness (slept most of the day) slight sore throat  joint pain, especially neck, back and wrists injection site swollen, hot  injection site/arm sore for 3 days
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Body temperature, Diarrhoea, Headache
Clinical narrative: Blood pressure was a little up; Diarrhea; Weak; 99.1 F body temperature; Very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure was a little up), DIARRHOEA (Diarrhea), ASTHENIA (Weak), PYREXIA (99.1 F body temperature) and HEADACHE (Very bad headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 106M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included SIMVASTATIN, METFORMIN, LISINOPRIL, OMEPRAZOLE and PIOGLITAZONE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure was a little up), DIARRHOEA (Diarrhea), ASTHENIA (Weak), PYREXIA (99.1 F body temperature) and HEADACHE (Very bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure was a little up), DIARRHOEA (Diarrhea), ASTHENIA (Weak), PYREXIA (99.1 F body temperature) and HEADACHE (Very bad headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 99.1 f (High) Other.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-099195 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Event outcomes updated. Patient stated he was doing fine now
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Blood pressure was a little up; Diarrhea; Weak; 99.1 F body temperature; Very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure was a little up), DIARRHOEA (Diarrhea), ASTHENIA (Weak), PYREXIA (99.1 F body temperature) and HEADACHE (Very bad headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 106M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included SIMVASTATIN, METFORMIN, LISINOPRIL, OMEPRAZOLE and PIOGLITAZONE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure was a little up), DIARRHOEA (Diarrhea), ASTHENIA (Weak), PYREXIA (99.1 F body temperature) and HEADACHE (Very bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure was a little up), DIARRHOEA (Diarrhea), ASTHENIA (Weak), PYREXIA (99.1 F body temperature) and HEADACHE (Very bad headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 99.1 f (High) Other.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-099195 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Event outcomes updated. Patient stated he was doing fine now
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Constipation, Decreased appetite
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of constipation (two days without bowel movements) and decreased appetite (can't eat) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 011A21A) for COVID-19 immunization. Concurrent medical conditions included diabetes. Concomitant products included insulin for an unknown indication. On Feb 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 27, 2021, patient experienced constipation (two days without bowel movements) and decreased appetite (can't eat). At the time of the report, constipation (two days without bowel movements) and decreased appetite (can't eat) outcome: unknown. Diagnostic results: On Feb 27, 2021, blood glucose: elevated (high) other. Treatment information included: Laxative.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Productive cough
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of productive cough (coughing phlegm) and fatigue in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 013M20A) for COVID-19 immunization. No medical history reported. On Feb 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced cough (coughing phlegm) and fatigue. At the time of the report, cough (coughing phlegm) and fatigue outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. No concomitant medications or treatment information reported. This case linked to MOD-2021-034212 (patient link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Muscular weakness, Pain in extremity
Clinical narrative: Leg pains; Legs feels weak; Fatigue; Headache; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pains), MUSCULAR WEAKNESS (Legs feels weak), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Low grade fever). On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Leg pains) and MUSCULAR WEAKNESS (Legs feels weak). At the time of the report, PAIN IN EXTREMITY (Leg pains) had not resolved and MUSCULAR WEAKNESS (Legs feels weak), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Low grade fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received updated patient information, Moderna Vaccine details, concomitant medication details, patient had no problems with first vaccination and event outcome.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Leg pains; Legs feels weak; Fatigue; Headache; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pains), MUSCULAR WEAKNESS (Legs feels weak), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Low grade fever). On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Leg pains) and MUSCULAR WEAKNESS (Legs feels weak). At the time of the report, PAIN IN EXTREMITY (Leg pains) had not resolved and MUSCULAR WEAKNESS (Legs feels weak), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Low grade fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received updated patient information, Moderna Vaccine details, concomitant medication details, patient had no problems with first vaccination and event outcome.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: injection site reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (injection site reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 VACCINATION SITE REACTION (injection site reaction). At the time of the report, VACCINATION SITE REACTION (injection site reaction) 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 medications were provided No Treatment information provided
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse reaction after his first Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction after his first Moderna shot) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction after his first Moderna shot). At the time of the report, VACCINATION COMPLICATION (Adverse reaction after his first Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication provided. No treatment information provided.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antibody test negative, COVID-19, Deep vein thrombosis, Fibrin D dimer increased, Nasal congestion
