chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: cerebral blood clot; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 48-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), 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 (Primary Immunization series completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: CEREBRAL THROMBOSIS (medically significant), 3 months after the suspect product(s) administration, outcome "unknown", described as "cerebral blood clot". The event "cerebral blood clot" required physician office visit.  Additional information: The reporter said that the patient developed a cerebral blood clot three months after the Pfizer Covid Booster. Reporter said that the team of cardiologists and neurologists narrowed down the cause of the blood clot to the mRNA vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; expired dose of RECOMBIVAX HB was administered to a patient; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.   On 23-DEC-2022, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) with expiration date of 22-NOV-2022 (expired product administered), (dose, route, anatomical location, lot number were not reported) for prophylaxis. No additional adverse events were reported.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; No additional AE reported; This spontaneous report was received from a  Health Care Professional and refers to a 2-year-old female. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in right thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose 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 adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA009024:
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No adverse event; VARIVAX was administered to a patient on 12/12/2022 after a supported temperature excursion that took place on 12/1/2022.; This spontaneous report has been received from a Health Professional and refers to a 15-month-old male patient (reported as 13-month-old). The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-DEC-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot number W018825 verified as valid, expiration date upon internal review established as 14-JUN-2024, administered subcutaneously for prophylaxis in the right thigh (strength was not provided) after a temperature excursion that occurred on 01-DEC-2022 at a temperature of 19.47 degree Fahrenheit for 30 minutes (product storage error).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001100:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; HCP reported PROQUAD was administered after a temperature excursion to a patient; This spontaneous report has been received from a registered nurse referring to a patient of unspecified age or gender. Information of concurrent condition, pertinent medical history, concomitant medications and drug reactions/allergies was not reported.  On 24-AUG-2022, the patient administered with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection (lot# U029323, expiration date 19-MAR-2023, once; dose, route of administration, anatomical location and strength were unknown) for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions at 8.42 degree Fahrenheit (F) for 1 hour and 2 minutes (product storage error). There was no previous temperature excursion. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; a patient was administered PROQUAD on 01/04/2023 after a temperature excursion; This spontaneous report has been received from a registered nurse referring to a patient of unspecified age or gender. Information of concurrent condition, pertinent medical history, concomitant medications and drug reactions/allergies was not reported.  On 04-JAN-2023, the patient administered with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection (lot# W019624, expiration date reported as 18-NOV-2023, but upon internal validation established as 19-DEC-2023; dose, route of administration, anatomical location and strength were unknown) for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions at -14 degree Celsius (?) up to -10 ? (-13.6 ?) for 72 hours (product storage error). There was no previous temperature excursion. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Caller explained ROTATEQ was administered to a patient after a temperature excursion.; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 12-JAN-2023, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliters (ml) orally (lot number W020110 which has been verified to be valid, expiration date reported and validated as 13-JUN-2023) as prophylaxis. The administered dose of the vaccine was stored at a temperature of 55.0 degrees Fahrenheit (F), during a time frame of 153 hours (product storage error). There was no previous temperature excursion. No additional adverse events were reported in the patient.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; An HCP is reporting an AE on behalf of a patient. The HCP reports that the patient was administered a dose of PNEUMOVAX 23 after it expired. No additional AE details were provided and no additional AE's were reported. No PQC.; This spontaneous report has been received from pharmacist and refers to an identified patient of unknown age and gender.  Information regarding the patient's medical history, concurrent conditions, concomitant therapies, and past drug allergies or drug reactions were not provided.  On 18-JAN-2023, the patient was vaccinated with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe injection, 0.5 milliliter (mL) (lot #U018309 confirmed to be valid, expiration date reported and stablished as 08-JAN-2023) administered intramuscularly for prophylaxis (strength was not provided) (expired product administered). No additional adverse event (no adverse event).
