chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: had a temperature excursion where the highest the vials got was 10.6 degrees Celsius from about 7:30am-3:30pm; Administered doses from excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (had a temperature excursion where the highest the vials got was 10.6 degrees Celsius from about 7:30am-3:30pm) and EXPIRED PRODUCT ADMINISTERED (Administered doses from excursion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-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 PRODUCT STORAGE ERROR (had a temperature excursion where the highest the vials got was 10.6 degrees Celsius from about 7:30am-3:30pm) and EXPIRED PRODUCT ADMINISTERED (Administered doses from excursion). At the time of the report, PRODUCT STORAGE ERROR (had a temperature excursion where the highest the vials got was 10.6 degrees Celsius from about 7:30am-3:30pm) and EXPIRED PRODUCT ADMINISTERED (Administered doses from excursion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Source document received on 25/5/2021 does not contain any new information
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Got the second shot still have diarrhea; 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 DIARRHOEA (Got the second shot still have diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Got the second shot still have diarrhea). At the time of the report, DIARRHOEA (Got the second shot still have diarrhea) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information was not provided.   This case was linked to MOD-2021-168393 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up was received on 25 May 2021 included no new information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Burning sensation, Chills, Dizziness, Dyspepsia
Clinical narrative: Some side effects after first Moderna vaccine.; Stomach pain; Indigestion; Burning in head/Head was on fire; Dizziness; Vertigo episode; Injection site pain; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Some side effects after first Moderna vaccine.), ABDOMINAL PAIN UPPER (Stomach pain), DYSPEPSIA (Indigestion), BURNING SENSATION (Burning in head/Head was on fire) and DIZZINESS (Dizziness) in a 59-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.     Concomitant products included RANITIDINE HYDROCHLORIDE (ZANTAC) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), DYSPEPSIA (Indigestion), BURNING SENSATION (Burning in head/Head was on fire), DIZZINESS (Dizziness), VERTIGO (Vertigo episode), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills) and FATIGUE (Fatigue). On an unknown date, the patient experienced VACCINATION COMPLICATION (Some side effects after first Moderna vaccine.). At the time of the report, VACCINATION COMPLICATION (Some side effects after first Moderna vaccine.), ABDOMINAL PAIN UPPER (Stomach pain), DYSPEPSIA (Indigestion), BURNING SENSATION (Burning in head/Head was on fire), DIZZINESS (Dizziness), VERTIGO (Vertigo episode), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient received concomitant medications like allergy medications and vertigo medications.   This case was linked to MOD-2021-168509 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow-up
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination complication, Vaccination site pain, Vertigo
Clinical narrative: Some side effects after first Moderna vaccine.; Stomach pain; Indigestion; Burning in head/Head was on fire; Dizziness; Vertigo episode; Injection site pain; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Some side effects after first Moderna vaccine.), ABDOMINAL PAIN UPPER (Stomach pain), DYSPEPSIA (Indigestion), BURNING SENSATION (Burning in head/Head was on fire) and DIZZINESS (Dizziness) in a 59-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.     Concomitant products included RANITIDINE HYDROCHLORIDE (ZANTAC) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), DYSPEPSIA (Indigestion), BURNING SENSATION (Burning in head/Head was on fire), DIZZINESS (Dizziness), VERTIGO (Vertigo episode), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills) and FATIGUE (Fatigue). On an unknown date, the patient experienced VACCINATION COMPLICATION (Some side effects after first Moderna vaccine.). At the time of the report, VACCINATION COMPLICATION (Some side effects after first Moderna vaccine.), ABDOMINAL PAIN UPPER (Stomach pain), DYSPEPSIA (Indigestion), BURNING SENSATION (Burning in head/Head was on fire), DIZZINESS (Dizziness), VERTIGO (Vertigo episode), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient received concomitant medications like allergy medications and vertigo medications.   This case was linked to MOD-2021-168509 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow-up
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Heart rate, Insomnia
