chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; VAQTA was in advertently administered past it's expiration date; This spontaneous report was received from a healthcare professional (HCP) and refers to a patient of unknown age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported.  On 17-FEB-2023, the patient was advertently administered with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot # reported as U013169, expiration date: 07-FEB-2023 (route of administration was not provided), administered for prophylaxis (expired product administered). No temperature excursions for the product and no symptomatic side effects were reported for the patient. No additional adverse event (AE) was reported.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Nurse reported that a patient received his first dose of GARDASIL9 at age 15 years and is currently 24 years receiving the second dose in 3 dose series; No additional AE/PQC reported at time of call.; This spontaneous report was received from a registered nurse and refers to a 24-year-old male patient. His medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in approximately 2014 (when he was 15-year-old), 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, administered for prophylaxis (exact dose, lot #, expiry date, and route of administration were not provided). The nurse reported the patient was receiving the second dose in 3 dose series, however, the date of administration was not known (inappropriate schedule of product administration). No additional adverse event (AE) was reported.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; LPN calling to report that expired lot of VAQTA ADULT (EXP 1/14/2023) was administered on 2/23/2023; This spontaneous report was received from licensed practical nurse and refers to a 20-year-old male.The  patients' concurrent conditions, medical history, concomitant therapies and historical drug were not provided.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 milliliter, lot #U021561, expiration date: 14-JAN-2023 (expired product administered), administered intramuscularly for prophylaxis (strength was not provided).  No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported,; Pharmacy tech called and reported that an expired MMR II vaccine was given to a patient.; This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 27-FEB-2023, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #u006489, expiration date: 26-FEB-2023, therapy type: rHA, administered for prophylaxis (dose, strength and route of administration were not provided) (expired product administered). No additional adverse events (AEs) were reported (no adverse event).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: he administered PROQUAD IM into the deltoid instead of SC; No additional AE; This spontaneous report was received from a nurse and referred to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneous injection, lot #W029553, expiration date: 14-MAR-2024, administered intramuscularly (IM) into the deltoid instead of subcutaneously (SC) for prophylaxis (strength, dose was not provided) (incorrect route of product administration); in combination with sterile diluent solution for injection/infusion, lot #U036871, expiration date: 11-MAY-2024, administered intramuscularly (strength, dose and indication were not provided). No additional adverse event was reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Healthcare provider is reporting administration of vaccines involved in a temperature excursion. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp) PEDVAXHIB W021183 2/22/2025  Temperature/Time frame 35.2F for; No additional AE reported.; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (1 dosage form, upon internal validation, lot #W021183 was valid for suspect vaccine, expiration date: 22-FEB-2025; strength, anatomical location, and route of administration were not provided) for prophylaxis after a temperature excursion (temperature: 35.2 Fahrenheit (F); time frame: 23 minutes) (product storage error). There was previous temperature excursion: temperature: 35.2 Fahrenheit (F); time frame: 9 minutes. No additional adverse event (AE) reported (no adverse event).
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional clarifying statements or AE details were provided and no additional AE's were reported.; The HCP reports that a patient received their first dose of GARDASIL on 25JUL2011 and then didn't receive their second dose of GARDASIL until 23MAY2012.; This spontaneous report was received from a nurse referring to a 19-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not applicable.  On 25-JUL-2011, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, 0.5ml, lot #0992Z, expiration date: 14-OCT-2012, administered intramuscularly for prophylaxis (strength was not provided). On 23-MAY-2012, the patient was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, 0.5ml, lot #0022AE, expiration date: 28-SEP-2014, administered intramuscularly for prophylaxis (strength was not provided) (inappropriate schedule of product administration). The patient never received her third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). No additional clarifying statements or adverse event (AE) details were provided and no additional AEs were reported (no adverse event).
