chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: The patient received second dose of RabAvert in the gluteus; Case reference number US-BN-2024-002923 is a spontaneous case initially received from nurse via Med Communication (reference number: USBAV24-3371) on 23-Dec-2024 and concerns a female patient with unspecified age.  The patient's medical history and concomitant medication details were not provided.  On unspecified date, the patient took the first dose of RabAvert (batch number: unknown) along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration, for post exposure prophylaxis.  On 23-Dec-2024, for unknown amount of time from the first dose, reported as day three, the patient took the second dose of RabAvert (batch number: unknown) along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, and route of administration in gluteus area (explicitly coded as 'Inappropriate site of vaccine administered').  At the time of the initial report, it was unknown if the patient experiences any adverse events due to RabAvert.  No further information was provided.; Reporter's Comments: A female patient with unspecified age took the second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, and route of administration in gluteus area which is considered as inappropriate site of vaccine administered. Product administered at inappropriate site is considered listed per company convention. At this point, it was unknown if the patient experiences any adverse events due to RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient with unspecified age took the second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, and route of administration in gluteus area which is considered as inappropriate site of vaccine administered. Product administered at inappropriate site is considered listed per company convention. At this point, it was unknown if the patient experiences any adverse events due to RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: The patient received RabAvert vaccine in tigh; Case reference number US-BN-2025-000118 is a spontaneous case initially received from nurse via Med Communications (reference number: USBAV25-0093) on 13-Jan-2025 and concerns a 61-years-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 13-Jan-2025, the patient received first dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at an unknown dose and route of administration, in thigh, for indication pre-exposure prophylaxis (explicitly coded as 'vaccine administered at inappropriate site').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to the RabAvert.   No further information provided.; Reporter's Comments: A 61-years-old male patient received first dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution, at an unknown dose and route of administration, in thigh, for indication pre-exposure prophylaxis which is considered as vaccine administered at inappropriate site. Product administered at inappropriate site is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to the RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 61-years-old male patient received first dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution, at an unknown dose and route of administration, in thigh, for indication pre-exposure prophylaxis which is considered as vaccine administered at inappropriate site. Product administered at inappropriate site is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to the RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: RAB, TTOX
Symptoms: Inappropriate schedule of product administration
Clinical narrative: After got bitten in Sunday, the patient was given a Tetanus shot instead of rabies vaccine, but after some time the patient received the first dose of RabAvert on 14-Jan-2025; Case reference number US-BN-2025-000123 is a spontaneous case initially received from consumer via Med Communication (reference number: USBAV25-0112) on 14-Jan-2025 and concerns a 26-year-old, female patient.  The patient's medical history and concomitant medication details were not provided.  On unspecified date, reported as on Sunday night, the patient got bitten.  On an unspecified date, for unknown amount of time from the bite, the patient got Tetanus shot (batch number: unknown), at unknown dose, route or site of administration for post exposure prophylaxis   On 14-Jan-2025, for unknown of time from the bite, the patient received the first dose of RabAvert vaccine along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route or site of administration for post-exposure prophylaxis ( explicitly coded as 'inappropriate schedule vaccine administrated') and received co-suspect vaccine HRIG (immunoglobulin human anti-rabies; batch number: unknown), at unknown dose, route or site of administration for unknown indication.  At the time of initial report, it was unknown if the patient experienced any adverse events due RabAvert.  No further information was provided.; Reporter's Comments: A 26-year-old female patient received the first dose of RabAvert vaccine, unknown time from the bite, along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, route or site of administration for post-exposure prophylaxis which is considered as inappropriate schedule vaccine administrated. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due RabAvert. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 26-year-old female patient received the first dose of RabAvert vaccine, unknown time from the bite, along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, route or site of administration for post-exposure prophylaxis which is considered as inappropriate schedule vaccine administrated. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due RabAvert. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient was unable to receive the second dose of RabAvert on day seven; Case reference number US-BN-2025-000164 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV25-0177) on 23-Jan-2025 and concerns a patient with unspecified age and gender.  The patient's medical history and concomitant medication details were not provided.  On unspecified date, the patient received first dose of RabAvert vaccine along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration for pre-exposure. As reported, reported as on day seven was unable to receive second dose of RabAvert vaccine (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of initial report, it was unknown if the patient experienced any adverse events due RabAvert.  No further information was provided.; Reporter's Comments: A patient with unspecified age and gender received first dose of RabAvert vaccine along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, route or site of administration for pre-exposure. Reportedly, the patient was unable to receive second dose of RabAvert vaccine on day seven which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient with unspecified age and gender received first dose of RabAvert vaccine along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, route or site of administration for pre-exposure. Reportedly, the patient was unable to receive second dose of RabAvert vaccine on day seven which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received the second dose of RabAvert, 18 days after the first dose; Case reference number US-BN-2025-000372 is a spontaneous case initially received from consumer via Med Communication (reference number: USBAV25-0585) on 14-Mar-2025 and concerns a 26-year-old, female patient.  The patient's medical history and concomitant medication details were not provided.  On 20-Feb-2025, the patient took the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration for indication pre-exposure prophylaxis.  On 10-Mar-2025, 18 days after the patient took first dose, the patient took second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration (explicitly coded as 'Inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown if the patient experienced any of adverse events due to RabAvert.  Additional information received from pharmacist via Med Communication (reference number: USBAV25-0586) on 14-Mar-2025: New information included patient information, new reporter information.; Reporter's Comments: A  26-year-old female patient who received RabAvert for pre-exposure prophylaxis. The first dose was administered on 20-Feb-2025, and the second dose on 10-Mar-2025, with an inappropriate schedule. The patient's medical history and concomitant medications were not provided. At the time of the initial report, it was unknown if the patient experienced any adverse events. The Inappropriate schedule of product administration is considered listed as per company conventions. The evaluation did not find enough evidence to suggest a reasonable possibility of a causal relationship between the reported events and RabAvert ,as it is related to human factors, therefore the causality is assessed as not related.; Sender's Comments: A  26-year-old female patient who received RabAvert for pre-exposure prophylaxis. The first dose was administered on 20-Feb-2025, and the second dose on 10-Mar-2025, with an inappropriate schedule. The patient's medical history and concomitant medications were not provided. At the time of the initial report, it was unknown if the patient experienced any adverse events. The Inappropriate schedule of product administration is considered listed as per company conventions. The evaluation did not find enough evidence to suggest a reasonable possibility of a causal relationship between the reported events and RabAvert ,as it is related to human factors, therefore the causality is assessed as not related.
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient received only one dose of RabAvert on 14-Nov-2024; Case reference number US-BN-2025-000422 is a spontaneous case initially received from pharmacist via Med Communication (reference number: USBAV25-0738) on 02-Apr-2025 and concerns a female patient of unspecified age.   The patient's medical history and concomitant medication details were not provided.  On 14-Nov-2024 (also reported as 14-Nov-2025), the patient took first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00555; expiration date: 01-Sep-2027) at an unknown dose, intramuscularly at unknown site of administration for indication pre-exposure for school.  As reported, the patient received only one dose of RabAvert and now she wanted to see if she can finish the series or if she needs to start over (explicitly coded as 'incomplete course of vaccination').  At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert.  No further information was provided.; Reporter's Comments: A female patient of unknown age/age group had received RabAvert vaccine for pre-exposure for school. As reported, patient had received only the first dose of RabAvert vaccine which is considered as incomplete course of vaccination. It was unknown if patient experienced any adverse events due to RabAvert vaccine. Incomplete course of vaccination is considered as listed as per company convention. The patient's medical history and concomitant medication details were not provided. Event incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age/age group had received RabAvert vaccine for pre-exposure for school. As reported, patient had received only the first dose of RabAvert vaccine which is considered as incomplete course of vaccination. It was unknown if patient experienced any adverse events due to RabAvert vaccine. Incomplete course of vaccination is considered as listed as per company convention. The patient's medical history and concomitant medication details were not provided. Event incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient received two doses of Rabavert and did not come back for the third; Case reference number US-BN-2025-000388 is a spontaneous case report initially received from a nurse via MisCommunication (reference number: USBAV25-0789) on 08-Apr-2025 and concerns a female patient of unspecified age.  The patient's relevant medical history and concomitant medications were not provided.  On an unspecified date, the patient took first dose of Rabavert vaccine along with prefilled syringe, needle for injection and injection for reconstitution (batch number: unknown) at an unknown dose, route and site of administration for unknown indication.  On an unspecified date, the patient took second dose of Rabavert vaccine along with prefilled syringe, needle for injection and injection for reconstitution (batch number: unknown) at an unknown dose, route and site of administration. As reported, an animal control person that had two doses but didn't come back for the third (explicitly coded as 'incomplete course of vaccination').  At the time of the initial report, it was unknown if the patient experienced any adverse events due to Rabavert vaccine.  No further information was provided.; Reporter's Comments: A female patient of unspecified age had two doses but didn't come back for the third which is considered as incomplete course of vaccination. Incomplete course of vaccination is considered listed per company convention. At the time of the initial report, it was unknown if the patient experienced any adverse events due to Rabavert vaccine. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age had two doses but didn't come back for the third which is considered as incomplete course of vaccination. Incomplete course of vaccination is considered listed per company convention. At the time of the initial report, it was unknown if the patient experienced any adverse events due to Rabavert vaccine. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: The patient received the second dose of RabAvert and experienced fever and right groin lymph node was swollen; The patient received the second dose of RabAvert and experienced fever and right groin lymph node was swollen; Case reference number US-BN-2025-000884 is a spontaneous case initially received from consumer via Med Communication (reference number: USBAV25-0957) on 28-Apr-2025 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On unspecified date, the patient received first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route or site of administration for unknown indication.   On 26-Apr-2025 also reported as three-day series, unknown amount of time from the first dose, the patient received second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route or site of administration.  On 27-Apr-2025, one day after the vaccination with second dose of RabAvert, the patient experienced a fever and right groin lymph node was swollen.   At the time of the initial report, the patient did not recover from the events 'swollen lymph nodes' and 'fever', as reported ongoing.  The reporter assessed the events 'swollen lymph nodes' and 'fever' as non-serious and did not provide causality assessment.  No further information was provided.; Reporter's Comments: This case concerns a female patient of unknown age/age group who experienced non-serious events of lymphadenopathy and pyrexia, one day after the vaccination with second dose of RabAvert for unknown indication. Lymphadenopathy and pyrexia are listed per CCDS V4 and expected per USPI. Patient's medical history and concomitant medications was not reported. Outcome of these events was not recovered/not resolved. Based on the limited information provided regarding this case, along with the latency of 1 day, the causal role of the suspect vaccine cannot be excluded in the occurrence of the events, hence the events are considered related to the suspect vaccine. This case is considered as non-serious.; Sender's Comments: This case concerns a female patient of unknown age/age group who experienced non-serious events of lymphadenopathy and pyrexia, one day after the vaccination with second dose of RabAvert for unknown indication. Lymphadenopathy and pyrexia are listed per CCDS V4 and expected per USPI. Patient's medical history and concomitant medications was not reported. Outcome of these events was not recovered/not resolved. Based on the limited information provided regarding this case, along with the latency of 1 day, the causal role of the suspect vaccine cannot be excluded in the occurrence of the events, hence the events are considered related to the suspect vaccine. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient was supposed to get her second dose of RABAVERT on April 23rd, but she never got it.; Case reference number US-BN-2025-000886 is a spontaneous case initially received from pharmacist via Med Communication (reference number: USBAV25-0963) on 29-Apr-2025 and concerns an adult female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On unspecified date, the patient received the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration for indication post-exposure vaccination.  As reported, the patient was supposed to get her second dose of RabAvert on April 23rd, but she never got it (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown if the patient experienced any of adverse events due to RabAvert.  No further information was provided.; Reporter's Comments: An adult female patient of unspecified age received the first dose of RabAvert for indication post-exposure vaccination. As reported, the patient was supposed to get her second dose of RabAvert on April 23rd, but she never got it, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any of adverse events due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult female patient of unspecified age received the first dose of RabAvert for indication post-exposure vaccination. As reported, the patient was supposed to get her second dose of RabAvert on April 23rd, but she never got it, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any of adverse events due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient took first dose of RabAvert in February and didn't receive second dose yet; Case reference number US-BN-2025-000898 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV25-1009) on 02-May-2025 and concerns a 19-year-old, male patient.  The patient's medical history and concomitant medication details were not provided.  On 24-Feb-2025, the patient received the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00595) at unknown dose and site of administration, intramuscularly, for indication pre-exposure prophylaxis. The patient hadn't received the second dose yet (explicitly coded as 'incomplete course of vaccination').  At the time of initial report, it was unknown if the patient experienced any of adverse events due to RabaVert.  No further information was provided.; Reporter's Comments: A 19-year-old male patient received the first dose of RabAvert in Feb 2025 for indication pre-exposure prophylaxis. The patient hadn't received the second dose yet, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any of adverse events due to RabaVert. Incomplete course of vaccination is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 19-year-old male patient received the first dose of RabAvert in Feb 2025 for indication pre-exposure prophylaxis. The patient hadn't received the second dose yet, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any of adverse events due to RabaVert. Incomplete course of vaccination is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient received booster of Rabavert after 30 years; Case reference number US-BN-2025-000902 is a spontaneous case report initially received from a other health care professional via MedCommunication (reference number: USBAV25-1011) on 02-May-2025 and concerns a female patient of unspecified age.  The patient's relevant medical history and concomitant medications were not provided.  On an unspecified date, as reported, 30 years ago, the patient had primary series of RabAvert vaccine along with prefilled syringe, needle for injection and injection for reconstitution (batch number: unknown) at an unknown dose, route and site of administration for unknown indication.  On 02-May-2025, as reported 30 years after first dose, the patient received first booster dose of RabAvert vaccine along with prefilled syringe, needle for injection and injection for reconstitution (batch number: unknown) at an unknown dose, route and site of administration (explicitly coded as 'Inappropriate schedule of vaccine administration').  At the time of the initial report, it was unknown if the patient experienced any adverse events due to RabAvert vaccine.  No further information was provided.; Reporter's Comments: A female patient of unspecified age received first booster dose of RabAvert vaccine for unknown indication, as reported 30 years after first dose, which is considered as inappropriate schedule of vaccine administration. It was unknown if the patient experienced any adverse events due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age received first booster dose of RabAvert vaccine for unknown indication, as reported 30 years after first dose, which is considered as inappropriate schedule of vaccine administration. It was unknown if the patient experienced any adverse events due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient received only one dose of Rabavert about three months ago; Case reference number US-BN-2025-000910 is a spontaneous case initially received from pharmacist via Med Communication (reference number: USBAV25-1033) on 06-May-2025 and concerns a 42-years-old female patient.   The patient's medical history and concomitant medication details were not provided.  On unspecified date, reported as three months ago, the patient took first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route or site of administration for indication pre-exposure prophylaxis.  As reported, the patient received only one dose of RabAvert about three months ago as the patient was not told about other doses needed (explicitly coded as 'incomplete course of vaccination').  At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert.  No further information was provided.; Reporter's Comments: This case concerns a 42-year-old adult female patient. On unspecified date, the patient received the first dose of RabAvert vaccine with an indication of pre-exposure prophylaxis. As reported, the patient received only one dose of RabAvert about three months ago as the patient was not told about other doses needed which is considered as incomplete course of vaccination'. At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert. Incomplete course of vaccination is considered as listed as per company convention. The patients' medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: This case concerns a 42-year-old adult female patient. On unspecified date, the patient received the first dose of RabAvert vaccine with an indication of pre-exposure prophylaxis. As reported, the patient received only one dose of RabAvert about three months ago as the patient was not told about other doses needed which is considered as incomplete course of vaccination'. At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert. Incomplete course of vaccination is considered as listed as per company convention. The patients' medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: VARZOS
Symptoms: Papule, Pruritus
Clinical narrative: Itching on his back, near the lumbar area; bumps are very small red spots the size of a pin head and are not blistered or open, they are just barely raised; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included atrial fibrillation, blood pressure high and hyperlipidemia. Concomitant products included flecainide, diltiazem (Cardizem), atorvastatin, acetylsalicylic acid (Aspirin) and colecalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, vitamin b1 nos (Multivitamin).   In APR-2025, the patient received Shingrix (intramuscular use, unknown deltoid) .5 ml. On 15-MAY-2025, less than 2 months after receiving Shingrix, the patient experienced pruritus (Verbatim: Itching on his back, near the lumbar area) and red papule (Verbatim: bumps are very small red spots the size of a pin head and are not blistered or open, they are just barely raised). The outcome of the pruritus and red papule were not resolved.   It was unknown if the reporter considered the pruritus and red papule to be related to Shingrix.     It was unknown if the company considered the pruritus and red papule to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-JUN-2025 The patient self-reported this case. The patient received 1st dose of Shingrix vaccine in mid-April this year and about 3 or 4 weeks later he noticed itching on his back, near the lumbar area.  He reported that it remained confined to that area until one week ago, when it spread around his waist just below the belt line, onto his hip, and up his chest almost to his nipples and the bumps were very small red spots the size of a pin head and were not blistered or open, they were just barely raised.  They crossed the midline in both the back and the front of his body, and it seemed to be progressing, getting more widespread and itchy. He started using a new soap about 6 months ago.  The information on the medications listed is all that is available. He did not wish to locate his bottles to tell me the dosage. He stated that he has been taking these medicines for a very long time and did not believe they could be impacting his experiences with the bumps or itching.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever (Verbatim: Fever). The outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.     It was unknown if the company considered the fever to be related to Shingrix.   Linked case(s) involving the same patient: US2025AMR079662   Additional Information: GSK Receipt Date: 24-JUN-2025 While asking questions about Shingrix, the caller mentioned that her daughter had a reaction to Shingrix.  When questioned about this event, she was reluctant to provide any information, only saying that her daughter received both doses of Shingrix vaccine a few months ago in 2024 and that she had a fever in 2024 after the first dose. She did not wish to provide any further information on behalf of her daughter without her daughter's consent.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I received one if the shingles vaccine , but failed to get the second one. Do i have to start all over again; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: I received one if the shingles vaccine , but failed to get the second one. Do i have to start all over again). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 31-MAY-2025 The patient self-reported this case. The patient received one of the Shingles vaccine, but failed to get the second one.  The reporter asked do they have to start all over, again. The patient asked was there a test to see if you have had chicken pox as patient was a baby when my brother had chicken pox, and she said she didn't see any signs that I ever had it. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Vaccine: RVX
Symptoms: Cough, Fatigue, Malaise
Clinical narrative: cough; exhaustion; sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: sick), cough (Verbatim: cough) and exhaustion (Verbatim: exhaustion). The outcome of the sickness was resolved (duration 1 week) and the outcome of the cough and exhaustion were not reported.   It was unknown if the reporter considered the sickness, cough and exhaustion to be related to RSV vaccine.     It was unknown if the company considered the sickness, cough and exhaustion to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 18-JUN-2025 This case was reported by a patient via interactive digital media. Patient had gotten the vaccine the previous fall, but the emergency room told him/her he/she had RSV.  Patient had been sick for over a week, and he/she finally went to the emergency room because his/her cough and exhaustion had gotten really bad.  The vaccine had not completely prevented the illness, just like the COVID vaccine had not been perfect.
Vaccine: VARZOS
Symptoms: Eye pain, Influenza like illness, Neck pain, Sleep disorder
Clinical narrative: Flu like symptoms; neck hurting; eyes hurting; could not sleep; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms), neck pain (Verbatim: neck hurting), eye pain (Verbatim: eyes hurting) and difficulty sleeping (Verbatim: could not sleep). The outcome of the influenza-like symptoms, neck pain, eye pain and difficulty sleeping were resolved.   It was unknown if the reporter considered the influenza-like symptoms, neck pain, eye pain and difficulty sleeping to be related to Shingles vaccine.     It was unknown if the company considered the influenza-like symptoms, neck pain, eye pain and difficulty sleeping to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-JUN-2025 This case was reported by a patient via interactive digital media. Patient just finished Shingles shot and it was not fun at all.  Flu-like symptoms could occur and patient also could not sleep without his/her neck and eyes hurting.  Patient was glad that was over.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got shingles 3 weeks after the shot; This non-serious 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 Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I got shingles 3 weeks after the shot). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-JUN-2025 This case was reported by a patient via interactive digital media. The patient got shingles 3 weeks after the shot.
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: painful rash; red itchy rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of painful rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced painful rash (Verbatim: painful rash) and itchy rash (Verbatim: itchy rash). The outcome of the painful rash and itchy rash were not reported.   It was unknown if the reporter considered the painful rash and itchy rash to be related to Shingles vaccine.     It was unknown if the company considered the painful rash and itchy rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-JUN-2025 This case was reported by a patient via (Shingrix GRC chatbot) interactive digital media. Patient had a red painful itchy rash on his/her tummy and did not know what it was.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; This serious 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 20-JUN-2025, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 21-JUN-2025 This case was reported by a patient via interactive digital media. Patient got both of the shingles vaccine and was diagnosed with shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine (Dose 1 & 2).
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; going through the most painful shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: going through the most painful shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-JUN-2025 This case was reported by a patient via interactive digital media. The patient got the shots and thought he/she was safe.  At the time of reporting the patient was going through the most painful shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had received 3 shots; two episodes when my body was under stress/mild pain-free outbreaks; This serious 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 and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: two episodes when my body was under stress/mild pain-free outbreaks) and extra dose administered (Verbatim: had received 3 shots). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 3 days) and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 21-JUN-2025 This case was reported by a patient via interactive digital media. Patient had all three shots but two episodes when body was under stress but because of the vaccine patient had mild pain free outbreaks. Took vancyclovir within three days and it is gone. Patient had 3 shots, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1, 2 and 3)