chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal discomfort
Clinical narrative: Soreness on the left side from his neck to the base of his skull within 4 hours of the vaccination.; Headache; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Soreness on the left side from his neck to the base of his skull within 4 hours of the vaccination.), HEADACHE (Headache) and FATIGUE (Extreme fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043LZ0A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020, Frontal headache and Fatigue (They both had Covid in October of 2020 had a minor case but a long stretch of frontal headache and fatigue, which were similar symptoms they experienced with the vaccine).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Soreness on the left side from his neck to the base of his skull within 4 hours of the vaccination.), HEADACHE (Headache) and FATIGUE (Extreme fatigue). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Soreness on the left side from his neck to the base of his skull within 4 hours of the vaccination.), HEADACHE (Headache) and FATIGUE (Extreme fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The symptoms lasted for 36-40 hours.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dyspnoea, Influenza like illness, Neck pain
Clinical narrative: neck pain; back pain; difficulty in breathing; flu like symptoms; chills; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), BACK PAIN (back pain), DYSPNOEA (difficulty in breathing), INFLUENZA LIKE ILLNESS (flu like symptoms) and CHILLS (chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified (medical heart condition reported.). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), FISH OIL and PARACETAMOL (TYLENOL) for an unknown indication.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced NECK PAIN (neck pain), BACK PAIN (back pain), DYSPNOEA (difficulty in breathing), INFLUENZA LIKE ILLNESS (flu like symptoms) and CHILLS (chills). At the time of the report, NECK PAIN (neck pain), BACK PAIN (back pain), DYSPNOEA (difficulty in breathing), INFLUENZA LIKE ILLNESS (flu like symptoms) and CHILLS (chills) outcome was unknown. Not Provided          No concomitant medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: 26-apr-2021: updated reporter details; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscle rigidity, Myalgia, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Muscles were rigid; Intense body aches; fever; Severe headache; This spontaneous case was reported by a physician and describes the occurrence of MUSCLE RIGIDITY (Muscles were rigid), MYALGIA (Intense body aches), PYREXIA (fever) and HEADACHE (Severe headache) 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 (No reported medical history).    On 22-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 MUSCLE RIGIDITY (Muscles were rigid), MYALGIA (Intense body aches), PYREXIA (fever) and HEADACHE (Severe headache). At the time of the report, MUSCLE RIGIDITY (Muscles were rigid), MYALGIA (Intense body aches), PYREXIA (fever) and HEADACHE (Severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2020, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.    This case was linked to MOD21-041645 (E2B Linked Report).; Sender's Comments:  MOD21-041645:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (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 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: inconclusive (Inconclusive) Inconclusive.     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.   This case was linked to MOD-2021-031890, MOD-2021-032239, MOD-2021-030077, MOD-2021-032129 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Outcome of the event was updated to recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Arthralgia, Back pain, Pain in extremity
Clinical narrative: Dull pain in right side of stomach; Burning pain in stomach; Lower back pain; Top of legs pain; Hip pain; Knees felt like could burst open with pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Dull pain in right side of stomach), ABDOMINAL DISCOMFORT (Burning pain in stomach), BACK PAIN (Lower back pain), PAIN IN EXTREMITY (Top of legs pain) and ARTHRALGIA (Hip pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia and Arthritis.    On 25-Feb-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Dull pain in right side of stomach), ABDOMINAL DISCOMFORT (Burning pain in stomach), BACK PAIN (Lower back pain), PAIN IN EXTREMITY (Top of legs pain), ARTHRALGIA (Hip pain) and ARTHRALGIA (Knees felt like could burst open with pain). At the time of the report, ABDOMINAL PAIN UPPER (Dull pain in right side of stomach), ABDOMINAL DISCOMFORT (Burning pain in stomach), BACK PAIN (Lower back pain), PAIN IN EXTREMITY (Top of legs pain), ARTHRALGIA (Hip pain) and ARTHRALGIA (Knees felt like could burst open with pain) was resolving.        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.  On 01-Mar-2021, patient's pain got a little better, she was able to sit up and eat.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Muscle tightness
