chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Practice manager calling to report that an expired vaccine was administered to a patient; This spontaneous report was received from an office manager, concerning a 46-year-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies.  On 11-MAY-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe (lot number T014590, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 15-APR-2021), as prophylaxis (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported) (expired product administered). Additionally, it was reported the vaccine was not part of a temperature excursion. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; improperly stored adverse event with MMR II; This spontaneous report was received from an office manager referring to a 2 tears old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.   The unit that had vaccine was making a noise. To prevent a loss of vaccine, all vaccine transformed to a unit that had intrinsic samples in it on 09-APR-2021. Due to the amount of product in the unit, the temperature got down to 35.2 on one day. On 22-APR-2021, the patient was vaccinated with first dose of the improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  (recombinant human albumin) (M-M-R II) (0.5 ml, strength was not reported, lot# S037503, expiration date 20-NOV-2021, albumin status recombinant Human albumin (rHA)) subcutaneously on left arm for prophylaxis operated by a healthcare professional. The event was supported by temperature stability evaluation. The vaccine administered experienced a temperature excursion of 35.2 F, with time frame 480 hours and 0 minutes. There was no previous temperature excursion. A digital data logger was involved. When a new unit was available and temperature at acceptable level, vaccine was put in the new unit on 04-MAY-2021. The vaccine was not available for return due to single use. No additional adverse events reported.  This is one of 6 reports received from the same reporter.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: V ARlV AX and MMR II that underwent multiple temperature excursions had been administered to patients.; no adverse event; This spontaneous report was received from a medical assistant regarding a 17 month old patient of unknown gender.  No information regarding concurrent conditions, medical history or concomitant medications was provided.  On 06-MAR-2021, the patient was administered improperly stored varicella virus vaccine live (Oka/Merck (VARIVAX) lot number T020652,  expiration date 16-JUN-2022 and recombinant Human albumin (rHA) Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)  lot number S035352, expiration date 05-NOV-2021, for prophylaxis (dose number, route of administration, anatomical location, vaccination scheme was not reported). The involved vaccines underwent a temperature excursion of -14.03 degrees Celsius for 1 hour 15 minutes, -14.9 degrees Celsius for 9 minutes, -10.3 degrees Celsius for 1 hour and -6.3 degrees Celsius for 2 hours.  This information was due to a digital data logger, and there were previous temperature excursions of -14.03 degrees Celsius for 1 hour 15 minutes and -14.9 degrees Celsius for 9 minutes. No additional adverse events were reported.
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: child spit up about half of it; the vaccine was given to a child and spit up about half of it; This spontaneous report was received from an office manager (other) referring to a two-month-old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.  On 13-MAY-2021 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 mL, orally for prophylaxis (strength, lot number, expiration date were not provided).  On the same date, the reporter stated the vaccine was given the child, who spat up about half of it. (infantile spitting up, underdose). No treatment was provided for the event. On an unspecified date in May 2021, the patient recovered from infantile spitting up No additional AE reported.  The causal relationship between rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and infantile spitting up was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Allodynia, Herpes zoster, Post herpetic neuralgia
Clinical narrative: Chronic Post Herpetic Neuralgia; allodynia; Shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 15-SEP-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered shingles with resulting chronic post herpetic neuralgia and allodynia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered the events shingles with resulting chronic post herpetic neuralgia and allodynia to be disability.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: potential administration of improperly stored VARlVAX, MMR II, and PROQUAD; potential administration of improperly stored VARlVAX, MMR II, and PROQUAD; No additional adverse events reported; This spontaneous report was received from a nurse referring to some patients of unknown age and gender. The patients' pertinent medical history, concomitant drugs and drug allergies were not reported.  The reporter reported potential administration of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot #: T010312, expiration date: 24-MAR-2022; lot #: T024284, expiration date: 15-JUL-2022; lot #: T012550, expiration date: 10-APR-2022; lot #: S025913, expiration date was reported as 28-AUG-2021 (upon internal validation established as 20-AUG-2021), dose, strength, and route were not reported), Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live, albumin status recombinant Human albumin (rHA) (M-M-R II) (lot #: S039316, expiration date: 04-DEC-2021; lot #: S037497, expiration date: 20-NOV-2021; lot #: S037501, expiration date: 20-NOV-2021, dose, strength, and route were not reported), Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, albumin status recombinant Human albumin (rHA) (PROQUAD) (lot #: T013540, expiration date: 17-OCT-2021, dose, strength, and route were not reported) for prophylaxis.  Temperature excursions of these vaccines were -10.9 degrees Celsius (C) for 25 minutes, -13.6C for 23 minutes, -14.7C for 7 minutes, -12C for 20 minutes, -13.9C for 14 minutes, -12.4C for 24 minutes, -14.2C for 11 minutes, -14.6C for 11 minutes, -11.2C for  29 minutes,-14.2C for 10 minutes, -14.7C for 7 minutes, and 3.8C for 1 hour and 11 minutes without any previous temperature excursion. The digital data logger was not involved.  This case was non-valid due to no specific patient identifier.