chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Decreased appetite, Fatigue, Hypersomnia
Clinical narrative: He could almost sleep 24 hours a day; Does not have any energy; Loss of appetite; Joint pain, right wrist is so painful that he can hardly move it; A lot of fatigue; Had an episode where his arms felt so heavy that he could not move it,his arms felt 3 times the size they are; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (He could almost sleep 24 hours a day), ASTHENIA (Does not have any energy), DECREASED APPETITE (Loss of appetite), LIMB DISCOMFORT (Had an episode where his arms felt so heavy that he could not move it,his arms felt 3 times the size they are) and ARTHRALGIA (Joint pain, right wrist is so painful that he can hardly move it) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL, LISINOPRIL, GLUCOSAMINE and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HYPERSOMNIA (He could almost sleep 24 hours a day), ASTHENIA (Does not have any energy), DECREASED APPETITE (Loss of appetite) and ARTHRALGIA (Joint pain, right wrist is so painful that he can hardly move it). 04-Mar-2021, the patient experienced FATIGUE (A lot of fatigue). In March 2021, the patient experienced LIMB DISCOMFORT (Had an episode where his arms felt so heavy that he could not move it,his arms felt 3 times the size they are). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HYPERSOMNIA (He could almost sleep 24 hours a day), LIMB DISCOMFORT (Had an episode where his arms felt so heavy that he could not move it,his arms felt 3 times the size they are) and FATIGUE (A lot of fatigue) outcome was unknown and ASTHENIA (Does not have any energy), DECREASED APPETITE (Loss of appetite) and ARTHRALGIA (Joint pain, right wrist is so painful that he can hardly move it) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up received on 04-MAY-2021 included no new information.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: He could almost sleep 24 hours a day; Does not have any energy; Loss of appetite; Joint pain, right wrist is so painful that he can hardly move it; A lot of fatigue; Had an episode where his arms felt so heavy that he could not move it,his arms felt 3 times the size they are; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (He could almost sleep 24 hours a day), ASTHENIA (Does not have any energy), DECREASED APPETITE (Loss of appetite), LIMB DISCOMFORT (Had an episode where his arms felt so heavy that he could not move it,his arms felt 3 times the size they are) and ARTHRALGIA (Joint pain, right wrist is so painful that he can hardly move it) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL, LISINOPRIL, GLUCOSAMINE and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HYPERSOMNIA (He could almost sleep 24 hours a day), ASTHENIA (Does not have any energy), DECREASED APPETITE (Loss of appetite) and ARTHRALGIA (Joint pain, right wrist is so painful that he can hardly move it). 04-Mar-2021, the patient experienced FATIGUE (A lot of fatigue). In March 2021, the patient experienced LIMB DISCOMFORT (Had an episode where his arms felt so heavy that he could not move it,his arms felt 3 times the size they are). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HYPERSOMNIA (He could almost sleep 24 hours a day), LIMB DISCOMFORT (Had an episode where his arms felt so heavy that he could not move it,his arms felt 3 times the size they are) and FATIGUE (A lot of fatigue) outcome was unknown and ASTHENIA (Does not have any energy), DECREASED APPETITE (Loss of appetite) and ARTHRALGIA (Joint pain, right wrist is so painful that he can hardly move it) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up received on 04-MAY-2021 included no new information.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Illness, Renal pain, Retching, Vomiting
Clinical narrative: kidney pain; Lower back pain; Dry heaves; Sick for 4 hours during the night; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (kidney pain), BACK PAIN (Lower back pain), RETCHING (Dry heaves), ILLNESS (Sick for 4 hours during the night) and VOMITING (Vomiting) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes mellitus. Concomitant products included AMLODIPINE, TAMSULOSIN, METFORMIN and ATORVASTATIN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced RENAL PAIN (kidney pain), BACK PAIN (Lower back pain), RETCHING (Dry heaves), ILLNESS (Sick for 4 hours during the night) and VOMITING (Vomiting). At the time of the report, RENAL PAIN (kidney pain), BACK PAIN (Lower back pain), RETCHING (Dry heaves), ILLNESS (Sick for 4 hours during the night) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-06-2021 contains no significant information.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Tremor
Clinical narrative: shakes; cold; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), FEELING COLD (cold) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced TREMOR (shakes), FEELING COLD (cold) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and GABAPENTIN (NEURONTIN) at an unspecified dose and frequency. At the time of the report, TREMOR (shakes), FEELING COLD (cold) and CHILLS (chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (On 25 or 26 Jan don't have clarity) and Knee surgery NOS on 04-Mar-2021.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (Aches) and PYREXIA (Fever). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Aches) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 101-101.2 (High) 101-101.2 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications includes painkillers and antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received on 23-Jul-2021 and does not contain any new information.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extremely tired and worst fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extremely tired and worst fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced FATIGUE (extremely tired and worst fatigue). On 12-Mar-2021, FATIGUE (extremely tired and worst fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue, SARS-CoV-2 test
