chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Wheezing
Clinical narrative: Vaccination failure; tested positive for Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid-19) and VACCINATION FAILURE (Vaccination failure) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 023C21A) for COVID-19 prophylaxis.     Concomitant products included MONTELUKAST, ALBUTEROL [SALBUTAMOL], PROMETHAZINE HYDROCHLORIDE (PROMETH), CEFUROXIME, METHYLPREDNISOLONE, COLECALCIFEROL (VITAMIN D3), MULTIVITAMIN, IRBESARTAN, HYDROCHLOROTHIAZIDE (HCTZ), ROSUVASTATIN and AMLODIPINE for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced COVID-19 (tested positive for Covid-19). On an unknown date, the patient experienced VACCINATION FAILURE (Vaccination failure). At the time of the report, COVID-19 (tested positive for Covid-19) and VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2021, SARS-CoV-2 test: (Positive) Positive.         Concomitant products included Bausch and Lomb Preservision Areds,  and Prometh-D. It was reported that the patient did not have a history or current diagnosis or pericarditis or myocarditis. No treatment medication was provided.  Company comment: This spontaneous case concerns a 63-year-old female patient with no reported medical history who experienced the unexpected non-serious AESI of COVID 19. Vaccination failure was considered as an additional event. The events occurred approximately 6 months after the second dose of mRNA-1273 Vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to MOD-2022-637077 (Patient Link).; Sender's Comments: This spontaneous case concerns a 63-year-old female patient with no reported medical history who experienced the unexpected non-serious AESI of COVID 19. Vaccination failure was considered as an additional event. The events occurred approximately 6 months after the second dose of mRNA-1273 Vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; tested positive for Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid-19) and VACCINATION FAILURE (Vaccination failure) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 023C21A) for COVID-19 prophylaxis.     Concomitant products included MONTELUKAST, ALBUTEROL [SALBUTAMOL], PROMETHAZINE HYDROCHLORIDE (PROMETH), CEFUROXIME, METHYLPREDNISOLONE, COLECALCIFEROL (VITAMIN D3), MULTIVITAMIN, IRBESARTAN, HYDROCHLOROTHIAZIDE (HCTZ), ROSUVASTATIN and AMLODIPINE for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced COVID-19 (tested positive for Covid-19). On an unknown date, the patient experienced VACCINATION FAILURE (Vaccination failure). At the time of the report, COVID-19 (tested positive for Covid-19) and VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2021, SARS-CoV-2 test: (Positive) Positive.         Concomitant products included Bausch and Lomb Preservision Areds,  and Prometh-D. It was reported that the patient did not have a history or current diagnosis or pericarditis or myocarditis. No treatment medication was provided.  Company comment: This spontaneous case concerns a 63-year-old female patient with no reported medical history who experienced the unexpected non-serious AESI of COVID 19. Vaccination failure was considered as an additional event. The events occurred approximately 6 months after the second dose of mRNA-1273 Vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to MOD-2022-637077 (Patient Link).; Sender's Comments: This spontaneous case concerns a 63-year-old female patient with no reported medical history who experienced the unexpected non-serious AESI of COVID 19. Vaccination failure was considered as an additional event. The events occurred approximately 6 months after the second dose of mRNA-1273 Vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Immediate post-injection reaction, Loss of consciousness, Tremor
Clinical narrative: patient received first janssen vaccine. Right after administration, passed out on the floor and started to shake a bit.  Pharmacist ran to get some water for pt while patient's friend was trying to wake patient up. Patient regained recovery in a couple of seconds to a minute. He was made to sit and we gave him ice to put on the head. We also called 911 and the ambulance came and checked the pt. He reported that his vitals were okay and the Emt told him he was okay. Pharmacist counseled patient to follow up with  primary doctor and to also have head checked out since he fell on the floor, However Patient declined and stated he was okay.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site irritation, Injection site pain, Injection site pruritus
Clinical narrative: Intermittent pain/itch on left side of shoulder above injection arm. Chronic irritation that has not subsided in 18 months.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; HCP reported VARIVAX was administered after a temperature excursion to a patient.; This spontaneous report has been received from a registered nurse regarding a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 02-AUG-2022, varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot number: W011625, expiration date 06-APR-2024; strength, dose, and route of administration were not reported) was administered to the patient once after a temperature excursion of -8.1 Celsius degree for 1 hour and 58 minutes (product storage error). There was no previous temperature excursion. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA002433: US-009507513-2208USA002443: US-009507513-2208USA002739: US-009507513-2208USA003187:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; HCP reported PROQUAD was administered after a temperature excursion to a patient.; This spontaneous report has been received from a registered nurse regarding a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 02-AUG-2022, measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD), subcutaneous injection (lot number: W007748, expiration date 04-SEP-2023; strength, dose, and route of administration were not reported) was administered to the patient once after a temperature excursion of -8.1 Celsius degree for 1 hour and 58 minutes (product storage error). There was no pervious temperature excursion. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA002433: US-009507513-2208USA002443: US-009507513-2208USA002737: US-009507513-2208USA003187:
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: HCP called for temperature stability evaluation of vaccines and reported that 10 pediatric patients received PROQUAD vaccine since excursion date on 7/14/2022. See additional AEs filed under interaction 02221034.  No PQCs reported at this time.; This spontaneous report has been received from a medical assistant, referring to a 3-year-old female patient.   The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with an improperly stored 1st dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter, 1st dose (vaccination scheme, frequency, route of administration and anatomical site of injection were not provided), lot number W002781 has been verified to be a valid lot number with expiration date on 24-JUL-2023, administered as prophylaxis (product storage error). The vaccine temperature excursion occurred on 14-JUL-2022.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA004105: US-009507513-2208USA003812: US-009507513-2208USA004086: US-009507513-2208USA003988: US-009507513-2208USA004011: US-009507513-2208USA004135: US-009507513-2208USA003812:
Age: 33.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient who received their first dose of GARDASIL 9 in MAY2020, missed their 3rd dose and asking to receive it today 9AUG2022; This spontaneous report was received from a health care professional (HCP) (reported as pharmacytech) referring to a currently 35-year-old (also reported as 36-year-old) patient of unknown gender. Information about the patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date in May 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) (strength, route of administration, anatomical location, dose, lot number and expiration date were not reported) for prophylaxis. The patient did receive the second dose of HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) but it was unsure of the date. The patient missed the third dose of HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and asked to receive it on 09-AUG-2022 (also reported as today) (Inappropriate schedule of product administration).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Temperature: 6F up to 14F 14 hourd 10 minutes; 14F up to 46F (16.7F) for 5 hours 40 minutes; This spontaneous report has been received from a medical assistant and refers to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, previous drugs allergies or reactions were not reported. Concomitant medications included sterile diluent  (manufacturer unknown).   On 15-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) at a dose of 0.5 milliliter once, lot #W003820, expiration date: 02-FEB-2024 (vaccination scheme, route of administration, and indication were not provided) following a temperature excursion of 6 degrees Farenheit (F) up to 14 F for 14 hours 10 minutes, 14 F up to 46 F (16.7 F) for 5 hours 40 minutes, time frame reported 19 hours 50 minutes. there was stated that no previous temperature excursion occurred. No adverse effects was reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2208USA006387: US-009507513-2208USA006344: US-009507513-2208USA006265: US-009507513-2208USA006030: US-009507513-2208USA006344:
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; A 26 month old patient received the first dose of PROQUAD on 27-JUN-2022, and then received a second dose of PROQUAD on 13-JUL-2022; This spontaneous report has been received from a clinical manager referring to a 26-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medications were not provided.  On 27-JUN-2022, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis, 0.5 milligram (mg), (lot number W004026 had been verified to be a valid number; expiration date was reported as 02-AUG-2019, and upon internal validation established as the same date) (strength, anatomical location, and route of administration were not provided). Additionally, on 13-JUL-2022, the patient was inadvertently given, earlier than recommended, a second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis, 0.5 milligram (mg), (lot number W004026 had been verified to be a valid number; expiration date was reported as 02-AUG-2019, and upon internal validation established as the same date) (strength, anatomical injection, and route of administration were not provided) (inappropriate schedule of vaccine administered).  No adverse event reported.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site swelling
Clinical narrative: Caller is nurse reporting a patient experienced localized swelling around injection site after receiving GARDASIL 9./It was just swollen, not red or warm.; This spontaneous report was received from a nurse and refers to a 14-year-old, non-pregnant female patient. She had no known drug reactions or allergies, nor pertinent medical history. There were no concomitant medication.  On an unknown date, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(exact dose, injection site, lot#, expiration date and route of administration were not provided) for prophylaxis. On 17-AUG-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe injection, 1 dose, lot # 1780876, expiration date: 09-NOV-2023, intramuscularly in the left deltoid for prophylaxis(exact dose, dosing schedule were not provided).  On 18-AUG-2022, the patient experienced localized swelling around injection site, which looked like "she had a second muscle" (vaccination site swelling). According to nurse it was just swollen, not red or warm. On the same day, the patient sought medical attention and called the office to report. On 19-AUG-2022 (also reported as today), she was seen by her provider for assessment. The only intervention was ibuprofen administered as needed for the treatment of the event. The patient denied a reaction with the first dose. No additional adverse events reported.  