chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 09-May-2022 and then administered on 29-Jun-2022; Dose administered after 30 day use by date/ Patient received a first dose Moderna Covid-19 51 days after thawed; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date/ Patient received a first dose Moderna Covid-19 51 days after thawed) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 09-May-2022 and then administered on 29-Jun-2022) in a 22-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 005M21A) for COVID-19 vaccination.     The patient did not have any allergies (medications, food and other products). The patient did not have any history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination.     On 29-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date/ Patient received a first dose Moderna Covid-19 51 days after thawed). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 09-May-2022 and then administered on 29-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date/ Patient received a first dose Moderna Covid-19 51 days after thawed) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 09-May-2022 and then administered on 29-Jun-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient did not take any concomitant medication.  The patient received first dose in deltoid muscle.  The vial was initially stored in the refrigerator on 09-May-2022. The vial did not undergo any temperature excursions. The patient did not seek medical care due to event.  No side effects from the patient have been reported yet.  No treatment information was reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Biopsy, Blood test, Colonoscopy, Diarrhoea
Clinical narrative: Bad chronic liquid diarrhea 8 to 10 times a day; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Bad chronic liquid diarrhea 8 to 10 times a day) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 024M20A and 010A21A) for COVID-19 vaccination.     Patient had no allergies to food, medications and other products. Patient did not test positive for Covid-19 diagnosis. Patient did not receive other manufacturer vaccine one month prior to receiving Moderna Covid-19 vaccine.  Concurrent medical conditions included Migraine (40 years ago, no changes observed recently). Concomitant products included SUMATRIPTAN for Migraine.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Bad chronic liquid diarrhea 8 to 10 times a day). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at a dose of Imodium for 4 months; CHOLESTYRAMINE at a dose of UNK, qid; CIPROFLOXACIN HCL at a dose of 500 milligram; METRONIDAZOLE at a dose of 250 milligram three times a day; PROBIOTICS NOS at an unspecified dose and frequency; ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE (DIPHENOXYLATE/ATROPINE) at an unspecified dose and frequency and LEVOTHYROXINE SODIUM (SYNTHROID) at a dose of Synthroid for 2 months. At the time of the report, DIARRHOEA (Bad chronic liquid diarrhea 8 to 10 times a day) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: nothing abnormal found nothing abnormal found (food allergy panel). On an unknown date, Biopsy: nothing abnormal found nothing abnormal found. (9 biopsies performed).. On an unknown date, Blood test: nothing abnormal found nothing abnormal found. On an unknown date, Colonoscopy: nothing abnormal found nothing abnormal found. On an unknown date, Endoscopy: nothing abnormal found nothing abnormal found. On an unknown date, Endoscopy small intestine: nothing abnormal found nothing abnormal found. On an unknown date, Exocrine pancreatic function test: nothing abnormal found nothing abnormal found.         Patient reported that received 3 vaccines on deltoid muscle upper arm.  Patient received booster dose. Patient reported that episodes always appeared 20 minutes after eating anything. Patient sometimes stayed 3 days without eating to avoid having any depositions. Patient sought medical care for the adverse event. It was reported that symptoms were  worsened with all the medication doctors gave to patient except for Imodium as this medication was suspended by doctors because had opioid on his formulation. .
