chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: RV5
Symptoms: Condition aggravated, Dysphagia, Respiratory arrest
Clinical narrative: Patient having 'stopped breathing'; had a little trouble swallowing.; This spontaneous report has been received from physician, regarding to a 3-month-old infant male patient. The patient's historical conditions included premature baby and respiratory arrest. His concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 29-JUL-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral liquid, orally administered, for prevention of rotavirus gastroenteritis (strength, dose, lot number and expiration date were not provided).   On 29-JUL-2022, the patient developed a little trouble swallowing (swallowing difficult) the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), and he had stopped breathing (respiratory arrest). Additionally, the patient's mom, confirmed how patient did this all the time. The outcome of swallowing difficult and respiratory arrest was not provided.  The causal relationship between aforementioned events and the suspect therapy was not provided.  Upon internal review, the event respiratory arrest was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Pain, Rash
Clinical narrative: I had the old vaccine nine years ago. Came down with shingles two weeks ago.; This spontaneous report was received from consumer concerning to a patient with unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2013 (also reported as nine years ago), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unspecified date in August 2022 (reported as two weeks ago), the patient experienced shingles. The patient reported that had some bad headaches, shooting pains but nothing like what most people have, and very little rash (all of them were considerate as symptoms of singles). Additionally reported that had shingles right now on the  forehead and the doctors were concerned it getting in the patient's eye. The patient did not has it nearly as bad as it could and the thought it was because of the vaccine.  Causality assessment between the event and the suspect vaccine was not provided.
Sex: U
Vaccine: MMR, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE details provided. No additional AE reported; MMR II was administered intramuscularly instead of subcutaneously; This spontaneous report was received form a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  On 02-SEP-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) intramuscularly instead of subcutaneously, with lot# T031436 with expiration date 15-SEP-2022 (albumin status rHA) for prophylaxis (dose and frequency not reported), together with sterile diluent lot # U005104 with expiration date 01-JUL-2023. No additional adverse event (AE) details provided or reported.
Age: 1.5
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No other adverse events reported; Caller reports that an 18 month old patient received GARDASIL 9 today due to human error. Caller reports that Hep A vaccine was intended and there were no other contributing factors due to the error that was made, specifically this was not a case of; 18 month old patient received GARDASIL 9; This spontaneous report was received from a registered nurse concerning an 18-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 02-SEP-2022 (also reported as "today"), the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, lot #W010663, expiration date: 11-MAR-2024, administered as prophylaxis (strength, and route of administration were not provided) (product administered to patient of inappropriate age), due to a human error since the vaccine intended to be administered was hepatitis a vaccine, inactivated (manufacturer unknown) intramuscular injection, as prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) (wrong product administered).   It was reported that there were no other contributing factors due to the error that was made, specifically this was not a case of product confusion. The healthcare professional that administered the vaccine did not complete the double check prior to administration. There were no other adverse events reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Be sure you get another shot if you were vaccinated before 2020 because that one was ineffective; I have shingles on my face and in my hair; This spontaneous report was received from a female patient of unknown age referring to herself via GlaxoSmithKline. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date (before 2020), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date in August 2022 (reported as "right now"), the patient experienced shingles on her face and in her hair. The patient's doctor gave her the information as the vaccine before 2020 was ineffective when she went to see what was wrong with her (Vaccination failure). The doctor also said that the vaccine had been taken off the market so she should be safe with the new shot. At the time of reporting, the outcome of both events was not reported.   The reporter considered vaccination failure to be related to zoster vaccine live (ZOSTAVAX). The causal relationship between shingles and zoster vaccine live (ZOSTAVAX) was not reported.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: there have been no reported side effects; Medical Assistant reported that an expired dose of MMR-II was administered to a patient; This spontaneous report has been received from a medical assistant and refers to a 16-month-old female patient.  The patient's medical history, concurrent conditions and previous drug reactions or allergies were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 15-AUG-2022, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) at a dose of 0.5 ml subcutaneously 1 dose,  lot #T029549, expiration date: 10-SEP-2022 for prophylaxis (Expired product administered). It was mentioned that the suspect vaccine had not previous temperature excursions. It was stated that no side effects occurred (no adverse event).  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2209USA002318: US-009507513-2209USA002394:
Age: 19.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs were reported; 19 year old received a dose of PROQUAD; This spontaneous report was received from a physician referring to a 19-year-old patient of unspecified gender. Information regarding the patient's medical history, concurrent conditions and previous drug reactions or allergies was not provided. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).   On 02-AUG-2022, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) as prophylaxis (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) (product administered to patient of inappropriate age). No additional adverse events were reported (no adverse event).
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No reported side effects; Medical Assistant reported that an expired dose of MMR-II was administered to a patient. Caller was unable to provide sterile diluent information stating they do not have a way to document the lot and expiration for the diluent. Caller confirmed ther; This spontaneous report was received from a medical assistant and refers to a 12-month-old female. patient.  The patient's medical history, concurrent conditions and previous drugs reactions or allergies were not reported. Concomitant medications included sterile diluent (manufacturer unknown).  On 15-AUG-2022, the patient was vaccinated with an expired  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) at a dose of 0.5ml subcutaneously,1 dose, lot #T029549, expiration date: 10-SEP-2022, for prophylaxis (vaccination scheme was not provided) (expired product administered). It was mentioned that no side effects occurred.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2209USA002251:02240957 US-009507513-2209USA002394:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; ROTATEQ was administered after a temperature excursion to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 06-SEP-2022, the patient was administered a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, once, lot # W002562 with expiration date 12-OCT-2023, administered orally for prophylaxis (exact dose was not provided) (product storage error). The vaccine was improperly stored in the temperature of 10.1 degrees Celsius (C) for 54 minutes. It was unknown if data logger was used to capture the temperature excursion. There was no previous temperature excursion. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE details available; HBP in charge of vaccine storage calling for TE evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. HBP provides initials for all patients involved.  Names of vaccines involved (including lot/e; This spontaneous report was received from a healthcare business professional (HBP) and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 07-SEP-2022, the patient was administered a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) syringe, intramuscular injection, lot # W002889 with expiration date 06-MAR-2023, for prophylaxis (exact dose, route of administration and anatomical site were not provided) (product storage error). The vaccine was improperly stored for 8 hours in the temperature above 46 degrees Fahrenheit (F) (62.8 F). It was unknown if data logger was used to capture the temperature excursion. There was no previous temperature excursion. No additional adverse event details were available (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; HBP in charge of vaccine storage calling for TE evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. HBP provides initials for all patients involved.  Names of vaccines involved (including lot/e; This spontaneous report was received from a healthcare business professional (HBP) and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 07-SEP-2022, the patient was administered a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) syringe, intramuscular injection, lot # W002889 with expiration date 06-MAR-2023, for prophylaxis (exact dose, route of administration and anatomical site were not provided) (product storage error). The vaccine was improperly stored for 8 hours in the temperature above 46 degrees Fahrenheit (F) (62.8 F). It was unknown if data logger was used to capture the temperature excursion. There was no previous temperature excursion. No additional adverse event details were available (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE details available; HBP in charge of vaccine storage calling for TE evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. HBP provides initials for all patients involved.  Names of vaccines involved (including lot/e; This spontaneous report was received from a healthcare business professional (HBP) and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 06-SEP-2022, the patient was administered a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot # 1879864 with expiration date 19-OCT-2023, administered orally for prophylaxis (exact dose was not provided) (product storage error). The vaccine was improperly stored for 8 hours in the temperature above 46 degrees Fahrenheit (F) (62.8 F). It was unknown if data logger was used to capture the temperature excursion. There was no previous temperature excursion. No additional adverse event details were available (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Vaccine administered after temperature excursion.; This spontaneous report was received from a certifies medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 01-SEP-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) at a dose of 0.5 ml, subcutaneously lot number W005206 and expiration date of 14-FEB-2024 for prophylaxis (anatomical location was not reported). The vaccine was exposed to a temperature excursion of  13.8°C with a time frame of 1 hour and 22 minutes. There was no previous temperature excursion. No additional adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 1st Dose of Heplisav-B, 2nd Dose Received Engerix-B; Initial Report Received on 09-Jun-2022  An office manager at a doctor's office  reported that a 44-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Engerix-B for the second dose instead of HEPLISAV-B.  No medical history at the time of vaccination was reported.   Concomitant medications at the time of vaccination were reported as unknown.  On 02-May-2022, the patient received the first dose of HEPLISAV-B (Lot # 01003435280030171723, expiration date 23-Mar-2023, NDC # 43528-003-01) intramuscularly in the left deltoid.   On 09-Jun-2022, 39 days after having been vaccinated with HEPLISAV-B, the patient received Engerix-B (Lot #, expiration date, NDC #, and route unknown) in the left deltoid as the second dose instead of HEPLISAV-B. The reporter denied that the patient had any adverse events.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Product was Expired; Initial Report Received on 16-Jun-2022  A medical assistant reported that 28-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history at the time of vaccination was reported. Allergies were unknown.  Concomitant medications at the time of vaccination were reported as unknown.  On 31-May-2022, the patient received an expired dose of HEPLISAV-B (Lot # 934599, expiration date 02-Feb-2022; serial # and NDC # unavailable) in the left deltoid. The patient did not experience any adverse effects and was not pregnant at the time of the injection.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: First Dose with Heplisav-B and Second Dose with Engerix; Initial Report Received on 21-Jun-2022  A pharmacist in the reported that a 69-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Engerix as the second dose.  Medical history at the time of vaccination was reported as unknown. The patient had no known allergies.  No concomitant medications at the time of vaccination were reported.  On 13-Apr-2022, the patient received the first dose of HEPLISAV-B (Lot # 4EA77, expiration date 13-Apr-2023, NDC # 43528-003-05; route and injection site unknown).  On 25-May-2022, 43 days after having been vaccinated with HEPLISAV-B, the patient received Engerix as the second dose instead (Lot # 9AX5P, expiration date 23-Nov-2023; NDC #, route, and injection site unknown). The patient did not report any adverse reactions.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: COVID-19
Clinical narrative: COVID-19; Initial Report Received on 11-Jul-2022  A registered nurse in the self-reported that she, a 38-year-old female (race and ethnicity unknown), contracted COVID-19 after receiving the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history at the time of vaccination was reported as none. Allergies were reported as unknown.  Concomitant medications at the time of vaccination were unknown.  On 25-May-2022, the patient received the first dose of HEPLISAV-B (Lot # 937232, expiration date 04-Mar-2023; NDC #; route, and injection site unknown).   On 20-Jun-2022, 27 days after having received the first dose of HELISAV-B, the patient subsequently contracted COVID-19. She had not received her second dose of HEPLISAV-B yet. No other adverse reactions were reported.   No other information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Received an Expired Dose of Heplisav-B; Initial Report Received on 13-Jul-2022  A pharmacy intern reported that a 23-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history at the time of vaccination was reported. The patient had no known allergies.  No concomitant medications at the time of vaccination were reported.  On 11-Jul-2022, the patient received an expired dose of HEPLISAV-B (Lot # 934600, expiration date 28-Feb-2022, NDC # 43528-003-05) route and injection site not provided by the pharmacy intern reporter.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received Heplisav-B then Energix; Initial Report Received on 18-Jul-2022  An office manager at a family practice reported that a 25-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and then Engerix as the second dose.  No medical history at the time of vaccination was reported. Allergies were unknown.  Concomitant medications at the time of vaccination were reported as unknown.  On 17-Jun-2022, the patient received the first dose of HEPLISAV-B (Lot # 935848; expiration date 02-Dec-2022, NDC # 43528-003-01) through an unknown route, and injection site.  On 18-Jul-2022, 32 days after having been vaccinated with HEPLISAV-B, the patient received Engerix as the second dose (details not provided). The patient reported no adverse reactions.  No other information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Received an Expired Dose of Heplisav-B; Initial Report Received on 28-Jul-2022  A Medical Assistant reported that a patient (age, gender, race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine).  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 28-Jul-2022, the patient received an expired dose of HEPLISAV-B (Lot #, expiration date 24-Jul-2022 and NDC # not reported) through an unknown route and site.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Took 3 doses on schedule and then travelled, missing the 4th dose; A spontaneous report was received from a nurse on 18AUG2022. It described a patient of unknown gender and age who "took 3 doses on schedule and then travelled, missed the fourth dose" (PT: Incomplete course of vaccination). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunization. It was reported a patient took 3 doses of Vivotif on schedule and then travelled and missed the fourth dose. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient took 3 doses of Vivotif on schedule and then travelled, missed the fourth dose (incomplete course of vaccination). Further information is limited. The causality of incomplete course of vaccination is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a patient took 3 doses of Vivotif on schedule and then travelled, missed the fourth dose (incomplete course of vaccination). Further information is limited. The causality of incomplete course of vaccination is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Missed last dose of Vivotif; A spontaneous report was received from a patient on 19AUG2022. It described a female patient (unknown age) who "missed last dose of Vivotif (PT: Product dose omission issue). The patient was taking Vivotif (typhoid vaccine live oral Ty21A) for immunization. The patient reported that her fourth dose of Vivotif was due to be taken last night (at the time of reporting) around 9:30 PM, however, she missed the dose because she lost the last dose of Vivotif. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer missed last dose of Vivotif (product dose omission issue). Vivotif dose should be taken every other day, and the causality of product dose omission issue is not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer missed last dose of Vivotif (product dose omission issue). Vivotif dose should be taken every other day, and the causality of product dose omission issue is not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took the first dose of Vivotif after left unrefrigerated for about 10 days; A spontaneous report was received from other health care professional on 22AUG2022. It described a male patient (unknown age) who "took the first dose of Vivotif after left unrefrigerated for about 10 days" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: 3033361) for immunisation. It was reported that on 22AUG2022 (morning) the patient took the first dose of Vivotif after he left the dose out unrefrigerated for about 10 days. It was confirmed that the patient did not report any adverse event yet. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  Reportedly, the patient was not currently on any medication.  No additional information was reported.  Company comment: It was reported that a consumer took the first dose of Vivotif after being left unrefrigerated for about 10 days (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error.; Sender's Comments: It was reported that a consumer took the first dose of Vivotif after being left unrefrigerated for about 10 days (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took second dose of Vivotif on day 4; A spontaneous report was received from the pharmacist on 23AUG2022. It described a male patient (unknown age) who "took second dose of Vivotif on day 4" (PT: Inappropriate schedule of product administration). The patient took the Vivotif capsule (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient started his Vivotif regimen on 19AUG2022, and instead of taking the next dose on 21AUG2022, he took it on 22AUG2022. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient took the second dose of Vivotif on day 4 (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. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient took the second dose of Vivotif on day 4 (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. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: No adverse event, Product container seal issue
Clinical narrative: Little capsule thing was open; A spontaneous report was received from the patient on 23AUG2022. Additional information was received on 28AUG2022. It described a 67-year-old female patient (height: 154 cm/61 inches, weight: 58.05 kgs/128 lbs) who observed that the "little capsule thing was open" (PT: Product dosage form issue). The patient took the Vivotif capsule (typhoid vaccine live oral Ty21A) [lot number: 3003783, expiry date: AUG2023, item number: 00369401000027, serial number (SN): 9150345807005] for travelling. On 21AUG2022, the patient took the first dose of Vivotif and later went to take her second dose on 23AUG2022 (this morning) and noticed that the little "capsule thing" was open. She stated that she consulted her pharmacist however the pharmacist did not know whether this was significant or not and asked her to consult with the manufacturing company. Furthermore, she confirmed that when she opened the Vivotif box the first time it didn't look like any of the sections were open and did not observe any sign of tampering so she did not know how her second pill opened however she believed it might have stretched while opening the first Vivotif pill. She also confirmed that she did consume the second Vivotif dose that was open. She further confirmed that she did not experience any adverse event after taking the opened second Vivotif dose and also confirmed the capsule itself was intact and was kept refrigerated.  Additionally, it was reported that the patient had taken all four Vivotif capsules by now (as per reporting).  The outcome of the reported event was not applicable.  The patient underwent eye surgery for cataract.   The patient was taking Fluoxetine for anxiety since 2011 and started an unspecified medication one week after eye surgery.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company Comment: It was reported that when a patient took the second Vivotif dose she observed that the little capsule thing was open (product dosage form issue). She confirmed that she did not experience any adverse event after taking the second Vivotif dose. The causality of product dosage form issue is assessed as not applicable to Vivotif .The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that when a patient took the second Vivotif dose she observed that the little capsule thing was open (product dosage form issue). She confirmed that she did not experience any adverse event after taking the second Vivotif dose. The causality of product dosage form issue is assessed as not applicable to Vivotif .The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TDAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: suspected vaccination failure; whooping cough; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 83-year-old female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   On an unknown date, the patient received dTpa vaccine. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown.   It was unknown if the reporter considered the vaccination failure and whooping cough to be related to dTpa vaccine.     Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's Comment: The patient received dose of dTpa vaccine 4 years prior to the reporting and she continued to get episodes of whooping cough. The patient asked was there a better vaccine for her. The patient stated that she got recurred cases of whooping cough and she need a better vaccine than the dtap. The patient also asked could GlaxoSmithKline help her. The patient stated the booster dTpa was not giving her protection. The dTpa booster given to her in the Hospital when she was discharged. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got 2 shots, still got them/Suspected vaccination failure; got them; terrible pain; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient received both doses of shingles vaccine and still got them and after seven weeks still had terrible pain. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding laboratory test and time to onset, confirming shingles was unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: I just got over my bout wit shingles,even after having the shot/Suspected vaccination failure; I just got over my bout wit shingles; I hear the Covid virus is a good precursor; 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), shingles and covid-19. On an unknown date, the outcome of the vaccination failure and covid-19 were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that he/she just got over his/her bout with shingles even after having the shot. The patient also stated that he/she heard the Covid virus was a good precursor, hopefully never again. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available. The event covid-19 was conservatively captured.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got a Shingles shot, came down with Shingles/Suspected vaccination failure; Shingles in left arm; Shingles in right arm; 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), shingles and shingles. On an unknown date, the outcome of the vaccination failure, shingles and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter stated that, his/her sister came down with shingles, so he/she immediately went out and got a shingles shot in his/her right arm. Then he/she caught shingles on his/her right side. So, later, he/she got a new and improved shingles hot in his/her left arm. The patient came down with shingles on his/her left side. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. Note: As vaccine name was not specified so new and improved was considered shingles vaccine conservatively.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure/ I've had it 9 times in the last 18 months; Shingles; Fatigue; Rash; 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), shingles, fatigue and rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and rash were recovered/resolved and the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, fatigue and rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient had it 9 times in the last 18 months due the jabbed shedding on him/her, but found an instant cure. The patient used EMUAIDMAX ointment and rub on at first sign which was gone in a couple hours,  The patient did not did much for the fatigue but would stopped the rash in it was tracks. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. Treatment product EMUAIDMAX ointment was not coded due to limitation of dictionary.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the 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.   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: 02-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received Shingles vaccine and then still got the shingles. Follow-up would not possible as no contact details were available. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: Took a shingles shot an ended with neuropathy; This case was reported by a consumer via interactive digital media and described the occurrence of neuropathy 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 neuropathy (serious criteria GSK medically significant). On an unknown date, the outcome of the neuropathy was unknown.   It was unknown if the reporter considered the neuropathy to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 02-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient took a shingles shot an ended with neuropathy. The patient further stated that, he/she would take shingles anytime. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Received the shot and gave shingles to his wife. Viral shedding/Suspected vaccination failure; Received the shot and gave shingles to his wife. Viral shedding; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (the patient gave shingles to his wife).   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: 02-SEP-2022 Reporter's Comments: This case was reported by the patient's neighbor via interactive digital media.  The reporter reported that the patient (his/her neighbor) had received the shot and gave shingles to his wife, it was called as viral shedding.  Additional supportive information: This case was considered as suspected vaccination failure as details regarding the completion of primary immunization, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  Follow-up could not be possible as no contact details were available. This case was linked with US2022AMR128123 reported by same reporter. The case was kept valid in worst approach considering the patient had shingles and then it was occurred to his wife via viral shedding.; Sender's Comments:  US-GSK-US2022AMR128123:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shingles by getting this shock/Suspected vaccination failure; I got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult 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 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: GSK receipt date: 3-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got shingles by getting this shock. The patient was currently 55 years with shingles. The patient have had to have monthly shots that cost 1000 dollars. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shingles from the vaccine/Suspected vaccination failure; I 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: 03-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got shingles from the vaccine. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Had it twice, 2nd time after got the vaccine; I've had it twice, 2nd time after the vaccine, milder case; 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.   The patient's past medical history included shingles.   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: 03-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient have had them twice. The second time was after he/she got the vaccine. The patient stated that milder case as a result. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.