At the time of reporting, the patient had not recovered from vaccination site swelling. The causality assessment between the suspect vaccines and the event was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; HCP reports patient was accidently administered an expired dose of MMR II on Aug 18, 2022.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 18-AUG-2022, the patient was accidently vaccinated with an expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) once, lot #: T018893, expiration date: 02-JUN-2022 (exact dose, strength, site and route of administration were not provided) for prophylaxis. No additional adverse event was reported. The reporter stated she did not have the information in front of her at the time of the call but "she was pretty sure" the date of administration was 18-AUG-2022. The vaccine had no prior temperature excursions.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details provided. No additional AE; Nurse calling for evaluation on frozen products mentions 2 doses of PROQUAD were administered to 2 patients. See additional AE case 02230619 for additional patient.    ?    Names of vaccines involved (including lot/exp) PROQUAD  U039261  6/9/202; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On 19-AUG-2022, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) reconstituted with a sterile diluent for prophylaxis, lot # U039261 and expiration date on 09-JUN-2023 (strength, dose number, anatomical location and route of administration were not reported).   It was reported that the vaccine underwent a temperature excursion of 14°F up to 46°F (21F) during a time frame of 1 hour 28 minutes 0 seconds. Previous temperature excursion was not occurred. No adverse event was reported.  This is one of 2 reports from the same reporter.; Sender's Comments:  US-009507513-2208USA008611:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No additional AE has been reported; she "made an error" and inadvertently administered PROQUAD and VARIVAX to a patient concomitantly.; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 18-AUG-2022, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, plus an sterile diluent, solution for injection/infusion and with varicella virus vaccine live (Oka/Merck) (VARIVAX), subcutaneous injection concomitantly. All of the vaccines were administered at a dose of 0.5 milliliters (ml) as prophylaxis (strengths, routes of administration, anatomical sites of injection, lot numbers and expiration dates were not reported)(accidental overdose).   No additional adverse events were reported.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: bloody and mucus stools; bloody and mucus stools; This spontaneous report was received from a physician and refers to a 8-week-old (discrepant information, also reported as 4-month-old) male patient. The patient was delivered via cesarean section however it was challenging to take him out during the process. When the baby was finally delivered, he was dark blue and only had a heart beat. The patient stayed after birth in the neonatal intensive care unit. He had a significant medical history including birth asphyxia, brain damage and seizures. Concomitant therapies were not reported.  On 14-JUN-2022, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #U037808, expiration date: 26-MAR-2023 (both confirmed to be valid), administered orally for prophylaxis (strength was not provided).  On 15-JUN-2022, also reported as 1 day after the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), the patient experienced bloody and mucus stools (haematochezia). The patient was seen by a pediatric gastroenterologist and no treatment was given. The patent was observed and on 17-JUN-2022, the patient recovered from the events.  The causal relationship between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown.  Upon internal review, the event bloody and mucus stools (haematochezia) was determined to be medically significant.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Patient reported soreness/pain for 36 hours at injection site; VARIVAX administered in 2018 PROQUAD administered March 2020 PROQUAD administered March 2022 PROQUAD administered AUG 2022; VARIVAX administered in 2018 PROQUAD administered March 2020 PROQUAD administered March 2022; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2018, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot #, expiry date, anatomical location and route of administration were not provided) administered as prophylaxis. On an unknown date in March 2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #, expiry date, anatomical location and route of administration were not provided) administered as prophylaxis. Then, on an unspecified date in March 2022, the patient received another dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #, expiry date, anatomical location and route of administration were not provided) administered as prophylaxis (extra dose administered). Later, on an unknown date in August 2022 the patient received another dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #, expiry date, anatomical location and route of administration were not provided) administered as prophylaxis (extra dose administered).  On an unknown date, the patient experienced soreness/pain for 36 hours at injection site (vaccination site pain). The outcome of the event was not reported.   The causal relationship between vaccination site pain and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported. The causal relationship between vaccination site pain and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further adverse events; Caller is HBP reporting on behalf of HCP an administered dose of expired MMR II. Caller reports no history of prior excursions on products. No additional details provided. No further adverse events/no product quality complaints.; This spontaneous report has been received from office manager and refers to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  On 25-AUG-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  (rHA) (M-M-R II) 1 dose, lot #T020656, expiration date: 16-JUN-2022, as prophylaxis (strength, vaccination scheme and route of administration were not provided) beyond the expiration date (Expired product administered). The was stated that no prior excursions occurred, and no further adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AEs; Caller reported VARIVAX administered after temperature excursion; This spontaneous report has been received from a medical assistant concerning to patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, a temperature excursion occurred for varicella virus vaccine live (oka/merck) (VARIVAX) in which the maximum temperature reached was 10.9 degrees Fahrenheit for a time frame of 5 hours and 30 minutes. No previous temperature excursions were reported.  On 29-AUG-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, administered subcutaneous (SQ), lot W012166, expiration date 12-APR-2024, (anatomical location was not provided) as prophylaxis (product storage error). No additional events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; Caller reported that VARIVAX and PROQUAD that underwent a temperature excursion were administered; This spontaneous report has been received from a health care worker concerning to patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, a temperature excursion occurred for varicella virus vaccine live (oka/merck) (VARIVAX) in which the maximum temperature was from 6 to 14 degrees Fahrenheit for a timeframe of 50 minutes. No previous temperature excursions were reported.  On 30-AUG-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U029496, expiration date 21-SEP-2023 (dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). No additional events were reported.  This is one of three reports from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: no adverse event; expired PNEUMOVAX 23 was inadvertently administered to a patient; This spontaneous report was received from a pharmacist and refers to a patient of unknown ange and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-JUL-2022, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot #T034630, expiration date: 22-JUN-2022 (strength, and route of administration were not provided) administered for prophylaxis. The reporter stated that the vaccine did not experience any temperature excursion through the date of administration. No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported that VARIVAX and PROQUAD that underwent a temperature excursion were administered; This spontaneous report has been received from a health care worker concerning to patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, a temperature excursion occurred for varicella virus vaccine live (oka/merck) (VARIVAX) in which the maximum temperature was from 6 to 14 degrees Fahrenheit for a timeframe of 50 minutes and 14 to 46 degrees Fahrenheit for a timeframe of 1 hour. No previous temperature excursions were reported.  On 30-AUG-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723, expiration date 15-DEC-2023 (dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). No additional events were reported.  This is one of three reports from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; Caller reported that VARIVAX and PROQUAD that underwent a temperature excursion were administered; This spontaneous report has been received from a health care worker concerning to patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, a temperature excursion occurred for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) in which the maximum temperature was from 6 to 14 degrees Fahrenheit for a timeframe of 50 minutes and from 14 to 46 degrees Fahrenheit for a timeframe of 1 hour. No previous temperature excursions were reported.  On 30-AUG-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) lot # W004026, expiration date 02-AUG-2023 (dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). No additional events were reported.  This is one of three reports from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness unilateral, Formication, Herpes zoster, Neuralgia
Clinical narrative: Blind in my right eye; Terrible neurological pain, felt like worms crawling in my head; Got it after the first shingles shot; Terrible neurological pain, felt like worms crawling in my head; This case was reported by a consumer via interactive digital media and described the occurrence of blind right eye 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 blind right eye (serious criteria GSK medically significant), nerve pain and shingles. On an unknown date, the outcome of the blind right eye, nerve pain and shingles were unknown.   It was unknown if the reporter considered the blind right eye, nerve pain and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-AUG-2022.  Reporter's Comments: This case was reported by patient via interactive digital media. The patient got shingles after the first Shingles shot. The patient went blind in his/her right eye and had terrible neurological pain felt like worms crawling in patient's head. Additional Supportive Information: The follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot, then got a bad case/Suspected vaccination failure; Got a bad case of 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 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: 26-Aug-2022 Reporter's Comments: The patient self-reported this case via interactive digital media and described the occurrence of suspected vaccination failure. The reporters friend got the shot, then got a bad case of shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure/got shingles on face, 4 months after second shot; shingles on face; Rash; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine and less than 9 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shingles shots this year and got shingles on his/her face 4 months after his/her second shot. The patient went to the physician who put him/her on an anti viral. Less than 9 months after first and second shot, the patient had rash and it  went away after two days and the patient never in any pain or discomfort. The patient was happy that he/she took the vaccine. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Had two shot deal and I still get shingles; Still get shingles at least once every month; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 22-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the vaccine and his/her was a two shot deal and honestly, he/she still get the shingles at least once every month. The patient stated that so it was not going to stop from getting them. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Had both shots, got shingles both times; Got shingles both times; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 22-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both shots and stated that shots did not work, got shingles both times. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypersensitivity, Neuralgia, Vaccination failure, Viral infection
Clinical narrative: they gave me meds for anti viral and nerve pain; they gave me meds for anti viral and nerve pain; Appears to have allergy to antiviral and pain nerve meds; Suspected vaccination failure/I have had shots, but I still get shingles; Get shingles 3 times, it's worse than the others; 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.   The patient's past medical history included shingles (had shingles two times).   On an unknown date, the patient received Shingles vaccine. In June 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced nerve pain, viral infection and allergy. On an unknown date, the outcome of the vaccination failure, nerve pain and viral infection were unknown and the outcome of the shingles and allergy were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve pain, viral infection and allergy to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had shots, but he/she still get shingles, always in the same place.  This was the third time and it was worse than the first two times, the patient got them. The patient got them in June and still have had them. The patient did not knew what to do. The patient went to physician in June and they gave him/her medication for anti viral and nerve pain. The patient stated that it appeared that he/she have had an allergy to them. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. In worst approach, viral infection event was coded as per narrative it seems that patient had viral infection for which medication was given and also allergy was coded in worst approach considering that patient was relating it with target disease.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure/I had the 2-shot vaccine and still get; Still get, just got over a bout; Exhausting painful; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the 2 shot vaccine and still get them. The patient was just over a bout. The patient stated that exhausting painful. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/took both shots and get shingles; Shingles/still get 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure 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 and Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient took both shingles shots and still get shingles. The patient stated that they were not as bad but they were there. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: Suspected vaccination failure/had shingles several times since the shot; shingles/had shingles several times since the shot; had Covid even with the shot; Received shingles shot at or below 45 years age; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 45-year-old 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), shingles, covid-19 and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccination failure, shingles, covid-19 and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The reporter was 51 years old, no shot had Covid in December. The patient (that's younger than the reporter) had shingles several times since she got the shot. The patient stated that never before.  The patient had Covid even with the shot. Additional supportive information: The patient received Shingles vaccine at inappropriate age, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. In worst approach, Covid-19 event was linked with Shingles shot as this was an interactive digital media case due to which no further clarification would raise.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shingles shot, still got shingles; 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.   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: 31-Aug-2022 Reporter's Comments: The reporter reported the case via interactive digital media. The reporter said that as with most shots the actual condition was usually better but no guarantee you would not get whatever.  The patient had the shingles shot and still got shingles but do believe patient had a much milder version. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR126032:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: I got the shot and still got shingles; Still got shingles; Horrible rash; horrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and pain. On an unknown date, the outcome of the vaccination failure, shingles, rash and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-Aug-2022 Reporter's Comments: The reporter reported the case via interactive digital media. The patient got the shot and still got shingles. It was horrible rash and pain. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.