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AE reported; the patient received her first dose of GARDASIL 9 two years ago, her second dose in February 2021 and her third dose 21-MAY-2021; This spontaneous report was received from a registered nurse and refers to a 27-year-old female patient. There was no information regarding her medical history, concurrent conditions nor concomitant therapies provided.  On an unspecified date in 2019 (reported as two years ago), 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) 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. In February 2021, she received the second dose of the vaccine (0.5 milliliter; route of administration, anatomical location, lot # and expiration date were not provided) and on 21-MAY-2021 (reported as today), the third dose was administered to her (0.5 milliliter; route of administration, anatomical location, lot # and expiration date were not provided) (inappropriate schedule of vaccine administered). The reporter declined to provide any additional information or verify administration dates. No adverse event (AE) was reported.
Age: 12.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; The MMR II was administered to a patient on 19-MAY-2021; This spontaneous report was received from a physician concerning a 12 year old patient, gender not provided. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.    On 19-MAY-2021, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (expired product administered) for prophylaxis (lot # S012944 has been determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and establish as 28-APR-2021) (strength, dose, route of administration and anatomical location were not provided) .       No adverse event reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot about three months before I got the shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via 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 4 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received shingles vaccine about 3 months before the patient got shingles. The patient reported that it was going on 10th months and the patient was still fighting with shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had my two shot/The last shot was in January of this year/I now have Shingles / suspected vaccination failure; I now have Shingles; I am in pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In January 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and less than 5 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2 doses of Shingles vaccine and both times he/she had a reaction (unspecified). At the time of reporting, the patient had shingles and was in pain. The patient stated that he/she could not recommend the shot as it did not work for him/her. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR108657:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Eyelid ptosis, Facial paralysis, Herpes zoster oticus, Vaccination failure
Clinical narrative: I had the shingles vaccine a year later I got the shingles in my left ear/ suspected vaccination failure; shingles in my left ear; The whole left side of my face dropped/ smile is crooked; My left eye droops; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster otitis externa (serious criteria GSK medically significant), facial droop (serious criteria GSK medically significant) and ptosis. On an unknown date, the outcome of the vaccination failure, herpes zoster otitis externa, facial droop and ptosis were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, facial droop and ptosis to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient had the shingles vaccine and a year later got the shingles in left ear. The patient also had dropped face on the whole left side with left eye droop and crooked smile. The patient thought of having a stroke. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shot didn't help. Still get them, but not as bad./Suspected Vaccination failure; Shot didn't help. Still get them, but not as bad.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and had shingles. The patient stated that he/she feel your pain as shot did not help and still, he/she get them, but not as bad and also stated 10 years of these devils. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster 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: Only know 2 people that had shingles and one is a vaccinated nurse /Suspected vaccination failure; Only know 2 people that had shingles and one is a vaccinated nurse; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The patient was a vaccinated nurse. The age at vaccination was not reported. The reporter stated that he/she know the patient had shingles. The reporter stated that almost everybody had chicken pox back in his/her youth. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. This case had been linked with US2021AMR111296, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR111296:Same reporter. Patient 1.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got them/I had that shot too got them . not fun , got the Two ones / Suspect vaccination failure; I got them/I had that shot too got them . not fun , got the Two ones; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and had shingles. The patient stated that he/she had that shot too and still got them, not fun and mentioned he/she got the two ones now they had to pay for each shot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Osteoarthritis
Clinical narrative: Osteoarthritis has been worse; This case was reported by a consumer via interactive digital media and described the occurrence of osteoarthritis aggravated in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included osteoarthritis.   On 21st May 2021, the patient received Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced osteoarthritis aggravated. On an unknown date, the outcome of the osteoarthritis aggravated was not recovered/not resolved.   It was unknown if the reporter considered the osteoarthritis aggravated to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that since they had received the vaccine on Friday, their osteoarthritis had been worse. The patient was questioning if it would continue and also if it was normal.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Developed blister-like eruptions on the trunk / which have not resolved; Developed blister-like eruptions on the trunk / which have not resolved; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 394KF, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 13th January 2021, refer case US2021111511).   On 29th April 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 6th May 2021, 7 days after receiving Shingrix, the patient experienced blister and eruption. On an unknown date, the outcome of the blister and eruption were not recovered/not resolved.   It was unknown if the reporter considered the blister and eruption to be related to Shingrix.  Additional details were reported as follows: The patient experienced blister-like eruptions on the trunk of her body. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021111511:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: nerve damage from past and shot caused more pain; Had all the reactions from shot except nausea; This case was reported by a consumer via media and described the occurrence of exacerbation of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in the past twice). Concurrent medical conditions included nerve damage (had from past shingles) and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced exacerbation of pain and nausea. On an unknown date, the outcome of the exacerbation of pain and nausea were unknown.   The reporter considered the exacerbation of pain to be related to Shingles vaccine. The reporter considered the nausea to be unrelated to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she just got the Shingles shot and himself/herself having shingles in the past twice and had nerve damage from past and shot caused more pain. The patient stated that he/she had all the reactions (unspecified) from Shingles shot except nausea. The follow-up would not possible as no contact details were available.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Tired; This case was reported by a consumer via other manufacturer and described the occurrence of tiredness in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included intervertebral disc protrusion, spondylitis, inguinal hernia and clot blood. Concurrent medical conditions included sarcoidosis, blood pressure high, blood cholesterol increased, looked pale, dizziness, numbness and multiple sclerosis relapse. Concomitant products included ocrelizumab (Ocrevus), brimonidine tartrate + timolol maleate (Combigan), travoprost (Travatan), rivaroxaban (Xarelto), rosuvastatin calcium (Crestor), ezetimibe (Zetia), ambiguous medication nos (Provigil (Nos)), tizanidine hydrochloride, hydrochlorothiazide (Hydrochloorthiazide), lisinopril and gabapentin.   On 22nd March 2021, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were reported as follows: No further information was reported. Consent to follow up was not asked.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Laboratory test, Vaccination failure
Clinical narrative: Had bad flu once ... AFTER VACCINATION/Suspected vaccination failure; Had bad flu once; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received flu vaccine and had bad flu once. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.; Sender's Comments:  DE-GLAXOSMITHKLINE-DE2021EME111766:
Sex: U
Vaccine: MENB, MENB, MENB
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Our baby got Bexsero vaccines 3 times; Our baby got Bexsero vaccines 3 times instead of 2; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device, the 2nd dose of Bexsero, Bexsero Pre-Filled Syringe Device, the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the patient's parent. The age at vaccination was not provided. The reporter stated that, patient received Bexsero vaccines 3 times instead of 2 because they moved to another country, which led to inappropriate age at vaccine administration and extra dose administered. No further information was reported.   Note-As no age was reported for the patient and as only baby was reported, hence conservatively inappropriate age at vaccine administration was captured as event
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got her Shingrix more than a year ago/ does the dose today count as second; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose more than a year ago from the time of reporting).   On 24th May 2021, the patient received the 2nd dose of Shingrix. On 24th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient got her 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter asked did the dose given on the day of reporting count as second or should the series be restarted.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; 1st thing I thought of was shingles / What are the possibilities that this could be shingles?; Hand size burning sensation near my lower ribs / Burning right lower ribs on torso; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and burning sensation. On an unknown date, the outcome of the vaccination failure, shingles and burning sensation were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and burning sensation to be related to Shingrix and Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient had chicken pox. The patient woke up this morning with a hand size burning sensation near my lower ribs on the right side lower ribs on torso. The patient thought of it was shingles. The patient asked what were the possibilities that this could be shingles? This case should be considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Female patient received the portion only of Shingrix / diluent portion only; Female patient received the portion only of Shingrix / diluent portion only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 34SD3, expiry date 15th November 2022) for prophylaxis.   On 19th May 2021, the patient received Shingrix. On 19th May 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the portion only diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received a single dose in February 2020. Does the patient need to restart the series; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose in February 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not received second dose of Shingrix which led to incomplete course of vaccination. The reporter asked if the patient need to restart the series. No further details provided via web form. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Customer / received / first dose greater than a year ago / has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The health care professional did not have more information. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021111509:Same reporter.
