chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RAB
Symptoms: COVID-19, Malaise, Pyrexia
Clinical narrative: Mild fever; Became sick with Covid 19 infection; Case reference number US-BN-2022-001550 is a spontaneous case report initially received on 13-Jul-2022 from other health care professional via Communications (reference number: USBAV22-0547) and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 07-Jul-2022, the patient was vaccinated with the first dose of Rabavert (Rabies Virus (Inactivated, Strain Flury LEP) (PCEC); batch number unknown), at a dose reported as 1ml, administered intramuscularly, for pre-exposure prophylaxis.  On 10-Jul-2022, three days after the vaccination, the patient became sick with COVID-19 infection.   On an unspecified date, an unknown amount of time after the vaccination, the patient developed mild fever.   At the time of this report, the outcome of the events was not resolved/ongoing.  The reporter assessed both events as non-serious and not related to the vaccine.   Additional information received from on 14-Jul-2022 included the local case ID.; Reporter's Comments: A female patient of unknown age experienced a non-serious event of COVID-19 on the day 3 after the vaccination with the first dose of Rabavert for pre-exposure prophylaxis, and a non-serious event of pyrexia an unknown amount of time after the vaccination. COVID-19 is not listed, whilst pyrexia is listed for RabAvert according to the guidelines. The patient's medical history and concomitant medication details were not provided. The outcome of the events was not resolved. The event of COVID-19 has been considered as not related to the suspect vaccine, but to incidental infection, and the event of pyrexia has been considered as not related to RabAvert, but more likely to be related with COVID-19 infection. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age experienced a non-serious event of COVID-19 on the day 3 after the vaccination with the first dose of Rabavert for pre-exposure prophylaxis, and a non-serious event of pyrexia an unknown amount of time after the vaccination. COVID-19 is not listed, whilst pyrexia is listed for RabAvert according to the guidelines. The patient's medical history and concomitant medication details were not provided. The outcome of the events was not resolved. The event of COVID-19 has been considered as not related to the suspect vaccine, but to incidental infection, and the event of pyrexia has been considered as not related to RabAvert, but more likely to be related with COVID-19 infection. This case is considered as non-serious.
Sex: U
Vaccine: RAB
Symptoms: COVID-19, Malaise
Clinical narrative: Became sick with COVID-19; Case reference number US-BN-2022-001551 is a spontaneous case report initially received on 13-Jul-2022 from health care professional (reference number: USBAV22-0547) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Rabavert (Rabies Virus (Inactivated, Strain Flury LEP); batch number unknown), at a dose reported as 1mL, administered intramuscularly, for pre-exposure prophylaxis.  On an unspecified date, an unknown amount of time after the vaccination, the patient became sick with COVID-19.  At the time of this report, the outcome of the event was not resolved/ongoing.  The reporter assessed the event as non-serious and not related to the vaccine.   Additional information received from Bavarian Nordic on 14-Jul-2022 included the local case ID.; Reporter's Comments: A patient of unknown demographics experienced as non-serious event of COVID-19 on an unspecified date, an unknown amount of time after the vaccination with the first dose of Rabavert for pre-exposure prophylaxis. COVID-19 is not listed for RabAvert according to the insert and Datasheet. The patient's medical history and concomitant medication details were not provided. The outcome of the event was not resolved. The event of COVID-19 has been considered as not related to the suspect vaccine, but to incidental infection. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics experienced as non-serious event of COVID-19 on an unspecified date, an unknown amount of time after the vaccination with the first dose of Rabavert for pre-exposure prophylaxis. COVID-19 is not listed for RabAvert according to the insert and Datasheet. The patient's medical history and concomitant medication details were not provided. The outcome of the event was not resolved. The event of COVID-19 has been considered as not related to the suspect vaccine, but to incidental infection. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: The second dose of Rabavert planned to be received on day 22; Case reference number US-BN-2022-001627 is a spontaneous case report initially received on 22-Jul-2022 from a health care professional via Communication (reference number USBAV22-0630) and concerns a 21-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 30-Jun-2022, the patient was vaccinated with the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP) (PCEC); batch number: unknown) at a dose reported as standard dose, intramuscularly, at an unknown site of administration, for pre-exposure immunization against rabies.  On an unspecified date, 22 days after the first dose (as reported), the patient showed up for the second dose of RabAvert (batch number: unknown) for pre-exposure immunization against rabies (explicitly coded as 'Missed dose').  At the time of this report, it was unknown whether the patient experienced any adverse events due to RabAvert vaccination, nor if the patient received the second dose.  Additional information received from on 22-Jul-2022 included local case ID.; Reporter's Comments: A 21-year-old female patient was vaccinated with the first dose of RabAvert for pre-exposure immunization against rabies and on an unspecified date, 22 days after the first dose the patient showed up for the second dose of RabAvert and it is unknown if the patient received the second dose, which is considered as product dose omission issue. No associated adverse events were reported. Product dose omission issue is listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A 21-year-old female patient was vaccinated with the first dose of RabAvert for pre-exposure immunization against rabies and on an unspecified date, 22 days after the first dose the patient showed up for the second dose of RabAvert and it is unknown if the patient received the second dose, which is considered as product dose omission issue. No associated adverse events were reported. Product dose omission issue is listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: RabAvert was given on the left gluteal area; Case reference number US-BN-2022-001790 is a spontaneous case report initially received on 05-Aug-2022 from consumer (reference number: USBAV22-0827) and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of RabAvert (rabies virus (inactivated, strain flury LEP); batch number: unknown) at an unknown dose or route, administered in the left gluteal regional, for post-exposure immunisation (post-exposure rabies treatment) due to possible bat exposure (explicitly coded as 'vaccine administered at inappropriate site').  