chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 14 people receive vaccine from an excursion vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT STORAGE ERROR (14 people receive vaccine from an excursion vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (14 people receive vaccine from an excursion vial). At the time of the report, PRODUCT STORAGE ERROR (14 people receive vaccine from an excursion vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-JUL-2021 contains there was no temperature excursion.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lip swelling
Clinical narrative: Swelling of lips; Redness over arm; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swelling of lips) and ERYTHEMA (Redness over arm) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced LIP SWELLING (Swelling of lips) and ERYTHEMA (Redness over arm). At the time of the report, LIP SWELLING (Swelling of lips) and ERYTHEMA (Redness over arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment was provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain (sore to the touch), erythema (noticed it was red) and erythema (got red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 011A21A) for COVID-19 vaccination. No medical history reported. On Mar 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 2, 2021, patient experienced erythema (noticed it was red). On Mar 9, 2021, patient experienced erythema (got red). On Mar 18, 2021, patient experienced pain (sore to the touch). The patient was treated with diphenhydramine hydrochloride), at an unspecified dose and frequency; and antibiotics, at an unspecified dose and frequency. At the time of the report, pain (sore to the touch), erythema (noticed it was red) and erythema (got red) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Blood pressure medicines were taken as concomitant medication.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Minor aches and pains; Headache; Small fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Minor aches and pains), HEADACHE (Headache) and PYREXIA (Small fever) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PYREXIA (Small fever). On an unknown date, the patient experienced PAIN (Minor aches and pains) and HEADACHE (Headache). At the time of the report, PAIN (Minor aches and pains), HEADACHE (Headache) and PYREXIA (Small fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information mentioned.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: lethargy; dry cough; fatigue; chills; slight fever, 99.9; soreness in her left arm; hot, then cold; cant shake symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (soreness in her left arm), FEELING HOT (hot, then cold), FEELING ABNORMAL (cant shake symptoms), LETHARGY (lethargy) and COUGH (dry cough) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in her left arm), FEELING HOT (hot, then cold), FEELING ABNORMAL (cant shake symptoms), COUGH (dry cough), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (slight fever, 99.9). On an unknown date, the patient experienced LETHARGY (lethargy). At the time of the report, PAIN IN EXTREMITY (soreness in her left arm), FEELING HOT (hot, then cold), FEELING ABNORMAL (cant shake symptoms), LETHARGY (lethargy), COUGH (dry cough), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (slight fever, 99.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medicines were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07 May 2021 and updated lab test and patient email id.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: lethargy; dry cough; fatigue; chills; slight fever, 99.9; soreness in her left arm; hot, then cold; cant shake symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (soreness in her left arm), FEELING HOT (hot, then cold), FEELING ABNORMAL (cant shake symptoms), LETHARGY (lethargy) and COUGH (dry cough) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in her left arm), FEELING HOT (hot, then cold), FEELING ABNORMAL (cant shake symptoms), COUGH (dry cough), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (slight fever, 99.9). On an unknown date, the patient experienced LETHARGY (lethargy). At the time of the report, PAIN IN EXTREMITY (soreness in her left arm), FEELING HOT (hot, then cold), FEELING ABNORMAL (cant shake symptoms), LETHARGY (lethargy), COUGH (dry cough), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (slight fever, 99.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medicines were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07 May 2021 and updated lab test and patient email id.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash in left leg/rash on both legs; Turned dark; This spontaneous case was reported by a physician and describes the occurrence of RASH ERYTHEMATOUS (Red rash in left leg/rash on both legs) and RASH (Turned dark) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hyperlipidemia, Chronic kidney disease (CKD 3), Vitamin D deficiency and Thrombocythemia. Concomitant products included DICLOFENAC for Arthritis, SIMVASTATIN for Hyperlipidemia, AMLODIPINE and IRBESARTAN (AVAPRO) for Hypertension, VITAMIN D NOS for Vitamin D deficiency.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash in left leg/rash on both legs) and RASH (Turned dark). The patient was treated with CLOBETASOL PROPIONATE at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red rash in left leg/rash on both legs) and RASH (Turned dark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Medication was high blood pressure medicine as provided by the patient. Treatment information include OTC tropical cream.