chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia, Vaccination site erythema
Clinical narrative: Stiffness on his neck and shoulder; Soreness; a red spot on his arm 6 inches below the injection site which now is getting bigger; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness on his neck and shoulder), PAIN (Soreness), VACCINATION SITE ERYTHEMA (a red spot on his arm 6 inches below the injection site which now is getting bigger) and PYREXIA (Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027l20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event since an unknown date.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness on his neck and shoulder), PAIN (Soreness), VACCINATION SITE ERYTHEMA (a red spot on his arm 6 inches below the injection site which now is getting bigger) and PYREXIA (Fever). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness on his neck and shoulder), PAIN (Soreness), VACCINATION SITE ERYTHEMA (a red spot on his arm 6 inches below the injection site which now is getting bigger) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Tremor
Clinical narrative: Whole body was trembling like she was in shock, Parkinson's like; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Whole body was trembling like she was in shock, Parkinson's like) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lung disease and Neurological disorder NOS.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced TREMOR (Whole body was trembling like she was in shock, Parkinson's like). At the time of the report, TREMOR (Whole body was trembling like she was in shock, Parkinson's like) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 7.5 (Inconclusive) antibody test results were 7.5..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Pain in extremity
Clinical narrative: Dizzy; Very weak; Had fatigue as if she had cheap drunk feel; Soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the left arm), DIZZINESS (Dizzy), ASTHENIA (Very weak) and FATIGUE (Had fatigue as if she had cheap drunk feel) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the left arm). On 03-Mar-2021, the patient experienced DIZZINESS (Dizzy), ASTHENIA (Very weak) and FATIGUE (Had fatigue as if she had cheap drunk feel). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Mar-2021, PAIN IN EXTREMITY (Soreness in the left arm) had resolved. On 09-Mar-2021, DIZZINESS (Dizzy), ASTHENIA (Very weak) and FATIGUE (Had fatigue as if she had cheap drunk feel) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable.  No relevant concomitant medications were reported.  Reportedly, soon after second shot the patient had soreness in the arm which increased by 03-Mar-2021 and it lasted for six days.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. C241420A and C48AAA) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. This case was linked to MOD-2021-040780.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Nausea, Neck pain, Somnolence
Clinical narrative: Achiness in his left side of the neck under the ear; Headache; Nausea; Stomach pains; Sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pains), SOMNOLENCE (Sleepiness), NECK PAIN (Achiness in his left side of the neck under the ear), NAUSEA (Nausea) and HEADACHE (Headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pains), SOMNOLENCE (Sleepiness) and NAUSEA (Nausea). On 11-Mar-2021, the patient experienced NECK PAIN (Achiness in his left side of the neck under the ear) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) on 07-Mar-2021 at an unspecified dose and frequency. On 07-Mar-2021, ABDOMINAL PAIN UPPER (Stomach pains), SOMNOLENCE (Sleepiness) and NAUSEA (Nausea) had resolved. At the time of the report, NECK PAIN (Achiness in his left side of the neck under the ear) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea; nausea; puking; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (nausea) and VOMITING (puking) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (nausea) and VOMITING (puking). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (nausea) and VOMITING (puking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Headache, Peripheral swelling
Clinical narrative: Swelling on their arm, like a hard bump with pain that comes and goes; Feel the vaccine messes up their mind from time to time; Feel they have less energy; feel lightheaded; Had one big throb on the head on Saturday evening, extreme headache, such a bad headache they felt their head was going to blow up; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling on their arm, like a hard bump with pain that comes and goes), FEELING ABNORMAL (Feel the vaccine messes up their mind from time to time), ASTHENIA (Feel they have less energy), DIZZINESS (feel lightheaded) and HEADACHE (Had one big throb on the head on Saturday evening, extreme headache, such a bad headache they felt their head was going to blow up) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Motor vehicle accident (mentions being in a car crash in the past, and felling and getting 2 bleedings in their head), Fever (June-July 2020 they were sick in the bed for a week with fever and chills, they felt terrible, and had headaches.), Chills, Feeling abnormal and Headache. Concurrent medical conditions included Diabetic, Iodine allergy and Psoriatic arthritis. Concomitant products included VITAMINS NOS for an unknown indication.    