Age: 59.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose every two weeks. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product reported by reporter. No treatment medication reported by reporter.  Company comment  This is a spontaneous case concerns a male patient of unknown age, with no relevant medical history reported, who experienced the unexpected, non-serious of Covid 19, unknown days after receiving the 3 dose of m RNA1273 vaccine in the covid 19 vaccination series, Patient had previously received the 2 primary doses with Moderna vaccines at an interval of about 28 days, with the 2 dose taken about 8 months prior to the 3 dose of Moderna vaccine. Details of co morbidities, labs and diagnostic tests, concomitant medications and treatment details was not provided. It was reported that the patient was taking Adalimumab (Humira) for Rheumatoid arthritis, which could be considered as a confounder. The event had resolved. The benefit-risk relationship of the vaccine is not affected by this report. Events' seriousness assessed as per medical judgement; Sender's Comments: This is a spontaneous case concerns a male patient of unknown age, with no relevant medical history reported, who experienced the unexpected, non-serious  of Covid 19, unknown days after receiving the 3 dose of m RNA1273 vaccine in the covid 19 vaccination series, Patient had previously received the 2 primary doses with Moderna vaccines at an interval of about 28 days, with the 2 dose taken about 8 months prior to the 3 dose of Moderna vaccine. Details of co morbidities, labs and diagnostic tests, concomitant medications and treatment details was not provided. It was reported that the patient was taking Adalimumab (Humira) for Rheumatoid arthritis, which could be considered as a confounder. The event had resolved. The benefit-risk relationship of the vaccine is not affected by this report. Events' seriousness assessed as per medical judgement
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pain, Vaccination site erythema
Clinical narrative: Redness at the injection site; Achy for 24 hours; Malaise for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Achy for 24 hours), MALAISE (Malaise for 24 hours) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Behcet's syndrome (Inflammation of the blood vessels), Lymphangioleiomyomatosis and Raynaud's disease. Concomitant products included AZATHIOPRINE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), AMLODIPINE, HYDROXYCHLOROQUINE, COLCHICINE and FOLIC ACID for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN (Achy for 24 hours) and MALAISE (Malaise for 24 hours). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site). On 16-Feb-2021, PAIN (Achy for 24 hours) and MALAISE (Malaise for 24 hours) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-596770 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Vaccination site erythema
Clinical narrative: Redness at the injection site; Achy for 24 hours; Malaise for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Achy for 24 hours), MALAISE (Malaise for 24 hours) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Behcet's syndrome (Inflammation of the blood vessels), Lymphangioleiomyomatosis and Raynaud's disease. Concomitant products included AZATHIOPRINE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), AMLODIPINE, HYDROXYCHLOROQUINE, COLCHICINE and FOLIC ACID for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN (Achy for 24 hours) and MALAISE (Malaise for 24 hours). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site). On 16-Feb-2021, PAIN (Achy for 24 hours) and MALAISE (Malaise for 24 hours) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-596770 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pain, Vaccination site erythema
Clinical narrative: patient experienced redness at the injection site/had a 3 inch spread of redness at the injection site.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (patient experienced redness at the injection site/had a 3 inch spread of redness at the injection site.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A, 032M20A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Behcet's syndrome (significant for an autoimmune condition called  Behchets Syndrome and this is an inflammation of the blood vessels.), Lymphangioleiomyomatosis, Raynaud's disease and Immunocompromised. Concomitant products included AZATHIOPRINE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), AMLODIPINE, HYDROXYCHLOROQUINE, COLCHICINE and FOLIC ACID for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced VACCINATION SITE ERYTHEMA (patient experienced redness at the injection site/had a 3 inch spread of redness at the injection site.). At the time of the report, VACCINATION SITE ERYTHEMA (patient experienced redness at the injection site/had a 3 inch spread of redness at the injection site.) outcome was unknown.            Patient had taken One time Antibody injection called EVUSheld on 01-April-2022.  Patient received her second vaccine and experienced redness at the injection site. Patient was immunocompromised and received her third full dose of the vaccine and reports that she had a 3 inch spread of redness at the injection site.  Patient received her first Moderna Covid-19 vaccine booster dose  on 3-FEB-2022 lot number 033H21A expiration date was not provided. she does not remember which arm that she received the vaccine booster dose in. she did not have any side effects or adverse reactions to her fourth Moderna Covid-19 vaccine booster dose.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-596758 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Vaccination site erythema
