chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEPA, PPV
Symptoms: Rash pruritic, Skin erosion, Skin lesion, Skin plaque
Clinical narrative: pneumococcal vaccine used in 15 months old patient; erythema multiforme; Literature report:   This literature marketed report has been received from authors of the literature article entitled as stated above and refers to a 15-month-old male patient. He was otherwise healthy. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) four doses (Inappropriate age) and hepatitis a vaccine, inactivated (manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported for both) for prophylaxis. On an unknown date, he presented to dermatology with a 12-day history of a generalized eruption consisting of raised pruritic plaques. Several plaques had central and linear erosions. The patient had no other symptoms and was afebrile. The parents of the patient report no relevant changes in diet, linen, or environment, and no drugs had been administered prior to the outbreak, but the patient had recently received an initial dose of hepatitis a vaccine, inactivated (manufacturer unknown) and the 4th dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). The rash was localized to lower extremities and temples 5 days post-vaccination, with an onset 3 days post-vaccination. Pediatricians advised applying hydrocortisone 1% cream to the plaques and giving colloidal oatmeal baths. Eight days post-vaccination new lesions formed. An oral H1 histamine antagonist, triamcinolone 0.1%, and mupirocin 2% ointments were added to the patient's treatment. Eleven days post-vaccination, new lesions continued to arise. The child was prescribed prednisone (15mg/5mL solution, 1mg/kg/dose, for 5 days) and referred to dermatology. During the physical examination, the patient was alert, afebrile, and appeared to be a healthy growing toddler. Physical examination revealed multiple well-defined, circular, erythematous plaques with a darker central vesicle on the extremities. Trunk, mucosal surfaces, and the palmoplantar regions were spared. Due to the history, physical findings, and the correlation of the eruption following vaccination, the patient was diagnosed with erythema multiforme (EM). Sixteen days post-vaccination, following a 10-day course of oral prednisone, most of the lesions had resolved with no new outbreaks. The authors considered the event of erythema multiforme to be related to suspect vaccines.  Upon internal review, the event of erythema multiforme was considered to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AE.; A 20 years old patient receiving a pediatric dose of RECOMBIVAX HB; This spontaneous report has been received from a nurse, concerning a 20-year-old patient of unknown gender.  Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 11-JUL-2022, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) thimerosal free (RECOMBIVAX HB) at a dose of 0,5 milligram, intramuscularly, for prophylaxis (frequency and anatomical injection site were not provided) (lot number W012032 has been verify to be a valid lot number with expiration date on 19-NOV-2023) (inappropriate age at vaccine administration). No additional adverse event.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pharmacist calling to report that a patient received a dose of VARIVAX in 1996 and is now coming back to finish the series.; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.   On an unspecified date in 1996, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, lot #, expiry date, and route of administration were not provided), administered as prophylaxis, and at the reporting time, the patient went back to finish the series (inappropriate schedule of product administration).
Sex: F
Vaccine: MMR, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE reported.; patient was administered MMRII [T033814 10/5/2022] and PROQUAD [U026794 2/26/2023], instead of MMRII and VARIVAX.; patient was administered MMRII [T033814 10/5/2022] and PROQUAD [U026794 2/26/2023], instead of MMRII and VARIVAX.; This spontaneous report was received from a medical assistant and refers to an 18-month-old female patient. Her medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUL-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot number U026794, expiration date: 26-FEB-2023 (dose, strength, and route of administration were not provided), and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, lot number T033814, expiration date: 05-OCT-2022 (dose, strength, and route of administration were not provided) both administered for prophylaxis (overdose); instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (dose, strength, lot number, expiration date, and route of administration were not provided) (wrong product administered). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD was administered to a patient after a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 13-JUL-2022, the patient was vaccinated with an improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W007744, expiration date 04-SEP-2023, once for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of 12.6 degree Fahrenheit (°F) for 1 Hour 6 Minutes. There was no previous temperature excursion reported. No additional adverse event reported. No product quality complaint (PQC) reported.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: HCP calling to report administration of ROTATEQ during temperature excursion on 7/14/22; This spontaneous report has been received from a nurse, regarding a 4-months-old male patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 14-JUL-2022, the patient was vaccinated with an improperly storage dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml orally, 3 doses every 4-10 week intervals, as prophylaxis (strength, lot number, and expiration date were not provided) (product storage error). Temperature and period of time of the temperature excursion were not provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA005211: US-009507513-2207USA005319: US-009507513-2207USA005454:
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: HCP calling to report administration of VAQTA during temperature excursion on 7/14/22; This spontaneous report has been received from a nurse, regarding a 2-year-old male patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 14-JUL-2022, the patient was vaccinated with an improperly storage dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliters, once as prophylaxis (route and anatomical location of administration, lot number and expiration date were not reported) (product storage error). Temperature and period of time of the temperature excursion was not provided.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No additional AEs were reported.; Nurse reported that a patient received an expired ROTATEQ.; This spontaneous report was received from a licensed practical nurse concerning a 10-week-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, and concomitant medications were not provided.   On 14-JUL-2022, the patient received orally an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot # 1742079, expiration date 08-JUL-2022 for prophylaxis (Expired product administered) (Dose was not provided). No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported.; Nurse reported that a patient received an expired ROTATEQ.; This spontaneous report was received from a licensed practical nurse concerning a 7-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, and concomitant medications were not provided.   On 14-JUL-2022, the patient received an expired first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot # 1742079, expiration date 08-JUL-2022 for prophylaxis (Expired product administered) (Dose, route of administration, and anatomical location was not provided). No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer regarding a case in litigation and referred to a patient (pt) of unknown age and gender. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, strength, route, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered multiple outbreaks of herpes zoster. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experience mental and emotional distress due to resulting physical limitations and seriousness of the pt's 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 of zoster vaccine live (ZOSTAVAX), 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 zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered as not recovered. The causality assessment between the event and suspect vaccine was related.   Herpes zoster was considered as disability by the reporter.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: A 35 year old female consumer had titers drawn and showed no evidence of adequate immunity.; This spontaneous report has been received from a nurse, concerning a 35-years- old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On an unknown date, the patient was administered vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (dose, dose number vaccination scheme, frequency, lot number, and expiration date were not provided) for prophylaxis.  On an unknown date, the patient experienced titers drawn and showed no evidence of adequate immunity (antibody test negative). The patient sought medical attention, and laboratory diagnostics were performed. Additionally, it was unknown by the reporter if she received any treatment. The outcome of the event antibody test negative was not provided.  The causality assessment between the event antibody test negative and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Sex: F
Vaccine: MMR
Symptoms: Epilepsy, Seizure
Clinical narrative: has epilepsy due to seizure following MMR II vaccination.; This spontaneous report was received from a physician and refers to her daughter, a 16-month-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided).   On an unknown date, the patient has epilepsy due to seizure following measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccination. At the time of reporting, the outcome of the event was unknown.  The causal relationship between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.  Upon internal review, the event epilepsy due to seizure was determined to be medically significant.
Sex: U
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: hepatitis B nonresponder; Literature Report:   This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 56 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 57 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 6. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2207USA004701:
Sex: U
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: hepatitis B nonresponder; This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 37 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 41 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 6. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2207USA004701:
Sex: U
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: hepatitis B nonresponder; Literature Report:  This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 47 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 48 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 6. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2207USA004701:
Sex: U
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: hepatitis B nonresponder;   This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 69 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 71 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 6. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2207USA004701:
Sex: U
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: hepatitis B nonresponder; Literature Report:  This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 41 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 42 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 7. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience. ; Sender's Comments:  US-009507513-2207USA004701:
Sex: U
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 50 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 53 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 8. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience. ; Sender's Comments:  US-009507513-2207USA004701:
Sex: U
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: hepatitis B nonresponder; Literature Report  This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 58 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 61 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 6. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience. ; Sender's Comments:  US-009507513-2207USA004701:
Sex: U
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: hepatitis B nonresponder; Literature Report:   This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 59 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 60 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 6. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2207USA004701:
Sex: U
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: hepatitis B nonresponder;  This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 21 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 22 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 9. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience. ; Sender's Comments:  US-009507513-2207USA004701:
Sex: U
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: hepatitis B nonresponder; Literature Report  This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 59 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 63 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 6. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience. ; Sender's Comments:  US-009507513-2207USA004701:
Sex: U
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at newborn (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 23 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 6. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience. ; Sender's Comments:  US-009507513-2207USA004701:
Sex: U
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: hepatitis B nonresponder; Literature Report:   This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 57 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 58 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 7. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience. ; Sender's Comments:  US-009507513-2207USA004701:
Age: 55.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient has had no side effects that she is aware of; Medical Assistant called stating a 55 year old female received the GARDASIL 9 vaccine on July 8, 2022 and would like to know if the patient should receive all 3 vaccines in the series. Information provided from medical information letter. Caller refu; This spontaneous report was received from medical assistant and refers to a 55-year-old female patient. The patient's medical history, current conditions, concomitant therapies, concurrent conditions and previous drugs reactions or allergies were not reported.  On 08-JUL-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 millimeter (mL) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age). The patient has had no side effects that she was aware of (no adverse event). The reporter would like to know if the patient should receive all 3 vaccines in the series.
Age: 0.33
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No symptomatic AEs reported; a 4 month old received the 12 month old vaccines inadvertently for MMR-II, VARIVAX, and VAQTA; This spontaneous report was received from a nurse and refers to a 4-month-old patient of unknown gender. No information regarding the patient's medical history or concurrent conditions was provided. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).  On 20-JUL-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, lot #U022174, expiration date: 14-JUL-2023 (strength, dose and route of administration were not provided), hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, lot #W002889, expiration date: 06-MAR-2023 (strength, dose and route of administration were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) lot #W003819, expiration date: 02-FEB-2024 (strength, dose and route of administration were not provided), all of them for prophylaxis (Product administered to patient of inappropriate age). No adverse events were reported (No adverse event).
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; HCP calling to report that PROQUAD was accidentally administered to a 13 year old on 29JUN2022. Caller also stated that the patient's birthdate may have been typed into their system incorrectly. No additional details provided. No additional AE/PQC.; This spontaneous report was received from a certified medical assistant and refers to a 13-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 29-JUN-2022, the patient was accidentally vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  (strength, lot #, expiration date, dose, route and frequency were not reported); along with a sterile diluent  (strength, lot #, expiration date, dose, route and frequency were not reported) for prophylaxis; as the patient's birth date was typed into their system incorrectly. No adverse events were reported.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took the second dose of Vivotif 24 hours after the first instead of taking every 48 hours; A spontaneous report was received from a physician on 03JUN2022. It described a male patient (unknown age) who "took the second dose of Vivotif 24 hours after the first instead of taking every 48 hours" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took his second dose 24 hours after the first dose instead of taking it every 48 hours.  Action taken with Vivotif with respect to the reported event was not applicable.  The outcome of the reported event was unknown.  No additional information was reported.  Company comment: It was reported that a patient took the second dose of Vivotif 24 hours after the first instead of taking every 48 hours (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a patient took the second dose of Vivotif 24 hours after the first instead of taking every 48 hours (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.
Sex: M
Vaccine: DTAP
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: multiple Grand mal seizures; This case was reported by a consumer via interactive digital media and described the occurrence of grand mal seizure in a male patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine. On an unknown date, less than a day after receiving DTaP vaccine, the patient experienced grand mal seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the grand mal seizure was unknown.   It was unknown if the reporter considered the grand mal seizure to be related to DTaP vaccine.     Additional Information: GSK Receipt Date: 12-July-2022 Reporter's Comments: This case was received from the patient's parent via interactive digital media. The reporter said that she was lucky that her son did not die from his shot.  But what he did was, had multiple Grand Mal Seizures within 4 hours of every one of his DTP shots.  After the 3rd time his doctor wrote No Pertussis in red letters on his chart.  She also saw to it that his sister only got the TD shot. Additional supportive information:  The reporter reported that "had multiple Grand Mal Seizures within 4 hours of every one of his DTP shots" but due to limited information on number of shots and FU-no contact details, only 1 case was created.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: ended up in hospital from your vaccine one day after having shot; This case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   The reporter considered the hospitalization to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-JUL-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had ended up in hospital from vaccine one day after Shingles shot. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain, Decreased appetite, Diarrhoea, Diverticulitis, Headache
Clinical narrative: 99.5oF; nonstop headache; severe night sweats; abdomen feels like I have diverticulitis; abdominal pain; poor appetite; semi-loose stools; disrupted my life and routine; This case was reported by a consumer via call center representative and described the occurrence of diverticulitis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2022, the patient received the 1st dose of Shingrix. On 14th July 2022, 1 days after receiving Shingrix, the patient experienced headache and fever. In July 2022, the patient experienced diverticulitis (serious criteria GSK medically significant), sweating, abdominal pain, appetite lost, loose stools and activities of daily living impaired. On 16th July 2022, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the diverticulitis, headache, sweating, abdominal pain, appetite lost and loose stools were not recovered/not resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the diverticulitis, headache, sweating, fever, abdominal pain, appetite lost, loose stools and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUL-2022  Reporter's Comments: This case was self-reported by patient. The patient received first dose of Shingrix vaccine on last Wednesday (before reporting) and today (on the day of reporting) was Saturday and the patient experienced nonstop headache since Thursday (before reporting) morning. The patient reported that Thursday and Friday night, less than a week the patient got up twice to change clothes and beds due to severe night sweats and the patient's abdomen felt like had diverticulitis for the first time in many years. The patient ran a fever of about 99.5 Degree Fahrenheit Thursday afternoon till Saturday morning (on the day of reporting).  The patient read that these were normal side effects.  The patient asked when patient should begin to see these side effects lessen and what was the average length of time for night sweats, headache, abdominal pain, poor appetite and semi-loose stools. The patient reported that this dose had severely disrupted patient's life and routine, so the patient would like to know when the patient might start feeling better as shown in the statistics GlaxoSmithKline collect.  The patient was just seeking the average recovery time for these symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Loss of personal independence in daily activities, Night sweats, Pyrexia
Clinical narrative: 99.5oF; nonstop headache; severe night sweats; abdomen feels like I have diverticulitis; abdominal pain; poor appetite; semi-loose stools; disrupted my life and routine; This case was reported by a consumer via call center representative and described the occurrence of diverticulitis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2022, the patient received the 1st dose of Shingrix. On 14th July 2022, 1 days after receiving Shingrix, the patient experienced headache and fever. In July 2022, the patient experienced diverticulitis (serious criteria GSK medically significant), sweating, abdominal pain, appetite lost, loose stools and activities of daily living impaired. On 16th July 2022, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the diverticulitis, headache, sweating, abdominal pain, appetite lost and loose stools were not recovered/not resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the diverticulitis, headache, sweating, fever, abdominal pain, appetite lost, loose stools and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUL-2022  Reporter's Comments: This case was self-reported by patient. The patient received first dose of Shingrix vaccine on last Wednesday (before reporting) and today (on the day of reporting) was Saturday and the patient experienced nonstop headache since Thursday (before reporting) morning. The patient reported that Thursday and Friday night, less than a week the patient got up twice to change clothes and beds due to severe night sweats and the patient's abdomen felt like had diverticulitis for the first time in many years. The patient ran a fever of about 99.5 Degree Fahrenheit Thursday afternoon till Saturday morning (on the day of reporting).  The patient read that these were normal side effects.  The patient asked when patient should begin to see these side effects lessen and what was the average length of time for night sweats, headache, abdominal pain, poor appetite and semi-loose stools. The patient reported that this dose had severely disrupted patient's life and routine, so the patient would like to know when the patient might start feeling better as shown in the statistics GlaxoSmithKline collect.  The patient was just seeking the average recovery time for these symptoms.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received the 2 vaccine and still got shingles / Suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 16-JUL-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The reporter stated patient received 2 doses of Shingles vaccine, however still got shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset was not known and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shot got shingles/Suspected Vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date :18 July 2022 Reporters comment: This case was reported by the patient via interactive digital media. The patient received Shingle vaccine and had shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine, was diagnosed with Shingles; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 16th July 2022, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: Additional Information: GSK Receipt Date: 16-JUL-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had received Shingles vaccine a year ago and was diagnosed with Shingles in the morning of reporting. The doctor said patient could still get Shingles even if the patient had been vaccinated, but usually it was a milder case. The doctor gave the patient anti-viral medicine. Additional supportive information: This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact detail were available.
Sex: U
Vaccine: HPVX
Symptoms: Central nervous system inflammation
Clinical narrative: Central Nervous System Inflammation; This case was reported in a literature article and described the occurrence of central nervous system inflammation in a patient who received HPV 16-18 (HPV vaccine) for prophylaxis.  On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced central nervous system inflammation (serious criteria GSK medically significant). On an unknown date, the outcome of the central nervous system inflammation was unknown.   The reporter considered the central nervous system inflammation to be related to HPV vaccine.   Additional Information: GSK Receipt Date: 13-JUL-2022 Author Comment: The patient was a part of study was aimed to determine the prevalence and clinical characteristics of iatrogenic CNS inflammation associated with vaccinations at a tertiary neuroimmunology clinic and compare the frequency of these events before and after the COVID-19 pandemic. The study analyzed 419 consecutive patients seen over 4 years (2017-2021) at a tertiary neuroimmunology clinic who were screened for iatrogenic CNS inflammation secondary to vaccinations. In patients with suspected iatrogenic events, the Adverse Drug Reaction Probability Scale was used to score the probability of vaccine-related events as doubtful, possible, probable, or definite. The patient received HPV vaccine and experienced central nervous system inflammation. In conclusions, Post-vaccination iatrogenic CNS inflammation is a rare but distinct neuroimmunological disease spectrum mostly involving spontaneous recovery or responsiveness to corticosteroids. We did not identify an excess of SARS-CoV-2vaccine-related events. The rare occurrence and predominantly favorable prognosis suggest the benefit of vaccination outweighs the neurological risks, especially during the COVID-19 pandemic.