chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL, MMR
Symptoms: Incorrect route of product administration, Product storage error
Clinical narrative: No additional AEs; the vaccines were administered IM (instead of SQ).; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies was not provided.   On 17-AUG-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) as prophylaxis (lot number U006596 has been verified to be valid, expiration date reported and established as 01-MAR-2023) 0.5 milliliters (ml) administered intramuscularly (IM) instead of subcutaneously (incorrect route of product administration).   It was reported that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) was stored within recommended temperature range. No additional adverse events were reported (no adverse event). The patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (case # 2208USA008558).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA008668: US-009507513-2208USA009718: US-009507513-2208USA008558: US-009507513-2208USA008497: US-009507513-2208USA008503: US-009507513-2208USA008699:
Sex: F
Vaccine: MMR
Symptoms: Accidental exposure to product, Injury associated with device, Occupational exposure to product
Clinical narrative: The medical assistant administering the vaccine had a needle-stick injury; The medical assistant administering the vaccine had a needle-stick injury; The medical assistant administering the vaccine had a needle-stick injury; This spontaneous report has been received from a prescriber nurse concerning a female patient of unknown age, who was also a medical assistant.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 22-AUG-2022, while the patient was vaccinating a child with a dose of  Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (Dose, route of administration, Lot # and expiration date were not provided), she had a needle stick injury (Injury associated with device) (Accidental exposure to product) (Occupational exposure to product).  At the time of reporting, the outcome of the events was not provided by the reporter. No additional adverse events were reported.   The causal relationship between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) to Injury associated with device was not reported.
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE for this patient; The caller said a patient received PROQUAD after a temperature excursion; This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-AUG-2022, the patient was vaccinated with an improperly storage dose of measles, mumps, rubella and varicella rHA (OKA-MERCK) virus vaccine live (PROQUAD) (valid lot #U022729, expiration date: 16-JAN-2023) (strength, anatomical location and route of administration were not provided) for prophylaxis. Temperature excursion occurred at 11.5 Fahrenheit (F) for 52 minutes. No additional information or adverse event was reported.; Sender's Comments:  US-009507513-2208USA008698: US-009507513-2208USA008545: US-009507513-2208USA008719:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AEs; Vaccines were administered IM (instead of SQ); This spontaneous report was received from a medical assistant and refers to a. patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not reported.  On 16-AUG-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) at a dose of 0.5 ml, lot #U006596, expiration date: 01-MAR-2023, administered intramuscularly instead of subcutaneous (Incorrect route of product administration) as prophylaxis. The outcome of the event was not provided. It was mentioned that the vaccine was stored within recommended range of temperature and that no additional adverse event occurred.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2208USA008668: US-009507513-2208USA008503: US-009507513-2208USA008558: US-009507513-2208USA010122: US-009507513-2208USA008497:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Vaccines were administered IM (instead of SQ); This spontaneous report was received from a medical assistant and refers to a. patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not reported.  On 16-AUG-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) at a dose of 0.5 ml, lot #U006596, expiration date: 01-MAR-2023, administered intramuscularly instead of subcutaneous (Incorrect route of product administration) as prophylaxis. The outcome of the event was not provided. It was mentioned that the vaccine was stored within recommended range of temperature and that no additional adverse event occurred.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2208USA008668: US-009507513-2208USA008503: US-009507513-2208USA008558: US-009507513-2208USA010122: US-009507513-2208USA008497:
Age: 50.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Cellulitis, Discomfort, Erythema, Pyrexia, Swelling
Clinical narrative: Suspected cellulitis; swelling; Arm erythema; discomfort; fever; This spontaneous report was received from pharmacist, referring to a 50-years-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-AUG-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)  injection 0.5 milliliter at arm (lot #U027357 has been verified to be a valid lot, expiration date: 25-MAR-2023) for prophylaxis (strength, and exact anatomical location were not provided); and  meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) in the same arm (strength, dose regimen, lot #, expiration date, route of administration, and indication were not provided).  On 23-AUG-2022 (also reported as "the next day, 24-AUG-2022", conflicting information), the patient experienced arm erythema, swelling, discomfort, fever and a suspected cellulitis. The physician prescribed amoxicillin (+)  clavulanate potassium (AUGMENTIN) as treatment. At the time of the report, the patient had not recovered from the events.  Causal relationship between the events with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) was not reported.
