chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: intestinal discomfort; strong acid indigestion after dinner; threw up dinner within a couple of hours of eating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 at 18:00 as dose 4 (booster), single (Lot number: GH9693) at the age of 80 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 2nd, Date: 10Feb2021, Time (24hr): midday, Anatomical Site of injection: Upper Left Arm, Route of administration: Intramuscular, Batch/Lot number: Pfizer EM9810), administration date: 10Feb2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "COVID 19"; BNT162b2 (Dose: 3rd, Date: 13Oct2021, Time (24hr): midday, Anatomical Site of injection: Upper Left Arm, Route of administration: Intramuscular, Batch/Lot number: Pfizer FE3590), administration date: 13Oct2021, when the patient was 79-year-old, for COVID-19 immunization, reaction(s): "COVID 19"; Bnt162b2 (Dose: 1st, Date: Jan2021, Time (24hr): 11 am, Anatomical Site of injection: Upper Left Arm, Route of administration: Intramuscular, Batch/Lot number: Pfizer EL3247), administration date: Jan2021, when the patient was 78 years old, for COVID-19 immunization, reaction(s): "COVID 19". The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset Dec2022, outcome "unknown", described as "intestinal discomfort"; DYSPEPSIA (non-serious) with onset Dec2022, outcome "unknown", described as "strong acid indigestion after dinner"; VOMITING (non-serious) with onset Dec2022, outcome "unknown", described as "threw up dinner within a couple of hours of eating".  Additional information: 1 and half week before 31Dec2022, had intestinal discomfort. Strong acid indigestion after dinner. Threw up dinner within a couple of hours of eating for several days.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Dyspepsia, Vomiting
Clinical narrative: intestinal discomfort; strong acid indigestion after dinner; threw up dinner within a couple of hours of eating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 at 18:00 as dose 4 (booster), single (Lot number: GH9693) at the age of 80 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 2nd, Date: 10Feb2021, Time (24hr): midday, Anatomical Site of injection: Upper Left Arm, Route of administration: Intramuscular, Batch/Lot number: Pfizer EM9810), administration date: 10Feb2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "COVID 19"; BNT162b2 (Dose: 3rd, Date: 13Oct2021, Time (24hr): midday, Anatomical Site of injection: Upper Left Arm, Route of administration: Intramuscular, Batch/Lot number: Pfizer FE3590), administration date: 13Oct2021, when the patient was 79-year-old, for COVID-19 immunization, reaction(s): "COVID 19"; Bnt162b2 (Dose: 1st, Date: Jan2021, Time (24hr): 11 am, Anatomical Site of injection: Upper Left Arm, Route of administration: Intramuscular, Batch/Lot number: Pfizer EL3247), administration date: Jan2021, when the patient was 78 years old, for COVID-19 immunization, reaction(s): "COVID 19". The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset Dec2022, outcome "unknown", described as "intestinal discomfort"; DYSPEPSIA (non-serious) with onset Dec2022, outcome "unknown", described as "strong acid indigestion after dinner"; VOMITING (non-serious) with onset Dec2022, outcome "unknown", described as "threw up dinner within a couple of hours of eating".  Additional information: 1 and half week before 31Dec2022, had intestinal discomfort. Strong acid indigestion after dinner. Threw up dinner within a couple of hours of eating for several days.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; Patient was accidently administered an expired dose of VAQTA on Jan 30, 2023. Product expired on Nov 11, 2022; This spontaneous report has been received from a medical assistance, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 30-JAN-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, once (lot number U031911 has been verified to be valid for hepatitis a vaccine, inactivated (VAQTA), expiration date reported and confirmed as 11-NOV-2022), administered as prophylaxis (exact dose, route of administration, and anatomical location were not provided) (Expired product administered). The vaccine administered had no prior temperature excursions.  No further information provided. No additional adverse event (AE) was reported.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was accidently administered an expired dose of VAQTA on Jan 30, 2023. Product expired on Nov 11, 2022; This spontaneous report has been received from a medical assistance, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 30-JAN-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, once (lot number U031911 has been verified to be valid for hepatitis a vaccine, inactivated (VAQTA), expiration date reported and confirmed as 11-NOV-2022), administered as prophylaxis (exact dose, route of administration, and anatomical location were not provided) (Expired product administered). The vaccine administered had no prior temperature excursions.  No further information provided. No additional adverse event (AE) was reported.