Clinical narrative: Syringe and needle not properly connected, Vaccination was leaking down the arm of the patient; Amount of vaccine that the patient actually received  is less than half dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Syringe and needle not properly connected, Vaccination was leaking down the arm of the patient) and ACCIDENTAL UNDERDOSE (Amount of vaccine that the patient actually received  is less than half dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 032B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Diagnosed by Rapid test) on 25-Dec-2020. Concurrent medical conditions included Blood pressure high.   On 12-Mar-2021 at 6:28 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021 at 6:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (Syringe and needle not properly connected, Vaccination was leaking down the arm of the patient) and ACCIDENTAL UNDERDOSE (Amount of vaccine that the patient actually received  is less than half dose). On 12-Mar-2021, DEVICE CONNECTION ISSUE (Syringe and needle not properly connected, Vaccination was leaking down the arm of the patient) and ACCIDENTAL UNDERDOSE (Amount of vaccine that the patient actually received  is less than half dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was revaccinated. No Concomitant medications were provided. No Treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up was received on 25-Jun-2021 and patient demographics were updated, new medical history was added, New dosing regimen was added for Suspect vaccine.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore for 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore for 2-3 days) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PAIN IN EXTREMITY (arm was sore for 2-3 days). At the time of the report, PAIN IN EXTREMITY (arm was sore for 2-3 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: felt hot and big; red and itchy / itchy like a mosquito bite; swelling like a tumor on my arm / it was swollen, red and itchy and a little bit sore; red; little bit sore; coupe little bumps / swelling like a tumor on her arm; got bruised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (coupe little bumps / swelling like a tumor on her arm), VACCINATION SITE BRUISING (got bruised), VACCINATION SITE PRURITUS (red and itchy / itchy like a mosquito bite), VACCINATION SITE WARMTH (felt hot and big) and VACCINATION SITE SWELLING (swelling like a tumor on my arm / it was swollen, red and itchy and a little bit sore) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE MASS (coupe little bumps / swelling like a tumor on her arm), VACCINATION SITE BRUISING (got bruised), VACCINATION SITE PRURITUS (red and itchy / itchy like a mosquito bite), VACCINATION SITE SWELLING (swelling like a tumor on my arm / it was swollen, red and itchy and a little bit sore), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (little bit sore). On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (felt hot and big). At the time of the report, VACCINATION SITE MASS (coupe little bumps / swelling like a tumor on her arm), VACCINATION SITE BRUISING (got bruised), VACCINATION SITE PRURITUS (red and itchy / itchy like a mosquito bite), VACCINATION SITE WARMTH (felt hot and big), VACCINATION SITE SWELLING (swelling like a tumor on my arm / it was swollen, red and itchy and a little bit sore), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (little bit sore) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were provided.  No treatment was reported for the events.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: felt hot and big; red and itchy / itchy like a mosquito bite; swelling like a tumor on my arm / it was swollen, red and itchy and a little bit sore; red; little bit sore; coupe little bumps / swelling like a tumor on her arm; got bruised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (coupe little bumps / swelling like a tumor on her arm), VACCINATION SITE BRUISING (got bruised), VACCINATION SITE PRURITUS (red and itchy / itchy like a mosquito bite), VACCINATION SITE WARMTH (felt hot and big) and VACCINATION SITE SWELLING (swelling like a tumor on my arm / it was swollen, red and itchy and a little bit sore) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE MASS (coupe little bumps / swelling like a tumor on her arm), VACCINATION SITE BRUISING (got bruised), VACCINATION SITE PRURITUS (red and itchy / itchy like a mosquito bite), VACCINATION SITE SWELLING (swelling like a tumor on my arm / it was swollen, red and itchy and a little bit sore), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (little bit sore). On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (felt hot and big). At the time of the report, VACCINATION SITE MASS (coupe little bumps / swelling like a tumor on her arm), VACCINATION SITE BRUISING (got bruised), VACCINATION SITE PRURITUS (red and itchy / itchy like a mosquito bite), VACCINATION SITE WARMTH (felt hot and big), VACCINATION SITE SWELLING (swelling like a tumor on my arm / it was swollen, red and itchy and a little bit sore), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (little bit sore) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were provided.  No treatment was reported for the events.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) 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.  Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) and FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-042832, MOD-2021-042866 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up has outcome information.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Chills, Fatigue, Musculoskeletal stiffness
