chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test, Diarrhoea, Hepatic cyst, Pancreatic cyst, SARS-CoV-2 test
Clinical narrative: Cysts in pancreas and liver; Cysts in pancreas and liver; From 27Sep2021, I had various episodes of diarrea.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Apr2021 14:00 (Lot number: EP6955) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asma" (unspecified if ongoing), notes: Other medical history : Asma. Concomitant medication(s) included: MONTELUKAST; CETRIZINE. Vaccination history included: Bnt162b2 (Dose Number: 1, SINGLE, Batch/Lot No: EP7534, Location of injection: Arm Left, Administration Time: 02:00 PM), administration date: 21Mar2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: HEPATIC CYST (non-serious) with onset 27Sep2021 12:00, outcome "not recovered", DIARRHOEA (non-serious) with onset 27Sep2021 12:00, outcome "not recovered" and all described as "From 27Sep2021, I had various episodes of diarrea."; PANCREATIC CYST (non-serious) with onset 05Oct2021 12:00, outcome "not recovered", described as "Cysts in pancreas and liver". The events "cysts in pancreas and liver", "from 27sep2021, i had various episodes of diarrea." and "cysts in pancreas and liver" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: The patient has not received any other vaccine in four weeks. The patient had not had covid prior to the vaccination. The patient tested covid post vaccine.    No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; MMRII was expired on 08-JAN-2022; This spontaneous report was received from a Medical Assistance referring to a 16 year old patient (patient's gender not reported). The patient's concurrent conditions and medical history were not reported.   On 25-JAN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (0.5 ml once, lot number T000889, which expired on 08-JAN-2022) for prophylaxis. Concomitant product included the sterile diluent used: (0.5 ml, lot number U013279, expiration date: 15-SEP-2023). There was no temperature excursion for the components administered. No adverse event was reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, Wrong product administered
Clinical narrative: The nurse states PROQUAD and VARIVAX was administered to the patient instead of MMR II and VARIVAX; The nurse states PROQUAD and VARIVAX was administered to the patient instead of MMR II and VARIVAX; This spontaneous report was received from a nurse practitioner, referring to a 12-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-FEB-2022, the patient received therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #U022726, expiration date: 16-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U020239, expiration date: 28-JUN-2023, administered for prophylaxis (strength, and route of administration were not provided). She received those medications instead of Measles and Mumps Virus Vaccine, Live (M-M-R-II) with varicella virus vaccine live (oka/merck) (VARIVAX)(accidental overdose and wrong product administered).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The medical assistant is reporting that a patient received improperly stored vaccine on 2/7/2022; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 07-FEB-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, (recombinant Human albumin) (PROQUAD) 1 dose, lot # U002532, expiration date 24-07-2022 (dose number, exact dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The vaccine was stored improperly at the temperature of -12.3 Celsius degrees for 1 hour on an unknown date. Previous temperature excursions included -13.3 Celsius degrees for 30 minutes, -11.1 Celsius degrees for 1 hour 15 minutes, -8.9 Celsius degrees for 1 hour 30 minutes and -14.4 Celsius degrees for 6 hours on unknown dates. No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PROQUAD was administered following a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 04-JAN-2022, following a temperature excursion (product storage error), the patient was administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # U002534, expiration date on 24-JUL-2022, for prophylaxis (strength, dose, route of administration and anatomical location was not reported). Vaccine were improperly stored at a temperature of -11°C, during a time frame of 3 hours. Previous temperature excursions were reported at -14°C to -10°C for 8 hours and -10°C to 8°C (-8-8°C) for 1 hour. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired dose of GARDASIL 9 was administered; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 03-FEB-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # S010729; expiration date 01-DEC-2021; strength, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). It was confirmed that the expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) did not experience a temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; temperature excursion; This spontaneous report was received from a registered nurse and refers to a male patient of unknown age. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 09-FEB-2022, the patient was administered with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U024221 was verified to be valid, expiration date reported and established as 04-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided).   The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) previously experienced a temperature excursion of 6 to 14 Fahrenheit (F) degrees (6.4F) for 15 minutes. No other information was available at this time. The vaccine had no previous temperature excursions. The patient did not experience any other adverse events.; Sender's Comments:  2202USA004245:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Poor quality product administered, Product expiration date issue, Product lot number issue
Clinical narrative: No additional AEs reported; She stated that a consumer made her aware that a vial of PROQUAD was found missing the lot and expiration.; She stated that a consumer made her aware that a vial of PROQUAD was found missing the lot and expiration.; an AE is being filed since a PQC product was administered to a patient; This spontaneous report has been received from a registered nurse via a company representative concerning to a 4-year old male patient. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 15-FEB-2022 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD)  0.5 milliliter, (lot number U019289, expiration date: 15-DEC-2022) (strength, route of administration, were not provided) for prophylaxis. However, the patient made the reporter aware that the vial of the vaccines had missing the lot and expiration numbers in the carton (product lot number issue,  product expiration date issue) but the carton did not present any damage. The label was intact, there were no other printing issues, the label did not look like was exposed to moisture or increased humidity. Nevertheless, the missing information the vial appeared normal. It was reported that, the vaccine was administered after the missing information was discovered (poor quality product administered). Additionally, the carton appeared normal and was not damaged, the other vials in the carton appeared normal and had the lot and expiration date printed on the vials.