Sex: F
Vaccine: MENB
Symptoms: Headache, Incorrect dose administered, Pyrexia
Clinical narrative: Experienced a headache; Experienced / fever; This case was reported by a physician via sales rep and described the occurrence of headache in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced headache and fever. Bexsero was discontinued. On an unknown date, the outcome of the headache and fever were unknown.   It was unknown if the reporter considered the headache and fever to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The age at vaccination was not reported however the patient was teenager at the time of vaccination. The patient's parents declined her receiving the 2nd dose due to the adverse events. The reporter consented to follow up. The field reptrsesntative was late in calling because she became ill and was not able to call for the adverse event report until the day of reporting.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Extra dose administered, Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Administration of a first dose of Kinrix to a patient; Administration of a second dose of Kinrix to a 4 month old female patient; Administration of a second dose of Kinrix to / patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number Z9MZ2, expiry date 3rd December 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th May 2021, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 24th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device and not applicable after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and extra dose administered. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported for the 1st dose of Kinrix. The reporter stated that the 4 months old patient received Kinrix, which led to inappropriate age at vaccine administration. The patient was vaccinated with 2 doses of Kinrix, which led to extra dose administered. No further events were reported. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / on 2019 and the second dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: Age at vaccination was not applicable for this report. The pharmacist informed that the patient received the first dose of Shingrix on 2019 and the second dose was not administered till the time of reporting which led to incomplete course of vaccination.  The reporter did not consent to follow-up The reporter did not provide patient's identifiers nor vaccine lot number and expiration date.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo was given with a different diluent than supplied in the box; Menveo was given with a different diluent than supplied in the box; This case was reported by a medical representative via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that Menveo was given with a different diluent than supplied in the box, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. There was no more information about it. The reporter did not consent to follow-up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Joint swelling, Oedema, Peripheral swelling
Clinical narrative: general pain at the injection site; experienced edema; has swelling in her fingers and between her knees and ankles; knee swelling/ ankle swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site pain, edema, swelling of fingers and swelling of knees. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the edema, swelling of fingers and swelling of knees were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, edema, swelling of fingers and swelling of knees to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient herself. The patient received 1st dose of Shingrix and 2 months after receiving the injection, she experienced edema. The patient claimed that she had swelling in her fingers and between her knees and ankles that was still unresolved. The patient also experienced general pain at the injection site. The reporter consented to follow up directly with him or her health care professional.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient may have received a dose / that was incorrectly reconstituted with sterile water /believed it  was the patient's 1st dose; patient may have received a dose / that was incorrectly reconstituted with sterile water /believed it  was the patient's 1st dose; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date 31st July 2022) for prophylaxis.   On 19th May 2021, the patient received the 1st dose of Menveo. On 19th May 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The patient might had receive the 1st dose of Menveo that was incorrectly reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No symptoms reported. The reporter consented to follow up. This case was one of the 3 linked cases, reported by the same reporter. The batch number was reported as AMXA379A for Menveo which was updated to AMVA379A as per sales data sheet.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021111535:Same Reporter, different pateint (3)
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient may have received a dose / that was incorrectly reconstituted with sterile water; patient may have received a dose / that was incorrectly reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date 31st July 2022) for prophylaxis.   On 19th May 2021, the patient received the 1st dose of Menveo. On 19th May 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received menveo that was incorrectly reconstituted with sterile water, which led wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No symptoms were reported. There were 3 possible patients, but the health care professional was not sure which 2 received the incorrectly reconstituted doses. The reporter consented to follow up. This case was linked case US2021111533 and US2021111535 reported by the same reporter. The batch number was reported as AMXA379A for Menveo which was updated to AMVA379A as per sales data sheet.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021111535:Same reporter US-GLAXOSMITHKLINE-US2021111533:Same Reporter
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient may have received a dose / that was incorrectly reconstituted with sterile water; patient may have received a dose / that was incorrectly reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 10-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date 31st July 2022) for prophylaxis.   On 17th May 2021, the patient received the 1st dose of Menveo. On 17th May 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received menveo which was incorrectly reconstituted with sterile water which led wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No symptoms reported. The reporter mentioned that, they were 3 possible patients but the HCP was not sure which 2 received the incorrectly reconstituted doses. The batch number was reported as AMXA379A for Menveo which was updated to AMVA379A as per sales data sheet. The reporter consented to follow up. This case was linked case US2021111533 and US2021111534,  reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021111534:Same Reporter US-GLAXOSMITHKLINE-US2021111533:Same Reporter