On unspecified dates, the patient was vaccinated with two doses of Human Rabies Immunoglobulin (HRIG) (immunoglobulin human anti-rabies; batch number: unknown) at an unknown dose, route or site of administration, for an unknown indication.  At the time of this repot, it was unknown it the patient experienced any adverse event or how any doses the patient received.  The case is linked to the case US-BN-2022-001789 concerning the same reporter.  Additional information received on 09-Aug-2022 included local case ID.; Reporter's Comments: A female patient of unknown age was vaccinated with a dose of RabAvert at an unknown dose or route, administered in the left gluteal regional, for post-exposure immunization (post-exposure rabies treatment) due to possible bat exposure, which is considered as vaccine administered at inappropriate site. No associated adverse events have been reported with the reported medication error. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site has been considered as 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 was vaccinated with a dose of RabAvert at an unknown dose or route, administered in the left gluteal regional, for post-exposure immunization (post-exposure rabies treatment) due to possible bat exposure, which is considered as vaccine administered at inappropriate site. No associated adverse events have been reported with the reported medication error. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: The Rabavert was administered intramuscularly to a patient in the thigh instead of the deltoid; Case reference number US-BN-2022-001983 is a spontaneous case report initially received on 19-Aug-2022 from other health care professional (reference number: USBAV22-1098) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the Rabavert vaccine (Rabies Virus (Inactivated, Strain Flury LEP); batch number: unknown), intramuscularly in the thigh instead of the deltoid, for post-exposure to rabies (explicitly coded as 'vaccine administered at inappropriate site').  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received on 22-Aug-2022 from Bavarian Nordic included local case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with the Rabavert vaccine intramuscularly in the thigh instead of the deltoid, for post-exposure to rabies, which is considered as vaccine administered at inappropriate site. No associated adverse events were reported. Vaccine administered at inappropriate site is listed per company convention. The patient's medical history and concomitant medication details were not provided. Vaccine administered at inappropriate site is not related to Rabavert, but to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the Rabavert vaccine intramuscularly in the thigh instead of the deltoid, for post-exposure to rabies, which is considered as vaccine administered at inappropriate site. No associated adverse events were reported. Vaccine administered at inappropriate site is listed per company convention. The patient's medical history and concomitant medication details were not provided. Vaccine administered at inappropriate site is not related to Rabavert, but to a human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Exposure to communicable disease, Paraesthesia
Clinical narrative: The patient arm was tingling where the RabAvert vaccine was administered; Case reference number US-BN-2022-002134 is a spontaneous case report initially received on 26-Aug-2022 from a consumer (reference number: USBAV22-1190) and concerns a 5-years-old female patient.  The patient's medical history and concomitant medication details were not reported.  On the unspecified date, it was noticed that the patient had a mark from a possible bat bite.  On 23-Aug-2022, the patient received the first RabAvert vaccine (Rabies Virus (Inactivated, Strain Flury LEP); batch number unknown), at an unknown dose and route, in the arm (unspecified), for minimal exposure to rabies (as reported).  On 24-Aug-2022, the morning after being vaccinated, the patient arm was tingling in the place where the RabAvert vaccine was administered.  On 24-Aug-2022, the same day, the event of the tingling extremity was resolved.  The reporter assessed the event as non-serious and did not provide a causality assessment.  Additional information received on 26-Aug-2022 from Bavarian Nordic included local case ID.; Reporter's Comments: A 5-year-old female patient experienced paraesthesia at the administration site (arm), 1 day after 1st vaccination with RabAvert, at an unknown dose and route, administered in the arm for minimal exposure to rabies. The event resolved within the same day. Paraesthesia is listed as per database and insert. The patient was believed to have had a possible bat bite on an unspecified date. No other medical history or concomitant medications were reported. Considering the short latency of the event, as well as the known safety profile, the event of paraesthesia is considered as related to RabAvert.; Sender's Comments: A 5-year-old female patient experienced paraesthesia at the administration site (arm), 1 day after 1st vaccination with RabAvert, at an unknown dose and route, administered in the arm for minimal exposure to rabies. The event resolved within the same day. Paraesthesia is listed as per database and insert. The patient was believed to have had a possible bat bite on an unspecified date. No other medical history or concomitant medications were reported. Considering the short latency of the event, as well as the known safety profile, the event of paraesthesia is considered as related to RabAvert.
Sex: U
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient was vaccinated with first dose of Rabavert in January, returned two months later for second dose; Case reference number US-BN-2023-000665 is a spontaneous case report initially received from health care professional via Communication (reference number: USBAV23-0523) on 12-Apr-2023 and concerns a patient of unknown age and gender.  The patient's relevant medical history and concomitant medication details were not provided.  On an unspecified day in January, a patient was vaccinated with the first dose of Rabavert vaccine (batch number not provided) at an unknown dose, route, or site of administration, for unknown indication.  On an unspecified day, reported as two months after the first dose of Rabavert, the patient returned for second dose (explicitly coded as 'incomplete course of vaccination').  At the time of this report, it was unknown if the patients experienced any adverse event due to Rabavert.  Additional information received from on 13-Apr-2023 included local case ID.; Reporter's Comments: A patient of unknown age and gender was vaccinated with the first dose of Rabavert vaccine for unknown indication and reportedly two months later the patient returned for second dose, which is considered as incomplete course of vaccination. No associated adverse events were reported. Incomplete course of vaccination is listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to Rabavert, but to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender was vaccinated with the first dose of Rabavert vaccine for unknown indication and reportedly two months later the patient returned for second dose, which is considered as incomplete course of vaccination. No associated adverse events were reported. Incomplete course of vaccination is listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to Rabavert, but to a human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Malaise
Clinical narrative: Injection pain; General malaise; Case reference number US-BN-2023-000767 is a spontaneous case report initially received on 27-Apr-2023 from a consumer via Manufacturer (reference number: NUS2023US062725) and concerns a female patient of unknown age.  The patients' relevant medical history and concomitant medication details were not provided.  On unspecified dates, the patient received unknown number of rabies vaccines (brand name: unknown, batch number not reported) at an unknown dose, route or site of administration, for an unknown indication.  On unspecified dates, an unknown amount of time after rabies vaccination, as reported, patient always experienced injection pain and general malaise.  At the time of initial report, the outcome for the events 'malaise' and 'injection site pain' was unknown.  The reporter did not provide seriousness and causality assessment.  Additional information received from Bavarian Nordic on 01-May-2023 included local case ID.  Additional information received from Manufacturer on 02-May-2023 included confirmation of country of occurrence.; Reporter's Comments: A female patient of unknown age experienced injection site pain and general malaise, unknown time she received  unknown number of rabies vaccines, at an unknown dose, route or site of administration, for an unknown indication. Injection site pain and malaise are both listed and expected according to database and insert. The outcome was unknown. The patients' relevant medical history and concomitant medication details were not provided. Injection site pain and malaise are both assessed as related due to known product safety profile and since contributory role of suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A female patient of unknown age experienced injection site pain and general malaise, unknown time she received  unknown number of rabies vaccines, at an unknown dose, route or site of administration, for an unknown indication. Injection site pain and malaise are both listed and expected according to database and insert. The outcome was unknown. The patients' relevant medical history and concomitant medication details were not provided. Injection site pain and malaise are both assessed as related due to known product safety profile and since contributory role of suspect product cannot be excluded. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received the first dose of RabAvert three weeks ago and coming back on 08-May; Case reference number US-BN-2023-000791 is a spontaneous case report initially received from a physician (reference number: USBAV23-0606) on 03-May-2023 and concerns an adult female patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported as three weeks ago, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at unknown dose, route or site of administration, for pre-exposure to rabies (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, that was a problem of pharmacies giving vaccines (*spacing of administration being stage of medication process where the error occurred*) and that the patient would have come back on 08-May-2023 for the second dose.  *Initial dose was administered in a pharmacy prior to patient's coming to travel medicine clinic for evaluation. It was also reported that there was human factor contributing as the patient was not informed by pharmacy that additional doses were needed. The patient went to pharmacy prior to her scheduled visit and requested a number of vaccines many of which were not needed for relocation (Yellow fever, MCV ), as reported.*  *As also reported, the patient did not experienced any adverse event due to RabAvert vaccination and was doing fine.*  Additional information received from Bavarian Nordic on 04-May-2023 included the local case ID.  All follow-up information is blended into the case narrative above, with the latest information pre-sented between asterisks (*).  Follow-up information received from a physician on 26-May-2023: New information included confirmation that the patient did not experience any adverse event due to RabAvert vaccination and additional information regarding error made.; Reporter's Comments: An adult female patient was vaccinated with the second dose of RabAvert approximately three weeks after the first dose for pre-exposure to rabies, which is considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse events associated to vaccination. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: An adult female patient was vaccinated with the second dose of RabAvert approximately three weeks after the first dose for pre-exposure to rabies, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Patient received first dose of Rabavert on 13-Mar-2023 and no further doses until now; Case reference number US-BN-2023-000807 is a spontaneous case report initially received on 08-May-2023 from a nurse (reference number: USBAV23-0620) and concerns a female patient in her 20's.  The patient's relevant medical history and concomitant medication details were not provided.  On 13-Mar-2023, the patient was vaccinated with the first dose of RabAvert vaccine (batch number not provided) at unknown dose, at an unknown route or site of administration, for pre-exposure for rabies. Patient was scheduled for second dose of RabAvert vaccine on day 7 from first dose, but no further doses were received after the first dose (explicitly coded as 'Incomplete course of vaccination').   At the time of this initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  Additional information received from Bavarian Nordic on 09-May-2023 included local ID.; Reporter's Comments: A female patient in her 20's was vaccinated with the first dose of RabAvert vaccine for pre-exposure for rabies. Patient was scheduled for second dose of RabAvert vaccine on day 7 from first dose, but no further doses were received after the first dose, which is considered as incomplete course of vaccination. No associated adverse events were reported. Incomplete course of vaccination is listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A female patient in her 20's was vaccinated with the first dose of RabAvert vaccine for pre-exposure for rabies. Patient was scheduled for second dose of RabAvert vaccine on day 7 from first dose, but no further doses were received after the first dose, which is considered as incomplete course of vaccination. No associated adverse events were reported. Incomplete course of vaccination is listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: M
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient received first dose of RabAvert on 14-Feb-2023 and did not receive second dose since then; Case reference number US-BN-2023-000809 is a spontaneous case report initially received from a pharmacist via Communication (reference number: USBAV23-0622) on 08-May-2023 and concerns a male patient of unknown age.   The patient's relevant medical history and concomitant medication details were not provided.  On 14-Feb-2023, the patient was vaccinated with the first dose of RabAvert (batch number not provided) at an unknown dose, route or site of administration for pre-exposure to rabies. As reported, the patient received the first dose and did not receive the second dose since then (explicitly coded as 'incomplete course of vaccination').    At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert.  Additional information received on 09-May-2023 included local case ID.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of RabAvert, at an unknown dose, route or site of administration for pre-exposure to rabies. As reported, the patient received the first dose and did not receive the second dose since then, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to RabAvert. Incomplete course of vaccination is considered as listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with the first dose of RabAvert, at an unknown dose, route or site of administration for pre-exposure to rabies. As reported, the patient received the first dose and did not receive the second dose since then, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to RabAvert. Incomplete course of vaccination is considered as listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Incomplete course of vaccination has been considered as 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, No adverse event
Clinical narrative: Vaccinated with the first dose of RabAvert in March, missed the date for the second dose; Case reference number US-BN-2023-000810 is a spontaneous case report initially received on 08-May-2023 from a consumer via Communication (reference number: USBAV23-0621) and concerns a male patient of unknown age.  The patient's relevant medical history and concomitant medication details were not provided.  On an unspecified date in March of unspecified year, the patient was vaccinated with the first dose of RabAvert vaccine (batch number not provided), at unknown dose, at an unknown route or site of administration, for pre-exposure prophylaxis.  As reported, the patient missed the date for the second RabAvert dose (explicitly coded as 'incomplete course of vaccination').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  Additional information received on 09-May-2023 included local case ID.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of RabAvert vaccine for pre-exposure prophylaxis and as reported, the patient missed the date for the second dose, which is considered as incomplete course of vaccination. No associated adverse events were reported. Incomplete course of vaccination is listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with the first dose of RabAvert vaccine for pre-exposure prophylaxis and as reported, the patient missed the date for the second dose, which is considered as incomplete course of vaccination. No associated adverse events were reported. Incomplete course of vaccination is listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Peripheral swelling, Vaccination failure
Clinical narrative: Got 2 Shingle shots, Got shingles/Suspected vaccination failure; Shingles all over body; left toe turned blood red; left toe swole up; 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 an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got 2 Shingle shots, Got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles all over body), erythema of extremities (Verbatim: left toe turned blood red) and swelling of feet (Verbatim: left toe swole up). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the erythema of extremities and swelling of feet were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, erythema of extremities and swelling of feet to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, erythema of extremities and swelling of feet to be related to Shingles vaccine. It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-JUN-2023 This case was reported by a patient via interactive digital media. The patient's physician talked him/her into getting the Shingles vaccine. The patient had 5 brothers and 5 sisters, none of them have ever gotten shingles.  After the second injection, the patient started with shingles all over body.  The patient's left toe turned blood red and swole up, like he/she had gout.  The patient looked up the side effects of the vaccine and had them. They tried all sorts of meds, and the stuff cleared up except on my arms. The patient had to out up with this everyday. The patient stated to beaware as there were side effects for people. The patient wished he/she had never gotten it. 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. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the 2 shot deal about 2 years ago guess what yep got shingles again/suspected vaccination failure; Shingels; 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.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the 2 shot deal about 2 years ago guess what yep got shingles again/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingels). The outcome of the vaccination failure was unknown 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 and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 27-JUN-2023 and 28-JUN-2023 This case was reported by a patient via interactive digital media. The patient got the 2 shot deal and I got it again last year, lasted couple of months and was worse than previous time.  Patient stated now I have it again. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding laboratory test and time to onset confirming shingles was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: bad case of Vertigo; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of vertigo in a 69-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included surgery and nerve damage (nerve damage from the surgery which is also very painful.).   On 08-JUN-2023, the patient received the 1st dose of Shingles vaccine. On 09-JUN-2023, 1 days after receiving Shingles vaccine, the patient experienced vertigo (Verbatim: bad case of Vertigo). The outcome of the vertigo was not reported.   It was unknown if the reporter considered the vertigo to be related to Shingles vaccine.     It was unknown if the company considered the vertigo to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 25-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received Shingles on Thursday and bad case of Vertigo on Friday, that was 2 weeks ago. The patient states that if it's related or not but Vertigo is no fun, & his/her Dr said he/she could have it another 2 weeks and also mentioned that never had this before. The patient states that he/she just had surgery 2 months ago & had nerve damage from the surgery which is also very painful.  From the sound of what people are saying about shingles, he/she think It still better get the 2nd shingles shot. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced tiredness (Verbatim: tired). The outcome of the tiredness was resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.     It was unknown if the company considered the tiredness to be related to Shingrix.   Additional Information: GSK Receipt date: 26-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received 2nd dose of Shingles vaccine and experienced tired the following day but over it quickly.  Follow up was not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Illness, Influenza like illness
Clinical narrative: Sick; flu like symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick) and influenza-like symptoms (Verbatim: flu like symptoms). The outcome of the sickness and influenza-like symptoms were resolved.   It was unknown if the reporter considered the sickness and influenza-like symptoms to be related to Shingles vaccine.     It was unknown if the company considered the sickness and influenza-like symptoms to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-JUN-2023 This case was reported by a patient via interactive digital media. The reporter reported that he had the vaccine and stated that it was not too bad at all. The reporter's wife got the vaccination shot and was sick for 2 to 3 days with flu like symptoms. The follow-up could not be possible as no contact details were available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received adjuvant component only; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 2BR9G, expiry date 09-JUL-2024) for prophylaxis.   On 28-JUN-2023, the patient received the 1st dose of Shingrix. On 28-JUN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received adjuvant component only) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-JUN-2023 The patient received adjuvant component of Shingrix only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: HEPAB, HEPAB
Symptoms: Incomplete course of vaccination, Incorrect dose administered, Product preparation issue
Clinical narrative: Patient was coming in today for their 3rd; The patient received a Hep B only immunization; The patient now missed the Hep A portion of their second dose; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 20-JAN-2023, the patient received the 2nd dose of Twinrix. On an unknown date, the patient received the 3rd dose of Twinrix. On 20-JAN-2023, an unknown time after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced inappropriate preparation of medication (Verbatim: The patient received a Hep B only immunization) and inappropriate dose of vaccine administered (Verbatim: The patient now missed the Hep A portion of their second dose). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Patient was coming in today for their 3rd ). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JUN-2023 The reporter reported that the patient received a hepatitis B immunization. The reporter stated that this was discovered when the patient was coming for their third dose. The patient was missed the hepatitis A portion of their second dose. The reporter wanted to know what would be the recommendation for completing the Twinrix series. The reporter did consent to follow up. Only Hepatitis B of Twinrix administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Till the time of reporting, the patient did not receive the 3rd dose of Twinrix vaccine, which led to incomplete course of vaccination.
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Inadvertently administered the boostrix vaccine following a temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 48-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 55RY7, expiry date 17-OCT-2025) for prophylaxis.   On an unknown date, the patient received the 1st dose of Boostrix (left deltoid). On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Inadvertently administered the boostrix vaccine following a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 26-JUN-2023 The reporter reported that the patient was inadvertently administered the Boostrix vaccine following the temperature excursion. The reporter did consent to follow up. The Boostrix vaccine temperature was exposed to temperature excursion, which led to incorrect storage of drug. This case had been linked with US2023088646 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023088646:Same reporter
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: fever; weakness; vomiting; nausea; headache; This non-serious case was reported by a physician via call center representative and described the occurrence of fever in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number 25DB5, expiry date 31-JUL-2023) for prophylaxis.   On 25-MAY-2023, the patient received the 1st dose of Bexsero. On 25-MAY-2023, 24 hrs after receiving Bexsero, the patient experienced fever (Verbatim: fever), weakness (Verbatim: weakness), vomiting (Verbatim: vomiting), nausea (Verbatim: nausea) and headache (Verbatim: headache). The outcome of the fever, weakness, vomiting, nausea and headache were resolved (duration 72 hrs).   It was unknown if the reporter considered the fever, weakness, vomiting, nausea and headache to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the fever, weakness, vomiting, nausea and headache to be related to Bexsero and Bexsero Pre-Filled Syringe 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: 26-JUN-2023 A physician reported about a patient who received Bexsero on 25May2023 and within 24 hours the patient developed fever, headache, nausea, vomiting, and weakness, the reactions subsided after 72 hours.  The vaccine Administration facility was the same as Primary Reporter. The reporter was consented to follow up via postal.
Age: 3.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: Boostrix underage administration; Boostrix instead of Dtap catch up administration; Underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 03-NOV-2024) for prophylaxis.   On 23-JUN-2023, the patient received Boostrix. On 23-JUN-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix underage administration), wrong vaccine administered (Verbatim: Boostrix instead of Dtap catch up administration) and underdose (Verbatim: Underdose). The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JUN-2023. Medical assistant reported on 26 June 2023 that male patient 3 years and 5 month of age who happened to be her son. The vaccine was administer on 23 June 2023 Boostrix instead of Dtap catch up administration the reporter did not know where in the series the patient was.  The reporter did not consent to follow-up.  The vaccine administration facility was the same as Primary Reporter. A 3 years and 5 month patient received a dose of Boostrix instead of Dtap vaccine, which led to wrong vaccine administered, inappropriate age at vaccine administration and underdose.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasal congestion, Urticaria
Clinical narrative: experienced hives 4 hours after the administration of the vaccine; as well as nasal congestion; This non-serious case was reported by a physician via call center representative and described the occurrence of hives in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 23YG7, expiry date 12-OCT-2023) for prophylaxis.   The patient's past medical history included hives (already being diagnosed with a condition of chronic hives, when he gets sick the hives would get activated). Previously administered products included Zostavax.   On 16-MAR-2023, the patient received the 1st dose of Shingrix. In MAR-2023, 4 hrs after receiving Shingrix, the patient experienced hives (Verbatim: experienced hives 4 hours after the administration of the vaccine) and nasal congestion (Verbatim: as well as nasal congestion). The outcome of the hives and nasal congestion were unknown.   It was unknown if the reporter considered the hives and nasal congestion to be related to Shingrix.     It was unknown if the company considered the hives and nasal congestion to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUN-2023 The patient got the Shingrix 1st dose and after 4 hours he did had the hives as he usually got that and he felt his nasal passages were a little closed off but 12 hours after the vaccination. The reporter did not consent to follow-up.