Sex: F
Vaccine: PNC15
Symptoms: Injection site pain
Clinical narrative: A lot of pain at the injection site; This spontaneous report was received from a company representative concerning an elderly, female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On an unknown date, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, expiration date and formulation were not provided).         On an unknown date, the patient experienced a lot of pain at the injection site (vaccination site pain), and after 15 minutes, the pain went away.      The outcome of vaccination site pain was reported as recovered.  The causal relationship between the suspect vaccine and the event occurrence was not reported. ; Sender's Comments:  US-009507513-2208USA009259:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; Medical Assistant reports the administration of improperly stored vaccine.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 25-AUG-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL (lot # W016358, expiration date: 16-NOV-2023) (dose, route of administration and anatomical location not provided) for prophylaxis. The vaccine underwent a temperature of -13.4 degrees Celsius (°C) during a time frame of 45 minutes. Moreover, it was reported that had previous temperature excursions between -14°C up to -10°C (-10.4°C) for 5 hours. No additional adverse event was reported. No further details provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; MMR vaccine that expired on Aug 18, 2022 was inadvertently administered to a patient on Aug 23, 2022.; This spontaneous report was received from a medical assistant 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 23-AUG-2022, the patient was vaccinated with an expired vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) at a dose  0.5 milliliter, lot #T027935, expiration date: 18-AUG-2022, as prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse events reported.; Caller reports that a patient was administered an expired MMR II; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 26-AUG-2022 (also reported as today), the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin, rHA) (M-M-R II), lot number: T018635, expiration date: 29-MAY-2022 (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). The reporter confirmed that the dose was properly stored up through the time of administration. No other adverse events were reported (no adverse event).
Age: 0.75
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; she mentioned that a 9 month old was administered GARDASIL 9 on 25Aug2022; This spontaneous report was received from a physician and refers to a 9-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 25-AUG-2022, the patient was vaccinated with a dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) pre-filled syringe, lot #U029033, expiration date: 13-MAR-2024 (dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis (Inappropriate age at vaccine administration). No adverse event was reported.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: received the GARDASIL vaccine many years ago and she commented on how badly it hurt when she received the shot; This spontaneous report was received from a female patient who was a nurse, concerning herself.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  The nurse reported that many years ago (date unspecified) she received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose description, lot #, expiry date, route of administration, and indication were not provided) and she commented on how badly it hurt when she received the shot. The outcome of the event was not known. No additional adverse event (AE) was reported. No additional information provided.   The causal relationship between injection site pain and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Heplisav-B Has Been Out of Temperature Range; Initial Report Received on 11-May-2022  An office front desk clerk reported that 5-10 patients (age, gender, race or ethnicity of patients were unknown) received HEPLISAV-B (hepatitis B vaccine) that was out of temperature range.  On an unspecified date, patient 1 received a dose of HEPLISAV-B.  Details of administration was not provided.   On 11-May-2022, an office front desk clerk reported that the HEPLISAV-B vaccine (Lot # 935845 and NDC # 4352-8003-05) has been out of temperature range since Dec-2021, with an average temperature of 11-12°C. This "affected 5-10 patients," but they had no information on them at time of report.   No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Heplisav-B Has Been Out of Temperature Range; Initial Report Received on 11-May-2022  An office front desk clerk reported that 5-10 patients (age, gender, race or ethnicity of patients were unknown) received HEPLISAV-B (hepatitis B vaccine) that was out of temperature range.  On an unspecified date, patient 2 received a dose of HEPLISAV-B. Details of administration was not provided.  On 11-May-2022, an office front desk clerk reported that the HEPLISAV-B vaccine (Lot # 935845 and NDC # 4352-8003-05) has been out of temperature range since Dec-2021, with an average temperature of 11-12°C. This affected 5-10 patients, but they had no information on them at time of report.   No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Heplisav-B Has Been Out of Temperature Range; Initial Report Received on 11-May-2022  An office front desk clerk reported that 5-10 patients (age, gender, race or ethnicity of patients were unknown) received HEPLISAV-B (hepatitis B vaccine) that was out of temperature range.  On an unspecified date, patient 3 received a dose of HEPLISAV-B. Details of administration was not provided.   On 11-May-2022, an office front desk clerk reported that the HEPLISAV-B vaccine (Lot # 935845 and NDC # 4352-8003-05) has been out of temperature range since Dec-2021, with an average temperature of 11-12°C. This "affected 5-10 patients", but they had no information on them at time of report.   No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Heplisav-B Has Been Out of Temperature Range; Initial Report Received on 11-May-2022  An office front desk clerk reported that 5-10 patients (age, gender, race or ethnicity of patients were unknown) received HEPLISAV-B (hepatitis B vaccine) that was out of temperature range.  On an unspecified date, patient 4 received a dose of HEPLISAV-B.  Details of administration was not provided.   On 11-May-2022, an office front desk clerk reported that the HEPLISAV-B vaccine (Lot # 935845 and NDC # 4352-8003-05 of current stock) has been out of temperature range since Dec-2021, with an average temperature of 11-12°C. This affected 5-10 patients, but they had no information on them at time of report.   No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Heplisav-B Has Been Out of Temperature Range; Initial Report Received on 11-May-2022  An office front desk clerk reported that 5-10 patients (age, gender, race or ethnicity of patients were unknown) received HEPLISAV-B (hepatitis B vaccine) that was out of temperature range.  