Clinical narrative: Pain in left calf (August 7) after Janssen vaccine (July 19th). But, also in context of COVID-19 positive rapid test (August 8, 2021) with nasal congestion and family members with COVID-19.  DVT evidence: d-dimer > 4,000. Venous ultrasound left calf confirmed DVT.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Platelet count normal, SARS-CoV-2 test positive, Ultrasound scan abnormal
Clinical narrative: Pain in left calf (August 7) after Janssen vaccine (July 19th). But, also in context of COVID-19 positive rapid test (August 8, 2021) with nasal congestion and family members with COVID-19.  DVT evidence: d-dimer > 4,000. Venous ultrasound left calf confirmed DVT.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Antibody test negative, COVID-19, Deep vein thrombosis, Fibrin D dimer
Clinical narrative: Pain in left calf (August 7) after Janssen vaccine (July 19th). But, also in context of COVID-19 positive rapid test (August 8, 2021) with nasal congestion and family members with COVID-19.  DVT evidence: d-dimer > 4,000. Venous ultrasound left calf confirmed DVT.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer increased, Heparin-induced thrombocytopenia, Nasal congestion, Pain in extremity, Platelet count
Clinical narrative: Pain in left calf (August 7) after Janssen vaccine (July 19th). But, also in context of COVID-19 positive rapid test (August 8, 2021) with nasal congestion and family members with COVID-19.  DVT evidence: d-dimer > 4,000. Venous ultrasound left calf confirmed DVT.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet count normal, SARS-CoV-2 test, SARS-CoV-2 test positive, Therapy non-responder, Ultrasound scan
Clinical narrative: Pain in left calf (August 7) after Janssen vaccine (July 19th). But, also in context of COVID-19 positive rapid test (August 8, 2021) with nasal congestion and family members with COVID-19.  DVT evidence: d-dimer > 4,000. Venous ultrasound left calf confirmed DVT.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan abnormal
Clinical narrative: Pain in left calf (August 7) after Janssen vaccine (July 19th). But, also in context of COVID-19 positive rapid test (August 8, 2021) with nasal congestion and family members with COVID-19.  DVT evidence: d-dimer > 4,000. Venous ultrasound left calf confirmed DVT.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Dizziness, Dyspnoea, Headache
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient  has history of anxiety, and admitted to being anxious before vaccine. Shortly after vaccine pt started to feel chest tightness, headache, tingling/numbness and increased heartrate/bp. I took bp was 165/104. Called and ambulance for pt since sx didnt improve and pt went to  hospital. Per friend, shes feeling better but still has some chest tightness.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient  has history of anxiety, and admitted to being anxious before vaccine. Shortly after vaccine pt started to feel chest tightness, headache, tingling/numbness and increased heartrate/bp. I took bp was 165/104. Called and ambulance for pt since sx didnt improve and pt went to  hospital. Per friend, shes feeling better but still has some chest tightness.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: Sever fatigue, joint pain, headaches for 48 hours
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Tinnitus
Clinical narrative: Ringing in my ears.  Swelling in my legs, feet and ankles.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) and HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (pain) and HEADACHE (headache). At the time of the report, PAIN (pain) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Flushing, Hyperhidrosis, Tremor
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Pain, Pyrexia, Restlessness
Clinical narrative: Pregnant at 8 weeks, 5 days at time of second dose. 10:45am 4/15/21: Received 2nd dose.  7pm 4/15/21: 102 fever, restlessness. 2-3 max doses of Tylenol were taken.  Fever kept at 102  5am 4/16/21: fever broke  4/16/21: Exhaustion, achy lasted for the day 4/17/21: vaginal bleeding for the day 4/18/21: no symptoms 4/19/21: visited obgyn: baby checked, no signs of complications  Evening 4/19/21: vaginal bleeding began again 4/20/21: visited Obgyn: ultrasound, found sub chorionic hematoma
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Subchorionic haematoma, Ultrasound scan, Vaginal haemorrhage
Clinical narrative: Pregnant at 8 weeks, 5 days at time of second dose. 10:45am 4/15/21: Received 2nd dose.  7pm 4/15/21: 102 fever, restlessness. 2-3 max doses of Tylenol were taken.  Fever kept at 102  5am 4/16/21: fever broke  4/16/21: Exhaustion, achy lasted for the day 4/17/21: vaginal bleeding for the day 4/18/21: no symptoms 4/19/21: visited obgyn: baby checked, no signs of complications  Evening 4/19/21: vaginal bleeding began again 4/20/21: visited Obgyn: ultrasound, found sub chorionic hematoma
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fever-Severe, Additional Details: Pt reported severe redness swollen, itchy, warm to touch at injection site. Symptoms started 1 day post injection and have been very severe. Pt is also immunocompromised and on injectable biologics. She will follow-up with her rheumatologist for further management of symptoms
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fever-Severe, Additional Details: Pt reported severe redness swollen, itchy, warm to touch at injection site. Symptoms started 1 day post injection and have been very severe. Pt is also immunocompromised and on injectable biologics. She will follow-up with her rheumatologist for further management of symptoms
