chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Pain in extremity
Clinical narrative: Arm is painful; Eyes are swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is painful) and EYE SWELLING (Eyes are swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm is painful) and EYE SWELLING (Eyes are swollen). At the time of the report, PAIN IN EXTREMITY (Arm is painful) and EYE SWELLING (Eyes are swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided Concomitant information was not provided.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Pain in extremity, Palpitations
Clinical narrative: sore arm; heart palpatations; chest tightness; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpatations), CHEST DISCOMFORT (chest tightness) and PAIN IN EXTREMITY (sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included LISINOPRIL, APREMILAST (OTEZLA), BUPROPION HYDROCHLORIDE (WELLBUTRIN), LORAZEPAM (ATIVAN), CEFIXIME (FLEXERIL [CEFIXIME]), PARACETAMOL (TYLENOL) and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PALPITATIONS (heart palpatations) and CHEST DISCOMFORT (chest tightness). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 28-Feb-2021, PALPITATIONS (heart palpatations) and CHEST DISCOMFORT (chest tightness) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Medications were not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-101121 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101121:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; Fever 101°F; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever 101°F) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever 101°F) and HEADACHE (Headache). At the time of the report, CHILLS (Chills), PYREXIA (Fever 101°F) and HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101 f 101 f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided. Treatment information was not provided.   Reporter did not allow further contact
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Back pain, Chills
Clinical narrative: Partial loss of taste and smell; Partial loss of taste and smell; Shortness of breath now and then; Cough now and then; Maybe post nasal drip; Sore arm; Nasty fever at night/Fever; Very tired; Mild headache; Nausea; Left arm near shoulder ached; Chills; Back pain at the waist line; Unable to sleep; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain at the waist line), INSOMNIA (Unable to sleep), AGEUSIA (Partial loss of taste and smell), ANOSMIA (Partial loss of taste and smell) and DYSPNOEA (Shortness of breath now and then) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Mitral valve prolapse, Sleep apnea and Kidney stones.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced BACK PAIN (Back pain at the waist line), INSOMNIA (Unable to sleep), PAIN IN EXTREMITY (Sore arm), PYREXIA (Nasty fever at night/Fever), FATIGUE (Very tired), HEADACHE (Mild headache), NAUSEA (Nausea), ARTHRALGIA (Left arm near shoulder ached) and CHILLS (Chills). On an unknown date, the patient experienced AGEUSIA (Partial loss of taste and smell), ANOSMIA (Partial loss of taste and smell), DYSPNOEA (Shortness of breath now and then), COUGH (Cough now and then) and UPPER-AIRWAY COUGH SYNDROME (Maybe post nasal drip). On 17-Feb-2021, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Mild headache) had resolved. On 18-Feb-2021, BACK PAIN (Back pain at the waist line) had resolved. At the time of the report, INSOMNIA (Unable to sleep), AGEUSIA (Partial loss of taste and smell), ANOSMIA (Partial loss of taste and smell), DYSPNOEA (Shortness of breath now and then), COUGH (Cough now and then), UPPER-AIRWAY COUGH SYNDROME (Maybe post nasal drip), PYREXIA (Nasty fever at night/Fever), FATIGUE (Very tired), NAUSEA (Nausea), ARTHRALGIA (Left arm near shoulder ached) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Insomnia
Clinical narrative: Partial loss of taste and smell; Partial loss of taste and smell; Shortness of breath now and then; Cough now and then; Maybe post nasal drip; Sore arm; Nasty fever at night/Fever; Very tired; Mild headache; Nausea; Left arm near shoulder ached; Chills; Back pain at the waist line; Unable to sleep; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain at the waist line), INSOMNIA (Unable to sleep), AGEUSIA (Partial loss of taste and smell), ANOSMIA (Partial loss of taste and smell) and DYSPNOEA (Shortness of breath now and then) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Mitral valve prolapse, Sleep apnea and Kidney stones.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced BACK PAIN (Back pain at the waist line), INSOMNIA (Unable to sleep), PAIN IN EXTREMITY (Sore arm), PYREXIA (Nasty fever at night/Fever), FATIGUE (Very tired), HEADACHE (Mild headache), NAUSEA (Nausea), ARTHRALGIA (Left arm near shoulder ached) and CHILLS (Chills). On an unknown date, the patient experienced AGEUSIA (Partial loss of taste and smell), ANOSMIA (Partial loss of taste and smell), DYSPNOEA (Shortness of breath now and then), COUGH (Cough now and then) and UPPER-AIRWAY COUGH SYNDROME (Maybe post nasal drip). On 17-Feb-2021, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Mild headache) had resolved. On 18-Feb-2021, BACK PAIN (Back pain at the waist line) had resolved. At the time of the report, INSOMNIA (Unable to sleep), AGEUSIA (Partial loss of taste and smell), ANOSMIA (Partial loss of taste and smell), DYSPNOEA (Shortness of breath now and then), COUGH (Cough now and then), UPPER-AIRWAY COUGH SYNDROME (Maybe post nasal drip), PYREXIA (Nasty fever at night/Fever), FATIGUE (Very tired), NAUSEA (Nausea), ARTHRALGIA (Left arm near shoulder ached) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Upper-airway cough syndrome
Clinical narrative: Partial loss of taste and smell; Partial loss of taste and smell; Shortness of breath now and then; Cough now and then; Maybe post nasal drip; Sore arm; Nasty fever at night/Fever; Very tired; Mild headache; Nausea; Left arm near shoulder ached; Chills; Back pain at the waist line; Unable to sleep; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain at the waist line), INSOMNIA (Unable to sleep), AGEUSIA (Partial loss of taste and smell), ANOSMIA (Partial loss of taste and smell) and DYSPNOEA (Shortness of breath now and then) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Mitral valve prolapse, Sleep apnea and Kidney stones.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced BACK PAIN (Back pain at the waist line), INSOMNIA (Unable to sleep), PAIN IN EXTREMITY (Sore arm), PYREXIA (Nasty fever at night/Fever), FATIGUE (Very tired), HEADACHE (Mild headache), NAUSEA (Nausea), ARTHRALGIA (Left arm near shoulder ached) and CHILLS (Chills). On an unknown date, the patient experienced AGEUSIA (Partial loss of taste and smell), ANOSMIA (Partial loss of taste and smell), DYSPNOEA (Shortness of breath now and then), COUGH (Cough now and then) and UPPER-AIRWAY COUGH SYNDROME (Maybe post nasal drip). On 17-Feb-2021, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Mild headache) had resolved. On 18-Feb-2021, BACK PAIN (Back pain at the waist line) had resolved. At the time of the report, INSOMNIA (Unable to sleep), AGEUSIA (Partial loss of taste and smell), ANOSMIA (Partial loss of taste and smell), DYSPNOEA (Shortness of breath now and then), COUGH (Cough now and then), UPPER-AIRWAY COUGH SYNDROME (Maybe post nasal drip), PYREXIA (Nasty fever at night/Fever), FATIGUE (Very tired), NAUSEA (Nausea), ARTHRALGIA (Left arm near shoulder ached) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Insomnia, Pollakiuria
Clinical narrative: increased frequency of urination; insomnia; chills; headache; soreness at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (increased frequency of urination), INSOMNIA (insomnia), CHILLS (chills), HEADACHE (headache) and INJECTION SITE PAIN (soreness at site of injection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], TRAZODONE, AMLODIPINE, VITAMINS NOS (MVI [VITAMINS NOS]) and SIMVASTATIN 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 POLLAKIURIA (increased frequency of urination), INSOMNIA (insomnia), CHILLS (chills), HEADACHE (headache) and INJECTION SITE PAIN (soreness at site of injection). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, SALICYLAMIDE (STANBACK HEADACHE) at an unspecified dose and frequency. On 26-Feb-2021, POLLAKIURIA (increased frequency of urination) had resolved. At the time of the report, INSOMNIA (insomnia), CHILLS (chills), HEADACHE (headache) and INJECTION SITE PAIN (soreness at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-MAY-2021 contains non-significant information.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: flushing in her face; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (flushing in her face) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20) for COVID-19 vaccination.     The patient's past medical history included Surgery (Surgery in right arm due to cancer).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FLUSHING (flushing in her face). On 05-Feb-2021, FLUSHING (flushing in her face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   Reporter did not allow further contact
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Dyspnoea, Myalgia
Clinical narrative: Abdominal pain; Difficulty of breathing; Muscle pain; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Difficulty of breathing) and MYALGIA (Muscle pain) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included VITAMIN B12 NOS for an unknown indication.   On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Jan-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Difficulty of breathing) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Jan-2021, ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Difficulty of breathing) and MYALGIA (Muscle pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-026685 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching around injection site), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE RASH (Rash around injection site) and RASH (Rash fades away and comes back) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. Concomitant products included TOCOPHERYL ACETATE (EVITA) for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 15-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching around injection site) and VACCINATION SITE RASH (Rash around injection site). On an unknown date, the patient experienced RASH (Rash fades away and comes back). At the time of the report, VACCINATION SITE PRURITUS (Itching around injection site), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE RASH (Rash around injection site) and RASH (Rash fades away and comes back) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included Blood pressure medications. Treatment information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Red band around arm; warm; itchiness; redness; soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Red band around arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE ERYTHEMA (redness) and MYALGIA (soreness) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL for Hypertension, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and FOLIC ACID for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE ERYTHEMA (redness) and MYALGIA (soreness). On 18-Feb-2021, the patient experienced VACCINATION SITE REACTION (Red band around arm). On 18-Feb-2021, VACCINATION SITE PRURITUS (itchiness) had resolved. On 20-Feb-2021, VACCINATION SITE WARMTH (warm) and MYALGIA (soreness) had resolved, VACCINATION SITE ERYTHEMA (redness) outcome was unknown. On 23-Feb-2021, VACCINATION SITE REACTION (Red band around arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received on 03-MAY-2021 and contains concomitant medications, events out come, new events were updated.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach feels weird) and PYREXIA (Fever of 101.2) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach feels weird) and PYREXIA (Fever of 101.2). At the time of the report, ABDOMINAL DISCOMFORT (Stomach feels weird) outcome was unknown and PYREXIA (Fever of 101.2) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 101.2 (Inconclusive) 101.2. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Patient has not taken anything to treat the symptom.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Dizziness, Fall, Nausea
Clinical narrative: Fell on the floor for almost an hour before help arrived; Light headedness; Sick to stomach; Nausea; Joint pain, kneel pain; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell on the floor for almost an hour before help arrived), DIZZINESS (Light headedness), ABDOMINAL DISCOMFORT (Sick to stomach), NAUSEA (Nausea) and ARTHRALGIA (Joint pain, kneel pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Broken bones. Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension, OXYCODONE, OXYCODONE HYDROCHLORIDE (OXYCONTIN) and GABAPENTIN (NEURONTIN) for Pain.    On 12-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 FALL (Fell on the floor for almost an hour before help arrived), DIZZINESS (Light headedness), ABDOMINAL DISCOMFORT (Sick to stomach), NAUSEA (Nausea) and ARTHRALGIA (Joint pain, kneel pain). At the time of the report, FALL (Fell on the floor for almost an hour before help arrived), DIZZINESS (Light headedness), ABDOMINAL DISCOMFORT (Sick to stomach), NAUSEA (Nausea) and ARTHRALGIA (Joint pain, kneel pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: administered 0.3 ml instead of the recommended 0.5 ml dose; A spontaneous report was received from a Pharmacist (a PharmD) concerning seven patient (reporter was not sure about the number) (ages and genders unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and were administered 0.3 ml instead of the recommended 0.5ml dose (accidental underdose).  No medical histories were provided.  Concomitant product use was not provided.  On unspecified dates, the patients received doses of mRNA-1273 (lot number: 031M20A) intramuscularly for prophylaxis of COVID-19 infection.  The reporter, who was calling on behalf of another pharmacist, stated that one "intern" administered 0.3 ml instead of the recommended 0.5ml dose of Moderna vaccine to seven patients (the reporter was not sure about the number of patients).   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of accidental underdose for mRNA-1273 (lot # 031M20A) with no associated AEs reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash throughout body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash throughout body) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 RASH (Rash throughout body). At the time of the report, RASH (Rash throughout body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
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.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information was not provided.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Feeling abnormal, Interchange of vaccine products, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (COVID Fogginess), INTERCHANGE OF VACCINE PRODUCTS (received Pfizer vaccine as 2nd dose) and PYREXIA (Fever - Temperature of 99.0F) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021 at 3:00 AM, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) .3 ml. On 21-Jan-2021, the patient experienced FEELING ABNORMAL (COVID Fogginess) and PYREXIA (Fever - Temperature of 99.0F). On 30-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received Pfizer vaccine as 2nd dose). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. On 23-Jan-2021, FEELING ABNORMAL (COVID Fogginess) and PYREXIA (Fever - Temperature of 99.0F) had resolved. On 30-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (received Pfizer vaccine as 2nd dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 99.0 (Inconclusive) 99.0F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Added reporter information and event.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Computerised tomogram, Headache, Joint noise, Musculoskeletal stiffness
Clinical narrative: ARTHRITIS; Dull headaches; Head and neck hurting; stiff neck/ PROBLEM MOVING MY NECK; crackling sound from her neck; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Head and neck hurting), MUSCULOSKELETAL STIFFNESS (stiff neck/ PROBLEM MOVING MY NECK), JOINT NOISE (crackling sound from her neck), ARTHRITIS (ARTHRITIS) and HEADACHE (Dull headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cerebral palsy.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN (Head and neck hurting) and JOINT NOISE (crackling sound from her neck). 17-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck/ PROBLEM MOVING MY NECK). On an unknown date, the patient experienced ARTHRITIS (ARTHRITIS) and HEADACHE (Dull headaches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Head and neck hurting), MUSCULOSKELETAL STIFFNESS (stiff neck/ PROBLEM MOVING MY NECK), JOINT NOISE (crackling sound from her neck), ARTHRITIS (ARTHRITIS) and HEADACHE (Dull headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) CT scan results includes diagnosis of  stenosis of spine..         No Concomitant medication was provided. Other treatment included 8 Hour arthritis   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up was received on 20-JUL-2021 Patient lab details CT scan was Added  diagnosed with stenosis of spine and Treatment information was added 8 hour arthrits
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ARTHRITIS; Dull headaches; Head and neck hurting; stiff neck/ PROBLEM MOVING MY NECK; crackling sound from her neck; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Head and neck hurting), MUSCULOSKELETAL STIFFNESS (stiff neck/ PROBLEM MOVING MY NECK), JOINT NOISE (crackling sound from her neck), ARTHRITIS (ARTHRITIS) and HEADACHE (Dull headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cerebral palsy.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN (Head and neck hurting) and JOINT NOISE (crackling sound from her neck). 17-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck/ PROBLEM MOVING MY NECK). On an unknown date, the patient experienced ARTHRITIS (ARTHRITIS) and HEADACHE (Dull headaches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Head and neck hurting), MUSCULOSKELETAL STIFFNESS (stiff neck/ PROBLEM MOVING MY NECK), JOINT NOISE (crackling sound from her neck), ARTHRITIS (ARTHRITIS) and HEADACHE (Dull headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) CT scan results includes diagnosis of  stenosis of spine..         No Concomitant medication was provided. Other treatment included 8 Hour arthritis   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up was received on 20-JUL-2021 Patient lab details CT scan was Added  diagnosed with stenosis of spine and Treatment information was added 8 hour arthrits
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (Covid-19) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 007A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 12-Jan-2021, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were given to the patient. The patient received monoclonal antibodies none days after vaccine administration.   This case was linked to MOD-2021-011079 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: email, address, birth date, product start date and batch number updated; Reporter's Comments: This case concerns a female of unknown age who experienced aa serious unexpected event of COVID-19.  The event occurred 6 days after the first dose of mRNA-1273 and was treated with monoclonal antibody infusion. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 341240) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Muscle pain). At the time of the report, MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant information was not provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: a little bit of pain; she has her arm in which she received the vaccine warm to the touch; he has her arm in which she received the vaccine red; she has her arm in which she received the vaccine tender; she has her arm in which she received the vaccine swollen; a little bit of pain; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN (a little bit of pain), VACCINATION SITE WARMTH (she has her arm in which she received the vaccine warm to the touch), INJECTION SITE ERYTHEMA (he has her arm in which she received the vaccine red), INJECTION SITE PAIN (she has her arm in which she received the vaccine tender) and VACCINATION SITE SWELLING (she has her arm in which she received the vaccine swollen) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041CZ010D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis since an unknown date. Concurrent medical conditions included Seasonal allergy (Patient is taking allergy medicine  for seasonal allergies.). Concomitant products included NAPROXEN for Arthritis.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced the first episode of PAIN (a little bit of pain), VACCINATION SITE WARMTH (she has her arm in which she received the vaccine warm to the touch), INJECTION SITE ERYTHEMA (he has her arm in which she received the vaccine red), INJECTION SITE PAIN (she has her arm in which she received the vaccine tender), VACCINATION SITE SWELLING (she has her arm in which she received the vaccine swollen) and the second episode of PAIN (a little bit of pain). At the time of the report, VACCINATION SITE WARMTH (she has her arm in which she received the vaccine warm to the touch), INJECTION SITE ERYTHEMA (he has her arm in which she received the vaccine red), INJECTION SITE PAIN (she has her arm in which she received the vaccine tender), VACCINATION SITE SWELLING (she has her arm in which she received the vaccine swollen) and the last episode of PAIN (a little bit of pain) outcome was unknown.            No treatment information provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dandruff, Dry skin, Rash, Rash pruritic, Skin exfoliation
Clinical narrative: Rash like flaky, dry, itchy, dandruff, broken skin; rash like flaky, dry, itchy, dandruff, broken skin; Like dandruff; rash like flaky, dry, itchy, dandruff, broken skin; Rash on chest that started like pimples and spread neck, below the scalp, and behind and inside ears; pain in muscle of injection site and soreness; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash like flaky, dry, itchy, dandruff, broken skin), SKIN EXFOLIATION (rash like flaky, dry, itchy, dandruff, broken skin), DANDRUFF (Like dandruff), DRY SKIN (rash like flaky, dry, itchy, dandruff, broken skin) and RASH (Rash on chest that started like pimples and spread neck, below the scalp, and behind and inside ears) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LISINOPRIL, GEMFIBROZIL, OMEPRAZOLE, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D [VITAMIN D NOS], ALPRAZOLAM and EZETIMIBE for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in muscle of injection site and soreness). On an unknown date, the patient experienced RASH PRURITIC (Rash like flaky, dry, itchy, dandruff, broken skin), SKIN EXFOLIATION (rash like flaky, dry, itchy, dandruff, broken skin), DANDRUFF (Like dandruff), DRY SKIN (rash like flaky, dry, itchy, dandruff, broken skin) and RASH (Rash on chest that started like pimples and spread neck, below the scalp, and behind and inside ears). At the time of the report, RASH PRURITIC (Rash like flaky, dry, itchy, dandruff, broken skin), SKIN EXFOLIATION (rash like flaky, dry, itchy, dandruff, broken skin), DANDRUFF (Like dandruff), DRY SKIN (rash like flaky, dry, itchy, dandruff, broken skin), RASH (Rash on chest that started like pimples and spread neck, below the scalp, and behind and inside ears) and VACCINATION SITE PAIN (pain in muscle of injection site and soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included OTC ointment, dry skin lotion, spray on hear, Topical cream  and special shampoo.