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up received on 10 May 2021 contain information: Patient  demographic details updated. Medical history was updated, Concomitant products was updated. Event onset date and outcome was updated.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient (gravida 1, para 0) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021 at 4:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in November 2020 and the estimated date of delivery was 26-Aug-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive and have symptoms of COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive and have symptoms of COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history).   On 19-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive and have symptoms of COVID). At the time of the report, COVID-19 (tested positive and have symptoms of COVID) outcome was unknown.      No concomitant medication reported.  No treatment information was provided.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fatigue; Temp 99.7; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue) and PYREXIA (Temp 99.7) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergy to Augmentin.), Hypothyroidism and Borderline diabetes. Concomitant products included THYROID (ARMOUR THYROID), IBUPROFEN (ADVIL [IBUPROFEN]), CETIRIZINE HYDROCHLORIDE (WAL ZYR), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), ZINC, IODINE (IOD [IODINE]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   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 20-Jan-2021, the patient experienced FATIGUE (Fatigue) and PYREXIA (Temp 99.7). On 20-Jan-2021, FATIGUE (Fatigue) and PYREXIA (Temp 99.7) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2020-001271 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: This follow-up will be processed at the same time as the initial. Duration for the symptoms was reported as only lasting one day after dose #2.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Headache, Insomnia
Clinical narrative: Feels weak; Awaken from sleep; Headache/headache on her left side of head; She couldn't breathe; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She couldn't breathe), ASTHENIA (Feels weak), INSOMNIA (Awaken from sleep) and HEADACHE (Headache/headache on her left side of head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001BZ21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sleep apnea. Concomitant products included GABAPENTIN, PARACETAMOL (TYLENOL) and CORTISONE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced DYSPNOEA (She couldn't breathe), INSOMNIA (Awaken from sleep) and HEADACHE (Headache/headache on her left side of head). On 18-Mar-2021, the patient experienced ASTHENIA (Feels weak). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DYSPNOEA (She couldn't breathe), ASTHENIA (Feels weak), INSOMNIA (Awaken from sleep) and HEADACHE (Headache/headache on her left side of head) outcome was unknown.            Patient was advised to lay on her side with a proper pillow under her head when sleeping  and to take rest. Healthcare provider was aware of the Moderna vaccine administration at the time of cortisone injection. Patient is not sure about the lot number as writing was not legible on the card.(might be 20B21A).
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site reaction
Clinical narrative: Same thing happened after the second dose,More redder than the first dose; itching more than 1st dose; reaction is little more than the reaction with 1st shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Same thing happened after the second dose,More redder than the first dose), PRURITUS (itching more than 1st dose) and VACCINATION SITE REACTION (reaction is little more than the reaction with 1st shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Same thing happened after the second dose,More redder than the first dose), PRURITUS (itching more than 1st dose) and VACCINATION SITE REACTION (reaction is little more than the reaction with 1st shot). At the time of the report, ERYTHEMA (Same thing happened after the second dose,More redder than the first dose), PRURITUS (itching more than 1st dose) and VACCINATION SITE REACTION (reaction is little more than the reaction with 1st shot) 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 reported by investigator  No treatment medications provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L204) 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 (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: NNI This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jan-2021 and was forwarded to Moderna on 19-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L204) 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 (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: NNI
