chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on the left arm), MYALGIA (Arm very painful when lifted and stretched,Every part of the body neck down hurts,Felt like a truck hit), VACCINATION SITE ERYTHEMA (Redness on the injection area), VACCINATION SITE PRURITUS (slight Itch on the injection area) and HEADACHE (Bad Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0461A21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History Information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness on the left arm). On 26-Mar-2021, the patient experienced MYALGIA (Arm very painful when lifted and stretched,Every part of the body neck down hurts,Felt like a truck hit), VACCINATION SITE ERYTHEMA (Redness on the injection area), VACCINATION SITE PRURITUS (slight Itch on the injection area), HEADACHE (Bad Headache), FATIGUE (Fatigue), DIZZINESS (Extreme Dizziness) and NAUSEA (Nausea). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. On 27-Mar-2021, MYALGIA (Arm very painful when lifted and stretched,Every part of the body neck down hurts,Felt like a truck hit), VACCINATION SITE ERYTHEMA (Redness on the injection area), VACCINATION SITE PRURITUS (slight Itch on the injection area), HEADACHE (Bad Headache), FATIGUE (Fatigue), DIZZINESS (Extreme Dizziness) and NAUSEA (Nausea) had resolved. On 01-Apr-2021, VACCINATION SITE PAIN (Soreness on the left arm) had resolved. No relevant Concomitant medications were reported. This case was linked to MOD-2021-048670. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-May-2021 and was forwarded to Moderna on 21-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on the left arm), MYALGIA (Arm very painful when lifted and stretched,Every part of the body neck down hurts,Felt like a truck hit), VACCINATION SITE ERYTHEMA (Redness on the injection area), VACCINATION SITE PRURITUS (slight Itch on the injection area) and HEADACHE (Bad Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0461A21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History Information was reported. No relevant Concomitant medications were reported. This case was linked to MOD-2021-048670.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: my knees are sore; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (my knees are sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (my knees are sore). At the time of the report, ARTHRALGIA (my knees are sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitants included. No Treatment included.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore right arm; fever but 1/10 of Dose 2 reactions; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm) and PYREXIA (fever but 1/10 of Dose 2 reactions) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore right arm) and PYREXIA (fever but 1/10 of Dose 2 reactions). On 10-Mar-2021, PAIN IN EXTREMITY (sore right arm) and PYREXIA (fever but 1/10 of Dose 2 reactions) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications provided by the reporter.     This case was linked to MOD-2021-162205 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up document received, contains: Updated patient demographics were updated dose and Updated Second dose information; Updated concomitant medication.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (soreness of arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 046A21A) for COVID-19 vaccination.     Concomitant products included RITUXIMAB (RITUXAN) for MS, DEXTROMETHORPHAN HYDROBROMIDE, QUINIDINE SULFATE (NUEDEXTA [DEXTROMETHORPHAN HYDROBROMIDE;QUINIDINE SULFATE]) for Pseudobulbar affect, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On 23-Mar-2021, the patient experienced MYALGIA (soreness of arm). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MYALGIA (soreness of arm) outcome was unknown.        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.   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: soreness of arm; wasn't performing as well for a week; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (soreness of arm) and MALAISE (wasn't performing as well for a week) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RITUXIMAB (RITUXAN) from 15-Jan-2021 to an unknown date for Multiple sclerosis, VITAMINS NOS (DAILY VITAMINS) for an unknown indication, DEXTROMETHORPHAN HYDROBROMIDE, QUINIDINE SULFATE (NUEDEXTA [DEXTROMETHORPHAN HYDROBROMIDE;QUINIDINE SULFATE]).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness of arm) and MALAISE (wasn't performing as well for a week). At the time of the report, VACCINATION SITE PAIN (soreness of arm) and MALAISE (wasn't performing as well for a week) outcome was unknown.        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.   The patient took Nudexta for Pseudo Bulbar Affect( PBA).   Reporter did not allow further contact
