chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Pain in extremity, Poor quality sleep
Clinical narrative: Sore arm; Didn't sleep well; Wasn't feeling well; headache; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), POOR QUALITY SLEEP (Didn't sleep well), MALAISE (Wasn't feeling well), HEADACHE (headache) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism, Acid reflux (oesophageal), Penicillin allergy and Drug allergy (Allergic to Sulfa drug and Zofran.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and PANTOPRAZOLE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), POOR QUALITY SLEEP (Didn't sleep well), MALAISE (Wasn't feeling well), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches). At the time of the report, PAIN IN EXTREMITY (Sore arm), POOR QUALITY SLEEP (Didn't sleep well), MALAISE (Wasn't feeling well), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.            Treatment medication was not reported.   This case was linked to MOD-2021-024115 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore arm; Didn't sleep well; Wasn't feeling well; headache; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), POOR QUALITY SLEEP (Didn't sleep well), MALAISE (Wasn't feeling well), HEADACHE (headache) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism, Acid reflux (oesophageal), Penicillin allergy and Drug allergy (Allergic to Sulfa drug and Zofran.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and PANTOPRAZOLE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), POOR QUALITY SLEEP (Didn't sleep well), MALAISE (Wasn't feeling well), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches). At the time of the report, PAIN IN EXTREMITY (Sore arm), POOR QUALITY SLEEP (Didn't sleep well), MALAISE (Wasn't feeling well), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.            Treatment medication was not reported.   This case was linked to MOD-2021-024115 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Peripheral coldness
Clinical narrative: leg weakness; cold hands/cold feet; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (leg weakness), PERIPHERAL COLDNESS (cold hands/cold feet) and CHILLS (chills) in a 71-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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced ASTHENIA (leg weakness), PERIPHERAL COLDNESS (cold hands/cold feet) and CHILLS (chills). On 17-Mar-2021, ASTHENIA (leg weakness) outcome was unknown. At the time of the report, PERIPHERAL COLDNESS (cold hands/cold feet) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: site of injection is swelling; site of injection has red mark; site of injection has pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (site of injection is swelling), VACCINATION SITE ERYTHEMA (site of injection has red mark) and VACCINATION SITE PAIN (site of injection has pain) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE SWELLING (site of injection is swelling), VACCINATION SITE ERYTHEMA (site of injection has red mark) and VACCINATION SITE PAIN (site of injection has pain). At the time of the report, VACCINATION SITE SWELLING (site of injection is swelling), VACCINATION SITE ERYTHEMA (site of injection has red mark) and VACCINATION SITE PAIN (site of injection has pain) outcome was unknown. Not Provided      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.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypersensitivity, Oropharyngeal discomfort
Clinical narrative: Severe allergic reaction; Heart was racing/heart rate was 180 bpm; Throat felt like it was closing; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Severe allergic reaction), HEART RATE INCREASED (Heart was racing/heart rate was 180 bpm) and OROPHARYNGEAL DISCOMFORT (Throat felt like it was closing) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced HYPERSENSITIVITY (Severe allergic reaction), HEART RATE INCREASED (Heart was racing/heart rate was 180 bpm) and OROPHARYNGEAL DISCOMFORT (Throat felt like it was closing). At the time of the report, HYPERSENSITIVITY (Severe allergic reaction), HEART RATE INCREASED (Heart was racing/heart rate was 180 bpm) and OROPHARYNGEAL DISCOMFORT (Throat felt like it was closing) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Blood pressure measurement: 204/100 (High) High and 130/80 (normal) After 1 hour. On 19-Mar-2021, Heart rate: 180 (High) 180bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment provided was IV in the ambulance.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up received on 06-Aug-2021 and included Outcome of all the events were updated to recovered and reporter details (e-mail ID) was added.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 33-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-Oct-2020 and the estimated date of delivery was 09-Jul-2021. On 20-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 20-Mar-2021, EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported No treatment medication was reported    Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: NNI