Sex: F
Vaccine: RV5
Symptoms: Abnormal faeces, Dyspepsia, Hyperhidrosis, Mucous stools, Muscle spasms
Clinical narrative: Caller reports patient was administered ROTATEQ on 07-MAR-2023; started experiencing toruble with digestion; Cramping; break out in sweats; Also reported having one stool that was "thicker, smaller, and mucus-y; Also reported having one stool that was "thicker, smaller, and mucus-y; This spontaneous report as received from a nurse and refers to a 4-month-old female patient. No information about patient medical history, concurrent conditions and concomitant medications was provided.     On 07-MAR-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1938950, 2 milliliter, oral for prophylaxis (product administered to patient of inappropriate age).        On 10-MAR-2023, the patient experienced dyspepsia, mucous stools, abnormal faeces, hyperhidrosis and muscle spasms. The outcome of dyspepsia, mucous stools, abnormal faeces, hyperhidrosis and muscle spasms is unknown. Action taken regarding events was not applicable  The causality between events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided; Sender's Comments:  US-009507513-2303USA004774:
Sex: F
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Caller reports patient was administered ROTATEQ on 07-MAR-2023; started experiencing toruble with digestion; Cramping; break out in sweats; Also reported having one stool that was "thicker, smaller, and mucus-y; Also reported having one stool that was "thicker, smaller, and mucus-y; This spontaneous report as received from a nurse and refers to a 4-month-old female patient. No information about patient medical history, concurrent conditions and concomitant medications was provided.     On 07-MAR-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1938950, 2 milliliter, oral for prophylaxis (product administered to patient of inappropriate age).        On 10-MAR-2023, the patient experienced dyspepsia, mucous stools, abnormal faeces, hyperhidrosis and muscle spasms. The outcome of dyspepsia, mucous stools, abnormal faeces, hyperhidrosis and muscle spasms is unknown. Action taken regarding events was not applicable  The causality between events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided; Sender's Comments:  US-009507513-2303USA004774:
Sex: F
Vaccine: RV5
Symptoms: Haematochezia, Irritability
Clinical narrative: be very fussy with specs of blood in the stool; be very fussy with specs of blood in the stool; This spontaneous report was received from a nurse and refers to a currently 4-month-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On 07-MAR-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml once, lot ##1938950, expiration date was reported as 31-MAR-2024, orally for prophylaxis (strength was not provided).  On 10-MAR-2022, the patient was very fussy (irritability) with specs of blood in the stool (haematochezia). No fever or vomiting was noted. As of 13-MAR-2022, symptoms were still persisting and the patient was sent to the Emergency Room (ER) and was hospitalized. The outcome of the events was unknown.  The causal relationship between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.  Upon internal review, the event of haematochezia was determined to be medically significant.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2303USA004758:MSD
Sex: F
Vaccine: HPV9
Symptoms: Premature menopause
Clinical narrative: Patients coming in read website about premature ovarian failure following Gardasil 9 administration; This spontaneous report as received from a physician and refers to a female patient of unknown age. No information on patients' medical history, concurrent condition and concomitant medication was provided.  On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route of administration, lot# and exp. date were not provided).  On an unknown date the patient experienced premature menopause. The outcome of premature menopause is unknown. Action taken with and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the event was not applicable.       The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.; Sender Comments:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AE occured/ no other AE; The caller said an expired dose was administered today; This spontaneous report was received from registered nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-MAR-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dose, lot #w006214, expiration date: 04-MAR-2023 (strength, and route of administration were not provided) administered for prophylaxis.  The vaccine did not had any temperature excursions prior to the administration. No additional adverse event was reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Patient was administered Improperly Stored PEDVAXHIB on 03/16/2023; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-MAR-2023, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W015927, expiration date: 15-FEB-2025, administered for prophylaxis (dose, strength, and route of administration were not provided) (product storage error). It was reported that the vaccine underwent temperature excursions on 06-MAR-2023 (temperature: 44.6 Fahrenheit (F), time frame: 15 minutes), and on 03-MAR-2023 (temperature below 36 F (31.8F) for 45 minutes). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no symptomatic side effects reported for the patient; Inbound call from HBP reporting a patient was inadvertently administered PROQUAD after it's expiration date. No temp excursions reported for the product and no symptomatic side effects reported for the patient.; This spontaneous report was received from Healthcare Business Partner (HBP) and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On 16-MAR-2023, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, albumin status has been verified as recombinant human albumin (rHa), lot #U028180, expiration date was reported as 08-MAR-2023 (expired product administered), for prophylaxis (strength, dose, anatomical location, and route of administration were not provided); and sterile diluent solution for injection/infusion, lot #U028180 has been verified to be invalid, expiry date was reported as 08-MAR-2023 (strength, dose, route of administration, and indication were not provided). No temperature excursions were reported for the product and no symptomatic side effects were reported for the patient (no adverse event).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post-herpetic neuralgia; herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 05-OCT-2012, the pt was vaccinated at her local pharmacy with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown dates, the pt was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster and post-herpetic neuralgia. The outcome of the events was not reported.  The reporter considered the events of herpes zoster and post herpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Death
Clinical narrative: a healthy teenage girl who died six months after a third HPV vaccine.; This spontaneous report was received from a physician via social media referring to a teenage female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, 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) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, the healthy teenage patient died six months after a third HPV vaccine. It was unknown whether an autopsy was performed.  The causal relationship between her death and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.; Sender's Comments:  US-009507513-2303USA005728:MSD
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, COVID-19, Herpes zoster, Hypoaesthesia, Pruritus
Clinical narrative: Been vaccinated, have them/suspected vaccination failure; shingles 50 times, worst case; COVID-19; numb skin; burning; Itching; 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: Been vaccinated, have them/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles 50 times, worst case), covid-19 (Verbatim: COVID-19), numbness (Verbatim: numb skin), burning sensation (Verbatim: burning) and pruritus (Verbatim: Itching). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the covid-19 and numbness were not reported and the outcome of the burning sensation and pruritus were recovered/resolved (duration 1 year).   It was unknown if the reporter considered the vaccination failure, shingles, covid-19, numbness, burning sensation and pruritus to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, covid-19, numbness, burning sensation and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that worse than anything he/she ever had.  The patient had shingles right now.  The patient had them over fifty times.  The first time lasted about ten months.  The patient's doctor said that he/she won the prize for the worst case of shingles he had ever seen.  The patient had been vaccinated with shingles.  The last vaccine really helped until he/she had covid.  The skin on her left leg was numb.  The patient just went through a year of burning and itching. 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. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Been vaccinated, have them/suspected vaccination failure; shingles 50 times, worst case; COVID-19; numb skin; burning; Itching; 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: Been vaccinated, have them/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles 50 times, worst case), covid-19 (Verbatim: COVID-19), numbness (Verbatim: numb skin), burning sensation (Verbatim: burning) and pruritus (Verbatim: Itching). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the covid-19 and numbness were not reported and the outcome of the burning sensation and pruritus were recovered/resolved (duration 1 year).   It was unknown if the reporter considered the vaccination failure, shingles, covid-19, numbness, burning sensation and pruritus to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, covid-19, numbness, burning sensation and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that worse than anything he/she ever had.  The patient had shingles right now.  The patient had them over fifty times.  The first time lasted about ten months.  The patient's doctor said that he/she won the prize for the worst case of shingles he had ever seen.  The patient had been vaccinated with shingles.  The last vaccine really helped until he/she had covid.  The skin on her left leg was numb.  The patient just went through a year of burning and itching. 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. The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shots got 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 male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, [the patient experienced vaccination failure (Verbatim: got the shots got 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 reported.   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: 07-MAR-2023 This case was reported by a patient's wife via interactive digital media. The reporter stated that you could get still get shingles even after you got the shingles vaccine, it was not guaranteed. The reporter stated that the patient got the shingles shot last year and guessed he got the shingles last week from the day of reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. Note: onset date not captured as last week could be February or March.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Vaccination failure
Clinical narrative: getting the shot never stopped from getting it/suspected vaccination failure; getting shingles; Painful; Burning; 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: getting the shot never stopped from getting it/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: getting shingles), pain (Verbatim: Painful) and burning sensation (Verbatim: Burning).         The outcome of the vaccination failure was unknown and the outcome of the shingles and burning sensation were not reported and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and burning sensation to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and burning sensation to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine but it was never stopped him/her from experiencing shingles. The patient stated that the shingles were painful and burning and he/she still had pain in there sometimes. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Took shot for shingles it gave her 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 female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included covid-19.   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: Took shot for shingles it gave her 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 reported.   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: 07-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she had a friend working with him/her for years when the covid struck all of them unfortunately. The friend experienced Covid and then she received Shingles vaccine and the vaccine gave her the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, Vaccination failure, Visual impairment
Clinical narrative: Got shot still got shingles/suspected vaccination failure; Shingles in her eyes; Shingles; Hard time seeing correctly; Hurts; 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.   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: Got shot still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles in her eyes) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), visual disturbance (Verbatim: Hard time seeing correctly) and pain (Verbatim: Hurts).         The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, visual disturbance and pain were not recovered/not resolved and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, visual disturbance and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, shingles, visual disturbance and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that his/her sister received Shingles vaccine and still experienced Shingles. The reporter stated that the worst place she still has shingles is in her eyes. The patient had been seeing a specialist and it was very hard to get rid of in your eyes. All the rest was cleared up but she had a very hard time seeing correctly and it hurts. The reporter pray about it all the time for it to clear up. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both shots and got shingles/Suspected Vaccination Failure; got the 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.   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: had both shots and got shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the shingles).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: 08-MAR-2023 This case was reported by a patient via interactive digital media. The patient had both shingles shots and still got the shingles.  The reporter stated that it was horrible experience. 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. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles after jab/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: Got shingles after jab/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 reported.   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: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she experienced shingles after received Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the 2 shots and have shingles/Suspected vaccination failure; Shingles on the back of neck; 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, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the 2 shots and have shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on the back of neck). 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.     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: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received two doses of Shingles vaccine in 2020. The patient now has experienced the shingles on the back of his/her neck and it was not picnic. 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. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot before getting 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, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot before getting 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 reported.   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: 08-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles shot about one year before getting shingles.  The reporter stated that it was true story. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Age: 18.0
