chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nasopharyngeal swab, Pyrexia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jun2022 at 14:30 as dose 3 (booster), single (Lot number: Fm7553), in left arm and on 09Jun2022 as dose 4 (booster), single (Lot number: fm7553) at the age of 73 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "autoimmune disease" (unspecified if ongoing), notes: autoimmune disease oral lichen planus stomach problems acid reflux had operation I March made worse; "oral lichen planus" (unspecified if ongoing); "stomach problems" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "operation" (unspecified if ongoing), notes: had operation I March made worse; "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tylenol, reaction(s): "known allergy: Tylenol"; Vicodin, reaction(s): "known allergy: Vicodin". Vaccination history included: Pfizer (Dose Number: 2, single, Batch/Lot No: Ew0173, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 04Oct2021, for COVID-19 Immunization; Pfizer (Dose Number: 1, single , Batch/Lot No: Ep7534, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 17Mar2021, for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "diarrhea"; PYREXIA (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "fever 101-104"; HEADACHE (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 10Jun2022 at 02:00, outcome "not recovered" and all described as "muscle and joint pain"; LIMB DISCOMFORT (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "sore arm"; ABDOMINAL PAIN UPPER (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "stomach pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, abdominal pain upper, diarrhea, limb discomfort, myalgia, arthralgia. Additional information: patient reported that, on 10Jun2022 at 2:00 AM, patient had very high fever 101-104, very bad headache, stomach pains, very bad diarrhea, sore arm, muscle and joint pain. Patient had the flu but this much worse only happened with last 2 boosters. No other vaccine received in four weeks. No Covid prior vaccination and tested for Covid post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: get temporary but severe Guillain-Barre syndrome; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Lot number: 701611) at the age of 70 years, in left arm for covid-19 immunisation. No other vaccine in four weeks. The patient's relevant medical history and concomitant medications were not reported. No COVID prior vaccination. Vaccination history included: BNT162b2 (dose 1, Pfizer Vaccine, lot unknown due to unable to locate or read the details, vaccine location=Left arm), administration date: 03Feb2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Covid after receiving the vaccine"; BNT162b2 (dose 2, Pfizer Vaccine, lot number: EN6202, vaccine location=Left arm), administration date: 02Mar2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Covid after receiving the vaccine". The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, medically significant) with onset 30Dec2021, outcome "recovered", described as "get temporary but severe Guillain-Barre syndrome". The event "get temporary but severe guillain-barre syndrome" required physician office visit and emergency room visit.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: get temporary but severe Guillain-Barre syndrome; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Lot number: 701611) at the age of 70 years, in left arm for covid-19 immunisation. No other vaccine in four weeks. The patient's relevant medical history and concomitant medications were not reported. No COVID prior vaccination. Vaccination history included: BNT162b2 (dose 1, Pfizer Vaccine, lot unknown due to unable to locate or read the details, vaccine location=Left arm), administration date: 03Feb2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Covid after receiving the vaccine"; BNT162b2 (dose 2, Pfizer Vaccine, lot number: EN6202, vaccine location=Left arm), administration date: 02Mar2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Covid after receiving the vaccine". The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, medically significant) with onset 30Dec2021, outcome "recovered", described as "get temporary but severe Guillain-Barre syndrome". The event "get temporary but severe guillain-barre syndrome" required physician office visit and emergency room visit.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Positive COVID test; Positive COVID test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EN5318), on 24Feb2021 as dose 2, single (Lot number: EN5318), on 30Sep2021 as dose 3 (booster), single (Lot number: 30130BA) and on 20Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Shingles vaccine (shingles vaccine), for Immunization, reaction(s): "localized reaction". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "unknown" and all described as "Positive COVID test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Caller stated that she had a positive COVID test in the morning of 25May2022 and then took all the Paxlovid until 30May2022 and ended with the morning dose on 30May2022. It was instructed to took 3 tablets in the morning and 3 tablets in the evening with food and drank tons of water. Additional vaccines administered on same date was not for the last 2 doses, caller stated it was hard to remember she had so many immunizations this year. She did not think so but she was not 100% certain. Added that on 30Sep2021 she could have gotten the flu shot that day but she did not know for sure.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID test; Positive COVID test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EN5318), on 24Feb2021 as dose 2, single (Lot number: EN5318), on 30Sep2021 as dose 3 (booster), single (Lot number: 30130BA) and on 20Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Shingles vaccine (shingles vaccine), for Immunization, reaction(s): "localized reaction". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "unknown" and all described as "Positive COVID test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Caller stated that she had a positive COVID test in the morning of 25May2022 and then took all the Paxlovid until 30May2022 and ended with the morning dose on 30May2022. It was instructed to took 3 tablets in the morning and 3 tablets in the evening with food and drank tons of water. Additional vaccines administered on same date was not for the last 2 doses, caller stated it was hard to remember she had so many immunizations this year. She did not think so but she was not 100% certain. Added that on 30Sep2021 she could have gotten the flu shot that day but she did not know for sure.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse reports possible administration of improperly stored vaccines; no adverse event; This spontaneous report was received from a nurse, referring to unspecified patients of unknown age and gender.  Nurse reported possible administration of improperly stored vaccines. No additional adverse events were reported.   The names of vaccines involved (including lot/exp): hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9): Lot: 1775808  Expiration: 20-AUG-2023; Lot: T030749  expiration date: 16-MAR-2023; Lot: 1687293  expiration date: 30-APR-2023; hepatitis a vaccine, inactivated (VAQTA): Lot: T031202, expiration date; 14-JUN-2022, Lot: U026792 expiration date: 28-OCT-2022; hepatitis b vaccine (recombinant) (RECOMBIVAX HB): Lot: T021327, expiration date: 14-NOV-2022; Lot: U008328, expiration date: 16-DEC-2022.  All lot number were verified to be valid, (route and anatomical location were not reported) administered for prophylaxis.   It was reported that the vaccines had been incorrectly stored at -0.3C for 5 minutes and then at 0.3C for 45 minutes. There was no previous temperature excursion  This case was considered non-valid due to lack of patient identifiers.  Follow up information was received from the nurse on 09-JUN-2022.  The patient's demographics were provided for all the patients involved in previous event of temperature excursion.  This spontaneous report was referring to a 9-month-old female patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 02-MAY-2022, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, lot #U001837, expiration date: 21-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided).  This is one of multiple reports received from the same source.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: HBP reporting AE for improperly stored administered vaccine.   Names of vaccines involved (including lot/exp):  ROTATEQ Lot U037809 Exp 03/26/2023  Temperature (28.0F) BELOW 36°F  Time frame 96 Hours  Previous temperature excursion? No  Additional A; This spontaneous report was received from an office manager (also reported as HBP) and refers to 9-week-old patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 16-MAY-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # U037809 with expiration date 26-MAR-2023 (exact dose was not reported) for prophylaxis. The vaccine underwent a temperature excursion of 28 degrees Fahrenheit (F) for 96 hours on an unknown date before administration (product storage error). There was no previous temperature excursion. The outcome of product storage error was unknown.  On 31-MAY-2022, inbound call received from a healthcare worker. The caller said she received 6 letters from Merck addressed to the office manager, and the office manager no longer worked at the office. The caller wanted to know why those letters were sent. Adverse event process explained to caller. The caller said she would fill out the forms and send back all available information. No further information provided.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2205USA005621: US-009507513-2205USA005673:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE details; patient was vaccinated with VARIVAX after temperature excursion; This spontaneous report was received from a customer and referred to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and drug reactions/allergies were not reported. Concomitant therapy was sterile diluent (manufacturer: Merck).  On an unknown date in May 2022 (between 11-MAY-2022 and 24-MAY-2022), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (valid lot #U039949 with expiration date: 16-DEC-2023; dose, and route of administration were not provided) for prophylaxis after temperature excursion -14 Celsius degrees up to -10 Celsius degrees for 2 hours 5 minutes 0 seconds; and -10 Celsius degrees up to 8 Celsius degrees (-0.4 Celsius degrees) for 1 hour 25 minutes 0 seconds (Product storage error). 1 week ago, this vaccine had another temperature excursion with -14 Celsius degrees up to-10 Celsius degrees (-12 Celsius degrees) for 0 hours 50 minutes 0 seconds. There were no additional adverse event details (no adverse event).  This is one of 13 reports received from the same reporter.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Product storage error; This spontaneous report was received from a medical assistant referring to a 5-year-old female patient.  The patient's pertinent medical history, current conditions, drugs reactions or allergies and concomitant medication were not provided.  On 25-APR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis, lot number U025790, has been verified to be a valid lot number with expiration date on 19-AUG-2023, administered subcutaneously (strength, dose, scheme frequency and anatomical location were not provided).  