chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: Headache; Stiff neck; Fatigue; A spontaneous report was received from a consumer concerning a 72 year old female patient who received Modern's COVID-19 vaccine (mRNA-1273) and felt fatigue, headache and stiff neck.  The patient's medical history was not provided. No relevant concomitant medications were reported.      01 FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 042L20A) intramuscularly for prophylaxis of COVID-19 infection.  On the same day, the patient experienced felt fatigued.  On 02 FEB 2021, the patient felt headache and stiff neck.  No Laboratory details provided.  No treatment information 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  fatigue, headache and stiff neck is Unknown.  Based on MSA comment, fatigue and headache  (Listed in CCDS), stiff neck (Unlisted in CCDS)
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: soreness and pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness and pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history). Concomitant products included LEVOCETIRIZINE for Allergy.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN (soreness and pain). At the time of the report, PAIN (soreness and pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included timoprazole 40 mg for her stomach.  =Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-004666 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: fever keeps on getting higher; itching; hot; red; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever keeps on getting higher), VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (hot) and VACCINATION SITE ERYTHEMA (red) 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 16-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 PYREXIA (fever keeps on getting higher), VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (hot) and VACCINATION SITE ERYTHEMA (red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and CORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PYREXIA (fever keeps on getting higher), VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (hot) and VACCINATION SITE ERYTHEMA (red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.    Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No new information
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: Felt dizzy; Throw up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt dizzy) and VOMITING (Throw up) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DIZZINESS (Felt dizzy) and VOMITING (Throw up). At the time of the report, DIZZINESS (Felt dizzy) and VOMITING (Throw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 08-Jun-2021, the patient reported, she was doing fine and did not need anything anymore.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received on 16-Apr-2021 did not contain any new information. On 08-Jun-2021: Outcome of events updated.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Arthralgias; Fever (Unknown T -max); This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRALGIA (Arthralgias) and PYREXIA (Fever (Unknown T -max)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced ARTHRALGIA (Arthralgias) and PYREXIA (Fever (Unknown T -max)). On 22-Jan-2021, ARTHRALGIA (Arthralgias) and PYREXIA (Fever (Unknown T -max)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications and treatment details were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: This follow-up was received by safety on 19-APR-2021 which reported the dose 1 & 2 details (date of administration, route of administration and anatomical location of vaccine administration).
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache, Heart rate, Heart rate increased
Clinical narrative: Heart started beating very rapidly; Raised blood pressure; Sore arm; Head started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart started beating very rapidly), BLOOD PRESSURE INCREASED (Raised blood pressure), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Head started to hurt) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced HEART RATE INCREASED (Heart started beating very rapidly), BLOOD PRESSURE INCREASED (Raised blood pressure), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Head started to hurt). On 23-Jan-2021, HEART RATE INCREASED (Heart started beating very rapidly), BLOOD PRESSURE INCREASED (Raised blood pressure) and HEADACHE (Head started to hurt) had resolved. On 25-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: After vaccine:136/104  Her normal BP:124/72. On an unknown date, Heart rate: 130 130 BPM.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were mentioned.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Heart started beating very rapidly; Raised blood pressure; Sore arm; Head started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart started beating very rapidly), BLOOD PRESSURE INCREASED (Raised blood pressure), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Head started to hurt) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced HEART RATE INCREASED (Heart started beating very rapidly), BLOOD PRESSURE INCREASED (Raised blood pressure), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Head started to hurt). On 23-Jan-2021, HEART RATE INCREASED (Heart started beating very rapidly), BLOOD PRESSURE INCREASED (Raised blood pressure) and HEADACHE (Head started to hurt) had resolved. On 25-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: After vaccine:136/104  Her normal BP:124/72. On an unknown date, Heart rate: 130 130 BPM.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were mentioned.