Clinical narrative: she couldn't sleep; feel a strong pressure on her left breast; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (she couldn't sleep) and BREAST DISCOMFORT (feel a strong pressure on her left breast) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] and CYANOCOBALAMIN (VITAMIN B12 FORTE) for an unknown indication.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (she couldn't sleep) and BREAST DISCOMFORT (feel a strong pressure on her left breast). At the time of the report, INSOMNIA (she couldn't sleep) and BREAST DISCOMFORT (feel a strong pressure on her left breast) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Heart rate: 59/min (Inconclusive) 59/min.         Treatment information in response to events was not provided.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-168412 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: Neck pain; headache; 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 NECK PAIN (Neck pain) and HEADACHE (headache) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Neck pain) and HEADACHE (headache). At the time of the report, NECK PAIN (Neck pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: On 25-may-2021, No new information was added(Non significant follow-up)
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient is only 16 years old and received 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is only 16 years old and received 1st dose) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is only 16 years old and received 1st dose). On 27-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is only 16 years old and received 1st dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up document is received on 25-MAY-2021 and it doesn't contain any new information
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Sleep terror
Clinical narrative: Night terror; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP TERROR (Night terror) and HYPERHIDROSIS (Sweating) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced SLEEP TERROR (Night terror) and HYPERHIDROSIS (Sweating). At the time of the report, SLEEP TERROR (Night terror) and HYPERHIDROSIS (Sweating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication included.  No treatment medication included.  Patient reported that after the second shot, her arm/shoulder started to hurt, she started feeling poorly around 12 hours in, she had a fever, aches, and a horrible headache that lasted for about 12 hours. She also tested positive for COVID-19 on 23May2021.   This case was linked to MOD-2021-168596 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received and contain no new information. On 27-Jul-2021: Follow-up received and contain non-significant information
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had a sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 047B21A) for COVID-19 vaccination.     No medical history was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced VACCINATION SITE PAIN (had a sore arm). At the time of the report, VACCINATION SITE PAIN (had a sore arm) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No concomitant and treatment medication was reported   This case was linked to MOD-2021-168611 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Erythema, Eye swelling, Injection site pain
Clinical narrative: Facial swelling still persists; Severe swelling under left eye, which blocks vision; Swelling under both eyes; Redness on face; dizziness; Injected arm was sore; Chills; fever; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness), EYE SWELLING (Swelling under both eyes), ERYTHEMA (Redness on face), SWELLING FACE (Facial swelling still persists) and SWELLING (Severe swelling under left eye, which blocks vision) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE and ALBUTEROL [SALBUTAMOL] for an unknown indication.   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) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced DIZZINESS (dizziness), INJECTION SITE PAIN (Injected arm was sore), CHILLS (Chills) and PYREXIA (fever). On 21-Mar-2021, the patient experienced EYE SWELLING (Swelling under both eyes) and ERYTHEMA (Redness on face). On an unknown date, the patient experienced SWELLING FACE (Facial swelling still persists) and SWELLING (Severe swelling under left eye, which blocks vision). The patient was treated with HYDROCORTISONE at a dose of 1 dosage form and FEXOFENADINE at a dose of 1 dosage form. At the time of the report, DIZZINESS (dizziness), EYE SWELLING (Swelling under both eyes), ERYTHEMA (Redness on face), SWELLING FACE (Facial swelling still persists), SWELLING (Severe swelling under left eye, which blocks vision), INJECTION SITE PAIN (Injected arm was sore), CHILLS (Chills) and PYREXIA (fever) outcome was unknown.            Treatment information includes Hydrocortisone cream and Fexofenadine   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-may-2021 contain no new information; Reporter's Comments: NA; Sender's Comments: NA
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Swelling face