Age: 0.42
Sex: M
Vaccine: HIBV, RV5, HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; PEDVAXHIB, and ROTATEQ were administered after a temperature excursion; This spontaneous report has been received from a vaccine provider, concerning a 5-month-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 02-DEC-2022, the patient was vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, on left thigh, lot number U031544, expiration date 23-JUN-2024 (exact dose was not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, orally, lot number W012143, expiration date 09-NOV-2023 (exact dose was not provided) for prophylaxis. On 01-DEC-2022, the doses of vaccines experienced the temperature excursion of 47.9 Fahrenheit degrees for 47 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse experiences reported; Caller reports that an improperly stored vaccine was administered to a patient. Caller reports there have been no additional adverse experiences reported. No further information provided. Caller declined being contacted regarding the event. Additiona; This spontaneous report was received from a physician, and refers to a patient of unknown age and gender. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications.  On 11-JAN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 1 dose, lot number: W023866, expiration date: 24-JAN-2024 (route of administration was not reported).  On an unknown date, the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) underwent temperature excursion of 10 Celsius degrees for a time frame of 1 hour and 28 minutes. No previous temperature excursions were reported. No adverse events were reported.
Sex: U
Vaccine: MMR, UNK, VARCEL
Symptoms: Expired product administered, No adverse event, Product preparation error
Clinical narrative: an expired DILUENT was administered to a patient with MMR-II and VARIVAX.  No additional AE details or PQC.; an expired DILUENT was administered to a patient with MMR-II and VARIVAX.  No additional AE details or PQC.; an expired DILUENT was administered to a patient with MMR-II and VARIVAX.  No additional AE details or PQC.; This spontaneous report was received from a other health professional referring to a patient of unknown age and gender. Information regarding the patient medical history, concomitant medications, drug allergies or reactions were not provided.   On 24-JAN-2023,  the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot number W021741, expired date 10-JUL-2024  and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot number W001519 expired date 13-JAN-2024 both for prophylaxis (dose, frequency, and administration route were not provided). The vaccines were diluted   with sterile diluent, lot # W003337 expired date 06-JAN-2023 (experienced expired product administered and product preparation issue).   No adverse events were reported.
Age: 0.17
Sex: M
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no advers event; temp excursion; This spontaneous report has been received from another reporter, concerning a 2-months-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 29-DEC-2022, the patient was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, on left thigh (valid lot number W006596 [expiration date 11-OCT-2024]) and with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (valid lot number 1892784 [expiration date 03-DEC-2023]) (doses, vaccination schemes, and frequencies were not provided for both vaccines) for prophylaxis, after a temperature excursion of 47.9 degrees Fahrenheit (F) for 47 minutes that occurred on 01-DEC-2022 (product storage error).  No additional adverse events (AE) were reported.
Age: 1.42
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Temperature excursion; This spontaneous report has been received from a non-health professional and refers to an 17-month-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 28-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot number W017343 verified as valid, expiration date reported and upon internal review established as 13-DEC-2023, administered intramuscularly in the right thigh for prophylaxis (strength was not provided) after a temperature excursion that happened on 01-DEC-2022 at a temperature of 47.9 degree Fahrenheit for 47 minutes (product storage error). No additional adverse event reported.  This is one of several reports from the same reporter.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Temperature excursion; This spontaneous report has been received from a non-health professional and refers to an 18-month-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 28-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot number W017343 verified as valid, expiration date reported and upon internal review established as 13-DEC-2023, administered intramuscularly in the right thigh for prophylaxis (strength was not provided) after a temperature excursion that happened on 01-DEC-2022 at a temperature of 47.9 degree Fahrenheit for 47 minutes (product storage error). No additional adverse event reported.  This is one of several reports from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: vertigo; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding the pt's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. In or around 2018, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (Strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified date (reported as "Shortly after"), the pt suffered vertigo. As a direct and proximate result of pt's use of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt sustained severe and permanent personal injuries, suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, and also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition and suffered incurred damages, including medical expenses; the loss of accumulations; and Other economic and non-economic damages. The outcome of vertigo was not recovered. The event was considered to be related to the suspect vaccine and to be disabling.