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: injection site reaction/ itchy and red round area on arm at injection site; vaccination site hardness with small bumps; Very itchy/ itch and red round area on arm at injection site; red circle/ red round area on arm at injection site; This spontaneous case was reported by a medical assistant (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (injection site reaction/ itchy and red round area on arm at injection site), VACCINATION SITE INDURATION (vaccination site hardness with small bumps), VACCINATION SITE PRURITUS (Very itchy/ itch and red round area on arm at injection site) and INJECTION SITE ERYTHEMA (red circle/ red round area on arm at injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included CLONAZEPAM for Anxiety, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 07-Jan-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE REACTION (injection site reaction/ itchy and red round area on arm at injection site), VACCINATION SITE INDURATION (vaccination site hardness with small bumps) and VACCINATION SITE PRURITUS (Very itchy/ itch and red round area on arm at injection site). 21-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red circle/ red round area on arm at injection site). The patient was treated with KETOTIFEN FUMARATE (ZYRTEC ITCHY) ongoing since an unknown date at an unspecified dose and frequency. On 26-Jan-2021, VACCINATION SITE REACTION (injection site reaction/ itchy and red round area on arm at injection site), VACCINATION SITE INDURATION (vaccination site hardness with small bumps), VACCINATION SITE PRURITUS (Very itchy/ itch and red round area on arm at injection site) and INJECTION SITE ERYTHEMA (red circle/ red round area on arm at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 15JAN2021 the patient called her HCP who prescribed cephalexin, but the patient did not believe it was bacterial so she did not take.  Treatment also included ice.   This case was linked to US-MODERNATX, INC.-MOD-2021-102067 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up contains updates to: patient demographics, event and event outcome, and treatment chronology; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-102067:second dose
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Pyrexia
Clinical narrative: Fever over 102°F; Chills; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever over 102°F) and CHILLS (Chills) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia. Concurrent medical conditions included Asthma and Lyme disease.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PYREXIA (Fever over 102°F) and CHILLS (Chills). At the time of the report, PYREXIA (Fever over 102°F) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 102 (High) 102 degree Fahrenheit. On 26-Jan-2021, COVID-19: positive (Positive) POSITIVE.     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 case was linked to US-MODERNATX, INC.-MOD-2021-014845 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-014845:Same reporter (female Patient's case)
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site erythema, Vaccination site nodule
Clinical narrative: a knot formed at the injection site.; did not sleep and it's not hard for me to fall asleep; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (a knot formed at the injection site.), INSOMNIA (did not sleep and it's not hard for me to fall asleep) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE NODULE (a knot formed at the injection site.), INSOMNIA (did not sleep and it's not hard for me to fall asleep) and VACCINATION SITE ERYTHEMA (redness at the injection site). At the time of the report, VACCINATION SITE NODULE (a knot formed at the injection site.), INSOMNIA (did not sleep and it's not hard for me to fall asleep) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided  No treatment product information was provided
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood lactic acid, Dizziness, Heart rate, Heart rate increased
Clinical narrative: elevated resting heart rate of 150 beats per minute; shaking/trembling; Dizziness; Large round red spot at the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (elevated resting heart rate of 150 beats per minute), TREMOR (shaking/trembling), DIZZINESS (Dizziness) and VACCINATION SITE ERYTHEMA (Large round red spot at the injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Acid reflux (oesophageal) and Sinus infection. Concomitant products included CETIRIZINE and VITAMINS NOS for an unknown indication.    On 09-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 VACCINATION SITE ERYTHEMA (Large round red spot at the injection site). On 23-Jan-2021, the patient experienced HEART RATE INCREASED (elevated resting heart rate of 150 beats per minute), TREMOR (shaking/trembling) and DIZZINESS (Dizziness). At the time of the report, HEART RATE INCREASED (elevated resting heart rate of 150 beats per minute), TREMOR (shaking/trembling) and DIZZINESS (Dizziness) outcome was unknown and VACCINATION SITE ERYTHEMA (Large round red spot at the injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Blood glucose: normal (normal) Normal. On 23-Jan-2021, Blood lactic acid: normal (normal) Normal. On 23-Jan-2021, Heart rate: high (High) 150 beats per minute. On 23-Jan-2021, Pregnancy: negative (Negative) Negative. On 23-Jan-2021, White blood cell count: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 23 Jan 2021, patient was treated with prednisone and Pepcid. On 26Jan 2021, the injection site was looking like ringworm - lighter in the middle, darker on the outside but huge.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2021: NNI
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy, Tremor, Vaccination site erythema, White blood cell count
Clinical narrative: elevated resting heart rate of 150 beats per minute; shaking/trembling; Dizziness; Large round red spot at the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (elevated resting heart rate of 150 beats per minute), TREMOR (shaking/trembling), DIZZINESS (Dizziness) and VACCINATION SITE ERYTHEMA (Large round red spot at the injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Acid reflux (oesophageal) and Sinus infection. Concomitant products included CETIRIZINE and VITAMINS NOS for an unknown indication.    On 09-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 VACCINATION SITE ERYTHEMA (Large round red spot at the injection site). On 23-Jan-2021, the patient experienced HEART RATE INCREASED (elevated resting heart rate of 150 beats per minute), TREMOR (shaking/trembling) and DIZZINESS (Dizziness). At the time of the report, HEART RATE INCREASED (elevated resting heart rate of 150 beats per minute), TREMOR (shaking/trembling) and DIZZINESS (Dizziness) outcome was unknown and VACCINATION SITE ERYTHEMA (Large round red spot at the injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Blood glucose: normal (normal) Normal. On 23-Jan-2021, Blood lactic acid: normal (normal) Normal. On 23-Jan-2021, Heart rate: high (High) 150 beats per minute. On 23-Jan-2021, Pregnancy: negative (Negative) Negative. On 23-Jan-2021, White blood cell count: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 23 Jan 2021, patient was treated with prednisone and Pepcid. On 26Jan 2021, the injection site was looking like ringworm - lighter in the middle, darker on the outside but huge.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2021: NNI
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness on his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on his arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007n28) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness on his arm). At the time of the report, PAIN IN EXTREMITY (soreness on his arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: MA Data correction; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excludes.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore on injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore on injection site arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029k20a) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore on injection site arm). At the time of the report, VACCINATION SITE PAIN (sore on injection site arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swelling around the injection site; Redness 3 inches in diameter around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness 3 inches in diameter around the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness 3 inches in diameter around the injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness 3 inches in diameter around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided by reporter. Treatment details were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Disorientation, Fatigue, Headache, Vaccination site pain
Clinical narrative: cough moving to the lungs which comes and goes; Disorienting; Very tired (in bed all the time); Feels like a basketball hit in the forehead; Soreness for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough moving to the lungs which comes and goes), DISORIENTATION (Disorienting), FATIGUE (Very tired (in bed all the time)), HEADACHE (Feels like a basketball hit in the forehead) and VACCINATION SITE PAIN (Soreness for 3 days) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sinus infection (Chronic).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness for 3 days). On 24-Jan-2021, the patient experienced COUGH (cough moving to the lungs which comes and goes), DISORIENTATION (Disorienting), FATIGUE (Very tired (in bed all the time)) and HEADACHE (Feels like a basketball hit in the forehead). On 21-Jan-2021, VACCINATION SITE PAIN (Soreness for 3 days) had resolved. At the time of the report, COUGH (cough moving to the lungs which comes and goes), DISORIENTATION (Disorienting), FATIGUE (Very tired (in bed all the time)) and HEADACHE (Feels like a basketball hit in the forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included acetaminophen.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: upset stomach; worst diarrhea of his life, pouring liquids; Felt like crap; headaches; fatigue; Muscle pain; Felt achy,arm was sore for a couple of days; very nauseous; flu-like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (worst diarrhea of his life, pouring liquids), FEELING ABNORMAL (Felt like crap) and NAUSEA (very nauseous) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 29L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) and NAUSEA (very nauseous). On 20-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (worst diarrhea of his life, pouring liquids), FEELING ABNORMAL (Felt like crap), HEADACHE (headaches), FATIGUE (fatigue), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Felt achy,arm was sore for a couple of days). On 20-Jan-2021, NAUSEA (very nauseous) had resolved. On 21-Jan-2021, ABDOMINAL DISCOMFORT (upset stomach) and DIARRHOEA (worst diarrhea of his life, pouring liquids) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (Felt like crap), HEADACHE (headaches), FATIGUE (fatigue), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Felt achy,arm was sore for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Nausea, Vaccination site pain
