chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Disability, Neuropathy peripheral, Pain in extremity
Clinical narrative: neuropathy in feet and in lower limbs; This spontaneous report was received from a physician assistant, referring to a 12-year-old female patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.   On an unknown date in August 2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis.    On an unknown date in August 2021 (also reported as about a month ago), the patient experienced pain and neuropathy in feet and in lower limbs and the patient was hospitalized for 2x weeks. The patient had experienced significant disability for 2x weeks.The outcome of the event was unknown. The reporter did not think this event was Guillain-Barre syndrome.  The reporter considered the event of pain and neuropathy in feet and in lower limbs to be not related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).     Upon internal review, the event of pain and neuropathy in feet and in lower limbs was determined as hospitalization, medically significant and disability. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the GARDASIL 9 vaccine and the reported event of neuropathy peripheral cannot be established. Additional information regarding patient's medical history, concurrent conditions, concomitant medications, vaccination/event onset date, additional clinical details, diagnostic evaluation and follow up is needed for a proper assessment.  Company Comment- No changes to the product safety information are warranted at this time. Continues to monitor the safety profile of the product.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A dose of improperly stored PEDVAXHIB was administered; This spontaneous report as received from an office manager, refers to a patient of unknown age and gender. Information regarding the patient's medical history and concomitant medications was not provided.   The reporter stated that between 15-OCT-2021 to 18-OCT-2021, 11 below temperature excursions occurred for haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB). On 18-OCT-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (strength ad route of administration were not reported; lot # T026962 and expiration date of 06-APR-2023) 0.5 mL, for prophylaxis (product storage error). The reporter was unable to provide the minimum temperature reached and the total temperature excursion time for each excursion. No additional Adverse Events were reported.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Drug dose administration interval too short; This spontaneous report was received from a nurse and refers to a 20 year old male patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 12-AUG-2021, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number U006800, expiration date 28-APR-2023 intramuscularly, and on 20-AUG-2021, he received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly by error for prophylaxis (inappropriate schedule of product administration).
Sex: M
Vaccine: PPV
Symptoms: Skin laceration, Syringe issue
Clinical narrative: Cut his finger requiring a bandaid; One of the two finger flanges broke off; This spontaneous report was received from a Licensed Practical Nurse, refers to a male patient, who was a physician of unknown age. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided.      On 28-SEP-2021, the physician administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), with lot # U003306 has been verified to be a valid lot number and expiration date on 15-OCT-2022 to a patient (captured in MARRS # 2109USA007035) for prophylaxis.  While administration, one of the two finger flanges of  the vaccine broke off (syringe issue), which caused a cut on his finger requiring a band aid (skin laceration). The vaccine was administered to the patient.  The physician disposed pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe into sharp container. Product was not able to be retrieved.  At the time of the report, the outcome of skin laceration was unknown. Causality between the event skin laceration and vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.  This is one of two cases received by the same reporter. ; Sender's Comments:  US-009507513-2109USA007035:
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: ocular shingles; shingles; Information has been received regarding a case in litigation from a lawyer referring to a currently 69 years old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 07-JAN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) at a health center for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a healthcare provider (HCP) and sought additional treatment by another HCP at a clinic for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles and ocular shingles. The outcome of the events was unknown.  Upon internal review, ocular shingles was determined to be medically significant.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer referring to a currently 75 years old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 10-AUG-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) at a clinic for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a healthcare provider (HCP) for the following injury resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of the event was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 09-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T041687 expiration date 10-DEC-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2110USA005066:
Sex: U
Vaccine: HEP
Symptoms: Asthenia, Fatigue, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Sweating; Weakness; Fever of At Least 99.4; Exhaustion; Headache; Initial Report Received on 05-Aug-2021 and 03-Sep-2021  A 30 year-old male patient (race and ethnicity not provided) in the US (CT) reported fever, sweating, weakness, exhaustion, and a headache the day after receiving a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Relevant medical history included asthma, hemorrhoids, and irritable bowel syndrome symptoms.   Relevant concomitant medications included vitamin D, magnesium, ibuprofen, multivitamin, and oral steroids (unspecified).  On or around 30-Jun-2021, the patient received the first HEPLISAV-B injection (Lot #, expiration date, NDC #, and site not available). He woke up the next day with a fever of at least 99.4 degrees Fahrenheit with sweating, weakness, exhaustion, and a headache. The fever resolved by the time he got to his doctor's appointment that day; the weakness, exhaustion, and headache all resolved by the next day.   On an unspecified date, the patient received the second dose of HEPLISAV-B injection (Lot #, expiration date, NDC #, and site not available).  No further information was provided.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine to patient
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Erythema, Headache, Insomnia
Clinical narrative: Fever (102*), all skin turned bright red and felt like a sunburn, nausea with vomiting, body aches, chills, insomnia, headache, extreme joint pain; especially in joints with previous arthritis. 36 hour duration.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever (102*), all skin turned bright red and felt like a sunburn, nausea with vomiting, body aches, chills, insomnia, headache, extreme joint pain; especially in joints with previous arthritis. 36 hour duration.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine to patient
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine to patient
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine to patient
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine to patient.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine to patient
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine to patient.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine to patient
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine to patient
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both shingles vaccinations, still gotten very mild cases; shingles, very mild cases; This case was reported by a consumer via (Facebook) interactive digital 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 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). 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 provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had both shingles vaccinations and still gotten very mild case of shingles. The patient stated he/she received the anti-viral as soon as had any signs of getting shingles again. The patient stated he/she could not imagine how awful a full-blown case. The follow-up would not possible as no contact details were available. The question was asked had physician not given the antiviral? Valacyclovir was what should be taking and using the cream. It would help a lot. 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, VARZOS
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: received doses that were impacted by the voluntary recall; received doses that were impacted by the voluntary recall; received doses that were impacted by the voluntary recall; received doses that were impacted by the voluntary recall; This case was reported by a pharmacist via call center representative and described the occurrence of recalled drug administered in a patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced recalled drug administered, drug dispensing error, recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered, drug dispensing error, recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received both the doses of Shingrix from recalled batch in the clinic, which led to recalled drug administered and drug dispensing error. The reporter asked if the patient need to be revaccinated. No further details provided on the call. The specialist neglected to note potential event during call, and thus limited details were obtained, and specialist neglected to ask whether safety had permission to follow up. This case was linked with case US2021AMR213388 and US2021212537 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021212537:same reporter US-GLAXOSMITHKLINE-US2021AMR213388:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both shingrix vaccines in 2019, got shingles 10 days ago/ Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital 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.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In October 2021, more than a year after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. In 2019, the patient received both the doses of Shingrix vaccine and 10 days before the date of reporting, the patient experienced shingles. The patient stated that he/she was at the tail end or middle of a shingles break out. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Sensitive in lymph nodes; This case was reported by a other health professional via sales rep and described the occurrence of lymph node disorder 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 lymph node disorder. On an unknown date, the outcome of the lymph node disorder was unknown.   It was unknown if the reporter considered the lymph node disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Health care professional reported that the patient received Shingrix vaccine and had sensitive in his/her lymph nodes.
Sex: M
Vaccine: TDAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: was given it during a surgery, came down with whooping cough/ suspected vaccination failure; whooping cough; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Concurrent medical conditions included surgery.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown.   It was unknown if the reporter considered the vaccination failure and whooping cough to be related to Tdap Vaccine.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received Tdap vaccine during a surgery and he came down with whooping cough. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for whooping cough and time to onset was unknown. This case was linked with the case US2021AMR214222 (wife's case), reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR214222:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had them in mouth; This case was reported by a consumer via interactive digital 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 herpes zoster. On an unknown date, the outcome of the vaccination failure and herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had the shingles shot and experienced shingles in mouth. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 53-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received first dose of Shingles and had no issues except a sore arm for a few days. For tolerance refer case US2021AMR214985, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR214985:same reporter, second dose
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Fluarix exposed to freezing temperature was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 27-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR215097:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215096:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215095:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215094:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215093:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215098:Different patient, same reporter US-GLAXOSMITHKLINE-US2021214412:Different patient, same reporter
