chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Irritation skin; hurts like he has been scratched; Welts; Headache; Tiredness; Fever; Chills/shivering; Soreness at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included pulled muscle (on his right flank). Concomitant products included alfuzosin.   On 26-APR-2025, the patient received the 1st dose of Shingrix (left arm). In APR-2025, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: Headache), tiredness (Verbatim: Tiredness), fever (Verbatim: Fever), chills (Verbatim: Chills/shivering), injection site pain (Verbatim: Soreness at injection site), skin pain (Verbatim: hurts like he has been scratched) and welts (Verbatim: Welts). On 30-APR-2025, the patient experienced skin irritation (Verbatim: Irritation skin). The patient was treated with methoxamine hydrochloride, neomycin sulfate, polymyxin b sulfate (Neosporin). The outcome of the headache, tiredness, fever and chills were unknown and the outcome of the injection site pain was resolved and the outcome of the skin irritation, skin pain and welts were not resolved.   It was unknown if the reporter considered the headache, tiredness, fever, chills, injection site pain, skin irritation, skin pain and welts to be related to Shingrix.     It was unknown if the company considered the headache, tiredness, fever, chills, injection site pain, skin irritation, skin pain and welts to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-APR-2025 The reporter was the patient. The patient received the first dose of Shingrix on 26th April 2025. The patient experienced headache, tiredness, fever, chills, shivering, and soreness at the injection site (Left arm). On the day of reporting, 30th April 2025, the patient noticed that he was experiencing skin irritation on the right side of his abdomen. The patient stated that the skin irritation looks like there were cuts/thin lines across his abdomen, they look like scratches or claw marks. The irritation also hurts like he had been scratched. The patient stated he had welts on his right side. The patient put Neosporin to the skin irritation, which he believed initially irritated the area even more, but towards the end of the call it calmed down. The patient stated that he had been sleeping on a heating pad to alleviate a pulled muscle on his right flank. The pulled muscle happened prior to receiving Shingrix.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin irritation, Tenderness, Urticaria
Clinical narrative: Irritation skin; hurts like he has been scratched; Welts; Headache; Tiredness; Fever; Chills/shivering; Soreness at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included pulled muscle (on his right flank). Concomitant products included alfuzosin.   On 26-APR-2025, the patient received the 1st dose of Shingrix (left arm). In APR-2025, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: Headache), tiredness (Verbatim: Tiredness), fever (Verbatim: Fever), chills (Verbatim: Chills/shivering), injection site pain (Verbatim: Soreness at injection site), skin pain (Verbatim: hurts like he has been scratched) and welts (Verbatim: Welts). On 30-APR-2025, the patient experienced skin irritation (Verbatim: Irritation skin). The patient was treated with methoxamine hydrochloride, neomycin sulfate, polymyxin b sulfate (Neosporin). The outcome of the headache, tiredness, fever and chills were unknown and the outcome of the injection site pain was resolved and the outcome of the skin irritation, skin pain and welts were not resolved.   It was unknown if the reporter considered the headache, tiredness, fever, chills, injection site pain, skin irritation, skin pain and welts to be related to Shingrix.     It was unknown if the company considered the headache, tiredness, fever, chills, injection site pain, skin irritation, skin pain and welts to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-APR-2025 The reporter was the patient. The patient received the first dose of Shingrix on 26th April 2025. The patient experienced headache, tiredness, fever, chills, shivering, and soreness at the injection site (Left arm). On the day of reporting, 30th April 2025, the patient noticed that he was experiencing skin irritation on the right side of his abdomen. The patient stated that the skin irritation looks like there were cuts/thin lines across his abdomen, they look like scratches or claw marks. The irritation also hurts like he had been scratched. The patient stated he had welts on his right side. The patient put Neosporin to the skin irritation, which he believed initially irritated the area even more, but towards the end of the call it calmed down. The patient stated that he had been sleeping on a heating pad to alleviate a pulled muscle on his right flank. The pulled muscle happened prior to receiving Shingrix.