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Fatigue, Headache, Postural orthostatic tachycardia syndrome
Clinical narrative: Syncope; Postural orthostatic tachycardia syndrome (POTS); Fatigue; Dizziness; Headache; Autonomic Dysfunction; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 24-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date,  the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported). On an unspecified date in 2013, the pt experienced following vaccination syncope, postural orthostatic tachycardia syndrome (POTS), fatigue, dizziness, headache, and autonomic dysfunction. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL).  Upon internal review, the syncope was considered as a medically significant event.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007522: US-009507513-2301USA007524: US-009507513-2301USA007498:
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncope; Postural orthostatic tachycardia syndrome (POTS); Fatigue; Dizziness; Headache; Autonomic Dysfunction; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 24-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date,  the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported). On an unspecified date in 2013, the pt experienced following vaccination syncope, postural orthostatic tachycardia syndrome (POTS), fatigue, dizziness, headache, and autonomic dysfunction. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL).  Upon internal review, the syncope was considered as a medically significant event.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007522: US-009507513-2301USA007524: US-009507513-2301USA007498:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Headache, Orthostatic intolerance, Postural orthostatic tachycardia syndrome
Clinical narrative: Syncope; Postural orthostatic tachycardia syndrome (POTS); Autonomic Dysfunction; Orthostatic Intolerence; Dizziness; Headache; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 24-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date,  the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported). On an unspecified date in 2013, the pt experienced following vaccination syncope, postural orthostatic tachycardia syndrome (POTS), orthostatic intolerance, dizziness, headache, and autonomic dysfunction. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). This is one of multiple cases from the same reporter.   Upon internal review, the syncope was considered as a medically significant event.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007498: US-009507513-2301USA007524: US-009507513-2301USA007521:
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncope; Postural orthostatic tachycardia syndrome (POTS); Autonomic Dysfunction; Orthostatic Intolerence; Dizziness; Headache; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 24-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date,  the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported). On an unspecified date in 2013, the pt experienced following vaccination syncope, postural orthostatic tachycardia syndrome (POTS), orthostatic intolerance, dizziness, headache, and autonomic dysfunction. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). This is one of multiple cases from the same reporter.   Upon internal review, the syncope was considered as a medically significant event.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007498: US-009507513-2301USA007524: US-009507513-2301USA007521:
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Autonomic nervous system imbalance, Dizziness, Headache, Orthostatic intolerance
Clinical narrative: Autoimmune Disorder; Postural orthostatic tachycardia syndrome (POTS); Dizziness; Headache; Orthostatic Intolerence; Autonomic Dysfunction; Palpitations; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 26-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported). On an unspecified date in 2013, the pt experienced following vaccination autoimmune disorder, postural orthostatic tachycardia syndrome (POTS), orthostatic intolerance, dizziness, headache, palpitations, and autonomic dysfunction. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.   Upon internal review, the autoimmune disorder was considered as a medically significant event.; Sender's Comments:  US-009507513-2301USA007498: US-009507513-2301USA007522: US-009507513-2301USA007524: US-009507513-2301USA007521:
Sex: F
Vaccine: HPV4
Symptoms: Palpitations, Postural orthostatic tachycardia syndrome
Clinical narrative: Autoimmune Disorder; Postural orthostatic tachycardia syndrome (POTS); Dizziness; Headache; Orthostatic Intolerence; Autonomic Dysfunction; Palpitations; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 26-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported). On an unspecified date in 2013, the pt experienced following vaccination autoimmune disorder, postural orthostatic tachycardia syndrome (POTS), orthostatic intolerance, dizziness, headache, palpitations, and autonomic dysfunction. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.   Upon internal review, the autoimmune disorder was considered as a medically significant event.; Sender's Comments:  US-009507513-2301USA007498: US-009507513-2301USA007522: US-009507513-2301USA007524: US-009507513-2301USA007521:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Fatigue, Headache, Orthostatic intolerance