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Dyspnoea, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Patient says she was dizzy. Was given some crakers and lots of ventilation. She appeared to be getting better and was given some crakers. After a few mins, she felt she was getting worse and that her throat was tightening. Was then given EPIPEN and felt better after a few mins.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: When I got the vaccine I drove over to the parking lot waiting area. I felt strange but ok. My arm had pain at the injection site with a burning sensation. I had a brief moment of narrowing vision or blurred  about 5 minutes after the injection but it went away. It lasted approximately 1-2 minutes at the most.  I felt just fine after I waited the 15 minutes and I left. I didn't feel the need for medical care. I filled out the V-Safe questionnaires to discuss my other symptoms that started at about 1 am the same day. but it didn't ask about at the time of injection. I reported my fever 101.8, severe chills, severe headache (worst I have ever had), joint pains, muscle and body aches, nausea, injection site pain, fatigue and tiredness, and that I was unable to attend work or do normal activities.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Injection site pain, Loss of personal independence in daily activities, Myalgia, Nausea
Clinical narrative: When I got the vaccine I drove over to the parking lot waiting area. I felt strange but ok. My arm had pain at the injection site with a burning sensation. I had a brief moment of narrowing vision or blurred  about 5 minutes after the injection but it went away. It lasted approximately 1-2 minutes at the most.  I felt just fine after I waited the 15 minutes and I left. I didn't feel the need for medical care. I filled out the V-Safe questionnaires to discuss my other symptoms that started at about 1 am the same day. but it didn't ask about at the time of injection. I reported my fever 101.8, severe chills, severe headache (worst I have ever had), joint pains, muscle and body aches, nausea, injection site pain, fatigue and tiredness, and that I was unable to attend work or do normal activities.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tunnel vision, Vision blurred
Clinical narrative: When I got the vaccine I drove over to the parking lot waiting area. I felt strange but ok. My arm had pain at the injection site with a burning sensation. I had a brief moment of narrowing vision or blurred  about 5 minutes after the injection but it went away. It lasted approximately 1-2 minutes at the most.  I felt just fine after I waited the 15 minutes and I left. I didn't feel the need for medical care. I filled out the V-Safe questionnaires to discuss my other symptoms that started at about 1 am the same day. but it didn't ask about at the time of injection. I reported my fever 101.8, severe chills, severe headache (worst I have ever had), joint pains, muscle and body aches, nausea, injection site pain, fatigue and tiredness, and that I was unable to attend work or do normal activities.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell?s palsy
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Eye swelling, Mouth swelling, Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: patient has redness over entire body including scalp area; also facial swelling and redness along with extreme itching.  Rash, swelling, and itching occured 10 days after receiving vaccination.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: patient has redness over entire body including scalp area; also facial swelling and redness along with extreme itching.  Rash, swelling, and itching occured 10 days after receiving vaccination.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Exhaustion / Lethargy-Severe
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: was given shingles vaccine 3 days after moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (was given shingles vaccine 3 days after moderna vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concomitant products included METFORMIN and GLIMEPIRIDE for Diabetes, LOSARTAN, LINACLOTIDE (LINZESS), OMEPRAZOLE, GABAPENTIN (NEURONTIN), POTASSIUM CHLORIDE, HYDROCHLOROTHIAZIDE and LEVOTHYROXINE for an unknown indication, Diclofenac.    On 28-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 HERPES ZOSTER (was given shingles vaccine 3 days after moderna vaccine). At the time of the report, HERPES ZOSTER (was given shingles vaccine 3 days after moderna vaccine) 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.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Disorientation, Dizziness, Fall, Myalgia
Clinical narrative: became very disoriented; seemed to loose their balance; they felt like they were going to fall; felt light-headed; soreness in their arm; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (became very disoriented), BALANCE DISORDER (seemed to loose their balance), FALL (they felt like they were going to fall), DIZZINESS (felt light-headed) and MYALGIA (soreness in their arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DISORIENTATION (became very disoriented), BALANCE DISORDER (seemed to loose their balance), FALL (they felt like they were going to fall), DIZZINESS (felt light-headed) and MYALGIA (soreness in their arm). At the time of the report, DISORIENTATION (became very disoriented), BALANCE DISORDER (seemed to loose their balance), DIZZINESS (felt light-headed) and MYALGIA (soreness in their arm) 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 included.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Temperature over 100; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Temperature over 100) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy, Drug allergy (morphine, vibramycin, clindamycin(pediatric) , Carafate, amoxicillin), Latex allergy and Penicillin allergy. Concomitant products included LISINOPRIL, VITAMIN D3, ONDANSETRON HCL, NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATE (NAPHCON-A), CARMELLOSE (LUBRICATING PLUS), PEMBROLIZUMAB (KEYTRUDA), LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETRIZINE HYDROCHLORIDE), ALBUTEROL SULFATE, HYDROXYZINE HCL, MIRTAZAPINE (MIRTAZAPINE A), FAMOTIDINE and LEVOTHYROXINE for an unknown indication, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Temperature over 100). At the time of the report, PYREXIA (Temperature over 100) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided.