chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events, treatment, outcome(s) or symptoms occurred from patient recieving the expired vaccine.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE details provided; PROQUAD was administered to a patient after a temperature excursion; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 13-JUN-2023, the patient was vaccinated with an improperly storage dose of measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) subcutaneous injection, at a dose of 0.5 milliliters once as prophylaxis (W024552, which was determined to be valid, with an expiration date on 31-JAN-2024) (strength, route of administration and anatomical location of administration were not reported), in combination with a sterile diluent.  The administered dose underwent a temperature excursion via digital data logger of 12.84 degrees Fahrenheit for 25 minutes. There was a no previous temperature excursion reported. No further adverse event details provided.  Follow-up information has been received from a nurse regarding a 4-year-old female patient, on 25-JUL-2023.  Her concomitant medications included polio vaccine (POLIO), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) and hepatitis a vaccine (HEPATITIS A VACCINE).   On 22-MAY-2023, the vaccine freezer was open to allow for scraping ice from sides. The door was left open too long, temperature excursion occurred and was inaccurately reported to manufacturer. The temperature excursion did not occur as a result of a reading from a Digital Data Logger (previously reported that temperature excursion was via Digital Data Logger, conflicting information). On 13-JUL-2023, the patient was vaccinated with an improperly stored vaccine of measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), first dose, administered subcutaneously in right thigh, and it was administered by a heathcare professional. The vaccine was administered according to the instruction leaflet and it was not available for return/evaluation. On 11-JUL-2023, the vaccine was properly reported to manufacturer and deemed safe for use. The patient received vaccine and did not have any medical events occur as a result of temperature excursion. This vaccine was no  longer in stock.  This is one of four cases received from the same reporter.  This case was previously considered non-valid but upon receipt of follow-up it was determined to be valid as patient's identifiers were provided.; Sender's Comments:  US-009507513-2307USA002154: US-009507513-2307USA002433: US-009507513-2308USA001000:
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, Patient uncooperative
Clinical narrative: Caller reporting that their patient received a partial dose of MMRII due to their leg moving during administration. No PQC. No additional information.; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 07-JUL-2023, the patient was vaccinated with a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live A (recombinant human albumin [rHA]) (M-M-R II) injection, 0.5 ml, lot #W002786 confirmed to be valid with expiration date 25-JAN-2024 (route of administration and anatomical location were not reported), for prophylaxis. The patient received partial dose due to their leg moving during administration (accidental underdose).
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: No additional AE details available; Inbound call from nurse who reports the first dose of GARDASIL 9 was administered to a pregnant patient today 12JUL2023. No additional AE details available. No additional AE reported. No PQC.; This prospective spontaneous report was received from nurse, regarding a 25-year-old female pregnant patient. The patient's pertinent medical history, previous drug reactions or allergies were not reported, concomitant medications included acetylsalicylic acid (ASPIRIN).  Patient time of gestation or last menstrual period (LPM) were not provided. On 12-JUL-2023, the patient was vaccinated with  the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  injection, as prophylaxis (lot number W026977, which was determined to be valid, with an expiration date on 04-JAN-2025) (strength, dose, route and anatomical location of administration were not reported) (Maternal exposure during pregnancy).   No adverse additional adverse event was provided.   At the time of reporting, the outcome of patient's pregnancy was pending.
Age: 34.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling, Vaccination site mass
Clinical narrative: He states he received his 3rd dose of GARDASIL 9 on 11Jun2023 in unspecified deltoid muscle and as of today, he still has a dark red quarter sized circular spot in the area where he had the vaccine. He also reports a "bump."; He states he received his 3rd dose of GARDASIL 9 on 11Jun2023 in unspecified deltoid muscle and as of today, he still has a dark red quarter sized circular spot in the area where he had the vaccine. He also reports a "bump."; This spontaneous report was received from a 34-year-old male patient referring to himself. The patient's pertinent medical history included heartburn. His drug reactions/allergies were reported as no known allergies (NKA). His concurrent conditions were not reported. Concomitant medication included esomeprazole magnesium trihydrate (NEXIUM).   On 11-JUN-2023, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly (IM) in unspecified deltoid muscle as prophylaxis (strength, dose, lot #, and expiry date were not provided).  On an unknown date in 2023, the patient had a dark red quarter sized circular spot in the area where he had the vaccine (vaccination site erythema). He also had a "bump" (vaccination site mass). He asked a pharmacist if this was normal, and he was referred to his primary care. He had not reached out to his primary care physician at this time. There was no treatment given for the events. At the reporting time, the patient had not recovered from vaccination site erythema and vaccination site mass, the symptoms still presented. He was requested information on whether the events were normal or if the events were seen before.   The causal relationship between the events and the suspect vaccine was not reported.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Chronic fatigue syndrome, Coeliac disease, Loss of personal independence in daily activities, Postural orthostatic tachycardia syndrome, Small fibre neuropathy
Clinical narrative: autoimmune injury/Systemic lupus erythematosus (SLE); Celiac Disease; Postural Orthostatic Tachycardia Syndrome (POTS); Chronic Fatigue Syndrome (CFS); Small Fiber Neuropathy; Information has been received on 25-JUL-2023 from a lawyer regarding a case in litigation, concerning an adolescent female patient (pt). Her medical history, concurrent conditions and concomitant medications were not reported. Pt's mother agreed to her daughter receiving Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) after being exposed to marketing that the vaccine is very safe, it prevents cancer, and that teenagers must get it. Prior to receiving her vacciantions, pt had no autoimmune, autonomic, or neurological issues. She enjoyed playing the piano, dancing and running cross country. She was identified as a gifted student and was in good health. On 30-AUG-2011, when the pt was 13 years old, she received her first dosage of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, units, route of administration, anatomical location, lot#, and expiration date were not reported), which was touted as a safe and effective vaccine for preventing cervical cancer. Soon after vaccination, pt began to show symptoms that were eventually diagnosed as symptoms of postural orthostatic tachycardia ayndrome (POTS), chronic fatigue syndrome (CFS), small fiber neuropathy (SFN), and celiac disease. On 22-NOV-2011, pt received her second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, units, route of administration, anatomical location, lot#, and expiration date were not reported) and shortly thereafter her symptoms significantly worsened. As a result of her post-GARDASIL symptoms, pt has been unable to engage in normal activities that a normal young person would enjoy. Based upon her chronic and severe post-GARDASIL symptoms, pt has been diagnosed with various medical conditions, including but not limited to, POTS, CFS, SFN, and celiac disease. Pt's GARDASIL injections caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to systemic lupus erythematosus (SLE), as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by GARDASIL or otherwise linked to her GARDASIL-induced autoimmune disorder. At the reporting time, the pt has not recovered from all the events. All the events were considered to be related to GARDASIL.  Upon internal review, the events of SLE and celiac disease were considered to be medically significant. Additionally, all the events were considered to be disabling.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Systemic lupus erythematosus
Clinical narrative: autoimmune injury/Systemic lupus erythematosus (SLE); Celiac Disease; Postural Orthostatic Tachycardia Syndrome (POTS); Chronic Fatigue Syndrome (CFS); Small Fiber Neuropathy; Information has been received on 25-JUL-2023 from a lawyer regarding a case in litigation, concerning an adolescent female patient (pt). Her medical history, concurrent conditions and concomitant medications were not reported. Pt's mother agreed to her daughter receiving Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) after being exposed to marketing that the vaccine is very safe, it prevents cancer, and that teenagers must get it. Prior to receiving her vacciantions, pt had no autoimmune, autonomic, or neurological issues. She enjoyed playing the piano, dancing and running cross country. She was identified as a gifted student and was in good health. On 30-AUG-2011, when the pt was 13 years old, she received her first dosage of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, units, route of administration, anatomical location, lot#, and expiration date were not reported), which was touted as a safe and effective vaccine for preventing cervical cancer. Soon after vaccination, pt began to show symptoms that were eventually diagnosed as symptoms of postural orthostatic tachycardia ayndrome (POTS), chronic fatigue syndrome (CFS), small fiber neuropathy (SFN), and celiac disease. On 22-NOV-2011, pt received her second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, units, route of administration, anatomical location, lot#, and expiration date were not reported) and shortly thereafter her symptoms significantly worsened. As a result of her post-GARDASIL symptoms, pt has been unable to engage in normal activities that a normal young person would enjoy. Based upon her chronic and severe post-GARDASIL symptoms, pt has been diagnosed with various medical conditions, including but not limited to, POTS, CFS, SFN, and celiac disease. Pt's GARDASIL injections caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to systemic lupus erythematosus (SLE), as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by GARDASIL or otherwise linked to her GARDASIL-induced autoimmune disorder. At the reporting time, the pt has not recovered from all the events. All the events were considered to be related to GARDASIL.  Upon internal review, the events of SLE and celiac disease were considered to be medically significant. Additionally, all the events were considered to be disabling.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No side effects reported; HCP calling to report VAQTA was administered after it experienced a temperature excursion. No side effects reported. Excursion was supported. No additional information provided.; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 27-JUL-2023, the patient was vaccinated with an improperly storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection, at a dose of 0.5 milliliters as prophylaxis (lot number: 1971534, which was determined to be valid as syringe formulation, with an expiration date on 06-OCT-2024) (strength, route and anatomical location of administration).  The reported vaccine underwent a temperature excursion of 50 degrees Fahrenheit (F) for 1 hour and 40 minutes, excursion was supported. No previous temperature excursions were reported.   No additional information was reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Consumer calling on behalf of his wife who received GARDASIL 9 while pregnant. Inquiring if Merck had any additional information that we could provide.  Caller was directed to contact physician for additional information.   Unknown treating provider,; No other AE; This spontaneous report was received from a consumer and refers to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, single dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On unknown date, the patient was pregnant with unknown date of last menstrual period and estimated delivery date (Exposure during pregnancy). No additional adverse event was reported.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HBP called to report a TE with PROQUAD from 8/19/2022.  Administered to this patient on 1/9/2023. Also administered to 7 other patients:  8 AE cross-reference cases: 02439769, 02439770, 02439771, 02439773, 02439801, 02439807, 02439777, 02439808. No a; This spontaneous report was received from an tther and refers to a 6-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-JAN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHa) (PROQUAD) injection, 0.5 milliliter, lot # U039261 and expirasion date 09-JUN-2024, administered for prophylaxis (strength and route of administration were not provided). This vaccine underwent temperature excursion on 19-AUG-2022 (Product storage error). No additional adverse event was reported.
Age: 1.25
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; HBP called to report a TE with PROQUAD from 8/19/2022.  Administered to this patient on 11/22/2022.; This spontaneous report was received from an other reporter referring to 1-year-old patient of gender. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 22-NOV-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection (0.5 mL, lot #U039621 was not valid, expiration date was not established but it was reported as 09-JUN-2023, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).  On 19-AUG-2022, the measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) had a temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) were reported (No adverse event).  This is one of several reports from the same reporter.
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; Pharmacist called stating they administered the adult formulation of VAQTA to a 14 year old. Caller stated the patient has not had any symptoms. No additional AE/no PQC.; This spontaneous report was received from a pharmacist and refers to a 14-year-old male patient. No information on patient's medical history, current conditions and concomitant medications was provided.     On 31-JUL-2023 the patient was vaccinated with adult dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (exact dose, dose number, route and site of administration, lot number and expiration date were not provided) (product administered to patient of inappropriate age and no adverse event).
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Caller said she took 1st dose on month 0, then took second dose at month 1 and then the 3rd dose at month 3; No other AE; This spontaneous report was received from a consumer and refers to a female patient of unknown age. No information on patient's medical history, current conditions and concomitant medications was provided.     On an unknown dates (reported as 1st dose on month 0, then took second dose at month 1 and then the 3rd dose at month 3) the patient was vaccinated with all three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration and no adverse event). The company unidentified HPV vaccine administered (name and lot number not provided).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have the shingles now; Very Painful; This serious 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I have the shingles now) and pain (Verbatim: Very Painful). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 26-Jul-2023 This case was reported the patient via interactive digital media. The patient now (at the time of reporting) had shingles, even got the 2nd shot. The 2nd shot was very painful. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting Follow-up not possible as no contact details provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took two Shingles shots to prevent shingles,not only got Shingles it was worst / suspected vaccination failure; took two Shingles shots to prevent shingles, not only got Shingles it was worst; This serious 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: took two Shingles shots to prevent shingles,not only got Shingles it was worst / suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: took two Shingles shots to prevent shingles, not only got Shingles it was worst). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 28-JUL-2023 The case was received from the patient's cousin via interactive digital media. The patient took two Shingles shots to prevent shingles and she not only got shingles, it was one of the worst cases that could imagine. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case was linked with case US2022AMR141810, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR141810:SAME REPORTER