Clinical narrative: Fatigue; Tightness in arm: 1 or 1.5 out of 10 (at the most, 4/10); This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Tightness in arm: 1 or 1.5 out of 10 (at the most, 4/10)) and FATIGUE (Fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AC1A) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis (Patient was possessing a rare disease myasthenia gravis and other complications from myasthenia gravis).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced MUSCLE TIGHTNESS (Tightness in arm: 1 or 1.5 out of 10 (at the most, 4/10)). On an unknown date, the patient experienced FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Feb-2021, MUSCLE TIGHTNESS (Tightness in arm: 1 or 1.5 out of 10 (at the most, 4/10)) had resolved. At the time of the report, FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  After receiving the vaccine patient also experienced fatigue which was same six to eight on ten points scale.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Medical history information, additional event were updated.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in his arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in his arm). At the time of the report, PAIN IN EXTREMITY (Soreness in his arm) 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.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hypersomnia
Clinical narrative: Pretty much sleeping; Chills; Extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Pretty much sleeping), CHILLS (Chills) and FATIGUE (Extremely fatigued) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), GLIPIZIDE, LEVOTHYROXINE SODIUM (SYNTHROID) and ATORVASTATIN for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (Pretty much sleeping), CHILLS (Chills) and FATIGUE (Extremely fatigued). At the time of the report, HYPERSOMNIA (Pretty much sleeping), CHILLS (Chills) and FATIGUE (Extremely fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchiness; Rash that was two inches from the injection site, but is spreading; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE RASH (Rash that was two inches from the injection site, but is spreading) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE RASH (Rash that was two inches from the injection site, but is spreading) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE RASH (Rash that was two inches from the injection site, but is spreading) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain in extremity
Clinical narrative: Stomach cramps in her stomach; Usual sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramps in her stomach) and PAIN IN EXTREMITY (Usual sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps in her stomach) and PAIN IN EXTREMITY (Usual sore arm). At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramps in her stomach) and PAIN IN EXTREMITY (Usual sore arm) 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.   This case was linked to MOD-2021-032103 (Linked Report).; Sender's Comments:  MOD-2021-032103:MOD21-042287- cross linked case
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Itchy red; Arm broke out; Itchy red; Swelling hurts; Swelling hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy red), VACCINATION SITE RASH (Arm broke out), VACCINATION SITE ERYTHEMA (Itchy red), VACCINATION SITE SWELLING (Swelling hurts) and VACCINATION SITE PAIN (Swelling hurts) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy red), VACCINATION SITE RASH (Arm broke out), VACCINATION SITE ERYTHEMA (Itchy red), VACCINATION SITE SWELLING (Swelling hurts) and VACCINATION SITE PAIN (Swelling hurts). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) on 01-Mar-2021 at a dose of One pill. At the time of the report, VACCINATION SITE PRURITUS (Itchy red), VACCINATION SITE RASH (Arm broke out), VACCINATION SITE ERYTHEMA (Itchy red), VACCINATION SITE SWELLING (Swelling hurts) and VACCINATION SITE PAIN (Swelling hurts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Patient was taken to urgent care two days later, on 27-Feb-2021 and was prescribed an antibiotic, Keflex and has not seen a change in her condition.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 67-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 HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) 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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of DECREASED APPETITE (no appetite), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (injection site really sore), PYREXIA (Fever) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Muscle relaxant. On 10-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 DECREASED APPETITE (no appetite), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (injection site really sore), PYREXIA (Fever) and NAUSEA (Nausea). The patient was treated with LOVASTATIN (LOVAREM) at an unspecified dose and frequency and HYDROGEN PEROXIDE (PEROXIDE) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (no appetite), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (injection site really sore), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 99.3 (Inconclusive) 99.3 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DECREASED APPETITE (no appetite) to be possibly related. No further causality assessments were provided for VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (injection site really sore), PYREXIA (Fever) and NAUSEA (Nausea).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of DECREASED APPETITE (no appetite), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (injection site really sore), PYREXIA (Fever) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Muscle relaxant. On 10-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 DECREASED APPETITE (no appetite), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (injection site really sore), PYREXIA (Fever) and NAUSEA (Nausea). The patient was treated with LOVASTATIN (LOVAREM) at an unspecified dose and frequency and HYDROGEN PEROXIDE (PEROXIDE) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (no appetite), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (injection site really sore), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 99.3 (Inconclusive) 99.3 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DECREASED APPETITE (no appetite) to be possibly related. No further causality assessments were provided for VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (injection site really sore), PYREXIA (Fever) and NAUSEA (Nausea).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Vaccination site swelling