Clinical narrative: upset stomach; worst diarrhea of his life, pouring liquids; Felt like crap; headaches; fatigue; Muscle pain; Felt achy,arm was sore for a couple of days; very nauseous; flu-like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (worst diarrhea of his life, pouring liquids), FEELING ABNORMAL (Felt like crap) and NAUSEA (very nauseous) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 29L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) and NAUSEA (very nauseous). On 20-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (worst diarrhea of his life, pouring liquids), FEELING ABNORMAL (Felt like crap), HEADACHE (headaches), FATIGUE (fatigue), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Felt achy,arm was sore for a couple of days). On 20-Jan-2021, NAUSEA (very nauseous) had resolved. On 21-Jan-2021, ABDOMINAL DISCOMFORT (upset stomach) and DIARRHOEA (worst diarrhea of his life, pouring liquids) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (Felt like crap), HEADACHE (headaches), FATIGUE (fatigue), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Felt achy,arm was sore for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.    Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: pain in the joints; Severe headache; Chills; Fever of 39°C that did not drop down after taking several Tylenol; This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRALGIA (pain in the joints), HEADACHE (Severe headache), CHILLS (Chills) and PYREXIA (Fever of 39°C that did not drop down after taking several Tylenol) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No reported medical history was provided.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced ARTHRALGIA (pain in the joints), HEADACHE (Severe headache), CHILLS (Chills) and PYREXIA (Fever of 39°C that did not drop down after taking several Tylenol). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 2 dosage form. At the time of the report, ARTHRALGIA (pain in the joints), HEADACHE (Severe headache), CHILLS (Chills) and PYREXIA (Fever of 39°C that did not drop down after taking several Tylenol) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: (Positive) Test done after first dose of Moderna vaccination..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Translated Document received on 10-JUN-2021 and does not have any new information On 01-Jun-2021: Email
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Heart rate, Myalgia
Clinical narrative: Tingling on her mouth; Body ache; Fatigue; Chills; Throat and mouth felt weird; Shaky; Brain fog; Throat and mouth felt weird; Rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Throat and mouth felt weird), NERVOUSNESS (Shaky), FEELING ABNORMAL (Brain fog), ORAL DISCOMFORT (Throat and mouth felt weird) and TACHYCARDIA (Rapid heart beat) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Graves' disease, Vitamin D deficiency and Latex allergy. Concomitant products included THIAMAZOLE (TAPAZOLE), VITAMIN D3 and LORATADINE (CLARITINE) for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat and mouth felt weird), NERVOUSNESS (Shaky), FEELING ABNORMAL (Brain fog), ORAL DISCOMFORT (Throat and mouth felt weird), TACHYCARDIA (Rapid heart beat), MYALGIA (Body ache), FATIGUE (Fatigue) and CHILLS (Chills). On 31-Dec-2020, the patient experienced PARAESTHESIA ORAL (Tingling on her mouth). On 31-Dec-2020, OROPHARYNGEAL DISCOMFORT (Throat and mouth felt weird), NERVOUSNESS (Shaky), FEELING ABNORMAL (Brain fog), ORAL DISCOMFORT (Throat and mouth felt weird) and TACHYCARDIA (Rapid heart beat) had resolved. In January 2021, MYALGIA (Body ache), FATIGUE (Fatigue) and CHILLS (Chills) had resolved. At the time of the report, PARAESTHESIA ORAL (Tingling on her mouth) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, Heart rate: (High) 150 beats per minute.     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.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up added on 27-APR-2021, medical history provided, vaccine date updated, second dose details added, new events added
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Oral discomfort, Oropharyngeal discomfort, Paraesthesia oral, Tachycardia
Clinical narrative: Tingling on her mouth; Body ache; Fatigue; Chills; Throat and mouth felt weird; Shaky; Brain fog; Throat and mouth felt weird; Rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Throat and mouth felt weird), NERVOUSNESS (Shaky), FEELING ABNORMAL (Brain fog), ORAL DISCOMFORT (Throat and mouth felt weird) and TACHYCARDIA (Rapid heart beat) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Graves' disease, Vitamin D deficiency and Latex allergy. Concomitant products included THIAMAZOLE (TAPAZOLE), VITAMIN D3 and LORATADINE (CLARITINE) for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat and mouth felt weird), NERVOUSNESS (Shaky), FEELING ABNORMAL (Brain fog), ORAL DISCOMFORT (Throat and mouth felt weird), TACHYCARDIA (Rapid heart beat), MYALGIA (Body ache), FATIGUE (Fatigue) and CHILLS (Chills). On 31-Dec-2020, the patient experienced PARAESTHESIA ORAL (Tingling on her mouth). On 31-Dec-2020, OROPHARYNGEAL DISCOMFORT (Throat and mouth felt weird), NERVOUSNESS (Shaky), FEELING ABNORMAL (Brain fog), ORAL DISCOMFORT (Throat and mouth felt weird) and TACHYCARDIA (Rapid heart beat) had resolved. In January 2021, MYALGIA (Body ache), FATIGUE (Fatigue) and CHILLS (Chills) had resolved. At the time of the report, PARAESTHESIA ORAL (Tingling on her mouth) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, Heart rate: (High) 150 beats per minute.     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.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up added on 27-APR-2021, medical history provided, vaccine date updated, second dose details added, new events added