The vaccines underwent temperature excursion of -14 degrees Celsius up to -10 degrees Celsius during a time frame of 3 hours; -10 degrees Celsius up to 8 degrees Celsius during a time frame of 1 hour and 30 minutes. No adverse event was reported.  There was no previous temperature excursion. It was stated that temperature was recorded by digital data logger.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2205USA008051: US-009507513-2205USA008004: US-009507513-2204USA009330:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: Consumer received her third dose of GARDASIL 9 on 26-MAY-2022 and is 4-6 weeks pregnant; no adverse event; This spontaneous prospective pregnancy report was received from a female consumer of unknown age reporting on herself. On 26-MAY-2022, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and lot # not reported). The patient reported she was 4-6 weeks pregnant. The patient stated the nurse administered the vaccine at the beginning of the appointment, before patient spoke with her doctor regarding the GARDASIL 9 vaccination and pregnancy. The patient's last menstrual period and her estimated date of delivery were unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional Ae's and no PQC's were reported.; An expired dose of VARIVAX that was administered to a patient on 6/2/2022.; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On 02-JUN-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) , lot #T010313, expiration date 24-MAR-2022 (strength, dose, anatomical location, and route of administration were not provided) used as directed to prevent varicella infection (expired product administered). No additional adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: Product prescribing issue
Clinical narrative: Caller is a pharmacist who states a HCP has prescribed GARDASIL 9 for a patient who is over the age of 45.  The pharmacist refused to administer the vaccine.  No other information provided.  No additional AEs or PQC reported.; Caller is a pharmacist who states a HCP has prescribed GARDASIL 9 for a patient who is over the age of 45.  The pharmacist refused to administer the vaccine.  No other information provided.  No additional AEs or PQC reported.; Caller is a pharmacist who states a HCP has prescribed GARDASIL 9 for a patient who is over the age of 45.  The pharmacist refused to administer the vaccine.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from pharmacist referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, a health care professional (HCP) prescribed hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for a patient who was over the age of 45 (product prescribing issue - product administered to patient of inappropriate age); therefore, the pharmacist refused to administered the vaccine. No other information provided. No additional adverse events.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 04-JUN-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter, lot #U034712, expiration date: 30-JUL-2023, administered intramuscularly for prophylaxis (strength was not provided) after a temperature excursion at 34.2 F for 12 hours (product storage error). There was no previous temperature excursion. No other information or additional adverse event (AE) was provided.
Age: 1.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; A dose of GARDASIL 9 was inadvertently administered to a 1 year old patient.; This spontaneous report has been received from a nurse referring a 1 year-old patient.  The patient's pertinent medical history, previous drugs reactions or allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter, lot number U028826, expiration date: 04-NOV-2023, as prophylaxis (vaccination scheme anatomical location and route of administration were not provided) (product administered to patient of inappropriate age). No additional adverse event was reported. The outcome of the event was not reported.
Age: 8.0
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no adverse event; Nurse reports possible administration of improperly stored vaccines; This spontaneous report was received from Other Health Professional, referring to unspecified patients.  Nurse reported possible administration of improperly stored vaccines. No additional adverse events were reported.   The names of vaccines involved (including lot/exp): hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9): Lot: 1775808  Expiration: 20-AUG-2023; Lot: T030749  expiration date: 16-MAR-2023; Lot: 1687293  expiration date: 30-APR-2023; hepatitis a vaccine, inactivated (VAQTA): Lot: T031202, expiration date; 14-JUN-2022, Lot: U026792 expiration date: 28-OCT-2022; hepatitis b vaccine (recombinant) (RECOMBIVAX HB): Lot: T021327, expiration date: 14-NOV-2022; Lot: U008328, expiration date: 16-DEC-2022.  All lot number were verified to be valid, (route and anatomical location were not reported) administered for prophylaxis.   It was reported that the vaccines had been incorrectly stored at -0.3C for 5 minutes and then at 0.3C for 45 minutes. There was no previous temperature excursion  Follow up information was received from the nurse on 09-JUN-2022.  The patient's demographics were provided for all the patients involved in previous event of improperly stored vaccines.  This spontaneous report was referring to a 8-year-old patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 02-MAY-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #U026792, expiration date: 28-OCT-2022, administered for prophylaxis (strength, and route of administration were not provided).  This is one of multiple reports received from the same source.
Age: 0.92
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: no adverse event; Nurse reports possible administration of improperly stored vaccines; This spontaneous report was received from Other Health Professional, referring to unspecified patients.  Nurse reported possible administration of improperly stored vaccines. No additional adverse events were reported.   The names of vaccines involved (including lot/exp): hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9): Lot: 1775808  Expiration: 20-AUG-2023; Lot: T030749  expiration date: 16-MAR-2023; Lot: 1687293  expiration date: 30-APR-2023; hepatitis a vaccine, inactivated (VAQTA): Lot: T031202, expiration date; 14-JUN-2022, Lot: U026792 expiration date: 28-OCT-2022; hepatitis b vaccine (recombinant) (RECOMBIVAX HB): Lot: T021327, expiration date: 14-NOV-2022; Lot: U008328, expiration date: 16-DEC-2022.  All lot number were verified to be valid, (route and anatomical location were not reported) administered for prophylaxis.   It was reported that the vaccines had been incorrectly stored at -0.3C for 5 minutes and then at 0.3C for 45 minutes. There was no previous temperature excursion  Follow up information was received from the nurse on 09-JUN-2022.  The patient's demographics were provided for all the patients involved in previous event of temperature excursion.  This spontaneous report was referring to a 11-month-old male patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 02-MAY-2022, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, lot #U001837, expiration date: 21-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided).  This is one of multiple reports received from the same source.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no adverse event; Nurse reports possible administration of improperly stored vaccines; This spontaneous report was received from Other Health Professional, referring to unspecified patients.  Nurse reported possible administration of improperly stored vaccines. No additional adverse events were reported.   The names of vaccines involved (including lot/exp): hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9): Lot: 1775808  Expiration: 20-AUG-2023; Lot: T030749  expiration date: 16-MAR-2023; Lot: 1687293  expiration date: 30-APR-2023; hepatitis a vaccine, inactivated (VAQTA): Lot: T031202, expiration date; 14-JUN-2022, Lot: U026792 expiration date: 28-OCT-2022; hepatitis b vaccine (recombinant) (RECOMBIVAX HB): Lot: T021327, expiration date: 14-NOV-2022; Lot: U008328, expiration date: 16-DEC-2022.  All lot number were verified to be valid, (route and anatomical location were not reported) administered for prophylaxis.   It was reported that the vaccines had been incorrectly stored at -0.3C for 5 minutes and then at 0.3C for 45 minutes. There was no previous temperature excursion  Follow up information was received from the nurse on 09-JUN-2022.  The patient's demographics were provided for all the patients involved in previous event of improperly stored vaccines.  This spontaneous report was referring to a 15-year-old patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 05-MAY-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1687293, expiration date: 30-APR-2023, administered for prophylaxis (strength, and route of administration were not provided).  This is one of multiple reports received from the same source.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report administered vaccine temperature excursion on multiple patients.; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 13-JUN-2022, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 injection, lot #U036586, expiration date: 21-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) (product storage error).  It was reported that the vaccine went out of range on 13-JUN-2022 (reported as "yesterday") and it was not discovered until the morning on 14-JUN-2022 when checking the data logger.  This is one of the cases reported by the same reporter. ; Sender's Comments:  US-009507513-2206USA004337:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Health business professional calling to report AE for improperly stored vaccines. Date of administration is unknown so AE onset date is unknown by reporter.; No additional AE information; This spontaneous report was received from a health business professional and referred to a patient of unknown gender, currently was 4 years old. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.   On an unknown date, the patient was vaccinated improperly stored with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection (lot #U022727, expiration date: 16-JAN-2023; strength, and route of administration were not provided) administered for prophylaxis) (product storage error).  It was reported that the suspect vaccine was exposed to a temperature of 6 Fahrenheit (F) up to 14 F (minus 14 degree Celsius up to minus 10 degree Celsius) (minus 11.6) for a time frame of 30 minutes. There were no previous temperature excursions.   No additional adverse event (AE) information or other AE was provided.   This is one of the several cases reported by the same reporter.; Sender's Comments:  US-009507513-2206USA004544:
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Incomplete course of vaccination, Lethargy
Clinical narrative: hasn't felt himself, just off; lethargic; patient last seen 2/7/2019, first dose; This case was reported by a physician via sales rep and described the occurrence of feeling abnormal in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 7th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced feeling abnormal, lethargy and incomplete course of vaccination. On an unknown date, the outcome of the feeling abnormal, lethargy and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the feeling abnormal and lethargy to be related to Shingrix.     Additional Information: GSK Receipt Date: 9-JUN-2022 Reporter's Comments: The reporter received a handwritten, single-spaced letter from a former patient last seen on 7th February 2019. In this letter, the patient said, after receiving the 1st dose of Shingrix vaccine, he had not felt himself. He had been lethargic and just off. The patient had not been seen since then and the letter was recently received. Wrote a letter in kind telling the patient he would report the event. The reporter gave consent to follow up. Additional supporting information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2022 13:40, the patient received Shingrix. In June 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-Jun-2022 Reporter's Comments: The patient self-reported this case. The patients doctor's office was closed hence he/she just wanted to see if it was normal to have redness around the injection site. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: rash that are itchy; small blisters all around face and neck; rash on face; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In June 2022, unknown after receiving Shingles vaccine, the patient experienced itchy rash, blistery rash and rash. On an unknown date, the outcome of the itchy rash, blistery rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash, blistery rash and rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-JUN-2022 Reporter's Comment: The patient had a rash on his/her face after receiving the shingles vaccine 2 days ago. The reporter mentioned It looks like very small blisters all around my face and neck that are itchy.  The patient could not find information about this type of reaction online and want to check In with someone about it.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Headache, Herpes zoster, Pain
Clinical narrative: I got the vax 3 years ago and got shingles last Friday/Suspected vaccination failure; Got shingles last Friday.; Nerve pain; Pain; tingle in my left eyebrow; swollen blsiter; swollen blsiter; shooting arrows into my head; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles for 41 years.), tingling skin, blister, swelling, pain, headache and nerve pain. Previously administered products included Antiviral.   On an unknown date, the patient received Shingrix. In June 2022, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia, pain, tingling skin, blister, swelling and headache. On an unknown date, the outcome of the vaccination failure, shingles, post herpetic neuralgia, pain, tingling skin, blister, swelling and headache were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, pain, tingling skin, blister, swelling and headache to be related to Shingrix.     Additional Information: GSK receipt date: 11-June-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had shingles for 41 years. The patient lost count how many times he/she had shingles. The patient felt a tingle in left eyebrow. That was where it always started. It turned into a horrible, swollen blister that was incredibly painful. The patient stated that he felt someone standing over him/her shooting arrows into head. The patient got immediately 2 scripts, an anti- viral and 1 for nerve pain. The patient got the Shingrix vax 3 years ago.  The physician said he/she would never get shingles again. Unfortunately the patient got shingles last Friday. Same place, same pain, same yuck. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia, Post herpetic neuralgia, Swelling, Vaccination failure
Clinical narrative: I got the vax 3 years ago and got shingles last Friday/Suspected vaccination failure; Got shingles last Friday.; Nerve pain; Pain; tingle in my left eyebrow; swollen blsiter; swollen blsiter; shooting arrows into my head; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles for 41 years.), tingling skin, blister, swelling, pain, headache and nerve pain. Previously administered products included Antiviral.   On an unknown date, the patient received Shingrix. In June 2022, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia, pain, tingling skin, blister, swelling and headache. On an unknown date, the outcome of the vaccination failure, shingles, post herpetic neuralgia, pain, tingling skin, blister, swelling and headache were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, pain, tingling skin, blister, swelling and headache to be related to Shingrix.     Additional Information: GSK receipt date: 11-June-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had shingles for 41 years. The patient lost count how many times he/she had shingles. The patient felt a tingle in left eyebrow. That was where it always started. It turned into a horrible, swollen blister that was incredibly painful. The patient stated that he felt someone standing over him/her shooting arrows into head. The patient got immediately 2 scripts, an anti- viral and 1 for nerve pain. The patient got the Shingrix vax 3 years ago.  The physician said he/she would never get shingles again. Unfortunately the patient got shingles last Friday. Same place, same pain, same yuck. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Got my 1st dose got a bad reaction felt like had a bad flu.; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms 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, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.   Linked case(s) involving the same patient:US2022AMR092900   Additional Information: GSK Receipt Date: 12-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got his/her shingles vaccine and got the bad reaction. It felt like he/she had a really bad flu.  The reporter stated that, he/she was glad that he/she got the vaccine.  The reporter further stated that, he/she rather suffered a few days than getting the shingles. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR092900, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR092900:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Vaccine positive rechallenge
Clinical narrative: Bad reaction like had a bad flu/been in bed recovering; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of influenza like illness (received 1st dose on an unknown date, refer case US2022AMR092895).   In June 2022, the patient received the 2nd dose of Shingles vaccine. In June 2022, less than a week after receiving Shingles vaccine, the patient experienced influenza-like symptoms. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the influenza-like symptoms was recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.   Linked case(s) involving the same patient:US2022AMR092895   Additional Information: GSK Receipt Date: 12-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got his/her shingles vaccine two days ago from reporting and got the bad reaction, felt like had a bad flu. The patient had been in bed recovering. The reporter stated that, he/she was glad that he/she got the vaccine.  The reporter further stated that, he/she rather suffered a few days than getting the shingles. Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR092895:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Shot hurt; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient got the shingles shot and it hurt for a few but better than that mess. The patient stated that, he/she had seen people suffered bad and seen some die. The reporter further stated that, got the shingles shot peeps and love, love and dance. Additional Supportive information: The follow up would not possible as no contact details were available.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Extra dose administered, Hyperhidrosis, Nausea
Clinical narrative: 6/14/22 1:45-2:30pm Metallic taste in mouth 6/15/22 3:15am Chills, aches 4:00am Chills, aches, sweating, fever (102.4°). Took Tylenol.  4:45am -3:15pm Chills, aches, sweating, fever (102.4°), Vomiting, Nausea, Unable to keep food or water down.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: 6/14/22 1:45-2:30pm Metallic taste in mouth 6/15/22 3:15am Chills, aches 4:00am Chills, aches, sweating, fever (102.4°). Took Tylenol.  4:45am -3:15pm Chills, aches, sweating, fever (102.4°), Vomiting, Nausea, Unable to keep food or water down.
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Pain
Clinical narrative: Lingering pain in arm at injection site,  pain when moving arm  and lifting arm, pain is aching and becomes sharper when moved. Has continued since 6/7 at time of  administration
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Little fever; Headache; This case was reported by a consumer via interactive digital media and described the occurrence of fever 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, unknown after receiving Shingles vaccine, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were recovered/resolved.   It was unknown if the reporter considered the fever and headache to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR092904   Additional Information: GSK Receipt Date: 12-JUN-2022  Reporter's Comments: This case was received from the patient via interactive digital media. The patient received 1st Shingles shot and had no problem only little fever and headache one day. Additional Supportive Information: The follow-up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR092904, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR092904:Same Reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine for shingles and got the 2nd worse case/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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) 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 Information: GSK receipt date: 11-June-2022 Reporter's comment: This case was reported by a patient's friend via interactive digital media. The patient had the vaccine for shingles and got the 2nd worse case her doctor had ever seen. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the worst case imaginable from the shot/Suspected vaccination failure; got the worst case imaginable from the shot; This case was reported by a consumer via interactive digital media and described the occurrence of 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-June-2022 Reporter's comment: This case was reported by a patient's cousin via interactive digital media. The patient got the worst shingles case imaginable from the shot.  Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine and it gave me shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 12-June-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient got the vaccine and experienced shingles. The patient have to take medicine every single day just to keep from having a flare up. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had a Shingrix shot in 2018; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   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 Information: GSK receipt date: 14-June-2022 Reporter's comment: This case was reported by a other health professional via interactive digital media. The patient had a Shingrix shot in 2018. The reporter asked if the patient just need 1 more shot to be fully covered or does patient need to start over. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination.