chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Weight
Clinical narrative: Diagnosed with exocrine pancreatic insufficiency; acute pancreatitis; This is a spontaneous report received from a contactable reporter(s) (Nurse) The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PANCREATITIS ACUTE (medically significant) with onset Dec2021, outcome "unknown", described as "acute pancreatitis"; PANCREATIC FAILURE (medically significant), outcome "unknown", described as "Diagnosed with exocrine pancreatic insufficiency". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (Jan2022) Positive, notes: Second time; Weight decreased: (unspecified date) 30lbs.  Clinical course: Patient had episode of acute pancreatitis Dec2021. Patient tested COVID-19 positive for the second time Jan2022. Diagnosed with exocrine pancreatic insufficiency (EPI) after several months of diarrhea, losing 30 lbs, and other classical signs of EPI. Patient had no preexisting medical history documented by regular pcp visits.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, and the reported events acute pancreatitis, Pancreatic failure cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Nausea
Clinical narrative: She was also sick to her stomach; she had a headache and felt that her head was going to blow up.; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (She was also sick to her stomach) and HEADACHE (she had a headache and felt that her head was going to blow up.) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First Primary monovalent dose. (Lot number 019B21A & Exp. Date: unknown).) on 31-Mar-2021, Moderna COVID-19 Vaccine (2nd Primary monovalent dose. (Lot number 039B21A & Exp. Date: unknown).) on 27-Apr-2021 and Moderna COVID-19 Vaccine (First Monovalent Booster dose. (Lot number 005C21A & Exp. Date:22DEC2021).) on 03-Dec-2021; for Blood pressure high: Metoprolol Succinate (controlled by taking Metoprolol Succinate 50mg (ER 24 hour)). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine; and No adverse event with Metoprolol Succinate. Concurrent medical conditions included Blood pressure high (She has a history of high blood pressure).    On 07-Feb-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Feb-2023, the patient experienced ABDOMINAL DISCOMFORT (She was also sick to her stomach) and HEADACHE (she had a headache and felt that her head was going to blow up.). The patient was treated with IBUPROFEN at a dose of 800 milligram. At the time of the report, ABDOMINAL DISCOMFORT (She was also sick to her stomach) and HEADACHE (she had a headache and felt that her head was going to blow up.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High Blood Pressure (148)..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications details were reported. Patient did not received any other vaccines in the 4 weeks of the Bivalent booster. On 21-Feb-2023 at 10:03 AM the patient was calling to report that next day after Bivalent Booster, on 08-Feb-2023, she had a headache and felt that her head was going to blow up. Patient was also sick to her stomach. Patient visited the doctor a week later, but MD did not prescribe anything. Patient had High Blood Pressure (148). Headache was still going on. Patient took Ibuprofen 800 mg and it did not help. Patient's blood pressure prior to receiving the bivalent booster was 110 to 120 with the medicine. Patient was asking, was her blood pressure going to come down. Agent referred patient to see her doctor again for the high blood pressure.
Age: 66.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Abdominal discomfort, Blood pressure measurement, Headache
Clinical narrative: She was also sick to her stomach; she had a headache and felt that her head was going to blow up.; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (She was also sick to her stomach) and HEADACHE (she had a headache and felt that her head was going to blow up.) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First Primary monovalent dose. (Lot number 019B21A & Exp. Date: unknown).) on 31-Mar-2021, Moderna COVID-19 Vaccine (2nd Primary monovalent dose. (Lot number 039B21A & Exp. Date: unknown).) on 27-Apr-2021 and Moderna COVID-19 Vaccine (First Monovalent Booster dose. (Lot number 005C21A & Exp. Date:22DEC2021).) on 03-Dec-2021; for Blood pressure high: Metoprolol Succinate (controlled by taking Metoprolol Succinate 50mg (ER 24 hour)). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine; and No adverse event with Metoprolol Succinate. Concurrent medical conditions included Blood pressure high (She has a history of high blood pressure).    On 07-Feb-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Feb-2023, the patient experienced ABDOMINAL DISCOMFORT (She was also sick to her stomach) and HEADACHE (she had a headache and felt that her head was going to blow up.). The patient was treated with IBUPROFEN at a dose of 800 milligram. At the time of the report, ABDOMINAL DISCOMFORT (She was also sick to her stomach) and HEADACHE (she had a headache and felt that her head was going to blow up.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High Blood Pressure (148)..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications details were reported. Patient did not received any other vaccines in the 4 weeks of the Bivalent booster. On 21-Feb-2023 at 10:03 AM the patient was calling to report that next day after Bivalent Booster, on 08-Feb-2023, she had a headache and felt that her head was going to blow up. Patient was also sick to her stomach. Patient visited the doctor a week later, but MD did not prescribe anything. Patient had High Blood Pressure (148). Headache was still going on. Patient took Ibuprofen 800 mg and it did not help. Patient's blood pressure prior to receiving the bivalent booster was 110 to 120 with the medicine. Patient was asking, was her blood pressure going to come down. Agent referred patient to see her doctor again for the high blood pressure.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1 year old patient got Kinrix; off label use; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix .5 ml and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the inappropriate age at vaccine administration and off label use were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-FEB-2023 Reporter's Comment: The vaccine was administered off label to a infant patient. Additional Supportive Information: 1 years old patient received Kinrix vaccine, which led to inappropriate age at vaccine administration and off label use.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; PNEUMOVAX 23 was inadvertently administered after a supported temp excursion; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 23-JAN-2023, the patient was inadvertently vaccinated with the improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot number: W021636, expiration date: 01-OCT-2023) 0.5 mL (route of administration not provided) (product storage error). The vaccine was stored in temperature 55.4 degrees Fahrenheit for 1 hour and 30 minutes. There was no previous temperature excursion.  No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No adverse event; Nurse reports improperly stored PROQUAD was administered; This spontaneous report was received from a Licensed Vocational Nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 28-DEC-2022, the patient was vaccinated with improperly storaged measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), lot number W012730 with expiration date 16-OCT-2023 for prophylaxis (dose, route of administration and anatomical location were not reported); administered along with sterile diluent.     The temperature excursion was -14 degree Celsius up to -10 degree Celsius (-13.7 degree Celsius) for a timeframe of 5 hours and 15 minutes, without previous excursion. No adverse events reported.; Sender's Comments:  US-009507513-2301USA008920:
Sex: F
Vaccine: HPV9
Symptoms: Vaccination site discolouration
Clinical narrative: tiny white milky ring about the size of syringe; This spontaneous report was received from a pharmacist, concerning a 20-year-old female patient. Information regarding the patient's medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies were not reported.  On 23-DEC-2022, she was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, at a dose of 0.5ml/once, lot #1775811, expiration date: 07-DEC-2023, administered intramuscularly for prophylaxis (dose number and anatomical location were not provided).  On the same date, immediately after withdrawal of needle tip, a tiny white milky ring about the size of syringe tip was noticed on patient's skin at injection site (vaccination site discolouration). No treatment was given for the adverse event, and she didn't seek for medical attention.  On an unknown date, the outcome of the event of vaccination site discolouration was resolved.  The causal relationship between the event of vaccination site discolouration and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Age: 5.0
Sex: M
Vaccine: HPV9
Symptoms: Off label use
Clinical narrative: 9-valent Human Papillomavirus vaccine for oral warts; Literature Report:   This literature marketed report has been received from the authors of a published literature abstract, titled as stated above, and refers to 5-year-old male patient with Trisomy 21, atrioventricular canal defect, asthma, and obstructive sleep apnea,  extensive oral warts and human papillomavirus infection (HPV). The patient's medical history included  biopsy. Concomitant medications included cimetidine and cidofovir.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) injection (dose, lot #, expiry date, anatomical location and route of administration were not provided) for prophylaxis (reported as extensive oral HPV warts) (Off label use). The patient received 2 doses of the vaccine.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 0.17
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion of 47.9 F for 47 min on 01-DEC-2022; This spontaneous report was received from a certified medical assistant (CMA) and referred to 2-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 28-DEC-2022, the patient was vaccinated with first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly for prophylaxis in left thigh (strength and dose was not provided), and with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892784, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and dose was not provided).  The administered doses of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved. No additional adverse event was reported (no adverse event).  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009088:
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; temp excursion of 47.9 F for 47min; This spontaneous report was received from a healthcare professional and refers to a 7-month-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) first dose administered orally (strength, dose, lot #, and expiration date were not provided) for prophylaxis. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) second dose administered orally (strength, dose, lot #, and expiration date were not provided) for prophylaxis. On 21-DEC-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #1892784, expiration date: 03-DEC-2023, administered orally (strength was not provided) for prophylaxis (Product storage error).  On 01-DEC-2022, the vaccine underwent a temperature excursion at 47.9 Fahrenheit degrees (F) for 47 minutes. The temperature excursion occurred as a result of reading from a Digital Data Logger. No previous temperature excursions were reported. No adverse events (No adverse event).
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient received GARDASIL 9 on an unspecified date of 2019 did not receive the 2nd and 3rd doses.; No additional adverse event reported; This spontaneous report was received from a pharmacist and refers to a currently 20-year-old male patient. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.      On unknown date in 2019, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (quantity dose, lot #, expiration date and route were not reported). The patient did not receive second and third doses. The pharmacist asked if the patient need to begin the series or would the next doses be considered the second and third doses (inappropriate schedule of product administration). No additional adverse events and nor product quality complain were reported.
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No reported patient side effects.; expired dose of PNEUMOVAX 23 was administered to a patient on 2/7/23 but expired on 1/13/23.; This spontaneous report was received from a pharmacist and referred to a 75-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 07-FEB-2023, the patient was vaccinated with an expired dose of  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliter(mL) injection, 0.5 milliliter, lot #U021995, expiration date: 13-JAN-2023, administered subcutaneously (SQ) for prophylaxis (expired product administered). Pharmacist confirmed that expired vaccine administered had never been stored out of temperature range therefore has never had a temperature excursion. No reported patient side effects. Information regarding revaccination provided to the pharmacist as requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: multiple outbreaks of herpes zoster; postherpetic neuralgia; vision issues; Information has been received from the lawyer and the consumer concerning a case in litigation and refers to a patient of unknown age and gender. On 04-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis. On an unknown date, the patient experienced multiple outbreaks of herpes zoster, postherpetic neuralgia and vision issues. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptomatic side effects reported; a patient was inadvertently administered and expired PNEUMOVAX 23; This spontaneous report was received from other and refers to a patient of an unknown age and gender.  The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 14-FEB-2023, the patient was inadvertently administered with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot # U018309, expiration date: 08-JAN-2023, administered for prophylaxis (strength, dose and route of administration were not provided). No symptomatic side effects or prior temperature excursion were reported (no adverse event).
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Gastrointestinal disorder, Malaise, Underdose, Vomiting
Clinical narrative: Vomiting/vomited fully intact second pill; Diarrhea; A spontaneous report was received from other healthcare professional on 10FEB2023 regarding a female patient (age: unknown) who had "vomiting/vomited fully intact second pill" (PT: Vomiting) and "diarrhea" (PT: Diarrhoea) following the administration of Vivotif capsule (Typhoid vaccine live oral Ty21A; lot number: 3003789) for typhoid for upcoming trip.  The patient's medical history, concomitant medications, or known allergies were not reported.   On 08JAN2023 (Sunday), the patient began the protocol and took the first dose of Vivotif, followed by the second dose on 10JAN2023. Reportedly, the patient vomited the second dose, which was fully intact. On the same day, in the evening, the patient had a violent reaction to the vaccine with vomiting and diarrhea, and she went to the emergency room (ER), where she received fluids for the events, and she seemed to improve.  Furthermore, it was reported that the patient visited ER five times and was admitted to the hospital to try to determine what was causing her to be so "sick with GI issues".  The outcome of the reported events was unknown, at the time of this report. The action taken with Vivotif with respect to the reported events was unknown.  No additional information was reported.  Company comment: It was reported that a patient took Vivotif and had vomiting/vomited the fully intact second pill (vomiting) and diarrhea. Considering the case information, the causality of vomiting and diarrhea is assessed as possible with Vivotif. The case is considered serious due to hospitalization of the patient. Vomiting and diarrhea are listed as per the Agency of Vivotif.; Sender's Comments: A spontaneous case report regarding a female consumer of an unknown age, with no reported medical history and concomitant medications, who experienced vomiting and diarrhea for which she had emergency room visits up to five times following the second dose of Vivotif with the that second pill being vomited in whole. She had intravenous fluids during the ER visits and was subsequently hospitalized. No information regarding the details and treatment of event was provided. The outcomes of the events were not reported. Diarrhea and vomiting are known effects of Vivotif; The causality of these events is assessed as related to Vivotif given the time to onset of the event and biological plausibility.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Vaccinated two or three times, acquired shingles/Suspected vaccination failure; Acquired shingles; Vaccinated two or three times; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 17-FEB-2023 Reporter's Comment: This case was reported by the husband of the patient via interactive digital media. The reporter reported that the patient had been vaccinated two or three times and acquired shingles. The reporter reported that so he could for sure call nonsense on any vaccinations. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test and time to onset confirming shingles were unknown at the time of reporting. The patient received third dose of Shingles vaccine, which led to extra dose administered. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient was given only the diluent portion; Patient was given only the diluent portion; This case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-FEB-2023 Reporter's Comments: No additional details are available. Medical information agent returned to health care professional's call, no answer, left message on answering service and will update adverse event once additional details were available. Additional Supportive Information: The patient was administered only the diluent portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: A bit sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 14-Feb-2023 Reporter's comment: The case was received form the patient via interactive digital media. The patient got his/her first shot Friday and experienced a bit sore but better then if he/she had shingles. Additional supportive information: The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: May be late for 2nd dose; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a female 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 did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-FEB-2023 Reporter's Comment: The doctor called to request information about a patient that might get a third dose of Shingrix vaccine, intention was to administer another dose if the doctor considered it safe enough and patient agreed. The patient had no recollection of receiving a second dose and pharmacy had no records of vaccination. The reporter reported that if no second dose was given the patient might be late for it, if a second dose was given the patient could be getting a third dose. At the time of reporting, the doctor had no patient or vaccine information. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 3 years-old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th May 2010, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 10th May 2010, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 03-Jan-2023. Reporter's Comment: Kinrix dose was the patient's 5th DTap and 4th IPV. The reporter did not consent to follow-up. Additional Supportive Information: Patient received Kinrix vaccine 7 days prior to 4th birthday,which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Adult patient received a pediatric dose; Adult patient received a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 68-year-old female patient who received HAV (Havrix 720) (batch number EP473, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-Feb-2023: Reporter comment: A nurse reported that the adult patient received a pediatric dose of Havrix.  The reporter consented to follow up. Additional supportive information : The adult patient received a pediatric dose of Havrix, which led to underdose and adult use of a child product.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired Shingrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number 9ZJ25, expiry date 23rd January 2023) for prophylaxis.   On 14th February 2023, the patient received the 2nd dose of Shingrix. On 14th February 2023, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-Feb-2023: Reporter comment: The patient inadvertently received an expired dose of Shingrix vaccination. This was the patient's second dose of the series.  This was a webform submission by healthcare professional for follow up. The healthcare professional phone and email address was in healthcare professional details. Additional supportive information:  The patient was administered an expired dose of Shingrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Headache
Clinical narrative: Mild headache; Tips of ears hurt; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2023, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and ear pain. On an unknown date, the outcome of the headache and ear pain were unknown.   It was unknown if the reporter considered the headache and ear pain to be related to Shingrix.     Additional Information: GSK Receipt date: 14-Feb-2023. Reporter's Comment: The case was reported by patient herself. The patient received the 1st dose of Shingrix, at the end of January 2023, she had a mild headache and the tips of her ears hurt a little. The patient disconnected the call before they could obtain her DOB, ask for consent to follow up with HCP,  or any other information about her 1st dose of Shingrix. The reporter did not consent to follow-up. The consent to follow up with HCP not obtained.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: red arm; itchy arm; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th February 2023, the patient received the 1st dose of Shingrix. In February 2023, unknown after receiving Shingrix, the patient experienced erythema of extremities and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities and itchy upper limbs were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities and itchy upper limbs to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-FEB-2023 Reporter's Comment:  The reporter did not wish to provide demographic information. The reporter stated that he had the Shingrix and he was experiencing a red and itchy arm.  Adverse event was filed. The reporter did not consent to follow-up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 25May2022, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 49-year-old male patient who received HAB (Twinrix) 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.   Previously administered products included Twinrix (Received 1st dose of Twinrix on 25th May 2022 from lot number 4F3YY (expiration date:1st January 2023)).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-FEB-2023 Reporter's Comment: The reporter reported that the patient did not present back for the second dose of Twinrix until 14th February 2023. At the time of reporting, the second dose had not yet been administered. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Twinrix , which led to incomplete course of vaccination. This was 1 of 3 case, reported by the same reporter. Note: VARES details pertained to 1st dose of Twinrix in product tab; Sender's Comments:  US-GSK-US2023024467:Same reporter US-GSK-US2023024466:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 4 years ago, has not received 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 4 years ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-FEB-2023 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received first dose of Shingrix vaccine four years ago and had not yet received their second dose of Shingrix vaccine. The reporter was unable to provide any additional adverse event information at the time of reporting. The reporter did consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-month-old male patient who received DTPa (DTaP vaccine) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   On 14th February 2023, the patient received DTaP vaccine. On 14th February 2023, unknown after receiving DTaP vaccine, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 15-FEB-2023 Reporter's Comment: A reporter reported that a patient received an expired dose of DTaP.  The reporter did not have the brand name of the vaccine but did provide lot number. The reporter consented to follow up via email. Additional Supportive Information: The patient received an expired dose of DTaP, which led to expired vaccine used. As brand name was not specified by the reporter, the product was captured as reported in the narrative.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes virus test abnormal, Herpes zoster, Laboratory test abnormal, Ophthalmic herpes zoster, Pain
Clinical narrative: Residual neuralgia; 2nd shot Sep2021, Shingles in Aug2022/Vaccination failure; Shingles involved his eye, positive eye test for HZ; Awful case of shingles in Aug2022; Has seen a pain/facial pain management expert; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer (was pre-existing and he was in remission when the Shingrix doses were administered).   In September 2021, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). In August 2022, between 10 and 12 months after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and pain. On an unknown date, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were recovering/resolving and the outcome of the pain and post herpetic neuralgia were not recovered/not resolved.   The reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, pain and post herpetic neuralgia to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 15-FEB-2023 Reporter's comment:  The reporter was the patient.  The patient reported that he had Shingrix shot number 2 in September 2021. He did not know the exact month that he had Shingrix shot number 1 but thight it was a month (or two) prior to shot number 2.  