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero was given to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old patient who received Men B NVS (Bexsero) (expiry date 28-FEB-2023) for prophylaxis.   On 06-MAR-2023, the patient received Bexsero. On 06-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero was given to patient). The outcome of the expired vaccine used was not reported.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-MAR-2023 The expired Bexsero was given to the patient at the time of reporting. The reporter wanted to know what would be the next step. The expired Bexsero was given to the patient, which led to expired vaccine used.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3 doses; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of extra dose administered in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first and second dose received 1 year prior).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, [the patient experienced extra dose administered (Verbatim: received 3 doses). The outcome of the extra dose administered was not reported.   Additional Information: GSK receipt date: 06-Mar-2023  The patient received 3rd doses of Shingrix vaccine because she forgot previous second dose. There were no noted adverse outcome. It was given one year prior. The patient was administered an 3rd dose of Shingrix, which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash; Painful rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced itchy rash (Verbatim: Itchy rash) and painful rash (Verbatim: Painful rash).  The outcome of the itchy rash and painful rash were not reported.   It was unknown if the reporter considered the itchy rash and painful rash to be related to Shingles vaccine.     It was unknown if the company considered the itchy rash and painful rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she had Shingles shot and still got that terrible itchy painful rash. The follow up would not be possible as no contact details were provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Urticaria
Clinical narrative: Hives; Didn't go back to the 2nd dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of hives 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 did not receive the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced hives (Verbatim: Hives) and incomplete course of vaccination (Verbatim: Didn't go back to the 2nd dose).  The outcome of the hives was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the hives to be unrelated to Shingles vaccine.   The company considered the hives to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-Mar-2023 This case was reported by a patient via interactive digital media. The patient reported that 2 weeks after he/she got the first shot he/she broke out in hives and have had them ever since. So annoying.  The physician said it was not related to the shot, and it just might be a coincidence.  However, the patient did not go back for the second shot. Till the time of reporting, the patient did not receive the second shot, which led to incomplete course of vaccination. The follow up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Shingles (had a breakout); No second shot for me; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles (had a breakout)) and incomplete course of vaccination (Verbatim: No second shot for me).  The outcome of the shingles was not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date- 06-MAR-2023 This case was reported by a patient via interactive digital media. The patient had outbreaks on and off for 45 years. The patient got first Shingles shot and had a breakout.  The patient had no second Shingles shot. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Scratch
Clinical narrative: Terrific rash on both legs; Itched so bad, still itch; Scratched all night, reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a female 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, 2 days after receiving Shingles vaccine, the patient experienced rash (Verbatim: Terrific rash on both legs), pruritus (Verbatim: Itched so bad, still itch) and scratch (Verbatim: Scratched all night, reaction). The outcome of the rash and scratch were not reported and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the rash, pruritus and scratch to be related to Shingles vaccine.     It was unknown if the company considered the rash, pruritus and scratch to be related to Shingles vaccine.   Additional Information: GSK Receipt date- 06-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the first of the two shingles vaccine and within two days she had a terrific rash on both legs from the knees down that itched so bad that she scratched all night. The patient stated that so intense that it woke her husband. A few days later was in his (patient's husband's) office with her husband and told him about the reaction.  The patient's husband replied that the patient would not be getting the second vaccine. The months later the patient's legs still itch but not as much.  There needs to be more research done on the vaccine. The follow-up could not be possible as no contact details were available. As per the reported verbatim,'So intense that it woke my husband,' patient's gender was coded as female.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Those shots are painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Those shots are painful).  The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2023. This case was reported by a patient via interactive digital media. The patient stated that Shingles shots were painful but so worth it. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: body hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included sepsis (It was painful).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, [the patient experienced general body pain (Verbatim: body hurt).The outcome of the general body pain was recovered/resolved.   The reporter considered the general body pain to be related to Shingles vaccine.     The company considered the general body pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR039602   Additional Information: GSK receipt date: 07-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she had 2 shingles shot. They made his/her body hurt for days so he/she didn't want to know what shingles was. The reporter had sepsis once that was painful. The follow-up could not be possible as no contact details were available. For tolerance to the 2nd dose refer case US2023AMR039602.; Sender's Comments:  US-GSK-US2023AMR039602:same patient, different dose
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: body hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included sepsis (It was painful). Previously administered products included Shingles vaccine with an associated reaction of pain (1st dose received on an unknown date, refer case US2023AMR039596).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, [the patient experienced general body pain (Verbatim: body hurt).Rechallenge with Shingles vaccine was positive. The outcome of the general body pain was recovered/resolved.   The reporter considered the general body pain to be related to Shingles vaccine.     The company considered the general body pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR039596   Additional Information: GSK receipt date: 07-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she had 2 shingles shot. They made his/her body hurt for days so he/she didn't want to know what shingles was. The reporter had sepsis once that was painful. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR039596:same patient, different dose US-GSK-US2023AMR039596:same patient, different dose