chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid after second dose; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid after second dose) and DRUG INEFFECTIVE (Lack of drug effect) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced COVID-19 (Covid after second dose) and DRUG INEFFECTIVE (Lack of drug effect). On 05-Apr-2021, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. At the time of the report, COVID-19 (Covid after second dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, COVID-19: positive (Positive) positive.         No concomitant or treatment information was provided.  This is a case of lack of efficacy of the vaccine.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Upon internal review on 06-Aug-2021, event of Lack of drug effect was added.; Sender's Comments: This is a case of lack of efficacy of the vaccine.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a patient family member or friend 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 immunization.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       "While reporting on herself for the Covid vaccine, caller mentioned the Headaches occurred after she got home from the hospital that Friday the 26th, and the 27th and 28th. For 2 solid days it was really unusual unlike any headache she has every had before. It was not sever, she didn't need Advil. Her daughter reported something similar after the Moderna shot.   Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded. Additional information is requested. No other medical information was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded. Additional information is requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Dyspnoea, Fatigue
Clinical narrative: Difficulty breathing; High blood pressure; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), HYPERTENSION (High blood pressure), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia since 01-Jan-1995. Concomitant products included LOSARTAN from 01-Jan-2014 to an unknown date and ROSUVASTATIN CALCIUM (CRESTOR) from 01-Jan-2021 to an unknown date for an unknown indication.   On 09-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing), HYPERTENSION (High blood pressure), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (Difficulty breathing) was resolving and HYPERTENSION (High blood pressure), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 165/135 (Inconclusive) 165/135. On an unknown date, Body temperature: 102 (Inconclusive) 102. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Treatment information was not provided.   This case was linked to MOD-2021-009919 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Pyrexia, SARS-CoV-2 test
Clinical narrative: Difficulty breathing; High blood pressure; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), HYPERTENSION (High blood pressure), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia since 01-Jan-1995. Concomitant products included LOSARTAN from 01-Jan-2014 to an unknown date and ROSUVASTATIN CALCIUM (CRESTOR) from 01-Jan-2021 to an unknown date for an unknown indication.   On 09-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing), HYPERTENSION (High blood pressure), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (Difficulty breathing) was resolving and HYPERTENSION (High blood pressure), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 165/135 (Inconclusive) 165/135. On an unknown date, Body temperature: 102 (Inconclusive) 102. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Treatment information was not provided.   This case was linked to MOD-2021-009919 (Patient Link).
Sex: F
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 female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine type meds).    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 VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided   This case was linked to MOD-2021-027385 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Lethargy
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of lethargy and asthenia  (hard to get going) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 014M20A and 031M20A) for COVID-19 immunization. Concurrent medical conditions included chronic fatigue and thyroid disorder. Concomitant products included Vitamin D (cholecalciferol) for an unknown indication. On Feb 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 12, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 12, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced lethargy. On an unknown date, patient experienced asthenia (hard to get going). At the time of the report, lethargy and asthenia (hard to get going) outcome: unknown/not provided. Concomitant medicines included thyroid medication. No treatment information reported. This case linked to MOD-2021-060629 (patient link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Pruritus, Rash, Somnolence
Clinical narrative: Only ate one meal; Hard to move it; Itchy neck; Rash all over my neck, down to my arms and up to my breast area; Slept all day; Really tired; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept all day), DECREASED APPETITE (Only ate one meal), VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to move it), PRURITUS (Itchy neck) and VACCINATION SITE PAIN (Sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU VACCINE VII.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and FATIGUE (Really tired). On 15-Apr-2021, the patient experienced SOMNOLENCE (Slept all day). On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Itchy neck) and RASH (Rash all over my neck, down to my arms and up to my breast area). On an unknown date, the patient experienced DECREASED APPETITE (Only ate one meal) and VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to move it). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Slept all day), DECREASED APPETITE (Only ate one meal), VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to move it), PRURITUS (Itchy neck), VACCINATION SITE PAIN (Sore arm), RASH (Rash all over my neck, down to my arms and up to my breast area) and FATIGUE (Really tired) outcome was unknown.            Concomitants were not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Only ate one meal; Hard to move it; Itchy neck; Rash all over my neck, down to my arms and up to my breast area; Slept all day; Really tired; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept all day), DECREASED APPETITE (Only ate one meal), VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to move it), PRURITUS (Itchy neck) and VACCINATION SITE PAIN (Sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU VACCINE VII.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and FATIGUE (Really tired). On 15-Apr-2021, the patient experienced SOMNOLENCE (Slept all day). On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Itchy neck) and RASH (Rash all over my neck, down to my arms and up to my breast area). On an unknown date, the patient experienced DECREASED APPETITE (Only ate one meal) and VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to move it). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Slept all day), DECREASED APPETITE (Only ate one meal), VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to move it), PRURITUS (Itchy neck), VACCINATION SITE PAIN (Sore arm), RASH (Rash all over my neck, down to my arms and up to my breast area) and FATIGUE (Really tired) outcome was unknown.            Concomitants were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm for 2 or 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for 2 or 3 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 2001 and Enlarged prostate since 2019. Concomitant products included LISINOPRIL for Blood pressure high, TAMSULOSIN for Enlarged prostate.    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 (Sore arm for 2 or 3 days). At the time of the report, PAIN IN EXTREMITY (Sore arm for 2 or 3 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-079696 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inhibitory drug interaction, Nasopharyngitis
Clinical narrative: cold; Since she is on Ibrance then the accine is less effective; This spontaneous case was reported by a consumer and describes the occurrence of INHIBITORY DRUG INTERACTION (Since she is on Ibrance then the accine is less effective) and NASOPHARYNGITIS (cold) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Cancer. Concomitant products included PALBOCICLIB (IBRANCE) for Cancer.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced INHIBITORY DRUG INTERACTION (Since she is on Ibrance then the accine is less effective). On an unknown date, the patient experienced NASOPHARYNGITIS (cold). At the time of the report, INHIBITORY DRUG INTERACTION (Since she is on Ibrance then the accine is less effective) and NASOPHARYNGITIS (cold) outcome was unknown.            No concomitant medications were reported.  The patient reported that the nurse practitioner told her since she is on Ibrance (palbociclibo) the vaccine is less effective. The patient wanted to know if it is true. Patient stated the doctor did not think that the cold and the vaccine are related. She also stated that her grandson got a cold from pre-school. There is a product complaint on Ibrance.  No treatment information was reported,  Action taken with mRNA-1273 in response to the event was not applicable.   Company Comment: Very limited information regarding these events has been provided at this time. Further information is required.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information is required.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Bump appeared on her face right side; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Bump appeared on her face right side) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Bump appeared on her face right side). At the time of the report, SWELLING FACE (Bump appeared on her face right side) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported    This case was linked to US-MODERNATX, INC.-MOD-2021-065220 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065220:1st dose.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: patient looked at the arm and it had like a 6 inches rash; Injection started to get itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (patient looked at the arm and it had like a 6 inches rash) and VACCINATION SITE PRURITUS (Injection started to get itchy) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L2014) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included LOSARTAN POTASSIUM (LOSARTAN POTASIUM FFP) and HYDROCHLOROTHIAZIDE for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection started to get itchy). On 25-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (patient looked at the arm and it had like a 6 inches rash). The patient was treated with CETIRIZINE HCL at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (patient looked at the arm and it had like a 6 inches rash) had resolved and VACCINATION SITE PRURITUS (Injection started to get itchy) outcome was unknown.            Treatment information includes hydrocortisone for itchy.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: The patient reported rash with both doses; denied additional follow-up