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Product dose omission issue, Vaccination complication, Vaccination site erythema
Clinical narrative: Had a bad reaction; Missed 2nd dose; Injection site became pinkish red and itchy; Injection site became pinkish red and itchy; Left arm was swollen; Bad chills; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a bad reaction), PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose), VACCINATION SITE PRURITUS (Injection site became pinkish red and itchy), VACCINATION SITE SWELLING (Left arm was swollen) and CHILLS (Bad chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information history was provided.  Concomitant products included LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Mar-2021, the patient experienced CHILLS (Bad chills) and NAUSEA (Nauseated). On 16-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Left arm was swollen). On 18-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site became pinkish red and itchy) and VACCINATION SITE ERYTHEMA (Injection site became pinkish red and itchy). On an unknown date, the patient experienced VACCINATION COMPLICATION (Had a bad reaction) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose). On 15-Mar-2021, CHILLS (Bad chills) had resolved. At the time of the report, VACCINATION COMPLICATION (Had a bad reaction), VACCINATION SITE PRURITUS (Injection site became pinkish red and itchy), VACCINATION SITE SWELLING (Left arm was swollen), NAUSEA (Nauseated) and VACCINATION SITE ERYTHEMA (Injection site became pinkish red and itchy) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medication.  Treatment details included cold compress.  Patient did not want to take 2nd dose after having serious side effects of 1st dose in march.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Narrative updated On 09-Aug-2021: Follow up received included new event was added.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Had a bad reaction; Missed 2nd dose; Injection site became pinkish red and itchy; Injection site became pinkish red and itchy; Left arm was swollen; Bad chills; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a bad reaction), PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose), VACCINATION SITE PRURITUS (Injection site became pinkish red and itchy), VACCINATION SITE SWELLING (Left arm was swollen) and CHILLS (Bad chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information history was provided.  Concomitant products included LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Mar-2021, the patient experienced CHILLS (Bad chills) and NAUSEA (Nauseated). On 16-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Left arm was swollen). On 18-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site became pinkish red and itchy) and VACCINATION SITE ERYTHEMA (Injection site became pinkish red and itchy). On an unknown date, the patient experienced VACCINATION COMPLICATION (Had a bad reaction) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose). On 15-Mar-2021, CHILLS (Bad chills) had resolved. At the time of the report, VACCINATION COMPLICATION (Had a bad reaction), VACCINATION SITE PRURITUS (Injection site became pinkish red and itchy), VACCINATION SITE SWELLING (Left arm was swollen), NAUSEA (Nauseated) and VACCINATION SITE ERYTHEMA (Injection site became pinkish red and itchy) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medication.  Treatment details included cold compress.  Patient did not want to take 2nd dose after having serious side effects of 1st dose in march.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Narrative updated On 09-Aug-2021: Follow up received included new event was added.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Hyperhidrosis, Mental disorder
Clinical narrative: Feel bad; Feel like the cold; Began to sweat/neck and armpit were sweating; Broke down; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel bad), FEELING COLD (Feel like the cold), HYPERHIDROSIS (Began to sweat/neck and armpit were sweating) and MENTAL DISORDER (Broke down) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Galactosemia.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced FEELING ABNORMAL (Feel bad), FEELING COLD (Feel like the cold), HYPERHIDROSIS (Began to sweat/neck and armpit were sweating) and MENTAL DISORDER (Broke down). At the time of the report, FEELING ABNORMAL (Feel bad), FEELING COLD (Feel like the cold), HYPERHIDROSIS (Began to sweat/neck and armpit were sweating) and MENTAL DISORDER (Broke down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included medication for GALT.  Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Induration, Myalgia, Rash, Swelling
