chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, Vomiting
Clinical narrative: chronic headaches; threw up; continues runny nose; blood sugar out of whack; Pain; small cough; terrible fatigue; blood pressure out of whack; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (chronic headaches), VOMITING (threw up), RHINORRHOEA (continues runny nose), COUGH (small cough) and FATIGUE (terrible fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (chronic headaches), VOMITING (threw up), RHINORRHOEA (continues runny nose), COUGH (small cough), FATIGUE (terrible fatigue), BLOOD PRESSURE INCREASED (blood pressure out of whack), BLOOD GLUCOSE INCREASED (blood sugar out of whack) and PAIN (Pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEADACHE (chronic headaches), VOMITING (threw up), RHINORRHOEA (continues runny nose), COUGH (small cough), FATIGUE (terrible fatigue), BLOOD PRESSURE INCREASED (blood pressure out of whack) and PAIN (Pain) outcome was unknown. Not Provided          No concomitant medications were reported.   Reporter did not allow further contact
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal dryness
Clinical narrative: Dry nose; This spontaneous case was reported by a patient and describes the occurrence of NASAL DRYNESS (Dry nose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Runny nose (It is reported that patient explained that they were experiencing a symptom of 'overly active nose' or a 'very runny nose' for most of their life.).  On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced NASAL DRYNESS (Dry nose). At the time of the report, NASAL DRYNESS (Dry nose) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  It is reported that after the first dose of the vaccine, the runny nose symptom was replaced with a dry nose between 18-Mar-2021 to 25-Mar-2021. Afterwards the runny nose symptom was still lessened to a certain extent.  Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune deficiency syndrome and Cancer. Concomitant products included AZATHIOPRINE for Autoimmune deficiency syndrome, RITUXIMAB (RITUXAN) for Cancer.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            The patient is on an immunisuppressant medicination, the caller has been taking Aziathioprine 50mg on one day and  increased dosage of Aziathioprine to 100mg the next day for autoimmune deficiency.  No treatment medications were reported.   This case was linked to MOD-2021-194120 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: blood pressure was elevated; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure was elevated) 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 Brain injury (Due to motor vehicle accident) in 2014, Jugular vein thrombosis (Due to motor vehicle accident; treated with warfarin) in 2014 and Motor vehicle accident in 2014. Concomitant products included BUPRENORPHINE HYDROCHLORIDE, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), PREGABALIN (LYRICA), CYCLOBENZAPRINE HYDROCHLORIDE (AMRIX), ZOLPIDEM TARTRATE (AMBIEN) and VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced HYPERTENSION (blood pressure was elevated). At the time of the report, HYPERTENSION (blood pressure was elevated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood pressure measurement: elevated (High) elevated. On 08-Jun-2021, Blood pressure measurement: 140/89 mmhg (High) 140/89 mmHg.         No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This spontaneous case was reported by a physician and describes the occurrence of VERTIGO (Vertigo) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   This case was linked to MOD-2021-214599 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Fever; Soreness at the injection site; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at the injection site) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and unknown) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in June 2020.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at the injection site). On 30-Apr-2021, PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose received was expired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose received was expired) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003c21a and 045b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose received was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose received was expired) had resolved.            Concomitant information was not reported. Treatment information was not reported   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up information received on 30-jun-2021 Contains No New information
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose less than 25 days after receiving 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose less than 25 days after receiving 1st dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose less than 25 days after receiving 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose less than 25 days after receiving 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications were reported. No treatment details were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Diarrhoea, Headache, Urinary tract infection
Clinical narrative: DIARRHEA; WAS DEHYDRATED; URINARY TRACT INFECTION; CHILLS; VOMITING; HEADACHE; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Jun-2021 and was forwarded to Moderna on 10-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (DIARRHEA), DEHYDRATION (WAS DEHYDRATED), URINARY TRACT INFECTION (URINARY TRACT INFECTION), CHILLS (CHILLS) and VOMITING (VOMITING) in a 60-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.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for Psoriasis.    No Medical History information was reported.   In October 2020, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral) 11 milligram once a day. On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced DIARRHOEA (DIARRHEA), DEHYDRATION (WAS DEHYDRATED), URINARY TRACT INFECTION (URINARY TRACT INFECTION), CHILLS (CHILLS), VOMITING (VOMITING) and HEADACHE (HEADACHE). At the time of the report, DIARRHOEA (DIARRHEA), DEHYDRATION (WAS DEHYDRATED), URINARY TRACT INFECTION (URINARY TRACT INFECTION), CHILLS (CHILLS), VOMITING (VOMITING) and HEADACHE (HEADACHE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not provided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: DIARRHEA; WAS DEHYDRATED; URINARY TRACT INFECTION; CHILLS; VOMITING; HEADACHE; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Jun-2021 and was forwarded to Moderna on 10-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (DIARRHEA), DEHYDRATION (WAS DEHYDRATED), URINARY TRACT INFECTION (URINARY TRACT INFECTION), CHILLS (CHILLS) and VOMITING (VOMITING) in a 60-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.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for Psoriasis.    No Medical History information was reported.   In October 2020, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral) 11 milligram once a day. On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced DIARRHOEA (DIARRHEA), DEHYDRATION (WAS DEHYDRATED), URINARY TRACT INFECTION (URINARY TRACT INFECTION), CHILLS (CHILLS), VOMITING (VOMITING) and HEADACHE (HEADACHE). At the time of the report, DIARRHOEA (DIARRHEA), DEHYDRATION (WAS DEHYDRATED), URINARY TRACT INFECTION (URINARY TRACT INFECTION), CHILLS (CHILLS), VOMITING (VOMITING) and HEADACHE (HEADACHE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of epistaxis (3 nose bleeds) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jun 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 9, 2021, patient experienced epistaxis (3 nose bleeds). At the time of the report, epistaxis (3 nose bleeds) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. Concomitant product use and treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects).   At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant products were reported by reporter. No treatment medication provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: painful local reaction at the injection site; painful local reaction at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (painful local reaction at the injection site) and VACCINATION SITE PAIN (painful local reaction at the injection site) 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 VACCINATION SITE REACTION (painful local reaction at the injection site) and VACCINATION SITE PAIN (painful local reaction at the injection site). At the time of the report, VACCINATION SITE REACTION (painful local reaction at the injection site) and VACCINATION SITE PAIN (painful local reaction at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dysuria, Pain in extremity, Prostatic specific antigen, Prostatitis
Clinical narrative: Prostatits; Burning of the urination; sore arm; Fever of 101 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATITIS (Prostatits), DYSURIA (Burning of the urination), PAIN IN EXTREMITY (sore arm) and PYREXIA (Fever of 101 degrees Fahrenheit) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 038B21A) for COVID-19 vaccination.     No medical history was provided.  The patient's past medical history included Meningioma (Meningeoma) on 04-Mar-2011. Concurrent medical conditions included PSA (PSA), Drug allergy (Tetracycline) and Drug allergy (Inapsine). Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) for Acid reflux (oesophageal), CITALOPRAM from 09-Jan-1992 to an unknown date for Depression, CLONAZEPAM (KLONOPIN) for Seizure, CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (Fever of 101 degrees Fahrenheit). On 10-May-2021, the patient experienced PROSTATITIS (Prostatits) and DYSURIA (Burning of the urination). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 07-May-2021, PYREXIA (Fever of 101 degrees Fahrenheit) outcome was unknown. On 03-Aug-2021, PROSTATITIS (Prostatits) and DYSURIA (Burning of the urination) had resolved with sequelae. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Prostatic specific antigen: normal (normal) normal. On 05-May-2021, Body temperature: 101 (High) 101 degrees fahrenheit. On an unknown date, Urine analysis: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-216975 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Follow up information received on 20-JUN-2021 contains No significant information. On 13-Jul-2021: follow up received contains Email: nonsafety info - question On 13-Jul-2021: Email: nonsafety info - Question On 06-Aug-2021: follow up received contains Additional information included reporter details On 12-Aug-2021: significant follow up appended. Patient demographics, relevant history and outcome of events was added
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Urine analysis
Clinical narrative: Prostatits; Burning of the urination; sore arm; Fever of 101 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATITIS (Prostatits), DYSURIA (Burning of the urination), PAIN IN EXTREMITY (sore arm) and PYREXIA (Fever of 101 degrees Fahrenheit) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 038B21A) for COVID-19 vaccination.     No medical history was provided.  The patient's past medical history included Meningioma (Meningeoma) on 04-Mar-2011. Concurrent medical conditions included PSA (PSA), Drug allergy (Tetracycline) and Drug allergy (Inapsine). Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) for Acid reflux (oesophageal), CITALOPRAM from 09-Jan-1992 to an unknown date for Depression, CLONAZEPAM (KLONOPIN) for Seizure, CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (Fever of 101 degrees Fahrenheit). On 10-May-2021, the patient experienced PROSTATITIS (Prostatits) and DYSURIA (Burning of the urination). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 07-May-2021, PYREXIA (Fever of 101 degrees Fahrenheit) outcome was unknown. On 03-Aug-2021, PROSTATITIS (Prostatits) and DYSURIA (Burning of the urination) had resolved with sequelae. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Prostatic specific antigen: normal (normal) normal. On 05-May-2021, Body temperature: 101 (High) 101 degrees fahrenheit. On an unknown date, Urine analysis: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-216975 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Follow up information received on 20-JUN-2021 contains No significant information. On 13-Jul-2021: follow up received contains Email: nonsafety info - question On 13-Jul-2021: Email: nonsafety info - Question On 06-Aug-2021: follow up received contains Additional information included reporter details On 12-Aug-2021: significant follow up appended. Patient demographics, relevant history and outcome of events was added
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Seasonal allergy
Clinical narrative: started to get menstrual spotting on 06May2021; The patient is with seasonal/pollen allergy; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (The patient is with seasonal/pollen allergy) and INTERMENSTRUAL BLEEDING (started to get menstrual spotting on 06May2021) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Birth control pill and ESCITALOPRAM for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced SEASONAL ALLERGY (The patient is with seasonal/pollen allergy). On an unknown date, the patient experienced INTERMENSTRUAL BLEEDING (started to get menstrual spotting on 06May2021).        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.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: received her first dose of the Moderna Covid -19 and did not return for the second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received her first dose of the Moderna Covid -19 and did not return for the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-articular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received her first dose of the Moderna Covid -19 and did not return for the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received her first dose of the Moderna Covid -19 and did not return for the second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-articular) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Had a temperature excursion recently where the temperature hit -12 C; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Had a temperature excursion recently where the temperature hit -12 C) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Had a temperature excursion recently where the temperature hit -12 C). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Had a temperature excursion recently where the temperature hit -12 C) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The reporter stated that they had a temperature excursion recently where the temperature hit -12 C. They moved the vaccines to other location's freezer within 30 minutes in a cooler with some ice packs.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm is so sore after second shot, terribly sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm is so sore after second shot, terribly sore) 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) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (My arm is so sore after second shot, terribly sore). At the time of the report, PAIN IN EXTREMITY (My arm is so sore after second shot, terribly sore) outcome was unknown.            No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: Received the second dose outside of the recommended intervals; Did not receive the second dose >35; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose >35) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose outside of the recommended intervals) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose >35). On 11-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose outside of the recommended intervals). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose >35) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose outside of the recommended intervals) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Added event  was received the second dose outside of the recommended intervals.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache; Fever; Chills; 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 HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) 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 10-Jun-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 11-Jun-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) was resolving.            Reporter did not allow further contact
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hunger, Nausea
Clinical narrative: Feels very hungry; Nauseous; Headache that hurts when she turns her head side to side; This spontaneous case was reported by a consumer and describes the occurrence of HUNGER (Feels very hungry), NAUSEA (Nauseous) and HEADACHE (Headache that hurts when she turns her head side to side) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A.) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced HUNGER (Feels very hungry), NAUSEA (Nauseous) and HEADACHE (Headache that hurts when she turns her head side to side). At the time of the report, HUNGER (Feels very hungry), NAUSEA (Nauseous) and HEADACHE (Headache that hurts when she turns her head side to side) outcome was unknown.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported. Treatment information as not reported.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Foggy head; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy head) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease (Patient was diagnosed with Hashimotos 2 years ago).   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 (Foggy head). At the time of the report, FEELING ABNORMAL (Foggy head) outcome was unknown. Not Provided          The patient had been feeling foggy head which is the side effect of hashimoto's disease.  Relevant concomitant medications were not reported. Treatment medication was  not reported. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Additional information received on 14 JUN 2021 and does not contain any new information.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: has been 10 weeks since first dose/ patient says they were not called to get their second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has been 10 weeks since first dose/ patient says they were not called to get their second dose) 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 05-Apr-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has been 10 weeks since first dose/ patient says they were not called to get their second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has been 10 weeks since first dose/ patient says they were not called to get their second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No information regarding corrective treatment was reported by the patient.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration (has been 10 weeks since first dose/ patient says they were not called to get their second dose) for mRNA-1273, lot # unknown is assessed as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Induration, Mass, Pruritus, Swelling