Clinical narrative: Facial swelling still persists; Severe swelling under left eye, which blocks vision; Swelling under both eyes; Redness on face; dizziness; Injected arm was sore; Chills; fever; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness), EYE SWELLING (Swelling under both eyes), ERYTHEMA (Redness on face), SWELLING FACE (Facial swelling still persists) and SWELLING (Severe swelling under left eye, which blocks vision) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE and ALBUTEROL [SALBUTAMOL] for an unknown indication.   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) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced DIZZINESS (dizziness), INJECTION SITE PAIN (Injected arm was sore), CHILLS (Chills) and PYREXIA (fever). On 21-Mar-2021, the patient experienced EYE SWELLING (Swelling under both eyes) and ERYTHEMA (Redness on face). On an unknown date, the patient experienced SWELLING FACE (Facial swelling still persists) and SWELLING (Severe swelling under left eye, which blocks vision). The patient was treated with HYDROCORTISONE at a dose of 1 dosage form and FEXOFENADINE at a dose of 1 dosage form. At the time of the report, DIZZINESS (dizziness), EYE SWELLING (Swelling under both eyes), ERYTHEMA (Redness on face), SWELLING FACE (Facial swelling still persists), SWELLING (Severe swelling under left eye, which blocks vision), INJECTION SITE PAIN (Injected arm was sore), CHILLS (Chills) and PYREXIA (fever) outcome was unknown.            Treatment information includes Hydrocortisone cream and Fexofenadine   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-may-2021 contain no new information; Reporter's Comments: NA; Sender's Comments: NA
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No specific follow-up information recorded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Toothache, Vaccination site pain
Clinical narrative: really unhappy tooth; Tooth swollen; shot hurt like a tetanus shot; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (really unhappy tooth), SWELLING (Tooth swollen) and VACCINATION SITE PAIN (shot hurt like a tetanus shot) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048b21a) for COVID-19 vaccination.     The patient's past medical history included Tooth abnormal. Concurrent medical conditions included Menopause.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced TOOTHACHE (really unhappy tooth), SWELLING (Tooth swollen) and VACCINATION SITE PAIN (shot hurt like a tetanus shot). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, TOOTHACHE (really unhappy tooth), SWELLING (Tooth swollen) and VACCINATION SITE PAIN (shot hurt like a tetanus shot) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Concomitant drug was not reported.     This case was linked to MOD-2021-168750 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Blood thyroid stimulating hormone increased, Product dose omission issue, Thyroxine increased, Tri-iodothyronine increased
Clinical narrative: Plans to receive second dose >35 days from first dose; TSH increased; T3 increased; t4 increased; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Plans to receive second dose >35 days from first dose), BLOOD THYROID STIMULATING HORMONE INCREASED (TSH increased), TRI-IODOTHYRONINE INCREASED (T3 increased) and THYROXINE INCREASED (t4 increased) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TAMSULOSIN for an unknown indication.    On 30-Mar-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 PRODUCT DOSE OMISSION ISSUE (Plans to receive second dose >35 days from first dose), BLOOD THYROID STIMULATING HORMONE INCREASED (TSH increased), TRI-IODOTHYRONINE INCREASED (T3 increased) and THYROXINE INCREASED (t4 increased). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Plans to receive second dose >35 days from first dose) outcome was unknown and BLOOD THYROID STIMULATING HORMONE INCREASED (TSH increased), TRI-IODOTHYRONINE INCREASED (T3 increased) and THYROXINE INCREASED (t4 increased) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: elevated (High) Routine bloodwork done and it came back with elevated TSH, T3, and T4..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  The patient then had a visit with his endocrinologist and was told to restart the series there while his HCP (health care professional) wanted him to get the second dose even though his thyroid values were abnormal. Currently, his values are all back within normal range and plans on following through with his HCPs recommendations about getting the second dose. Wanted to know if that had been reported before and if he needs to restart the series due to him currently being at day 55.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Feeling abnormal, Headache