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; both shingles vaccines and still got it; This serious 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: both shingles vaccines and still got it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 31-JUL-2023 The case was received from the patient interactive digital media. The patient had both shingles vaccines and still got it and it was awful. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding 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: I have Friends that got the Shingles Shot 11 of them now have shingles/ Suspected Vaccination failure; I have Friends that got the shingles shot 11 of them now have shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have Friends that got the Shingles Shot 11 of them now have shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient got shingles shot and now he/she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This was 1 of 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR104624:Same Reporter US-GSK-US2023AMR104625:Same Reporter US-GSK-US2023AMR104620:Same Reporter US-GSK-US2023AMR104627:Same Reporter US-GSK-US2023AMR104628:Same Reporter US-GSK-US2023AMR104623:Same Reporter US-GSK-US2023AMR104622:Same Reporter US-GSK-US2023AMR104621:Same Reporter US-GSK-US2023AMR104626:Same Reporter US-GSK-US2023AMR104619:Same Reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104620:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104623:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have Friends that got the shingles shot 11 of them now have shingles/ Suspected Vaccination failure; I have Friends that got the shingles shot 11 of them now have shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient got shingles shot and now he/she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This was 1 of 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR104625:Same reporter US-GSK-US2023AMR104620:Same reporter US-GSK-US2023AMR104628:Same reporter US-GSK-US2023AMR104622:Same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104617:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104620:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have Friends that got the shingles shot 11 of them now have shingles/suspected vaccination failure; I have Friends that got the shingles shot 11 of them now have shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient got shingles shot and now he/she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This was 1 of 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104617:same reporter US-GSK-US2023AMR104619:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have Friends that got the shingles shot 11 of them now have shingles/ Suspected Vaccination failure; I have Friends that got the shingles shot 11 of them now have shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via  interactive digital media. The patient got shingles shot and now he/she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This was 1 of 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104620:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104617:same reporter US-GSK-US2023AMR104619:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have Friends that got the shingles shot 11 of them now have shingles/ Suspected Vaccination failure; I have Friends that got the shingles shot 11 of them now have shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient got shingles shot and now he/she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This was 1 of 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR104620:same reporter US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104617:same reporter US-GSK-US2023AMR104619:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have Friends that got the shingles shot 11 of them now have shingles/ Suspected Vaccination failure; I have Friends that got the shingles shot 11 of them now have shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient got shingles shot and now he/she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This was 1 of 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104620:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104619:same reporter US-GSK-US2023AMR104617:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have Friends that got the Shingles Shot 11 of them NOW HAVE SHINGLES/ Suspected Vaccination failure; Shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have Friends that got the Shingles Shot 11 of them NOW HAVE SHINGLES/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient received shingles vaccine and now he or she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset  and laboratory test confirming shingles were unknown at the time of reporting. This case was 7 of 11 cases for the patient reported by same reporter. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104620:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104617: US-GSK-US2023AMR104619:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have Friends that got the Shingles shot 11 of them now have shingles/ Suspected Vaccination failure; Shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have Friends that got the Shingles shot 11 of them now have shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient received shingles vaccine and now he or she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset  and laboratory test confirming shingles were unknown at the time of reporting. This case was 8 of 11 cases for the patient reported by same reporter. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104620:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104617:same reporter US-GSK-US2023AMR104619:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have Friends that got the Shingles Shot 11 of them now have shingles/ Suspected Vaccination failure; Shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have Friends that got the Shingles Shot 11 of them now have shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient received shingles vaccine and now he or she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset  and laboratory test confirming shingles were unknown at the time of reporting. This case was 9 of 11 cases for the patient reported by same reporter. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104620:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104619:same reporter US-GSK-US2023AMR104617:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have Friends that got the Shingles shot 11 of them now have shingles/ Suspected Vaccination failure; Shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have Friends that got the Shingles shot 11 of them now have shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient received shingles vaccine and now he or she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset  and laboratory test confirming shingles were unknown at the time of reporting. This case was 10 of 11 cases for the patient reported by same reporter. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104620:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104617:same reporter US-GSK-US2023AMR104619:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have Friends that got the Shingles Shot 11 of them now have shingles/ Suspected Vaccination failure; Shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have Friends that got the Shingles Shot 11 of them now have shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient received shingles vaccine and now he or she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset  and laboratory test confirming shingles were unknown at the time of reporting. This case was 11 of 11 cases for the patient reported by same reporter. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR104617:same reporter US-GSK-US2023AMR104619:same reporter US-GSK-US2023AMR104620:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104627:same reporter