Sex: U
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: no adverse event; the full dose was not administered to the patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age. Patient's medical history, concurrent conditions, concomitant medications and allergy history were not reported.  On 11-FEB-2022, the patient received the second in the series of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (dose, route of administration, lot number, expiration date were not reported) for prophylaxis. The full dose was not administered to the patient (underdose). No adverse events were reported (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: her 2 sisters received their second dose of GARDASIL 9 on an unknown date last week/they received their first dose of Gardasil 9 in January 2020; This spontaneous report was received from a consumer and refers to a her sister of unknown age. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date in January 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. The consumer reported that the patient received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage, route of administration, anatomical location, lot number and expiration date were not reported) on an unknown date in February 2022 (reported as "last week") (Inappropriate schedule of product administration).  This is one of several reports reported by the same reporter.; Sender's Comments:  US-009507513-2202USA006120: US-009507513-2203USA002098:
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no additional information available or provided; VARlVAX underwent a temperature excursion and was then administered to a patient; This spontaneous report was received from a reporter with an unspecified qualification (reported as "administrator") and refers to 7-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 05-FEB-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, lot # U022732was confirmed to be valid, expiration date 20-JUL-2023, for prophylaxis (route and site of administration were not reported).  The administered dose was exposed to the temperature of 12 degrees Fahrenheit (F) for 9 hours and 38 minutes. There were also previous temperature excursions reported as follows: 9.7 F for 2 hours and 41 minutes; 10.8 F for 2 hours and 45 minutes; 10.6 F for 4 hours and 16 minutes; 11.1 F for 3 hours and 14 minutes; 10.9 F for 4 hours and 43 minutes; 10.8 F for 2 hours and 17 minutes; 18.3 F for 2 hours and 36 minutes; 18.7 F for 3 hours and 4 minutes; 12.4 F for 9 hours and 43 minutes; 17. 4 F for 24 hours and 0 minutes; 19.9 F for 10 hours and 57 minutes. No additional information was available or provided.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional adverse events; child has already had their 2 dose series as recommended and the provider accidentally ordered it; This spontaneous report was received from office manager and referring to a 6-year-old patient of an unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On an unknown date, the patient vaccinated with first and second dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (dose, route of administration, vaccination scheme, and anatomical location of vaccination were not reported).   On 24-FEB-2022 (reported as today), the patient vaccinated with dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) was given by mistake in the office today. (0.5 milliliter, lot number U024507 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) expiration date was reported and established as 02-FEB-2023 ; route of administration was not provided) for prophylaxis. The child has already had their 2 dose series as recommended and the provider accidentally ordered it again, and it was given (Incorrect dose administered).  No product quality complaint (PQC) and no additional adverse event (AEs) was reported.
Sex: U
Vaccine: HEPA
Symptoms: Exposure via eye contact
Clinical narrative: this patient's adult caregiver received an accidental exposure in an unspecified eye to a partial unspecified volume of the vaccine during the administration event; patient's caregiver has not reported any symptoms after the accidental exposure to the vaccine.; This spontaneous report was received from a licensed practical nurse, referring to an adult patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) injection (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.  On an unknown date, the patient received an accidental exposure in an unspecified eye to a partial unspecified volume of the vaccine during the administration event (accidental exposure to product). The nurse stated that the patient's eye was irrigated/flushed with water after the exposure. The nurse reported that the patient had not reported any symptoms after the accidental exposure to the vaccine.
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Mouth swelling, Scratch, Swollen tongue, Throat tightness
Clinical narrative: throat tightening up; trouble breathing; I had scratches all over my body; tounge and mouth were swollen; tounge and mouth were swollen; hives; This spontaneous report was received from a 67-year-old female consumer reporting on herself. The patient's concurrent conditions included diabetes. The patient's concomitant therapies included losartan, ezetimibe(ZETIA), levothyroxine sodium(SYNTHROID), duloxetine hydrochloride(CYMBALTA), gabapentin, insulin aspart(NOVOLOG), insulin detemir(LEVEMIR), dulaglutide(TRULICITY), omega 3 and metformin. The patient's historical medications included a pneumococcal vaccination in 2020. The patient's historical conditions were not reported.      On 22-FEB-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in the left upper arm for prophylaxis (dose, route of administration, lot number and expiration date not reported).      In February 2022, the patient experienced hives (urticaria), swollen tongue, mouth swelling and scratches all over her body.  On 24-FEB-2022, the patient experienced throat tightness and dyspnoea. the patient went to the emergency department where Benadryl, prednisone and pepcid were administered intravenously, and was prescribed famotidine, banophen and prednisone tablets 50 milligrams all for 7 days to be taken at home,     The outcome of urticaria, swollen tongue, mouth swelling, scratch, dyspnoea and throat tightness was reported as resolved on 28-FEB-2022. The reporter considered the events related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).     Upon internal review, all the events were considered medically significant.
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: throat tightening up; trouble breathing; I had scratches all over my body; tounge and mouth were swollen; tounge and mouth were swollen; hives; This spontaneous report was received from a 67-year-old female consumer reporting on herself. The patient's concurrent conditions included diabetes. The patient's concomitant therapies included losartan, ezetimibe(ZETIA), levothyroxine sodium(SYNTHROID), duloxetine hydrochloride(CYMBALTA), gabapentin, insulin aspart(NOVOLOG), insulin detemir(LEVEMIR), dulaglutide(TRULICITY), omega 3 and metformin. The patient's historical medications included a pneumococcal vaccination in 2020. The patient's historical conditions were not reported.      On 22-FEB-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in the left upper arm for prophylaxis (dose, route of administration, lot number and expiration date not reported).      In February 2022, the patient experienced hives (urticaria), swollen tongue, mouth swelling and scratches all over her body.  On 24-FEB-2022, the patient experienced throat tightness and dyspnoea. the patient went to the emergency department where Benadryl, prednisone and pepcid were administered intravenously, and was prescribed famotidine, banophen and prednisone tablets 50 milligrams all for 7 days to be taken at home,     The outcome of urticaria, swollen tongue, mouth swelling, scratch, dyspnoea and throat tightness was reported as resolved on 28-FEB-2022. The reporter considered the events related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).     Upon internal review, all the events were considered medically significant.
Sex: U
Vaccine: MMRV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Inadvertently administered an expired PROQUAD; This spontaneous report was received from registered nurse referring to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not provided.   On 01-MAR-2022, the patient was inadvertently administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (expired product administered) as prophylaxis (lot number T028296, expiration date: 16-FEB-2022 ; dose, dose number, vaccination scheme, anatomical location of vaccination, and route of administration were not provided) reconstituted with sterile diluent (lot number, expiration date, dose, route of administration and indication were not provided were not provided).  No product quality complaint (PQC) and no additional adverse event was reported.
Sex: F
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Did not have any adverse event; Administered Proquad via intramuscular route not subcutaneously; This spontaneous report was received from a pharmacist referred to her daughter of unknown age. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were not provided.  On 01-MAR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), 0.5 milliliter, intramuscularly as prophylaxis. (lot number, rHa, expiration date and anatomical location were not provided).  On 01-MAR-2022, the patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) via intramuscular route instead of subcutaneous route (Incorrect route of product administration). The reporter confirmed that her daughter did not have any adverse event associated with the vaccination. Caller declined consent to contact the health care professional (HCP). No additional information provided.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: her 2 sisters received their second dose of GARDASIL 9 on an unknown date last week/they received their first dose of Gardasil 9 in January 2020; This spontaneous report was received from a consumer and refers to a her sister of unknown age. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date in January 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. The consumer reported that the patient received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage, route of administration, anatomical location, lot number and expiration date were not reported) on an unknown date in February 2022 (reported as "last week") (Inappropriate schedule of product administration).  This is one of several reports reported by the same reporter.; Sender's Comments:  US-009507513-2202USA006120: US-009507513-2202USA005968:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: 1st dose July31, also had shingles this year; It's been seven months since my first shot; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in March of unspecified year).   On 31st July 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported for the 1st dose and the age at vaccination was not applicable for 2nd dose of Shingrix. After receiving 1st dose of Shingrix, the patient had shingles in the year of reporting. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The patient asked if he/she could take the 2nd shot now or needed to start over. No contact Information was given by the patient. Note- As follow up is not possible and the patient mentioned he/she had shingles this year (year of reporting), shingles was coded as event for 1st dose.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pruritus, Rash vesicular
Clinical narrative: pain, 4/10; Suspected vaccination failure; breakthrough herpes zoster, shingles; vesicular rash on buttocks; burning; itching; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a elderly 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 .5 ml and the 1st dose of Shingrix .5 ml. In December 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced vesicular rash, burning sensation, pruritus and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown and the outcome of the vesicular rash, burning sensation and pruritus were recovered/resolved.   The reporter considered the vaccination failure, shingles, vesicular rash, burning sensation, pruritus and pain to be unrelated to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported a case of breakthrough herpes zoster disease in December 2021 (exact date was unknown).  The patient completed the 2-dose series of Shingrix, received on left arm, when it first became available, in 2018 (exact dates unknown). The reporter stated that, herpes zoster was diagnosed based on visual presentation (not polymerase chain reaction- PCR) 3 days after symptom initiation. It presented as a vesicular rash on the buttocks 3x3 cm, other symptoms included burning and itching which resolved after 1 week. The vesicles crusted over after 2 weeks. The patient stated the pain was not painful, rated as a 4/10. No antivirals, no pain medicines were taken, and no further care was provided. The reporter described it as a very minor case of shingles. The reporter acknowledged the vaccine efficacy and attributed the episode as a breakthrough case brought on by other stresses occurring at the same time. The reporter did not think the herpes zoster episode was caused by Shingrix. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure, Vaccine breakthrough infection
Clinical narrative: pain, 4/10; Suspected vaccination failure; breakthrough herpes zoster, shingles; vesicular rash on buttocks; burning; itching; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a elderly 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 .5 ml and the 1st dose of Shingrix .5 ml. In December 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced vesicular rash, burning sensation, pruritus and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown and the outcome of the vesicular rash, burning sensation and pruritus were recovered/resolved.   The reporter considered the vaccination failure, shingles, vesicular rash, burning sensation, pruritus and pain to be unrelated to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported a case of breakthrough herpes zoster disease in December 2021 (exact date was unknown).  The patient completed the 2-dose series of Shingrix, received on left arm, when it first became available, in 2018 (exact dates unknown). The reporter stated that, herpes zoster was diagnosed based on visual presentation (not polymerase chain reaction- PCR) 3 days after symptom initiation. It presented as a vesicular rash on the buttocks 3x3 cm, other symptoms included burning and itching which resolved after 1 week. The vesicles crusted over after 2 weeks. The patient stated the pain was not painful, rated as a 4/10. No antivirals, no pain medicines were taken, and no further care was provided. The reporter described it as a very minor case of shingles. The reporter acknowledged the vaccine efficacy and attributed the episode as a breakthrough case brought on by other stresses occurring at the same time. The reporter did not think the herpes zoster episode was caused by Shingrix. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting. The reporter consented to follow up.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administrated with an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number dk23d, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 2nd March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 were provided as follows: The age at vaccination was not reported. No patient's identifiers was provided. Pharmacist reported that the patient was administrated with an expired dose of Twinrix, which led to expired vaccine used. No adverse event was reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. This case had been linked with case US2022039289, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039289:same reporter
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injected limb mobility decreased, Injection site swelling
Clinical narrative: burning/Injection site pain/ Injection site tenderness; swelling at injection site; could not move her arm; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th December 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 8th December 2021, immediately after receiving Shingrix, the patient experienced burning sensation. In December 2021, the patient experienced injected limb mobility decreased and injection site swelling. On an unknown date, the outcome of the injected limb mobility decreased, burning sensation and injection site swelling were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, burning sensation and injection site swelling to be related to Shingrix.     Linked case(s) involving the same patient:  US2022038198  Additional details were provided as follows: The patient self-reported this case. The patient received vaccine into the muscle of her left arm. Immediately after the 1st shot of Shingrix, patient reported that she felt burning with the injection and pain at the injection site.  The reporter stated that, she could not move her arm for 2 days after the first dose and that she also had swelling and tenderness at the injection site. The reporter did not consent to follow up. For tolerance to 2nd dose, refer case US2022038198.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022038198:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pain in extremity
Clinical narrative: arm still hurts, pain travels down the arm; pain travels down the arm; Can't sleep very well; This case was reported by a consumer via interactive digital media and described the occurrence of painful l arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In February 2022, the patient received Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced painful l arm, radiating pain and sleeplessness. On an unknown date, the outcome of the painful l arm, radiating pain and sleeplessness were not recovered/not resolved.   It was unknown if the reporter considered the painful l arm, radiating pain and sleeplessness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received the shingles shot 15 days before the date of reporting. The patient stated that the left arm still hurts and sometimes the pain travels down the arm and also could not sleep very well. No further information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st Shingrix in 2020; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The reporter asked if a patient received 1st Shingrix in 2020, whether he need to restart series. It was unknown if the patient received 2nd dose, which led to incomplete course of vaccination. Follow up would not be possible since contact details were not provided.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: received BOOSTRIX, subject to temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 24th February 2022, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported.  The reporter did not have patient identifiers. The health care professional reported that a patient received Boostrix that was subject to temperature excursion, which led incorrect storage of drug. The reporter consented to follow-up. The case was linked with case US2022039272 and US2022AMR040208, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039272:Same reporter US-GLAXOSMITHKLINE-US2022AMR040208:Same reporter
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: received BOOSTRIX, subject to temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 24th February 2022, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported.  The reporter did not have patient identifiers. The health care professional reported that a patient received Boostrix that was subject to temperature excursion, which led incorrect storage of drug. The reporter consented to follow-up. The case was linked with case US2022039272 and US2022AMR040207, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039272:Same reporter US-GLAXOSMITHKLINE-US2022AMR040207:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I took 1st shot about 3-4 years ago but did not get 2nd shot until last month; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (First dose received about 3-4 years ago).   In February 2022, the patient received the 2nd dose of Shingles vaccine. In February 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient inquired about shingles shot. The patient took 1st shot about 3 to 4 years ago but did not get 2nd shot until last month, which led to lengthening of vaccination schedule. The reporter stated that the pharmacist who gave the 2nd shot was uncertain if reporter needed to do another shot within next 90 days.  The reporter inquired that whether the time between shots critical.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: After 2 doses, I continue to get outbreaks/ suspected vaccination failure; I continue to get outbreaks; 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.   In August 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir (Valacyclovir). 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 Shingrix and Shingrix.     Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received 2 doses of Shingrix 2 months apart and continued to get outbreaks of shingles, so took 1000 mg of Valacyclovir every day as suppression therapy. The patient asked if he/she could try third shingles vaccine to see if it works. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were not provided. This case was linked with case US2022AMR041251 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR041251:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Fever blisters; This case was reported by a consumer via interactive digital media and described the occurrence of fever blister in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was not recovered/not resolved.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional details were reported as follows:  The case was self-reported by the patient. The age at vaccination was not reported. The patient received 2nd Shingrix shot a week ago from reporting date.  The patient now had two fever blisters. The patient asked was that a common occurrence or just coincidence. Follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I got one vaccine just over 2 years ago, then I couldn't afford the second dose; This case was reported by a consumer 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 over 2 years before the date 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 details were reported as follows: The case was self reported by the patient. The age at vaccination was not applicable for this report. The reporter reported that they got one Shingrix vaccine just over 2 years before the date of reporting, then they lost their health insurance and amp. The patient could not afford the second dose. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient now had insurance again and wanted to be fully vaccinated. The patient asked if he/she should get one more shot or two. Follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I had my first shingles vaccine in December 2020; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose in an unknown date of December 2020).   On an unknown date, the patient received 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 details were reported as follows: The case was self reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First shot over a year ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over a year ago at the time 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 details were reported as follows: The case was self reported by the patient. The age at vaccination was not applicable for this report. The reporter reported that he/she received the first Shingrix shot over a year ago, should he/she get the second, which led to incomplete course of vaccination. The reporter reported for patients 50 years or older, was there a time that was preferred in the 2 to 6 month time frame to get second dose of Shingrix. Follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Dose 1 in 2018, did not complete my second; This case was reported by a consumer 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 of Shingrix in 2018).   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 reported as follows: The case was self reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter reported his/her physician recommended to restart the series. The reporter wanted to know what were the recommendations for restarting the series.