chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE reported; ROTATEQ was inadvertently administered on 13APR2021 after a temperature excursion ocurred; This spontaneous report was received from a physician concerning a patient of unknown age and gender. Information regarding the patient's current concomitant therapies, conditions, medical history and historical drug was not provided.  On 13-APR-2021, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral (dosage regimen was not reported), lot # T039454 and expiration date 14-DEC-2021 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -9 degree celsius (°C) for timeframe of 10 hours and 56 minutes on an unknown date; no previous temperature excursions were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.; Sender's Comments:  US-009507513-2104USA003768:
Age: 1.67
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Patient has had no reported side effects at this time; an expired dose of V ARlV AX was accidentlyadministered to a patient; This spontaneous report was received from an office Manager referring to a 20-month-old patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 20-APR-2021, in the morning, the patient was accidently administered with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number S012036, and expiration date of 17-APR-2021, at a dose of 0.5mL x 1 dose, subcutaneously for prophylaxis (anatomical location was not reported). The varicella virus vaccine live (oka/merck)(VARIVAX) administered had no temperature excursions. The patient had no reported side effects at this time.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer referring to a currently 56 year old patient of unknown gender regarding a case in litigation. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In or about 2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, route and lot # were not provided) at a physician's office for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX): shingles. At the time of the report, the patient's outcome was unknown.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no adverse event; incorrect product storage; This spontaneous report as received from a medical assistant and refers to a currently 4 year old patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) dose, frequency, route of administration were not provided (lot # T029099 has been verified to be a valid lot number, expiration date 23-FEB-2022) for prophylaxis.        The reporter stated that the vaccine was administered following a temperature excursion on 12-APR-2021; temperature range was -58°F/5°F: 6.3F for 6 hours 0 minutes 30 seconds, 10.9F for 0 hours 7 minutes 30 seconds, previous excursions were reported. The call was due to a data logger.       No adverse effects were reported, no Product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA008219: US-009507513-2104USA008134:
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Vaccination complication
Clinical narrative: severe reaction; This spontaneous report as received from a consumer who is the patient's grandfather, concerning a 15-year-old female patient. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided.  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) for prophylaxis (strength, dose, route, vaccination schedule, anatomical site, lot# and expiration date were not provided).  On an unknown date, the patient experienced a severe reaction (vaccination complication).  The outcome of vaccination complication was unknown.  The reporter considered vaccination complication to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).
Sex: U
Vaccine: VARZOS
Symptoms: Granulomatosis with polyangiitis, Visual impairment
Clinical narrative: vision problems and was diagnosed with Wegener's granulomatosis; This spontaneous report was received from a lawyer referring to a patient of unknown age.  The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, dosage schedule, lot number and expiration date were not reported).  On an unknown date, the patient suffered vision problems and was diagnosed with Wegener's granulomatosis. The patient's symptoms have resulted in physical limitations, mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. The patient sustained serious, progressive, severe, permanent, and incurable injuries personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a result of these injuries, the patient was seen and treated by medical providers and is still under their care (not recovered). The reporter considered Wegener's granulomatosis to be related to zoster vaccine live (ZOSTAVAX).     Upon internal review, Wegener's granulomatosis was considered a medically significant and disabling event.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021826, expiration date: 25-JUN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021826, expiration date: 25-JUN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021826, expiration date: 25-JUN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021826, expiration date: 25-JUN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021826, expiration date: 25-JUN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021826, expiration date: 25-JUN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-APR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021826, expiration date: 25-JUN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-APR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021826, expiration date: 25-JUN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-APR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T024284, expiration date: 15-JUL-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-APR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T024284, expiration date: 15-JUL-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-APR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T024284, expiration date: 15-JUL-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-APR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T024284, expiration date: 15-JUL-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-APR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T024284, expiration date: 15-JUL-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-APR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T024284, expiration date: 15-JUL-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no AE reported; The product was administered on 06 MAY 2021 and expired on 04 MAY 2021.; Information has been received from a medical assistant , referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 06-MAY-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R020949, expiration date on 04-MAY-2021, 0.5 milligram (administration route and anatomical location were not reported) for prophylaxis.   The reporter confirmed that the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  vaccine did not had any temperature excursion. No additional adverse event (AE) were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R020949; expirationdate: 04-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got my shot, but still got shingles; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; He gave his wife the shot and. She got it!!; This case was reported by a consumer via media and described the occurrence of suspected 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. The patient was treated with antivirals nos. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination not reported. The reporter stated that the physician gave his wife the shingles shot and she experienced shingles. The physician gave her the Anti Viral Shot to help her and it went away. This case was considered as suspected vaccination failure since the details regarding the dose number, time to onset and laboratory confirmation of shingles was not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR100411:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot and then had shingles to/ Suspect vaccination failure; got the shot and then had shingles to?; This case was reported by a consumer via media and described the occurrence of suspected 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 details were provided as follows: The case was reported by the patient's son in law. The age at vaccination was not reported. The reporter stated that, the patient got the shot and then had shingles too. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got the shingles vaccine and gets a shingles breakout several times a year; This case was reported by a consumer via media and described the occurrence of suspected 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 details were provided as follows: This case was reported by patient's cousin. The age at vaccination was not reported. The patient had got the shingles vaccine and gets a shingles breakout several times a year. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and lab test confirmation was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had the shingle shot it gave me the shingles three yrs ago/ suspected vaccination failure; Had the shingle shot it gave me the shingles three yrs ago; awful pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   The reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had the shingle shot and the patient stated that it gave the patient shingles three years ago from the time of reporting. The patient stated he/she had awful pain. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Herpes zoster, Pain, Vaccination failure
Clinical narrative: have had shingles 5 times/ suspected vaccination failure; have had shingles 5 times / always seem to get it on the left side of my back; allergic to the vaccine; Very painful / pain is unbearable.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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, allergy to vaccine and pain. On an unknown date, the outcome of the vaccination failure, shingles, allergy to vaccine and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, allergy to vaccine and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient was allergic to the vaccine.  The patient had shingles 5 times and always seemed to get it on the left side of the back. The shingles were very painful and the pain was unbearable. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; took the singles shot / still got the singless; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 details were provided as follows: The reporter was the concerned patient. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. The patient received Shingles vaccine and still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Peripheral swelling, Pruritus
Clinical narrative: my mom received the first dose / had a very severe headache; itchy / arm / several days after the shot.; swollen arm / several days after the shot.; This case was reported by a consumer via ( Chatbot) interactive digital media and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, itchy upper limbs and swelling arm. On an unknown date, the outcome of the headache was unknown and the outcome of the itchy upper limbs and swelling arm were recovered/resolved.   It was unknown if the reporter considered the headache, itchy upper limbs and swelling arm to be related to Shingrix.  Additional details was reported as follows: The patient reported for her mother. The age at vaccination was not reported. The patient received Shingrix and experienced severe headache and itchy swollen arm. The arm was swollen and itchy for several days. The reporter was wondering about the data on the effectiveness of only receiving one dose.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine and then got shingles?suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient got Shingles vaccine and then got shingles, but they were not as bad as could had been. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I get it all the time / had shingle shot and it hasn't helped 1 bit; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   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 details were provided as follows: The case was reported by the patient herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the dose of Shingles vaccine and patient experienced shingles. The reporter stated he/she got it all the time and he/she have had shingles shot and it has not helped one bit. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: we have had 3 doses total; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first 2 doses on unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional information was provided as follows:  The age at vaccination was not provided. The age group was not reported but was captured as adult as per vaccine indication. The patient received 3 doses of Shingrix, which led to extra dose administered. The reporter stated that, after getting shingrix vaccine, The reporter found paperwork which showed that the patient had already received 2 doses. The reporter asked for the risk of having 3 doses of Shingrix. This case has been linked with US2021AMR101279, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101279:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; Pain not good for your wrist enmity; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving 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 shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication.  The patient received Shingles vaccine and a year later got the shingles and been with the patient for a year and still got the pain not good for your worst enemy the shot did not help me. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule and laboratory test confirmation for shingles infection were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: we have had 3 doses total; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional information was provided as follows:  The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. The patients received 3 doses of Shingrix, which led to extra dose administered. The reporter stated that, after getting shingrix vaccine, they found paperwork which showed that patients had already received 2 doses. This case has been linked with US2021AMR101266, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101266:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose / on 8/5/2020 / not reminded for my second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 5th August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by the consumer. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix , which led to incomplete course of vaccination. The patient also reported that he/she was not reminded for his/her second dose. The patient was also asked was it too late for second dose. No further information was reported. Reporter consent to follow up was unknown.