Sex: M
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: poor Pneumovax response; Literature Report. This literature marketed report was received from a health care professional concerning to a 41-year-old male patient. The patient's medical history included pyrexia, lymphadenopathy, cytomegalovirus infection, pneumonia, appendicitis, cholecystitis, epididymitis, sinusitis, meningitis aseptic, transaminases increased, inflammatory marker increased, hypogammaglobulinaemia and antinuclear antibody increased.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, formulation, dose, frequency, route of administration, lot number and expiration date were not reported).  On an unknown date, the patient had a poor pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) response (vaccination failure).    The outcome of vaccination failure was unknown.   The causality assessment between vaccination failure and Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) was considered to be related.
Age: 1.25
Sex: M
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 15-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided). and with the third dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #W012143, expiration date: 09-NOV-2023, administered orally for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2301USA009943: US-009507513-2302USA000456: US-009507513-2302USA000412: US-009507513-2302USA000403: US-009507513-2302USA001303: US-009507513-2302USA000949:
Age: 0.17
Sex: M
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 5-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-DEC-2022, the patient was vaccinated with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided). and with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #W012143, expiration date: 09-NOV-2023, administered orally for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2301USA009943: US-009507513-2302USA000456: US-009507513-2302USA000412: US-009507513-2302USA000403: US-009507513-2302USA000949: US-009507513-2302USA001303:
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; VAQTA was administered after a temperature excursion; This spontaneous report was received from a certified medical assistant (CMA) and refers to a 18-month-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On 30-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, intramuscularly in a left thigh, lot #W017343 has been verified to be valid, expiration date reported as 13-DEC-2023 for prophylaxis (strength and dose were not provided).  On 01-DEC-2022, the administered dose of the vaccine experienced a temperature excursion (product storage error). The administered vaccine was stored at temperature of 47.9 degrees Fahrenheit for 47 minutes (storage in clinical practice). No additional adverse events (AE) were reported. ; Sender's Comments:  US-009507513-2301USA001175:MSD
Age: 0.25
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Improper storage of product in use; This spontaneous report was received from a medical assistant and refers to a 3-month-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 21-DEC-2022, the patient started therapy with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892784, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength was not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly for prophylaxis (strength was not provided). The administered doses of the vaccines experienced a temperature excursion of 47.9 degrees Fahrenheit (F) (storage in clinical practice) for 47 min on 01-DEC-2022. (product storage error). Data logger was involved. No information provided regarding a previous temperature excursion. No additional adverse event was reported (no adverse event).  This is one of several reports received from the same reporter.
Sex: M
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; temp excursion 47.9; This spontaneous report was received from a medical assistant referring to a 4-month-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not provided.  On 01-DEC-2022, doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 47.9 Celsius degrees (C) for 47 minutes which occur as a result of a reading from a digital data logger (Product storage error).  On 28-DEC-2022, the patient was vaccinated with aforementioned doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot #W006596 with an expiration date on 11-OCT-2024), administered intramuscularly in left thigh for prophylaxis (strength and dose were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #1892784 with an expiration date on 03-DEC-2023), administered orally for prophylaxis (strength and dose were not provided). These were the second doses of both vaccines administered (number of previous doses was also reported as one, no details provided).  No adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Dose of Heplisav-B Administered; Initial Report Received on 09-DEC-2022  This is a spontaneous report, received from a Support Specialist at a distributor supply chain regarding a patient who received HEPLISAV-B for hepatitis B immunisation.   Medical history was reported as unknown.  Concomitant medications were not reported.  On an unknown date, a dose of HEPLISAV B (Lot # unknown, expiration date unknown, NDC # unknown), route and site not specified, was administered for hepatitis B immunisation.  The reported stated that a doctor reported that  a patient was administered an expired dose of HEPLISAV B.   No further information was available at the time of the report.   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: Hepatitis B, Hepatitis B virus test
Clinical narrative: Tested Positive for Hepatitis B; Initial Report Received on 16-Dec-2022  A pharmacist reported that a patient (age, gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient tested positive for hepatitis-B.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received a dose of HEPLISAV-B (Lot #, expiration date, NDC # 43528-002-01, and route not reported) in an unspecified route and site from a pharmacist.   On an unspecified date, 1.5 days after having been vaccinated with HEPLISAV-B, the patient tested positive for hepatitis-B.  The reported indicated that he did not have any additional details regarding the case.    Company Comment: The company assessed the event as non-serious.  Immunological vaccine failure not confirmed due to lack of information on serological titer and doses of vaccine administered.; Sender's Comments: The company assessed the event as non-serious.  Immunological vaccine failure not confirmed due to lack of information on serological titer and doses of vaccine administered.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Deep vein thrombosis, Hypoaesthesia, Paraesthesia, Pulmonary embolism
Clinical narrative: Bilateral PE; Distal DVT; Numbness; Tingling; This case was reported by a other health professional via sales rep and described the occurrence of pulmonary embolism in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2022, the patient received Shingrix. On 8th December 2022, 35 days after receiving Shingrix, the patient experienced pulmonary embolism (serious criteria GSK medically significant), deep vein thrombosis (serious criteria GSK medically significant), numbness and tingling. On an unknown date, the outcome of the pulmonary embolism, deep vein thrombosis, numbness and tingling were unknown.   It was unknown if the reporter considered the pulmonary embolism, deep vein thrombosis, numbness and tingling to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comments: The healthcare professional reported that the patient received a dose of Shingrix around first week on November 2022 and diagnosed with bilateral pulmonary embolism, distal vein thrombosis and experienced numbness and tingling. Additional Supportive Information: The vaccination date and event onset date captured as per query clarification received.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Got GBS from it (flu shot); This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be possibly related to Flu vaccine.     Additional Information: GSK Receipt Date: 02-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that her doctor said she must not get flu shots, ever again. Because the patient once got GBS from it, which would happen each time. Additional supportive information:  This case had been linked with US2023AMR017300 by same reporter for multiple patients. Follow-up would not possible as no contact details were available; Sender's Comments:  US-GSK-US2023AMR017300:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Shingles vaccine is also commonly known to cause it (GBS); This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in an unspecified number of patients 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 guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient got GBS(Guillain barre syndrome) each time and the shingles vaccine was commonly known to cause it. Additional supportive information: According to narrative verbatim the causality was conservatively captured as possible. This case had been linked with US2023AMR017295 by same reporter for different patient Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR017295:Same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had all the shots and still got a bad case/Suspected vaccination failure; Bad case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 3-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient had all the shots and still got a bad case of the shingles. The reporter denied for follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Both doses in 2022, last week got shingles/suspected vaccination failure; I got shingles, unexpected and very strong; This case was reported by a consumer and described the occurrence of vaccination failure in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 5th July 2022, the patient received the 2nd dose of Shingrix. On 8th April 2022, the patient received the 1st dose of Shingrix. In January 2023, between 6 and 7 months after receiving Shingrix and between 9 and 10 months after receiving 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 Information: GSK receipt date: 3-Feb-2023 Reporter's comment: The patient got both Shingrix doses and last week got the shingles. It was very unexpected and very strong, the patient had it before and knew the symptoms, so the patient knew what to do. But the patient was wondering, why this happened even that, had the vaccine already. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain, Vaccination failure
Clinical narrative: Had the shot, still got it a year later/Suspected vaccination failure; Still got it; Had pain; nerve pain sometimes; This case was reported by a consumer via interactive digital media and described the occurrence of 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, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and nerve pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and nerve pain were not recovered/not resolved.   The reporter considered the vaccination failure, shingles, pain and nerve pain to be possibly related to Shingles vaccine.     Additional Information: GSK receipt date: 3-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shot, still got shingles a year later after the shot. The patient had pain, but no blisters or sores. The patient tool medication about a month, still experiencing nerve pain. The reporter denied for follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles hit me, I had one shot/ horrible after effects; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 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 shingles. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JAN-2023 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient reported that shingles were wicked, one of the worst thing to hit him/her and the patient had one shot, didn't quite make it to two doses. The patient was still in process of recovery with the horrible after effects. No follow up attempts possible as no contact information available.
Sex: U
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: almost lost right eye; This case was reported by a consumer via interactive digital media and described the occurrence of visual impairment 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 visual impairment. On an unknown date, the outcome of the visual impairment was unknown.   It was unknown if the reporter considered the visual impairment to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got new and improved shot and reported that almost lost his/her right eye. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got booster shot, got shingles the next day; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient had when he was about ten.).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-FEB-2023 Reporter's Comment: This case was reported by the patient via interactive digital media.  The patient got booster shot and started getting shingles the next day. The patient also had shingles when he was about ten. Additional supportive information: Follow-up would not possible as no contact details were available.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pneumonia
Clinical narrative: hospitalized for pneumonia; He did not get dose 2 of SHINGRIX yet; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 15th April 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pneumonia (serious criteria hospitalization and GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the pneumonia was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pneumonia to be related to Shingrix.     Additional Information: GSK receipt date: 31-JAN-2023 Reporter comment:  The patient reported that, he had received first dose of Shingrix in the left arm via intramuscular route. He stated that in late July (2022), he was hospitalized for pneumonia.  He did not get second dose of Shingrix yet at the time of reporting. The reporter did not consent to follow-up. Additional supportive information: Until the time of reporting, the patient did not receive the second dose of vaccine, which had led to incomplete course of vaccination. Since, it was not clear from the response received from the agency that due to hospitalization the patient had not taken the second dose as it also said that he forgot and hence incomplete course of vaccination was coded conservatively.
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Pediarix instead of 4th dose of dtap; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number GT39Z, expiry date 3rd December 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st January 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 31st January 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-Jan-2023 Reporter's comment: The email was requested to follow-up, but information was declined. The reporter did not consent to follow-up. Additional supportive information: The patient received Pediarix instead of 4th dose of dtap, which led to wrong vaccine administered.
Age: 0.42
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to a 4 month old patient; 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 5-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th January 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 24th January 2023, 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 Information: GSK receipt date: 31-Jan-2023 Reporter's comment: Adverse event contains all reported information. The health care professional gave consent for safety team follow-up. The reporter consented to follow-up. Additional supportive information: The patient was inadvertently administered of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration. Patient's age was captured based upon date of birth and vaccination date and further clarification request was already raised by the intake team.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Vx exposed at 72°F  more than 7 days; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 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.   On 31st January 2023, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 1-Feb-2023 Reporter's comment: The pharmacist called to check stability on a Engerix-B that was administered to the patient but they suspect that the vaccine was exposed to highest temperature of 72 degree fahrenheit  for probably more than 7 days. Lot number was not available at the moment of the call.  The reporter consented to follow-up. Additional supportive information: The patient received Engerix-B after temperature excursion, which led to incorrect storage of drug.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only diluent portion given; Only diluent portion given; 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) (batch number AMVA749A, expiry date 30th November 2023) for prophylaxis.   On 1st February 2023, the patient received Menveo. On 1st February 2023, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 01-Feb-2023 Reporter's comment: The exact patient was unknown, no patient demographics were available at the time of call. The reporter consented to follow-up. Additional supportive information: The patient received only diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: 5-month-old received Pediarix after temperature excursion; This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 5-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st January 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 31st January 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-FEB-2023 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the patient received Pediarix vaccine which was involved in a temperature excursion of 31.4 Fahrenheit for 15 minutes. The reporter did consent to follow up. Additional supportive information: The vaccine was exposed to 31.4 for 15 minutes degree Fahrenheit, which led to incorrect storage of drug This case had been linked with US2023AMR016941 by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR016941:same reporter
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 31st January 2023, the patient received Havrix. On 31st January 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 1-Feb-2023 Reporter's comment: The reporter did not had the patient's date of birth. The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 48-year-old male patient who received HAV (Havrix) (batch number H4h53, expiry date 30th January 2023) for prophylaxis.   On 1st February 2023, the patient received Havrix. On 1st February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 1-Feb-2023 Reporter's comment: A nurse called to ask for information regarding the administration of an expired dose of Havrix to a patient. The reporter asked how to proceed with the patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.