Vaccine: VARZOS
Symptoms: Oropharyngeal pain
Clinical narrative: Is a sore throat post shingrix a common side effect or allergic; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sore throat in a 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 sore throat (Verbatim: Is a sore throat post shingrix a common side effect or allergic). The outcome of the sore throat was not reported.   It was unknown if the reporter considered the sore throat to be related to Shingrix.     It was unknown if the company considered the sore throat to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-MAR-2025 This case was reported by a patient via (Shingrix GSK CHATBOT) interactive digital media. he reporter asked was the sore throat after Shingrix vaccine a common side effect or allergic.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, 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.   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 failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2025 This case was reported by a patient via interactive digital media. Reporter stated that unfortunately it was happening very frequently more than ever and the patient got it and it was horrible, she was vaccinated twice. Physician told them that you could get it but not as severe if you did not but patient said it hurt like hell and also they gave her meds to put on it and take but she said it was horrible. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine ( dose 1 and dose 2)
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 01-APR-2025 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available. Patient stated that despite having 2 series of shots they had Shingles 3 times and it was very painful. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine ( dose 1 and dose 2)
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not recived 2nd dose yet; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not recived 2nd dose yet). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 28-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she wondered what would happen if he/she did not get the second dose of the vaccine within 6 months. The patient had a questioned could he/she had gotten the second dose of the shingles vaccine 17 months after the first dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Eye disorder, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles in my eye; 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, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: got shingles in my eye) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAY-2025 This case was reported by a patient via interactive digital media. The patient got the shots and 2 years later got shingles in eye. The patient heard vaccine was about 90 percent effective. The reporter stated that it had been a bitch, the patient eye would never be normal. This case was considered as suspected vaccination failure as details regarding primary vaccination schedule 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  completion of primary vaccination schedule and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: painful side effects; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a 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 pain (Verbatim: painful side effects). The outcome of the pain was not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-APR-2025 This case was reported by a patient via interactive digital media. Patient was suffering 2 weeks post Shingrix a slew of painful side effects.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: first one gave me shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: first one gave me shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-MAY-2025 This case was reported by a patient via interactive digital media. The patient stated that first one gave him/her shingles.
Vaccine: RVX
Symptoms: Intensive care, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Had RSV; suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, 6 months after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Had RSV) (serious criteria hospitalization). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine.     The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 03-MAY-2025 This case was reported by a patient via interactive digital media. The patient had respiratory syncytial virus infection (RSV) and was put into intensive care unit (ICU). The patient had the shot 6 months earlier. It was reported as the patient had the hospital, if not have had a premier staff, he/she was would have died. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding respiratory syncytial virus infection 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 and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. Respiratory syncytial virus infection is an unlisted event which is considered unrelated to GSK RSV vaccine.
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received Twinrix on 4/10/2023, then the patient received a separated HepA and HepB on 10/15/2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Hepatitis A and Hepatitis B vaccine) for prophylaxis.   Previously administered products included Twinrix (received Twinrix vaccine on 10-APR-2023).   On 15-OCT-2024, the patient received Hepatitis A and Hepatitis B vaccine. On 15-OCT-2024, an unknown time after receiving Hepatitis A and Hepatitis B vaccine, the patient experienced drug dose administration interval too long (Verbatim: Patient received Twinrix on 4/10/2023, then the patient received a separated HepA and HepB on 10/15/2024). The outcome of the drug dose administration interval too long 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: 28-APR-2025 The pharmacist reported that a patient received Twinrix on 10th April 2023 and then the patient received a separated HepA and HepB on 15th October 2024 (She did not confirm if it was Havrix and Engerix-B). The reporter reported that and then the patient received Havrix 14th April 2025. The patient received a dose of Hepatitis A and Hepatitis B vaccine later than the recommended interval, which led to lengthening of vaccination schedule. The reporter had a questioned how did they had to proceed, was she considered complete with her doses.
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: 29 years old Patient and she received the pediatric dose; 29 years old Patient and she received the pediatric dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 29-year-old female patient who received HAV (Havrix pediatric) (batch number DN273, expiry date 28-AUG-2026) for prophylaxis.   On 16-APR-2025, the patient received the 1st dose of Havrix pediatric. On 16-APR-2025, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: 29 years old Patient and she received the pediatric dose) and underdose (Verbatim: 29 years old Patient and she received the pediatric dose). The outcome of the adult use of a child product and underdose were 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: 29-APR-2025 Nurse reported they had a patient of 29 years old and she received the pediatric dose of Havrix.  So wanted to know what the next step is to restart the series with the adult dose.  Adult patient received pediatric dose of Havrix, which led to adult use of child product and underdose.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; 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 male patient who received Men ACWY-CRM NVS (Menveo) (batch number XL223) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number 8274J) for prophylaxis.   On 23-APR-2025, the patient received Menveo and Bexsero. On an unknown date, an unknown time after receiving Menveo and Bexsero, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug 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: 29-APR-2025 Reporter stated that between the time that the excursion happened there was 8 vaccines vaccines administered and asked if that's completely fine. The patient received Bexsero and Menveo (1 vial). Patient received vaccines after temperature excursion, which led to incorrect storage of drug. This case is one of the three linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2025051843:same reporter/different patient US-GSK-US2025051844:same reporter/different patient
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: a little bit of redness; a little bit of swelling; warm to the touch; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of redness in a female patient who received Herpes zoster (Shingrix) (batch number F35YS, expiry date 31-MAR-2027) for prophylaxis.   On 26-APR-2025, the patient received the 1st dose of Shingrix. In APR-2025, an unknown time after receiving Shingrix, the patient experienced redness (Verbatim: a little bit of redness), swelling (Verbatim: a little bit of swelling) and skin warm (Verbatim: warm to the touch). The outcome of the redness, swelling and skin warm were unknown.   It was unknown if the reporter considered the redness, swelling and skin warm to be related to Shingrix.     It was unknown if the company considered the redness, swelling and skin warm to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-APR-2025 The pharmacist reported that female patient received Shingrix first dose. The patient started with a little bit of redness and swelling, and then it did sort of continue in the Sunday. It was pretty warm to the touch and the border has expanded over those few days. On Monday, Doctor checked the patient and it was treated as cellulitis and now was trying to determine whether this was vaccine severe reaction or a formal culture infection. They want to know it had been other reports to this lot number. The vaccine administration facility was the same as primary reporter.
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: injection site is very itchy; injection site is painful; injection site is red and looks like a rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-APR-2025, the patient received Shingrix. In APR-2025, less than a week after receiving Shingrix, the patient experienced injection site itching (Verbatim: injection site is very itchy), injection site pain (Verbatim: injection site is painful) and injection site rash (Verbatim: injection site is red and looks like a rash). The outcome of the injection site itching, injection site pain and injection site rash were unknown.   It was unknown if the reporter considered the injection site itching, injection site pain and injection site rash to be related to Shingrix.     It was unknown if the company considered the injection site itching, injection site pain and injection site rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-APR-2025 Patient had received the vaccine on Monday.  By wednesday, the injection site had become very itchy, red, and painful, and it had appeared as a rash.
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Menveo-Administration in patients older than 55 years; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patients received Menveo. On an unknown date, an unknown time after receiving Menveo, the patients experienced inappropriate age at vaccine administration (Verbatim: Menveo-Administration in patients older than 55 years). The outcome of the inappropriate age at vaccine administration was not applicable.   Additional Information: GSK receipt date: 01-MAY-2025 Pharmacist was concerned because some patients were going to travel abroad, and they had been administered Menveo to people other than 55 years because they need it the vaccine to travel abroad, which led to inappropriate age at vaccine administration. Centers for disease control and prevention (CDC) did not mentioned an specific vaccine brand for this population over 55 years. Follow up was not requested during the call.
Sex: F
Vaccine: RSV
Symptoms: Accidental exposure to product, Device connection issue, Erythema, Pruritus
Clinical narrative: Spilled it all over my hands and that are turning red and itching; Spilled it all over my hands and that are turning red and itching; Completely broke off of the thread; the syringe did off of the lower lock part; It went all over the place; did not even go in and it got all over me; Completely broke off of the thread; the syringe did off of the lower lock part; It went all over the place; did not even go in and it got all over me; This is a spontaneous report received from a Pharmacist.  A 42-year-old female patient was exposed to rsv vaccine prot.subunit pref 2v (ABRYSVO), (Lot number: LL8391, Expiration Date: May2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "Spilled it all over my hands and that are turning red and itching"; SYRINGE ISSUE (non-serious), ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), outcome "unknown" and all described as "Completely broke off of the thread; the syringe did off of the lower lock part; It went all over the place; did not even go in and it got all over me". Additional information: reporter was preparing Abrysvo for a patient and when she attached the syringe to the vial adapter, it like completely broke off of the thread. The syringe did off of the lower lock part. The tip of the syringe separated from the lower lock of the syringe and it had never had that happened before her life. So, reporter thought well, she can always put on one of her own syringes. So, she put the syringe back on and pushed the liquid in. So, she could at least mix it but it went all over the place. It did not even go in and it got all over the reporter. Reporter had two questions: should she worry that the diluent all got over her and if there is a way for her to get a replacement from Pfizer. Reporter gave a different one to the patient, not the one that exploded all over her. Reporter was asking if she needs to go to the hospital since she spilled it all over her hands and that are turning red and itching.  Causality for "spilled it all over my hands and that are turning red and itching" and "completely broke off of the thread; the syringe did off of the lower lock part; it went all over the place; did not even go in and it got all over me" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: F
Vaccine: COVID19
Symptoms: Endotracheal intubation
Clinical narrative: COVID vaccine was the very first one and the patient ended up in ICU and they had to intubate her; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ENDOTRACHEAL INTUBATION (hospitalization, life threatening), outcome "unknown", described as "COVID vaccine was the very first one and the patient ended up in ICU and they had to intubate her".  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: its caused nothing but pain and suffering I even after getting it and I'm talking about both shots not even 2 weeks later and I was sick with COVID then 6 months later I got COVID again; its caused nothing but pain and suffering I even after getting it and I'm talking about both shots not even 2 weeks later and I was sick with COVID then 6 months later I got COVID again; its caused nothing but pain and suffering I even after getting it and I'm talking about both shots not even 2 weeks later and I was sick with COVID then 6 months later I got COVID again; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "its caused nothing but pain and suffering I even after getting it and I'm talking about both shots not even 2 weeks later and I was sick with COVID then 6 months later I got COVID again".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Autoimmune hepatitis
Clinical narrative: Autoimmune hepatitis; This is a spontaneous report received from a consumer, Program ID.  A patient (age and gender not provided) received BNT162b2 Omicron (KP.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE HEPATITIS (medically significant), outcome "unknown". The patient had been recently diagnosed with autoimmune hepatitis and believed he/she got it from the COVID-19 vaccines (as reported) the patient received.  The information on the batch/lot number for BNT162b2 Omicron (KP.2) will be requested and submitted if and when received.
Sex: M
Vaccine: MMR, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: t after receiving his  second dose of MMR-II, the patient "developed a rash and had fevers."; t after receiving his  second dose of MMR-II, the patient "developed a rash and had fevers."; This spontaneous report was received from patient's grandmother and refers to a(n) 6-year-old male patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection 0.5 mL administered by intramuscular route (lot # and expiration date were not reported) as prophylaxis which was diluted with a sterile diluent (expiration date, and lot # were not reported).  On an unknown date, after receiving his second dose of this vaccine, he developed a rash and had fevers. No other symptoms were reported by the patient's grandmother. The patient received some fever medication as treatment. The patient recovered from the events on an unspecified date.   The causal relationship between the events and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not provided.
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported AE on behalf of a patient who was administered improperly stored PROQUAD on 4/9/2025 following a TE that started on 3/17/2025. No symptoms reported. No additional AE details reported. Obtained consent to contact HCP. TE Filed (Case #0; This spontaneous report was received from another health professional and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 09-APR-2025, the patient was vaccinated with an improper stored dose of  Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) at a dose of 0.5 ml (lot #Y009982, which had been verified to be a valid lot number; expiration date reported and confirmed as 24-NOV-2025; route of administration and anatomical location were not provided) as prophylaxis which was diluted with a sterile diluent (lot and expiry date not provided). The suspect vaccine was administered following a temperature excursion of 13.91 degrees Celsius / 14.4 degrees Celsius up to -10.4 degrees Celsius with a time frame of 360 Hours 0 Minutes 0 Seconds (on 17-MAR-2025). No symptoms reported (no adverse event).  No previous temperature excursion was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: He states he will be getting dose 2 today but it will be 10 days late; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19-OCT-2024).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: He states he will be getting dose 2 today but it will be 10 days late). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 29-APR-2025 The patient self-reported this case for himself. The patient received 1st dose of Shingrix and he stated he would be getting dose 2 today (on the day of reporting) but it would be 10 days late. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination.
Age: 62.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: ADMINISTERED  HALF THE DOSE OR 0.5ML ONLY INSTEAD OF THE FULL 1ML DOSE. NO ADVERSE REACTIONS REPORTED BY THE PATIENT.
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Local hypersensitivity reaction to injection site (redness, swelling, pain, mild fever/chills)
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Illness, Painful respiration
Clinical narrative: Patient developed painful breathing and extreme fatigue/general illness within 24 hours of vaccine administration. He was seen in the ER, provided antibiotics and given the all clear, but still feels like the general fatigue is not going away one month later.
Age: 64.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever starting night of vaccination, 5/2-5/5. Redness at injection sit with distinct edges that progressed down patients arm. Intermittent stinging sensation at the site.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pt received just diluent. The vaccine was not reconstituted. Vaccine error has been reported. No adverse effects reported.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Feeling of body temperature change, Injection site rash, Injection site swelling
Clinical narrative: Hot and cold flashes, swelling and rash at injection site and diarrhea
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy, Dark circles under eyes, Malaise, Muscular weakness
Clinical narrative: pt felt unwell and had to go to hospital. per pt they told him he had bells palsy. he got some muscle weakness and deep dark circles under his eyes. pt is getting better but still recovering
Age: 8.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Gait disturbance, Injection site pain, Weight bearing difficulty
Clinical narrative: Patient has pain at the injection site less than 24 hours after immunization, making him reticent to bear full weight and unwilling to walk
Age: 8.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Cardiac failure, Injection site oedema, Injection site pain, Injection site swelling, Limb discomfort
Clinical narrative: Patient has pain at the injection site less than 24 hours after immunization, making him reticent to bear full weight and unwilling to walk
Age: 8.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Limb ultrasound, Localised oedema, Oedema peripheral, Pain in extremity, Ultrasound joint normal
Clinical narrative: Patient has pain at the injection site less than 24 hours after immunization, making him reticent to bear full weight and unwilling to walk
Age: 8.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Ultrasound scan abnormal, Weight bearing difficulty, Wheelchair user, X-ray limb normal
Clinical narrative: Patient has pain at the injection site less than 24 hours after immunization, making him reticent to bear full weight and unwilling to walk
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Adacel vaccine was administered instead of Quadracel.Parent was notified by primary care provider and informed that patient will still need a TDAP vaccine at the age of 11/12 years old.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Wrong product administered
Clinical narrative: I took my patient vitals he was roomed in room 7, I printed a form and went based of off that form, pt was due for HPV, Tdap, MenQ. i went ahead and grabbed Hep A instead of HPV. I always verify for some reason I didn't this time I administered the extra Dose of Hep A in the Rt deltoid instead of of HPV.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Vaccination error
Clinical narrative: Patient was seen today 05/08/2025 for 11 y/o well child, patient was brought back, and vitals and physical was done/taken.  Patient was only due for HPV, Tdap, and Meningococcal vaccines. Person then drew all vaccine and ordered all vaccines. I helped administer vaccine because person said mom wants both at the same time, I then helped her administer vaccine and caught the mistake once I was entering the vaccine information.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, IPV, MNQ, TDAP
Symptoms: Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: voiced concern for numbness and decreased movement from the left arm
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain
Clinical narrative: Had Pfizer before without problem, this time I ache bad neck and all muscles after me derma. No rash, no vomiting, no headache so far
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event
Clinical narrative: No adverse events or sx. No treatment needed
Age: 0.33
Sex: M
Vaccine: PNC20, RV5
Symptoms: Tremor
Clinical narrative: per mom, eyes closed and tremor for 15 sec while breastfeeding
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Nausea, Rash
Clinical narrative: I got the shingles.  Headache, nausea, rash on left buttocks extending down to upper hamstring area.  Took valACYclovir (VALTREX) 21 pills over 7 days.
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Erythema, Muscle rigidity, Pain, Peripheral vascular disorder, Rash
Clinical narrative: pain; Paralysis; hives; This serious case was reported by a consumer and described the occurrence of pain in a 37-year-old male patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 7kd5b, expiry date 14-JUN-2027) for prophylaxis.   On 18-APR-2025, the patient received Tdap Vaccine .5 ml. On 18-APR-2025, less than a day after receiving Tdap Vaccine, the patient experienced pain (Verbatim: pain) (serious criteria clinically significant/intervention required), paralysis (Verbatim: Paralysis) (serious criteria GSK medically significant and clinically significant/intervention required) and hives (Verbatim: hives) (serious criteria clinically significant/intervention required). The outcome of the pain, paralysis and hives were not resolved.   It was unknown if the reporter considered the pain, paralysis and hives to be related to Tdap Vaccine.     The company considered the pain and hives to be related to Tdap Vaccine. The company considered the paralysis to be unrelated to Tdap Vaccine.   Additional Information: GSK Receipt Date: 03-MAY-2025 The reporter reported that the patient had this vaccine before with no issues. No issues with any other vaccines in his life. This was sudden and abrupt impeding his quality of life.; Sender's Comments: Pain and Urticaria are listed events which, due to the following criteria (insufficient information regarding medical history, concurrent conditions and concomitant medications) are considered unrelated to GSK Tdap vaccine. Paralysis is an unlisted event which is considered unrelated to GSK Tdap vaccine.
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Urticaria
Clinical narrative: pain; Paralysis; hives; This serious case was reported by a consumer and described the occurrence of pain in a 37-year-old male patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 7kd5b, expiry date 14-JUN-2027) for prophylaxis.   On 18-APR-2025, the patient received Tdap Vaccine .5 ml. On 18-APR-2025, less than a day after receiving Tdap Vaccine, the patient experienced pain (Verbatim: pain) (serious criteria clinically significant/intervention required), paralysis (Verbatim: Paralysis) (serious criteria GSK medically significant and clinically significant/intervention required) and hives (Verbatim: hives) (serious criteria clinically significant/intervention required). The outcome of the pain, paralysis and hives were not resolved.   It was unknown if the reporter considered the pain, paralysis and hives to be related to Tdap Vaccine.     The company considered the pain and hives to be related to Tdap Vaccine. The company considered the paralysis to be unrelated to Tdap Vaccine.   Additional Information: GSK Receipt Date: 03-MAY-2025 The reporter reported that the patient had this vaccine before with no issues. No issues with any other vaccines in his life. This was sudden and abrupt impeding his quality of life.; Sender's Comments: Pain and Urticaria are listed events which, due to the following criteria (insufficient information regarding medical history, concurrent conditions and concomitant medications) are considered unrelated to GSK Tdap vaccine. Paralysis is an unlisted event which is considered unrelated to GSK Tdap vaccine.
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Pain, Paralysis, Urticaria
Clinical narrative: pain; Paralysis; hives; This serious case was reported by a consumer and described the occurrence of pain in a 37-year-old male patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 7kd5b, expiry date 14-JUN-2027) for prophylaxis.   On 18-APR-2025, the patient received Tdap Vaccine .5 ml. On 18-APR-2025, less than a day after receiving Tdap Vaccine, the patient experienced pain (Verbatim: pain) (serious criteria clinically significant/intervention required), paralysis (Verbatim: Paralysis) (serious criteria GSK medically significant and clinically significant/intervention required) and hives (Verbatim: hives) (serious criteria clinically significant/intervention required). The outcome of the pain, paralysis and hives were not resolved.   It was unknown if the reporter considered the pain, paralysis and hives to be related to Tdap Vaccine.     The company considered the pain and hives to be related to Tdap Vaccine. The company considered the paralysis to be unrelated to Tdap Vaccine.   Additional Information: GSK Receipt Date: 03-MAY-2025 The reporter reported that the patient had this vaccine before with no issues. No issues with any other vaccines in his life. This was sudden and abrupt impeding his quality of life.; Sender's Comments: Pain and Urticaria are listed events which, due to the following criteria (insufficient information regarding medical history, concurrent conditions and concomitant medications) are considered unrelated to GSK Tdap vaccine. Paralysis is an unlisted event which is considered unrelated to GSK Tdap vaccine.
Age: 4.0
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; GARDASIL-9 was administered to a 4-year-old consumer; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 16-Apr-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y010656, expiration date: 29-Nov-2026) 0.5 mL administered by unknown route as prophylaxis (Product administered to patient of inappropriate age). No additional adverse event reported (No adverse event). No additional information provided.
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; 1-year-old consumer received an expired dose of PROQUAD.; Information has been received from Business Partner/CRO on .  This spontaneous report was received from a/an Unknown and refers to a(n) 1-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On Feb-2025, the patient started therapy with sterile diluent (BAXTER STERILE DILUENT), (lot # and expiration date were not reported).  On Jan-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # and expiration date were not reported). The patient started therapy with sterile diluent (BAXTER STERILE DILUENT), for the treatment of Prophylaxis.  The patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), for the treatment of Prophylaxis.  On Jan-2025, the patient experienced 1-year-old consumer received an expired dose of PROQUAD.. On an unknown date, the patient experienced No additional AE reported.   At the reporting time, the outcome of 1-year-old consumer received an expired dose of PROQUAD. and No additional AE reported was unknown.   The action taken with sterile diluent and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live was reported as not applicable.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02801045-02801044 , CLIC number : , ESTAR number : , IRMS number : 500UW00000aFbwzYAC|07052025230039|7503 , Central date : 2025-05-08 , Classification : DMC, Attachment description : NSC Call , Safety case number : , MNSC case number : 02801045 , MNSC interaction number : 02801044 , Integration log UniqueID : 500UW00000aFbwzYAC|07052025230039|7503 , Service cloud CaseID : 500UW00000aFbwzYAC