Clinical narrative: Hot flushes at night; I am feeling nervousness; I have high Blood pressure. Ranging from 145-160 to 90-98; headache, it is dull headache; fever; chills; ringing of ear, it is like something buzzing in ear in ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing of ear, it is like something buzzing in ear in ear), HOT FLUSH (Hot flushes at night), FEELING ABNORMAL (I am feeling nervousness), HYPERTENSION (I have high Blood pressure. Ranging from 145-160 to 90-98) and HEADACHE (headache, it is dull headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced TINNITUS (ringing of ear, it is like something buzzing in ear in ear), HEADACHE (headache, it is dull headache), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced HOT FLUSH (Hot flushes at night), FEELING ABNORMAL (I am feeling nervousness) and HYPERTENSION (I have high Blood pressure. Ranging from 145-160 to 90-98). On 02-Mar-2021, PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, TINNITUS (ringing of ear, it is like something buzzing in ear in ear), HOT FLUSH (Hot flushes at night), FEELING ABNORMAL (I am feeling nervousness), HYPERTENSION (I have high Blood pressure. Ranging from 145-160 to 90-98) and HEADACHE (headache, it is dull headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Blood pressure measurement: 145-160/90-98 (Inconclusive) 145-160 Systolic 90-98 Diastolic. On 27-Feb-2021, Body temperature: 103.4 (Inconclusive) 103.4.         Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No concomitant medications were reported. No treatment was reported.  Symptoms: Patient reported that she had hot flushes in night which got worst and kept her awake at night Action taken with mRNA-1273 in response to the event was not applicable.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hypertension, Pyrexia, Tinnitus
Clinical narrative: Hot flushes at night; I am feeling nervousness; I have high Blood pressure. Ranging from 145-160 to 90-98; headache, it is dull headache; fever; chills; ringing of ear, it is like something buzzing in ear in ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing of ear, it is like something buzzing in ear in ear), HOT FLUSH (Hot flushes at night), FEELING ABNORMAL (I am feeling nervousness), HYPERTENSION (I have high Blood pressure. Ranging from 145-160 to 90-98) and HEADACHE (headache, it is dull headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced TINNITUS (ringing of ear, it is like something buzzing in ear in ear), HEADACHE (headache, it is dull headache), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced HOT FLUSH (Hot flushes at night), FEELING ABNORMAL (I am feeling nervousness) and HYPERTENSION (I have high Blood pressure. Ranging from 145-160 to 90-98). On 02-Mar-2021, PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, TINNITUS (ringing of ear, it is like something buzzing in ear in ear), HOT FLUSH (Hot flushes at night), FEELING ABNORMAL (I am feeling nervousness), HYPERTENSION (I have high Blood pressure. Ranging from 145-160 to 90-98) and HEADACHE (headache, it is dull headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Blood pressure measurement: 145-160/90-98 (Inconclusive) 145-160 Systolic 90-98 Diastolic. On 27-Feb-2021, Body temperature: 103.4 (Inconclusive) 103.4.         Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No concomitant medications were reported. No treatment was reported.  Symptoms: Patient reported that she had hot flushes in night which got worst and kept her awake at night Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: I took the Moderna vaccine on the 15th, my arm has a red PII(28):AdwnHnismDUvdy9+FqxlmmYqxNnr and itchy; took the Moderna vaccine on the 15th, my arm has a red PII(28):AdwnHnismDUvdy9+FqxlmmYqxNnr and itchy; 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 VACCINATION SITE ERYTHEMA (I took the Moderna vaccine on the 15th, my arm has a red PII(28):AdwnHnismDUvdy9+FqxlmmYqxNnr and itchy) and VACCINATION SITE PRURITUS (took the Moderna vaccine on the 15th, my arm has a red PII(28):AdwnHnismDUvdy9+FqxlmmYqxNnr and itchy) in a patient of an unknown age and gender 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) (unknown route) Unknown. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (I took the Moderna vaccine on the 15th, my arm has a red PII(28):AdwnHnismDUvdy9+FqxlmmYqxNnr and itchy) and VACCINATION SITE PRURITUS (took the Moderna vaccine on the 15th, my arm has a red PII(28):AdwnHnismDUvdy9+FqxlmmYqxNnr and itchy). At the time of the report, VACCINATION SITE ERYTHEMA (I took the Moderna vaccine on the 15th, my arm has a red PII(28):AdwnHnismDUvdy9+FqxlmmYqxNnr and itchy) and VACCINATION SITE PRURITUS (took the Moderna vaccine on the 15th, my arm has a red PII(28):AdwnHnismDUvdy9+FqxlmmYqxNnr and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Ear discomfort
Clinical narrative: developed sudden onset ear popping  (as if on an airplane); significant feeling of intense pressure; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of EAR DISCOMFORT (developed sudden onset ear popping  (as if on an airplane)) and EAR DISCOMFORT (significant feeling of intense pressure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EAR DISCOMFORT (developed sudden onset ear popping  (as if on an airplane)) and EAR DISCOMFORT (significant feeling of intense pressure). At the time of the report, EAR DISCOMFORT (developed sudden onset ear popping  (as if on an airplane)) and EAR DISCOMFORT (significant feeling of intense pressure) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.  Patient reported events occurred one month after the second dose.  No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow up appended
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Myalgia
Clinical narrative: Almost feels like a head rush that doesn't go away; "spells" of EXTREME exhaustion and body aches that come and go since; got my vaccine on Friday and have been having "spells" of EXTREME exhaustion and body aches that come and go since; 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 HEAD DISCOMFORT (Almost feels like a head rush that doesn't go away), FATIGUE ("spells" of EXTREME exhaustion and body aches that come and go since) and MYALGIA (got my vaccine on Friday and have been having "spells" of EXTREME exhaustion and body aches that come and go since) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (Almost feels like a head rush that doesn't go away), FATIGUE ("spells" of EXTREME exhaustion and body aches that come and go since) and MYALGIA (got my vaccine on Friday and have been having "spells" of EXTREME exhaustion and body aches that come and go since). At the time of the report, HEAD DISCOMFORT (Almost feels like a head rush that doesn't go away), FATIGUE ("spells" of EXTREME exhaustion and body aches that come and go since) and MYALGIA (got my vaccine on Friday and have been having "spells" of EXTREME exhaustion and body aches that come and go since) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Followup case
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Brain fog a few weeks after second shot; 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 FEELING ABNORMAL (Brain fog a few weeks after second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Brain fog a few weeks after second shot). At the time of the report, FEELING ABNORMAL (Brain fog a few weeks after second shot) outcome was unknown. Not Provided          No concomitant medication was reported. No treatment was reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: she felt pretty ill and had to take a sick day from work after second dose/ feeling poorly; after the second shot, her arm started to hurt,aches; after the second shot, her arm/shoulder started to hurt; Fever; horrible headache that lasted for about 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she felt pretty ill and had to take a sick day from work after second dose/ feeling poorly), MYALGIA (after the second shot, her arm started to hurt,aches), ARTHRALGIA (after the second shot, her arm/shoulder started to hurt), PYREXIA (Fever) and HEADACHE (horrible headache that lasted for about 12 hours) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A; and 025L20A) for COVID-19 vaccination.     No medical history was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced MALAISE (she felt pretty ill and had to take a sick day from work after second dose/ feeling poorly), MYALGIA (after the second shot, her arm started to hurt,aches), ARTHRALGIA (after the second shot, her arm/shoulder started to hurt), PYREXIA (Fever) and HEADACHE (horrible headache that lasted for about 12 hours). At the time of the report, MALAISE (she felt pretty ill and had to take a sick day from work after second dose/ feeling poorly), MYALGIA (after the second shot, her arm started to hurt,aches), ARTHRALGIA (after the second shot, her arm/shoulder started to hurt), PYREXIA (Fever) and HEADACHE (horrible headache that lasted for about 12 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2021, SARS-CoV-2 test: positive for covid-19 (Positive) positive for COVID-19.         Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.        Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: she felt pretty ill and had to take a sick day from work after second dose/ feeling poorly; after the second shot, her arm started to hurt,aches; after the second shot, her arm/shoulder started to hurt; Fever; horrible headache that lasted for about 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she felt pretty ill and had to take a sick day from work after second dose/ feeling poorly), MYALGIA (after the second shot, her arm started to hurt,aches), ARTHRALGIA (after the second shot, her arm/shoulder started to hurt), PYREXIA (Fever) and HEADACHE (horrible headache that lasted for about 12 hours) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A; and 025L20A) for COVID-19 vaccination.     