Clinical narrative: Uncontrolled shaking/shakes; pain in chest; stiffness everywhere; weak and tired; Pain an left arm, pain in neck; chills; muscle pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Uncontrolled shaking/shakes), CHEST PAIN (pain in chest), MUSCULOSKELETAL STIFFNESS (stiffness everywhere), ASTHENIA (weak and tired) and PAIN (Pain an left arm, pain in neck) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TREMOR (Uncontrolled shaking/shakes), CHEST PAIN (pain in chest), MUSCULOSKELETAL STIFFNESS (stiffness everywhere), ASTHENIA (weak and tired), PAIN (Pain an left arm, pain in neck), CHILLS (chills), MYALGIA (muscle pain) and FATIGUE (fatigue). At the time of the report, TREMOR (Uncontrolled shaking/shakes), CHEST PAIN (pain in chest), MUSCULOSKELETAL STIFFNESS (stiffness everywhere), ASTHENIA (weak and tired), PAIN (Pain an left arm, pain in neck), CHILLS (chills), MYALGIA (muscle pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment was reported for the events.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Tremor
Clinical narrative: Uncontrolled shaking/shakes; pain in chest; stiffness everywhere; weak and tired; Pain an left arm, pain in neck; chills; muscle pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Uncontrolled shaking/shakes), CHEST PAIN (pain in chest), MUSCULOSKELETAL STIFFNESS (stiffness everywhere), ASTHENIA (weak and tired) and PAIN (Pain an left arm, pain in neck) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TREMOR (Uncontrolled shaking/shakes), CHEST PAIN (pain in chest), MUSCULOSKELETAL STIFFNESS (stiffness everywhere), ASTHENIA (weak and tired), PAIN (Pain an left arm, pain in neck), CHILLS (chills), MYALGIA (muscle pain) and FATIGUE (fatigue). At the time of the report, TREMOR (Uncontrolled shaking/shakes), CHEST PAIN (pain in chest), MUSCULOSKELETAL STIFFNESS (stiffness everywhere), ASTHENIA (weak and tired), PAIN (Pain an left arm, pain in neck), CHILLS (chills), MYALGIA (muscle pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment was reported for the events.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex, Hypoaesthesia
Clinical narrative: Sensitivity on left side of face and eyeball; herpes simplex breakout between lip and nose; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Sensitivity on left side of face and eyeball) and HERPES SIMPLEX (herpes simplex breakout between lip and nose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Herpes simplex since an unknown date.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HYPOAESTHESIA (Sensitivity on left side of face and eyeball) and HERPES SIMPLEX (herpes simplex breakout between lip and nose). At the time of the report, HYPOAESTHESIA (Sensitivity on left side of face and eyeball) and HERPES SIMPLEX (herpes simplex breakout between lip and nose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  No treatment information was provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: A red spot appeared at the injection site, it is swollen and it itches like hell; Red spot at injection site; A red spot appeared at the injection site, it is swollen and it itches like hell; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (A red spot appeared at the injection site, it is swollen and it itches like hell), VACCINATION SITE ERYTHEMA (Red spot at injection site) and VACCINATION SITE SWELLING (A red spot appeared at the injection site, it is swollen and it itches like hell) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included METOPROLOL for an unknown indication.    On 28-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 VACCINATION SITE PRURITUS (A red spot appeared at the injection site, it is swollen and it itches like hell), VACCINATION SITE ERYTHEMA (Red spot at injection site) and VACCINATION SITE SWELLING (A red spot appeared at the injection site, it is swollen and it itches like hell). At the time of the report, VACCINATION SITE PRURITUS (A red spot appeared at the injection site, it is swollen and it itches like hell), VACCINATION SITE ERYTHEMA (Red spot at injection site) and VACCINATION SITE SWELLING (A red spot appeared at the injection site, it is swollen and it itches like hell) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for events included antibiotics.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: significant sore arm that protruded to her shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (significant sore arm that protruded to her shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (significant sore arm that protruded to her shoulder). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (significant sore arm that protruded to her shoulder) outcome was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, Vomiting
Clinical narrative: vomiting; fever; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) and PYREXIA (fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VOMITING (vomiting) and PYREXIA (fever). On 12-Mar-2021, VOMITING (vomiting) and PYREXIA (fever) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site bruising