On an unspecified date, patient 5 received a dose of HEPLISAV-B.  Details of administration was not provided.   On 11-May-2022, an office front desk clerk reported that the HEPLISAV-B vaccine (Lot # 935845 and NDC # 4352-8003-05) has been out of temperature range since Dec-2021, with an average temperature of 11-12°C. This affected 5-10 patients, but they had no information on them at time of report.   No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received an Expired Dose of Heplisav-B; Initial Report Received on 17-May-2022  A pharmacist reported that 42-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history at the time of vaccination was reported.   Concomitant medications at the time of vaccination were reported as unknown.  On 17-May-2022, the patient received an expired dose of HEPLISAV-B (Lot # 934967, serial # 179060910493, expiration date 11 Apr-2022, NDC # 43528-003-05) intramuscularly in the right deltoid. The patient did not experience any adverse reactions.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Given a Heplisav-B Vaccine Yesterday While It was Out of Temperature Range; Initial Report Received on 27-May-2022  A registered nurse reported that a 27-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was out of temperature range.  No medical history at the time of vaccination was reported.   Concomitant medications at the time of vaccination were reported as unknown.  On 26-May-2022, the patient received a dose of HEPLISAV-B that was out of temperature range between 0°C and 1°C (Lot # 935843, expiration date 08-Oct-2022, NDC # and route unknown) in the right deltoid. The patient did not experience any adverse reactions.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; Initial Report Received on 31-May-2022  A pregnant patient (age, race, ethnicity, and gestation period not provided) spontaneously reported to the HEPLISAV-B pregnancy registry that she, received one dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant.  No relevant medical history was reported.    The last menstrual period date, estimated date of delivery, pregnancy history, and pregnancy risk factors were not reported.  No relevant concomitant medications were reported.  On an unspecified date (# weeks of gestation or # trimester not reported), the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported). The patient was referred to the pregnancy registry by a pharmacist. She wanted to know if it was safe to take the second dose of ~HEPLISAV-B.  No additional information was reported. The patient declined follow up from the pregnancy registry.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: was vaccinated and had a shingles outbreak/ suspected vaccination failure; shingles outbreak, close to 4 months; pulsating pain; burning; itching; 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), shingles, pain, burning sensation and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, burning sensation and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, burning sensation and pruritus to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-AUG-2022 Reporter's Comments: The reporter reported the case via interactive digital media.. Patient was vaccinated and had a shingles outbreak, close to 4 months and was still experiencing pulsating pain and burning and itching. In 2022, the patient experienced vaccination failure, shingles, pain, burning sensation and itching.  Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset, dose number and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/got both doses in 2020 just recovering from shingles; horrible case of internal shingles; entire body was on fire, utter hell; 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 burning sensation. On an unknown date, the outcome of the vaccination failure and burning sensation were unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and burning sensation to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 17-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got both doses of shingles vaccine in 2020 and just he/she was recovering from a horrible case of shingles that just about killed him/her. The patient stated that the entire body was on fire as it went internal, utter hell. The patient also stated that the shot did not always work. 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, Vaccination failure
Clinical narrative: had the vaccine and just diagnosed with them/Suspected vaccination failure; diagnosed with them; 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 16th August 2022, 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: 17-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the vaccine and just diagnosed with them one day before the reporting date. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had Shingles, then after Shingles vaccine/suspected vaccination failure; had 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: 17-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had shingles, then after shingles vaccine. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/got the shot for them, didn't keep them away; didn't keep them away, but they were much milder; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 18-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient have had them twice. The patient got smart and got the shot for them. The shot did not kept them away, but they were much milder. 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.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Had both shingles vaccines, had shingles twice; Had shingles twice; 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.   The patient's past medical history included shingles.   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: 18-Aug-2022 Reporter's comment: The case was received from the patient via  interactive digital media. The patient had both shingles vaccines and now have had shingles twice. The patient was currently enduring it. The patient asked that anyone else has gotten shingles after getting vaccinated. 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: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Product use in unapproved indication
