chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARCEL
Symptoms: Viraemia
Clinical narrative: vaccine-strain measles/vaccine-strain varicella; skin lesions along his scalp, thigh and groin with vaccine-strain varicella viremia; Litarature report.  This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 19-month-old male was diagnosed with intermediate risk, PRETEXT Ill P+ hepatoblastoma at 14 months of age. Concomitant therapy included measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II) .  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, 11 days after receiving varicella vaccines the patient treated per AHEP1531 with vincristine, cisplatin, oxorubicin and 5-fluorouracil for intermediate risk, PRETEXT Ill P+ hepatoblastoma. After two cycles of treatment, he developed skin lesions along his scalp, thigh, and groin with vaccine-strain varicella viremia, treated with acyclovir (Vaccination failure and Varicella post vaccine). The subsequent three months of chemotherapy were complicated by fevers and progressive lung infiltrates with no identified etiology. Despite broad anti-infective coverage and chemotherapy being withheld, progression of his nodules led to an extensive evaluation for bacterial, fungal and viral causes. A lung biopsy showed nodular histiocytic infiltrates with reactive multinucleate cells. Polymerase chain reaction testing and histopathology of the sample were negative for tuberculosis, varicella, adenovirus, herpes simplex and cytomegalovirus.  The reporter considered Vaccination failure and Varicella post vaccine to be related to varicella virus vaccine live (oka/merck) (VARIVAX).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of three cases derived from the same literature article.; Sender's Comments:  US-009507513-2206USA004317: US-009507513-2206USA006540:
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, Measles antibody negative
Clinical narrative: Nurse prescriber reported that the patient had received MMR II on unspecified date many years ago so a titer test was done 2 weeks ago.  It came back negative for measles so a dose of MMR II was given but an expired MMR II dose was given; Nurse prescriber reported that the patient had received MMR II on unspecified date many years ago so a titer test was done 2 weeks ago.  It came back negative for measles so a dose of MMR II was given but an expired MMR II dose was given; This spontaneous report was received from a nurse prescriber referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date many years ago, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). So, a titer test was done 2 weeks ago on 07-JUN-2022 and it came back negative for measles, therefore on 20-JUN-2022 a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was given but this vaccine was expired (lot# T013728 with an expired date on 21-APR-2022).   At the time of reporting, the outcome of the events was not known.    The causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller is a HCP calling to report a TE for PNEUMOVAX 23.; This spontaneous report has been received from a registered nurse, concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 08-MAR-2022, the patient was administered vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (valid lot number U022819 [expiration date 14-JAN-2023]) for prophylaxis, after a temperature excursion of 0.5 degrees Celsius (C) for 24 hours (product storage error) (dose, vaccination scheme, and frequency were not provided). Additionally, a previous temperature excursion was reported.  No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA007070: US-009507513-2206USA006852: US-009507513-2206USA007090: US-009507513-2206USA006674: US-009507513-2206USA006674: US-009507513-2206USA006670: US-009507513-2206USA006731: US-009507513-2206USA006770: US-009507513-2206USA006952: US-009507513-2206USA006981: US-009507513-2206USA007045:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; PNEUMOVAX 23 was administered to the patient after the excursion occured/ temperature 0.3C for 24 hours; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-APR-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U021995, expiration date: 13-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided).   It was reported that on that day, pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered to the patient after the excursion occurred. Administered dose of vaccine experienced the temperature excursion of 0.3 degrees Celsius for 24 hours (product storage error). Previous temperature excursion was reported as yes.  No additional adverse event of product quality complaint were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administered a Dose of Heplisav-B to 15 Year-Old; Initial Report Received on 30-Mar-2022  A registered nurse in the reported that a 15 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 28-Mar-2022, a nurse administered to  the 15 year-old patient a dose of HEPLISAV-B (Lot # 93584, expiration date 13-Jan-2023 and NDC # not reported) in the left deltoid   At the time of the report, the nurse reported that the patient had not reported any adverse reactions.  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: Product storage error
Clinical narrative: Temperature Excursion Product Administered; Initial Report Received on 07-Apr-2022  An administrative manager from a Hospital reported that a 32 year-old female (race and ethnicity not provided) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization involved in a temperature excursion.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 30-Mar-2022, the patient received the first dose of HEPLISAV-B (Lot # 937233, expiration date 11-Mar-2023, NDC # 43528-003-05 and serial number 659541770826) intramuscularly in the right deltoid from a registered nurse. The patient received the vaccine that was involved in a temperature excursion, which was 0.8 degrees Celsius for 31 hours and 12 minutes from 30-Mar-2022 through 04-Apr-2022.  No additional information was reported. It was reported that the patient did not experience adverse reactions.  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 storage error
Clinical narrative: Temperature Excursion Product Administered; Initial Report Received on 07-Apr-2022  An administrative manager from a Hospital in the reported that a 56 year-old male (race and ethnicity not provided) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization involved in a temperature excursion.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 31-Mar-2022, the patient received the first dose of HEPLISAV-B (Lot # 937233, expiration date 11-Mar-2023, NDC # 43528-003-05 and serial number 659541770826) intramuscularly in the left deltoid from a registered nurse. The patient received the vaccine that was involved in a temperature excursion, which was 0.8 degrees Celsius for 31 hours and 12 minutes from 30-Mar-2022 through 04-Apr-2022.  No additional information was reported. It was reported that the patient did not experience adverse reactions.   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 storage error
Clinical narrative: Temperature Excursion Product Administered; Initial Report Received on 07-Apr-2022  An administrative manager from a Hospital reported that a 62 year-old male (race and ethnicity not provided) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization involved in a temperature excursion.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 04-Apr-2022, the patient received the first dose of HEPLISAV-B (Lot # 937233, expiration date 11-Mar-2023, NDC # 43528-003-05 and serial number 659541770826) intramuscularly in the left deltoid from a registered nurse. The patient received the vaccine that was involved in a temperature excursion, which was 0.8 degrees Celsius for 31 hours and 12 minutes from 30-Mar-2022 through 04-Apr-2022.  No additional information was reported. It was reported that the patient did not experience adverse reactions.  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 storage error
Clinical narrative: Temperature Excursion Product Administered; Initial Report Received on 07-Apr-2022  An administrative manager from a Hospital reported that a 66 year-old female (race and ethnicity not provided) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization involved in a temperature excursion.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 07-Apr-2022, the patient received the first dose of HEPLISAV-B (Lot # 937233, expiration date 11-Mar-2023, NDC # 43528-003-05 and serial number 659541770826) intramuscularly in the left deltoid from a licensed practical nurse. The patient received the vaccine that was involved in a temperature excursion, which was 0.8 degrees Celsius for 31 hours and 12 minutes from 30-Mar-2022 through 04-Apr-2022.  No additional information was reported. It was reported that the patient did not experience adverse reactions.  Company Comment:
Sex: U
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: Received 3 Doses of Hepatitis Vaccine (Heplisav, Engerix, Heplisav); Initial Report Received on 08-Apr-2022  A pharmacist reported that a 68 year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for the first dose of hepatitis B immunization. The second dose was Engerix, and the third dose was HEPLISAV-B.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 08-Oct-2021, the patient received the first dose of HEPLISAV-B (Lot # 934975, expiration date 15-Aug-2022, NDC # 43528-003-05, Serial Number Unknown) in the left deltoid from a pharmacist.  In Nov-2021, 1 month after being vaccinated with HEPLISAV-B, the patient received the second dose of a hepatitis B vaccine, Engerix, from the pharmacist.  On 08-Apr-2022, the patient received a third dose hepatitis B vaccine, HEPLISAV-B (Lot # 937231, expiration date 30-Jan-2023, NDC # 43528-003-05, Serial Number 971303248430), in the left deltoid from the pharmacist.  The patient did not experience adverse reactions. 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: Pyrexia, Rash, Urticaria
Clinical narrative: Intermittent Fever of 100F; Half Dollar Size Hives Type Rash; Initial Report Received on 12-Apr-2022  A registered nurse reported that a 47 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed an intermittent fever of 100 °F, and a Half Dollar size "Hives Type" rash over her entire body.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received the first dose of HEPLISAV-B (details not provided).  On 08-Apr-2022, the patient received the second dose of HEPLISAV-B (Lot # 934967, expiration date 11-Apr-2022 and NDC # not reported) in the left deltoid.  On 09-Apr-2022, 2 days after having been vaccinated with the second dose of HEPLISAV-B, the patient experienced an intermittent fever of 100 °F, and a Half Dollar size "Hives Type" rash over her entire body.  The patient reportedly did not have a reaction after having received the first dose of HEPLISAV-B.  At the time of the report, the reactions were still occurring. 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: Received an Expired Dose of Heplisav-B; Initial Report Received on 21-Apr-2022  A registered nurse reported that 46-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history at the time of vaccination was reported. Allergies included cyclosporine, ciprofloxacin, metronidazole (Flagyl), acetaminophen/hydrocodone (Norco), piperacillin/tazobactam (Zosyn), and sulfa antibiotics.  No concomitant medications at the time of vaccination were reported.  On 13-Apr-2022, the patient received an expired dose of HEPLISAV-B (Lot # 934967, expiration date 11 Apr-2022, NDC # 43528-003-05) in the right deltoid. No adverse reactions were reported.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Administered an Expired Dose; Initial Report Received on 22-Apr-2022  A pharmacist reported that patient (age, gender, race, and ethnicity unknown) was administered an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history at the time of vaccination was reported.   No concomitant medications at the time of vaccination were reported.  On 21-Apr-2022, the patient was administered a dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site unknown). The reporter thought the HEPLISAV-B vaccine expired 8 days ago.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received Heplisav-B and then Another Hepatitis B Vaccine; Initial Report Received on 25-Apr-2022  A registered nurse reported that a 23-year-old female patient (race and ethnicity unknown) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and then another hepatitis B vaccine (RECOMBIVAX) as the second dose.  No medical history at the time of vaccination was reported.   No concomitant medications at the time of vaccination were reported.  On 22-Mar-2022, the patient received the first dose of HEPLISAV-B (Lot # 937231, expiration date 30 Jan 2023, NDC # 43528-003-05; serial number and route unknown) in the left deltoid.   On 22-Apr-2022, 32 days after having received the HEPLISAV-B vaccine, the patient received RECOMBIVAX (Lot #, expiration date, route, and injection site unknown) as the second dose. This was discovered on 25-Apr-2022, when the patient came into the facility for an immunization update and the vaccine registry was pulled up. The patient reported no adverse effects.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Delivery, Exposure during pregnancy
Clinical narrative: Pregnancy; Initial Report Received on 02-May-2022  A health care professional (HCP) reported to the HEPLISAV-B pregnancy registry that a female patient (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant.  No relevant medical history was reported.  The last menstrual period (LMP), estimated date of delivery (EDD), pregnancy history, and pregnancy risk factors were not reported.    No relevant concomitant medications were reported.    On an unspecified date (# weeks of gestation or # trimester unknown), the pregnant patient received a dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, injection site not reported).   On an unspecified date, the patient delivered the baby (no additional information was provided).   On 02-May-2022, the HCP reported that the patient delivered recently and received a dose of the HEPLISAV-B vaccine. The HCP wanted to see if her patient could enroll in the pregnancy registry. She was informed that the pregnancy registry did not take retrospective cases unless there was a birth effect, which she confirmed that the baby did not have any birth defects. No further information was provided since the HCP did not obtain permission from the patient.   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: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Pregnancy; Initial Report Received on 02-May-2022  A health care professional (HCP) reported to the HEPLISAV-B pregnancy registry that a female patient (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant.  No relevant medical history was reported.  The last menstrual period (LMP), estimated date of delivery (EDD), pregnancy history, and pregnancy risk factors were not reported.    No relevant concomitant medications were reported.    On an unspecified date, received one dose of HEPLISAV-B (date, Lot #, expiration date, NDC #, route, injection site not reported).  On an unspecified date, the patient had a positive home pregnancy test (# of week of gestation unknown).   On 03-May-2022, the HCP reported that the pregnant patient received a dose of the HEPLISAV-B but did not know the dosage the patient took. The HCP was provided information about the HEPLISAV-B pregnancy registry and was informed that her patient would be eligible to enroll in the registry. The HCP did not obtain permission from her patient to pass on any additional information. Permission to follow up with the HCP on the potential patient was not granted.  No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First Dose of Heplisav-B and Second Dose got Engerix-B; Initial Report Received on 06-May-2022  A registered pharmacist reported to a Dynavax sales representative that a patient (age, gender, race and ethnicity unknown) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Engerix-B as the second dose.  No medical history at the time of vaccination was reported.   No concomitant medications at the time of vaccination were reported.  On an unspecified date, the patient received dose 1 of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site unknown).  On an unspecified date, one month after having received the HEPLISAV-B vaccine, the patient received Engerix-B as the second dose (Lot #, expiration date, NDC #, route, and injection site unknown).  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injury, Pruritus, Swelling face
Clinical narrative: I have an injury from the SHINGRIX vaccine; getting my SHINGRIX vaccine and then immediately experiencing side effects / Face began to swell; Face began to itch, possibly a case of shingles; This case was reported by a consumer and described the occurrence of facial swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 10 hrs after receiving Shingrix, the patient experienced facial swelling, pruritus facial and injury. The patient was treated with ophthalmologicals (nos) (Eye Drops (Nos)). On an unknown date, the outcome of the facial swelling and pruritus facial were recovered/resolved and the outcome of the injury was unknown.   It was unknown if the reporter considered the facial swelling and pruritus facial to be related to Shingrix. The reporter considered the injury to be possibly related to Shingrix.     Linked case(s) involving the same patient: US2022AMR094423   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: This case was self-reported by patient. The patient received first dose of Shingrix vaccine into unknown arm about 18 months ago from reporting. The patient reported that about ten hours after receiving the Shingrix vaccine face began to swell and itch near to left eye. The patient went to her eye doctor. The doctor tried several eye drops before swelling and itching cleared up about 8 weeks later.  At that time, the eye doctor told to the patient that he was suspicious that it was related to the Shingrix vaccine and possibly a case of shingles. Shingles was never diagnosed by anyone. The patient strongly suspect that she had an injury less than 2 years from the Shingrix vaccine.  The reporter consented to follow up both her and her eye doctor. Additional supportive Information: This case had been linked with case US2022AMR094423 reported by same reporter for 2nd episodes of adverse events.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094423:Same reporter. 2nd episode of AEs.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Cerebrovascular accident
Clinical narrative: Found out I have atrial fibrillation; Stroke after first dose; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix. On 21st April 2022, 20 days after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the patient experienced atrial fibrillation (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke and atrial fibrillation were unknown.   It was unknown if the reporter considered the stroke and atrial fibrillation to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR094009   Additional Information: GSK Receipt Date: 16-Jun-2022 Reporter's Comments: The patient self-reported this case. The patient had a stroke after his/her 1st dose of Shingrix vaccine and also found that he/she had atrial fibrillation. The patient had been going to doctor physical once a year and twice a year after he/she turned 65 year old. The patient stated he/she would have to go to assisted living soon. Additional Supportive Information: For tolerance to 2nd dose, refer case US2022AMR094009. GSK note: There was a discrepancy in product onset dates and event onset dates, AI was raised for the same and will be clarified in the next follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094009:Same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Incomplete course of vaccination, Pruritus, Swelling face
Clinical narrative: Never received the second Shingrix vaccine; Swelling face reappeared, not yet resolved. Shingles was never diagnosed; Itchy face reappeared, not yet resolved. Shingles was never diagnosed; Headache since the current symptoms started; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In June 2022, between 1 and 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced facial swelling, pruritus facial and headache. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with ophthalmologicals (nos) (Eye Drop (Nos)). On an unknown date, the outcome of the facial swelling, pruritus facial and headache were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the facial swelling, pruritus facial and headache to be possibly related to Shingrix.     Linked case(s) involving the same patient:  US2021AMR077318, US2022094114   Additional Information: GSK Receipt Date: 15-June-2022 Reporter's Comment: The patient reports this case for herself for the 2nd episodes of adverse events. The patient received 1st dose of Shingrix on an unknown arm, about 18 months ago. On an unknown date, two weeks ago, the patient experinced same symptoms (swelling/itchy face) reappeared near the left eye. A new eye doctor started her on another eye drop but the swelling and itching has yet to resolve. The patient was also reporting a headache since the current symptoms started. This eye doctor told the patient that it could be a reoccurrence from the Shingrix vaccine 18 months ago. The reporter consented to follow up. Additional supportive information: The patient reports that she never received the second Shingrix vaccine. which led to incomplete course of vaccination. This case has been linked with case US2021AMR077318 reported by same reporter for 1st episodes of adverse events. Note: From the narrative it was not clear if the patient did not received 2nd dose due to medical reason hence incomplete course of vaccination was coded as event.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022094114:Same reporter. Case deleted - FU1 of US2021AMR077318 US-GLAXOSMITHKLINE-US2021AMR077318:Same reporter. 1st episode of AEs.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Illness
Clinical narrative: sick; exhausted; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness and exhaustion. On an unknown date, the outcome of the sickness was unknown and the outcome of the exhaustion was recovered/resolved.   It was unknown if the reporter considered the sickness and exhaustion to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient was sick since he/she got the first shot, scared to death of the second shot. The patient had a bad reaction to the first shot, exhausted for over 4 days. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In June 2022, the patient received Shingles vaccine. In June 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 16-June-2022 Reporter's comment: The patient self-reported the case via interactive digital media. The patient had vaccine last week and felt sick at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Product supply issue, Social problem
Clinical narrative: with the combination of COVID, I never got my 2nd/booster shot; Shingrix shortage, I never got my 2nd/booster shot; This case was reported by a consumer via call center representative and described the occurrence of social problem in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2020.).   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 and product supply issue. On an unknown date, the outcome of the social problem and product supply issue were unknown.    Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's comment: The patient stated that he/she received 1st Shingrix dose in December of 2020. The reporter said that with the combination of COVID and a Shingrix shortage in his/her area, the patient never got the 2nd /booster shot. The patient asked would he/she had to start over with the first shot. The administer at his/her local said this, and based on what he/she had read, that did not sound correct. Additional Supportive Information: The patient could not get the 2nd dose of Shingrix vaccine due to Shingrix shortage in his/her area, which led to product supply issue.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Pain in jaw
Clinical narrative: Headache; Jaw pain; Fatigue; 1st dose on October 2021 2nd dose on 13-JUN-2022; This case was reported by a consumer via call center representative and described the occurrence of headache in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received in October 2021, for tolerance of dose refer case US2022094109).   On 13th June 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 13th June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In June 2022, the patient experienced headache, jaw pain and fatigue. Rechallenge with Shingrix was positive. In June 2022, the outcome of the headache, jaw pain and fatigue were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the headache, jaw pain and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-Jun-2022. Reporter's Comments: The reporter was the patient.  The patient received 2nd dose of Shingrix late, in an unknown arm. Less than a week after receiving Shingrix, the patient experienced headache, jaw pain and fatigue. The effects were now resolved at the time of reporting.  The patient had nothing else to report.  The consent to follow up was granted. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule This case was linked with US2022094110 with same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022094110:Same Reporter US-GLAXOSMITHKLINE-US2022094109:Same Reporter for 1st dose
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Infant irritability, Injection site rash, Pain
Clinical narrative: Rash around the injection site area; Signs of being in pain and fussy; Signs of being in pain and fussy; This case was reported by a other health professional via sales rep and described the occurrence of injection site rash in a 2-month-old male patient who received Hib (Hiberix) (batch number FY4E9, expiry date unknown) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date unknown) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) (batch number 23339G, expiry date unknown) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis.   On 13th June 2022, the patient received the 1st dose of Hiberix .5 ml, the 1st dose of Pediarix .5 ml, Pediarix Pre-Filled Syringe Device, the 1st dose of Rotarix lyophilized formulation (oral) 1 ml, Rotarix Oral Applicator Device and PREVNAR. On 14th June 2022, 1 days after receiving Hiberix, Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation and Rotarix Oral Applicator Device and not applicable after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced injection site rash, pain and irritability. On an unknown date, the outcome of the injection site rash, pain and irritability were unknown.   It was unknown if the reporter considered the injection site rash, pain and irritability to be related to Hiberix, Pediarix and Pediarix Pre-Filled Syringe Device. It was unknown if the reporter considered the pain and irritability to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. 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: 16-JUN-2022 Reporter's Comments: The patient's parent brought patient in for a rash around the injection site area. The patient also displayed signs of being in pain and fussy.  The reporter wanted to know if these side effects had happened in past.  The reporter reached out to report adverse events to see if the vaccines could have been of cause.  On 14th June 2022, 1 day after receiving Prevnar, patient experienced injection site rash, pain and irritability. It was unknown if the reporter considered the injection site rash, pain and irritability to be related to PREVNAR.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: Extreme fatigue; Kicked my butt; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue extreme in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Had shingles on back at age of 15, very unusual but vividly remember the pain and not had it since) and pain. Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (Received first dose on an unknown date, for tolerance refer case US2022AMR094989).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fatigue extreme and feeling abnormal. On an unknown date, the outcome of the fatigue extreme was recovered/resolved and the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the fatigue extreme and feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient stated that he/she had received the 2nd shingles shot recently. It kicked patient's butt and patient experienced extreme fatigue for a day or 2. The patient stated that he or she would still rather have the shingles shot than experiencing shingles again. Additional supportive information: No follow-up was possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094989:same report, 1st dose
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had both my vaccinations, now getting over shingles/suspected vaccination failure; Getting over having shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antibiotics nos. 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 and Shingles vaccine.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had both his/her vaccinations and just now getting over having shingles. The patient was still taking antibiotics for it. The patient stated that was not a real bad case of it, but it was still. Additional supportive information: This case was considered as suspected vaccination failure as details regarding the time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both shots in 2019, had shingles this year/ Suspected vaccination failure; 2 episodes of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 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 Information: GSK Receipt Date: 17-JUN-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient received both dose of Shingrix and this year patient had two episodes of shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding the laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 97-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, more than 2 years 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.     Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter stated that the patient was his/her mother, the patient had Shingrix vaccines in 2019, then got shingles in 2022. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the vaccines still got the shingles/suspected vaccination failure; Got the shingles, not the rash but other symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUN-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the shingles vaccines and still got the shingles not the rash but other symptoms. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: booster shot activated the shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in 1987).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that the booster shot activated the shingles that he/she had in 1987. No more shots for him/her. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: felt like biting pain all over body; still have the burning; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 8 months after receiving Shingles vaccine, the patient experienced general body pain and burning sensation. On an unknown date, the outcome of the general body pain was unknown and the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the general body pain and burning sensation to be related to Shingles vaccine.     Additional Information: GSK receipt date: 17-Jun-2022 Reporter's comment: The patient self-reported the case via interactive digital media. The patient got the shingles poster and had a terrible reaction, felt like biting pain all over body, still had the burning and it was eight months later.  The patient asked if he or she could be helped.
Sex: U
Vaccine: UNK
Symptoms: Near death experience
Clinical narrative: Because last one i took nearlykilled me; This case was reported by a consumer via market research programs and described the occurrence of near death experience in a patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   On an unknown date, the patient received Hz/su + AS01B. On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to Hz/su + AS01B.   Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's Comments: The patient self-reported the case via market research programs. The patient reported that, last one dose of Shingrix, nearly killed him/her
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Get the shot 6 months before then l went to Dr for sun poison, It was shingles/ suspected vaccination failure; Went to Dr for sun poison, It was shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 6 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 Information: GSK Receipt Date: 18-Jun-2022. Reporter's Comments: This case was reported by a patient via interactive digital media. The patient signed to get the shot 6 months before. It was stated that it would not prevent shingles, but it would get a lighter case of it if visit to doctor within a week for further medicine. The patient thought it was a sun poison since patient was working on a roof for a month. The patient went to doctor and it was shingles. As no contact detailes were provided, hence follow up was not possible. Additional Supportive Information: This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule time to onset for event and laboratory confirmation for herpes zoster were unknown.