Clinical narrative: her other arm hurts as well / pain in her arms; Has a black and blue mark; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her other arm hurts as well / pain in her arms), VACCINATION SITE BRUISING (Has a black and blue mark) and FATIGUE (Fatigue) in a 120-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (her other arm hurts as well / pain in her arms), VACCINATION SITE BRUISING (Has a black and blue mark) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (her other arm hurts as well / pain in her arms), VACCINATION SITE BRUISING (Has a black and blue mark) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose in less than 21 days period/18 days later after receiving the 1st dose; A spontaneous report was received from a nurse, concerning a 57-years old male patient, who received first dose of Moderna's COVID-19 vaccine (mRNA-1273) and received 2nd dose in less than 21 days period/18 days later after receiving the 1st dose/inappropriate schedule of product administration.   The patient's medical history was not provided. The patient had no concomitant medications.  On 22 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number:002A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 12 Mar 2021, 18 days after receiving the 1st dose of vaccine, the patient received second dose of vaccine in less than 21 days period that was 18 days after receiving the 1st dose. Patient had no other symptoms after receiving both the doses.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.  The outcome of the event 2nd dose in less than 21 days period/18 days later after receiving the 1st dose was resolved on 12 Mar 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #002121A for second dose) with no associated AEs reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea, Headache, Nasal congestion, Sneezing
Clinical narrative: Asthma flared up; Sneezing; Congestion; Shortness of Breath; headache; This spontaneous case was reported by a patient and describes the occurrence of ASTHMA (Asthma flared up), SNEEZING (Sneezing), NASAL CONGESTION (Congestion), DYSPNOEA (Shortness of Breath) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergic to oak) and Pollen allergy.    On 13-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 ASTHMA (Asthma flared up), SNEEZING (Sneezing), NASAL CONGESTION (Congestion), DYSPNOEA (Shortness of Breath) and HEADACHE (headache). At the time of the report, ASTHMA (Asthma flared up), SNEEZING (Sneezing), NASAL CONGESTION (Congestion), DYSPNOEA (Shortness of Breath) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Non significant follow up received on 04-MAY-2021, no new information
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Pain in extremity, Pyrexia
Clinical narrative: weird dreams; fever of 100.6; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), ABNORMAL DREAMS (weird dreams) and PYREXIA (fever of 100.6) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm sore). On 13-Mar-2021, the patient experienced ABNORMAL DREAMS (weird dreams) and PYREXIA (fever of 100.6). The patient was treated with PARACETAMOL (TYLENOL) on 12-Mar-2021 at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm sore), ABNORMAL DREAMS (weird dreams) and PYREXIA (fever of 100.6) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and VERTIGO (Vertigo) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN, DENOSUMAB (PROLIA), Prednisone, ALPRAZOLAM (XANAX) and TRAMADOL for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizziness) and VERTIGO (Vertigo). The patient was treated with MECLIZINE [MECLOZINE] at an unspecified dose and frequency. On 08-Mar-2021, DIZZINESS (Dizziness) and VERTIGO (Vertigo) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Pruritus
Clinical narrative: burning in her eyes/the feeling you get when you get soap in your eyes; Experiencing itchiness here and there/itchiness around the body; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (burning in her eyes/the feeling you get when you get soap in your eyes) and PRURITUS (Experiencing itchiness here and there/itchiness around the body) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRURITUS (Experiencing itchiness here and there/itchiness around the body). On an unknown date, the patient experienced EYE IRRITATION (burning in her eyes/the feeling you get when you get soap in your eyes). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, EYE IRRITATION (burning in her eyes/the feeling you get when you get soap in your eyes) outcome was unknown and PRURITUS (Experiencing itchiness here and there/itchiness around the body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Mar-2021: Follow-up information received on 19-Mar-2021, contains significant information. Added new event. and treatment medication updated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: left arm is swollen; Left arm red; Left arm tender; left arm sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm sore arm), PERIPHERAL SWELLING (left arm is swollen), ERYTHEMA (Left arm red) and TENDERNESS (Left arm tender) in a 60-year-old female 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) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm sore arm). On 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (left arm is swollen), ERYTHEMA (Left arm red) and TENDERNESS (Left arm tender). At the time of the report, PAIN IN EXTREMITY (left arm sore arm), PERIPHERAL SWELLING (left arm is swollen), ERYTHEMA (Left arm red) and TENDERNESS (Left arm tender) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; fever; chills; headache; Nauseous; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and NAUSEA (Nauseous) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. In March 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and NAUSEA (Nauseous). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and NAUSEA (Nauseous) had not resolved.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant and treatment medications were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: Chills; Fever; soreness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (soreness at the site of injection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (soreness at the site of injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (soreness at the site of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysgeusia, Fatigue, Paraesthesia oral, Vaccination site pain