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Fluarix exposed to freezing temperature was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 29-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR215096:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215097:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215095:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215094:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215098:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215092:Different patient, same reporter US-GLAXOSMITHKLINE-US2021214412:Different patient, same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: their first shot more than six months ago; This case was reported by a other health professional via interactive digital media 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 first shot on an unknown date more than six months 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, the patient did not receive the second dose, which led to incomplete course of vaccination. The reporter wanted to know what should he/she advise his/her patient if they received their first shot more than six months ago.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Misses the 6 month second shot schedule; This case was reported by a other health professional via interactive digital media 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 on an unknown date).   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. The reporter asked if the patient missed the 6-month second shot schedule, did they need to have two more shots. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: covid-19 came never received my 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Original Shingles vaccine (had gotten the original 1 shot).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient self reported this case. The age at the vaccination was not applicable. The patient received 1st Shingrix shot about the time COVID-19 came into country so never received his/her 2nd shot within 6 months, which led social problem. Till the time of reporting, it had been 12 + months since 1st shot,  so the patient enquired if he/she could still get the booster shot.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles on face, neck, chest and nose; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 details were provided as follows: The patient was the reporter's daughter. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got mild shingles on face, neck, chest and nose. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: F
Vaccine: TDAP
Symptoms: Near death experience
Clinical narrative: almost killed my youngest daughter; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   On an unknown date, the patient received dTpa vaccine. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to dTpa vaccine.  Additional details were provided as follows: This case was reported by the patient's parent. The age at vaccination was not reported. The reporter stated that dtap almost killed the patient and also stated it was hard pass for them.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood potassium abnormal, Blood pressure abnormal, Bone pain, Condition aggravated, Gait disturbance
Clinical narrative: Started physical therapy so she could walk; Sometimes bones hurt worse; Physical therapy helps when she has more pain; This case was reported by a consumer via other manufacturer and described the occurrence of walking difficulty in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included back surgery (the patient was in hospital for back surgery in January 2020 and was told to stop taking medication 2 weeks before and 2 weeks after), foot surgery, shingles (4 months after back surgery), pernicious anemia (most recent) and conjunctivitis. Previously administered products included Shingles shot with an associated reaction of herpes zoster (received 5 years ago), COVID-19 VACCINE MODERNA (1st dose received in left arm on 30th March 2021, lot number 018B21A), COVID-19 VACCINE MODERNA (2nd dose received in left arm on 29th April 2021, lot number 043B21A), vitamin B12 (received every months), METHOTREXATE (received in May 2019 (2.5 mg, 8 tablets by mouth once a week)) and Xeljanz (received on 30th October 2020, (unknown dose once daily by mouth) not taking for a year). Concurrent medical conditions included rheumatoid arthritis, goiter, warthin's tumor (biopsy of right salivary gland lesion in 2019), graves' disease (was in remission, so patient's eyes were doing better) and bone pain. Concomitant products included Herpes zoster (Shingrix) and cyanocobalamin (Vitamin B12).   On 9th September 2021, the patient received the 2nd dose of Shingrix. In September 2021, less than 3 weeks after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced walking difficulty, bone pain aggravated and pain. On an unknown date, the outcome of the walking difficulty, bone pain aggravated and pain were unknown.   It was unknown if the reporter considered the walking difficulty, bone pain aggravated and pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient had stopped taking Methotrexate when she started taking shingles vaccine. The patient received Vitamin B12 shot every month. On 14th June 2021, the patient received the 1st dose of Shingrix. The patient received 2nd dose of Shingrix vaccine and experienced sometimes bones hurt worse on certain days, started physical therapy so she could walk. Physical therapy helped to the patient when she had more pain. The patient's blood pressure and potassium went wacko. The patient was currently prescribed with Xeljanz XR 11 mg. The last time the patient went to the doctor, he asked if she ever played cards and then said she had the worst hand dealt. No lot number or expiry date was reported for Shingrix The reporter consented to follow up with her and her healthcare professional. No further details were reported.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Started physical therapy so she could walk; Sometimes bones hurt worse; Physical therapy helps when she has more pain; This case was reported by a consumer via other manufacturer and described the occurrence of walking difficulty in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included back surgery (the patient was in hospital for back surgery in January 2020 and was told to stop taking medication 2 weeks before and 2 weeks after), foot surgery, shingles (4 months after back surgery), pernicious anemia (most recent) and conjunctivitis. Previously administered products included Shingles shot with an associated reaction of herpes zoster (received 5 years ago), COVID-19 VACCINE MODERNA (1st dose received in left arm on 30th March 2021, lot number 018B21A), COVID-19 VACCINE MODERNA (2nd dose received in left arm on 29th April 2021, lot number 043B21A), vitamin B12 (received every months), METHOTREXATE (received in May 2019 (2.5 mg, 8 tablets by mouth once a week)) and Xeljanz (received on 30th October 2020, (unknown dose once daily by mouth) not taking for a year). Concurrent medical conditions included rheumatoid arthritis, goiter, warthin's tumor (biopsy of right salivary gland lesion in 2019), graves' disease (was in remission, so patient's eyes were doing better) and bone pain. Concomitant products included Herpes zoster (Shingrix) and cyanocobalamin (Vitamin B12).   On 9th September 2021, the patient received the 2nd dose of Shingrix. In September 2021, less than 3 weeks after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced walking difficulty, bone pain aggravated and pain. On an unknown date, the outcome of the walking difficulty, bone pain aggravated and pain were unknown.   