Clinical narrative: Skin around the bump is hard; Bump right on the crease of her behind; Feel a little sore when she sat down; Rash; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Mar-2021. The most recent information was received on 15-Jul-2021 and was forwarded to Moderna on 15-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Bump right on the crease of her behind) and RASH (Rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination.     Concomitant products included CAFFEINE, CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEIN #3) for Back pain, VERAPAMIL for Blood pressure management, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 03-Feb-2021 at 5:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 5:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced SWELLING (Bump right on the crease of her behind) and RASH (Rash). The patient was treated with CORTISONE (topical) ongoing from 03-May-2021 at a dose of 1 dosage form once a day. At the time of the report, SWELLING (Bump right on the crease of her behind) and RASH (Rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 117/77 mmHg (Low) 117/77.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided.  Action taken with mRNA-1273 in response to events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Updated the address of the secondary reporter. Added the patient details which includes height, weight, race and ethinicity. Added lab data which includes Blood pressure. Added the reported indication and dosage regimen for concomitant medication Tylenol-Codeine #3 and Verapamil. Added the concomitant medication multivitamins along with the dosage regimen. Added starting date of the events. Updated the outcome of the events from  unknown to not recovered.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Wrong product administered
Clinical narrative: Found out that he received Pfizer Vaccine; Shivering,Chills; Nausea continuing; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Found out that he received Pfizer Vaccine), CHILLS (Shivering,Chills) and NAUSEA (Nausea continuing) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. E1269) for COVID-19 vaccination.     Concurrent medical conditions included Hormone therapy.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced CHILLS (Shivering,Chills) and NAUSEA (Nausea continuing). On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Found out that he received Pfizer Vaccine). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, WRONG PRODUCT ADMINISTERED (Found out that he received Pfizer Vaccine), CHILLS (Shivering,Chills) and NAUSEA (Nausea continuing) had resolved.            Concomitant medications taken were hormones injections.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up information was received on 21 May 2021 in which first dose details and new event nausea was added. On 06-Aug-2021: Follow-up information received: Event outcome updated
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching all over the body got worse; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRURITUS (Itching all over the body got worse) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hard of hearing since an unknown date and Chemotherapy (Patient on chemo since NOV2020.) in November 2020.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Itching all over the body got worse). At the time of the report, PRURITUS (Itching all over the body got worse) had not resolved.            No concomitant medication provided.   No treatment information provided.  Action taken with mRNA-1273 in response to the event was not applicable as patient took both doses of the vaccine.    This case was linked to MOD-2021-053344.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Fatigue, Feeling cold, Pain in extremity
Clinical narrative: sore arm; left dizzy; coldness that started in her sternum, radiated to chest, lungs and down arms to wrists; Pressure in chest area; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DIZZINESS (left dizzy), FEELING COLD (coldness that started in her sternum, radiated to chest, lungs and down arms to wrists), CHEST DISCOMFORT (Pressure in chest area) and FATIGUE (Tiredness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Vegetable allergy (Green peppers, Egg plant), Drug allergy (Parabens, Codeine), Toothpaste allergy, Seasonal allergy (Respiratory/seasonal allergies) and High cholesterol. Concomitant products included ROSUVASTATIN and EZETIMIBE for High cholesterol, UBIDECARENONE (COQ10 [UBIDECARENONE]) and LUTEIN [XANTOFYL] for Supplementation therapy, DIPHENHYDRAMINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL ALLERGY & SINUS), EZETIMIBE (ZETIA), MULTIVITAMIN [VITAMINS NOS] and CENTRUM SILVER +50 for an unknown indication.    On 10-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), DIZZINESS (left dizzy), FEELING COLD (coldness that started in her sternum, radiated to chest, lungs and down arms to wrists), CHEST DISCOMFORT (Pressure in chest area) and FATIGUE (Tiredness). On 10-Mar-2021, PAIN IN EXTREMITY (sore arm), DIZZINESS (left dizzy) and FEELING COLD (coldness that started in her sternum, radiated to chest, lungs and down arms to wrists) had resolved. At the time of the report, CHEST DISCOMFORT (Pressure in chest area) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (sore arm), DIZZINESS (left dizzy), FEELING COLD (coldness that started in her sternum, radiated to chest, lungs and down arms to wrists), CHEST DISCOMFORT (Pressure in chest area) and FATIGUE (Tiredness) to be related.    This case was linked to MOD-2021-130045 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Patient demographic details, Past Medical history, 2nd dose information, concomitant medications, reporter causality, and outcome of events added.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Periorbital swelling, Swelling face