Clinical narrative: Syncope; Autonomic Dysfunction; Orthostatic Intolerence; Fatigue; Dizziness; Headache; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 31-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported). On an unspecified date in 2013, the pt experienced following vaccination syncope, orthostatic intolerance, dizziness, headache, fatigue, and autonomic dysfunction. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.   Upon internal review, the syncope was considered as a medically significant event.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007602: US-009507513-2301USA007498: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007521: US-009507513-2301USA007594:
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncope; Autonomic Dysfunction; Orthostatic Intolerence; Fatigue; Dizziness; Headache; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 31-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported). On an unspecified date in 2013, the pt experienced following vaccination syncope, orthostatic intolerance, dizziness, headache, fatigue, and autonomic dysfunction. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.   Upon internal review, the syncope was considered as a medically significant event.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007602: US-009507513-2301USA007498: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007521: US-009507513-2301USA007594:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; Customer reported expired VAQTA was administered to a patient.; This spontaneous report has been received from a nurse referring to a 57-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 16-JAN-2023 the patient has vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA SYRINGE (DEVICE)) 0.5 milligrams, for prophylaxis (lot #U021561 had been verified to be a valid number; expiration date 14-JAN-2023, and upon internal validation established as the same date) (vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported) (expired product administered). There was no adverse effect reported.
Sex: U
Vaccine: MMR, UNK, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs were reported; The patient received first MMR II and VARIVAX  on 1/3/2023 and second MMR II and VARIVAX on 1/16/2023.; This spontaneous report has been received from another health professional referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 03-JAN-2023 the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot #U015682 had been verified to be a valid number; expiration date 18-MAY-2023, and upon internal validation established as the same date) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #U039664 had been verified to be a valid number; expiration date 15-DEC-2023, and upon internal validation established as the same date) both vaccines administered for prophylaxis (dose, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported). Other suspect therapies included sterile diluent (STERILE DILUENT).   On 16-JAN-2023, 14 days after the first dose the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot #U015682 had been verified to be a valid number; expiration date 18-MAY-2023, and upon internal validation established as the same date) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #U039664 had been verified to be a valid number; expiration date 15-DEC-2023, and upon internal validation established as the same date) both vaccines administered for prophylaxis (dose, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported) (inappropriate schedule of product administration). Other suspect therapies included sterile diluent (STERILE DILUENT). There was no adverse effect reported.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: syncope; POTS; dizziness; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 16-year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis. On an unspecified date in 2009 (reported date of injury), the patient experienced Postural orthostatic tachycardia syndrome (POTS), syncope and dizziness. At the time of the report, the patient's outcome was unknown. According to reporter, the events were related to the suspect therapy.   Upon internal review, the event of syncope was considered medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; dose of VARIVAX was administered after a temperature excursion.; This spontaneous report was received from office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JAN-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #W020540, expiration date: reported as 29-JUN-2024, however upon internal validation it was established as 28-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error).  Administered doses of vaccines experienced the temperature excursion of 41.4 degrees Fahrenheit (F) for 1 hour 58 minutes. There was no adverse event reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA008267:Same Reporter US-009507513-2301USA008103:Same Reporter