On 05-Mar-2021 at 3:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling on their arm, like a hard bump with pain that comes and goes), FEELING ABNORMAL (Feel the vaccine messes up their mind from time to time), ASTHENIA (Feel they have less energy), DIZZINESS (feel lightheaded) and HEADACHE (Had one big throb on the head on Saturday evening, extreme headache, such a bad headache they felt their head was going to blow up). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Tylenol every 5 hours; BAKING SODA at an unspecified dose and frequency and WATER at a dose of Teaspoon baking soda and water. At the time of the report, PERIPHERAL SWELLING (Swelling on their arm, like a hard bump with pain that comes and goes), FEELING ABNORMAL (Feel the vaccine messes up their mind from time to time), ASTHENIA (Feel they have less energy), DIZZINESS (feel lightheaded) and HEADACHE (Had one big throb on the head on Saturday evening, extreme headache, such a bad headache they felt their head was going to blow up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient additionally takes an unspecified diabetic medication as a concomitant medication.    Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Historical conditions were updated.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Food poisoning, Vomiting
Clinical narrative: food poisoning; diarrhea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FOOD POISONING (food poisoning), DIARRHOEA (diarrhea) and VOMITING (vomiting) in a 74-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FOOD POISONING (food poisoning), DIARRHOEA (diarrhea) and VOMITING (vomiting). At the time of the report, FOOD POISONING (food poisoning), DIARRHOEA (diarrhea) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  Reportedly, the patient had food poisoning and had to miss his second dose. He experienced vomiting and diarrhea. The patient wanted to know when he could receive the second dose since he missed his first.  No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Rhinorrhoea
Clinical narrative: coughing, sneezing, has a runny nose; fatigue, extremely tired; headache; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (coughing, sneezing, has a runny nose), FATIGUE (fatigue, extremely tired), HEADACHE (headache) and MYALGIA (muscle pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (coughing, sneezing, has a runny nose, and does not taste, but that these side effects are not related to COVID or the vaccine because she has had them for years due to allergies). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RHINORRHOEA (coughing, sneezing, has a runny nose), FATIGUE (fatigue, extremely tired), HEADACHE (headache) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, RHINORRHOEA (coughing, sneezing, has a runny nose), FATIGUE (fatigue, extremely tired), HEADACHE (headache) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included diabetic medication and Vitamins Treatment medication included Tylenol
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on back and chest mainly; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on back and chest mainly) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included METFORMIN, ATORVASTATIN, LEVOTHYROXINE, DOXYCYCLINE, VITAMIN B12 NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced RASH (rash on back and chest mainly). At the time of the report, RASH (rash on back and chest mainly) outcome was unknown.            Concomitant products includes inhaler, and multivitamin. treatment medication include cream on the area.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: Lost her appetite; Back pain very intense and unpleasant; Pain in upper body; Pain in neck area; Pain in thighs; Could not get out of bed; Mental fog; Chills; Intense fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain very intense and unpleasant), PAIN (Pain in upper body), NECK PAIN (Pain in neck area), PAIN IN EXTREMITY (Pain in thighs) and GAIT INABILITY (Could not get out of bed) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant Medical history Reported.  Concomitant products included ROSUVASTATIN, FLUTICASONE PROPIONATE (FLOVENT) and ESTRADIOL for an unknown indication.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN (Pain in upper body), NECK PAIN (Pain in neck area), PAIN IN EXTREMITY (Pain in thighs), GAIT INABILITY (Could not get out of bed), FEELING ABNORMAL (Mental fog), CHILLS (Chills) and FATIGUE (Intense fatigue). On 10-Mar-2021, the patient experienced BACK PAIN (Back pain very intense and unpleasant). On an unknown date, the patient experienced DECREASED APPETITE (Lost her appetite). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form; ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at a dose of 1 dosage form and Physical therapy (Massage her arm and compressors) for Pain. At the time of the report, BACK PAIN (Back pain very intense and unpleasant), PAIN (Pain in upper body), NECK PAIN (Pain in neck area), PAIN IN EXTREMITY (Pain in thighs), GAIT INABILITY (Could not get out of bed), FEELING ABNORMAL (Mental fog), DECREASED APPETITE (Lost her appetite), CHILLS (Chills) and FATIGUE (Intense fatigue) had not resolved.            concomitant medication include promethium and other supplements. Treatment medication include applied compressor.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Neck pain, Pain, Pain in extremity