Clinical narrative: Tightness in calves; Swelling in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Tightness in calves) and VACCINATION SITE SWELLING (Swelling in injection arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031220A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), METFORMIN, TRAMADOL, CEFIXIME (FLEXERIL [CEFIXIME]), METOPROLOL, CLOPIDOGREL and SERTRALINE 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 13-Feb-2021, the patient experienced MUSCLE TIGHTNESS (Tightness in calves) and VACCINATION SITE SWELLING (Swelling in injection arm). At the time of the report, MUSCLE TIGHTNESS (Tightness in calves) and VACCINATION SITE SWELLING (Swelling in injection arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Patient said she was feeling better.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Outcome of the events were updated as resolved.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Test COVID positive; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Test COVID positive) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes mellitus (Diabetes type 2 reported.).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Test COVID positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Test COVID positive) had not 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 were provided. No treatments were reported   This case was linked to MOD21-042702 (E2B Linked Report).; Sender's Comments:  MOD21-042702:Crosslinked MOD-2021-032080
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Still tired the next day; Photophobia; Felt as if she had the COVID-19 virus all over again; Nausea; Muscle ache; Headaches, sore head; Fever of 100.4 then 101.4; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of PHOTOPHOBIA (photophobia), SUSPECTED COVID-19 (Felt as if she had the COVID-19 virus all over again), NAUSEA (Nausea), MYALGIA (Muscle ache) and HEADACHE (Headaches, sore head) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 11-Jan-2021 to 26-Jan-2021 and Cardiac ablation (ablation in 2016) in 2016. Concurrent medical conditions included Thyroid disorder (Past Medical History includes thyroid since 1993 or 1994) and Atrial fibrillation since 2015. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PHOTOPHOBIA (photophobia), SUSPECTED COVID-19 (Felt as if she had the COVID-19 virus all over again), NAUSEA (Nausea), MYALGIA (Muscle ache), HEADACHE (Headaches, sore head), PYREXIA (Fever of 100.4 then 101.4) and FATIGUE (Fatigue). On 25-Feb-2021, the patient experienced FATIGUE (Still tired the next day). On 24-Feb-2021, PHOTOPHOBIA (photophobia), NAUSEA (Nausea), MYALGIA (Muscle ache), HEADACHE (Headaches, sore head) and PYREXIA (Fever of 100.4 then 101.4) had resolved, SUSPECTED COVID-19 (Felt as if she had the COVID-19 virus all over again) outcome was unknown. At the time of the report, FATIGUE (Fatigue) outcome was unknown and FATIGUE (Still tired the next day) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: 103 (Inconclusive) Temperature was 103 degrees Fahrenheit. On 24-Feb-2021, Body temperature: 100.4 (Inconclusive) Fever of 100.4 and 101.4 (Inconclusive) Fever of 101.4.     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 also included thyroid medications.  Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Pyrexia, Suspected COVID-19
Clinical narrative: Still tired the next day; Photophobia; Felt as if she had the COVID-19 virus all over again; Nausea; Muscle ache; Headaches, sore head; Fever of 100.4 then 101.4; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of PHOTOPHOBIA (photophobia), SUSPECTED COVID-19 (Felt as if she had the COVID-19 virus all over again), NAUSEA (Nausea), MYALGIA (Muscle ache) and HEADACHE (Headaches, sore head) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 11-Jan-2021 to 26-Jan-2021 and Cardiac ablation (ablation in 2016) in 2016. Concurrent medical conditions included Thyroid disorder (Past Medical History includes thyroid since 1993 or 1994) and Atrial fibrillation since 2015. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PHOTOPHOBIA (photophobia), SUSPECTED COVID-19 (Felt as if she had the COVID-19 virus all over again), NAUSEA (Nausea), MYALGIA (Muscle ache), HEADACHE (Headaches, sore head), PYREXIA (Fever of 100.4 then 101.4) and FATIGUE (Fatigue). On 25-Feb-2021, the patient experienced FATIGUE (Still tired the next day). On 24-Feb-2021, PHOTOPHOBIA (photophobia), NAUSEA (Nausea), MYALGIA (Muscle ache), HEADACHE (Headaches, sore head) and PYREXIA (Fever of 100.4 then 101.4) had resolved, SUSPECTED COVID-19 (Felt as if she had the COVID-19 virus all over again) outcome was unknown. At the time of the report, FATIGUE (Fatigue) outcome was unknown and FATIGUE (Still tired the next day) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: 103 (Inconclusive) Temperature was 103 degrees Fahrenheit. On 24-Feb-2021, Body temperature: 100.4 (Inconclusive) Fever of 100.4 and 101.4 (Inconclusive) Fever of 101.4.     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 also included thyroid medications.