chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Ear discomfort, Feeling abnormal, Vision blurred
Clinical narrative: Constant Dizziness for the last year. Pressure in ears. Brain fog. Balance issues. Blurry vision. Symptoms get worse when I tip my head or lay it flat.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle atrophy
Clinical narrative: muscle atrophy in left arm at location of injection.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned. The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: rapid heart rate; This case was received via regulatory authority (Reference number: 152415) on 13-Oct-2021 and was forwarded to Moderna on 13-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart rate) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-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 experienced HEART RATE INCREASED (rapid heart rate). At the time of the report, HEART RATE INCREASED (rapid heart rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Electrocardiogram: normal (normal) Normal. On an unknown date, Heart rate: elevated (High) Elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 901D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old). On 18-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: fever of 101-102F; nauseated; felt very, very tired /would not get back her energy for 3 months; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101-102F), NAUSEA (nauseated) and FATIGUE (felt very, very tired /would not get back her energy for 3 months) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced PYREXIA (fever of 101-102F), NAUSEA (nauseated) and FATIGUE (felt very, very tired /would not get back her energy for 3 months). At the time of the report, PYREXIA (fever of 101-102F), NAUSEA (nauseated) and FATIGUE (felt very, very tired /would not get back her energy for 3 months) outcome was unknown.            no concomitant medication is reported no treatement of medication is reported   This case was linked to MOD-2021-371152 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: arm soreness; a welt on their back; 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 PAIN IN EXTREMITY (arm soreness) and RASH (a welt on their back) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness) and RASH (a welt on their back). At the time of the report, PAIN IN EXTREMITY (arm soreness) and RASH (a welt on their back) outcome was unknown. Not Provided          No concomitant and no treatment medication were not provided by reporter .
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: left injection site arm turned red/Redness lasted for 10 days; My left arm became red and itched; area of redness extended 5 inches from the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (left injection site arm turned red/Redness lasted for 10 days), VACCINATION SITE PRURITUS (My left arm became red and itched) and VACCINATION SITE SWELLING (area of redness extended 5 inches from the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 027A21A) for COVID-19 vaccination.     No Medical History was provided by reporter.  Concomitant products included PREDNISONE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (left injection site arm turned red/Redness lasted for 10 days), VACCINATION SITE PRURITUS (My left arm became red and itched) and VACCINATION SITE SWELLING (area of redness extended 5 inches from the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (left injection site arm turned red/Redness lasted for 10 days), VACCINATION SITE PRURITUS (My left arm became red and itched) and VACCINATION SITE SWELLING (area of redness extended 5 inches from the injection site) outcome was unknown.            Treatment medications were not provided by reporter.   This case was linked to MOD-2021-370313 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Myalgia, Pyrexia
Clinical narrative: Did not get very ill.; Little achy; A little feverish but didn't run a fever; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Did not get very ill.), MYALGIA (Little achy) and PYREXIA (A little feverish but didn't run a fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Bedridden and Housebound. Concurrent medical conditions included Myalgic encephalomyelitis, Connective tissue disorder, Immunodeficiency, Immunoglobulin M decreased and Neuropathy peripheral. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Did not get very ill.), MYALGIA (Little achy) and PYREXIA (A little feverish but didn't run a fever). At the time of the report, ILLNESS (Did not get very ill.), MYALGIA (Little achy) and PYREXIA (A little feverish but didn't run a fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.   This case was linked to MOD-2021-380837 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a booster dose that was past 15 hours of initial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a booster dose that was past 15 hours of initial puncture) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a booster dose that was past 15 hours of initial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a booster dose that was past 15 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication is reported.  No treatment of medication is reported.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) Date and time vial was first punctured: 05Nov2021 7:00 PM and administration of vaccine: 06Nov2021 10:00AM.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The medical history was not provided by the reporter  .  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and IBUPROFEN for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.   This case was linked to MOD-2021-385822, MOD-2021-385823 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose was given more than 35 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given more than 35 days after first dose) in a 45-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 013L20A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given more than 35 days after first dose). On 09-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given more than 35 days after first dose) had resolved.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.    This case was linked to MOD-2021-385925 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pruritus
Clinical narrative: a little itching (after dose 1 & 2); little sore arm (after dose 1 & 2); little tired (after dose 1 & 2); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (a little itching (after dose 1 & 2)), MYALGIA (little sore arm (after dose 1 & 2)) and FATIGUE (little tired (after dose 1 & 2)) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concomitant products included ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) for an unknown indication. On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (a little itching (after dose 1 & 2)), MYALGIA (little sore arm (after dose 1 & 2)) and FATIGUE (little tired (after dose 1 & 2)). The patient was treated with GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) at a dose of 1 dosage form and CORTISONE at a dose of 1 dosage form. At the time of the report, PRURITUS (a little itching (after dose 1 & 2)), MYALGIA (little sore arm (after dose 1 & 2)) and FATIGUE (little tired (after dose 1 & 2)) outcome was unknown.    This case was linked to MOD-2021-402840, MOD-2021-402893 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (after expiration date). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (after expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. It was reported that numerous patients have received doses of the Moderna covid-19 vaccine after the published expiration date between 28-Oct-2021 and 14-Dec-2021.   Most recent FOLLOW-UP information incorporated above includes: On 16-Dec-2021: Added information in I narrative On 20-Dec-2021: Significant information received. Product start date and dose number  was given.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 003B21A and 003B21) for COVID-19 vaccination.     The patient's past medical history included Diarrhea and Full term baby. Family history included Family history of cancer (Family history of breast cancer, paternal aunt and grandmother). Concurrent medical conditions included Hyperlipidemia since 12-Aug-2020, Hypothyroidism, Migraine headache since 13-Mar-2018 and Breast nodule (Benign nodule of breast of right). Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN ALMUS), RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ODT), FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D), RIBOFLAVIN SODIUM PHOSPHATE (RIBOFLAVIN [RIBOFLAVIN SODIUM PHOSPHATE]), MAGNESIUM, UBIDECARENONE (COQ 10) and VITAMIN D3 for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment details were reported. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Exposure via ingestion: not reported not reported. On an unknown date, Investigation: not reported not reported, not reported not reported, not reported not reported, not reported not reported, not reported not reported, not reported not reported and not reported not reported. On an unknown date, Laboratory test: not reported not reported. On an unknown date, Physical examination: not reported not reported. It was stated that on an unknown date patient delivered child prior to the vaccination and pregnancy outcome reported as live full term birth.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jan-2022: Upon internal review on 24-Feb-2022, significant corrections were performed: patient was not pregnant and event maternal exposure during pregnancy was deleted.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: if patient receives second injection further apart than 42 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (if patient receives second injection further apart than 42 days) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (if patient receives second injection further apart than 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (if patient receives second injection further apart than 42 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Non-Significant Follow up- Email Address updated
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac disorder
Clinical narrative: Arrhythmia; Severe heart problems; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant) and CARDIAC DISORDER (Severe heart problems). At the time of the report, ARRHYTHMIA (Arrhythmia) and CARDIAC DISORDER (Severe heart problems) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medication was not provided.  This is a spontaneous case concerning  a female patient of unknown age,  with no reported medical history, who experienced the unexpected Serious (AESI) event of Arrhythmia and unexpected non-serious event of cardiac disorder. The events occurred on an unspecified date and unspecified dose of mRNA-1273 COVID 19 Vaccine. The events outcome were unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning  a female patient of unknown age,  with no reported medical history, who experienced the unexpected Serious (AESI) event of Arrhythmia and unexpected non-serious event of cardiac disorder. The events occurred on an unspecified date and unspecified dose of mRNA-1273 COVID 19 Vaccine. The events outcome were unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Chills, Foetal death, Foetal hypokinesia, Maternal exposure during pregnancy
Clinical narrative: Mild headache; Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of HEADACHE (Mild headache) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039d21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 30-Nov-2020. Concurrent medical conditions included Hypothyroidism (Levothyroxine 5 mcg daily) since 01-Aug-2018 and Polycystic ovarian syndrome (PCOs Letrozole - 7/25 - 7/29) since 01-Aug-2019. Concomitant products included PRENATAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;S from 04-Apr-2019 to an unknown date for Pregnancy.    On 25-Oct-2021 at 12:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. The patient's last menstrual period was on 23-Jul-2021 and the estimated date of delivery was 03-May-2022. On 25-Oct-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced HEADACHE (Mild headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy. The vaginal delivery occurred, which was reported as Still birth. For foetus 1, The outcome was reported as Stillbirth NOS. The patient was treated with LEVOTHYROXINE (oral) ongoing from 02-Aug-2018 for Hypothyroidism, at a dose of 50 microgram once a day. On 25-Oct-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, HEADACHE (Mild headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive. On 17-Jul-2021, Ultrasound scan: normal (normal) Normal viable first trimester ultrasound, estimated gestational age 7 weeks 3 days.. On 22-Aug-2021, Pregnancy test: positive (Positive) Positive Pregnancy test.     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.   Date of LMP was mentioned as 23-Jul-2021.  Patient had no known drug allergies. On 29-Oct-2021 the patient had taken Influenza vaccine with lot number 3p3ty 1st dose via intramuscular route on left deltoid    This case was linked to MOD-2022-486683 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2022: Follow up information was received on 23-Feb-2022: Reporter details updated, Relevant history, Lab data and pregnancy details was added
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Myalgia, SARS-CoV-2 test, Stillbirth, Ultrasound scan
Clinical narrative: Mild headache; Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of HEADACHE (Mild headache) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039d21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 30-Nov-2020. Concurrent medical conditions included Hypothyroidism (Levothyroxine 5 mcg daily) since 01-Aug-2018 and Polycystic ovarian syndrome (PCOs Letrozole - 7/25 - 7/29) since 01-Aug-2019. Concomitant products included PRENATAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;S from 04-Apr-2019 to an unknown date for Pregnancy.    On 25-Oct-2021 at 12:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. The patient's last menstrual period was on 23-Jul-2021 and the estimated date of delivery was 03-May-2022. On 25-Oct-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced HEADACHE (Mild headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy. The vaginal delivery occurred, which was reported as Still birth. For foetus 1, The outcome was reported as Stillbirth NOS. The patient was treated with LEVOTHYROXINE (oral) ongoing from 02-Aug-2018 for Hypothyroidism, at a dose of 50 microgram once a day. On 25-Oct-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, HEADACHE (Mild headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive. On 17-Jul-2021, Ultrasound scan: normal (normal) Normal viable first trimester ultrasound, estimated gestational age 7 weeks 3 days.. On 22-Aug-2021, Pregnancy test: positive (Positive) Positive Pregnancy test.     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.   Date of LMP was mentioned as 23-Jul-2021.  Patient had no known drug allergies. On 29-Oct-2021 the patient had taken Influenza vaccine with lot number 3p3ty 1st dose via intramuscular route on left deltoid    This case was linked to MOD-2022-486683 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2022: Follow up information was received on 23-Feb-2022: Reporter details updated, Relevant history, Lab data and pregnancy details was added
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Maternal exposure during pregnancy, Pregnancy test, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: Mild headache; Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of HEADACHE (Mild headache) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039d21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 30-Nov-2020. Concurrent medical conditions included Hypothyroidism (Levothyroxine 5 mcg daily) since 01-Aug-2018 and Polycystic ovarian syndrome (PCOs Letrozole - 7/25 - 7/29) since 01-Aug-2019. Concomitant products included PRENATAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;S from 04-Apr-2019 to an unknown date for Pregnancy.    On 25-Oct-2021 at 12:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. The patient's last menstrual period was on 23-Jul-2021 and the estimated date of delivery was 03-May-2022. On 25-Oct-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced HEADACHE (Mild headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy. The vaginal delivery occurred, which was reported as Still birth. For foetus 1, The outcome was reported as Stillbirth NOS. The patient was treated with LEVOTHYROXINE (oral) ongoing from 02-Aug-2018 for Hypothyroidism, at a dose of 50 microgram once a day. On 25-Oct-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, HEADACHE (Mild headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive. On 17-Jul-2021, Ultrasound scan: normal (normal) Normal viable first trimester ultrasound, estimated gestational age 7 weeks 3 days.. On 22-Aug-2021, Pregnancy test: positive (Positive) Positive Pregnancy test.     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.   Date of LMP was mentioned as 23-Jul-2021.  Patient had no known drug allergies. On 29-Oct-2021 the patient had taken Influenza vaccine with lot number 3p3ty 1st dose via intramuscular route on left deltoid    This case was linked to MOD-2022-486683 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2022: Follow up information was received on 23-Feb-2022: Reporter details updated, Relevant history, Lab data and pregnancy details was added
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Pruritus, Rash, SARS-CoV-2 test positive, Stress
Clinical narrative: Bleeding; Itching; She has a rash all over her body; she has stress all over; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding), PRURITUS (Itching), RASH (She has a rash all over her body) and STRESS (she has stress all over) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046821A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol and Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety.    On 22-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 HAEMORRHAGE (Bleeding), PRURITUS (Itching), RASH (She has a rash all over her body) and STRESS (she has stress all over). At the time of the report, HAEMORRHAGE (Bleeding), PRURITUS (Itching), RASH (She has a rash all over her body) and STRESS (she has stress all over) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, SARS-CoV-2 test positive: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have any allergies. Patient did not experienced a similar event on the past.  Patient did not had any acute or chronic illness at the time of the vaccination.  Patient was using unknown medication for Blood pressure and cholesterol. Patient states that her symptoms was ongoing.  Dermatologist prescribed her a cleansing cream for the shower.   This case was linked to MOD-2021-419456 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood albumin, Computerised tomogram, Hypoalbuminaemia, Swelling
Clinical narrative: Swelling in my left leg groin area; Albumin down to 2.2; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in my left leg groin area) and HYPOALBUMINAEMIA (Albumin down to 2.2) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Ovarian cancer NOS (Dx Ovarian CA) since 2018.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced SWELLING (Swelling in my left leg groin area). In February 2021, the patient experienced HYPOALBUMINAEMIA (Albumin down to 2.2). At the time of the report, SWELLING (Swelling in my left leg groin area) and HYPOALBUMINAEMIA (Albumin down to 2.2) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Computerised tomogram: results not reported CT scan related to ovarian cancer history. In February 2021, Blood albumin (3.5-3.7): 2.2 (Low) Albumin down to 2.2.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that albumin ranges normally 3.5 to 3.7 but in early February it was down to 2.2 and she was not able to get it back to the normal level. Patient reported that the swelling in her left leg groin area was worsening.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-490077 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Experienced an anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Experienced an anaphylactic reaction) 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.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ANAPHYLACTIC REACTION (Experienced an anaphylactic reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Experienced an anaphylactic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.  Patient mentioned that he experienced an anaphylactic reaction last year with our Vaccine and wanted an actual list of the ingredients for testing with his HCP.  Patient didn't want to provide any type of information as he "already reported to VAERS".  Company comment:  This case concerns a male patient of an unknown age with no medical history provided, who experienced serious expected event of Anaphylactic reaction after the administration of the mRNA-1273 vaccine (the dose of the vaccine was not specified). The temporal relationship between vaccine administration and the event occurrence cannot be determined as vaccination date and start date of the event were not provided. The outcome of the event was not specified and no details regarding the clinical course of the event were disclosed at the time of this report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no medical history provided, who experienced serious expected event of Anaphylactic reaction after the administration of the mRNA-1273 vaccine (the dose of the vaccine was not specified). The temporal relationship between vaccine administration and the event occurrence cannot be determined as vaccination date and start date of the event were not provided. The outcome of the event was not specified and no details regarding the clinical course of the event were disclosed at the time of this report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Cerebrovascular accident, Gait disturbance, Hypoaesthesia, Movement disorder