It was unknown if the reporter considered the walking difficulty, bone pain aggravated and pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient had stopped taking Methotrexate when she started taking shingles vaccine. The patient received Vitamin B12 shot every month. On 14th June 2021, the patient received the 1st dose of Shingrix. The patient received 2nd dose of Shingrix vaccine and experienced sometimes bones hurt worse on certain days, started physical therapy so she could walk. Physical therapy helped to the patient when she had more pain. The patient's blood pressure and potassium went wacko. The patient was currently prescribed with Xeljanz XR 11 mg. The last time the patient went to the doctor, he asked if she ever played cards and then said she had the worst hand dealt. No lot number or expiry date was reported for Shingrix The reporter consented to follow up with her and her healthcare professional. No further details were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose two or three years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date two or three years  before the day of reporting).   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 information was provided as follow: The age at vaccination was not applicable for this report. The patient received their first dose of Shingrix at another facility two or three years ago. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-TV2021214451:Deleted (incorrect COO)
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: Passed out; Puked; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 10-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than 2 months after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced passed out (serious criteria GSK medically significant) and vomiting. On an unknown date, the outcome of the passed out and vomiting were recovered/resolved.   It was unknown if the reporter considered the passed out and vomiting to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra 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 unknown. The case was reported by patient's mother. The patient received Fluarix Quadrivalent 2021-2022 season vaccine and passed out 3 to 4 times and also puked. Call disconnected before obtaining patient's demographics. The reporter did not consent to follow up. No additional details were provided.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure
Clinical narrative: received both Shingrix shots/ get shingles/ suspected vaccination failure; Shingles; Post-herpetic neuralgia pain; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On 4th July 2019, the patient received the 2nd dose of Shingrix. In April 2019, the patient received 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 post herpetic neuralgia. The patient was treated with valaciclovir (Valacyclovir) and gabapentin. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received both Shingrix shots in 2019, 3 months apart. Since getting the Shingrix vaccine series, the patient has continued to get shingles (twice) and suffers from the post-herpetic neuralgia pain. The patient received Gabapentin and Valacyclovir for pain and to treat the shingles. Spoke per content in terms of her inquiry about getting a 3rd shot of Shingrix and supplied her with  number for her health care professional.  The reporter did not consent to follow up. 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.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: low grade fever; Fatigue; Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for covid-19 prophylaxis and COVID-19 VACCINE for covid-19 prophylaxis.   On 8th March 2021, the patient received the 1st dose of Shingrix (intramuscular). In May 2021, the patient received the 2nd dose of COVID-19 VACCINE. In April 2021, the patient received the 1st dose of COVID-19 VACCINE. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced low grade fever, fatigue and muscle pain. On an unknown date, the outcome of the low grade fever, fatigue and muscle pain were recovered/resolved.   It was unknown if the reporter considered the low grade fever, fatigue and muscle pain to be related to Shingrix.  Additional details were provided as follows: The reporter could not provide the lot or expiration of the vaccine but stated that the doctor's office administered the vaccines and would have that information. The patient received 1st dose of Shingrix in her right arm and experienced low grade fever, muscle pain and fatigue. The patient also received her Covid vaccine in April and May 2021. For the tolerance of second dose refer case US2021AMR213454, reported by same reporter. It was unknown if the reporter considered the fever, fatigue and muscle pain to be related to Covid-19 vaccine. She gave consent to contact her doctor.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR213454:Same patient
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: shingles; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2021, the patient received Shingrix (intramuscular). On 6th October 2021, 10 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by health care professional for himself. The patient received Shingrix vaccine in left deltoid and developed shingles just under the injection site. The patient was unaware if it was first or second dose. Till the time of reporting, the patient still had shingles. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eyelid rash, Herpes zoster, Rash, Vaccination failure, Vaccine breakthrough infection
Clinical narrative: had both doses, shingles/suspected Vaccination failure; breakthrough shingles; rash, left side of face, forehead, eyelid; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd July 2018, the patient received the 1st dose of Shingrix (intramuscular). In July 2021, more than 2 years after receiving Shingrix and 3 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and rash were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported for 2nd dose. The patient got both doses Shingrix in 2018. At the end of July 2021, patient had a breakthrough case of shingles and developed rash on the left side of face, forehead and left eyelid.  The patient mentioned the rash lasted for 3 weeks and then cleared up. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Sleep disorder, Vomiting
Clinical narrative: arm was sore; queasy; Threw up; Trouble sleeping; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2021, the patient received the 1st dose of Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced pain in arm, queasy, vomiting and difficulty sleeping. On an unknown date, the outcome of the pain in arm, queasy, vomiting and difficulty sleeping were unknown.   It was unknown if the reporter considered the pain in arm, queasy, vomiting and difficulty sleeping to be related to Shingrix.   Additional details were reported as follows; This case was reported by the patient for herself. The age at vaccination was not reported. The patient stated she received shingrix vaccine yesterday. The patient stated that her arm was sore, she feels queasy, she threw up everything she ate this morning, and she had trouble sleeping last night. The patient enquired about side effects of shingrix vaccine. The patient also mentioned that Provided information from Shingrix PI and Shingrix FAQ's, Provided medical advice disclaimer. The patient stated that referred to health care professional. Caller disconnected call before I could obtain additional information. The reporter did not consented to follow-up.