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: got the first dose of moderna after being a part of manufacturer trial; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (got the first dose of moderna after being a part of manufacturer) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (got the first dose of moderna after being a part of manufacturer trial). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (got the first dose of moderna) 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.   Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: follow up was received on 08-JUN-2021 contains updated information about patient Demographics and dose information; Sender's Comments: This report refers to a case of Interchange of vaccine productsfor m RNA-1273, lot # unknown with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Knot near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Knot near the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE REACTION (Knot near the injection site). At the time of the report, VACCINATION SITE REACTION (Knot near the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment drug included  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up received TCR document and contain no new information.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Felt weak; Skin turned red; Hands turned red; Nausea; Sweating; Flushing; Red ring around injection site; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (Sweating), FLUSHING (Flushing), ASTHENIA (Felt weak), ERYTHEMA (Skin turned red) and ERYTHEMA (Hands turned red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red ring around injection site). On 24-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating), FLUSHING (Flushing) and NAUSEA (Nausea). On an unknown date, the patient experienced ASTHENIA (Felt weak), ERYTHEMA (Skin turned red) and ERYTHEMA (Hands turned red). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating), FLUSHING (Flushing), ASTHENIA (Felt weak), ERYTHEMA (Skin turned red), ERYTHEMA (Hands turned red), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (Red ring around injection site) was resolving.        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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Felt weak; Skin turned red; Hands turned red; Nausea; Sweating; Flushing; Red ring around injection site; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (Sweating), FLUSHING (Flushing), ASTHENIA (Felt weak), ERYTHEMA (Skin turned red) and ERYTHEMA (Hands turned red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red ring around injection site). On 24-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating), FLUSHING (Flushing) and NAUSEA (Nausea). On an unknown date, the patient experienced ASTHENIA (Felt weak), ERYTHEMA (Skin turned red) and ERYTHEMA (Hands turned red). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating), FLUSHING (Flushing), ASTHENIA (Felt weak), ERYTHEMA (Skin turned red), ERYTHEMA (Hands turned red), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (Red ring around injection site) was resolving.        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.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: Hives/ welts/ hives on arms and leg/ hives on left upper arm; Bumps; Itchiness/ itching/ back of right knee seemed itchy/ "The more I itched it, the itchier it got"; Red spots on back of leg and on back of other leg; Burning; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hives/ welts/ hives on arms and leg/ hives on left upper arm), SWELLING (Bumps), PRURITUS (Itchiness/ itching/ back of right knee seemed itchy/ "The more I itched it, the itchier it got"), ERYTHEMA (Red spots on back of leg and on back of other leg) and BURNING SENSATION (Burning) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZ1A) for COVID-19 vaccination.     The patient's past medical history included Shingles in January 2021 and Surgery (Surgery in shoulder) in 2020. Previously administered products included for Shingles: Shingles vaccine in January 2021. Past adverse reactions to the above products included No adverse event with Shingles vaccine. Concurrent medical conditions included Allergy to arthropod bite (Reacting to bug bites severely- usually swell up and get itchy and hives). Concomitant products included CORTISONE and PREDNISOLONE for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced URTICARIA (Hives/ welts/ hives on arms and leg/ hives on left upper arm), SWELLING (Bumps), PRURITUS (Itchiness/ itching/ back of right knee seemed itchy/ "The more I itched it, the itchier it got"), ERYTHEMA (Red spots on back of leg and on back of other leg) and BURNING SENSATION (Burning). The patient was treated with HYDROCORTISONE (topical) for Hives, at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives/ welts/ hives on arms and leg/ hives on left upper arm), SWELLING (Bumps), PRURITUS (Itchiness/ itching/ back of right knee seemed itchy/ "The more I itched it, the itchier it got"), ERYTHEMA (Red spots on back of leg and on back of other leg) and BURNING SENSATION (Burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Medical history includes 30 days prior to vaccine, had shingles. 6 days prior to vaccination, completed cortisone patch.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received on 21-Jul-2021 contains Non significant information AE Contact information Updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Rash
