chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: The patient did not notice and took all four Vivotif capsules instead of one capsule every other day; The patient did not notice and took all four Vivotif capsules instead of one capsule every other day; Case reference number US-BN-2024-002905 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-3328) on 18-Dec-2024 and concerns a female patient of unknown age.   The patient's medical history and concomitant medication details were not provided.   On unspecified date, the patient got Vivotif and was aware it should be taken every other day, however, did not notice it was just one capsule and took all four doses of Vivotif (batch number: unknown), at a dose of four capsules, orally, for an unknown indication (explicitly coded as 'inappropriate schedule of vaccine administered' and 'vaccine overdose').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: A female patient of unknown age got Vivotif and was aware it should be taken every other day, however, did not notice it was just one capsule and took all four doses of Vivotif for an unknown indication, which is considered as inappropriate schedule of vaccine administered and vaccine overdose. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration and overdose are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and overdose are 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 got Vivotif and was aware it should be taken every other day, however, did not notice it was just one capsule and took all four doses of Vivotif for an unknown indication, which is considered as inappropriate schedule of vaccine administered and vaccine overdose. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration and overdose are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and overdose are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient received first dose of Vivotif capsule when it had been in the counter for about a week and a half and then skipped a day and took second dose without being refrigerated; The patient received first dose of Vivotif capsule when it had been in the counter for about a week and a half and then skipped a day and took second dose without being refrigerated; Case reference number US-BN-2024-002912 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-3349) on 19-Dec-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  As reported, the patient is travelling in two weeks and had left the Vivotif in the counter for 2 weeks.   On unspecified date, the patient received first dose of defected Vivotif capsule when it had been in the counter for about a week and a half and then skipped a day and took second dose without being refrigerated (batch number: unknown) at a dose of one capsule, orally, for indication reported as travelling (explicitly coded as product storage error temperature too high', and 'product administration error').   At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: A female patient of unknown age received first dose of defected Vivotif capsule when it had been in the counter for about a week and a half and then skipped a day and took second dose without being refrigerated, at a dose of one capsule, orally, for indication reported as travelling which is considered as product storage error temperature too high, and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age received first dose of defected Vivotif capsule when it had been in the counter for about a week and a half and then skipped a day and took second dose without being refrigerated, at a dose of one capsule, orally, for indication reported as travelling which is considered as product storage error temperature too high, and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Asthenia, Balance disorder, Bone pain, Burning sensation, Dizziness
Clinical narrative: Bone pain, Balance issues. weakness, dizziness, burning sensation throughout body, severe temperature fluctuations (freezing then sweating),
Age: 78.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Feeling cold, Hyperhidrosis
Clinical narrative: Bone pain, Balance issues. weakness, dizziness, burning sensation throughout body, severe temperature fluctuations (freezing then sweating),
Age: 34.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site nodule
Clinical narrative: The patient developed a localized lump (knot) on the left arm where the Gardasil injection was administered.
Age: 69.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt requested to receive the Prevnar 20 shot. State Shots system wasn't checked but pt had received a dose of the Prevnar 20 back in November of 2022. There are currently no treatments or symptoms the pt has reported to us.
Age: 7.0
Sex: F
Vaccine: IPV
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: No adverse reaction in patient.  This was a vaccine error or suspected error.  The IPOL is a 10 dose vial and 11 doses were pulled from vial.  According to system, the 11th dose is invalid.  We had siblings vaccinated together and we are unsure of who actually received the 11th dose, so was told we needed to delete both, notify the parents and recommend re vaccination, in addition to creating this VAERS report. Parents were notified.