Clinical narrative: little red area; swelling; lump very hard; itch; lump very hard; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of ERYTHEMA (little red area), SWELLING (swelling), MASS (lump very hard), PRURITUS (itch) and INDURATION (lump very hard) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (little red area), SWELLING (swelling), MASS (lump very hard), PRURITUS (itch) and INDURATION (lump very hard). At the time of the report, ERYTHEMA (little red area), SWELLING (swelling), MASS (lump very hard), PRURITUS (itch) and INDURATION (lump very hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was included. No treatment drug details was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: what medication can I take after my 2nd covid shot to help with pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (what medication can I take after my 2nd covid shot to help with pain) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (what medication can I take after my 2nd covid shot to help with pain). At the time of the report, PAIN (what medication can I take after my 2nd covid shot to help with pain) outcome was unknown.            No concomitant medications were reported.  No information regarding corrective treatment was reported by the patient.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The 1st one no side effects besides sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The 1st one no side effects besides sore arm) 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 PAIN IN EXTREMITY (The 1st one no side effects besides sore arm). At the time of the report, PAIN IN EXTREMITY (The 1st one no side effects besides sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Patient experienced no side effects besides sore arm after the first dose of vaccine Treatment information was not provided.   This case was linked to MOD-2021-220986 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: 103 to 104 fever/high fever; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (103 to 104 fever/high fever) and HEADACHE (Severe 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 13-Jun-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 an unknown date, the patient experienced PYREXIA (103 to 104 fever/high fever) and HEADACHE (Severe headache). At the time of the report, PYREXIA (103 to 104 fever/high fever) and HEADACHE (Severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 103 to 104.         No relevant concomitant medications were reported.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Myalgia
Clinical narrative: feel like I got hit by a bus/Still feeling awful, it feels like my skin; woke up at 5 this morning with all over muscle and joint aches and chills; woke up at 5 this morning with all over muscle and joint aches and chills; woke up at 5 this morning with all over muscle and joint aches and chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel like I got hit by a bus/Still feeling awful, it feels like my skin), MYALGIA (woke up at 5 this morning with all over muscle and joint aches and chills), ARTHRALGIA (woke up at 5 this morning with all over muscle and joint aches and chills) and CHILLS (woke up at 5 this morning with all over muscle and joint aches and chills) 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) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced FEELING ABNORMAL (feel like I got hit by a bus/Still feeling awful, it feels like my skin), MYALGIA (woke up at 5 this morning with all over muscle and joint aches and chills), ARTHRALGIA (woke up at 5 this morning with all over muscle and joint aches and chills) and CHILLS (woke up at 5 this morning with all over muscle and joint aches and chills). At the time of the report, FEELING ABNORMAL (feel like I got hit by a bus/Still feeling awful, it feels like my skin), MYALGIA (woke up at 5 this morning with all over muscle and joint aches and chills), ARTHRALGIA (woke up at 5 this morning with all over muscle and joint aches and chills) and CHILLS (woke up at 5 this morning with all over muscle and joint aches and chills) outcome was unknown.            No concomitant medications were reported.  No information regarding corrective treatment was reported by the patient.   This case was linked to MOD-2021-220983 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: bulging of veins on her both feet, both hands and on right side of forehead and it is still there; soreness of left arm; Body ache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VEIN DISORDER (bulging of veins on her both feet, both hands and on right side of forehead and it is still there), PAIN IN EXTREMITY (soreness of left arm), MYALGIA (Body ache), PYREXIA (Fever) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure since 01-May-2006. Concomitant products included AMLODIPINE for Blood pressure.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced PAIN IN EXTREMITY (soreness of left arm), MYALGIA (Body ache), PYREXIA (Fever) and CHILLS (Chills). On 12-Jun-2021, the patient experienced VEIN DISORDER (bulging of veins on her both feet, both hands and on right side of forehead and it is still there). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 mg. At the time of the report, VEIN DISORDER (bulging of veins on her both feet, both hands and on right side of forehead and it is still there) had not resolved and PAIN IN EXTREMITY (soreness of left arm), MYALGIA (Body ache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jun-2021, Body temperature: 39.2 (abnormal) 39.2 degree Celsius.         This case was linked to MOD-2021-221001 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up information received contains patient's race, height and weight, Lot number.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vein disorder
Clinical narrative: bulging of veins on her both feet, both hands and on right side of forehead and it is still there; soreness of left arm; Body ache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VEIN DISORDER (bulging of veins on her both feet, both hands and on right side of forehead and it is still there), PAIN IN EXTREMITY (soreness of left arm), MYALGIA (Body ache), PYREXIA (Fever) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure since 01-May-2006. Concomitant products included AMLODIPINE for Blood pressure.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced PAIN IN EXTREMITY (soreness of left arm), MYALGIA (Body ache), PYREXIA (Fever) and CHILLS (Chills). On 12-Jun-2021, the patient experienced VEIN DISORDER (bulging of veins on her both feet, both hands and on right side of forehead and it is still there). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 mg. At the time of the report, VEIN DISORDER (bulging of veins on her both feet, both hands and on right side of forehead and it is still there) had not resolved and PAIN IN EXTREMITY (soreness of left arm), MYALGIA (Body ache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jun-2021, Body temperature: 39.2 (abnormal) 39.2 degree Celsius.         This case was linked to MOD-2021-221001 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up information received contains patient's race, height and weight, Lot number.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Inappropriate schedule of vaccine administration; 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 PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine administration) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine administration). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.