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: incorrect age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (incorrect age) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (incorrect age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (incorrect age) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication has been reported.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Fatigue, Myalgia, Nasopharyngitis, Pain
Clinical narrative: cold; body hurts; pain in both legs; had fever; tired; muscle ache; ankle pain; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), PAIN (body hurts), PAIN IN EXTREMITY (pain in both legs), PYREXIA (had fever) and FATIGUE (tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    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 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold), PAIN (body hurts), PAIN IN EXTREMITY (pain in both legs), PYREXIA (had fever), FATIGUE (tired), MYALGIA (muscle ache) and ARTHRALGIA (ankle pain). At the time of the report, NASOPHARYNGITIS (cold), PAIN (body hurts), PAIN IN EXTREMITY (pain in both legs), PYREXIA (had fever), FATIGUE (tired), MYALGIA (muscle ache) and ARTHRALGIA (ankle pain) had not resolved.            Patient took Tylenol for her symptoms. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No relevant concomitant medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-065229 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065229:First dose
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: cold; body hurts; pain in both legs; had fever; tired; muscle ache; ankle pain; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), PAIN (body hurts), PAIN IN EXTREMITY (pain in both legs), PYREXIA (had fever) and FATIGUE (tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    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 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold), PAIN (body hurts), PAIN IN EXTREMITY (pain in both legs), PYREXIA (had fever), FATIGUE (tired), MYALGIA (muscle ache) and ARTHRALGIA (ankle pain). At the time of the report, NASOPHARYNGITIS (cold), PAIN (body hurts), PAIN IN EXTREMITY (pain in both legs), PYREXIA (had fever), FATIGUE (tired), MYALGIA (muscle ache) and ARTHRALGIA (ankle pain) had not resolved.            Patient took Tylenol for her symptoms. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No relevant concomitant medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-065229 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065229:First dose
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 CHILLS (Chills). At the time of the report, CHILLS (Chills) had not resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-020834, MOD-2021-020834 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: fever; chills; ache; Nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), PAIN (ache), NAUSEA (Nausea) and FATIGUE (fatigue) 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 an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), PAIN (ache), NAUSEA (Nausea) and FATIGUE (fatigue).   At the time of the report, PYREXIA (fever), CHILLS (chills), NAUSEA (Nausea) and FATIGUE (fatigue) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-047767 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-047767:2nd dose
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore in the shoulder; This spontaneous case was reported by an other and describes the occurrence of ARTHRALGIA (Sore in the shoulder) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hospitalization on 29-Mar-2021, Dehydration (Patient hospitalized, outcome unknown), Sores mouth (Patient hospitalized, outcome unknown), Sinus infection (Patient hospitalized, outcome unknown), Dry mouth (Patient hospitalized, outcome unknown) and Dysphagia (Patient hospitalized, outcome unknown). Previously administered products included for an unreported indication: LENVIMA (8 mg daily dose taken orally,  Medication on hold.) from 16-Nov-2020 to 29-Mar-2021 and EVEROLIMUS (5 mg taken orally.  Medication status unknown.) until 29-Mar-2021. Concurrent medical conditions included Pinched nerve (Recovering) and Carpal tunnel syndrome (Recovering). Concomitant products included LENVATINIB MESILATE (LENVIMA) from 16-Nov-2020 to an unknown date for Renal cancer.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ARTHRALGIA (Sore in the shoulder). In March 2021, ARTHRALGIA (Sore in the shoulder) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking an unknown antibiotic for an unknown indication and using a mouth rinse for an unknown indication.  Patient was scheduled for a neurological visit for his hands to receive an injection.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: fallow up received on 20-may-21 contain no new information
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Vomiting
Clinical narrative: Diarrhea; Not feeling well; Vomiting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of DIARRHEA (Diarrhea), MALAISE (Not feeling well) and VOMITING (Vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHEA (Diarrhea), MALAISE (Not feeling well) and VOMITING (Vomiting). At the time of the report, DIARRHEA (Diarrhea), MALAISE (Not feeling well) and VOMITING (Vomiting) outcome was unknown.            Patient received first vaccine from Pfizer. The concomitant medications and treatment details were not provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: warm to touch; red rash at injection arm; sensitive to touch; itchy at times; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm to touch), INJECTION SITE ERYTHEMA (red rash at injection arm), INJECTION SITE PAIN (sensitive to touch) and INJECTION SITE PRURITUS (itchy at times) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0121209 and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa medicatiion).   On 13-Jan-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021 at 3:10 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE WARMTH (warm to touch), INJECTION SITE ERYTHEMA (red rash at injection arm), INJECTION SITE PAIN (sensitive to touch) and INJECTION SITE PRURITUS (itchy at times). On 28-Jan-2021, INJECTION SITE ERYTHEMA (red rash at injection arm) had resolved. At the time of the report, INJECTION SITE WARMTH (warm to touch), INJECTION SITE PAIN (sensitive to touch) and INJECTION SITE PRURITUS (itchy at times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Skin wrinkling
Clinical narrative: tingling in cheeks; nasolabial folds; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (tingling in cheeks) and SKIN WRINKLING (nasolabial folds) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYALURONIC ACID, LIDOCAINE (RESTYLANE L) for an unknown indication.    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 PARAESTHESIA (tingling in cheeks) and SKIN WRINKLING (nasolabial folds). At the time of the report, PARAESTHESIA (tingling in cheeks) and SKIN WRINKLING (nasolabial folds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Fatigue, Injection site pain
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of cough (coughing starting-up), diarrhea, injection site pain (sore arm) and fatigue (tiredness) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced cough (coughing starting-up), diarrhea, injection site pain (sore arm) and fatigue  (tiredness). At the time of the report, cough (coughing starting-up), diarrhea, injection site pain (sore arm) and fatigue (tiredness) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Disorganised speech, Dizziness
Clinical narrative: Balance was off; feel dizzy; Trouble talking last night; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feel dizzy), DISORGANISED SPEECH (Trouble talking last night) and BALANCE DISORDER (Balance was off) 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 (no medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced DISORGANISED SPEECH (Trouble talking last night). On an unknown date, the patient experienced DIZZINESS (feel dizzy) and BALANCE DISORDER (Balance was off). At the time of the report, DIZZINESS (feel dizzy), DISORGANISED SPEECH (Trouble talking last night) and BALANCE DISORDER (Balance was off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment was reported.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chest discomfort, Chest pain
Clinical narrative: Odd joint aches; stomach pain; felt like they were having a heart attack in the middle of night; felt like an elephant was sitting on her chest; This spontaneous case was reported by an other and describes the occurrence of CHEST PAIN (felt like they were having a heart attack in the middle of night), ABDOMINAL PAIN UPPER (stomach pain), ARTHRALGIA (Odd joint aches) and CHEST DISCOMFORT (felt like an elephant was sitting on her chest) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-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 18-Feb-2021, the patient experienced CHEST PAIN (felt like they were having a heart attack in the middle of night) and CHEST DISCOMFORT (felt like an elephant was sitting on her chest). On 28-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). On 01-Mar-2021, the patient experienced ARTHRALGIA (Odd joint aches). At the time of the report, CHEST PAIN (felt like they were having a heart attack in the middle of night) and ABDOMINAL PAIN UPPER (stomach pain) had not resolved, ARTHRALGIA (Odd joint aches) was resolving and CHEST DISCOMFORT (felt like an elephant was sitting on her chest) outcome was unknown.            Concomitant medication use was unknown Treatment information was unknown
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Interchange of vaccine products
Clinical narrative: Interchange of vaccination products; Dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headache) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccination products) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Depression. Concurrent medical conditions included Diabetes and Smoker. Concomitant products included METFORMIN for Diabetes.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccination products). At the time of the report, DIZZINESS (Dizziness) and HEADACHE (Headache) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccination products) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patient had grumpy and cranky voice.  patient had taken Pfizer as first shot
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema, Swelling
