chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms were reported by any of the patients; Improperly stored vaccines administered; MMR II Lot: S039309 Exp: 4-DEC-2021, but upon internal validation established as 31-MAR-2018; 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, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 14-MAY-2021, the patient was vaccinated with one improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (formulation, strength, exact dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number S039309, which have been verified to be a valid lot number, expiration date reported as 04-DEC-2021, but upon internal validation established as 31-MAR-2018) as prophylaxis (product storage error and expired product administered).  The administered dose of the vaccine experienced a temperature excursion of 50 degrees Fahrenheit (F) for 10 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No adverse events were reported.; Sender's Comments:  US-009507513-2105USA003872: US-009507513-2105USA003873: US-009507513-2105USA003867:
Sex: U
Vaccine: HPV9, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms were reported by any of the patients; Improperly stored vaccines administered; 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, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 13-MAY-2021, the patient was vaccinated with one improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, strength, exact dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number 1687292, which have been verified to be a valid lot number, expiration date reported and upon internal validation established as 25-AUG-2022) as prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion of 50 degrees Fahrenheit (F) for 10 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA003873: US-009507513-2105USA003871: US-009507513-2105USA003867: US-009507513-2105USA003867:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms were reported by any of the patients; Improperly stored vaccines administered; 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, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 17-MAY-2021, the patient was vaccinated with one improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, strength, exact dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number T005737, which have been verified to be a valid lot number, expiration date reported and upon internal validation established as 10-JUN-2022) as prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion of 50 degrees Fahrenheit (F) for 10 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No adverse events were reported.; Sender's Comments:  US-009507513-2105USA003867: US-009507513-2105USA003871: US-009507513-2105USA003872:
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Cardiac failure congestive, Herpes zoster, Visual impairment
Clinical narrative: congestive heart failure; vision problems; balance issues; shingles, herpes zoster; Information was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information regarding the pt's current condition, historical condition, concomitant medication was not provided. On or about 05-MAR-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles, herpes zoster, congestive heart failure, vision problems, and balance issues. The outcome of the events was unknown. The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX). The pt claimed damages as results of injury to themselves, loss of consortium, loss of service and economic losses.  Upon inernal review, congestive heart failure was considered as medically significant.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's.; Caller stated that the GARDASIL 9 was administered on the same day as the excursion to one patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.   On 01-APR-2021, the patient was vaccinated with and improperly store hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (concentration, number of dose administered, dosage, vaccination scheme frequency, route of administration and anatomical location were not reported; lot number S023476 and expiration date 26-MAR-2022). No adverse events were reported for the patient.  According to the reporter, the temperature excursion was 36 degrees Fahrenheit to 46 degrees Fahrenheit (48 degrees Fahrenheit) for a time frame of 1 hour and 35 minutes and above 47 degrees Fahrenheit (48. degrees Fahrenheit) for 3 hours 35 minutes on 01-APR-2021 (product storage error), without any previous temperature excursion, which was detected by a digital data logger.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S023476; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEP
Symptoms: Hypoaesthesia, Paraesthesia, Pruritus, Sleep disorder
Clinical narrative: Hands Feeling Numb; Itching all over body; Feet Feeling Numb; Hands would Tingle; Initial Report Received on 31-Mar-2021  A 38-year old female certified pharmacy technician (race and ethnicity not provided) reported that she received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed itching all over her body, but mostly in her hands and feet, feeling numbness in her hands and feet, and tingling in her hands.  No relevant medical history or drug allergies were reported.    No relevant concomitant medications were reported.    On 23-Feb-2021, the patient received the first dose of HEPLISAV-B (Lot # 033093, expiration date 11-Apr-2021 and NDC # not reported) to the left deltoid. The patient reported no adverse reactions to this dose.   On 30-Mar-2021 at around 1100, 36 days after having been vaccinated with HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot # 934600, expiration date 28-Feb-2022, NDC # not reported and serial number 334287615870) to left deltoid. At about 1930 the same night, the patient started having itching all over her body. While she was sleeping, she woke up about three times with her hands and feet feeling numb and reported that her hands would tingle. The patient reported that she does not have a rash, and while she stated that the itching was all over her body, it was mostly in her hands and feet.   At the time of the report, she had no further complaints of numbness since waking up that day. Her doctor advised her to take Claritin (loratadine) 10 mg and Benadryl (diphenhydramine) 25 mg three times daily as needed for itching.   No additional information was reported.   Company Comment:  The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Received an Expired Dose; Received Second Dose 10 Months After First Dose; Initial Report Received on 08-Apr-2021  A pharmacist in the reported that a 23 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization 305 days after the first dose.   The patient reported having no known allergies.   No relevant concomitant medications were reported.    Between 1997 to 1998, the patient had received her 3-dose hepatitis B vaccines.  In Jun-2020, she was tested and found to have no antibodies and needed to be re-dosed for school.  On 08-Jun-2020, the patient received the first dose of HEPLISAV-B (Lot # 933621, expiration date 26-Jul-2021 and NDC # not reported) to the left deltoid.   No adverse reactions were reported.  On 08-Apr-2021, 305 days after the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot # 933839, expiration date 28-Feb-2021 and NDC # not reported) which was expired.  No adverse reactions were reported.   No additional information was reported.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose of Heplisav-B; Initial Report Received on 23-Apr-2021  A vaccine coordinator reported that a 24 year-old male (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 20-Apr-2021, the patient received a dose of HEPLISAV-B (Lot # 933094, expiration date 17-Apr-2021, serial number 304810276431 NDC # 43528-003-05) , in the right deltoid at a student health center.   At the time of report, no adverse events were reported.  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: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HEPLISAV-B Given to a Patient Under the Age of 18; Initial Report Received on 27-Apr-2021  A pharmacist reported that a 17 year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No relevant medical or allergy history or was reported.    No relevant concomitant medications were reported.    On 16-Apr-2021, the patient received the first dose of HEPLISAV-B (Lot # 933838, expiration date 11-Jul-2021, serial number 934083544477 and NDC # not reported) in the left deltoid from a pharmacist. No other vaccines or medication were given at the time of HEPLISAV-B injection.  At the time of report, the patient had reported no adverse reactions to the injection.  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: HEP
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired Dose of Heplisav-B was Administered; Initial Report Received on 30-Apr-2021  A pharmacist in the US (KY) reported that a 19 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 29-Apr-2021, the patient received a dose of HEPLISAV-B (Lot # 933094, expiration date 17-Apr-2021, NDC # 43528-003-05 and serial number 410737010614) in the left deltoid from a pharmacist on staff. The pharmacist had not realized that the vaccine was expired until filling out the card for the patient. She was then notified that this incident occurred.  At the time of the report, no adverse events were reported.  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: HEP
Symptoms: No adverse event, Urine analysis abnormal
Clinical narrative: Urine Smelled Bad; Initial Report Received on 04-May-2021  A pharmacy intern reported that a 73 year-old female (race and ethnicity not provided) was administered HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and her urine smelled bad 4 days after receiving the first dose of HEPLISAV-B.  No other medical history was reported.  No relevant concomitant medications were reported.    On 28-Apr-2021, the patient received the first dose of HEPLISAV-B (Lot # 934259, expiration date 28-Sep-2021 and NDC number 43528-003-05) to the right deltoid at a doctor's office.   On 03-May-2021, four days after receiving the first dose of HEPLISAV-B, the patient reported that her urine smelled bad. No other information was provided about this event and no other adverse reactions were 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: VARZOS
Symptoms: Illness
Clinical narrative: Got the first shingles shot but I was in bed for 2 days sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got the first shingles shot but was in bed for 2 days sick so the patient did not get the second one. The patient stated that his/her doctor said just getting the first one makes about 90 some percent sure of not getting it.  The patient never even heard of getting shingle every year. No contact details provided for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Feeling hot, Headache, Influenza like illness
Clinical narrative: Incredibly sore arm; Redness / of the arm; Swelling of the arm; Flu like symptoms; Headache; Achy; Hot/fever; Fatigue; This case was reported by a consumer via market research programs and described the occurrence of pain in arm in a 54-year-old female patient who received Herpes zoster (Shingrix) for shingles.   In July 2018, the patient received the 1st dose of Shingrix. On an unknown date, between 4 and 6 months after receiving Shingrix, the patient experienced pain in arm, erythema of extremities, swelling arm, influenza-like symptoms, headache, pain, fever and fatigue. On an unknown date, the outcome of the pain in arm, erythema of extremities, swelling arm, influenza-like symptoms, headache, pain, fever and fatigue were recovered/resolved.   The reporter considered the pain in arm, erythema of extremities, swelling arm, influenza-like symptoms, headache, pain, fever and fatigue to be related to Shingrix.  Additional details provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced sore arm,redness and swelling of the arm,flu like symptoms,headache,achy, hot/fever,and fatigue which lasted for a week. The patient did not seek medical care. This case has been linked with US2021AMR106935, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR106935:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Incredibly sore arm; Redness / of the arm; Swelling of the arm; Flu like symptoms; Headache; Achy; Hot/fever; Fatigue; This case was reported by a consumer via market research programs and described the occurrence of pain in arm in a 54-year-old female patient who received Herpes zoster (Shingrix) for shingles.   In July 2018, the patient received the 1st dose of Shingrix. On an unknown date, between 4 and 6 months after receiving Shingrix, the patient experienced pain in arm, erythema of extremities, swelling arm, influenza-like symptoms, headache, pain, fever and fatigue. On an unknown date, the outcome of the pain in arm, erythema of extremities, swelling arm, influenza-like symptoms, headache, pain, fever and fatigue were recovered/resolved.   The reporter considered the pain in arm, erythema of extremities, swelling arm, influenza-like symptoms, headache, pain, fever and fatigue to be related to Shingrix.  Additional details provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced sore arm,redness and swelling of the arm,flu like symptoms,headache,achy, hot/fever,and fatigue which lasted for a week. The patient did not seek medical care. This case has been linked with US2021AMR106935, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR106935:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a other health professional via other manufacturer and described the occurrence of sickness in an adult patient who received Herpes zoster (Shingrix) (batch number UNK, expiry date unknown) for prophylaxis. The patient's past medical history included accident (years ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the sickness to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, however captured as adult as per vaccine indication. The patient  experienced sickness for 24 hrs after 2nd dose of Shingrix. There were no further details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got the shingle shot,than a few years after that got the shingles/ Suspected vaccination failure; I got the shingle shot,than a few years after that got the shingles; Cannot describe the pain for 8 weeks; This case was reported by a consumer via media and described the occurrence of suspected 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, several years after receiving 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 recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got the Shingles shot and few years after that got the shingles in/ on his or her head and could not describe the pain for 8 weeks. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confiding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I had both shots and have them/Suspected vaccination failure; I had both shots and have them.; Worse pain i ever had!; This case was reported by a consumer via media and described the occurrence of suspected 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, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had both the shots of Shingles and still had shingles. The patient stated that worst pain event had. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got them a few months after I got the vaccine / worse case of shingles than the first case/ Suspected vaccination failure; I got them a few months after I got the vaccine / worse case of shingles than the first case; This case was reported by a consumer via media and described the occurrence of suspected 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, several months 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 details were provided as follows: The patient self reported the case. The age at vaccination was not reported. A few months after the patient got the vaccine, the patient experienced worse case of Shingles than the first case. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Got the vaccine have had Shingles 3 times since; This case was reported by a consumer via media and described the occurrence of suspected 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 details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and had Shingles 3 times since. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles no bad I got them on the left side of my head; This case was reported by a consumer via media and described the occurrence of suspected 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles on the left side of head. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot. Then got shingles/Suspected Vaccination failure; got the shot. Then got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male 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 details were reported as follows: The case was reported by the patient's spouse. The age at vaccination was not reported. The patient got the Shingle shot and then got shingles, still had a patch on forehead, a patch on boob and the patch on waist for three years. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: was vaccinated and still got Shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female 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 details were reported as follows: The patient was the reporter's niece. The age at vaccination was not reported. The patient received shingles vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster 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: Was vaccinated and still got shingles twice/Suspected vaccination failure; Shingles twice; This case was reported by a consumer via media and described the occurrence of suspected 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 details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and and still got shingles twice. The patient stated that no thanks to vaccines. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster 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: had both old and new shingles shots in past years. I recently got shingles/Suspected vaccination failure; shingles / my case was only about a 4 out of 10 compared to the worst cases; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (old shingles vaccine received on an unknown date in past years).   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 details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received both old and new shingles shots in past years and recently got shingles. The patient stated that, so the word prevent was BS (unspecified) and however, his/her case was only about a 4 out of 10 compared to the worst cases. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Has been vaccinated / Shingles and it's broken out down his leg /Suspected vaccination failure; Shingles / broken out down his leg; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male 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 details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient received Shingles vaccine and and he was just told that he had Shingles and it was broken out down his leg and was bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster 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, Neuralgia, Pain, Rash, Vaccination failure
Clinical narrative: I got vaccinated and was hospitalized for a serious breakout, suspected vaccination failure; serious breakout all over my back; Horrific pain; still suffer nerve pain; This case was reported by a consumer and described the occurrence of suspected 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 hospitalization and GSK medically significant), shingles (serious criteria hospitalization), pain and nerve pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the pain and nerve pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and nerve pain to be related to Shingles vaccine.  Additional details were provided as follows:  The case was reported by the patient for himself/herself. The age at vaccination was not reported.  The patient got vaccinated with the Shingles vaccine and was hospitalized for a serious breakout all over the back and horrific pain. The breakout was healed but the nerve pain persisted at the time of reporting. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset were unknown.
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix pfs given on 4/2 Instead of infanrix; Kinrix pfs given on 4/2 Instead of infanrix; This case was reported by a other health professional via sales rep and described the occurrence of wrong vaccine administered in a 21-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd April 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported but could be 20 or 21 months old. The patient received Kinrix instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. No side effects were reported. The reporter had asked for the date of birth of the patient and further additional information but had not got any updates. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: missed the second dose /due to covid-19 pandemic; This case was reported by a nurse via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about one year and 6 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of vaccination did not receive the second dose due to Covid-19 pandemic. The patient received 1st dose 1 year and 6 month prior to reporting and did not know the exact date. The HCP declined to provide any data and declined to follow up.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Illness, Near death experience
Clinical narrative: Got so sick from the flu shot that it almost killed her / came to see her; Got so sick from the flu shot; This case was reported by a consumer via other manufacturer and described the occurrence of near death experience in a adult female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2016-2017 season) (batch number 7K45B, expiry date unknown) for prophylaxis.   The patient's past medical history included mumps (experienced mumps after mumps vaccine) and measles (experienced measles after measles vaccine). Previously administered products included Mumps vaccine with an associated reaction of mumps and Measles vaccine with an associated reaction of measles.   On 8th December 2016, the patient received Fluarix Quadrivalent 2016-2017 season .5 ml. On an unknown date, unknown after receiving Fluarix Quadrivalent 2016-2017 season, the patient experienced near death experience (serious criteria GSK medically significant and life threatening) and sickness. On an unknown date, the outcome of the near death experience and sickness were unknown.   The reporter considered the near death experience and sickness to be related to Fluarix Quadrivalent 2016-2017 season.  Additional details were provided as follows: It was reported that as a child the patient got Mumps after the Mumps vaccine and measles after the measles vaccine. She had no further information on the dates or lot numbers of these vaccines.  The patient did not have history including any illness at time of vaccination. The patient did not have medical history relevant to adverse event. The patient got so sick from the flu shot that it almost killed her. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Laboratory test, Vaccination failure
Clinical narrative: Had a mild case of shingles a year and a half after her second shot / Diagnosed by her HCP/ Confirmed vaccination failure; Had a mild case of shingles a year and a half after her second shot / Diagnosed by her HCP; This case was reported by a consumer via call center representative and described the occurrence of confirmed vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2018, the patient received the 1st dose of Shingrix. In September 2018, the patient received the 2nd dose of Shingrix. In January 2020, less than 2 years after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional details were provided as follows: The patient stated that, she had a mild case of shingles a year and a half after her second shot.  The reporter did not have the specific dates. The patient had phoned to praise the company about not using aborted fetus cells for vaccinations and upcoming Covid Shot. This case was considered as confirmed vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation were known at the time of reporting. The reporter did not consent to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: arm pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2021, the patient received the 1st dose of Shingrix (intramuscular). On 10th May 2021, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient received his 1st dose of Shingrix vaccine on 10th May 2021 and was still experiencing arm pain at the injection site. The reporter consented  to follow up. No further information was reported.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered the Menveo Diluent only / instead of the full reconstituted vaccine; administered the Menveo Diluent only / instead of the full reconstituted vaccine; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows : The age at vaccination was not reported. The reporter stated that, the  patient was received only  the Menveo diluent only instead of the full reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacy technician unable to provide full vaccine and patient details at the time of reporting. No further information was reported. The reporter consented to follow up.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received a late second dose / first dose was administered on 03Mar2020 and the second dose on 31Mar2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 35-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (1st dose received on 3rd March 2020.).   On 31st March 2021, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 31st March 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received the 2nd dose of Engerix B vaccine, more than recommended interval, which was lengthening of the vaccination schedule. No further information was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she did not receive 2nd dose / first dose was received on nov 26 2019; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up. No further information was available.
Age: 27.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 27 years old received a Havrix pediatric dose; 27 years old received a Havrix pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 27-year-old male patient who received HAV (Havrix pediatric) (batch number B23EA, expiry date 15th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th May 2021, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 20th May 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: A 27 years old patient received a Havrix pediatric dose which led to underdose and adult use of a child product. The reporter informed that, till the reporting, the patient was in the clinic and asked how to proceed in this scenario. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: an 11-year-old patient received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th May 2021, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 11th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a clinic employee. The reporter stated that the 11 year old patient received kinrix which led to inappropriate age at vaccine administration. The reporter consented to follow up.