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: Feeling dizzy; both legs are hurting from the hip down not including the feet; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy), PAIN IN EXTREMITY (both legs are hurting from the hip down not including the feet) and HEADACHE (headache) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced DIZZINESS (Feeling dizzy), PAIN IN EXTREMITY (both legs are hurting from the hip down not including the feet) and HEADACHE (headache). At the time of the report, DIZZINESS (Feeling dizzy), PAIN IN EXTREMITY (both legs are hurting from the hip down not including the feet) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter.  No treatment medications were provided by reporter.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Tremor
Clinical narrative: Tremors/ shaking uncontrollably; Cried for 28hours; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremors/ shaking uncontrollably) and CRYING (Cried for 28hours) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced TREMOR (Tremors/ shaking uncontrollably) and CRYING (Cried for 28hours). On 31-Mar-2021, TREMOR (Tremors/ shaking uncontrollably) and CRYING (Cried for 28hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information included Tylenol and drinking plenty of fluid   This case was linked to MOD-2021-162234 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hypothyroidism, Somnolence
Clinical narrative: Tiredness; Thyroid count  Very low; I feel like I'm in a hazy/Lifeless; I find it difficult to wake up in the morning; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHYROIDISM (Thyroid count  Very low) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event, Prostate cancer on 05-Jan-2013 and Heart attack on 05-Jan-2014. Concurrent medical conditions included Barrett's esophagus (Check every 3 months) since 03-Jan-2019. Concomitant products included LISINOPRIL from 01-Jan-2019 to an unknown date for Blood pressure, GABAPENTIN from 01-Jan-2016 to an unknown date for Pain, PANTOPRAZOLE from 01-Jan-2017 to an unknown date for Stomach pain, TESTOSTERONE from 01-Jan-2019 to an unknown date and TADALAFIL (CIALIS) from 01-Jan-2017 to an unknown date for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced FEELING ABNORMAL (I feel like I'm in a hazy/Lifeless) and SOMNOLENCE (I find it difficult to wake up in the morning). On 01-Mar-2021, the patient experienced HYPOTHYROIDISM (Thyroid count  Very low) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, HYPOTHYROIDISM (Thyroid count  Very low), FEELING ABNORMAL (I feel like I'm in a hazy/Lifeless), SOMNOLENCE (I find it difficult to wake up in the morning) and FATIGUE (Tiredness) had not resolved.            No treatment information was provided by the reporter.  Both doses were given in the right, non dominant arm.  Company comment: This case concerns a 73-year-old male with a serious unexpected event of hypothyroidism, and non-serious feeling abnormal, somnolence and fatigue. Event latency within 24 hours after second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received and added patient information, medical history, suspect product first dose Batch/lot number, concomitant medication and new events.; Sender's Comments: This case concerns a 73-year-old male with a serious unexpected event of hypothyroidism, and non-serious feeling abnormal, somnolence and fatigue. Event latency within 24 hours after second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Dyspnoea, Headache, Oropharyngeal pain, Pain in extremity
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of dysgeusia (metallic taste in mouth), oropharyngeal pain (sore throat), dyspnea (slight labored breathing), pain in extremity (pain in the right heel) and headache in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 032B21A) for COVID-19 immunization. No medical history reported. Concomitant products included Lipitor (atorvastatin calcium) for an unknown indication. On Apr 7, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 7, 2021, patient experienced dysgeusia (metallic taste in mouth), oropharyngeal pain (sore throat) and headache. On Apr 17, 2021, patient experienced dyspnea (slight labored breathing). On Apr 30, 2021, patient experienced pain in extremity (pain in the right heel). On Apr 9, 2021, dysgeusia (metallic taste in mouth), oropharyngeal pain (sore throat) and headache resolved. On Apr 28, 2021, dyspnea (slight labored breathing) resolved. At the time of the report, pain in extremity (pain in the right heel) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No treatment information provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Rash, Vaccination site erythema, Vaccination site pain