Clinical narrative: patient experienced redness at the injection site/had a 3 inch spread of redness at the injection site.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (patient experienced redness at the injection site/had a 3 inch spread of redness at the injection site.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A, 032M20A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Behcet's syndrome (significant for an autoimmune condition called  Behchets Syndrome and this is an inflammation of the blood vessels.), Lymphangioleiomyomatosis, Raynaud's disease and Immunocompromised. Concomitant products included AZATHIOPRINE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), AMLODIPINE, HYDROXYCHLOROQUINE, COLCHICINE and FOLIC ACID for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced VACCINATION SITE ERYTHEMA (patient experienced redness at the injection site/had a 3 inch spread of redness at the injection site.). At the time of the report, VACCINATION SITE ERYTHEMA (patient experienced redness at the injection site/had a 3 inch spread of redness at the injection site.) outcome was unknown.            Patient had taken One time Antibody injection called EVUSheld on 01-April-2022.  Patient received her second vaccine and experienced redness at the injection site. Patient was immunocompromised and received her third full dose of the vaccine and reports that she had a 3 inch spread of redness at the injection site.  Patient received her first Moderna Covid-19 vaccine booster dose  on 3-FEB-2022 lot number 033H21A expiration date was not provided. she does not remember which arm that she received the vaccine booster dose in. she did not have any side effects or adverse reactions to her fourth Moderna Covid-19 vaccine booster dose.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-596758 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes simplex, SARS-CoV-1 test
Clinical narrative: Herpes outbreaks more often; This spontaneous case was reported by a patient and describes the occurrence of HERPES SIMPLEX (Herpes outbreaks more often) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Herpes simplex (Patient had the Herpes Simplex Virus since kid) and Seasonal allergy.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced HERPES SIMPLEX (Herpes outbreaks more often). The patient was treated with DOCOSANOL (ABREVA) at an unspecified dose and frequency and ALLIUM CEPA EXTRACT (MEDERMA) at an unspecified dose and frequency. At the time of the report, HERPES SIMPLEX (Herpes outbreaks more often) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-1 test: not reported not reported before getting any Moderna COVID-19 vaccines.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported. No other vaccines given within one  month prior to Moderna COVID-19 vaccine. The patient went to the doctor, they prescript him a medicine that was too expensive so he didn't buy it.   This case was linked to MOD-2022-597073 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye infection, Herpes simplex, SARS-CoV-2 test
Clinical narrative: Herpes outbreaks more often; This spontaneous case was reported by a patient and describes the occurrence of HERPES SIMPLEX (Herpes outbreaks more often) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Herpes simplex (Patient had the Herpes Simplex Virus since kid) and Seasonal allergy.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced HERPES SIMPLEX (Herpes outbreaks more often). The patient was treated with DOCOSANOL (ABREVA) at an unspecified dose and frequency and ALLIUM CEPA EXTRACT (MEDERMA) at an unspecified dose and frequency. At the time of the report, HERPES SIMPLEX (Herpes outbreaks more often) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-1 test: not reported not reported before getting any Moderna COVID-19 vaccines.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported. No other vaccines given within one  month prior to Moderna COVID-19 vaccine. The patient went to the doctor, they prescript him a medicine that was too expensive so he didn't buy it.   This case was linked to MOD-2022-597073 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes simplex, SARS-CoV-1 test
Clinical narrative: Herpes outbreaks more often and that these are still ongoing; Eye infection; This spontaneous case was reported by a patient and describes the occurrence of HERPES SIMPLEX (Herpes outbreaks more often and that these are still ongoing) and EYE INFECTION (Eye infection) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 040C21A) for COVID-19 prophylaxis.     No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 (before getting any Moderna COVID-19 vaccines.) in March 2021. Concurrent medical conditions included Herpes simplex (Herpes Simplex Virus since he was a kid.) and Seasonal allergy (Spring allergies).   On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced EYE INFECTION (Eye infection). On an unknown date, the patient experienced HERPES SIMPLEX (Herpes outbreaks more often and that these are still ongoing). The patient was treated with DOCOSANOL (ABREVA) (topical) at an unspecified dose and frequency and ALLIUM CEPA EXTRACT (MEDERMA) (topical) at an unspecified dose and frequency. At the time of the report, HERPES SIMPLEX (Herpes outbreaks more often and that these are still ongoing) and EYE INFECTION (Eye infection) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications information was reported.  It was reported that patient went to the doctor, they prescribed a medicine that was too expensive so he didn't buy it.   This case was linked to MOD-2022-596858.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye infection, Herpes simplex, SARS-CoV-2 test
Clinical narrative: Herpes outbreaks more often and that these are still ongoing; Eye infection; This spontaneous case was reported by a patient and describes the occurrence of HERPES SIMPLEX (Herpes outbreaks more often and that these are still ongoing) and EYE INFECTION (Eye infection) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 040C21A) for COVID-19 prophylaxis.     No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 (before getting any Moderna COVID-19 vaccines.) in March 2021. Concurrent medical conditions included Herpes simplex (Herpes Simplex Virus since he was a kid.) and Seasonal allergy (Spring allergies).   On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced EYE INFECTION (Eye infection). On an unknown date, the patient experienced HERPES SIMPLEX (Herpes outbreaks more often and that these are still ongoing). The patient was treated with DOCOSANOL (ABREVA) (topical) at an unspecified dose and frequency and ALLIUM CEPA EXTRACT (MEDERMA) (topical) at an unspecified dose and frequency. At the time of the report, HERPES SIMPLEX (Herpes outbreaks more often and that these are still ongoing) and EYE INFECTION (Eye infection) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications information was reported.  It was reported that patient went to the doctor, they prescribed a medicine that was too expensive so he didn't buy it.   This case was linked to MOD-2022-596858.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza
Clinical narrative: Sick; Tested positive for flu/Had the flu/Cold viruses; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) and INFLUENZA (Tested positive for flu/Had the flu/Cold viruses) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick) and INFLUENZA (Tested positive for flu/Had the flu/Cold viruses). At the time of the report, ILLNESS (Sick) and INFLUENZA (Tested positive for flu/Had the flu/Cold viruses) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not reported.   Patient tested positive from the flu as cold viruses were in their home and had lot of problems in the family. Patient worked in the hospital and might have bought the flu home.    Treatment medications were not reported.   This case was linked to MOD-2022-596523, MOD-2022-596527, MOD-2022-596527, MOD-2022-596527 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: HSV-2 and had a frequent outbreak from the time patient got vaccinated with the covid 19 vaccine from Moderna; This spontaneous case was reported by a patient and describes the occurrence of HERPES SIMPLEX (HSV-2 and had a frequent outbreak from the time patient got vaccinated with the covid 19 vaccine from Moderna) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Herpes simplex type II (since patient was a teenager).    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES SIMPLEX (HSV-2 and had a frequent outbreak from the time patient got vaccinated with the covid 19 vaccine from Moderna). At the time of the report, HERPES SIMPLEX (HSV-2 and had a frequent outbreak from the time patient got vaccinated with the covid 19 vaccine from Moderna) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  The patient had HSV2 since he was a teenager, and was getting more frequent outbreaks.  Patient was looking online for answers and found a trial working on a similar vaccine for herpes simplex and interested in being a trial or in whatever mechanism for patient to try the vaccine and see if would work. Patient had 2 young children and was frightened that would pass the infection. Patient used patches and creams, but both were troublesome, and patient would like to have better option. Patient was prescribed a preventive medicine before, but couldn't afford it and never got to try it.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza, Influenza virus test
Clinical narrative: Sick; Tested positive for flu / Had the flu; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Sick) and INFLUENZA (Tested positive for flu / Had the flu) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick) and INFLUENZA (Tested positive for flu / Had the flu). At the time of the report, ILLNESS (Sick) and INFLUENZA (Tested positive for flu / Had the flu) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza virus test: positive (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported.   It was reported that cold viruses were in patient's home and had lot of problems in the family.    No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-596527 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-596527:MOD22-017437, Reporter's case
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Received a half a dose instead of a full dose on their booster shot; This spontaneous case was reported by a patient and describes the occurrence of UNDERDOSE (Received a half a dose instead of a full dose on their booster shot) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 027A21A and 026B21A) for COVID-19 prophylaxis.     Patient was not allergic to medications, food and other products. Patient never had COVID + test or diagnosis.  Concurrent medical conditions included Blood pressure management, Cholesterol, Kidney disorder and Type 2 diabetes mellitus. Concomitant products included INSULIN for Type 2 diabetes mellitus, ATORVASTATIN and METFORMIN for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced UNDERDOSE (Received a half a dose instead of a full dose on their booster shot). At the time of the report, UNDERDOSE (Received a half a dose instead of a full dose on their booster shot) outcome was unknown.            Concomitant medication also included blood thinner medication, blood pressure medication, kidney medication, cholesterol medication, diabetes 2 medication.  On 01-APR-2022, patient received second booster lot number 045J21A.  Treatment details was not reported by the reporter.   This case was linked to MOD-2022-597349 (Patient Link).
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: myalgia; pain at the injection site, painful during the injection; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site, painful during the injection) and MYALGIA (myalgia) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jun-2022, the patient experienced VACCINATION SITE PAIN (pain at the injection site, painful during the injection). On 28-Jun-2022, the patient experienced MYALGIA (myalgia). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (pain at the injection site, painful during the injection) outcome was unknown and MYALGIA (myalgia) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  It was reported that it was painful during the injection  It was reported that reporter was awaiting a callback from the pediatrician
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness, Oropharyngeal pain
Clinical narrative: Sick; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) and OROPHARYNGEAL PAIN (Sore throat) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis.    No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. On an unknown date, the patient experienced ILLNESS (Sick) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, ILLNESS (Sick) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.            No concomitant medication were provided.  There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment details were provided
Sex: U
Vaccine: COVID19, UNK
Symptoms: Psoriasis, Vaccination complication
Clinical narrative: COMPLICATIONS FROM THE COVID VACCINE; PSORIASIS FLARE UPS AGAIN; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COMPLICATIONS FROM THE COVID VACCINE) and PSORIASIS (PSORIASIS FLARE UPS AGAIN) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    There was no reported medical history.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On an unknown date, the patient experienced VACCINATION COMPLICATION (COMPLICATIONS FROM THE COVID VACCINE) and PSORIASIS (PSORIASIS FLARE UPS AGAIN). At the time of the report, VACCINATION COMPLICATION (COMPLICATIONS FROM THE COVID VACCINE) outcome was unknown and PSORIASIS (PSORIASIS FLARE UPS AGAIN) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medications were not reported.   It was unknown if patient was enrolled in COVID-19 vaccine trial. Treatment medications were not reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthropathy, Laboratory test, Pain, Unevaluable event
Clinical narrative: Needed to increase b vitamins and other supplements; Joint disorder; Pain; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Needed to increase b vitamins and other supplements), ARTHROPATHY (Joint disorder) and PAIN (Pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced UNEVALUABLE EVENT (Needed to increase b vitamins and other supplements), ARTHROPATHY (Joint disorder) and PAIN (Pain). At the time of the report, UNEVALUABLE EVENT (Needed to increase b vitamins and other supplements) outcome was unknown and ARTHROPATHY (Joint disorder) and PAIN (Pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: needed to increase b vitamins and other supplement needed to increase B vitamins and other supplements.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication was reported.  The patient needed to increase B vitamins and other supplements so took Rinvoq.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The causality with the events was reported as reasonable possibility.  No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia areata, Fatigue
Clinical narrative: Alopecia areata; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA AREATA (Alopecia areata) and FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ALOPECIA AREATA (Alopecia areata) and FATIGUE (Fatigue). At the time of the report, ALOPECIA AREATA (Alopecia areata) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event's of alopecia areata and fatigue was not provided for Skyrizi. No treatment drug details was reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Skin plaque
Clinical narrative: after his first Moderna Covid-19 vaccine last year in 2021,he developed a few of the plaque spot; This spontaneous case was reported by a consumer and describes the occurrence of SKIN PLAQUE (after his first Moderna Covid-19 vaccine last year in 2021,he developed a few of the plaque spot) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hip replacement.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced SKIN PLAQUE (after his first Moderna Covid-19 vaccine last year in 2021,he developed a few of the plaque spot). At the time of the report, SKIN PLAQUE (after his first Moderna Covid-19 vaccine last year in 2021,he developed a few of the plaque spot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2022-597447 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Macule
Clinical narrative: I have hypopigmented macules on my hands and face; This spontaneous case was reported by a patient and describes the occurrence of MACULE (I have hypopigmented macules on my hands and face) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023021A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MACULE (I have hypopigmented macules on my hands and face). At the time of the report, MACULE (I have hypopigmented macules on my hands and face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient don't had personal nor family history of vitiligo, autoimmune disease and no other pigmentary disorders. No concomitant medications was reported. No treatment information was reported.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received 0.5 ml pediatric (NDC 80777-279-05)  Moderna COVID-19 vaccine for the first primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 0.5 ml pediatric (NDC 80777-279-05)  Moderna COVID-19 vaccine for the first primary dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS14146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Jun-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 0.5 ml pediatric (NDC 80777-279-05)  Moderna COVID-19 vaccine for the first primary dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 0.5 ml pediatric (NDC 80777-279-05)  Moderna COVID-19 vaccine for the first primary 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.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient took Dose 1 (19-MAY-2021 ,and Dose 2- 16-NOV-2021); This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Dose 1 (19-MAY-2021 ,and Dose 2- 16-NOV-2021)) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A and 023C219) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19.  It was unknown if the patient had acute illness at the time of vaccination and up to one month before. It was unknown if the patient had any chronic or long standing health conditions.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Dose 1 (19-MAY-2021 ,and Dose 2- 16-NOV-2021)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Dose 1 (19-MAY-2021 ,and Dose 2- 16-NOV-2021)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies had been taken by the patient at the time of vaccination and/or at the time of the adverse event.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-581743 (Patient Link).
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: VAXELIS was administered after three major temperature excursions: Temperature/Time frame: 35.1 F for 4 hours 40 minutes; 35.2 F for 54 hours, 35.3 F for 30minutes; This spontaneous safety report, with reference number 02140661 was received by the partner on 04-APR-2022 and forwarded to agency on 05-APR-2022, from a nurse.   Due to the nature of the event, the causality between the event "VAXELIS was administered after three major temperature excursions" and Vaxelis is not applicable.   Further information is expected.   NON-SIGNIFICANT Follow-up information, with reference number 02140661, was received by a partner on 13-APR-2022, and forwarded to agency on 14-APR-2022, from a nurse. This case is maintained as non-serious.   Due to the nature of the event, the causality between Vaxelis and the event "VAXELIS was administered after three major temperature excursions" remains not applicable.   No further information is expected. The reporter had no new information to offer just wanted to know if the AE letter had to be sent back because there was no other information about the event.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: VAXELIS was administered after a temperature excursion; This non-serious spontaneous safety report was received by the partner on 04-Apr-2022 and forwarded on 05-Apr-2022 from another health care professional.  Due to the nature of the event, the causality assessment between the event "VAXELIS was administered after a temperature excursion" and the product is not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received by a health care professional on 22-APR-2022. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality assessment between the event "VAXELIS was administered after a temperature excursion" and the product remains not applicable.  No further information is expected.
Sex: U
Vaccine: DTAPHEPBIP, DTPPVHBHPB
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: 9 month old was given VAXELIS at 2 months old and 4 months old, and then given PEDIARIX at 6 months old.; This non-serious spontaneous safety report with reference #02144115 was received by a partner on 08-APR-2022 and forwarded on 11-APR-2022 from a health care professional.  The causal relationship between Vaxelis and the reported event "9 month old was given VAXELIS at 2 months old and 4 months old, and then given PEDIARIX at 6 months old" is assessed as not applicable due to the nature of the event.  Further information is expected.   FOLLOW-UP information was received by a partner on 18-APR-2022 and forwarded on 19-APR-2022 from a health care professional. The case is maintained as non-serious.  The causal relationship between Vaxelis and the reported event "9 month old was given VAXELIS at 2 months old and 4 months old, and then given PEDIARIX at 6 months old"  remains not applicable due to the nature of the event.  Further information is expected.  SIGNIFICANT FOLLOW-UP information was received on 18-MAY-2022 from a health care professional. The case is maintained as non-serious.   It was reported that no adverse reactions occurred due to the interchange of vaccines (event onset date 06-JAN-2022).  Patient's concomitant vaccinations at 6 months appointment were Prevnar, RotaTeq, and Influenza along with Pediarix.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product supply issue
Clinical narrative: The facility does not have Vaxelis on hand and may decide to use Pentacel for the second dose in the series; This non-serious spontaneous safety report with reference number # 2022SA128494 was received by a partner on 11-APR-2022 and forwarded to agency on 12-APR-2022 from a health care professional.  The causal relationship between Vaxelis and the reported event "the facility does not have Vaxelis on hand and may decide to use Pentacel for the second dose in the series" is assessed as not applicable due to the nature of the event.  No further information is expected since consent to follow-up was not provided.
Sex: M
Vaccine: DTPPVHBHPB, PNC, RVX
Symptoms: Erythema of eyelid, Eyelid oedema
Clinical narrative: ERYTHEMA OF EYELID; Eyelid oedema; This non-serious spontaneous case was received during monitoring on 11-APR-2022 with the following Primary ID 2188005-1. The original narrative from the sender is as below:  10 minutes after vaccine administration, physician noticed right eye lid edema and erythema. Patient sent to ED via ambulance for observation.
Sex: F
Vaccine: DTPPVHBHPB, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: EXTRA DOSE ADMINISTERED; NO ADVERSE EVENT; This case was retrieved during the ICSR monitoring on Vaccine Adverse Event Reporting System (VAERS) on 11-Apr-2022 with the following reference number: 2028440-1. The original narrative from the sender is:  No adverse reaction, gave two doses of Hep B at time of vaccine.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 73 years old patient; No adverse event; This case was retrieved during the monitoring on 11-Apr-2022 with the following reference number: 2151278-1. The original narrative from the sender is as follows:  There were no adverse affects.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Given combination vaccine containing Hep B & Hep B wasnt due. Vaccine (Hep B) before minimum interval; This non-serious case was received during the monitoring on 11-APR-2022 with the following Primary ID 2194488-1. The original narrative from the sender is as below:  Pt was given combination vaccine containing Hep B & Hep B wasnt due. Vaccine (Hep B) before minimum interval.