Age: 12.0
Sex: M
Vaccine: IPV
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: No adverse reaction in patient.  This was a vaccine error or suspected error.  The IPOL is a 10 dose vial and 11 doses were pulled from vial.  According to system, the 11th dose is invalid.  We had siblings vaccinated together and we are unsure of who actually received the 11th dose, so was told we needed to delete both, notify the parents and recommend re vaccination, in addition to creating this VAERS report. Parents were notified.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Pruritus
Clinical narrative: Itching all over that started within 1 hour of vaccination.  Then for that day and the next I had very low blood pressure and a feeling like I was going to pass out.  The same thing happened with my Pfizer booster one month later.  The itching and low blood pressure lasted almost 48 hours
Age: 51.0
Sex: F
Vaccine: FLU3, HEP, IPV, MMR, PNC20, TDAP
Symptoms: Computerised tomogram head, Dysarthria, Dysphagia, Electrocardiogram, Facial paralysis
Clinical narrative: Two weeks after vaccinations client developed tingling and numbness to the lower and upper extremities, numbness of tongue and right face paralysis, slurred speech and unable to swallow.
Age: 51.0
Sex: F
Vaccine: FLU3, HEP, IPV, MMR, PNC20, TDAP
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Laboratory test, Lumbar puncture, Paraesthesia
Clinical narrative: Two weeks after vaccinations client developed tingling and numbness to the lower and upper extremities, numbness of tongue and right face paralysis, slurred speech and unable to swallow.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: The patient ate after first and second dose of Vivotif, and did not wait an hour; Case reference number US-BN-2024-002918 is a spontaneous case initially received from physician via Med Communications (reference number: USBAV24-3321) on 17-Dec-2024 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 took the first dose on Vivotif (batch number: unknown), at a dose of one capsule, orally, for unknown indication.  On unspecified date, unknown amount of time after the first dose, the patient took the second dose on Vivotif (batch number: unknown), at a dose of one capsule, orally.   As reported, the patient ate after the first and second dose of Vivotif and did not wait an hour (explicitly coded as 'Product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif.  No further information was provided.; Reporter's Comments: A female patient of unspecified age ate after the first and second dose of Vivotif and did not wait an hour, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product administration error is considered as unlisted per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error 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 ate after the first and second dose of Vivotif and did not wait an hour, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product administration error is considered as unlisted per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient took second dose of Vivotif vaccine on day two instead on day three; Case reference number US-BN-2024-002925 is a spontaneous case initially received from pharmacist via Med Communication (reference number: USBAV24-3373) on 23-Dec-2024 and concerns a adult female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 21-Dec-2024, the patient received first dose of Vivotif vaccine (batch number: unknown), at an unknown dose, route or site of administration for unknown indication.   On 22-Dec-2024, one day after the first dose, the patient received second dose of Vivotif vaccine (batch number: unknown), at an unknown dose, route or site of administration. (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 to Vivotif.  No further information was provided.; Reporter's Comments: An adult female patient of unspecified age received second dose of Vivotif vaccine one day after the first dose, at an unknown dose, route or site of administration 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 to Vivotif. 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: An adult female patient of unspecified age received second dose of Vivotif vaccine one day after the first dose, at an unknown dose, route or site of administration 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 to Vivotif. 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: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient forgot to take the fourth dose of Vivotif and left town, the patient was due last dose at the time of the report; Case reference number US-BN-2024-002930 is a spontaneous case initially received from nurse via Med Communication (reference number: USBAV24-3392) on 26-Dec-2024 and concerns adult female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 20-Dec-2024, the patient received first dose of Vivotif vaccine (batch number: unknown), at an unknown dose, route or site of administration for unknown indication.   On 22-Dec-2024, two days after the first dose, the patient received second dose of Vivotif vaccine (batch number: unknown), at an unknown dose, route or site of administration.   On 24-Dec-2024, four days after the first dose, the patient received third dose of Vivotif vaccine (batch number: unknown), at an unknown dose, route or site of administration.   The patient forgot to take the fourth dose of Vivotif and left town (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 to Vivotif.  No further information was provided.; Reporter's Comments: An adult female patient of unspecified age forgot to take the fourth dose of Vivotif 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 to Vivotif. 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: An adult female patient of unspecified age forgot to take the fourth dose of Vivotif 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 to Vivotif. 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: TYP
