chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Tenderness
Clinical narrative: from top of ankle to all the way down to toe, I touch it and it hurts; tender; both ankles are extremely tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (from top of ankle to all the way down to toe), TENDERNESS, and ARTHRALGIA in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Guillain-Barre syndrome and Paralyzed (At young age).    On 22-Jan-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 PAIN IN EXTREMITY (from top of ankle to all the way down to toe), TENDERNESS, and ARTHRALGIA. The patient was treated with TYLENOL at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (from top of ankle to all the way down to toe), TENDERNESS, and ARTHRALGIA had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received Tylenol but it did not help.
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Fatigue, Nausea, Vomiting
Clinical narrative: Dehydration; extremely dizzy; felt violently nauseous; threw up profusely for hours; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION, DIZZINESS, FATIGUE, NAUSEA, and VOMITING in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 029L20A) for an unknown indication.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced FATIGUE. On 07-Feb-2021, the patient experienced DEHYDRATION, DIZZINESS, NAUSEA, and VOMITING. On 08-Feb-2021, DEHYDRATION, DIZZINESS, NAUSEA, and VOMITING had resolved. At the time of the report, FATIGUE had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not provided. At the ER he received treatment for vomiting and dehydration, they put him on a drip and gave him meds for nausea and dizziness
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Ultrasound abdomen
Clinical narrative: Pregnant; This case was received via an unknown source (no reference has been entered for a health authority) on 11-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 004M20A) for COVID-19 vaccination.     Patient medication history was not provided by the reporter.  Concomitant products included PRENATAL + DHA for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 06-Sep-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound abdomen: ultrasound done two times as a part of pregnancy..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity, Pregnancy test, Pyrexia
Clinical narrative: sore left arm; LOW fever; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (sore left arm), MATERNAL EXPOSURE DURING PREGNANCY, and PYREXIA (LOW fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (40 weeks 4 days) in October 2014, In vitro fertilization and Miscarriage in October 2020. Concomitant products included PRENATAL VITAMIN and BABY ASPIRIN for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 18-Nov-2020 and the estimated date of delivery was 05-Sep-2021. On 13-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore left arm) and PYREXIA (LOW fever). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy.  On 13-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY had resolved. At the time of the report, PAIN IN EXTREMITY (sore left arm) had not resolved and PYREXIA (LOW fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, Pregnancy test: positive.     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.   Treatment medications were not provided. Estimated Date of conception was 18-Dec-2020
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy and vaccinated; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy and vaccinated) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Crohn's disease and Asthma. Concurrent medical conditions included Shellfish allergy and Drug allergy (Patient have allergy towards aspirin and ibuprofen.). Concomitant products included ASPIRINETAS for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 14-May-2021. On 10-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy and vaccinated). On 10-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy and vaccinated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications Aspirinetas Treatment medications were not provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Got the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got the vaccine while pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Gestational diabetes. Concomitant products included INSULIN, LEVOTHYROXINE, VITAMIN D, PRENATAL VITAMINS for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Aug-2020 and the estimated date of delivery was 22-May-2021. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got the vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy.  On 15-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Got the vaccine while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Reporter details and patient demographic details were updated.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity, Paraesthesia
Clinical narrative: pain fierce for almost a month in arm - sharp pain up and down; pinky and finer next to pink are numb; looks like a spasm sporadically from elbow to hand; A spontaneous report was received from a consumer concerning male patient of unknown age who was administered Moderna's COVID-19 vaccine for prophylaxis of COVID-19 infection experienced pain fierce for almost a month in arm, sharp pain up and down, looks like a spasm sporadically from elbow to hand.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12/Jan/2021, the patient received their first of two planned doses of mRNA-1273 (Lot number:026L20A) intramuscularly for prophylaxis of COVID-19 infection.    On 12/Jan/2021 the patient reported adverse events such as pain fierce for almost a month in arm, sharp pain up and down pinky and finger next to pinky are numb, also a spasm felt sporadically from elbow to hand.   The treatment information for the events were calcium and vitamin D intake provided.  Action taken with the first dose of mRNA-1273 vaccine was not reported.  Th e outcome for the events pain fierce for alomst a month in arm, sharp pain up and down, looks like a spasm sporadically from elbow to hand was unknown. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Haemoptysis, Haemorrhage
Clinical narrative: BLEEDING; SPITTING BLOOD; This spontaneous report received from a consumer concerned a female of unspecified age of an unknown ethnic origin and race. Initial information processed with additional information received from reporter on 04-AUG-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unkown expiry:unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the reporter stated that her friend was spitting blood and bleeding after receiving her Janssen covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bleeding and spitting blood was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210812102-Covid-19 vaccine ad26.cov2. s, Bleeding and spitting blood - This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Headache, Pyrexia
Clinical narrative: Pain in the armpit area of the left arm.; Low grade fever 98.8F; Light headache; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration in the left arm on 19Mar2021 at 09:30 (at the age of 59-year-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151), via an unspecified route of administration in the left arm on 09Apr2021 at 10:00 (at the age of 59-year-old), as a single dose for COVID-19 immunisation. Medical history included Hashimoto's and the patient had a history of beets allergy. Concomitant medications included levothyroxine sodium (SYNTHROID) 25 milligrams and vitamins (MANUFACTURER UNKNOWN) for an unknown indication form an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, 14 hours after vaccination the patient experienced low grade fever 98.8 degrees Fahrenheit, light headache, pain in the armpit area of the left arm. These started at approximately 14 hours after vaccination. The pain in the armpit got worse, extending to arm by 48 hrs. and still feeling the pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of low-grade fever 98.8 degrees Fahrenheit, light headache, pain in the armpit area of the left arm was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; Customer reporting administration of expired dose of MMR II.; This spontaneous report was received from a Licensed Practical Nurse (L.P.N.) and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.     On 14-JUL-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot number S018594, which has been verified to be valid, the expiration date was reported and validated as 17-JUN-2021), 1 dose as prophylaxis (expired product administered) (exact dose, route of administration, and anatomical site of vaccination were not provided). The vaccine was diluted with a sterile diluent (MERCK STERILE DILUENT) (lot number S021105, which has been verified to be valid, the expiration date was reported and validated as 14-MAY-2022). No additional adverse events were reported.
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; vaccines were exposed to high and low temperatures and administered to two patients; This spontaneous report was received from a healthcare professional referring to a 4-year old patient of unspecified gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On  01-JUL-2021, the patient was vaccinated with an improperly stored dose of   hepatitis b vaccine (recombinant)(RECOMBIVAX HB) pre-filled syringe, lot # T004378 (expiration date not reported, but upon internal validation established as 01-NOV-2022) for prophylaxis (dose, route and site of administration were not reported).  The administered dose of the vaccine experienced multiple high and low temperature excursions from below 33.9°F to above 49.7°F, for 4 hours and 05 minutes. There was no adverse effect reported. No product quality complaint was involved. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T004378; expirationdate: 01-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA005117:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE reported; a dose of Gardasil 9 was administered following a temperature excursion; This spontaneous report has been received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided.  On 19-JUL-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe as prophylaxis (vaccine scheme, route of administration, and anatomical site of vaccination were not reported; lot number T030746 has been verified to be a valid lot number, expiration date reported and established as 16-MAR-2023).  The vaccine was improperly stored at 49.69 degrees Fahrenheit for 1 hour, 24 minutes (product storage error), which was detected by a digital data logger; with no previous temperature excursion. No additional adverse event was reported. 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: T030746; expirationdate: 16-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HPV9, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE reported; Gardasil 9 underwent a temperature excursion and was administered to a patient.; This spontaneous report has been received from a Registered Nurse and refers to a patient of unspecified age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions, or allergies.  On 27-JUL-2021, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliters (mL) (dose number, vaccination scheme frequency, route and anatomical site of administration were not provided; lot number 1687290, that was verified to be valid, expiration date reported and established as 06-SEP-2022) as prophylaxis. It was reported that the administered vaccine had experienced a temperature excursion of 59 degrees Fahrenheit (F) with a time frame of 15 minutes, which was detected by data logger (product storage error). No previous temperatures excursions were reported. No additional adverse events (AEs) were reported. 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: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: F
Vaccine: HPV9, UNK
Symptoms: Syringe issue, Wound
Clinical narrative: Puncture wound to right index finger; the flange was bronken/ the circular flange around the syringe was broken in 2 pieces - one was a chip and the other was the sice of about half the flange; This spontaneous report has been received from a nurse referring to herself, as a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 19-JUL-2021, the patient went to remove HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number T028583 has been verified to be a valid lot number, expiration date reported and established as 04-MAR-2023) from the package and noticed something stocked in her finger, then she realized that the circular flange around the syringe was broken in 2 pieces, one was a chip and the other was the size of about half the flange (syringe issue). The patient experienced a puncture wound (injury associated with device) in her right index finger. At the time of this report, the patient had healed, and she was not sure which finger was injured (conflicting information).   The syringe had been disposed; therefore, it was not possible to be returned. 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: T028583; expirationdate: 04-MAR-2023; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: No additional AE reported; an 11 year old patient was administered his first dose of GARDASIL 9 on 8AUG2020/ the patient has come into the pharmacy today, 20JUL2021, to receive the second dose; This spontaneous report was received from a pharmacist and refers to a 11 years old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 08-AUG-2020, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter for prophylaxis (anatomical location, route of administration, lot # and expiration date were not reported). On 20-JUL-2021, the patient has come into the pharmacy to receive the second dose. No additional adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: HCP reporting a temperature excursion states that doses have been administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.      On 23-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # T030479, expiration date 07-MAR-2022, 0.5 milliliter for prophylaxis (anatomical location and route of administration were not reported).  Digital Data logger was involved. The vaccine was stored at the temperature that was reported as -7.2 degrees of Celsius for 2 hours 21 minutes. There was a previous temperature excursion reported (-5.9 degrees of C for 2 hours 31 minutes).
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative, Product administered to patient of inappropriate age
Clinical narrative: a 40-year-old patient received MMR II; mumps titer was negative; This spontaneous report was received from a nurse and refers to a 40-year-old, female patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On 30-JUL-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, 1 dose, lot #S035355, expiration date was reported and also validated as 05-NOV-2021 (dose, strength, route of administration and anatomical location were not provided) for prophylaxis (inappropriate age at vaccine administration).  On an unspecified date in 2021, the titer was done. Measles and Rubella titer came back positive but Mumps titer was negative (mumps antibody test negative). The nurse did not know if the patient had received additional measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) doses in the past. No further information was available. The outcome of mumps antibody test negative was not reported (unknown).
Sex: M
Vaccine: MMR
Symptoms: Measles, Measles post vaccine
Clinical narrative: The doctor informed her that his son had modified measles after an MMR 2 shot; This spontaneous report was received from consumer referring to a male patient of unknown age. Information regarding the patient's pertinent medical history, concomitant therapies,  previous drug reactions, or allergies was not reported.     On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)  (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported) as prophylaxis  On an unknown date, during the reporter's daughter's doctor visit, the physician informed to the reporter,  that his son had modified measles after the vaccination with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (measles post vaccine) It was unknown by the reporter if treatment was given, or if lab diagnostics were performed due to event, and the outcome of the event.    The consumer's causal relationship between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II ) and measles post vaccine was not reported.  Upon internal review, the event measles post vaccine was considered to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no symptoms were reported by  the patient after administration; VARlVAX was administered to patient since the excursion; This spontaneous report was received from a certified medical assistant referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-JUL-2021, the temperature exurcion ocurred.  On 26-JUL-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), dose reported as 1 (units not provided),  lot # T032319, expiration date:22-SEP-2022 for prophylaxis (dose number and  route of administration were not reported) during the excursion. The administered dose of the vaccine experienced a temperature excursion was 10.2 degrees Fahrenheit~for 1 hour 15 minutes, as recorded by a data logger. No previous excursions were reported. No symptoms were reported by the patients after administration. No product quality complaint reported.  This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-2108USA001788: US-009507513-2108USA001787: US-009507513-2108USA001789: US-009507513-2108USA001786:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no symptoms were reported by  the patient after administration; VARlVAX was administered to patient since the excursion; This spontaneous report was received from a certified medical assistant referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-JUL-2021, the temperature exurcion ocurred.  On 03-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), dose reported as 1 (units not provided),  lot # T032319, expiration date:22-SEP-2022 for prophylaxis (dose number and  route of administration were not reported) during the excursion. The administered dose of the vaccine experienced a temperature excursion was 10.2 degrees Fahrenheit~for 1 hour 15 minutes, as recorded by a data logger. No previous excursions were reported. No symptoms were reported by the patients after administration. No product quality complaint reported.  This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-2108USA001788: US-009507513-2108USA001787: US-009507513-2108USA001770: US-009507513-2108USA001789:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no symptoms were reported by  the patient after administration; VARlVAX was administered to patient since the excursion; This spontaneous report was received from a certified medical assistant referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-JUL-2021, the temperature exurcion ocurred.  On 29-JUL-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), dose reported as 1 (units not provided),  lot # T032319, expiration date:22-SEP-2022 for prophylaxis (dose number and  route of administration were not reported) during the excursion. The administered dose of the vaccine experienced a temperature excursion was 10.2 degrees Fahrenheit~for 1 hour 15 minutes, as recorded by a data logger. No previous excursions were reported. No symptoms were reported by the patients after administration. No product quality complaint reported.  This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-2108USA001788: US-009507513-2108USA001770: US-009507513-2108USA001789: US-009507513-2108USA001786:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no symptoms were reported by  the patient after administration; VARlVAX was administered to patient since the excursion; This spontaneous report was received from a certified medical assistant referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-JUL-2021, the temperature exurcion ocurred.  On 03-AUG-2021 , the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), dose reported as 1 (units not provided),  lot # T032319, expiration date:22-SEP-2022 for prophylaxis (dose number and  route of administration were not reported) during the excursion. The administered dose of the vaccine experienced a temperature excursion was 10.2 degrees Fahrenheit~for 1 hour 15 minutes, as recorded by a data logger. No previous excursions were reported. No symptoms were reported by the patients after administration. No product quality complaint reported. This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-2108USA001770: US-009507513-2108USA001787: US-009507513-2108USA001789: US-009507513-2108USA001786:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no symptoms were reported by  the patient after administration; VARlVAX was administered to patient since the excursion; This spontaneous report was received from a certified medical assistant referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-JUL-2021, the temperature exurcion ocurred.  On 05-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), dose reported as 1 (units not provided),  lot # T032319, expiration date:22-SEP-2022 for prophylaxis (dose number and  route of administration were not reported) during the excursion. The administered dose of the vaccine experienced a temperature excursion was 10.2 degrees Fahrenheit~for 1 hour 15 minutes, as recorded by a data logger. No previous excursions were reported. No symptoms were reported by the patients after administration. No product quality complaint reported. This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-2108USA001788: US-009507513-2108USA001787: US-009507513-2108USA001770: US-009507513-2108USA001786:
Age: 16.0
Sex: M
Vaccine: HPV9, JEV1, MNQ
Symptoms: Face injury, Immediate post-injection reaction, Loss of consciousness, Somnolence, Syncope
Clinical narrative: Loss of consciousness; Syncope; Face injury; Tooth loss; Immediate post-injection reaction; Somnolence; This spontaneous report was received from the agency, referring to a 16-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 20-OCT-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly in the right arm (lot number S004578, expiration date 29-SEP-2021) as prophylaxis, the third dose of Japanese encephalitis vaccine inact (IXIARO), administered intramuscularly in the left arm (lot number reported as JEV18L97E, expiration date was not reported), and the second dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), administered intramuscularly in the left arm (lot number reported as U6691AB, expiration date was not reported).  On the same date, immediately after receiving final vaccine, patient fainted from treatment bed (loss of consciousness, syncope, and immediate post-injection reaction). Patient lost consciousness and hit face (face injury) on the floor knocking out two front right teeth (tooth loss). Patient took approximately 30 seconds to rouse but was still somnolent (somnolence). Patient oriented to person, place, and time. Vital signs taken BP 130/76 HR 81 PaO2 100% on room air and 14 breathes/min. Rapid response called, ER arrived to evaluate patient. Pt escorted onto gurney and brought to ER to be further evaluated.  The outcome of loss of consciousness, somnolence, immediate post-injection reaction, tooth loss, face injury and syncope, and the causal relationship between the events and the suspect therapies was not reported were not reported.  Upon internal review, the events loss of consciousness and syncope were determined to be medically significant. 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); devicelotnumber: S004578; expirationdate: 29-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 16.0
Sex: M
Vaccine: HPV9, JEV1, MNQ
Symptoms: Tooth loss
Clinical narrative: Loss of consciousness; Syncope; Face injury; Tooth loss; Immediate post-injection reaction; Somnolence; This spontaneous report was received from the agency, referring to a 16-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 20-OCT-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly in the right arm (lot number S004578, expiration date 29-SEP-2021) as prophylaxis, the third dose of Japanese encephalitis vaccine inact (IXIARO), administered intramuscularly in the left arm (lot number reported as JEV18L97E, expiration date was not reported), and the second dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), administered intramuscularly in the left arm (lot number reported as U6691AB, expiration date was not reported).  On the same date, immediately after receiving final vaccine, patient fainted from treatment bed (loss of consciousness, syncope, and immediate post-injection reaction). Patient lost consciousness and hit face (face injury) on the floor knocking out two front right teeth (tooth loss). Patient took approximately 30 seconds to rouse but was still somnolent (somnolence). Patient oriented to person, place, and time. Vital signs taken BP 130/76 HR 81 PaO2 100% on room air and 14 breathes/min. Rapid response called, ER arrived to evaluate patient. Pt escorted onto gurney and brought to ER to be further evaluated.  The outcome of loss of consciousness, somnolence, immediate post-injection reaction, tooth loss, face injury and syncope, and the causal relationship between the events and the suspect therapies was not reported were not reported.  Upon internal review, the events loss of consciousness and syncope were determined to be medically significant. 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); devicelotnumber: S004578; expirationdate: 29-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Rash
Clinical narrative: 102 Fever; head to toe rash; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2015-2016 season) (batch number 33FF2, expiry date 30th June 2016) for prophylaxis.   The patient's past medical history included allergic reaction.   On 19th October 2015, the patient received Fluarix Quadrivalent 2015-2016 season (intramuscular). On 19th October 2015, less than a day after receiving Fluarix Quadrivalent 2015-2016 season, the patient experienced fever and rash. On an unknown date, the outcome of the fever and rash were recovered/resolved.   It was unknown if the reporter considered the fever and rash to be related to Fluarix Quadrivalent 2015-2016 season.  Additional details provided were as follows: Patient was called to enquired about Fluarix description.  Patient stated that she wanted to get a Covid-19 vaccine, but her allergist was concerned because of an allergic reactions she had from Fluarix in the past. The patient received the Shingrix vaccine at her job site and experienced head to toe rash with a 102 fever. Consumer stated that she came back to work the next day and her supervisor sent her back. VAERS details were captured. Reporter reported that emergency room visit is required. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Illness, Injection site pain, Mobility decreased
Clinical narrative: Second vaccine in april of 2021 / got very sick; Second / shot hurt; Feels like raw flesh and alot of burning!; Feels like raw flesh / pain is in the skin; Buttocks! / started hurting in may / a lot of pain / Still having pain this is aug; Cant sit on one side; suspected vaccination failure; 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 Herpes zoster (Shingles vaccine) for prophylaxis.   In April 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. In May 2021, less than 2 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, buttock pain and mobility decreased. On an unknown date, the patient experienced sickness, pain, burning sensation and skin pain. On an unknown date, the outcome of the vaccination failure, shingles, sickness, mobility decreased, burning sensation and skin pain were unknown and the outcome of the buttock pain and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, sickness, buttock pain, mobility decreased, pain, burning sensation and skin pain to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received both Shingles vaccines but with the 2nd dose he/she got very sick and shot hurt. The reporter stated, if could get shingles on one side of the buttocks, started hurting in May 2021 with a lot of pain could not sit on one side but physician said did not thought its shingles. The patient knows it had something with Shingles. At the time of reporting, less than 5 months after vaccination, the patient had pain, felts like raw flesh and a lot of burning. The pain was in the skin, the patient knows the shingles shot did something. The patient stated that like the Covid vaccine no one told him/her about the adverse events. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation was not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Pain, Pain of skin, Vaccination failure
Clinical narrative: Second vaccine in april of 2021 / got very sick; Second / shot hurt; Feels like raw flesh and alot of burning!; Feels like raw flesh / pain is in the skin; Buttocks! / started hurting in may / a lot of pain / Still having pain this is aug; Cant sit on one side; suspected vaccination failure; 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 Herpes zoster (Shingles vaccine) for prophylaxis.   In April 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. In May 2021, less than 2 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, buttock pain and mobility decreased. On an unknown date, the patient experienced sickness, pain, burning sensation and skin pain. On an unknown date, the outcome of the vaccination failure, shingles, sickness, mobility decreased, burning sensation and skin pain were unknown and the outcome of the buttock pain and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, sickness, buttock pain, mobility decreased, pain, burning sensation and skin pain to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received both Shingles vaccines but with the 2nd dose he/she got very sick and shot hurt. The reporter stated, if could get shingles on one side of the buttocks, started hurting in May 2021 with a lot of pain could not sit on one side but physician said did not thought its shingles. The patient knows it had something with Shingles. At the time of reporting, less than 5 months after vaccination, the patient had pain, felts like raw flesh and a lot of burning. The pain was in the skin, the patient knows the shingles shot did something. The patient stated that like the Covid vaccine no one told him/her about the adverse events. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event, Incomplete course of vaccination
Clinical narrative: first dose /on Dec-10-2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10th December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. No other information about the patient was provided. Pharmacist declined to give adverse event information because he was busy. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient's husband reported that, the patient was tested positive for Covid-19 virus and was hospitalized (date and duration not specified). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210807871 and 20210808196.; Sender's Comments: V0: 20210807550-Covid-19 vaccine ad26.cov2.s -Covid-19 test positive . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).