chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I have developed tinnitus in both ears which is massively effecting my quality of life. Fatigue Headaches all of the time Periods of confusion/brain fog Dizziness
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Covid arm: red, itchy,  hot rash.  Lightheadedness for a couple of days  Low grade fever  Headaches
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Covid arm: red, itchy,  hot rash.  Lightheadedness for a couple of days  Low grade fever  Headaches
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about their concurrent conditions, concomitant therapies or medical history provided.  On 12-MAR-2021, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) dose/frequency: 1, lot # T027118, expiration date 07-FEB-2022, recombinant human albumin (rHA) (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was stored in a temperature of 13.5 Fahrenheit degrees (F) for 40 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No additional adverse event was reported.  Follow-up information has been received from the medical assistant and an office manager on 30-MAR-2021 and on 28-MAY-2021. The date of vaccination was additionally reported as between 04-MAR-2021 and 25-MAR-2021 by the medical assistant and details of the facility where the patient was vaccinated were provided. As of 28-MAY-2021, no further information was available as the office manager stated she was not familiar with the case and the medical assistant has no longer been working in the facility.  This is one of several reports from the same reporter.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product formulation administered
Clinical narrative: No additional AE reported.; the vaccine was administered while out of recommended range, Temperature 89 F; This spontaneous report was received from a registered nurse and refers to a 14-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 15-MAY-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # 1687292, expiration date 25-AUG-2022 (route of administration and anatomical location were not reported) for prophylaxis. The vaccine was administered while out of recommended range. Temperature excursion was 89 degrees Fahrenheit (F) which lasted 24 hours, there was no previous temperature excursion. A digital data logger was involved in recording the excursion. No product quality complaints or additional adverse events were reported, and no further information was provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; operatorofdevice: Nurse; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, Measles antibody negative, Mumps antibody test positive, Rubella antibody positive
Clinical narrative: only has antibodies for mumps and rubella; first dose administered at 28 months and second at 3 years old; This spontaneous report was received from a male patient concerning to himself, a 4 years old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 08-NOV-2001, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, lot#, expiration date and site of administration were not provided) as mandatory vaccination after moving to the country. He received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) on 06-FEB-2004 (inappropriate schedule).   On an unknown date, the patient was tested for the antibodies for measles, mumps and rubella and discovered he only had antibodies for mumps and rubella. At the time of the report, the outcome of the event was not provided.  The causal relationship between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; temperature excursion/ vaccines have been administered to patients; This spontaneous report was received from a licensed vocational nurse and refers to 8-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-MAR-2021, the patient was vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate (LIQUID PEDVAXHIB) lot # 1742460, expiration date 16-NOV-2021 (exact dose, route of administration and anatomical location were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # T006849, expiration date 16-JUN-2022 (exact dose,was not reported). Both vaccines were administered for prophylaxis. On 09-MAR-2021, administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 30 minutes. There was no previous excursion reported. Digital data logger was involved. There was no adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA006817: US-009507513-2105USA007003: US-009507513-2105USA006749: US-009507513-2105USA007032:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/ PQC reported atthis time.; temperature excursion/ vaccines have been administered to patients; This spontaneous report was received from a nurse and refers to a 4-month-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-MAR-2021, the vaccine experienced the temperature excursion of 9 degrees Celsius for 30 minutes.  On 18-MAR-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1742460 has been verified to be a valid lot number, expiration date was reported as 16-NOV-2021 (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Data logger was involved. There were no previous excursions reported.; Sender's Comments:  US-009507513-2105USA007003: US-009507513-2105USA006817:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: GARDASIL 9 was administered to a pregnant patient; No additional AE reported; Information has been received from a medical assistant referring to a female patient of unknown age. The patient was pregnant (estimated last menstrual period (LMP), estimated date of conception (EDC) and estimated date of delivery (EDD) were unknown, fetus number was one). Information of concomitant medication, pertinent medical history and drug reactions/allergies was unknown.     On 27-MAY-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose detail, frequency, route, lot# and expiration date were unknown) for prophylaxis (Vaccine exposure during pregnancy). The pregnancy outcome was outcome pending. The fetal outcome was unknown. No adverse event was reported.
Age: 61.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pneumococcal vaccine 23 valent administered on 02-NOV-2012 and pneumococcal vaccine 13 valent on 09-APR-2015; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for Zoster Vaccine Live (ZOSTAVAX) (MARRS# 1903USA012114), concerning a 64-year-old female patient. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 02-NOV-2012, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (reported as PPSV23) and on 09-APR-2015, she received a dose of pneumococcal vaccine 13v (reported as PCV13) (inappropriate schedule of product administration), both administered as prophylaxis (strength, dosage schedule, route of administration, anatomical site of vaccination, vaccination scheme frequency, lot number, and expiration date were not reported for both doses). No adverse effects were reported.; Sender's Comments:  US-009507513-1903USA012114:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; Temperature excursion that ocurred on VARIVAX / was administered; This spontaneous report as received from a medical assitant, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 27-MAY-2021, the patient was vaccinated with an incorrect stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T028305, expiration date reported as 20-AUG-2022, for prophylaxis (strength, dose, route and frequency were not reported).  The temperature excursion was of -58 Fahrenheit degrees (°F) to 5 (°F) (15.2°F), during 2 hours 15 minutes 0 seconds.Aprevious temperature excursion was not reported. A digital data logger was involved. No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; PROQUAD that underwent a tempreature excursion was administered; This spontaneous report as received from a medical assistant, referring to a patient of unknown age and gender.The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 27-MAY-2021, the patient was vaccinated with an incorrect stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine liverecombinant Human albumin (rHA)(PROQUAD) lot# T035393, expiration date 14-APR-2022, for prophylaxis (strength, dose, route and frequency were not reported).       The temperature excursion was of -58 Fahrenheit degrees (°F) to 5 (°F) (15.2°F), during 2 hours 15 minutes 0 seconds. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Product use in unapproved indication
Clinical narrative: HPV vaccine to beef up his T cells; This spontaneous report has been received from  a 63 year old male patient regarding himself. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 25-MAY-2021, the patient was vaccinated with an unspecified HPV vaccine (lot #, expiration date, dose and route were not reported) to "beef uo his T cells" (Drug use for unapproved indication).  It was further mentioned that the patient started therapy with pembrolizumab (KEYTRUDA) on the same date, and experienced several adverse events (captured into MARRS # 2105USA006345).    This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2105USA006345:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; temperature excursion; This spontaneous report was received from a medical assistant and an office manager and refers to a patient of unknown age and gender (number reported as 64675). There was no information about their concurrent conditions, concomitant therapies or medical history provided.  On 13-MAR-2021 (reported also as reported as between 04-MAR-2021 and 25-MAR-2021), the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) dose/frequency: 1, lot # T027118, expiration date 07-FEB-2022, recombinant human albumin (rHA) (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was stored in a temperature of 13.5 Fahrenheit degrees (F) for 40 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No additional adverse event was reported.  As of 28-MAY-2021, no further information was available as the office manager stated she was not familiar with the case and the medical assistant has not been working at the facility anymore.  This is one of several reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; temperature excursion; This spontaneous report was received from a medical assistant and an office manager and refers to a patient of unknown age and gender (number reported as 65496). There was no information about their concurrent conditions, concomitant therapies or medical history provided.  On 09-MAR-2021 (reported also as reported as between 04-MAR-2021 and 25-MAR-2021), the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) dose/frequency: 1, lot # T021823, expiration date 25-JUN-2022 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was stored in a temperature of 13.5 Fahrenheit degrees (F) for 40 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No additional adverse event was reported.  As of 28-MAY-2021, no further information was available as the office manager stated she was not familiar with the case and the medical assistant has not been working at the facility anymore.  This is one of several reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; temperature excursion; This spontaneous report was received from a medical assistant and an office manager and refers to a patient of unknown age and gender (number reported as 65414). There was no information about their concurrent conditions, concomitant therapies or medical history provided.  On 09-MAR-2021 (reported also as between 04-MAR-2021 and 25-MAR-2021), the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) dose/frequency: 1, lot # T021823, expiration date 25-JUN-2022 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was stored in a temperature of 13.5 Fahrenheit degrees (F) for 40 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No additional adverse event was reported.  As of 28-MAY-2021, no further information was available as the office manager stated she was not familiar with the case and the medical assistant has not been working at the facility anymore.  This is one of several reports from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; temperature excursion; This spontaneous report was received from a medical assistant and an office manafer and refers to a patient of unknown age and gender (number reported as 56173). There was no information about their concurrent conditions, concomitant therapies or medical history provided.  On 18-MAR-2021 (reported also as between 04-MAR-2021 and 25-MAR-2021), the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) dose/frequency: 1, lot # S030215, expiration date 25-MAR-2021, recombinant human albumin (rHA) (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was stored in a temperature of 13.5 Fahrenheit degrees (F) for 40 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No additional adverse event was reported.  As of 28-MAY-2021, no further information was available as the office manager stated she was not familiar with the case and the medical assistant has not been working at the facility anymore.  This is one of several reports from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; temperature excursion; This spontaneous report was received from a medical assistant and an office manager and refers to a patient of unknown age and gender (number reported as 25780). There was no information about their concurrent conditions, concomitant therapies or medical history provided.  On 17-MAR-2021 (reported also as between 04-MAR-2021 and 25-MAR-2021), the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) dose/frequency: 1, lot # T027118, expiration date 07-FEB-2022, recombinant human albumin (rHA) (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was stored in a temperature of 13.5 Fahrenheit degrees (F) for 40 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No additional adverse event was reported.  As of 28-MAY-2021, no further information was available as the office manager stated she was not familiar with the case and the medical assistant has not been working at the facility anymore.  This is one of several reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; temperature excursion; This spontaneous report was received from a medical assistant and an office manager and refers to a patient of unknown age and gender (number reported as 65584). There was no information about their concurrent conditions, concomitant therapies or medical history provided.  On 18-MAR-2021 (reported also as between 04-MAR-2021 and 25-MAR-2021), the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) dose/frequency: 1, lot # T021823, expiration date 25-JUN-2022 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was stored in a temperature of 13.5 Fahrenheit degrees (F) for 40 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No additional adverse event was reported.  As of 28-MAY-2021, no further information was available as the office manager stated she was not familiar with the case and the medical assistant has not been working at the facility anymore.  This is one of several reports from the same reporter.
Sex: M
Vaccine: COVID19, FLUN3
Symptoms: Urticaria
Clinical narrative: HIVES AFTER ADMINISTRATION OF NASAL FLUMIST; A spontaneous report has been received from a consumer. The report concerns a male patient (age not provided).    No medical history was reported.     No concomitant products were reported.    On an unknown date, the patient received Flumist (influenza vaccine) once/single administration, via nasal route. The patient started treatment with Covid Vaccine (covid-19 vaccine) on an unknown date.     A Unknown administered FLUMIST. No malfunction has been reported for this combination product.    On an unknown date, the patient experienced hives after administration of nasal flumist (preferred term: Urticaria).     It was unknown if any action was taken with Flumist and Covid Vaccine.     The outcome of the event hives after administration of nasal flumist was unknown.    The event was considered non-serious.     The reporter assessed the event hives after administration of nasal flumist as non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray   Product Role: Suspect
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Chills, Contusion, Facial paralysis, Fatigue
Clinical narrative: Bell's palsy; Facial paralysis; Contusion; Chills; Fatigue; This case was received via FDA VAERS (Reference number: 1108212) on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Bell's palsy) and FACIAL PARALYSIS (Facial paralysis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant), FACIAL PARALYSIS (Facial paralysis) (seriousness criterion medically significant), CONTUSION (Contusion), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with VALACICLOVIR at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bell's palsy), FACIAL PARALYSIS (Facial paralysis), CONTUSION (Contusion), CHILLS (Chills) and FATIGUE (Fatigue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient mild chills and fatigue the following day after vaccination. The morning of the 17-MAR-2021, patient woke up and felt like the right side of my face was bruised, just under the apple of cheek. Looking in the mirror, patient saw right side of mouth had a droop. Patient notified the  Health Department where she had received the vaccine and then called PCP.  PCP did a telehealth visit with patient and confirmed Bell's Palsy characteristics. Patient had no other issues so no further testing was deemed needed and PCP prescribed a short course of steroids and vancyclovir. Patient have an in person visit with PCP next day.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Atrial fibrillation, Body temperature decreased, Dizziness, Myalgia
Clinical narrative: Body temperature decreased; Myalgia; Atrial fibrillation; Alopecia; Nasopharyngitis; Vision blurred; Vasculitis; Dizziness; This case was received via FDA VAERS (Reference number: 1124402) on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine, hydrocodone and tramadol.) and Autoimmune disorder.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant), ALOPECIA (Alopecia), NASOPHARYNGITIS (Nasopharyngitis), VISION BLURRED (Vision blurred), VASCULITIS (Vasculitis), DIZZINESS (Dizziness) and MYALGIA (Myalgia). On an unknown date, the patient experienced BODY TEMPERATURE DECREASED (Body temperature decreased). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) had resolved and ALOPECIA (Alopecia), NASOPHARYNGITIS (Nasopharyngitis), VISION BLURRED (Vision blurred), VASCULITIS (Vasculitis), DIZZINESS (Dizziness), BODY TEMPERATURE DECREASED (Body temperature decreased) and MYALGIA (Myalgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter.  Patient vaccine administration arm coldness and temperature drop. Patient reported the symptoms to her doctors and they recommended she get the second shot.  Treatment information was not provided.  Company comment: Very limited information regarding this event has been provided at this time. Details regarding autoimmune disorder and concomitant medications are required for further evaluation.; Sender's Comments: Very limited information regarding this event has been provided at this time. Details regarding autoimmune disorder and concomitant medications are required for further evaluation.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Vasculitis, Vision blurred
Clinical narrative: Body temperature decreased; Myalgia; Atrial fibrillation; Alopecia; Nasopharyngitis; Vision blurred; Vasculitis; Dizziness; This case was received via FDA VAERS (Reference number: 1124402) on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine, hydrocodone and tramadol.) and Autoimmune disorder.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant), ALOPECIA (Alopecia), NASOPHARYNGITIS (Nasopharyngitis), VISION BLURRED (Vision blurred), VASCULITIS (Vasculitis), DIZZINESS (Dizziness) and MYALGIA (Myalgia). On an unknown date, the patient experienced BODY TEMPERATURE DECREASED (Body temperature decreased). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) had resolved and ALOPECIA (Alopecia), NASOPHARYNGITIS (Nasopharyngitis), VISION BLURRED (Vision blurred), VASCULITIS (Vasculitis), DIZZINESS (Dizziness), BODY TEMPERATURE DECREASED (Body temperature decreased) and MYALGIA (Myalgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter.  Patient vaccine administration arm coldness and temperature drop. Patient reported the symptoms to her doctors and they recommended she get the second shot.  Treatment information was not provided.  Company comment: Very limited information regarding this event has been provided at this time. Details regarding autoimmune disorder and concomitant medications are required for further evaluation.; Sender's Comments: Very limited information regarding this event has been provided at this time. Details regarding autoimmune disorder and concomitant medications are required for further evaluation.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Maternal exposure during breast feeding; This case was received via VAERS (Reference number: 1230062) on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Postural orthostatic tachycardia syndrome. Concurrent medical conditions included Drug allergy (Codeine), Marfan's syndrome and Allergy (Adhesives). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion disability). On 21-Mar-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved.        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.   This is a case of product exposure during breastfeeding with an associated adverse event of Alopecia areata in the nursing baby. The event started 8 days after the mother's vaccination and was reported as not resolved. No other causes have been identified. Based on temporal association a causal relationship cannot be excluded.; Sender's Comments: This is a case of product exposure during breastfeeding with an associated adverse event of Alopecia areata in the nursing baby. The event started 8 days after the mother's vaccination and was reported as not resolved. No other causes have been identified. Based on temporal association a causal relationship cannot be excluded
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Malaise
Clinical narrative: she got "sick."; her body did NOT build up the titers.; This case was reported by a consumer via call center representative and described the occurrence of sickness in a elderly female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, several months after receiving Hepatitis B vaccine, the patient experienced sickness and therapy non-responder. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the sickness to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination not reported. The patient report to herself  that many years ago she had  hepatitis B shot series.  She thought it was a 3 or a 4 shot series.  After Several months she got sick.  Her doctor checked her for titer but she stated, her body did not built up the titer. This case is one of 3 cases, reported by the same patient. GSK Note- since the patient was not sure, if she had 3 doses or 4 doses of Hepatitis B, only one Hepatitis B is coded without any dose number.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR116458:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: arm was quite sore; arm was/ red; arm / had swelling; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included glaucoma and blood cholesterol increased. Additional patient notes included Ethnicity.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the pain in arm, erythema of extremities and swelling arm were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities and swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The age at vaccination was not reported, however could be 69 or 70 years. The patient was taking statin, a blood pressure medication for high cholesterol and eye drops for glaucoma. The patient did not provide any product names. In 2018, the patient received 2 doses of Shingrix vaccine. After 1st Shingrix vaccination, the patient experienced that arm was quite sore, red, and had swelling. The patient stated that there was little more redness and swelling than the Covid vaccine. The reporter consented to follow up. No further information was reported. This case has been linked with US2021AMR116503, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR116503:2nd dose, same reporter same patient
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Feeling abnormal, Herpes zoster, Pain, Ultrasound scan
Clinical narrative: got shingles; my right side/ the pain was/still have pains on right side bad; thought I was dying; This case was reported by a consumer via  interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine, the patient experienced shingles (serious criteria hospitalization), pain localized and impending doom. On an unknown date, the outcome of the shingles was unknown and the outcome of the pain localized and impending doom were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain localized and impending doom to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient got the first shot of Shingles vaccine, then in 4 months got shingles. The patient spent two days in hospital and could not find what was wrong. The patient did an ultrasound on the right side and that was where the pain was. The patient thought he/she was dying. The patient said he/she wanted to go home and next day at home, the patient self diagnosed. Till the time of reporting, the patient had pains on right side, which started two years ago.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Burning sensation, Condition aggravated, Herpes zoster, Neck pain
Clinical narrative: Rough Shot!/Then I developed silent shingles/Suspect vaccination failure; Then I developed silent shingles; Severe right sided neck pain; Debilitating.; Burned like fire; fever/for 3 days; body aches for 3 days/painful months; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, fever, general body pain, neck pain, debility and burning sensation. On an unknown date, the outcome of the vaccination failure, shingles, neck pain, debility and burning sensation were unknown and the outcome of the fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, fever, general body pain, neck pain, debility and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and experienced fever, body aches for 3 days, developed silent shingles, severe right sided neck pain from an old auto accident that had lo g healed, debilitating and burned like fire. The reporter reported that should have left well enough alone and lasted 6 extremely painful months. The patient said I am not an anti-vaxer. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Vaccination failure
Clinical narrative: Rough Shot!/Then I developed silent shingles/Suspect vaccination failure; Then I developed silent shingles; Severe right sided neck pain; Debilitating.; Burned like fire; fever/for 3 days; body aches for 3 days/painful months; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, fever, general body pain, neck pain, debility and burning sensation. On an unknown date, the outcome of the vaccination failure, shingles, neck pain, debility and burning sensation were unknown and the outcome of the fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, fever, general body pain, neck pain, debility and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and experienced fever, body aches for 3 days, developed silent shingles, severe right sided neck pain from an old auto accident that had lo g healed, debilitating and burned like fire. The reporter reported that should have left well enough alone and lasted 6 extremely painful months. The patient said I am not an anti-vaxer. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Vaccination failure
Clinical narrative: I had the vaccine, two injections/ got the Shingles a few months later/suspected Vaccination failure; got the Shingles/ Not as severe, but still uncomfortable; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (off and on for years).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The patient had 2 shingles vaccine which were expensive and got Shingles few months later after vaccination. The shingles was not as severe, but still it was uncomfortable to patient. This case was considered as suspected vaccination failure as details regarding laboratory confirmation was unknown at the time of reporting .
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: had the shot but got the shingles anyway/suspected vaccination failure; got the shingles/ in his eye; got the shingles/ forehead into his hairline; This case was reported by a contact via interactive digital media and described the occurrence of Suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient got Shingles after vaccination. The patient had shingles in his eye and forehead into his hairline. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: even having had the shingles shot, you can get shingles/it happened to me!/suspect vaccination failure; get shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   Concurrent medical conditions included immunocompromised (compromised immune system).   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and Covid vaccine and had shingles. The patient stated that if you had a compromised immune system, even had the shingles shot, you could get shingles with the covid shot and no one wanted to talk about this, but it was happening, he/she know because it happened to him/her. The patient considered that there was a direct link to getting shingles and the covid vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: had the pain when I got it it hurt for 5 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingles vaccine. On an unknown date, between 1 and 3 months after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingles vaccine and experienced pain for 5 days. This case has been linked with the case US2021AMR116873, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR116873:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Vaccination failure
Clinical narrative: I got the shot and got shingles anyway./every now and then/ suspect vaccination failure; got shingles anyway. In my ear and my head of all places; got shingles anyway. In my ear and my head of all places; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster otitis externa (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the herpes zoster otitis externa and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and got shingles anyway in his/her ear and head of all places. The patient stated still a ya up every now and then. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: pharmacist told me he gave it to me in my vein / I know this is not going to be effective!; This case was reported by a consumer via interactive digital media and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose on an unknown date in November 2020 and experienced pain, refer case US2021AMR116857).   In January 2021, the patient received the 2nd dose of Shingles vaccine (intravenous). In January 2021, unknown after receiving Shingles vaccine, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The patient was the reporter. The age at vaccination was not reported. The patient received 2nd dose of Shingles vaccine in vein which led to intramuscular formulation administered by other route. The patient did not experienced pain. The reporter mentioned that, it was not going to be effective. This case has been linked with the case US2021AMR116857, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR116857:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: I had shingles shot last February and only little pain in two days on my arm after no more; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In February 2021, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received shingles shot and experienced little pain in arm in two days and after that no more.