Clinical narrative: Face got puffy; burning sensation on chest and neck, feels like needles; neck area is slightly red about 4-5 inches area; Eyes got puffy; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face got puffy), BURNING SENSATION (burning sensation on chest and neck, feels like needles), ERYTHEMA (neck area is slightly red about 4-5 inches area) and PERIORBITAL SWELLING (Eyes got puffy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced SWELLING FACE (Face got puffy), BURNING SENSATION (burning sensation on chest and neck, feels like needles), ERYTHEMA (neck area is slightly red about 4-5 inches area) and PERIORBITAL SWELLING (Eyes got puffy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Face got puffy), BURNING SENSATION (burning sensation on chest and neck, feels like needles), ERYTHEMA (neck area is slightly red about 4-5 inches area) and PERIORBITAL SWELLING (Eyes got puffy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant FU- Outcome of events provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: flu like symptoms; Her arm is still a bit sore; she reported experiencing fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (Her arm is still a bit sore) and FATIGUE (she reported experiencing fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A24A) for COVID-19 vaccination.     Concurrent medical conditions included UTI (she takes antibiotics for a suspected UTI).    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 INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (Her arm is still a bit sore) and FATIGUE (she reported experiencing fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (Her arm is still a bit sore) and FATIGUE (she reported experiencing fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Vaccination site erythema, Vaccination site infection
Clinical narrative: Developed an infection at the injection site; 5 days after shot I developed a cold. I never get a cold. It's basically in my chest; 2 weeks after shot my arm is still red an inch or two below where I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (5 days after shot I developed a cold. I never get a cold. It's basically in my chest), VACCINATION SITE INFECTION (Developed an infection at the injection site) and VACCINATION SITE ERYTHEMA (2 weeks after shot my arm is still red an inch or two below where I got the shot) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and #040A214) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (2 weeks after shot my arm is still red an inch or two below where I got the shot). On 14-Mar-2021, the patient experienced NASOPHARYNGITIS (5 days after shot I developed a cold. I never get a cold. It's basically in my chest). On an unknown date, the patient experienced VACCINATION SITE INFECTION (Developed an infection at the injection site). At the time of the report, NASOPHARYNGITIS (5 days after shot I developed a cold. I never get a cold. It's basically in my chest), VACCINATION SITE INFECTION (Developed an infection at the injection site) and VACCINATION SITE ERYTHEMA (2 weeks after shot my arm is still red an inch or two below where I got the shot) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medicines includes antibiotic for 3 weeks.  Action taken with the drug in response to events was not applicable.   This case was linked to MOD-2021-272299, MOD-2021-272299 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Added New event and  Event Outcome. Second dose information were added. On 30-Jul-2021: Follow-up contains no significant information.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache lasted for 3 weeks) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. No medical history was reported. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced HEADACHE (Headache lasted for 3 weeks). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache lasted for 3 weeks) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-053409.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) 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 No adverse event.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.            No concomitant medications were provided.  Treatment medications were unknown.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Biliary colic