No medical history was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced MALAISE (she felt pretty ill and had to take a sick day from work after second dose/ feeling poorly), MYALGIA (after the second shot, her arm started to hurt,aches), ARTHRALGIA (after the second shot, her arm/shoulder started to hurt), PYREXIA (Fever) and HEADACHE (horrible headache that lasted for about 12 hours). At the time of the report, MALAISE (she felt pretty ill and had to take a sick day from work after second dose/ feeling poorly), MYALGIA (after the second shot, her arm started to hurt,aches), ARTHRALGIA (after the second shot, her arm/shoulder started to hurt), PYREXIA (Fever) and HEADACHE (horrible headache that lasted for about 12 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2021, SARS-CoV-2 test: positive for covid-19 (Positive) positive for COVID-19.         Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.        Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: very itchy left arm; arm is red; swollen, it feels like a ball is hanging; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (very itchy left arm), VACCINATION SITE ERYTHEMA (arm is red) and VACCINATION SITE SWELLING (swollen, it feels like a ball is hanging) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No medical history was reported.     On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (very itchy left arm), VACCINATION SITE ERYTHEMA (arm is red) and VACCINATION SITE SWELLING (swollen, it feels like a ball is hanging). At the time of the report, VACCINATION SITE PRURITUS (very itchy left arm), VACCINATION SITE ERYTHEMA (arm is red) and VACCINATION SITE SWELLING (swollen, it feels like a ball is hanging) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant was reported. No treatment was reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in arm) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE PAIN (Soreness in arm). On 11-Apr-2021, VACCINATION SITE PAIN (Soreness in arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-168633 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nasal congestion
Clinical narrative: hand pain; having chills; feeling achy; tired; slight headache; slight congestion; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (slight congestion), PAIN IN EXTREMITY (hand pain), CHILLS (having chills), MYALGIA (feeling achy) and FATIGUE (tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 24-May-2021, the patient experienced NASAL CONGESTION (slight congestion), CHILLS (having chills), MYALGIA (feeling achy), FATIGUE (tired) and HEADACHE (slight headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (hand pain). At the time of the report, NASAL CONGESTION (slight congestion), PAIN IN EXTREMITY (hand pain), CHILLS (having chills), MYALGIA (feeling achy), FATIGUE (tired) and HEADACHE (slight headache) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: hand pain; having chills; feeling achy; tired; slight headache; slight congestion; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (slight congestion), PAIN IN EXTREMITY (hand pain), CHILLS (having chills), MYALGIA (feeling achy) and FATIGUE (tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 24-May-2021, the patient experienced NASAL CONGESTION (slight congestion), CHILLS (having chills), MYALGIA (feeling achy), FATIGUE (tired) and HEADACHE (slight headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (hand pain). At the time of the report, NASAL CONGESTION (slight congestion), PAIN IN EXTREMITY (hand pain), CHILLS (having chills), MYALGIA (feeling achy), FATIGUE (tired) and HEADACHE (slight headache) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: I missed my 2nd vaccine passed 42 days...can i still get the 2nd; 2nd vaccine passed 42 days; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I missed my 2nd vaccine passed 42 days...can i still get the 2nd) and PRODUCT DOSE OMISSION ISSUE (2nd vaccine passed 42 days) in a patient of an unknown age and gender who received mRNA-1273 (batch no. Unknown) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I missed my 2nd vaccine passed 42 days...can i still get the 2nd) and PRODUCT DOSE OMISSION ISSUE (2nd vaccine passed 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I missed my 2nd vaccine passed 42 days..can i still get the 2nd) and PRODUCT DOSE OMISSION ISSUE (2nd vaccine passed 42 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Eye swelling, Periorbital swelling
Clinical narrative: left eye twitching; left eye swelling; left eye puffy; This spontaneous case was reported by a health care professional and describes the occurrence of BLEPHAROSPASM (left eye twitching), EYE SWELLING (left eye swelling) and PERIORBITAL SWELLING (left eye puffy) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 011L20A) for COVID-19 vaccination.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced BLEPHAROSPASM (left eye twitching), EYE SWELLING (left eye swelling) and PERIORBITAL SWELLING (left eye puffy). At the time of the report, BLEPHAROSPASM (left eye twitching), EYE SWELLING (left eye swelling) and PERIORBITAL SWELLING (left eye puffy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment- The consumer is using a cold compress to alleviate symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow up