chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, Incorrect dose administered, No adverse event
Clinical narrative: No additional AE/PQC; Adult patient was inadvertently administered a pediatric dose of VAQTA; Adult patient was inadvertently administered a pediatric dose of VAQTA/Expiration date 06-FEB-2022; This spontaneous report was received from a certified medical assistant concerning a 38-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.   On 27-MAY-2022, the patient was inadvertently vaccinated with a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA) 0.5 ml, lot # U013476, for prophylaxis (Lot No. U013476 has been verified to be a valid lot number for Hepatitis A Vaccine, Inactivated, expiration date reported as 06-FEB-2023, but upon internal validation established as 06-FEB-2022) (dose number, route of administration and anatomical location were not provided) (Incorrect dose administered) (Expired product administered). No additional adverse events were reported (No adverse event).
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE.; expired diluent was used to reconstitute VARIVAX; expired diluent was used to reconstitute VARIVAX and administered to a patient; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 15-JUN-2022, expired sterile diluent solution for injection/infusion (lot #T000495, expiration date: 03-JUN-2022) was used to reconstitute varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot #U039722, expiration date: 15-DEC-2023, indication: prophylaxis) and administered to the patient (product preparation issue and expired product administered). Regrading the suspect drug/vaccine, strengths, doses and routes of administration were not reported. Varicella virus vaccine live (oka/merck) (VARIVAX) was not expired, neither product experienced a temperature excursion.  No additional AE details provided, no additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE occurred; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-JUN-2022, the patient was vaccinated with improperly stored vaccine of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (dose: 1 dose, lot #: U039948, expiration date: 16-DEC-2023; route and strength were unknown) for prophylaxis (Product storage error).   The vaccine underwent temperature excursion of -2.5 Celsius for 5 hours and 6 minutes.  There was no previous temperature excursion. No other adverse event (AE) occurred.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2206USA005711: US-009507513-2206USA005697: US-009507513-2206USA005588: US-009507513-2206USA005579:
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: she was a little sick; experienced injection site pain; experienced injection site pain and swelling; This spontaneous report was received from a female consumer of an unknown age, referring to herself. Her medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date in June 2022 (reported as "a few days ago"), the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) injection (route of administration, dosage, exact anatomical location, lot # and expiration date were not reported) for prevention of pneumococcal disease.  On an unknown date in June 2022, the patient was a little sick and experienced injection site pain and swelling for a few days following vaccination. It was stated that at the time of reporting, the patient was fine and her reaction was as expected for immunizations. The outcome of the events was recovered.  The causality assessment between the suspect vaccine and the events was related.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse events; Caller is medical assistant reporting that 2 patients had received second dose of GARDASIL 9  one year after first dose; This spontaneous report was received from a medical assistant, referring to a 16-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not provided.  On 21-JUN-2021, the patient was vaccinated with the first dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, strength, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 22-JUN-2022 the patient was vaccinated with the second dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, strength, route of administration, anatomical location, lot# and expiration date were not provided), which was over 1 year after his initial first dose (inappropriate schedule of product administration). No additional adverse events were reported (no adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA006986:MSD
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; Caller is a medical assistant who reports six expired doses of VAQTA were administered;; This spontaneous report was received from a medical assistant and referring to a patient of an unknown age and gender.  The patient's medical history concurrent conditions drugs reactions or allergies and concomitant medication was not provided.  On 17-JUN-2022, the patient was vaccinated with an expired dose of  hepatitis a vaccine, inactivated (VAQTA), intramuscular injection, at a dose of 0.5 milliliter once, lot number T031201, expiration date: 14-JUN-2022, as prophylaxis (strength, vaccination scheme, anatomical location of administration and route of administration were not provided) for prophylaxis (expired product administered).  It was stated that the patient had no adverse effects or symptoms from this dose. It was also mentioned that there was no previous temperature excursion.  This is one 5 reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA007065: US-009507513-2206USA007033: US-009507513-2206USA006900: US-009507513-2206USA006955: US-009507513-2206USA006951:
Age: 2.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; Caller is a nurse who reports PEDVAXHIB has been administered to a patient following temperature excursion. See case 02192612 for AE report for another vaccine which was also in the same excursion and also administered. No further information was pro; This spontaneous report was received from a nurse, referring to a 2-year-old patient of unknown gender. Information about the patient's medical history, concurrent conditions and concomitant medications was not provided.  On 10-JUN-2022, the patient was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # U034519, expiration date reported as 08-MAR-2024 but established to be 28-MAR-2024 (dose and route of administration were not reported) for prophylaxis (Product storage error). Administered dose of vaccine experienced the temperature of 47.7 degrees Fahrenheit for 12 minutes. There were no previous excursions and no other adverse events reported (No adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007901:MSD
Sex: U
Vaccine: MMR
Symptoms: Accidental exposure to product, No adverse event, Occupational exposure to product
Clinical narrative: No additional AEs were reported; assistant got some of MMR II vaccine splashed into the eyes while handling a syringe which contained reconstituted MMR II; assistant got some of MMR II vaccine splashed into the eyes while handling a syringe which contained reconstituted MMR II; This spontaneous report was received from an office manager and refers to a medical assistant of unknown age and gender.  On 24-JUN-2022, the medical assisstant got some of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA) lot #U031359, expiration date: 07-OCT-2023 splashed into the eyes while handling a syringe (occupational exposure to product, accidental exposure to product). No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient did not experience any adverse effects from intramuscular injection. No additional AE; HCP reporting that PROQUAD was given intramuscularly instead of subcutaneously.; This spontaneous report was received from a registered pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 24-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered intramuscularly instead of subcutaneously (dose, dose number, anatomical location, lot # and expiration date were not provided) for prophylaxis (incorrect route of product administration). The patient did not experience any adverse effects from intramuscular injection, no additional adverse event was reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Nurse reported a patient was administered an expired dose of MMR II.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 27-JUN-2022, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (rHA) (M-M-R II) subcutaneous injection, lot # T020655, expiration date 16-JUN-2022 (dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). The reporter confirmed that the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II) had no temperature excursions and was provided the supported disclaimer based on the information in the Post Expiry Memo. No additional adverse events were reported (no adverse event).
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Medical Assistant calling in to report a temperature excursion on GARDASIL 9. Medical Assistant reports the vaccine was administered to a patient.; This spontaneous report was received from a medical assistant and refers to a 15-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 22-JUN-2022, the patient was vaccinated with improperly stored (product storage error) dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe, 1 time dose, lot #: T028929, expiration date: 08-MAR-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. No additional information regarding temperature excursion was provided. There was no additional adverse event reported.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No symptomatic side effects. No additional AE; patient was administered VARIVAX intramuscularly instead of subcutaneously.; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant therapies were not provided.   On 10-MAY-2022, the patient received a dose of varicella virus vaccine live (Oka/Merck) injection, by intramuscular route as prophylaxis (lot number U007471 which has been verified to be valid, expiration date reported and validated as 08-MAR-2023) (dose was unknown by the reporter; strength, vaccination scheme, and anatomical site of injection were not reported) (incorrect route of product administration). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), lot number T030955 and expiration date 23-APR-2023 (dose was unknown by the reporter). The reporter mentioned that the patient had no symptomatic side effects (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient older than 13 years of age was administered PROQUAD instead of MMR II and VARIVAX; patient older than 13 years of age was administered PROQUAD instead of MMR II and VARIVAX; This spontaneous report was received from the nurse and refers to a patient of an unknown gender and exact age (reported as older than 13 years of age). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (product administered to patient of inappropriate age) (wrong product administered).; Sender's Comments:  US-009507513-2207USA000734: US-009507513-2207USA000538: US-009507513-2207USA000766:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: No additional AE reported; Caller reports that the third dose of ROTATEQ was accidentally administered on 1-JUL-2022 at 9 months age; Caller reports that the third dose of ROTATEQ was accidentally administered on 1-JUL-2022 at 9 months age; Caller reports that dose 1 was administered on 23-NOV-2021 and dose 2 was administered on 15-FEB-2022; This spontaneous report was received from a nurse and refers to a 9-month-old at the reporting time patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 23-NOV-2021, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (exact dose, strength, lot # and expiration date were not provided) for prophylaxis. On 15-FEB-2022, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (exact dose, strength, lot # and expiration date were not provided) for prophylaxis (product use issue). On 01-JUL-2022, the patient was accidentally vaccinated with the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml, lot #: U037815, expiration date: 28-MAY-2023, administered orally (strength was not provided) for prophylaxis at 9 months of age (product use issue; product administered to patient of inappropriate age). There was no additional adverse event reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report was received from a lawyer and a patient (pt) of unknown age and gender regarding a case in litigation on 01-JUL-2022. The pt's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around July 2017, the pt was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for the prevention of shingles. Shortly after the vaccine, the pt suffered shingles. As a result of these symptoms, the pt had experienced physical limitations not present prior vaccinations. The pt also experience mental and emotional distress due to resulting physical limitations and serious condition. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of patients conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damage. At the reporting time, the outcome of shingles was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered herpes zoster to be disabling event.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: SHINGLES; This spontaneous report was received from a lawyer and a patient (pt) of unknown age and gender regarding a case in litigation on 01-JUL-2022. The pt's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around July 2017, the pt was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for the prevention of shingles. Shortly after the vaccine, the pt suffered shingles. As a result of these symptoms, the pt had experienced physical limitations not present prior vaccinations. The pt also experience mental and emotional distress due to resulting physical limitations and serious condition. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of patients conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of shingles was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered herpes zoster to be disabling event.
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A patient older than 13 years of age was administered PROQUAD instead of MMR II and VARIVAX; A patient older than 13 years of age was administered PROQUAD instead of MMR II and VARIVAX; This spontaneous report was received from a nurse referring to an unknown age and gender patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 24-JUN-2022, a patient older than 13 years of age  was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection and  varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, doses, and routes of administration, lot numbers and expiration dates were not provided) (product administered to patient of inappropriate age)(wrong product administered).
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Anxiety, Autoimmune disorder, Conversion disorder, Dizziness
Clinical narrative: functional neurological disorder; functional limb weakness; Postural Orthostatic Tachycardia ("POTS").; vision disorder; speech symptoms; functional movement disorder; central and vestibular abnormalities; central and vestibular abnormalities; Other Related Injuries; autoimmune disease; First dose on 14-AUG-2018 and second dose on 10-SEP-2019; Information was received from a lawyer regarding a case in litigation and refers to a 13 year old female patient. Prior to receiving her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, she had no autoimmune diseases and no autonomic issues. Information about historical drugs and concomitant medications were not reported.  On 14-AUG-2018 and 10-SEP-2019, the patient was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) respectively for prophylaxis (dose, route, lot number and expiration date were not reported) (Inappropriate schedule of vaccine administered).  On 10-SEP-2019 at the evening, she began falling out of her turns, later that week began to experience tremors and dizzy spells. As the months progressed, she was seen by multiple physicians for her complaints which now included: tunnel vision, headaches, tremors, dizziness, severe lethargy, anxiety, elevated heart rate and painful periods.  As a result of her post-Gardasil symptoms, the patient was unable to engage in normal activities that a normal young person could enjoy. Due to her unrelenting stomach aches, headaches, constant dizziness, tremors, fatigue, and extremely elevated heart rate, she now struggles in school and could not complete tasks she could before the Gardasil vaccine. Because it was so difficult for her to learn, her grades in school had suffered and that is affecting her ability to attend college.   On an unknown date she was diagnosed with functional neurological disorder (conversion disorder), nervous system disorder (medically significant), vestibular disorder (medically significant), functional movement disorder, functional speech symptoms, functional vision disorder, postural orthostatic tachycardia syndrome (POTS), functional muscular weakness, autoimmune disease and other related injuries (ill-defined disorder).      The outcome of conversion disorder, nervous system disorder, vestibular disorder, movement disorder, speech disorder, visual impairment, postural orthostatic tachycardia syndrome, muscular weakness, autoimmune disease and ill-defined disorder was unknown.     The reporter considered conversion disorder, nervous system disorder, vestibular disorder, movement disorder, speech disorder, visual impairment, postural orthostatic tachycardia syndrome, muscular weakness, autoimmune disease and ill-define disorder to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).     It was reported that the events had resulted in her suffering from severe, serious, disabling and painful chronic Injuries.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, Fall, Fatigue, Headache, Heart rate increased
Clinical narrative: functional neurological disorder; functional limb weakness; Postural Orthostatic Tachycardia ("POTS").; vision disorder; speech symptoms; functional movement disorder; central and vestibular abnormalities; central and vestibular abnormalities; Other Related Injuries; autoimmune disease; First dose on 14-AUG-2018 and second dose on 10-SEP-2019; Information was received from a lawyer regarding a case in litigation and refers to a 13 year old female patient. Prior to receiving her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, she had no autoimmune diseases and no autonomic issues. Information about historical drugs and concomitant medications were not reported.  On 14-AUG-2018 and 10-SEP-2019, the patient was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) respectively for prophylaxis (dose, route, lot number and expiration date were not reported) (Inappropriate schedule of vaccine administered).  On 10-SEP-2019 at the evening, she began falling out of her turns, later that week began to experience tremors and dizzy spells. As the months progressed, she was seen by multiple physicians for her complaints which now included: tunnel vision, headaches, tremors, dizziness, severe lethargy, anxiety, elevated heart rate and painful periods.  As a result of her post-Gardasil symptoms, the patient was unable to engage in normal activities that a normal young person could enjoy. Due to her unrelenting stomach aches, headaches, constant dizziness, tremors, fatigue, and extremely elevated heart rate, she now struggles in school and could not complete tasks she could before the Gardasil vaccine. Because it was so difficult for her to learn, her grades in school had suffered and that is affecting her ability to attend college.   On an unknown date she was diagnosed with functional neurological disorder (conversion disorder), nervous system disorder (medically significant), vestibular disorder (medically significant), functional movement disorder, functional speech symptoms, functional vision disorder, postural orthostatic tachycardia syndrome (POTS), functional muscular weakness, autoimmune disease and other related injuries (ill-defined disorder).      The outcome of conversion disorder, nervous system disorder, vestibular disorder, movement disorder, speech disorder, visual impairment, postural orthostatic tachycardia syndrome, muscular weakness, autoimmune disease and ill-defined disorder was unknown.     The reporter considered conversion disorder, nervous system disorder, vestibular disorder, movement disorder, speech disorder, visual impairment, postural orthostatic tachycardia syndrome, muscular weakness, autoimmune disease and ill-define disorder to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).     It was reported that the events had resulted in her suffering from severe, serious, disabling and painful chronic Injuries.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Tunnel vision, Vestibular disorder, Visual impairment
Clinical narrative: functional neurological disorder; functional limb weakness; Postural Orthostatic Tachycardia ("POTS").; vision disorder; speech symptoms; functional movement disorder; central and vestibular abnormalities; central and vestibular abnormalities; Other Related Injuries; autoimmune disease; First dose on 14-AUG-2018 and second dose on 10-SEP-2019; Information was received from a lawyer regarding a case in litigation and refers to a 13 year old female patient. Prior to receiving her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, she had no autoimmune diseases and no autonomic issues. Information about historical drugs and concomitant medications were not reported.  On 14-AUG-2018 and 10-SEP-2019, the patient was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) respectively for prophylaxis (dose, route, lot number and expiration date were not reported) (Inappropriate schedule of vaccine administered).  On 10-SEP-2019 at the evening, she began falling out of her turns, later that week began to experience tremors and dizzy spells. As the months progressed, she was seen by multiple physicians for her complaints which now included: tunnel vision, headaches, tremors, dizziness, severe lethargy, anxiety, elevated heart rate and painful periods.  As a result of her post-Gardasil symptoms, the patient was unable to engage in normal activities that a normal young person could enjoy. Due to her unrelenting stomach aches, headaches, constant dizziness, tremors, fatigue, and extremely elevated heart rate, she now struggles in school and could not complete tasks she could before the Gardasil vaccine. Because it was so difficult for her to learn, her grades in school had suffered and that is affecting her ability to attend college.   On an unknown date she was diagnosed with functional neurological disorder (conversion disorder), nervous system disorder (medically significant), vestibular disorder (medically significant), functional movement disorder, functional speech symptoms, functional vision disorder, postural orthostatic tachycardia syndrome (POTS), functional muscular weakness, autoimmune disease and other related injuries (ill-defined disorder).      The outcome of conversion disorder, nervous system disorder, vestibular disorder, movement disorder, speech disorder, visual impairment, postural orthostatic tachycardia syndrome, muscular weakness, autoimmune disease and ill-defined disorder was unknown.     The reporter considered conversion disorder, nervous system disorder, vestibular disorder, movement disorder, speech disorder, visual impairment, postural orthostatic tachycardia syndrome, muscular weakness, autoimmune disease and ill-define disorder to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).     It was reported that the events had resulted in her suffering from severe, serious, disabling and painful chronic Injuries.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: outbreaks of herpes zoster; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.      On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles.   On an unknown date, the patient suffered multiple outbreaks of herpes zoster and was treated by medical providers.      The outcome of herpes zoster was not recovered/not resolved.     The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     The patient's symptoms had resulted severe and permanent personal injuries.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; rash on her front, side and back  has not gone away; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2022, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR101725   Additional Information: GSK Receipt Date: 01-JULY-2022 Reporter's Comment:  The patient stated, received her first dose of Shingrix a month prior to the reporting. The patient stated that a few days after her dose, patient experienced a rash on her front, side and back which was diagnosed as shingles by her doctor. The patient had been taking Valtrex to treat the shingles. The rash had not gone away.  The reporter did not consent to follow up. Additional supportive information: This case has been linked to the case US2022AMR101725 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR101725:same patient
Sex: U
Vaccine: TDAP
Symptoms: Device connection issue, Incorrect dose administered, Product complaint
Clinical narrative: leaking when administered; leaking issue; Product Complaint; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 22MS7, expiry date 1st April 2024) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incomplete dose administered, syringe connection issue and pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered, syringe connection issue and pharmaceutical product complaint 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: 1-Jul-2022  Reporter's comment: The nurse from the clinic reported that 3 doses of Boostrix were leaking from the connection hub when administered to 3 different patients. The reporter was unable to confirm what type needle was attached to the syringe for the administration but stated that the luer lock device appeared to be attached crooked.  The content questions were asked as  where did the vaccine leak,  at the luer lock connection hub.  The syringe was not pre-assembled with needle some time before administration.  The size of gauge needle was uncertain.  The reporter will call back with additional information when she returns to the office.  The reporter believed it was 22G. Product quality complaint was filed. No blister and/or carton damaged.  No luer lock was damaged.  The needle used to administer was discarded in sharps container but the reporter will return an unused needle of the same type that was used during administration.  The reporter reported that she had emailed in pictures and might be attached to parent case.  The reporter was unable to provide GlaxoSmithKline information and will call back with information.  The reporter did not have specific patient identifiers.  No further information provided.  The consent to contact patient's health care professional unable to be obtained. Additional supportive information: The vaccine was leaking from the connection hub when administered to the patient which led to incomplete dose administered and syringe connection issue. The case was 1 of 3 linked cases. Follow-up request was raised for the patient's gender.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104308:Same reporter US-GLAXOSMITHKLINE-US2022AMR104307:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Large patch of redness and rash; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced red rash. On an unknown date, the outcome of the red rash was not recovered/not resolved.   It was unknown if the reporter considered the red rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 03-JUL-2022. Reporter's Comments: This case was reported by a consumer via interactive digital media The patient had large patch of redness and rash. The patient asked what should he/she do.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: took vaccination on 12/31/2019, dont know if it was Part 1; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 31st December 2019). Concurrent medical conditions included aphasia ((difficulty speaking)).   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:  02-JUL-2022 and 5-JUL-2022 Reporter's Comments: The patient took the Shingrix vaccination on 31st December 2019. She did not know if it was Part 1 of the 2nd shot regime. Outbound call was made. She mentioned that she had aphasia (difficulty speaking). She indicated this was a pre-existing condition that she had prior to receiving Shingrix. The patient indicated she thought that the shot she got was shot 2 but pharmacy in records only go back so far and they could not confirm when shot 1 was received. No further information was gathered due to customer wanting to get off the phone. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: TDAP
Symptoms: Device connection issue, Syringe issue, Underdose
Clinical narrative: leaking when administered; leaking issue; Product Complaint; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 22MS7, expiry date 1st April 2024) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incomplete dose administered, syringe connection issue and pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered, syringe connection issue and pharmaceutical product complaint 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: 1-Jul-2022  Reporter's comment: The nurse from the clinic reported that 3 doses of Boostrix were leaking from the connection hub when administered to 3 different patients. The reporter was unable to confirm what type needle was attached to the syringe for the administration but stated that the luer lock device appeared to be attached crooked.  The content questions were asked as  where did the vaccine leak,  at the luer lock connection hub.  The syringe was not pre-assembled with needle some time before administration.  The size of gauge needle was uncertain.  The reporter will call back with additional information when she returns to the office.  The reporter believed it was 22G. Product quality complaint was filed. No blister and/or carton damaged.  No luer lock was damaged.  The needle used to administer was discarded in sharps container but the reporter will return an unused needle of the same type that was used during administration.  The reporter reported that she had emailed in pictures and might be attached to parent case.  The reporter was unable to provide GlaxoSmithKline information and will call back with information.  The reporter did not have specific patient identifiers.  No further information provided.  The consent to contact patient's health care professional unable to be obtained. Additional supportive information: The vaccine was leaking from the connection hub when administered to the patient which led to incomplete dose administered and syringe connection issue. The case was 2 of 3 linked cases. Follow-up request was raised for the patient's gender.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022103828:Same reporter US-GLAXOSMITHKLINE-US2022AMR104308:Same reporter
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administrated an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-year-old male patient who received DTPa (Infanrix) (batch number ng5gf, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 29th June 2022, unknown after receiving Infanrix and Infanrix 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: 01-JULY-2022 Reporter's Comment: The Medical assistance stated that patient was administrated with an expired dose of Infanrix. No adverse event was reported . The reporter consented to follow up. Additional supportive information The patient administered expired dose of Infanrix, which led to expired vaccine used.
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered dose expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 53-year-old female patient who received HAV (Havrix adult) (batch number EK59B, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 30th June 2022, unknown after receiving Havrix adult and Havrix 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: 01-JULY-2022 Reporter's Comment: The reporter stated that patient was administrated with an expired dose of Havrix. The patient had not reported any side effects, thus far. Reporter consented to follow up. Additional supportive information The patient administered expired dose of Havrix, which led to expired vaccine used.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient received a 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 9Y92A, expiry date 28th June 2023) for prophylaxis.   Previously administered products included Shingrix (2 doses received on an unknown dates).   On 28th June 2022, the patient received the 3rd dose of Shingrix. On 28th June 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 1st July 2022. Reporter's Comments: The patient received 3rd dose of Shingrix. The consent to follow up was granted. Additional supportive information: The patient received 3rd dose of Shingrix, which led to extra dose administered. This case was linked with US2022101099, reported by same reporter for patient's wife.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022101099:same report, other patient
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Inappropriate schedule of product administration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: heat at the injection site/ hot at injection site; pain at injection site; redness at injection site; chills; first dose well over a year ago, second dose in March 2022; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over a year ago before reporting date).   In March 2022, the patient received the 2nd dose of Shingrix (intramuscular). In March 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In 2022, the patient experienced injection site warmth, injection site pain, injection site redness and chills. On an unknown date, the outcome of the injection site warmth, injection site pain, injection site redness and chills were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site warmth, injection site pain, injection site redness and chills to be related to Shingrix.     Additional Information: GSK Receipt Date: 1-JUL-2022 Reporter's Comments: The reporter was the patient.  She received her first Shingrix dose well over a year ago and second dose was in March 2022 which led to lengthening of vaccination schedule.  In 2022, less than 4 months after receiving Shingrix, the patient experienced injection site warmth (heat at the injection site), injection site pain, injection site redness and chills. These effects lasted two or three days. She had nothing else to report.  The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired dose of Menveo administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA517A, expiry date 30th April 2022) for prophylaxis.   On 16th June 2022, the patient received Menveo. On 16th June 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 01-JUL-2022. Reporter's Comments: The patient was vaccinated with Menveo which was already expired. The Vaccine Administration Facility was the same as Primary Reporter. It was reported that they were forgot to asked about follow up. Additional supportive information: The patient administered expired dose of Menveo, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late on receiving 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's Comments: The pharmacist stated that he had a couple of patients come in who were late on receiving their 2nd dose of Shingrix. The HCP did not have any additional information (patient demographics) at this time. The reporter consented to follow up via postal. Additional supportive information: The patients received their 2nd dose of Shingrix late which led to Drug dose administration interval too long.