Clinical narrative: Lost her appetite; Back pain very intense and unpleasant; Pain in upper body; Pain in neck area; Pain in thighs; Could not get out of bed; Mental fog; Chills; Intense fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain very intense and unpleasant), PAIN (Pain in upper body), NECK PAIN (Pain in neck area), PAIN IN EXTREMITY (Pain in thighs) and GAIT INABILITY (Could not get out of bed) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant Medical history Reported.  Concomitant products included ROSUVASTATIN, FLUTICASONE PROPIONATE (FLOVENT) and ESTRADIOL for an unknown indication.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN (Pain in upper body), NECK PAIN (Pain in neck area), PAIN IN EXTREMITY (Pain in thighs), GAIT INABILITY (Could not get out of bed), FEELING ABNORMAL (Mental fog), CHILLS (Chills) and FATIGUE (Intense fatigue). On 10-Mar-2021, the patient experienced BACK PAIN (Back pain very intense and unpleasant). On an unknown date, the patient experienced DECREASED APPETITE (Lost her appetite). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form; ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at a dose of 1 dosage form and Physical therapy (Massage her arm and compressors) for Pain. At the time of the report, BACK PAIN (Back pain very intense and unpleasant), PAIN (Pain in upper body), NECK PAIN (Pain in neck area), PAIN IN EXTREMITY (Pain in thighs), GAIT INABILITY (Could not get out of bed), FEELING ABNORMAL (Mental fog), DECREASED APPETITE (Lost her appetite), CHILLS (Chills) and FATIGUE (Intense fatigue) had not resolved.            concomitant medication include promethium and other supplements. Treatment medication include applied compressor.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Feeding disorder
Clinical narrative: Does not want to get out of bed; unable to eat; Stomach pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Does not want to get out of bed), FEEDING DISORDER (unable to eat), ABDOMINAL PAIN UPPER (Stomach pain) and FATIGUE (fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ASTHENIA (Does not want to get out of bed), FEEDING DISORDER (unable to eat), ABDOMINAL PAIN UPPER (Stomach pain) and FATIGUE (fatigue). At the time of the report, ASTHENIA (Does not want to get out of bed), FEEDING DISORDER (unable to eat), ABDOMINAL PAIN UPPER (Stomach pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchiness is very intense; 2.5x2.5 inches rash in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness is very intense) and VACCINATION SITE RASH (2.5x2.5 inches rash in the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) 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 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness is very intense) and VACCINATION SITE RASH (2.5x2.5 inches rash in the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness is very intense) and VACCINATION SITE RASH (2.5x2.5 inches rash in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment for the events included Benadryl, Caladryl and cortisone cream
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm was sore; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and FATIGUE (Tired) 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 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and FATIGUE (Tired) was resolving.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: fuzzy headed - not 100% herself mentally, efer to as brain fog.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (fuzzy headed - not 100% herself mentally, efer to as brain fog.) 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 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING ABNORMAL (fuzzy headed - not 100% herself mentally, efer to as brain fog.). At the time of the report, FEELING ABNORMAL (fuzzy headed - not 100% herself mentally, efer to as brain fog.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported Treatment information was not provided