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: The patient took the third dose of the Vivotif vaccine six days after the first dose, and the fourth dose eight days after the first dose.; Case reference number US-BN-2025-000001 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-3417) on 31-Dec-2024 and concerns a 74-years-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 21-Dec-2024, the patient took first dose of Vivotif (batch number: unknown), at unknown dose, orally for Typhoid immunization.  On 23-Dec-2024, two days after first dose of Viviotif, the patient took second dose of Vivotif (batch number: unknown), at unknown dose, orally.  On 27-Dec-2024, six days after first dose of Viviotif, the patient took third dose of Vivotif (batch number: unknown), at unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered').  On 29-Dec-2024, eight days after first dose of Viviotif, the patient took fourth dose of Vivotif (batch number: unknown), at unknown dose, orally. As reported, the patient missed the middle dose and extended the last dose by another day (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  Additional information received from health care professional via Med Communications (reference number: USBAV24-3419) on 31-Dec-2024: Information included reference number, additional reporter and confirmation that the patient took Vivotif incorrectly.; Reporter's Comments: A 74-years-old male patient missed the middle dose and extended the last dose by another day 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 event due to Vivotif. 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 74-years-old male patient missed the middle dose and extended the last dose by another day 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 event due to Vivotif. 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: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: The patient received Jynneos in the muscle instead of under the skin; Case reference number US-BN-2025-000157 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV25-0180) on 23-Jan-2025 and concerns a 57-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (batch number: unknown), at an unknown dose or site of administration in the muscle instead of under the skin for an unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to the Jynneos vaccination.  No further information was provided.; Reporter's Comments: A 57-year-old male patient was vaccinated with a dose of Jynneos, at an unknown dose or site of administration in the muscle instead of under the skin for an unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to the Jynneos vaccination. 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 57-year-old male patient was vaccinated with a dose of Jynneos, at an unknown dose or site of administration in the muscle instead of under the skin for an unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to the Jynneos vaccination. 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.
Vaccine: VARZOS
Symptoms: Malaise, Pneumonia
Clinical narrative: Pneumonia/ sick; This serious case was reported by a consumer via interactive digital media and described the occurrence of pneumonia 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 pneumonia (Verbatim: Pneumonia/ sick) (serious criteria GSK medically significant). The outcome of the pneumonia was not resolved.   It was unknown if the reporter considered the pneumonia to be related to Shingles vaccine.     The company considered the pneumonia to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-FEB-2025 This case was reported by a patient via interactive digital media. Patient took the vaccine for shingles. Patient was not sure if he/she should have had the vaccine. Patient said he/she had no clue what they had put in the body. Patient was currently sick for the 2nd time in two months. Patient had pneumonia right now for almost 3 weeks. The follow-up could not be possible as no contact details were available.; Sender's Comments: Pneumonia is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: Pain; swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included mucinous breast carcinoma.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: Pain) and swelling (Verbatim: swelling). The outcome of the pain and swelling were not reported.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.     It was unknown if the company considered the pain and swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-FEB-2025 The reporter reported a chatbot conversation in which the patient reported that he/she was currently being treated for mucinous carcinoma of the breast.  Patient had his first Shingrix shot the day before his/her biopsy. Patient asked that could he/she take Shingrix while being treated for mucinous carcinoma.  Also, had the first shot and experienced pain, swelling.
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling abnormal, Feeling cold, Pain
Clinical narrative: very painful/body painful; all the join hurt; chilly; feeling very very bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on unknown date).   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 general body pain (Verbatim: very painful/body painful), joint pain (Verbatim: all the join hurt), chilliness (Verbatim: chilly) and feeling bad (Verbatim: feeling very very bad). The outcome of the general body pain, joint pain, chilliness and feeling bad were not reported.   It was unknown if the reporter considered the general body pain, joint pain, chilliness and feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the general body pain, joint pain, chilliness and feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that the vaccine was very very painful. Patient had 2nd dose It notch patient down. The night got vaccine all his/her body painful, all the join hurt, chilly. Patient was feeling very very bad. He/she just over 50 athletic healthy and active.
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: headache; body aches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient got shingles during covid). Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose on unknown date, no reaction to first shot).   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 headache (Verbatim: headache) and general body pain (Verbatim: body aches). The outcome of the headache and general body pain were not reported.   It was unknown if the reporter considered the headache and general body pain to be related to Shingles vaccine.     It was unknown if the company considered the headache and general body pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-FEB-2025 This case was reported by a patient via interactive digital media.  Patient got the vaccine, no reaction to first shot, second one he/she had minor headache and body aches. Patient got shingles during covid, he/she got the vaccine two years later, insurance did not cover until he/she turned 60. Patient indicated to get the shot shingles because it was awful. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: 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 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 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.     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: 23-FEB-2025 This case was reported by patient's husband via interactive digital media.. The patient had the Shingles shot and still got them. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles very badly even after receiving the vaccine/ suspected vaccination failure; shingles very badly; 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: shingles very badly even after receiving the vaccine/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles very badly). 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.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-FEB-2025 This case was reported by a patient via interactive digital media. The reporter's friend had the shingles very badly even after receiving the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: 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.   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: 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.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-FEB-2025 This case was reported by a patient via interactive digital media. Patient had the Shingles vaccine, but he/she had shingles bad twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination 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, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: RVX
Symptoms: Cough, Malaise, Nasopharyngitis
Clinical narrative: Cough; cold symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In DEC-2024, the patient received RSV vaccine. On 27-JAN-2025, between 1 and 2 months after receiving RSV vaccine, the patient experienced cough (Verbatim: Cough) and cold symptoms (Verbatim: cold symptoms). The patient was treated with prednisone. The outcome of the cough and cold symptoms were resolving.   It was unknown if the reporter considered the cough and cold symptoms to be related to RSV vaccine.     It was unknown if the company considered the cough and cold symptoms to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 24-FEB-2025 This case was reported by a patient via interactive digital media. The patient had the RSV shot in December. On January 27th, he/she had a terrible cough and cold symptoms. The patient had scheduled appointment with his/her physician on that day. The physician prescribed antibiotics and something for the cough. One week in and patient was still sick, so the physician sent him/her a prednisone pack. Three weeks later the patient was just getting better. The patient was thanking his/her physician. The patient further stated, he/she could not remember when he/she was that sick.
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever; Tiredness; Muscle pain; This non-serious case was reported by a nurse via call center representative and described the occurrence of fever in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: Fever), tiredness (Verbatim: Tiredness) and muscle pain (Verbatim: Muscle pain). The outcome of the fever, tiredness and muscle pain were unknown.   It was unknown if the reporter considered the fever, tiredness and muscle pain to be related to Shingrix.     It was unknown if the company considered the fever, tiredness and muscle pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-FEB-2025 The registered nurse mentioned during the call as an example that his mother felt muscle pain, tiredness and fever after receiving Shingrix, and that 95% of their patients are usually feeling similar symptoms after a Shingrix dose. The reporter did not have lot number for the vaccine and refused to provide any additional details about this case.; Sender's Comments:  US-GSK-US2025018347:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; Shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspeceted 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 Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-FEB-2025 and 28-FEB-2025 The patient had been vaccinated with Shingrix and still developed a mild case of shingles with a small area of rash. The physician felt as if the Shingrix had prevented the patient case of shingles from being more severe. The reported felt that the patient's case of shingles would have been much worse if the patient had not previously been vaccinated with Shingrix. This case was considered as suspected vaccination failure as completion of primary vaccination schedule, time to onset 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Scar, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Scars; 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, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and scar (Verbatim: Scars). The outcome of the vaccination failure and shingles were not reported and the outcome of the scar was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and scar 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 and scar to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-FEB-2025 This case was reported by a patient via interactive digital media. The patient had been vaccinated three years before he/she got shingles, was not diagnosed by medical people for five days because it could not be shingles.  The patient had excruciating pain, the blisters was awful. The patient still had the scars.  When the patient asked if he/she should get vaccinated again they said no, only once was necessary and further he/she stated you were susceptible to getting shingles again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming 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, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failuer; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 60-year-old 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: suspected vaccination failuer) (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: 25-FEB-2025 This case was reported by a patient via interactive digital media. The patient had the two shingles vaccines and had 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 provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine dose 1 and Shingles vaccine dose 2.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: received a 2nd Flulaval during the same flu season; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 63-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 4LM54, expiry date 30-JUN-2025) for prophylaxis.   Previously administered products included Flulaval (received 1st dose on an unknown date).   On 07-FEB-2025, the patient received the 2nd dose of FluLaval 2024-2025 season. On 07-FEB-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced extra dose administered (Verbatim: received a 2nd Flulaval during the same flu season). The outcome of the extra dose administered was not applicable.   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: 10-FEB-2025 The register nurse called and reported that so they had one of our adult patients, received a 2nd Flulaval during the same flu season, so they were wondering what were the typical adverse reactions that could occurred just they could notify the patient which led to extra dose administered. The vaccine administration facility was the same as primary reporter.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: placed in the refrigerator on Friday at 3pm then administere to pateint today at 10am.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 7349L, expiry date 25-MAR-2027) for prophylaxis.   On 24-FEB-2025 10:00, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: placed in the refrigerator on Friday at 3pm then administere to pateint today at 10am.). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 24-FEB-2025 The reporter reported that patient received shingrix which was prepared, reconstituted and withdrawn into syringe which was placed in the refrigerator on Friday at 3 pm then administered to patient on the day of reporting at 10 am, which led to incorrect storage of drug.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: Interchangeability; This non-serious case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number 5YP3L, expiry date 31-JAN-2026) for prophylaxis.   Co-suspect products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis.   Previously administered products included Menactra  (received 1st dose on 03-AUG-2016) and Menactra  (received 2nd dose on 16-NOV-2021).   On 12-FEB-2025, the patient received Bexsero. On 23-AUG-2022, the patient received Trumenba. On 12-FEB-2025, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: Interchangeability). The outcome of the interchange of vaccine products was not applicable.   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: 27-FEB-2025 The nurse reported that a patient received in the past 2 Menactra doses on August 3rd 2016 and November 16th 2021, and 1 dose of Trumenba on August 23rd 2022, and on February 12th 2025 they received a Bexsero vaccine, which led to interchange of vaccine products. Only Bexsero was given at their facility.
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: in the muscle in the upper arm instead of the subcutaneous area; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: in the muscle in the upper arm instead of the subcutaneous area). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   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: 27-FEB-2025 The pharmacist reported that a patient mentioned they got the new Measles, Mumps, and Rubella Vaccine in the muscle in the upper arm instead of the subcutaneous area which led to subcutaneous injection formulation administered by other route. The patient mentioned that vaccine comes in a vial with a syringe, but they were not sure of the brand name and did not provide a lot number.  The pharmacist enquired if it was Priorix, the patient said that probably that was the one they got.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Post-acute COVID-19 syndrome, Weight decreased, Weight increased
Clinical narrative: she had "26 side effects"; Patient had the "long covid" and continued to get covid and said that has been going on 5 years/had COVID multiple times; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (Patient had the "long covid" and continued to get covid and said that has been going on 5 years/had COVID multiple times) and IMMUNISATION REACTION (she had "26 side effects") in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form and fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. In 2020, the patient experienced POST-ACUTE COVID-19 SYNDROME (Patient had the "long covid" and continued to get covid and said that has been going on 5 years/had COVID multiple times). On an unknown date, the patient experienced IMMUNISATION REACTION (she had "26 side effects"). At the time of the report, POST-ACUTE COVID-19 SYNDROME (Patient had the "long covid" and continued to get covid and said that has been going on 5 years/had COVID multiple times) and IMMUNISATION REACTION (she had "26 side effects") had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight decreased: went down to 100 lbs. On an unknown date, Weight increased: gained 5 lbs in 5 years.         No concomitant medication was reported.  Caller stated she had 5 shots. She said she got COVID back in 2020 when COVID hit, she got it really bad and it continued and continued. Then she had the long covid and she continued to get covid and said that had been going on 5 years. She verified she had had 5 COVID vaccines but had COVID multiple times. She had seen her doctor, but he had not helped according to her. She reiterated that she has been really sick, in the bed and she has missed her birthday New Year's Eve. No treatment information was reported.