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reported vaccine administered after temperature excursion.; This spontaneous report has been received from a nurse and refers to a patient of an unknown age and gender. The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 23-JAN-2023, the patient was vaccinated with an improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA (recombinant human albumin)) (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliter (ml), subcutaneously (SQ)(strength and vaccination scheme frequency were not provided; lot number W024973 that was verified to be valid, expiration date reported and established as 05-FEB-2024, for prophylaxis (product storage error).  The administered vaccine experienced a temperature excursion of -13.25 degrees celsius (C) during a time frame of 11 minutes. There was not a previously temperature excursion reported.  There was no additional adverse event (AE) reported (no adverse event).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthritis, Herpes zoster
Clinical narrative: Patient experienced shingles; inflammatory arthritis; This spontaneous report was received from a consumer via GlaxoSmithKline concerning a female patient of unspecified age. The patient's medical history, concurrent conditions and concomitant medications were unknown by the reporter.   On an unspecified date, reported as 10 years prior to receiving varicella zoster vaccine rge (cho) (SHINGRIX), the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) for prophylaxis (dose, route of administration, injection anatomical location, lot # and expiration date were not reported).   On unknown dates, when the patient was around 81 to 82 years old, she received two doses of varicella zoster vaccine rge (cho) (SHINGRIX) (dose, route of administration, injection anatomical location, indication, lot # and expiration date were not reported).  On an unspecified date, when the patient was 84 years old, she experienced shingles (Herpes zoster). Also, on an unknown date, the patient had inflammatory arthritis (Arthritis) and received low dose prednisolone as treatment.   The outcome of the events, and causal relationship between the events and the suspect therapies was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis, Ear pain, Eye pain, Facial paralysis, Headache
Clinical narrative: Paralysis of right face, loss of motor function; Inflammation of right face; loss of motor function; Excruciating pain in right eye; Pain in ear; Pain in teeth; Pain in jaw; Severe migraine; Headches; Lack of sleep; This case was reported by a consumer and described the occurrence of facial paralysis in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 23YG7, expiry date unknown) for prophylaxis.   Concurrent medical conditions included bell's palsy. Concomitant products included prednisone and valaciclovir (Valacyclovir).   On 6th January 2023, the patient received Shingrix. On 7th January 2023, 1 days after receiving Shingrix, the patient experienced facial paralysis (serious criteria GSK medically significant and clinically significant/intervention required), skin inflammation (serious criteria clinically significant/intervention required), motor dysfunction (serious criteria clinically significant/intervention required), eye pain (serious criteria clinically significant/intervention required), ear pain (serious criteria clinically significant/intervention required), toothache (serious criteria clinically significant/intervention required), jaw pain (serious criteria clinically significant/intervention required), migraine (serious criteria clinically significant/intervention required), headache (serious criteria clinically significant/intervention required) and sleep loss (serious criteria clinically significant/intervention required). On an unknown date, the outcome of the facial paralysis, skin inflammation, motor dysfunction, eye pain, ear pain, toothache, jaw pain, migraine, headache and sleep loss were unknown.   It was unknown if the reporter considered the facial paralysis, skin inflammation, motor dysfunction, eye pain, ear pain, toothache, jaw pain, migraine, headache and sleep loss to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR008523   Additional Information: GSK Receipt Date: 18-JAN-2023 Reporter's Comment: The case was self-reported by the patient. The patient received a dose of Shingrix and experienced inflammation or paralysis of right face with loss of motor function with excruciating pain in right eye, ear, teeth and jaw, also the patient had developed severe migraine headaches and lack of sleep. The reporter gave permission to contact. Additional Supportive Information: For tolerance of Pharma product refer link case US2023AMR008523, reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR008523:Same patient/Pharma case
