chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: multiple outbreaks of herpes zoster; This spontaneous report was received from a lawyer, regarding a case in litigation and refers to a male patient (pt) of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot #, and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not resolved. The reporter determined the event to be related to zoster vaccine live (ZOSTAVAX).  The event was considered to be disabling by a reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: A patient was administered VARIVAX after a temperature excursion; This spontaneous report was received from a medical assitant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 01-JUN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number U029496, expiration date 21-SEP-2023 for prophylaxis (dose and route of administration not reported) (product storage error).      The vaccine underwent a temperature excursion of 8.3 degrees Farhrenheit for 15 minutes. No previous excursions were detected.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Medical assistant reporting that a patient was administered VARIVAX after a temperature excursion. No additional information provided. Additional AE cases: 02177149, 02177161, 02177162, 02177163, 02177164, 02177165, 02177166, 02177167, 02177168 filed; This spontaneous report was received from a medical assitant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 31-MAY-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number U029496, expiration date 21-SEP-2023 for prophylaxis (dose and route of administration not reported) (product storage error).      The vaccine underwent a temperature excursion of 8.3 degrees Farhrenheit for 15 minutes. No previous excursions were detected.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE reported; an improperly stored dose of VAQTA was administered to a patient; This spontaneous report was received from a Licensed Practical Nurse and referred to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On an unknown date in May 2022, the patient  was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot #U033212, expiration date: 07-NOV-2022) administered for prophylaxis (strength, dose, and route of administration were not provided) (product storage error).  It was reported that the suspect vaccine was exposed to a temperature of above 9 degree Celsius (9.04 degree Celsius) for a time frame of 30 minutes. There were no previous temperature excursions. No additional adverse effects were noted.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 06-months-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 23-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 12-months-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # U014656 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 23-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot number reported as U014656 confirmed as valid, expiration date reported and stablished as 07-MAY-2023) administered as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001103:
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 04-months-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 23-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 12-months-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # U014656 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 24-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot number reported as U014656 confirmed as valid, expiration date reported and stablished as 07-MAY-2023) administered as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001103:
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 10-weeks-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 25-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001103:
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Nasal congestion, Rhinorrhoea
Clinical narrative: This spontaneous report received from a patient who was a health care professional via other manufacturer (Pfizer Inc) concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: ESRD (end stage renal disease), chronic kidney disease, anxiety, allergy (drug name not specified) and depression, and other pre-existing medical conditions included: The patient was a health care professional. The patient was not pregnant at the time of reporting. The patient was previously received two doses of Pfizer biontech covid-19 vaccine (Tozinameran) (Dose number in series 1) (form of admin, route of admin was not reported, batch number: unknown and expiry date: unknown) doses were not reported, administered on 28-JAN-2021 at 19:00 (first dose) and on 21-FEB-2021 at 16:00 (second dose) for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with 2 doses of Pfizer biontech covid-19 vaccine (Tozinameran) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (third dose) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 06-JUN-2021 15:00 for prophylactic vaccination. Age at time of vaccination 26 years old. The batch number was not reported and has been requested. Concomitant medications included belatacept (Nulojix), bupropion hydrochloride (Wellbutrin), ferrous sulfate  (iron), mycophenolate mofetil, and prednisone. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2.s (Dose number in series 2). The patient received additional dose of non-company suspect vaccine Pfizer biontech covid-19 vaccine (Tozinameran) (Dose number in series 3) (fourth dose) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 26-SEP-2021 at 16:00 for prophylactic vaccination. The patient was prescribed with non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on 10-MAY-2022 and last dose on 15-MAY-2022 for covid-19 infection. On 21-MAY-2022, at 08:00, the patient started having cough and nasal congestion/ runny nose approximately 6 days after patient last day of the 5 day treatment course of paxlovid. The patient reported that she was coughing a fair bit every few minutes or so and also had rhinorrhea (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from cough/ coughing a fair bit every few minutes or so, nasal congestion/ runny nose, and rhinorrhea. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Covid-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19 virus test positive) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ADW2586, EW0180, 3005690 and 34396TB) for COVID-19 vaccination.     Concomitant products included CITRALEX for an unknown indication.   On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19 virus test positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 virus test positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Company Comment: This is a spontaneous case concerning a 70-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, SARS-CoV-2 Test Positive (reported as Covid-19 virus test positive) which occurred approximately 1 month after receiving a dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 70-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, SARS-CoV-2 Test Positive (reported as Covid-19 virus test positive) which occurred approximately 1 month after receiving a dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient was tested positive/ tested positive twice; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient was tested positive/ tested positive twice) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022, the patient experienced COVID-19 (Patient was tested positive/ tested positive twice). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient was tested positive/ tested positive twice) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Continued testing negative for next 9 days, with no symptoms. On 19-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 21-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 31-May-2022, SARS-CoV-2 test: positive (Positive) tested positive twice.         No Concomitant product use was reported.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient took Paxlovid on first day of testing positive and tested negative for Covid on Day 3 of Paxlovid course. The patient continued testing negative for next 9 days, with no symptoms. On Day 12, the patient experienced congestion and sore throat, tested positive twice. The device date reported as 31-May-2022.  Company Comment: This is an spontaneous case concerning an 31-year-old female patient with medical history of PAXLOVID  for COVID-19 treatment from 19-May-2022 to 24-May-2022 who experienced the unexpected event of COVID-19 (AESI) unknown days after  3rd. dose of  mRNA-1273 vaccine. On 19-May-2022, SARS-CoV-2 test: positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is an spontaneous case concerning an 31-year-old female patient with medical history of PAXLOVID  for COVID-19 treatment from 19-May-2022 to 24-May-2022 who experienced the unexpected event of COVID-19 (AESI) unknown days after  3rd. dose of  mRNA-1273 vaccine. On 19-May-2022, SARS-CoV-2 test: positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Weight decreased
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Cardiac disorder NOS (Heart patient). 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 29-May-2022 at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Weight decreased: decreased Decreased. No concomitant medications were reported. It was reported patient lost weight during COVID. Patient tested positive for COVID-19 after finishing the course with Paxlovid. Dosage text for Paxlovid was reported as in the morning took two tablets, in the evening took two tablets because of patient's health and it was prescribed due to patient's age and being heart patient. Patient knew that the home test for COVID-19 have two bright red lines if they are positive. The lower line was faded on patient's test. That might make a difference patient was unsure. Patient was not felt bad or sick after taking Moderna vaccines. Number of Paxlovid was reported as Unknown. Company comment: This spontaneous case concerns a 77-year-old female gender patient, with no relevant medical history, who experienced the unexpected non-serious AESI COVID-19 that occurred on an unknown date after the 3rd dose of mRNA-1273 vaccine. Patient was prescribed with Paxlovid for 5 days as treatment regimen. Three days after completion of treatment, patient was tested positive for COVID. Clinical course and treatment details were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgement. Sender's Comments: This spontaneous case concerns a 77-year-old female gender patient, with no relevant medical history, who experienced the unexpected non-serious AESI COVID-19 that occurred on an unknown date after the 3rd dose of mRNA-1273 vaccine. Patient was prescribed with Paxlovid for 5 days as treatment regimen. Three days after completion of treatment, patient was tested positive for COVID. Clinical course and treatment details were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgement.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The patient received dose after the beyond use date; Vial initially stored on 31-JAN-2022 and then administered on 10-MAR-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 10-MAR-2022) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022 at 8:37 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 10-MAR-2022). On 10-Mar-2022 at 8:37 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 10-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that HCP provided doses of the Moderna COVID19 vaccine after the beyond use date as the HCP didn't know that the vials shouldn't be used past 30 days from thawing the vials Vial did not undergo any temperature excursions. Total 20 doses were administered. Total 15 vials were used. Thaw expiration date was reported as 02-Mar-2022. No treatment medications were reported   This case was linked to MOD-2022-583498, MOD-2022-583519 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2022: Follow up received contains patient information , reporter email and suspect product information and additional event of product storage error was added.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac failure, Cardiomegaly, Myocardial infarction
Clinical narrative: Had two heart attacks shortly after I received my first shot; Months later I experienced another failure; Heart is enlarged; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Had two heart attacks shortly after I received my first shot) and CARDIAC FAILURE (Months later I experienced another failure) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was reported that patient never had any health problems until Moderna vaccination.     On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Had two heart attacks shortly after I received my first shot) (seriousness criterion medically significant), CARDIAC FAILURE (Months later I experienced another failure) (seriousness criterion medically significant) and CARDIOMEGALY (Heart is enlarged). At the time of the report, MYOCARDIAL INFARCTION (Had two heart attacks shortly after I received my first shot), CARDIAC FAILURE (Months later I experienced another failure) and CARDIOMEGALY (Heart is enlarged) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant drug was reported.  The patient had two heart attacks shortly after receiving first shot. Patient stated Cardiologists said that the vaccine might have been a factor in its failure.  No treatment drug was reported.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious (medically significant) events of Myocardial infarction(AESI) and Cardiac failure (AESI), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient reported that the heart was enlarged. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious (medically significant) events of Myocardial infarction(AESI) and Cardiac failure (AESI), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient reported that the heart was enlarged. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Influenza
Clinical narrative: Like two days with the flu; Patient had uncomfortable side effects to Moderna doses 1, 2 and 3; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Like two days with the flu) and IMMUNISATION REACTION (Patient had uncomfortable side effects to Moderna doses 1, 2 and 3) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cardiomyopathy, Heart disease, unspecified (Heart disease), Blood pressure high, Cancer (NOS) (Treated cancer), Pollen allergy (Seasonal allergy pollen) and Chronic sinusitis (Chronic sinusitis).    In January 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 INFLUENZA (Like two days with the flu) and IMMUNISATION REACTION (Patient had uncomfortable side effects to Moderna doses 1, 2 and 3). At the time of the report, INFLUENZA (Like two days with the flu) and IMMUNISATION REACTION (Patient had uncomfortable side effects to Moderna doses 1, 2 and 3) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient's height was reported as 5 feet 2 inches and 5 feet 3 inches. No concomitant medication was provided. Patient was not sure howgot the virus. No treatment information was provided.   This case was linked to MOD-2022-583435, MOD-2022-583436, MOD-2022-575167 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, Influenza
Clinical narrative: Like two days with the flu; I had uncomfortable side effects to Moderna doses 1, 2 and 3; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Like two days with the flu) and IMMUNISATION REACTION (I had uncomfortable side effects to Moderna doses 1, 2 and 3) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer (NOS) (Treated cancer). Concurrent medical conditions included Cardiomyopathy (Cardiomyopathy), Heart disease, unspecified (Heart disease), Blood pressure high (High blood pressure), Chronic sinusitis (chronic sinuses) and Seasonal allergy (Seasonal allergy pollen).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 INFLUENZA (Like two days with the flu) and IMMUNISATION REACTION (I had uncomfortable side effects to Moderna doses 1, 2 and 3). At the time of the report, INFLUENZA (Like two days with the flu) and IMMUNISATION REACTION (I had uncomfortable side effects to Moderna doses 1, 2 and 3) outcome was unknown.            No concomitant medication information provided. No treatment information provided.   This case was linked to MOD-2022-583433, MOD-2022-583436, MOD-2022-575167 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, Influenza
Clinical narrative: Like two days with the flu; Patient had uncomfortable side effects to Moderna doses 1, 2 and 3; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Like two days with the flu) and IMMUNISATION REACTION (Patient had uncomfortable side effects to Moderna doses 1, 2 and 3) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cardiomyopathy, Heart disease, unspecified, Blood pressure high, Cancer (Treated cancer), Seasonal allergy (Seasonal allergy pollen) and Sinus infection (Chronic).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Like two days with the flu) and IMMUNISATION REACTION (Patient had uncomfortable side effects to Moderna doses 1, 2 and 3). At the time of the report, INFLUENZA (Like two days with the flu) and IMMUNISATION REACTION (Patient had uncomfortable side effects to Moderna doses 1, 2 and 3) outcome was unknown.            Patient's height: between 5 feet 2 inches and 5 feet 3 inches. No concomitant medication was provided. Patient still don't know how she got the virus. No treatment information was provided.   This case was linked to MOD-2022-583435, MOD-2022-583433, MOD-2022-575167 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Tested positive for COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication reported. The reporter reported that the patient was vaccinated with Moderna COVID-19 vaccine and boosted as well. No treatment medication details reported.  Company comment- This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 (with a positive SARS-CoV-2 test) which occurred at an unknown time with regards to Covid-19 vaccination. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 (with a positive SARS-CoV-2 test) which occurred at an unknown time with regards to Covid-19 vaccination. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound COVID, sx started 06/02/2022, tested positive on home test again; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Rebound COVID, sx started 06/02/2022, tested positive on home test again) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Patient had no known allergies.  Concurrent medical conditions included Hypertension and Depression. Concomitant products included FAMOTIDINE, OXYBUTYNIN, AMLODIPINE, LOSARTAN, FLUTICASONE and FLUOXETINE for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Jun-2022, the patient experienced COVID-19 (Rebound COVID, sx started 06/02/2022, tested positive on home test again). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 24-May-2022 to 29-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound COVID, sx started 06/02/2022, tested positive on home test again) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Device Date was reported as 03-Jun-2022.  Company comment: This spontaneous case concerns a 70-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI of Covid-19, on an unspecified date after receiving a dose of mRNA-1273 vaccine. She tested positive for SARS-CoV-2 at home, diagnosed with Covid-19 Rebound and was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. The outcome was reported as not resolved. Details of symptoms, start date, clinical course, further investigation reports were not provided. Details of Vaccination history and prior Covid-19 infection were not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 70-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI of Covid-19, on an unspecified date after receiving a dose of mRNA-1273 vaccine. She tested positive for SARS-CoV-2 at home, diagnosed with Covid-19 Rebound and was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. The outcome was reported as not resolved. Details of symptoms, start date, clinical course, further investigation reports were not provided. Details of Vaccination history and prior Covid-19 infection were not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial initially stored on 31-JAN-2022 and then administered on 10-MAR-2022; The patient received dose after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 10-MAR-2022) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022 at 8:41 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Mar-2022 at 8:41 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 10-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 10-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the vials were initially stored on 31-Jan-2022 and the thaw expiration date was 02-Mar-2022. It was also reported that the vial didn't undergo any temperature excursions.  The patient received their first booster dose.  No treatment information was provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The patient received dose after the beyond use date; Vial initially stored on 31-JAN-2022 and then administered on 03-MAR-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 03-MAR-2022) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022 at 8:12 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 03-MAR-2022). On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 03-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  It was reported that HCP provided doses of the Moderna COVID19 vaccine after the beyond use date as the HCP didn't know that the vials shouldn't be used past 30 days from thawing the vials Vial did not undergo any temperature excursions. Total 20 doses were administered. Total 15 vials were used. Thaw expiration date was reported as 02-Mar-2022.  No treatment medications were reported
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 03-Mar-2022; dose of the Moderna COVID-19 vaccine was administered after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 vaccine was administered after the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 03-Mar-2022) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022 at 8:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Mar-2022 at 8:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 vaccine was administered after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 03-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 vaccine was administered after the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 03-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Thaw expiration date was 02-Mar-2022. It was reported that the HCP did not know that the vial should not be used past 30 days from thawing the vial. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-583132 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date vials initially stored was 31-Jan-2022, Thaw expiration date: 02-Mar-2022, vaccine administered on 03-Mar-2022; Receiving doses after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving doses after the beyond use date) and PRODUCT STORAGE ERROR (Date vials initially stored was 31-Jan-2022, Thaw expiration date: 02-Mar-2022, vaccine administered on 03-Mar-2022) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022 at 8:19 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Mar-2022 at 8:19 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving doses after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vials initially stored was 31-Jan-2022, Thaw expiration date: 02-Mar-2022, vaccine administered on 03-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving doses after the beyond use date) and PRODUCT STORAGE ERROR (Date vials initially stored was 31-Jan-2022, Thaw expiration date: 02-Mar-2022, vaccine administered on 03-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the vials were initially stored on 31-Jan-2022 and the thaw expiration date was 02-Mar-2022. It was also reported that the vial didn't undergo any temperature excursions.  The patient received their first booster dose.  No treatment information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: Sudden onset of vitiligo/vitiligo on torso and legs/hands cotton white, snow white/not dissipated at all/white splotches here and there; This spontaneous case was reported by a consumer and describes the occurrence of VITILIGO (Sudden onset of vitiligo/vitiligo on torso and legs/hands cotton white, snow white/not dissipated at all/white splotches here and there) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VITILIGO (Sudden onset of vitiligo/vitiligo on torso and legs/hands cotton white, snow white/not dissipated at all/white splotches here and there). At the time of the report, VITILIGO (Sudden onset of vitiligo/vitiligo on torso and legs/hands cotton white, snow white/not dissipated at all/white splotches here and there) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications was reported. No treatment was reported Patient had 2nd dose administered on 12-Mar-2021: 016M20A. Booster dose administered on 19-Jan-2022: 013F21A