Clinical narrative: Horrible metallic taste in the mouth; Tingling sensation of the tongue; Dryness of mouth; Slightly tired; Soreness at the site if injection; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Horrible metallic taste in the mouth), PARAESTHESIA ORAL (Tingling sensation of the tongue), DRY MOUTH (Dryness of mouth), FATIGUE (Slightly tired) and VACCINATION SITE PAIN (Soreness at the site if injection) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DYSGEUSIA (Horrible metallic taste in the mouth), PARAESTHESIA ORAL (Tingling sensation of the tongue), DRY MOUTH (Dryness of mouth), FATIGUE (Slightly tired) and VACCINATION SITE PAIN (Soreness at the site if injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Mar-2021, FATIGUE (Slightly tired) and VACCINATION SITE PAIN (Soreness at the site if injection) had resolved. At the time of the report, DYSGEUSIA (Horrible metallic taste in the mouth), PARAESTHESIA ORAL (Tingling sensation of the tongue) and DRY MOUTH (Dryness of mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Shingles) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  Patient was given steroids as treatment for shingles.   This case was linked to MOD-2021-209942 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Second dose outside of 42 day window; Red, bruised like a deep purple rash; Itchy; Hive near the injection site; Red at injection site; Swollen at injection site; Arm has some soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm has some soreness), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE URTICARIA (Hive near the injection site), VACCINATION SITE RASH (Red, bruised like a deep purple rash) and VACCINATION SITE ERYTHEMA (Red at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 25-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 PAIN IN EXTREMITY (Arm has some soreness), VACCINATION SITE URTICARIA (Hive near the injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swollen at injection site). On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy). On 12-Mar-2021, the patient experienced VACCINATION SITE RASH (Red, bruised like a deep purple rash). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose outside of 42 day window). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm has some soreness), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE URTICARIA (Hive near the injection site), VACCINATION SITE RASH (Red, bruised like a deep purple rash), VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE SWELLING (Swollen at injection site) and PRODUCT DOSE OMISSION ISSUE (Second dose outside of 42 day window) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included blood pressure medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: Follow-up information received  contains non-significant information. On 22-Jun-2021: Follow up received on 22-JUN-2021: Event was added.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Second dose outside of 42 day window; Red, bruised like a deep purple rash; Itchy; Hive near the injection site; Red at injection site; Swollen at injection site; Arm has some soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm has some soreness), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE URTICARIA (Hive near the injection site), VACCINATION SITE RASH (Red, bruised like a deep purple rash) and VACCINATION SITE ERYTHEMA (Red at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 25-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 PAIN IN EXTREMITY (Arm has some soreness), VACCINATION SITE URTICARIA (Hive near the injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swollen at injection site). On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy). On 12-Mar-2021, the patient experienced VACCINATION SITE RASH (Red, bruised like a deep purple rash). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose outside of 42 day window). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm has some soreness), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE URTICARIA (Hive near the injection site), VACCINATION SITE RASH (Red, bruised like a deep purple rash), VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE SWELLING (Swollen at injection site) and PRODUCT DOSE OMISSION ISSUE (Second dose outside of 42 day window) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included blood pressure medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: Follow-up information received  contains non-significant information. On 22-Jun-2021: Follow up received on 22-JUN-2021: Event was added.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: Chills; Fever of 104 degrees F; Muscle pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (Fever of 104 degrees F), MYALGIA (Muscle pain) and CHILLS (Chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 19-Nov-2020. Concomitant products included METFORMIN, METOPROLOL, CYANOCOBALAMIN (VITAMIN B-12), LISINOPRIL, HYDROCHLOROTHIAZIDE, TIOTROPIUM, METHOCARBAMOL, SIMVASTATIN, PREGABALIN, MELATONIN, PANTOPRAZOLE, DULOXETINE, FERROUS GLUCONATE, MAGNESIUM OXIDE, VITAMIN D [VITAMIN D NOS] and TIOTROPIUM BROMIDE (SPIRIVA) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (Fever of 104 degrees F) and MYALGIA (Muscle pain). On 06-Mar-2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 07-Mar-2021, MYALGIA (Muscle pain) and CHILLS (Chills) had resolved. On 08-Mar-2021, PYREXIA (Fever of 104 degrees F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 104 (High) Fever.     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.