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: area was itchy; rash around his injection site; area was red; area was tender; area was swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (area was itchy), VACCINATION SITE RASH (rash around his injection site), VACCINATION SITE ERYTHEMA (area was red), VACCINATION SITE PAIN (area was tender) and VACCINATION SITE SWELLING (area was swollen) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (area was itchy), VACCINATION SITE RASH (rash around his injection site), VACCINATION SITE ERYTHEMA (area was red), VACCINATION SITE PAIN (area was tender) and VACCINATION SITE SWELLING (area was swollen). At the time of the report, VACCINATION SITE PRURITUS (area was itchy), VACCINATION SITE RASH (rash around his injection site), VACCINATION SITE ERYTHEMA (area was red), VACCINATION SITE PAIN (area was tender) and VACCINATION SITE SWELLING (area was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. no concomitant were provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up received on 06-May-2021, no new information was recorded
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Yellow skin
Clinical narrative: feet turning yellow; This spontaneous case was reported by a consumer and describes the occurrence of YELLOW SKIN (feet turning yellow) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced YELLOW SKIN (feet turning yellow). On 07-Mar-2021, YELLOW SKIN (feet turning yellow) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The  concomitant medications on use were not provided. No laboratory data was provided.  No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Headache, Malaise
Clinical narrative: Arm got puffy; Didn't feel well; Arm got red; Arm got hot; Horrible headache; Didn't want to do anything other than lay down or sit,tired; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm got puffy), MALAISE (Didn't feel well), ERYTHEMA (Arm got red), FEELING HOT (Arm got hot) and HEADACHE (Horrible headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm got puffy), MALAISE (Didn't feel well), ERYTHEMA (Arm got red), FEELING HOT (Arm got hot), HEADACHE (Horrible headache) and FATIGUE (Didn't want to do anything other than lay down or sit,tired). At the time of the report, PERIPHERAL SWELLING (Arm got puffy), MALAISE (Didn't feel well), ERYTHEMA (Arm got red), FEELING HOT (Arm got hot), HEADACHE (Horrible headache) and FATIGUE (Didn't want to do anything other than lay down or sit,tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment was reported for the events.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Arm got puffy; Didn't feel well; Arm got red; Arm got hot; Horrible headache; Didn't want to do anything other than lay down or sit,tired; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm got puffy), MALAISE (Didn't feel well), ERYTHEMA (Arm got red), FEELING HOT (Arm got hot) and HEADACHE (Horrible headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm got puffy), MALAISE (Didn't feel well), ERYTHEMA (Arm got red), FEELING HOT (Arm got hot), HEADACHE (Horrible headache) and FATIGUE (Didn't want to do anything other than lay down or sit,tired). At the time of the report, PERIPHERAL SWELLING (Arm got puffy), MALAISE (Didn't feel well), ERYTHEMA (Arm got red), FEELING HOT (Arm got hot), HEADACHE (Horrible headache) and FATIGUE (Didn't want to do anything other than lay down or sit,tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment was reported for the events.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: knot at the injection site; itchy at the injection site; sore at the injection site; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (knot at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site), VACCINATION SITE PAIN (sore at the injection site) and NAUSEA (nauseous) in a 53-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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced NAUSEA (nauseous). On 10-Mar-2021, the patient experienced VACCINATION SITE MASS (knot at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE PAIN (sore at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) ongoing since an unknown date at a dose of 1 dosage form. On 09-Mar-2021, NAUSEA (nauseous) had resolved. At the time of the report, VACCINATION SITE MASS (knot at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE PAIN (sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received and patient email added
Sex: F
Vaccine: COVID19
Symptoms: Melanocytic naevus
Clinical narrative: Mole of skin; This spontaneous case was reported by a consumer and describes the occurrence of MELANOCYTIC NAEVUS (Mole of skin) 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MELANOCYTIC NAEVUS (Mole of skin). At the time of the report, MELANOCYTIC NAEVUS (Mole of skin) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: almost passed out this morning, claims to have dizziness.; Very fatigued after the second dose; Headache after second dose; Muscle pain after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very fatigued after the second dose), HEADACHE (Headache after second dose), MYALGIA (Muscle pain after 2nd dose) and DIZZINESS (Dizziness after 2nd dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (Very fatigued after the second dose), HEADACHE (Headache after second dose) and MYALGIA (Muscle pain after 2nd dose). On 10-Mar-2021, the patient experienced DIZZINESS (Dizziness after 2nd dose). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, FATIGUE (Very fatigued after the second dose), HEADACHE (Headache after second dose), MYALGIA (Muscle pain after 2nd dose) and DIZZINESS (Dizziness after 2nd dose) outcome was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) outcome was unknown.            No concomitant medication use was provided by the reporter.  Treatment of events were reported with camphor, menthol and eucalyptus oil (Vicks Vapor Rub) on an unknown start date.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema
Clinical narrative: Itching all over the body; Red circle in the injection site that goes almost from the shoulder to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over the body) and VACCINATION SITE ERYTHEMA (Red circle in the injection site that goes almost from the shoulder to the elbow) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Reaction to previous exposure to any vaccine (shingle shot).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PRURITUS (Itching all over the body) and VACCINATION SITE ERYTHEMA (Red circle in the injection site that goes almost from the shoulder to the elbow). At the time of the report, PRURITUS (Itching all over the body) and VACCINATION SITE ERYTHEMA (Red circle in the injection site that goes almost from the shoulder to the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness; itchiness; Injection site is also swollen & it feels warm.; Feels warm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (itchiness), VACCINATION SITE SWELLING (Injection site is also swollen & it feels warm.) and VACCINATION SITE WARMTH (Feels warm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced ERYTHEMA (Redness), PRURITUS (itchiness), VACCINATION SITE SWELLING (Injection site is also swollen & it feels warm.) and VACCINATION SITE WARMTH (Feels warm). At the time of the report, ERYTHEMA (Redness), PRURITUS (itchiness), VACCINATION SITE SWELLING (Injection site is also swollen & it feels warm.) and VACCINATION SITE WARMTH (Feels warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient said that the person that administered the injection gave it to her in fatty part of the arm.  No concomitant information was reported.  No treatment information was reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 and received vaccine; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and received vaccine) in a 17-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and received vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and received vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthritis, Body temperature, Chills
Clinical narrative: Loss of taste; Loss of smell; Extreme Fatigue; Constant headache; chills; fever; Her arthritis in her knees and hands hurt worse than usual.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Her arthritis in her knees and hands hurt worse than usual.), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), FATIGUE (Extreme Fatigue) and HEADACHE (Constant headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia from November 2020 to January 2021. Concurrent medical conditions included Drug allergy (sulpha drugs), Penicillin allergy and Arthritis (Arthritis in knees and hands).    On 26-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 ARTHRITIS (Her arthritis in her knees and hands hurt worse than usual.), FATIGUE (Extreme Fatigue), HEADACHE (Constant headache), CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). On 28-Feb-2021, PYREXIA (fever) had resolved. On 02-Mar-2021, ARTHRITIS (Her arthritis in her knees and hands hurt worse than usual.), FATIGUE (Extreme Fatigue), HEADACHE (Constant headache) and CHILLS (chills) outcome was unknown. At the time of the report, AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 102 (High) elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter. Treatment of events was not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Loss of taste; Loss of smell; Extreme Fatigue; Constant headache; chills; fever; Her arthritis in her knees and hands hurt worse than usual.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Her arthritis in her knees and hands hurt worse than usual.), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), FATIGUE (Extreme Fatigue) and HEADACHE (Constant headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia from November 2020 to January 2021. Concurrent medical conditions included Drug allergy (sulpha drugs), Penicillin allergy and Arthritis (Arthritis in knees and hands).    On 26-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 ARTHRITIS (Her arthritis in her knees and hands hurt worse than usual.), FATIGUE (Extreme Fatigue), HEADACHE (Constant headache), CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). On 28-Feb-2021, PYREXIA (fever) had resolved. On 02-Mar-2021, ARTHRITIS (Her arthritis in her knees and hands hurt worse than usual.), FATIGUE (Extreme Fatigue), HEADACHE (Constant headache) and CHILLS (chills) outcome was unknown. At the time of the report, AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 102 (High) elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter. Treatment of events was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Bronchitis, Fatigue, Lethargy