Clinical narrative: had a stokes; Don't recommend it if recipient is still recovering from shingles; This case was reported by a consumer via interactive digital media and described the occurrence of stroke in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant) and drug use for unapproved indication. On an unknown date, the outcome of the stroke and drug use for unapproved indication were unknown.   It was unknown if the reporter considered the stroke to be related to Shingles vaccine.     Additional Information: GSK receipt date: 18-Aug-2022 Reporter's comment: The case was received from the patient's wife via interactive digital media. The patient had a stokes after vaccination.  The reporter stated that did not recommend vaccine if recipient was still recovering from shingles. Additional supportive information: The patient received the vaccine when he still having shingles, which led to drug used for unapproved indication. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: get this on head, shot does not help/suspected vaccination failure; get this on head, comes and goes at will; painful, sore; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 18-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got them on his/her head and its painful, sore and kinda gross lol.  The shot did not helped. The patient stated that it comes and goes at will. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vaccine didn't help, still got shingles/suspected vaccination failure; shingles, under breast; 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: 18-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated that the so called vaccine did not helped him/her. The patient still got shingles under his/her breast. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure/was vaccinated and boostered and still got them; still got them; so 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.   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.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 19-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient was vaccinated and boostered and still got them. The patient stated not as bad as most people but it was so painful. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure/Had the shingles vaccine, but had shingles; shingles around my left eye/shingles in forehead; residual pain over my left eye; 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), shingles and residual pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the residual pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and residual pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 19-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shingles vaccine, but had shingles around his/her left eye and forehead, early this year. The patient still having residual pain over his/her eye. 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.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/had two doses of the vaccine and still got shingles; still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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: 20-Aug-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The patient (school nurse) had two doses of the vaccine and still got shingles. 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/had the shot and now has a bad case of shingles; bad case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In August 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 20-Aug-2022 Reporter's comment: The case was received from the patient's wife via interactive digital media. The reporter reported that she hate to burst the bubble, but getting the shot did not guarantee that you will never had them. The patient had the shot and now had a bad case of shingles. The reporter stated that they thought they were safe too, surprised. 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.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Has taken the vaccine for years, got shingles; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 84-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) 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: 21-Aug-2022 Reporter's comment: The case was received from the patient's children via interactive digital media. The reporter stated that you can still get them with the vaccine. The patient was 84 years old and had taken the vaccines for years and got shingles about 4 months ago. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR123595   Additional Information: GSK receipt date: 22-AUG-2022 Reporter's comments: This case was reported by the patient via interactive digital media. Patient had 2 shingles vaccines and second made patient sicker than all. Patient said that it was better than 2 months of shingles pain though. Additional Supportive Information: It was reported that "Patient had 2 shingles vaccines and second made patient sicker than all" from this line it was not clear if patient was comparing sickness happened after 2nd dose with 1st shingles dose or any other vaccine hence conservatively sickness was captured as event for 1st dose. Also, it was reported that "this sickness was better than 2 months of shingles pain" from this it was not clear if patient had experienced shingles pain or was only using it as a general statement for comparison hence shingles pain was not captured.; Sender's Comments:  US-GSK-US2022AMR123595:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: ENGERIX-B pediatric administered to Adult; ENGERIX-B pediatric administered to Adult; This case was reported by a nurse via other manufacturer and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.    Additional Information: GSK Receipt Date: 24-AUG-2022.  Reporter's Comments: The reporter stated that, the adult patient was administered Engerix B pediatric dose on unknown, previous date.  The reporter was unable further clarify the statement. No additional adverse event (AE) reported. No product quality complain (PQC) reported.  Additional Supportive Information: As adult patient received Engerix B pediatric dose, which led to adult use of a child product and underdose.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Second made me sicker than all; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, for tolerance of previous dose refer case US2022AMR123589).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR123589   Additional Information: GSK Receipt Date: 22-AUG-2022.  Reporter's Comments: This case was reported by the patient via interactive digital media. The patient had 2nd shingles vaccine and it made him/her sicker than all get out. The patient thought it better than 2 months of shingles pain though. Additional Supportive Information: The follow up would not be possible as contact details were not provided. It was reported that "Patient had 2 shingles vaccines and second made patient sicker than all" from this line it was not clear if patient was comparing sickness happened after 2nd dose with 1st shingles dose or any other vaccine hence conservatively sickness was captured as event for 1st dose. Also, it was reported that "this sickness was better than 2 months of shingles pain" from this it was not clear if patient had experienced shingles pain or was only using it as a general statement for comparison hence shingles pain was not captured.; Sender's Comments:  US-GSK-US2022AMR123589:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hurt for a week; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got shingles injection for shingles and he/she was hurt for a week.  The reporter stated that, one more to go and he/she was then done. Additional Supportive Information: The follow up would not possible as no contact details were available.