Clinical narrative: Transient nausea; Chills; Debilitating nausea; A rash on back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (A rash on back), NAUSEA (Transient nausea), CHILLS (Chills) and NAUSEA (Debilitating nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced RASH (A rash on back). On 03-Mar-2021, the patient experienced CHILLS (Chills) and NAUSEA (Debilitating nausea). On an unknown date, the patient experienced NAUSEA (Transient nausea). At the time of the report, RASH (A rash on back), NAUSEA (Transient nausea), CHILLS (Chills) and NAUSEA (Debilitating nausea) 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.    This case was linked to MOD-2021-032000, MOD-2021-032170, MOD-2021-032170 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hypoaesthesia
Clinical narrative: Pronounced face flush; Facial numbness; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Pronounced face flush) and HYPOAESTHESIA (Facial numbness) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) 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 FLUSHING (Pronounced face flush) and HYPOAESTHESIA (Facial numbness). On 03-Mar-2021, FLUSHING (Pronounced face flush) and HYPOAESTHESIA (Facial numbness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: flu like symptoms; muslce pain; headache; fever; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (muslce pain), HEADACHE (headache), PYREXIA (fever) and FATIGUE (tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (muslce pain), HEADACHE (headache), PYREXIA (fever) and FATIGUE (tiredness). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (muslce pain), HEADACHE (headache), PYREXIA (fever) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details not provided by the reporter.   This case was linked to MOD-2021-032128 (E2B Linked Report).; Sender's Comments:  MOD-2021-032128:Source: MOD21-042382
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dysarthria, Dyspnoea, Headache
Clinical narrative: Slurring his words; Difficulty breathing; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (Slurring his words), DYSPNOEA (Difficulty breathing) and HEADACHE (Bad headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Blood pressure. Concomitant products included METOPROLOL for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DYSARTHRIA (Slurring his words), DYSPNOEA (Difficulty breathing) and HEADACHE (Bad headache). On 01-Mar-2021, DYSARTHRIA (Slurring his words), DYSPNOEA (Difficulty breathing) and HEADACHE (Bad headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product also included cholesterol medications, blood pressure medication and nebulizer.  Treatment medication included rescue inhaler.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion from refrigerated temperature to frozen temperature) 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 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion from refrigerated temperature to frozen temperature). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion from refrigerated temperature to frozen temperature) outcome was unknown. No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable. The patient would like to know if the patient was vaccinated from a non-viable, or less viable supply. The patient also reported that the side effects from second vaccination were very mild compared to those that from the first dose.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nasopharyngitis, Pain in extremity
Clinical narrative: leg pain; was cold; mild headache; severe thigh pain; shaking; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg pain), NASOPHARYNGITIS (was cold), PAIN IN EXTREMITY (severe thigh pain), CHILLS (shaking) and HEADACHE (mild headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (severe thigh pain) and CHILLS (shaking). On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain), NASOPHARYNGITIS (was cold) and HEADACHE (mild headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (leg pain), NASOPHARYNGITIS (was cold), PAIN IN EXTREMITY (severe thigh pain), CHILLS (shaking) and HEADACHE (mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Vaccination site erythema
Clinical narrative: Redness near injection site; Shingles or insect bites; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles or insect bites) and VACCINATION SITE ERYTHEMA (Redness near injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO historical condition reported.). Concomitant products included ATENOLOL and LORAZEPAM (ATIVAN) 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 01-Mar-2021, the patient experienced HERPES ZOSTER (Shingles or insect bites). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness near injection site). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) ongoing since an unknown date at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles or insect bites) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness near injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up received from 16-JUL-2021,added new event and its outcome.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder a little tight after first dose; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (Shoulder a little tight after first dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Kidney failure (in recovery time), Spinal fusion surgery and Spinal fusion surgery (Cervical spine surgery -dire placement).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Shoulder a little tight after first dose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (Shoulder a little tight after first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-241200 (Patient Link).