Clinical narrative: Itchiness; Heat; Redness spread below the injection site; Soreness at the injection site; she developed a rash; She was slightly tender on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), VACCINATION SITE WARMTH (Heat), RASH (she developed a rash), MYALGIA (She was slightly tender on the arm) and VACCINATION SITE ERYTHEMA (Redness spread below the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced MYALGIA (She was slightly tender on the arm). On 07-May-2021, the patient experienced RASH (she developed a rash). On an unknown date, the patient experienced PRURITUS (Itchiness), VACCINATION SITE WARMTH (Heat), VACCINATION SITE ERYTHEMA (Redness spread below the injection site) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, PRURITUS (Itchiness), VACCINATION SITE WARMTH (Heat), VACCINATION SITE ERYTHEMA (Redness spread below the injection site) and VACCINATION SITE PAIN (Soreness at the injection site) had resolved and RASH (she developed a rash) and MYALGIA (She was slightly tender on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported by the reporter. Treatment information was not reported. The patient weight reported as 130 unit was not provided. On 20 Jun 2021 Patient told that she felt almost "back to normal" by the Day 5 had no lingering symptoms.   This case was linked to MOD-2021-093330, MOD-2021-229809 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Additional information was received symptoms Outcome was updated from Unknown to Recovered. On 21-Jun-2021: Follow up received on 21 June 2021: added new events Myalgia and Rash, added vaccine information patient route of administration and batch number added second dose details.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Itchiness; Heat; Redness spread below the injection site; Soreness at the injection site; she developed a rash; She was slightly tender on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), VACCINATION SITE WARMTH (Heat), RASH (she developed a rash), MYALGIA (She was slightly tender on the arm) and VACCINATION SITE ERYTHEMA (Redness spread below the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced MYALGIA (She was slightly tender on the arm). On 07-May-2021, the patient experienced RASH (she developed a rash). On an unknown date, the patient experienced PRURITUS (Itchiness), VACCINATION SITE WARMTH (Heat), VACCINATION SITE ERYTHEMA (Redness spread below the injection site) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, PRURITUS (Itchiness), VACCINATION SITE WARMTH (Heat), VACCINATION SITE ERYTHEMA (Redness spread below the injection site) and VACCINATION SITE PAIN (Soreness at the injection site) had resolved and RASH (she developed a rash) and MYALGIA (She was slightly tender on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported by the reporter. Treatment information was not reported. The patient weight reported as 130 unit was not provided. On 20 Jun 2021 Patient told that she felt almost "back to normal" by the Day 5 had no lingering symptoms.   This case was linked to MOD-2021-093330, MOD-2021-229809 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Additional information was received symptoms Outcome was updated from Unknown to Recovered. On 21-Jun-2021: Follow up received on 21 June 2021: added new events Myalgia and Rash, added vaccine information patient route of administration and batch number added second dose details.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: node swelling; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (node swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 LYMPHADENOPATHY (node swelling). At the time of the report, LYMPHADENOPATHY (node swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
Sex: U
Vaccine: COVID19
Symptoms: Illness, Myalgia, Weight decreased
Clinical narrative: 3 weeks since my second dose and I still feel sick; losing weight; body ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (3 weeks since my second dose and I still feel sick), WEIGHT DECREASED (losing weight) and MYALGIA (body ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (3 weeks since my second dose and I still feel sick), WEIGHT DECREASED (losing weight) and MYALGIA (body ache). At the time of the report, ILLNESS (3 weeks since my second dose and I still feel sick), WEIGHT DECREASED (losing weight) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in joints; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in joints) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO MEDICAL HISTORY 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 ARTHRALGIA (pain in joints). At the time of the report, ARTHRALGIA (pain in joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided by the reporter  No treatment information reported by the reporter
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Ear pain, Influenza like illness, Migraine
Clinical narrative: felt like a soft ball size; migraine; intense ear pain; flu like symptoms; burning up; Sore arm; fever with temperature of 102; body ache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (felt like a soft ball size), MIGRAINE (migraine), EAR PAIN (intense ear pain), INFLUENZA LIKE ILLNESS (flu like symptoms) and BURNING SENSATION (burning up) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced SWELLING (felt like a soft ball size), MIGRAINE (migraine), EAR PAIN (intense ear pain), INFLUENZA LIKE ILLNESS (flu like symptoms), BURNING SENSATION (burning up), PYREXIA (fever with temperature of 102) and MYALGIA (body ache). 20-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, SWELLING (felt like a soft ball size), MIGRAINE (migraine), EAR PAIN (intense ear pain), INFLUENZA LIKE ILLNESS (flu like symptoms), BURNING SENSATION (burning up), PAIN IN EXTREMITY (Sore arm), PYREXIA (fever with temperature of 102) and MYALGIA (body ache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Body temperature: 102 (High) 102 temperature.         Concomitant products include other unspecified medication.  Patient was drinking plenty of fluid.   This case was linked to MOD-2021-162224 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Swelling
Clinical narrative: felt like a soft ball size; migraine; intense ear pain; flu like symptoms; burning up; Sore arm; fever with temperature of 102; body ache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (felt like a soft ball size), MIGRAINE (migraine), EAR PAIN (intense ear pain), INFLUENZA LIKE ILLNESS (flu like symptoms) and BURNING SENSATION (burning up) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced SWELLING (felt like a soft ball size), MIGRAINE (migraine), EAR PAIN (intense ear pain), INFLUENZA LIKE ILLNESS (flu like symptoms), BURNING SENSATION (burning up), PYREXIA (fever with temperature of 102) and MYALGIA (body ache). 20-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, SWELLING (felt like a soft ball size), MIGRAINE (migraine), EAR PAIN (intense ear pain), INFLUENZA LIKE ILLNESS (flu like symptoms), BURNING SENSATION (burning up), PAIN IN EXTREMITY (Sore arm), PYREXIA (fever with temperature of 102) and MYALGIA (body ache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Body temperature: 102 (High) 102 temperature.         Concomitant products include other unspecified medication.  Patient was drinking plenty of fluid.   This case was linked to MOD-2021-162224 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness; Headache; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 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 DIZZINESS (Dizziness) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Covid symptoms since I got my second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Covid symptoms since I got my second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Covid symptoms since I got my second shot). At the time of the report, INFLUENZA (Covid symptoms since I got my second shot) outcome was unknown.            Concomitant medications were not provided.  No treatment information was provided.   Reporter did not allow further contact
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: getting worse [taste and smell]; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (getting worse [taste and smell]) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 017B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Everything he eats tastes like dirt or garbage.  He also had altered smell.) in October 2020.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-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 CONDITION AGGRAVATED (getting worse [taste and smell]). At the time of the report, CONDITION AGGRAVATED (getting worse [taste and smell]) outcome was unknown.            Concomitant medications were not provided.  The patient received  his first dose (lot #017B21A) of Moderna COVID19 Vaccine 05Apr2021 and second dose (lot #036B21A) on 03May2021.  Everything he eats tastes like dirt or garbage, which started 4 or 5 months ago. He also had altered smell. He thinks it has been getting worse in the last few weeks, but he doesn't think it is from the vaccine.  No treatment information was provided.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Might not get 2nd dose between day 25-35 of 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Might not get 2nd dose between day 25-35 of 1st dose) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     no medical history was provided by the reporter.     On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Might not get 2nd dose between day 25-35 of 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Might not get 2nd dose between day 25-35 of 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no Concomitant products were provided. no treatment medications were provided
Sex: U
Vaccine: COVID19
Symptoms: Aphthous ulcer, Blood blister, Lip pain, Oral pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of APHTHOUS ULCER (a sore with cracks in my mouth), ORAL PAIN (patches of sores in mouth), BLOOD BLISTER (looks like a blood blister) and LIP PAIN (Spots in  mouth on .lips has foredb) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced ORAL PAIN (patches of sores in mouth). On an unknown date, the patient experienced APHTHOUS ULCER (a sore with cracks in my mouth), BLOOD BLISTER (looks like a blood blister) and LIP PAIN (Spots in  mouth on .lips has foredb). At the time of the report, APHTHOUS ULCER (a sore with cracks in my mouth), ORAL PAIN (patches of sores in mouth), BLOOD BLISTER (looks like a blood blister) and LIP PAIN (Spots in  mouth on .lips has foredb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: being sick; forgetting to get the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (being sick) and PRODUCT DOSE OMISSION ISSUE (forgetting to get the second dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 ILLNESS (being sick) and PRODUCT DOSE OMISSION ISSUE (forgetting to get the second dose). At the time of the report, ILLNESS (being sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (forgetting to get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  The patient had no adverse reaction and had Pfizer vaccine previously.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received updated significant information in narrative.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: horrible rash on her back and torso, not on her arm, close to her hind legs; Arm turned red and stayed red for 4 days; Arm was painful; Arm was swelled; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm turned red and stayed red for 4 days), PAIN IN EXTREMITY (Arm was painful), PERIPHERAL SWELLING (Arm was swelled) and RASH (horrible rash on her back and torso, not on her arm, close to her hind legs) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 036D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced ERYTHEMA (Arm turned red and stayed red for 4 days). 04-May-2021, the patient experienced PAIN IN EXTREMITY (Arm was painful) and PERIPHERAL SWELLING (Arm was swelled). On an unknown date, the patient experienced RASH (horrible rash on her back and torso, not on her arm, close to her hind legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 07-May-2021, ERYTHEMA (Arm turned red and stayed red for 4 days), PAIN IN EXTREMITY (Arm was painful) and PERIPHERAL SWELLING (Arm was swelled) had resolved. At the time of the report, RASH (horrible rash on her back and torso, not on her arm, close to her hind legs) outcome was unknown.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information also included cream.   This case was linked to MOD-2021-162214 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait inability
Clinical narrative: all of a sudden cannot walk without holding on to someone or using a cane; even then I feel very unstable; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (all of a sudden cannot walk without holding on to someone or using a cane) and FEELING ABNORMAL (even then I feel very unstable) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-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 GAIT INABILITY (all of a sudden cannot walk without holding on to someone or using a cane) and FEELING ABNORMAL (even then I feel very unstable). At the time of the report, GAIT INABILITY (all of a sudden cannot walk without holding on to someone or using a cane) and FEELING ABNORMAL (even then I feel very unstable) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Head ache; Body pain; Little fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Head ache), MYALGIA (Body pain) and PYREXIA (Little fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-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 HEADACHE (Head ache), MYALGIA (Body pain) and PYREXIA (Little fever). At the time of the report, HEADACHE (Head ache), MYALGIA (Body pain) and PYREXIA (Little fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.   Reporter did not allow further contact
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: dry cough, sinus; achy body \  felt muscle soreness like hard cord working out; hard time sleeping; bad headache; chills; fever 103F; fatigue/tired; Patient received the second dose 37 days after the first dose; shakes; little cough/dry cough; heavier breathing; lost 8 lbs; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 37 days after the first dose), TREMOR (shakes), COUGH (little cough/dry cough), DYSPNOEA (heavier breathing) and WEIGHT DECREASED (lost 8 lbs) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, IMMUNOGLOBULIN HUMAN NORMAL (CUVITRU) for Antibody NOS abnormal, COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA) for HIV disease.   On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 37 days after the first dose), TREMOR (shakes), COUGH (little cough/dry cough), DYSPNOEA (heavier breathing), WEIGHT DECREASED (lost 8 lbs), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever 103F) and FATIGUE (fatigue/tired). On 16-May-2021, the patient experienced INSOMNIA (hard time sleeping). On 23-May-2021, the patient experienced SINUSITIS (dry cough, sinus) and MYALGIA (achy body \  felt muscle soreness like hard cord working out). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 1000 mg and IBUPROFEN for Symptomatic treatment, at a dose of 200 mg 3 tablets (600mg). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 37 days after the first dose), TREMOR (shakes), COUGH (little cough/dry cough), DYSPNOEA (heavier breathing), WEIGHT DECREASED (lost 8 lbs), INSOMNIA (hard time sleeping), SINUSITIS (dry cough, sinus), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever 103F), FATIGUE (fatigue/tired) and MYALGIA (achy body \  felt muscle soreness like hard cord working out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Body temperature: 103 (Inconclusive) 103F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was Not Applicable.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Insomnia, Myalgia, Pyrexia
Clinical narrative: dry cough, sinus; achy body \  felt muscle soreness like hard cord working out; hard time sleeping; bad headache; chills; fever 103F; fatigue/tired; Patient received the second dose 37 days after the first dose; shakes; little cough/dry cough; heavier breathing; lost 8 lbs; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 37 days after the first dose), TREMOR (shakes), COUGH (little cough/dry cough), DYSPNOEA (heavier breathing) and WEIGHT DECREASED (lost 8 lbs) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, IMMUNOGLOBULIN HUMAN NORMAL (CUVITRU) for Antibody NOS abnormal, COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA) for HIV disease.   On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 37 days after the first dose), TREMOR (shakes), COUGH (little cough/dry cough), DYSPNOEA (heavier breathing), WEIGHT DECREASED (lost 8 lbs), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever 103F) and FATIGUE (fatigue/tired). On 16-May-2021, the patient experienced INSOMNIA (hard time sleeping). On 23-May-2021, the patient experienced SINUSITIS (dry cough, sinus) and MYALGIA (achy body \  felt muscle soreness like hard cord working out). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 1000 mg and IBUPROFEN for Symptomatic treatment, at a dose of 200 mg 3 tablets (600mg). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 37 days after the first dose), TREMOR (shakes), COUGH (little cough/dry cough), DYSPNOEA (heavier breathing), WEIGHT DECREASED (lost 8 lbs), INSOMNIA (hard time sleeping), SINUSITIS (dry cough, sinus), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever 103F), FATIGUE (fatigue/tired) and MYALGIA (achy body \  felt muscle soreness like hard cord working out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Body temperature: 103 (Inconclusive) 103F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was Not Applicable.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis, Tremor, Weight decreased
Clinical narrative: dry cough, sinus; achy body \  felt muscle soreness like hard cord working out; hard time sleeping; bad headache; chills; fever 103F; fatigue/tired; Patient received the second dose 37 days after the first dose; shakes; little cough/dry cough; heavier breathing; lost 8 lbs; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 37 days after the first dose), TREMOR (shakes), COUGH (little cough/dry cough), DYSPNOEA (heavier breathing) and WEIGHT DECREASED (lost 8 lbs) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, IMMUNOGLOBULIN HUMAN NORMAL (CUVITRU) for Antibody NOS abnormal, COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA) for HIV disease.   On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 37 days after the first dose), TREMOR (shakes), COUGH (little cough/dry cough), DYSPNOEA (heavier breathing), WEIGHT DECREASED (lost 8 lbs), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever 103F) and FATIGUE (fatigue/tired). On 16-May-2021, the patient experienced INSOMNIA (hard time sleeping). On 23-May-2021, the patient experienced SINUSITIS (dry cough, sinus) and MYALGIA (achy body \  felt muscle soreness like hard cord working out). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 1000 mg and IBUPROFEN for Symptomatic treatment, at a dose of 200 mg 3 tablets (600mg). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 37 days after the first dose), TREMOR (shakes), COUGH (little cough/dry cough), DYSPNOEA (heavier breathing), WEIGHT DECREASED (lost 8 lbs), INSOMNIA (hard time sleeping), SINUSITIS (dry cough, sinus), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever 103F), FATIGUE (fatigue/tired) and MYALGIA (achy body \  felt muscle soreness like hard cord working out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Body temperature: 103 (Inconclusive) 103F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was Not Applicable.