Clinical narrative: swelling; malar edema; This spontaneous case was reported by a health care professional and describes the occurrence of SWELLING (swelling) and OEDEMA (malar edema) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 SWELLING (swelling) and OEDEMA (malar edema). At the time of the report, SWELLING (swelling) and OEDEMA (malar edema) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medicines include steroids and antihistamines. Concomitant medicines were not included. Upon internal review on 04-Aug-2021, the age was corrected to 60 years.   Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Hot flush, Polymerase chain reaction
Clinical narrative: COVID-19; severe hot flashes; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), HOT FLUSH (severe hot flashes), HEADACHE (headache) and FATIGUE (fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Aspirin, vancomycin incision powder), Asthma, Depression, Anxiety and Atrophic vaginitis. Concomitant products included FAMOTIDINE from 01-Jan-2020 to an unknown date for GERD.   On 13-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On 15-Jan-2021, the patient experienced HOT FLUSH (severe hot flashes), HEADACHE (headache) and FATIGUE (fatigue). On 21-Jan-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, HOT FLUSH (severe hot flashes), HEADACHE (headache) and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Polymerase chain reaction: (Positive) PCR nasal swab test taken 1/19/21 and returned positive 1/21/21..         March 13 took first COVID vaccine, morning of 1/15/21 I awoke with runny nose, severe hot flashes, headache and fatigue. I reported symptoms to my meployer who requested testing. PCR nasal swab test taken 1/19/21 and returned positive 1/21/21. Headache and hot flashed were severe. Runny nose, marked fatigue and brain fogginess noted. In 5 days I lost taste and smell, increased fatigue, hot flashes and headache.  I used tylenol 500mg 2 tabs every 6 hours for headache, test and fluids as tolerated COVID infection in March 2020 was much more severe with lung symptoms, fever, gi problems. COVID infection in January 2021 much more mild but continue brain fog is annoying.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 12-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment information reported.   The vaccine was received on 3/9/2021 and a thawed expiration on 4/8/2021. The vaccine was administered on 4/12/2021, 4 days past the date of expiration
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Pain
Clinical narrative: feeling unwell; dizziness/lightheadedness; Generalized aching; This spontaneous case was reported by an other and describes the occurrence of MALAISE (feeling unwell), DIZZINESS (dizziness/lightheadedness) and PAIN (Generalized aching) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   In November 2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 mg every two weeks. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN (Generalized aching). On 26-Mar-2021, the patient experienced MALAISE (feeling unwell) and DIZZINESS (dizziness/lightheadedness). On 26-Mar-2021, PAIN (Generalized aching) had resolved. At the time of the report, MALAISE (feeling unwell) and DIZZINESS (dizziness/lightheadedness) was resolving.        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.   This case was linked to MOD-2021-101973 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Migraine, Myalgia, Pyrexia
Clinical narrative: Migraine type headache; Sleep disturbance; Vomiting; Shoulder pain; Body ache; Headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine type headache), SLEEP DISORDER (Sleep disturbance), HEADACHE (Headache), PYREXIA (fever) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine type headache), SLEEP DISORDER (Sleep disturbance), HEADACHE (Headache), PYREXIA (fever), VOMITING (Vomiting), ARTHRALGIA (Shoulder pain) and MYALGIA (Body ache). At the time of the report, MIGRAINE (Migraine type headache), SLEEP DISORDER (Sleep disturbance), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown, PYREXIA (fever) and MYALGIA (Body ache) had resolved and ARTHRALGIA (Shoulder pain) had not resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Vomiting
Clinical narrative: Migraine type headache; Sleep disturbance; Vomiting; Shoulder pain; Body ache; Headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine type headache), SLEEP DISORDER (Sleep disturbance), HEADACHE (Headache), PYREXIA (fever) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine type headache), SLEEP DISORDER (Sleep disturbance), HEADACHE (Headache), PYREXIA (fever), VOMITING (Vomiting), ARTHRALGIA (Shoulder pain) and MYALGIA (Body ache). At the time of the report, MIGRAINE (Migraine type headache), SLEEP DISORDER (Sleep disturbance), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown, PYREXIA (fever) and MYALGIA (Body ache) had resolved and ARTHRALGIA (Shoulder pain) had not resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Down's syndrome.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: her blood pressure was 235/145; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (her blood pressure was 235/145) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (her blood pressure was 235/145). At the time of the report, HYPERTENSION (her blood pressure was 235/145) outcome was unknown.            On an unspecified date, the patient's CT scan showed negative fluid. Concomitant medications were not provided. Treatment information was not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.