Sex: U
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose of Havrix on july 5th, 2019 but didn't receive the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old patient who received HAV (Havrix 1440) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix 1440 (received Havrix 1440 on 5th July 2019, batch number N39BM, expiry date 31st January 2022).   On an unknown date, the patient received Havrix 1440 and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient did not receive 2nd dose of Havrix till the time of reporting, which lead to incomplete course of vaccination. The reporter did not consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097940:Same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Lethargy, Nausea, Paranasal sinus discomfort
Clinical narrative: nausea; lethargy; a sinus pressure headache; sinus pressure; chills; This case was reported by a consumer via call center representative and described the occurrence of lethargy in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number BA5GK, expiry date 4th November 2022) for prophylaxis.   Previously administered products included Zostavax.   On 27th April 2021, the patient received the 2nd dose of Shingrix. On 4th May 2021, 7 days after receiving Shingrix, the patient experienced lethargy, headache, sinus pressure and chills. On 6th May 2021, the patient experienced nausea. On 6th May 2021, the outcome of the lethargy, headache, sinus pressure and chills were recovered/resolved. On an unknown date, the outcome of the nausea was unknown.   It was unknown if the reporter considered the lethargy, headache, sinus pressure, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The patient received Zostavax years ago, but was unsure of the date. The patient received second dose of Shingrix in left arm and did not experienced immediate adverse events. The patient experienced lethargy, sinus pressure, headache and chills.  On 6th May 2021, 9 days after vaccination, the patient experienced nausea. The patient saw a nurse practitioner, who ordered some unknown tests. The patient reported that she felt a lot better on day of reporting. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, Product storage error
Clinical narrative: received a dose / Shingrix on 03May2021 / expired on 30Nov2020; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 30th November 2020) for prophylaxis.   On 3rd May 2021, the patient received the 1st dose of Shingrix. On 3rd May 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The office manager reported that on 3 May 2021, the patient received a dose of Shingrix which was already expired on 30 November 2020. No symptoms were reported.  The reporter consented to follow up. No additional information was available. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021099711:same reporter
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: administration of an adult dose of Engerix-B to a child / 4 yeard old patient; administration of an adult dose of Engerix-B to a child / 4 yeard old patient; This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 4-year-old male patient who received HBV (Engerix B adult) (batch number 4F472, expiry date 6th November 2022) for prophylaxis.   On 5th May 2021, the patient received the 2nd dose of Engerix B adult. On 5th May 2021, unknown after receiving Engerix B adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional details were reported as follows: The reporter stated that 4 years old patient was vaccinated with an adult dose of Engerix-B, which led to the adult product administered to child and overdose. The reporter was asked information regarding the administration of an adult dose of Engerix-B to a child. The reporter consented to follow up by email but did not provide address.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: his arm felt sore / it is worse today; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (minor outbreak prior to getting the vaccine). Concomitant products included acyclovir.   On 6th May 2021, the patient received the 1st dose of Shingrix. On 6th May 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient experienced that his arm felt sore starting last night and it is worse on the day of reporting. The reporter did not consent to follow up.
Age: 14.0
Sex: M
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 14 year old / received the first dose of Twinrix on the 1st May, 2021; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st May 2021, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 1st May 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received the 1st dose of Twinrix before he was 18 years old, which led to inappropriate age at vaccine administration. No further information was reported. The reporter consented to follow up.