Clinical narrative: stroke; foreign neuropathy; can't talk well/can't sing the way she used to/hard to talk; can't walk well; dominant hand doesn't work; angry; numb; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and NEUROPATHY PERIPHERAL (foreign neuropathy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperthyroidism (started a decade ago and still taking medication for it). Concomitant products included METHIMAZOLE for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (foreign neuropathy) (seriousness criterion medically significant), SPEECH DISORDER (can't talk well/can't sing the way she used to/hard to talk), GAIT DISTURBANCE (can't walk well), MOVEMENT DISORDER (dominant hand doesn't work), ANGER (angry) and HYPOAESTHESIA (numb). The patient was hospitalized for 30 days due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), NEUROPATHY PERIPHERAL (foreign neuropathy), SPEECH DISORDER (can't talk well/can't sing the way she used to/hard to talk), GAIT DISTURBANCE (can't walk well), MOVEMENT DISORDER (dominant hand doesn't work), ANGER (angry) and HYPOAESTHESIA (numb) outcome was unknown.            The patient reported that she was given blood thinners and cholesterol medications.  Company comment: This is a spontaneous case concerning a 68-year-old female patient with  Hyperthyroidism, who experienced the serious unexpected event cerebrovascular accident,  approximately 54 days after the second dose of mRNA-1273.  Patient was hospitalized for 30 days due to CVA: events related included speech disorder, gait disturbance and movement disorder on dominant hand. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 68-year-old female patient with  Hyperthyroidism, who experienced the serious unexpected event cerebrovascular accident,  approximately 54 days after the second dose of mRNA-1273.  Patient was hospitalized for 30 days due to CVA: events related included speech disorder, gait disturbance and movement disorder on dominant hand. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Speech disorder
Clinical narrative: stroke; foreign neuropathy; can't talk well/can't sing the way she used to/hard to talk; can't walk well; dominant hand doesn't work; angry; numb; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and NEUROPATHY PERIPHERAL (foreign neuropathy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperthyroidism (started a decade ago and still taking medication for it). Concomitant products included METHIMAZOLE for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (foreign neuropathy) (seriousness criterion medically significant), SPEECH DISORDER (can't talk well/can't sing the way she used to/hard to talk), GAIT DISTURBANCE (can't walk well), MOVEMENT DISORDER (dominant hand doesn't work), ANGER (angry) and HYPOAESTHESIA (numb). The patient was hospitalized for 30 days due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), NEUROPATHY PERIPHERAL (foreign neuropathy), SPEECH DISORDER (can't talk well/can't sing the way she used to/hard to talk), GAIT DISTURBANCE (can't walk well), MOVEMENT DISORDER (dominant hand doesn't work), ANGER (angry) and HYPOAESTHESIA (numb) outcome was unknown.            The patient reported that she was given blood thinners and cholesterol medications.  Company comment: This is a spontaneous case concerning a 68-year-old female patient with  Hyperthyroidism, who experienced the serious unexpected event cerebrovascular accident,  approximately 54 days after the second dose of mRNA-1273.  Patient was hospitalized for 30 days due to CVA: events related included speech disorder, gait disturbance and movement disorder on dominant hand. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 68-year-old female patient with  Hyperthyroidism, who experienced the serious unexpected event cerebrovascular accident,  approximately 54 days after the second dose of mRNA-1273.  Patient was hospitalized for 30 days due to CVA: events related included speech disorder, gait disturbance and movement disorder on dominant hand. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Scratch, Urticaria
Clinical narrative: hives; itchiness; scratch marks; rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PRURITUS (itchiness), SCRATCH (scratch marks) and RASH (rash all over the body) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced URTICARIA (hives), PRURITUS (itchiness), SCRATCH (scratch marks) and RASH (rash all over the body). At the time of the report, URTICARIA (hives), PRURITUS (itchiness), SCRATCH (scratch marks) and RASH (rash all over the body) had not resolved.            No concomitant medication information provided. The reporter reported that the patient has been taking allergy medicines as a treatment to calm down the events occurred for the past month and a half. The patient took her booster dose and experienced events after 4-5 days after taking vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (17 patients administered expired Moderna COVID-19 vaccine) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 003B21A) for COVID-19 immunization. No medical history reported. On Sep 10, 2021, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient administered expired product (17 patients administered expired Moderna COVID-19 vaccine). At the time of the report, administered expired product (17 patients administered expired Moderna COVID-19 vaccine) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported by the reporter.  Treatment medication was not provided by the reporter.  The vial was initially stored in the refrigerator on 06 Jul 2021 and the vaccine vial had not undergone any temperature excursions. It was reported that the patient did not report any other adverse events. It was unknown which arm the patient received the Moderna covid-19 vaccine in.  This case was created for 5th patient out of 17 patient's   This case was linked to MOD-2022-489263 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2022: Upon internal review on 22-Feb-2022, significant correction was performed. The report type was updated from Invalid case to Spontaneous and case narrative was updated accordingly