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: vaccination site pain; vaccination site swelling; vaccination site erythema; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain), VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (vaccination site erythema) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-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 PAIN (vaccination site pain), VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (vaccination site erythema). At the time of the report, VACCINATION SITE PAIN (vaccination site pain), VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (vaccination site erythema) 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. Treatment information was not provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (As if I could not breath - feels as if her chest is constantly pressed) and CHEST DISCOMFORT (Heavy feeling on the left side of my heart) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (As if I could not breath - feels as if her chest is constantly pressed) and CHEST DISCOMFORT (Heavy feeling on the left side of my heart). At the time of the report, DYSPNOEA (As if I could not breath - feels as if her chest is constantly pressed) and CHEST DISCOMFORT (Heavy feeling on the left side of my heart) 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 product used was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Malaise
Clinical narrative: felt like got run over by a mac truck; upset stomach; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (felt like got run over by a mac truck) and ABDOMINAL DISCOMFORT (upset stomach) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and METHOTREXATE for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe rheumatoid arthritis).   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and METHOTREXATE (unknown route) at an unspecified dose. On an unknown date, the patient experienced MALAISE (felt like got run over by a mac truck) and ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, MALAISE (felt like got run over by a mac truck) had resolved and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown.            Concomitant medication and treatment information were not reported. No treatment information provided.  Action taken with mRNA-1273 in response to the event was Not Applicable
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was slightly sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was slightly sore) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 016M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for Cholesterol, OMEPRAZOLE for GERD.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was slightly sore). At the time of the report, PAIN IN EXTREMITY (arm was slightly sore) outcome was unknown.            No Treatment information provided    This case was linked to MOD-2021-013746 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: was sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (was sick) 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 08-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 ILLNESS (was sick). At the time of the report, ILLNESS (was sick) 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 reported.   Patient received antibiotics from physician for treatment.   This case was linked to MOD-2021-050776 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Influenza like illness
Clinical narrative: Flu-like symptoms; Feels weak; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ASTHENIA (Feels weak) 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 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ASTHENIA (Feels weak). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ASTHENIA (Feels weak) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product used was not provided by the reporter.  Treatment information was not provided by the reporter.  This patient reported she used her walker all the time due to the weakness. She spoke with her physician and her physician was not sure if it is a reaction to the vaccine.   This case was linked to MOD-2021-050765 (Patient Link).   Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L208 and 011M20A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve disease (medical history: microvalave disorder). Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included VITAMINS NOS for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient was using blood pressure pills and cholesterol pills as a concomitant medication for an unknown indications.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-016692, MOD-2021-016692 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue) in a 47-year-old male patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Extreme fatigue). At the time of the report, FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Peripheral swelling, Pyrexia
Clinical narrative: felt like light case of flu; arm swelled; slight temperature 100-ish; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like light case of flu), PERIPHERAL SWELLING (arm swelled) and PYREXIA (slight temperature 100-ish) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (felt like light case of flu), PERIPHERAL SWELLING (arm swelled) and PYREXIA (slight temperature 100-ish). At the time of the report, INFLUENZA LIKE ILLNESS (felt like light case of flu), PERIPHERAL SWELLING (arm swelled) and PYREXIA (slight temperature 100-ish) outcome was unknown.            No concomitant medications reported.  No treatment reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Urinary tract infection
Clinical narrative: Sinus Infection; UTI; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus Infection) and URINARY TRACT INFECTION (UTI) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced SINUSITIS (Sinus Infection) and URINARY TRACT INFECTION (UTI). The patient was treated with CIPROFLOXACIN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SINUSITIS (Sinus Infection) and URINARY TRACT INFECTION (UTI) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: chills; fever; pain at injection; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and VACCINATION SITE PAIN (pain at injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and VACCINATION SITE PAIN (pain at injection). At the time of the report, CHILLS (chills), PYREXIA (fever) and VACCINATION SITE PAIN (pain at injection) outcome was unknown.            No concomitant information was reported.  No treatment information was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Peripheral swelling
Clinical narrative: very large axillary swelling, the size of an orange. 9cm in diameter x 7cm in height; general fatigue; headache; body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (very large axillary swelling, the size of an orange. 9cm in diameter x 7cm in height), FATIGUE (general fatigue), HEADACHE (headache) and MYALGIA (body aches) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 039K20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included CITALOPRAM, DEXLANSOPRAZOLE (DEXILANT), HYDROCHLOROTHIAZIDE, LOSARTAN, METOPROLOL and VITAMIN D3 for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 04-Mar-2021, the patient experienced PERIPHERAL SWELLING (very large axillary swelling, the size of an orange. 9cm in diameter x 7cm in height), FATIGUE (general fatigue), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, PERIPHERAL SWELLING (very large axillary swelling, the size of an orange. 9cm in diameter x 7cm in height) had not resolved and FATIGUE (general fatigue), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown.            Other concomitant medications included OTC supplements. No treatment information was reported.  Action taken with mRNA-1273 in response to the event was not applicable
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea
Clinical narrative: Diarrhea; Fullness of Stomache; Stomachache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomachache) and ABDOMINAL DISTENSION (Fullness of Stomache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache). On 17-Mar-2021, the patient experienced ABDOMINAL DISTENSION (Fullness of Stomache). On 18-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved and ABDOMINAL PAIN UPPER (Stomachache) and ABDOMINAL DISTENSION (Fullness of Stomache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.  No treatment information was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Insomnia, Nausea, Pyrexia, Vomiting
Clinical narrative: flulike symptoms; bad night; nausea; vomiting; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flulike symptoms), INSOMNIA (bad night), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flulike symptoms), INSOMNIA (bad night), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever). On 19-Mar-2021, INFLUENZA LIKE ILLNESS (flulike symptoms), INSOMNIA (bad night), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever) had resolved.            No concomitant and treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lip swelling, Vaccination site pain
Clinical narrative: woke up with swollen lips; his arm was sore at the injection site; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (woke up with swollen lips), VACCINATION SITE PAIN (his arm was sore at the injection site) and HEADACHE (slight headache) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (his arm was sore at the injection site) and HEADACHE (slight headache). On 18-Mar-2021, the patient experienced LIP SWELLING (woke up with swollen lips). At the time of the report, LIP SWELLING (woke up with swollen lips), VACCINATION SITE PAIN (his arm was sore at the injection site) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.  No medical history was provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, COVID-19, Chills, Headache
Clinical narrative: cold; heaviness; pain on the arm of injection (L arm) that spread to the back; pain on the arm of injection (L arm) that spread to the back; chills; fever 101F; headache; body ache; vomiting; joint pain/knee pain; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), LIMB DISCOMFORT (heaviness), BACK PAIN (pain on the arm of injection (L arm) that spread to the back), PAIN IN EXTREMITY (pain on the arm of injection (L arm) that spread to the back) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 04-Dec-2020. Concomitant products included AMLODIPINE, VITAMIN B12 [VITAMIN B12 NOS], MULTIVITAMIN [VITAMINS NOS], FISH OIL (OMEGA 3 [FISH OIL]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), LIMB DISCOMFORT (heaviness), BACK PAIN (pain on the arm of injection (L arm) that spread to the back), PAIN IN EXTREMITY (pain on the arm of injection (L arm) that spread to the back), CHILLS (chills), PYREXIA (fever 101F), HEADACHE (headache), MYALGIA (body ache), VOMITING (vomiting) and ARTHRALGIA (joint pain/knee pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, qid. At the time of the report, NASOPHARYNGITIS (cold), LIMB DISCOMFORT (heaviness), BACK PAIN (pain on the arm of injection (L arm) that spread to the back), PAIN IN EXTREMITY (pain on the arm of injection (L arm) that spread to the back), CHILLS (chills), PYREXIA (fever 101F), HEADACHE (headache), MYALGIA (body ache), VOMITING (vomiting) and ARTHRALGIA (joint pain/knee pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Dec-2020, COVID-19: positive (Positive) COVID-19 with mild symptoms.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had pO2 97 mmHg. Patient reported that she has had all the side effects that are listed on the Fact Sheet she was given except for the ones of severe allergic reaction.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Myalgia, Nasopharyngitis, Pain in extremity, Pyrexia