Clinical narrative: bronchial infection, chest discomfort and cough; bruise, erythem and swelling; body aches; fatigue; fever of 100.9 degrees Fahrenheit for 5 days; lethargy; shortness of breath; chronic back pain issues; A spontaneous report was received from a consumer concerning a 71- year old-female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bronchitis, chest discomfort, back pain, dyspnea, cough, fatigue, myalgia, lethargy, contusion, swelling, erythema and fever.  The patient's medical history included, common variable immune deficiency and reccuring bronchial infections back to 2014.Concomitant medications included,gamma globulin was reported.   On 29-jan-2021, the patient received the first of two planned doses of mRNA-1273 (lot/batch 010W20A) for prophylaxis of COVID-19 infection.On 26-Feb-2021,prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 013A21A) for prophylaxis of COVID-19 infection  On 26-Feb-2021,the patient experienced arm began to swell,getting to the size of a baseball and had an indent in the middle, it was red on the outside and white in the middle, the next day it turned into a bruise, she had a fever of 100.9 degrees Fahrenheit for 5 days, lethargy, body aches and she continues to feel fatigue, soon after the vaccination, she developed a dry cough and continues to have it, also experienced shortness of breath which did not allow her to lay flat on her back in her bed.   She got a steroid injection to treat her chronic back pain issues, after the injection the symptoms she was having improved her discomfort, her cough is little bit better. Patient has an autoimmune disorder CVID (Common variable immune deficiency).No laboratory data was provided.  Treatment information included, steroid injection to treat her chronic back pain issues, gamma globulin injections every Friday for CVID (Common variable immune deficiency) and steroid inhaler for bronchial infection.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   The outcome of the event pyrexia was considered as resolved on 02 Mar 2021. The outcome of the events, bronchitis, chest discomfort, back pain, dyspnea, cough, fatigue, myalgia, lethargy, contusion, swelling, erythema was considered as unknown at the time of the report.; Reporter's Comments: Based on the 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.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Orthopnoea, Pyrexia, Vaccination site induration
Clinical narrative: bronchial infection, chest discomfort and cough; bruise, erythem and swelling; body aches; fatigue; fever of 100.9 degrees Fahrenheit for 5 days; lethargy; shortness of breath; chronic back pain issues; A spontaneous report was received from a consumer concerning a 71- year old-female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bronchitis, chest discomfort, back pain, dyspnea, cough, fatigue, myalgia, lethargy, contusion, swelling, erythema and fever.  The patient's medical history included, common variable immune deficiency and reccuring bronchial infections back to 2014.Concomitant medications included,gamma globulin was reported.   On 29-jan-2021, the patient received the first of two planned doses of mRNA-1273 (lot/batch 010W20A) for prophylaxis of COVID-19 infection.On 26-Feb-2021,prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 013A21A) for prophylaxis of COVID-19 infection  On 26-Feb-2021,the patient experienced arm began to swell,getting to the size of a baseball and had an indent in the middle, it was red on the outside and white in the middle, the next day it turned into a bruise, she had a fever of 100.9 degrees Fahrenheit for 5 days, lethargy, body aches and she continues to feel fatigue, soon after the vaccination, she developed a dry cough and continues to have it, also experienced shortness of breath which did not allow her to lay flat on her back in her bed.   She got a steroid injection to treat her chronic back pain issues, after the injection the symptoms she was having improved her discomfort, her cough is little bit better. Patient has an autoimmune disorder CVID (Common variable immune deficiency).No laboratory data was provided.  Treatment information included, steroid injection to treat her chronic back pain issues, gamma globulin injections every Friday for CVID (Common variable immune deficiency) and steroid inhaler for bronchial infection.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   The outcome of the event pyrexia was considered as resolved on 02 Mar 2021. The outcome of the events, bronchitis, chest discomfort, back pain, dyspnea, cough, fatigue, myalgia, lethargy, contusion, swelling, erythema was considered as unknown at the time of the report.; Reporter's Comments: Based on the 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.