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy/ light headed; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizzy/ light headed) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (Dizzy/ light headed). At the time of the report, DIZZINESS (Dizzy/ light headed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medications included unspecified diabetes and high blood pressure medications.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral coldness, Pruritus
Clinical narrative: feet felt cold; I have little shooting pains in both feet and hands; generalized, mild, intermittent itching; feet feld cold and tingly; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of PRURITUS (generalized, mild, intermittent itching), PERIPHERAL COLDNESS (feet felt cold), PARAESTHESIA (feet felt cold and tingly) and PAIN IN EXTREMITY (I have little shooting pains in both feet and hands) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.  No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced PRURITUS (generalized, mild, intermittent itching). On 09-Jan-2021, the patient experienced PERIPHERAL COLDNESS (feet felt cold), PARAESTHESIA (feet felt cold and tingly) and PAIN IN EXTREMITY (I have little shooting pains in both feet and hands). On 09-Jan-2021, PRURITUS (generalized, mild, intermittent itching) had resolved. At the time of the report, PERIPHERAL COLDNESS (feet felt cold), PARAESTHESIA (feet felt cold and tingly) and PAIN IN EXTREMITY (I have little shooting pains in both feet and hands) 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 reported.  The patient did not receive any treatment.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchiness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchiness) 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 PRURITUS (itchiness). The patient was treated with ACRIVASTINE (BENADRYL ALLERGY RELIEF) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: My arm is red; It is itchy at time; My arm is swollen; My arm is hot; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (My arm is swollen), VACCINATION SITE WARMTH (My arm is hot), VACCINATION SITE ERYTHEMA (My arm is red) and VACCINATION SITE PRURITUS (It is itchy at time) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (My arm is swollen), VACCINATION SITE WARMTH (My arm is hot), VACCINATION SITE ERYTHEMA (My arm is red) and VACCINATION SITE PRURITUS (It is itchy at time). At the time of the report, PERIPHERAL SWELLING (My arm is swollen), VACCINATION SITE WARMTH (My arm is hot), VACCINATION SITE ERYTHEMA (My arm is red) and VACCINATION SITE PRURITUS (It is itchy at time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Feels awful all over; Achy all over; Pain at injection site; Redness at the injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels awful all over), MYALGIA (achy all over), VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and HEADACHE (headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 22-Jan-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced FEELING ABNORMAL (Feels awful all over), MYALGIA (achy all over), VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and HEADACHE (headache). At the time of the report, FEELING ABNORMAL (Feels awful all over), MYALGIA (achy all over), VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and HEADACHE (headache) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported. The patient was treated with ibuprofen.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Arm hurt; Swelling at the injection site; Tenderness at the injection site; nausea; Fever; Tiredness; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Tenderness at the injection site), NAUSEA (nausea) and PYREXIA (Fever) in a 52-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.     The patient's past medical history included No adverse event.    On 16-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 PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Tenderness at the injection site), NAUSEA (nausea), PYREXIA (Fever), FATIGUE (Tiredness) and HEADACHE (Headaches). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Tenderness at the injection site), NAUSEA (nausea), PYREXIA (Fever), FATIGUE (Tiredness) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Products known to have been used by the patient, within two weeks prior to the event were not provided.  No laboratory investigations were provided. The Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm hurt; Swelling at the injection site; Tenderness at the injection site; nausea; Fever; Tiredness; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Tenderness at the injection site), NAUSEA (nausea) and PYREXIA (Fever) in a 52-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.     The patient's past medical history included No adverse event.    On 16-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 PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Tenderness at the injection site), NAUSEA (nausea), PYREXIA (Fever), FATIGUE (Tiredness) and HEADACHE (Headaches). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Tenderness at the injection site), NAUSEA (nausea), PYREXIA (Fever), FATIGUE (Tiredness) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Products known to have been used by the patient, within two weeks prior to the event were not provided.  No laboratory investigations were provided. The Treatment information was not provided.