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Rash like flaky, dry, itchy, dandruff, broken skin; rash like flaky, dry, itchy, dandruff, broken skin; Like dandruff; rash like flaky, dry, itchy, dandruff, broken skin; Rash on chest that started like pimples and spread neck, below the scalp, and behind and inside ears; pain in muscle of injection site and soreness; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash like flaky, dry, itchy, dandruff, broken skin), SKIN EXFOLIATION (rash like flaky, dry, itchy, dandruff, broken skin), DANDRUFF (Like dandruff), DRY SKIN (rash like flaky, dry, itchy, dandruff, broken skin) and RASH (Rash on chest that started like pimples and spread neck, below the scalp, and behind and inside ears) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LISINOPRIL, GEMFIBROZIL, OMEPRAZOLE, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D [VITAMIN D NOS], ALPRAZOLAM and EZETIMIBE for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in muscle of injection site and soreness). On an unknown date, the patient experienced RASH PRURITIC (Rash like flaky, dry, itchy, dandruff, broken skin), SKIN EXFOLIATION (rash like flaky, dry, itchy, dandruff, broken skin), DANDRUFF (Like dandruff), DRY SKIN (rash like flaky, dry, itchy, dandruff, broken skin) and RASH (Rash on chest that started like pimples and spread neck, below the scalp, and behind and inside ears). At the time of the report, RASH PRURITIC (Rash like flaky, dry, itchy, dandruff, broken skin), SKIN EXFOLIATION (rash like flaky, dry, itchy, dandruff, broken skin), DANDRUFF (Like dandruff), DRY SKIN (rash like flaky, dry, itchy, dandruff, broken skin), RASH (Rash on chest that started like pimples and spread neck, below the scalp, and behind and inside ears) and VACCINATION SITE PAIN (pain in muscle of injection site and soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included OTC ointment, dry skin lotion, spray on hear, Topical cream  and special shampoo.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (really sick). At the time of the report, ILLNESS (really sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Influenza like illness, Vaccination site erythema
Clinical narrative: Arm feeling very warm; Redness that is spreading on her vaccination arm; Chills like she had the flu; Chills like she had the flu; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Chills like she had the flu), FEELING HOT (Arm feeling very warm), VACCINATION SITE ERYTHEMA (Redness that is spreading on her vaccination arm) and CHILLS (Chills like she had the flu) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant concomitant medications reported. No relevant medical history 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 INFLUENZA LIKE ILLNESS (Chills like she had the flu) and CHILLS (Chills like she had the flu). On 01-Mar-2021, the patient experienced FEELING HOT (Arm feeling very warm) and VACCINATION SITE ERYTHEMA (Redness that is spreading on her vaccination arm). The patient was treated with PARACETAMOL (TYLENOL) for Chills, at an unspecified dose and frequency. On 28-Feb-2021, INFLUENZA LIKE ILLNESS (Chills like she had the flu) and CHILLS (Chills like she had the flu) had resolved. At the time of the report, FEELING HOT (Arm feeling very warm) and VACCINATION SITE ERYTHEMA (Redness that is spreading on her vaccination arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysgeusia, Hypertension, Palpitations
Clinical narrative: High blood pressure; up and down heart rate; Dry mouth; Taste of Salt; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure), PALPITATIONS (up and down heart rate), DRY MOUTH (Dry mouth) and DYSGEUSIA (Taste of Salt) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HYPERTENSION (High blood pressure), PALPITATIONS (up and down heart rate), DRY MOUTH (Dry mouth) and DYSGEUSIA (Taste of Salt). At the time of the report, HYPERTENSION (High blood pressure), PALPITATIONS (up and down heart rate) and DRY MOUTH (Dry mouth) had not resolved and DYSGEUSIA (Taste of Salt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-101121 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101121:
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Body ache; Fatigue; Fever of 100.2F; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), FATIGUE (Fatigue) and PYREXIA (Fever of 100.2F) in an 89-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.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced MYALGIA (Body ache), FATIGUE (Fatigue) and PYREXIA (Fever of 100.2F). The patient was treated with TRAMADOL at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MYALGIA (Body ache), FATIGUE (Fatigue) and PYREXIA (Fever of 100.2F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pyrexia: 100.2 Fever of 100.2F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Nausea
Clinical narrative: Heat goes right to her head; Chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Heat goes right to her head), CHILLS (Chills) and NAUSEA (Nauseous) 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 19-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 FEELING HOT (Heat goes right to her head), CHILLS (Chills) and NAUSEA (Nauseous). At the time of the report, FEELING HOT (Heat goes right to her head), CHILLS (Chills) and NAUSEA (Nauseous) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment information were not provided.