Clinical narrative: Pain in gallbladder; This spontaneous case was reported by a consumer and describes the occurrence of BILIARY COLIC (Pain in gallbladder) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included Gallstones.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced BILIARY COLIC (Pain in gallbladder). At the time of the report, BILIARY COLIC (Pain in gallbladder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: soreness of her lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (soreness of her lymph nodes) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced LYMPH NODE PAIN (soreness of her lymph nodes). At the time of the report, LYMPH NODE PAIN (soreness of her lymph nodes) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Musculoskeletal stiffness, Pruritus, Swelling face, Vaccination site swelling
Clinical narrative: suddenly at night I felt itchy hands, knees, neck, face, you could not believe it, you can't imagine; in the place of the shot is swollen; started feeling very bad, swollen, tired and I wasn't able to move my neck, everything was bad; face was swollen; neck became like red red red red, it was very hot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (started feeling very bad, swollen, tired and I wasn't able to move my neck, everything was bad), SWELLING FACE (face was swollen), ERYTHEMA (neck became like red red red red, it was very hot), PRURITUS (suddenly at night I felt itchy hands, knees, neck, face, you could not believe it, you can't imagine) and VACCINATION SITE SWELLING (in the place of the shot is swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (started feeling very bad, swollen, tired and I wasn't able to move my neck, everything was bad), SWELLING FACE (face was swollen), ERYTHEMA (neck became like red red red red, it was very hot) and VACCINATION SITE SWELLING (in the place of the shot is swollen). On 19-Mar-2021, the patient experienced PRURITUS (suddenly at night I felt itchy hands, knees, neck, face, you could not believe it, you can't imagine). On 19-Mar-2021, MUSCULOSKELETAL STIFFNESS (started feeling very bad, swollen, tired and I wasn't able to move my neck, everything was bad), SWELLING FACE (face was swollen), ERYTHEMA (neck became like red red red red, it was very hot) and VACCINATION SITE SWELLING (in the place of the shot is swollen) had resolved. At the time of the report, PRURITUS (suddenly at night I felt itchy hands, knees, neck, face, you could not believe it, you can't imagine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included applying rosewater topically for itching
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Exercise lack of, Muscular weakness, Myalgia
Clinical narrative: Not able to exercise as much as he normally does; more muscle weakness than usual; Chills; Achiness; Fever of 100.5 (his normal temp is 96.5); Shakes; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), EXERCISE LACK OF (Not able to exercise as much as he normally does), MUSCULAR WEAKNESS (more muscle weakness than usual), CHILLS (Chills) and MYALGIA (Achiness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 326289) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DICLOFENAMIDE (KEVEYIS) and SERTRALINE for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced TREMOR (Shakes), EXERCISE LACK OF (Not able to exercise as much as he normally does), MUSCULAR WEAKNESS (more muscle weakness than usual), CHILLS (Chills), MYALGIA (Achiness) and PYREXIA (Fever of 100.5 (his normal temp is 96.5)). At the time of the report, TREMOR (Shakes), EXERCISE LACK OF (Not able to exercise as much as he normally does), MUSCULAR WEAKNESS (more muscle weakness than usual), CHILLS (Chills), MYALGIA (Achiness) and PYREXIA (Fever of 100.5 (his normal temp is 96.5)) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 °F and 101 °F.         The patient advised that he had a reaction to his 2nd COVID-19 vaccination. He had fever around 101 degrees and chills for 2 days and they went away only to return 2 weeks later and last another 30 hours. The patient stated he also had an autoimmune response to the vaccine during this time. No other details provided.  Company comment: Based on current available information and the temporal association between product date and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Based on current available information and the temporal association between product date and the start date of the events a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Not able to exercise as much as he normally does; more muscle weakness than usual; Chills; Achiness; Fever of 100.5 (his normal temp is 96.5); Shakes; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), EXERCISE LACK OF (Not able to exercise as much as he normally does), MUSCULAR WEAKNESS (more muscle weakness than usual), CHILLS (Chills) and MYALGIA (Achiness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 326289) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DICLOFENAMIDE (KEVEYIS) and SERTRALINE for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced TREMOR (Shakes), EXERCISE LACK OF (Not able to exercise as much as he normally does), MUSCULAR WEAKNESS (more muscle weakness than usual), CHILLS (Chills), MYALGIA (Achiness) and PYREXIA (Fever of 100.5 (his normal temp is 96.5)). At the time of the report, TREMOR (Shakes), EXERCISE LACK OF (Not able to exercise as much as he normally does), MUSCULAR WEAKNESS (more muscle weakness than usual), CHILLS (Chills), MYALGIA (Achiness) and PYREXIA (Fever of 100.5 (his normal temp is 96.5)) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 °F and 101 °F.         