chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Within approximately 24 hours signs of allergic hives began to appear.  First, ears turned red and itchy.  Next, arms began becoming covered with hives.  The hives moved and spread.  Eventually, over the next 24-hour period, the hives became progressively worse covering at least 50 percent of the body.  The back, chest, were involved.  The face became red.  Then treatment began.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AEs; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report has been received from a healthcare worker referring a 4-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 27-AUG-2022, the patient was vaccinated with one dose of an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis, lot number W004504 with expiration date 16-JUN-2023 or lot number W002562 with expiration date 12-OCT-2023.  (Healthcare worker did not specify which actual lot number the patient received) (strength, dose, frequency and route of administration not provided) (product storage error).  The administered dose of the vaccine experienced a temperature excursion of 11.3 degrees Celsius (C) for 34 minutes; no previous temperature excursion happened. There was no adverse effect reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events were reported; The healthcare worker reported that a patient received improperly stored vaccine.  The patient received only one dose but the healthcare worker did not specify which actual lot the patient received.  No additional AEs were reported, no further inform; This spontaneous report has been received from a health care professional, concerning a 6-months-old patient of unknown gender.  The patients' medical history, concurrent conditions, concomitant medications, previous drug allergies, and reactions were not provided.  On 25-AUG-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), once, for prophylaxis, the reported did not specify which lot number received it could be either the (lot number W004504 has been verified to be valid; expiration reported and established as 16-JUN-2023, or lot number W002562 has been verified to be valid; expiration reported and established as 12-OCT-2023) (dosage, vaccination scheme, and route of administration were not provided) (product storage error). The patient received only one dose.   The administered dose of the vaccine was stored at a temperature of 11.3 degrees Celsius (C), during a time frame of 34 minutes. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA001469:MSD
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report has been received from a healthcare worker referring a 7-week-old patient of unknown gender. The patient'spertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 01-SEP-2022, the patient was vaccinated with one dose of an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis, lot number W004504 with expiration date 16-JUN-2023 or lot number W002562 with expiration date 12-OCT-2023.  (Healthcare worker did not specify which actual lot number the patient received) (strength, dose, frequency and route of administration not provided) (product storage error).  The administered dose of the vaccine experienced a temperature excursion of 11.3 degrees Celsius (C) for 34 minutes; no previous temperature excursion happened. There was no adverse effect reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse events were reported; The healthcare worker reported that a patient received improperly stored vaccine.  The patient received only one dose but the healthcare worker did not specify which actual lot the patient received.  No additional AEs were reported, no further inform; This spontaneous report has been received from a health care professional, concerning a 9-weeks-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant medications, previous drug allergies, and reactions were not provided.  On 30-AUG-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), once, for prophylaxis, but the healthcare worker did not specify which actual lot the patient received (it could be either the lot(lot number W004504 has been verified to be valid; expiration reported and established as 16-JUN-2023, and lot number W002562 has been verified to be valid; expiration reported and established as 12-OCT-2023) (dosage, vaccination scheme, and route of administration were not provided) (product storage error). The patient received only one dose.   The administered dose of the vaccine was stored at a temperature of 11.3 degrees Celsius (C), during a time frame of 34 minutes. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA001450
Age: 2.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Product storage error
Clinical narrative: no additional adverse event; The healthcare worker reported that a patient received improperly stored vaccine.  The patient received only one dose but the healthcare worker did not specify which actual lot the patient received the vaccine.  No additional AEs were reported, no fu; This spontaneous report was received from a health care worker concerning a 2-year-old patient of unknown gender.  The patient's medical, concurrent conditions and concomitant therapies were not reported.   On 24-AUG-2022, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W003118, expiration date: 13-JUL-2023, or lot #W015191, expiration date: 27-OCT-2023, administered as prophylaxis (strength, and route of administration were not provided) (product storage error). The patient received only one dose but the reporter did not specify which actual lot # the patient received.    It was reported that the vaccines were stored at a temperature of 11.3 Celsius degrees for 34 minutes. No previous temperature excursions and no additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 54 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U032852 with expiration date 20-OCT-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 54 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U032852, expiration date 20-OCT-2023) administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 54 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U032852 with expiration date 20-OCT-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 54 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U032852, expiration date 20-OCT-2023) administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; A dose of PROQUAD was administered after a temperature excursion; This spontaneous report has been received from a Physician referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 31-AUG-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot number: W017570 with expiration date: 29-NOV-2023, administered for prophylaxis (strength and route of administration not provided) (product storage error) , which had temperature excursion between 5.7F for 0 hours 30 minutes and 0 seconds, 6F up to 14F (9.1F} for 1 hour 6 minutes and 0 seconds.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A dose of VARIVAX was administered after a temperature excursion; This spontaneous report has been received from a Physician referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 02-SEP-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number: W002601 with expiration date: 24-JAN-2024, administered for prophylaxis (strength and route of administration not provided) (product storage error) which had temperature excursion between 5.7F for 0 hours 30 minutes and 0 seconds, 6F up to 14F (9.1F} for 1 Hour 6 Minutes and 0 seconds and 6F up to 14F {10F) for 1 hour 8 minutes 0 seconds. No additional adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: no adverse event; patient was administered an expired dose of VARIVAX; This spontaneous report was received from a registered pharmacist and referred to an unknown age and gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 15-SEP-2022, the patient was administered an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot #T009587, expiration date: 18-MAR-2022, administered for prophylaxis (strength and route of administration were not provided) (expired product administered). The reporter confirmed vaccines was stored at the recommended storage range until administration and not involved in any temperature excursions. No additional event was reported (no adverse event).
Sex: U
Vaccine: PNC13, PPV
Symptoms: Immunodeficiency
Clinical narrative: immunocompromised condition; This spontaneous report was received from a nurse via Pfizer and refers to an elderly (age reported as "65+") patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown dates, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (exact dose, route of administration, anatomical location, lot #, and expiration date were not reported) and pneumococcal vaccine conj 13V (CRM197) (PREVENAR 13) (exact dose, formulation, route of administration, anatomical location, lot #, and expiration dates were not reported), both for prophylaxis.  On an unspecified date, the patient developed immunocompromised condition. The outcome of the event was not reported.  The causality between the event and the suspect vaccines was not provided.  Upon internal review, the event of immunodeficiency was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: other zoster-related conditions; shingles; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On or about 07-NOV-2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the long-term prevention of shingles (herpes zoster) and for zoster-related conditions (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered shingles (herpes zoster) and zoster-related conditions (ill-defined disorder). As a result of those symptoms, the pt was seen and treated by a physician. Further, the pt had suffered and would continue to suffer ongoing injuries including but not limited to: mental and physical pain and suffering; medical care and treatment for those injuries; significant medical and related expenses as a result of those injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was unknown. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported.; administration of improperly stored STERILE DILUENT vials to reconstitute MMR II.; This spontaneous report was received from a nurse (also reported as medical assistant) referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On an unknown date, sterile diluent experienced temperature excursion with -20.4 Celsius degrees for 109 hours.   On 17-SEP-2022, the patient received the improperly stored sterile diluent vials (0.7 mL, lot # U034540, expiration date: 15-MAY-2024; strength, dose, frequency and route of administration were not reported) to reconstitute measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis (product storage error). No additional adverse events (AEs) or product quality complaints (PQCs) were reported.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; received RECOMBIVAX HB via subcutaneous route instead of intramuscular route; This spontaneous report was received from a nurse referring to a 18 year old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 21-SEP-2022, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) via subcutaneous route today instead of intramuscular route (0.5 ml, lot number U001837 which was determined to be valid, with expiration date: 21-NOV-2022) for prophylaxis (incorrect route of product administration). No additional adverse event (AE) information was provided.
Age: 35.0
Sex: F
Vaccine: FLUN4
Symptoms: Lymphadenopathy, Oropharyngeal pain
Clinical narrative: SORE THROAT; SWOLLEN LYMPH NODE ON LEFT SIDE; MISUNDERSTOOD IFU AND ADMINISTERED FLUMIST QUADRIVALENT DEMO DEVICE INTO BILATERAL NARES; A spontaneous report has been received from a pharmacist. The report concerns a female patient (age 33 years).    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown) unknown, via nasal route, on 24-AUG-2022.     A Health Professional administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.    The report described a medication error for Flumist Quadrivalent. The reported term was misunderstood ifu and administered flumist quadrivalent demo device into bilateral nares (Preferred term: Wrong technique in device usage process).     On 24-AUG-2022, the patient experienced sore throat (preferred term: Oropharyngeal pain) and swollen lymph node on left side (preferred term: Lymphadenopathy).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v).     The patient recovered from the event(s) of misunderstood ifu and administered flumist quadrivalent demo device into bilateral nares on 24-AUG-2022. At the time of reporting, the event of sore throat and swollen lymph node on left side was ongoing.     The events were considered non-serious.     The reporter considered that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following event: misunderstood ifu and administered flumist quadrivalent demo device into bilateral nares.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Still fighting shingles in eye; Broke out with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster 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 ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster was not recovered/not resolved and the outcome of the shingles was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received dose of Shingles vaccine and the next day he/she broke out with shingles still fighting it in his/her eye one year later. The patient stated that do not get the vaccine whatever you do. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Heat therapy, Muscle strain, Vaccination failure
Clinical narrative: Got shingles shots, got it (shingles) on thighs/Suspected vaccination failure; Got it (shingles) on thighs; Thought had pulled muscle; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (sister in law got it on her stomach and back andwasn't able to move.) and 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), shingles and pulled muscle. The patient was treated with non-drug therapy (Heat Therapy). On an unknown date, the outcome of the vaccination failure, shingles and pulled muscle were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pulled muscle to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's Comment: This case was reported by a consumer via  interactive digital media. The reporter reported that it was an awful place to had shingles. The reporter's sister in law did not received Shingles vaccine and experienced shingles on stomach and back was not able to move. The reporter's girlfriend's mom got shingles on her face. The reporter husband got shingles on his thighs and he thought he had pulled muscle from doing yard work and put deep heat.  Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. In the narrative it was stated that So glad you recovered' but its not clear if the patient was recovered or not hence outcome was kept unknown.  This is 1 of 3 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR134884:Same reporter/ master case US-GSK-US2022AMR134931:Same reporter/ invalid case
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot, ended up with shingles /Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's comment: This case was reported by the patient's friend via interactive digital media. The reporter stated that the patient got the shingles shot and ended up with getting shingles anyway. Additional supportive information: Follow-up would not possible, as no contact, details were available. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was reported at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: I'm fighting that in my eye now. I had the vaccine/ Suspected vaccination failure; I'm fighting that in my eye now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-Sep-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient was fighting that (shingles) in his/her eye now.  The patient had the vaccine. It was almost cleared up with lots of treatments. Additional Supportive Information: 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: Incomplete course of vaccination
Clinical narrative: I totally forgot, I never had the second shot; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose at the beginning of Covid).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-SEP-2022 Reporter's Comment: The patient stated shortly after that his/her elderly mother moved in etc. and patient totally forgot that and never had second shot. The patient asked what to do now.  The patient reported that it's been three years and asked did he/she start from scratch. The patient asked to pharmacist and got two different answers. Additional Supportive Information: 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 would not possible, as no contact details were available.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: Bad pain around the site of the rejection; Redness around the injection site; Chills; Sweating; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2022, the patient received Shingrix. In September 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, chills and sweating. On an unknown date, the outcome of the injection site pain, injection site erythema, chills and sweating were not recovered/not resolved.   The reporter considered the injection site pain, injection site erythema, chills and sweating to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-SEP-2022 Reporter's Comment: This case was reported by the patient. The patient had the Shingrix vaccine 2 days ago.  The patient had the side effects from the vaccine. The patient had bad pain around the site of the injection. The patient had chills overnight and sweating last night.  At the time of reporting, the 3rd day he/she was having redness around the injection site still. The reporter just wanted to know if it was normal or he/she was having a bad reaction.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Tingling sensation in arm and leg; This case was reported by a physician via other and described the occurrence of tingling of extremity in a 37-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number B4C44, expiry date 10th November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 15th September 2022, less than a day after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced tingling of extremity. On an unknown date, the outcome of the tingling of extremity was unknown.   It was unknown if the reporter considered the tingling of extremity to be related to Boostrix and Boostrix 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 Information: GSK Receipt Date: 16-SEP-2022 Reporter's Comments:  The reporter stated that a patient was injected with tdap (immunization), they started experiencing a tingling sensation in their arm and leg.  The reporter mentioned no initial/follow up treatment was provided as they physician was continuing to monitor the patients' health. The patient had no allergies.  The reporter stated that this was the first time it occurred.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain at the site where had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles last year in 2021).   In September 2022, the patient received Shingles vaccine. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-SEP-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter was a consumer who had stated he/she was experiencing pain at the site where had shingles last year, following shot this week. Additional supportive information: Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness; Swelling; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown.   It was unknown if the reporter considered the erythema and swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient experienced redness and swelling after Shingrix shot. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: TTOX, VARZOS
Symptoms: Bone pain, Pyrexia
Clinical narrative: bone pain; Fever; This case was reported by a consumer via interactive digital media and described the occurrence of bone pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   On 15th September 2022, the patient received Shingles vaccine and TETANUS VACCINE. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced bone pain and fever. On an unknown date, the outcome of the bone pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the bone pain and fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date:16-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. Reporter stated that patient's bones hurts so bad and had fever. Yesterday patient had the shingles vaccine and the tetanus vaccine at the same time. Additional supportive information: The follow up would not possible as no contact details were available. It was unknown if the reporter considered the bone pain and fever to be related to TETANUS VACCINE.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: slightly sore arm at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site 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, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-SEP-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient received a dose of Shingles vaccine into unknown arm and experienced slightly sore arm at the injection site.  Additional Supportive Information: The follow-up would not possible as no contact details were available.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo reconstituted with sterile water; Menveo reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA728A, expiry date 30th September 2023) for prophylaxis.   On 12th September 2022, the patient received Menveo. On 12th September 2022, 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 Information: GSK Receipt Date: 16-SEP-2022 Reporter's Comment: The nurse reported that the patient received a dose of Menveo that was inadvertently reconstituted with sterile water instead of the liquid component. No further details provided during call. The reporter consented to follow up. Additional Supportive Information: The nurse reported that the patient inadvertently received Menveo which was reconstituted with sterile water instead of the liquid component, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Hypoaesthesia, Influenza like illness, Insomnia
Clinical narrative: finger tips were numb; "can't sleep"/ she couldn't sleep; flu-like symptoms; fever twice 101.8; muscle aches; queasy/queasiness; teeth chattering; Sweating (diaphoretic); This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis. Concomitant products included meloxicam.   On 9th September 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 10th September 2022, 1 days after receiving Shingrix, the patient experienced fever, muscle pain and queasy. On 11th September 2022, the patient experienced numbness in fingers, sleeplessness and influenza-like symptoms. In September 2022, the patient experienced teeth chattering and sweating. The patient was treated with paracetamol (Tylenol) and ibuprofen. On an unknown date, the outcome of the fever, teeth chattering, muscle pain, queasy, numbness in fingers, sweating, sleeplessness and influenza-like symptoms were unknown.   It was unknown if the reporter considered the fever, teeth chattering, muscle pain, queasy, numbness in fingers, sweating, sleeplessness and influenza-like symptoms to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-SEP-2022 Reporter's Comment: The patient reports she received 2nd dose on left arm.  She stated that on the next day, she had experienced a fever (twice) 101.8 degree Fahrenheit, muscle aches, queasiness.  Two days after receiving vaccination, she stated she could not sleep, had flu-like symptoms and finger tips were numb.  She had gone to urgent care, tested negative for COVID, and was recommended to take tylenol and Ibuprofen.  She had mentioned that she was also on Meloxicam for her arthritis.  She had read about Guillain-Barre syndrome and had decided to call GlaxoSmithKline (GSK). The reporter had consented to follow-up. Additional supportive information: The time taken to onset for event - Teeth chattering, Sweating was conservatively captured as Less than a week and for event - numbness in fingers, sleeplessness and influenza-like symptoms was captured as 2 days. The temperature for fever was also considered as degree Fahrenheit conservatively as per the reported verbatim.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: finger tips were numb; "can't sleep"/ she couldn't sleep; flu-like symptoms; fever twice 101.8; muscle aches; queasy/queasiness; teeth chattering; Sweating (diaphoretic); This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis. Concomitant products included meloxicam.   On 9th September 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 10th September 2022, 1 days after receiving Shingrix, the patient experienced fever, muscle pain and queasy. On 11th September 2022, the patient experienced numbness in fingers, sleeplessness and influenza-like symptoms. In September 2022, the patient experienced teeth chattering and sweating. The patient was treated with paracetamol (Tylenol) and ibuprofen. On an unknown date, the outcome of the fever, teeth chattering, muscle pain, queasy, numbness in fingers, sweating, sleeplessness and influenza-like symptoms were unknown.   It was unknown if the reporter considered the fever, teeth chattering, muscle pain, queasy, numbness in fingers, sweating, sleeplessness and influenza-like symptoms to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-SEP-2022 Reporter's Comment: The patient reports she received 2nd dose on left arm.  She stated that on the next day, she had experienced a fever (twice) 101.8 degree Fahrenheit, muscle aches, queasiness.  Two days after receiving vaccination, she stated she could not sleep, had flu-like symptoms and finger tips were numb.  She had gone to urgent care, tested negative for COVID, and was recommended to take tylenol and Ibuprofen.  She had mentioned that she was also on Meloxicam for her arthritis.  She had read about Guillain-Barre syndrome and had decided to call GlaxoSmithKline (GSK). The reporter had consented to follow-up. Additional supportive information: The time taken to onset for event - Teeth chattering, Sweating was conservatively captured as Less than a week and for event - numbness in fingers, sleeplessness and influenza-like symptoms was captured as 2 days. The temperature for fever was also considered as degree Fahrenheit conservatively as per the reported verbatim.
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Lip erythema, Oral mucosal eruption
Clinical narrative: rash in mouth, gums and lips; rash in mouth, gums and lips; lips turned red due to rash; This case was reported by a consumer via call center representative and described the occurrence of rash mouth in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingrix. In September 2022, less than a week after receiving Shingrix, the patient experienced rash mouth, lip redness and rash lips. On an unknown date, the outcome of the rash mouth, lip redness and rash lips were recovered/resolved.   It was unknown if the reporter considered the rash mouth, lip redness and rash lips to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-Sep-2022 Reporter's comment: This case was self reported by patient. The patient received first dose of Shingrix 2 weeks ago.  The patient states that a day or two after the dose, the patient developed a rash in her mouth, which extended into her gums and over her lips.  The patient also stated that lips turned red due to the rash.  The rash resolved on its own after 4 or 5 days. The reporter consent to follow up. Additional supportive information: This case had been linked with US2022133814, reported by same reporter.; Sender's Comments:  US-GSK-US2022133814:Same reporter
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo  reconstituted with sterile diluent; 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 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date unknown) for prophylaxis.   On 20th September 2022, the patient received Menveo. On 20th September 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received Menveo vaccine which was reconstituted with a non-GlaxoSmithKline supplied diluent (Sterile diluent), which led to wrong solution used in drug reconstitution.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose less than 4 weeks apart from 1st dose; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 4-year-old male patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number J7C77, expiry date 26th February 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On an unknown date, the patient received the 2nd dose of FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The patient received 2nd dose of flulaval less than 4 weeks apart from the 1st dose. The reporter consented to follow-up.  Additional supportive information: The patient received 2nd dose of Flulaval earlier than the recommended interval, which led to shortening of vaccine schedule.
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy
Clinical narrative: patient in third trimester of pregnancy received Fluarix; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 53Y2G, expiry date 30th June 2023) for prophylaxis.   On 20th September 2022, the patient received Fluarix Quadrivalent 2022-2023 season. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2022-2023 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The nurse practitioner reported that the patient who was in her third trimester of pregnancy, received Fluarix on the day of reporting (season and formulation not reported). The reporter (also a GlaxoSmithKline employee) reported that suspect product was reported as Fluarix only with lot number and expiration date (season was not reported).  No general option for Fluarix was available, hence product was selected with one or the available options in the system. The reporter consented to follow-up. Additional supportive information: The patient received Fluarix during pregnancy, which led to vaccine exposure during pregnancy.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 11Sep2018, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11th September 2018).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The pharmacist reported that the patient was at the office to receive the 2nd dose of Shingrix. The reporter asked that does the patient need to restart the whole series or complete it with 2nd dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue, Single component of a two-component product administered
Clinical narrative: Menveo administered without reconstitution; Menveo administered without reconstitution; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA724Z, expiry date 30th September 2023) for prophylaxis.   On 14th September 2022, the patient received Menveo. On 14th September 2022, unknown after receiving Menveo, 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 Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The nurse reported that a new staff member administered a dose of Menveo to the patient without reconstituting with the powder portion. Therefore, the patient only received the liquid CYW component of the vaccine. At the time of reporting, the dose has not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. This case is for 1 of 2 linked patients, reported by same reporter. Additional supportive information: The patient received only liquid CYW component of Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022135068:Same reporter