Clinical narrative: cold; heaviness; pain on the arm of injection (L arm) that spread to the back; pain on the arm of injection (L arm) that spread to the back; chills; fever 101F; headache; body ache; vomiting; joint pain/knee pain; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), LIMB DISCOMFORT (heaviness), BACK PAIN (pain on the arm of injection (L arm) that spread to the back), PAIN IN EXTREMITY (pain on the arm of injection (L arm) that spread to the back) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 04-Dec-2020. Concomitant products included AMLODIPINE, VITAMIN B12 [VITAMIN B12 NOS], MULTIVITAMIN [VITAMINS NOS], FISH OIL (OMEGA 3 [FISH OIL]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), LIMB DISCOMFORT (heaviness), BACK PAIN (pain on the arm of injection (L arm) that spread to the back), PAIN IN EXTREMITY (pain on the arm of injection (L arm) that spread to the back), CHILLS (chills), PYREXIA (fever 101F), HEADACHE (headache), MYALGIA (body ache), VOMITING (vomiting) and ARTHRALGIA (joint pain/knee pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, qid. At the time of the report, NASOPHARYNGITIS (cold), LIMB DISCOMFORT (heaviness), BACK PAIN (pain on the arm of injection (L arm) that spread to the back), PAIN IN EXTREMITY (pain on the arm of injection (L arm) that spread to the back), CHILLS (chills), PYREXIA (fever 101F), HEADACHE (headache), MYALGIA (body ache), VOMITING (vomiting) and ARTHRALGIA (joint pain/knee pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Dec-2020, COVID-19: positive (Positive) COVID-19 with mild symptoms.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had pO2 97 mmHg. Patient reported that she has had all the side effects that are listed on the Fact Sheet she was given except for the ones of severe allergic reaction.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: cold; heaviness; pain on the arm of injection (L arm) that spread to the back; pain on the arm of injection (L arm) that spread to the back; chills; fever 101F; headache; body ache; vomiting; joint pain/knee pain; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), LIMB DISCOMFORT (heaviness), BACK PAIN (pain on the arm of injection (L arm) that spread to the back), PAIN IN EXTREMITY (pain on the arm of injection (L arm) that spread to the back) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 04-Dec-2020. Concomitant products included AMLODIPINE, VITAMIN B12 [VITAMIN B12 NOS], MULTIVITAMIN [VITAMINS NOS], FISH OIL (OMEGA 3 [FISH OIL]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), LIMB DISCOMFORT (heaviness), BACK PAIN (pain on the arm of injection (L arm) that spread to the back), PAIN IN EXTREMITY (pain on the arm of injection (L arm) that spread to the back), CHILLS (chills), PYREXIA (fever 101F), HEADACHE (headache), MYALGIA (body ache), VOMITING (vomiting) and ARTHRALGIA (joint pain/knee pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, qid. At the time of the report, NASOPHARYNGITIS (cold), LIMB DISCOMFORT (heaviness), BACK PAIN (pain on the arm of injection (L arm) that spread to the back), PAIN IN EXTREMITY (pain on the arm of injection (L arm) that spread to the back), CHILLS (chills), PYREXIA (fever 101F), HEADACHE (headache), MYALGIA (body ache), VOMITING (vomiting) and ARTHRALGIA (joint pain/knee pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Dec-2020, COVID-19: positive (Positive) COVID-19 with mild symptoms.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had pO2 97 mmHg. Patient reported that she has had all the side effects that are listed on the Fact Sheet she was given except for the ones of severe allergic reaction.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: the rash and the redness expanded, "like they connected"; rash around injection site; fever; felt sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (felt sore at injection site), VACCINATION SITE RASH (rash around injection site), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (the rash and the redness expanded, "like they connected") in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (felt sore at injection site). On 16-Mar-2021, the patient experienced VACCINATION SITE RASH (rash around injection site) and PYREXIA (fever). On 17-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (the rash and the redness expanded, "like they connected"). At the time of the report, VACCINATION SITE PAIN (felt sore at injection site), VACCINATION SITE RASH (rash around injection site), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (the rash and the redness expanded, "like they connected") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient went to ER and her labs were normal. No concomitant information was reported. No treatment information was reported.    Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Very tired; Light pain everywhere on his body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (Very tired) and MYALGIA (Light pain everywhere on his body) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE (Very tired) and MYALGIA (Light pain everywhere on his body). At the time of the report, FATIGUE (Very tired) and MYALGIA (Light pain everywhere on his body) was resolving.            No concomitant medications were reported.  Treatment information was not provided.