The patient advised that he had a reaction to his 2nd COVID-19 vaccination. He had fever around 101 degrees and chills for 2 days and they went away only to return 2 weeks later and last another 30 hours. The patient stated he also had an autoimmune response to the vaccine during this time. No other details provided.  Company comment: Based on current available information and the temporal association between product date and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Based on current available information and the temporal association between product date and the start date of the events a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Ligament pain, Limb discomfort, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Shoulders down to her wrist are so sore), LIGAMENT PAIN (Almost affected her ligaments) and LIMB DISCOMFORT (Spread into her left arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. G12M20A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DENOSUMAB (PROLIA).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Shoulders down to her wrist are so sore), LIGAMENT PAIN (Almost affected her ligaments) and LIMB DISCOMFORT (Spread into her left arm). At the time of the report, PAIN IN EXTREMITY (Shoulders down to her wrist are so sore), LIGAMENT PAIN (Almost affected her ligaments) and LIMB DISCOMFORT (Spread into her left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was unknown
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Pain in my heart; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain in my heart) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Mar-2021, the patient experienced CHEST PAIN (Pain in my heart). At the time of the report, CHEST PAIN (Pain in my heart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Bowel discomfort; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Bowel discomfort) in a 51-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 ABDOMINAL DISCOMFORT (Bowel discomfort). At the time of the report, ABDOMINAL DISCOMFORT (Bowel discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported by the reporter  No treatment medication reported by the reporter
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: felt sore; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt sore ) and FATIGUE (tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 02AL20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), CALCIUM, TRAMADOL and VITAMIN B COMPLEX for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PAIN (felt sore ) and FATIGUE (tired). On 30-Jan-2021, PAIN (felt sore ) and FATIGUE (tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-043113 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced 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.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Insomnia, Myalgia, Pyrexia
Clinical narrative: shaking that She thought of like having seizure; feverish feeling; troubled sleeping; joint pain; achy feeling; tiredness; only had one experience; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INSOMNIA (troubled sleeping), TREMOR (shaking that She thought of like having seizure), VACCINATION COMPLICATION (only had one experience), ARTHRALGIA (joint pain) and MYALGIA (achy feeling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARVEDILOL, SPIRONOLACTONE, LOSARTAN, MULTIVITAMINS [VITAMINS NOS] and CALCIUM for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION COMPLICATION (only had one experience). On 18-Mar-2021, the patient experienced FATIGUE (tiredness). On 20-Mar-2021, the patient experienced INSOMNIA (troubled sleeping), ARTHRALGIA (joint pain) and MYALGIA (achy feeling). On 21-Mar-2021, the patient experienced TREMOR (shaking that She thought of like having seizure) and PYREXIA (feverish feeling). On 20-Mar-2021, FATIGUE (tiredness) had resolved. On 21-Mar-2021, TREMOR (shaking that She thought of like having seizure) had resolved. On 22-Mar-2021, INSOMNIA (troubled sleeping), VACCINATION COMPLICATION (only had one experience), ARTHRALGIA (joint pain), MYALGIA (achy feeling) and PYREXIA (feverish feeling) had resolved.            The patient was advised by primary care doctor to report these events as the side effects that occurred several days after the injection. The patient has not experienced any more side effects since the first experience. The patient consented to healthcare provider followup.  No treatment information was provided by the reporter.     Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant follow-up- Event added, first dose information was added, updated start and stop dates of events, and changed the primary regimen of the vaccine.