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Migraine, Motor dysfunction, Pain in jaw, Toothache
Clinical narrative: Paralysis of right face, loss of motor function; Inflammation of right face; loss of motor function; Excruciating pain in right eye; Pain in ear; Pain in teeth; Pain in jaw; Severe migraine; Headches; Lack of sleep; This case was reported by a consumer and described the occurrence of facial paralysis in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 23YG7, expiry date unknown) for prophylaxis.   Concurrent medical conditions included bell's palsy. Concomitant products included prednisone and valaciclovir (Valacyclovir).   On 6th January 2023, the patient received Shingrix. On 7th January 2023, 1 days after receiving Shingrix, the patient experienced facial paralysis (serious criteria GSK medically significant and clinically significant/intervention required), skin inflammation (serious criteria clinically significant/intervention required), motor dysfunction (serious criteria clinically significant/intervention required), eye pain (serious criteria clinically significant/intervention required), ear pain (serious criteria clinically significant/intervention required), toothache (serious criteria clinically significant/intervention required), jaw pain (serious criteria clinically significant/intervention required), migraine (serious criteria clinically significant/intervention required), headache (serious criteria clinically significant/intervention required) and sleep loss (serious criteria clinically significant/intervention required). On an unknown date, the outcome of the facial paralysis, skin inflammation, motor dysfunction, eye pain, ear pain, toothache, jaw pain, migraine, headache and sleep loss were unknown.   It was unknown if the reporter considered the facial paralysis, skin inflammation, motor dysfunction, eye pain, ear pain, toothache, jaw pain, migraine, headache and sleep loss to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR008523   Additional Information: GSK Receipt Date: 18-JAN-2023 Reporter's Comment: The case was self-reported by the patient. The patient received a dose of Shingrix and experienced inflammation or paralysis of right face with loss of motor function with excruciating pain in right eye, ear, teeth and jaw, also the patient had developed severe migraine headaches and lack of sleep. The reporter gave permission to contact. Additional Supportive Information: For tolerance of Pharma product refer link case US2023AMR008523, reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR008523:Same patient/Pharma case
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Shingrix 3 years ago and developed GBS; This case was reported by a consumer via other manufacturer and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant and other: serious as per reporter). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-Jan-2023 Reporter's Comments: The patient had the Shingrix vaccine 3 years ago from reporting and developed Guillain barre syndrome.
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Extensive swelling of vaccinated limb, Feeling hot, Pruritus
Clinical narrative: Extensive swelling of vaccinated limb/swelling; Arm redness, large red area; Itching, itchiness; puffy skin; Arm Heat; Temp 99.3 degrees; This case was reported by a consumer and described the occurrence of extensive swelling of vaccinated limb in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 11th January 2023, the patient received the 1st dose of Shingrix. On 11th January 2023, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, erythema of extremities, pruritus and puffy skin. In January 2023, the patient experienced extremities hot feeling of and body temperature increased. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities, pruritus and puffy skin were not recovered/not resolved and the outcome of the extremities hot feeling of and body temperature increased were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities, pruritus, extremities hot feeling of, body temperature increased and puffy skin to be related to Shingrix.  Additional Information: GSK Receipt Date: 16-JAN-2023 Reporter's Comment: The case was reported by the patient. The reporter stated that it had been 4 days.  Her arm had large red area with itchiness and heat (Just to temperature 99.3 degrees F). The patient also experienced puffy skin.  The arm redness, swelling, puffy skin and itching and the symptoms were not treated. Permission to contact the reporter. Additional Supportive Information: Fever was not captured as event because it was not cleared if patient experienced it or not. Additional Supportive Information: The case US2023005866 was found to be duplicate of case US2023006720. Hence case US2023006720 would be deleted and all the information of this case would be added in case US2023005866 which was the case of record for this patient.
Sex: F
Vaccine: VARZOS
Symptoms: Skin swelling
Clinical narrative: Extensive swelling of vaccinated limb/swelling; Arm redness, large red area; Itching, itchiness; puffy skin; Arm Heat; Temp 99.3 degrees; This case was reported by a consumer and described the occurrence of extensive swelling of vaccinated limb in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 11th January 2023, the patient received the 1st dose of Shingrix. On 11th January 2023, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, erythema of extremities, pruritus and puffy skin. In January 2023, the patient experienced extremities hot feeling of and body temperature increased. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities, pruritus and puffy skin were not recovered/not resolved and the outcome of the extremities hot feeling of and body temperature increased were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities, pruritus, extremities hot feeling of, body temperature increased and puffy skin to be related to Shingrix.  Additional Information: GSK Receipt Date: 16-JAN-2023 Reporter's Comment: The case was reported by the patient. The reporter stated that it had been 4 days.  Her arm had large red area with itchiness and heat (Just to temperature 99.3 degrees F). The patient also experienced puffy skin.  The arm redness, swelling, puffy skin and itching and the symptoms were not treated. Permission to contact the reporter. Additional Supportive Information: Fever was not captured as event because it was not cleared if patient experienced it or not. Additional Supportive Information: The case US2023005866 was found to be duplicate of case US2023006720. Hence case US2023006720 would be deleted and all the information of this case would be added in case US2023005866 which was the case of record for this patient.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only the liquid portion was administered; Only the liquid portion was administered; This case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced 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: 17-Jan-2023. Reporter's Comments: Only the liquid portion of Menveo from 2 vial presentation was administered to a patient. Reporter stated that she had a call from another HCP that only the liquid portion of Menveo was administered. The reporter did not consent to follow-up. Additional Supportive Information: Patient received only the liquid portion of Menveo from 2 vial presentation, which led to inappropriate preparation of medication and inappropriate dose of vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness, side effect; tingling in arms and legs, side effect; This case was reported by a consumer via interactive digital media and described the occurrence of numbness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced numbness and tingling of extremity. On an unknown date, the outcome of the numbness and tingling of extremity were unknown.   It was unknown if the reporter considered the numbness and tingling of extremity to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 18-Jan-2023. Reporter's Comment: This case was reported by a consumer via (Shingrix GSK) interactive digital media.  The reporter reported after getting the shingles vaccine, could experience side effects like numbness and tingling in arms and legs a side effect from the vaccine. Follow-up would not possible as no contact details were available.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 23-year-old female patient who received HBV (Engerix B) (batch number N4GA4, expiry date 2nd January 2023) for prophylaxis.   On 13th January 2023, the patient received the 1st dose of Engerix B. On 13th January 2023, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 17-Jan-2023 Reporter's comment: Office staff member reported that a medical assistant administered a dose of Engerix-B vaccine which had an expired. This was the patient's first dose in the series.  At the time of reporting, the dose had not been repeated.  The reporter gave permission for follow-up. Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered by error a Shingrix adjuvant portion only; Administered by error a Shingrix adjuvant portion only; This case was reported by a physician via call center representative 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 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: 18-JAN-2023 Reporter's Comment: The reporter was a medical assistant reported on behalf of the physician. The reporter reported that they were administered Shingrix adjuvant portion only by error to the patient. The healthcare professional was disconnected the call and no other information was possible to obtain. Although agent was called several times to the phone number provided and finally, a front desk assistant confirmed that the physician had already received medical information on this scenario. The reporter did consent to follow up. Additional supportive information: The reporter gave by error only adjuvant of shingrix administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only liquid portion was used; Only liquid portion was administered; This case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 14th January 2023, the patient received Menveo. On 14th January 2023, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt date: 18-Jan-2023. Reporter's Comments: The patient received Menveo on an unknown arm. The reporter stated that the liquid portion of the vaccine was injected. The reporter consented to follow up. Additional Supportive Information: The patient was injected only the liquid portion of Menveo which led inappropriate preparation of medication and inappropriate dose of vaccine administered .
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 3 years ago, never completed the series; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about 3 years ago).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 18-JAN-2023 Reporter's Comments: The case was reported by the husband of the patient. The reporter reported that the patient received first dose of Shingrix three years ago but never completed the series. The reporter reported that the patient plans on getting the second dose as soon as possible. Details reported for 1st dose. 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. The case was linked with case US2023007568, reported by same reporter.; Sender's Comments:  US-GSK-US2023007568:Same reporter
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: received 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 unknown, expiry date 1st January 2023) 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 18th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 18th January 2023, 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 Information: GSK Receipt Date: 19-Jan-2023 Reporter's Comments: The pharmacist reported that a patient inadvertently received an expired dose of Twinrix. The reporter consented to follow up. The healthcare professional could not provide the patient demographics or lot number of dose Additional supportive information: The patient was administered an expired dose of Twinrix, which led to expired vaccine used.