Both shots were given intramuscularly in unspecified arm.  The reporter provided the phone number of the pharmacy where the shots were administered.  The pharmacy should have the exact dates (and lot numbers) on file.  The patient did not have access to this information at the time of the call.  The reporter a provided his primary care physician's (PCP) contact information and gave consent for GSK to follow up with his PCP as the Shingrix dates of administration and lot number data might have been forwarded to the PCP from the pharmacy.  The patient developed an awful case of shingles in August 2022.  The shingles involved his eye.  He had seen several doctors regarding this including an eye doctor, a pain management expert, and a facial pain management specialist. One of his doctors Oncologist suspected it was shingles and administered a test where he, put some kind of a strip on eye and that test came back positive for herpes zoster.  The reporter said that the shingles was not completely resolved.  He said it was a lot better, about 90 percent better but he still was residual neuralgia.  The reporter was consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Post herpetic neuralgia, Vaccination failure
Clinical narrative: Residual neuralgia; 2nd shot Sep2021, Shingles in Aug2022/Vaccination failure; Shingles involved his eye, positive eye test for HZ; Awful case of shingles in Aug2022; Has seen a pain/facial pain management expert; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer (was pre-existing and he was in remission when the Shingrix doses were administered).   In September 2021, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). In August 2022, between 10 and 12 months after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and pain. On an unknown date, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were recovering/resolving and the outcome of the pain and post herpetic neuralgia were not recovered/not resolved.   The reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, pain and post herpetic neuralgia to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 15-FEB-2023 Reporter's comment:  The reporter was the patient.  The patient reported that he had Shingrix shot number 2 in September 2021. He did not know the exact month that he had Shingrix shot number 1 but thight it was a month (or two) prior to shot number 2.  Both shots were given intramuscularly in unspecified arm.  The reporter provided the phone number of the pharmacy where the shots were administered.  The pharmacy should have the exact dates (and lot numbers) on file.  The patient did not have access to this information at the time of the call.  The reporter a provided his primary care physician's (PCP) contact information and gave consent for GSK to follow up with his PCP as the Shingrix dates of administration and lot number data might have been forwarded to the PCP from the pharmacy.  The patient developed an awful case of shingles in August 2022.  The shingles involved his eye.  He had seen several doctors regarding this including an eye doctor, a pain management expert, and a facial pain management specialist. One of his doctors Oncologist suspected it was shingles and administered a test where he, put some kind of a strip on eye and that test came back positive for herpes zoster.  The reporter said that the shingles was not completely resolved.  He said it was a lot better, about 90 percent better but he still was residual neuralgia.  The reporter was consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain of skin, Vaccination failure
Clinical narrative: shingles; Scalp quite painful; Received 2 doses on 2018, shingles on 04-Nov-2022/Suspected vaccination failure; Shingles since both doses, 2 severe cases; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2018, the patient received the 2nd dose of Shingrix. On 28th May 2018, the patient received the 1st dose of Shingrix. On 4th November 2022, 1514 days after receiving Shingrix and 1621 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On 3rd February 2023, the patient experienced shingles and scalp pain. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the shingles and scalp pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, shingles and scalp pain to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter was a retired pharmacist who was also the patient. The reporter reported that for her the vaccine only lasted for 4 years and had 2 severe cases of shingles and other occurrences since received both doses. The reporter stated that after received both Shingrix vaccine the patient experienced shingles episode on her right abdomen. The patient received Valacyclovir as a treatment and the shingles episode was resolved. The reporter stated that on 3rd February 2023, the patient experienced 2nd episode of shingles on scalp and it was quite painful. The reporter stated that the patient received Valacyclovir for a week but it was still painful. The reporter reported that the patient had several other outbreaks but they were not painful and were minimal. The reporter did not had lot numbers and expiration dates. The reporter did not consent to follow up. Additional supportive information: This case was considered as suspected vaccination failure as laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathyin legas and feet; This case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced peripheral neuropathy (serious criteria GSK medically significant). The patient was treated with gabapentin. On an unknown date, the outcome of the peripheral neuropathy was not recovered/not resolved.   It was unknown if the reporter considered the peripheral neuropathy to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-Feb-2023 Reporter's comment: The patient self-reported this case. The patient was now experiencing neuropathy in his legs and feet. The was being treated with Gabapentin. Reporter did not consent to follow up.