chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Blood test normal, Computerised tomogram normal, Deafness unilateral, Dizziness
Clinical narrative: I got home around 12:30 PM, I was feeling okay. But then i started feeling weak and tired and i thought it could have been an affect from the shot because the nurse told me my arm would be sore from the shot. I thought i would take a nap and that would make me feel better. I napped for 30 mins and then i got up and felt dizzy and light headed. I walked to the kitchen sick and I felt ringing in my ear right ear. And then my boyfriend started talking to me and i couldn't hear him and im like WOAH what is going on and it was ringing and i am completely deaf on my right side. So i panicked and i sat down for a moment and i thought it would go away. So by that time the docs office had closed and i was supposed to see them on thursday but there was bad weather so i went wednesday. So i then reached out to my heart team. And they told me to give it some time and it would go away and the check my blood pressure and my blood sugar every 2 hours and i did and that was fine. And then on Friday the same thing was going on so i reached out to my transplant team they told me to go the hospital. And they told me to go to the ER, Medical Center-There i had CT scan done and blood work. And after all that the doc came and checked both ear and there was no build up or wax and he said it was unexplainable and states that it had to come from the vaccine. Then i was discharged and he gave me a number to go see ENT.
Age: 46.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Tinnitus
Clinical narrative: I got home around 12:30 PM, I was feeling okay. But then i started feeling weak and tired and i thought it could have been an affect from the shot because the nurse told me my arm would be sore from the shot. I thought i would take a nap and that would make me feel better. I napped for 30 mins and then i got up and felt dizzy and light headed. I walked to the kitchen sick and I felt ringing in my ear right ear. And then my boyfriend started talking to me and i couldn't hear him and im like WOAH what is going on and it was ringing and i am completely deaf on my right side. So i panicked and i sat down for a moment and i thought it would go away. So by that time the docs office had closed and i was supposed to see them on thursday but there was bad weather so i went wednesday. So i then reached out to my heart team. And they told me to give it some time and it would go away and the check my blood pressure and my blood sugar every 2 hours and i did and that was fine. And then on Friday the same thing was going on so i reached out to my transplant team they told me to go the hospital. And they told me to go to the ER, Medical Center-There i had CT scan done and blood work. And after all that the doc came and checked both ear and there was no build up or wax and he said it was unexplainable and states that it had to come from the vaccine. Then i was discharged and he gave me a number to go see ENT.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient was given this dose unnecessarily. In September and October of 2023, patient received first 2 doses of influenza vaccine, so they should only have gotten one single dose for the 2024 season.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cough, Influenza A virus test positive, Injection site bruising, Injection site erythema, Injection site nodule
Clinical narrative: Pt received Kinrix and Proquad on 2/20/25.  Mom noticed on 2/22/25 that pt had large area of redness to left medial thigh. Reddened area turned to light colored bruising by 2/24/25. This was near the site of Kinrix injection. Pt also experiencing high fevers, cough, and nasal congestion. Mom brought pt to clinic on 2/24/25. There is a 8cm x 4 cm area of light colored blue bruising approx 2cm medial to injection site, there is a knot approx 2cm in diameter. Pt tested positive for flu at this visit 2/24/25.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Nasal congestion, Pyrexia
Clinical narrative: Pt received Kinrix and Proquad on 2/20/25.  Mom noticed on 2/22/25 that pt had large area of redness to left medial thigh. Reddened area turned to light colored bruising by 2/24/25. This was near the site of Kinrix injection. Pt also experiencing high fevers, cough, and nasal congestion. Mom brought pt to clinic on 2/24/25. There is a 8cm x 4 cm area of light colored blue bruising approx 2cm medial to injection site, there is a knot approx 2cm in diameter. Pt tested positive for flu at this visit 2/24/25.
Age: 34.0
Sex: M
Vaccine: RAB
Symptoms: Nausea, Vomiting
Clinical narrative: acute nausea and vomiting x1, post emesis donor states that he felt better and the signs and symptoms subsided
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Dizziness, Rash
Clinical narrative: Patient had stomach ache, dizziness and developed rash.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given 2nd dose of Hepatitis A too soon. First dose was given on 7/9/2024. Patient should not have had 2nd dose until at least 1/9/2025.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Post giving vaccine it was noted that vaccine expiration was 02/11/2025.  Date given 01/24/2025. No adverse reaction noted at this time.  Reaching out to see if we need to re vaccinate pt.
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3rd HPV vaccine too early; Product origin unknown; This spontaneous report was received from an other health professional and refers to an adult 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 an unknown date, the patient was vaccinated third (3rd) dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) or Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (reported as HPV vaccine) too early (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis (Product origin unknown; Inappropriate schedule of product administration). It was questioned that would they need to repeat it? Lot# is being requested and will submitted if received.
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Pruritus, Rash
Clinical narrative: increased rash; itching; This non-serious case was reported by a consumer and described the occurrence of rash in a 83-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 3p993) for prophylaxis.   On 04-NOV-2024, the patient received Fluarix 2024-2025 season .5 ml. In DEC-2024, less than 2 months after receiving Fluarix 2024-2025 season, the patient experienced rash (Verbatim: increased rash) and pruritus (Verbatim: itching). The outcome of the rash and pruritus were not resolved.   It was unknown if the reporter considered the rash and pruritus to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     It was unknown if the company considered the rash and pruritus to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JAN-2025 The patient self-reported this case for herself. The patient reported that she took the Fluarix vaccine and experienced increased rash and itching. The reporter specifically wanted to know if this vaccine had a preservative and if so, what it was, or plus any other possible contributors toward Grovers disease's.
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Rash
Clinical narrative: increased rash; itching; This non-serious case was reported by a consumer and described the occurrence of rash in a 83-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 3p993) for prophylaxis.   On 04-NOV-2024, the patient received Fluarix 2024-2025 season .5 ml. In DEC-2024, less than 2 months after receiving Fluarix 2024-2025 season, the patient experienced rash (Verbatim: increased rash) and pruritus (Verbatim: itching). The outcome of the rash and pruritus were not resolved.   It was unknown if the reporter considered the rash and pruritus to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     It was unknown if the company considered the rash and pruritus to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JAN-2025 The patient self-reported this case for herself. The patient reported that she took the Fluarix vaccine and experienced increased rash and itching. The reporter specifically wanted to know if this vaccine had a preservative and if so, what it was, or plus any other possible contributors toward Grovers disease's.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin burning sensation
Clinical narrative: Burning skin; Painful arm; This non-serious case was reported by a consumer and described the occurrence of burning skin in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included bupropion hydrochloride (Wellbutrin Xl).   On 05-JUL-2024, the patient received Shingrix. On 05-JUL-2024, less than a day after receiving Shingrix, the patient experienced burning skin (Verbatim: Burning skin) and pain in arm (Verbatim: Painful arm). On 15-JUL-2024, the outcome of the burning skin was resolved (duration 10 days) and the outcome of the pain in arm was resolved.   It was unknown if the reporter considered the burning skin and pain in arm to be related to Shingrix.     It was unknown if the company considered the burning skin and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JAN-2025 The reporter reported that the Shingrix was known to have injection pain and redness more than other types of injection. Please take the tylenol or ibuprofen as needed, especially the same night. The reporter was 20 and more year consultant with GSK and he/she know the difference between side effects and an adverse events.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Adult patient received Engerix B pediatric; Adult patient received Engerix B pediatric; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of underdose in a 37-year-old male patient who received HBV (Engerix B pediatric) (batch number 47XP4, expiry date 16-JUL-2026) for prophylaxis.   On 19-FEB-2025, the patient received Engerix B pediatric .5 ml. On 19-FEB-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Adult patient received Engerix B pediatric) and adult use of a child product (Verbatim: Adult patient received Engerix B pediatric). The outcome of the underdose and adult use of a child product 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: 19-FEB-2025 The patient weight reported 67.59 kilogram. Adult patient received Engerix B pediatric, which led to an underdose and adult use of a child product.
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose of HAVRIX (1440  EL.U./mL)  in July 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a male patient who received HAV (Havrix 1440) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   Previously administered products included Havrix (received 1st dose of Havrix in 1998) and Havrix (received 2nd dose of Havrix in 1998).   In JUL-2024, the patient received the 3rd dose of Havrix 1440. In JUL-2024, an unknown time after receiving Havrix 1440, the patient experienced extra dose administered (Verbatim: received a 3rd dose of HAVRIX (1440  EL.U./mL)  in July 2024). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-FEB-2025 The reporter reported that patient received 2 doses of Havrix 1440 vaccine in 1998 for prevention. The patient was going somewhere and eat a lot of seafood, and it was advised to get immunized.  The patient received a 3rd dose of Havrix 1440 in July 2024, which led to extra dose administered. The manufacturer did not know how long the vaccines lasts. The patient did not have details of the Havrix from the 1998 immunization.
Vaccine: RVX
Symptoms: Cough, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had the RSV shot but I still got it 6 months later; 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: I had the RSV shot but I still got it 6 months later). 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 to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 09-FEB-2025 This case was reported by a patient via interactive digital media. The patient had the RSV shot but  still got it 6 months later.  The patient thought he/she had covid, because the cough was bad. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for respiratory syncytial virus and 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine.
Vaccine: MNQ
Symptoms: Wrong technique in product usage process
Clinical narrative: used the Monoject SmartTip Needleless Cannula to withdraw Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong technique in product usage process in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong technique in product usage process (Verbatim: used the Monoject SmartTip Needleless Cannula to withdraw Menveo). The outcome of the wrong technique in product usage process was not applicable.   Additional Information: GSK Receipt Date: 27-JAN-2025 The medical assistant used the Monoject SmartTip needleless cannula to withdraw Menveo which led to wrong technique in product usage process. The case was reported with limited information based off of notes from medical information agent.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives spread all over the body; Itching all over; This non-serious case was reported by a nurse via call center representative and described the occurrence of generalized urticaria in a 20-year-old female patient who received HBV (Engerix B) (batch number 3X937, expiry date 07-DEC-2025) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B).   On 29-JAN-2025, the patient received the 2nd dose of Engerix B. On 29-JAN-2025, 10 hrs after receiving Engerix B, the patient experienced generalized pruritus (Verbatim: Itching all over). On 30-JAN-2025, the patient experienced generalized urticaria (Verbatim: Hives spread all over the body). On 30-JAN-2025, the outcome of the generalized urticaria was resolved and the outcome of the generalized pruritus was resolved (duration 1 day).   It was unknown if the reporter considered the generalized urticaria and generalized pruritus to be related to Engerix B and Engerix B Pre-Filled Syringe Device.     It was unknown if the company considered the generalized urticaria and generalized pruritus to be related to Engerix B and Engerix B Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date 04-FEB-2025 Nurse explained that a patient got 2 dose of Engerix-B but after the second dose, the patient experienced an adverse reaction approximately 10 hours later, the patient started itching all over and next morning she got hives on palms of her hands and then it started spread all over her body.  On 30th January 2025, the patient went to an urgent care clinic and got a steroid injection, so currently symptoms were almost completely gone.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site discolouration, Injection site erythema, Rash
Clinical narrative: Redness at injection site; injection site with white dots; red skin/extension to arm and neck; rash that extended to the neck and back; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   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 injection site erythema (Verbatim: Redness at injection site), injection site hypopigmentation (Verbatim: injection site with white dots), erythema (Verbatim: red skin/extension to arm and neck) and rash (Verbatim: rash that extended to the neck and back). The outcome of the injection site erythema, injection site hypopigmentation, erythema and rash were unknown.   It was unknown if the reporter considered the injection site erythema, injection site hypopigmentation, erythema and rash to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site hypopigmentation, erythema and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-FEB-2025 A pharmacist contacted GSK to request information about administering the second dose of Shingrix male patient mentioned that they previously suffered  from adverse events which consisted in redness, with white dots present on the red skin and a rash that extended to the neck and back.  They mentioned that they do not have information about when this first vaccine was given, the lot number or expiration date. The Health Care Professional enquired if GSK had any information about administering the second dose after a patient with such symptoms.
Age: 1.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: patient was inadvertently given an extra dose of Flulaval today; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-month-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 27gb4, expiry date 30-JUN-2025) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) and INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL).   On 11-FEB-2025, the patient received the 3rd dose of FluLaval 2024-2025 season. On 11-FEB-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced extra dose administered (Verbatim: patient was inadvertently given an extra dose of Flulaval today). 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: 11-FEB-2025 The nurse stated that a patient was inadvertently given an extra dose of Flulaval on the date of reporting, which led to extra dose administered. The patient was indicated for two doses, but the second dose was not captured in the electronic medical record (EMR). Thus, when the patient was at his well-child check on the day of reporting, the system showed he was due for a dose of FluLaval.  The dose was given, and then afterward the parent pointed out the patient had already been given the second dose.
Sex: F
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 a 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 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 and 14-FEB-2025 The reporter mentioned during the call as an example that his mother felt muscle pain, tiredness and fever after receiving Shingrix. The reporter did not had lot number for the vaccine and refused to provide any additional details about this case and declined consent to follow up with Safety Team in regards to his mother's symptoms since he mentioned that was not the reason why he was calling and he felt it was a violation to his mother's privacy. Did not consent to follow-up.; Sender's Comments:  US-GSK-US2025018347:same reporter
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: only diluent administration instead of full dose with powder part; accidentally administered the liquid part only; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 6-month-old female patient who received Hib (Hiberix) (batch number M7422, expiry date 15-JUN-2027) for prophylaxis.   On 17-FEB-2025, the patient received Hiberix. On 17-FEB-2025, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: only diluent administration instead of full dose with powder part) and inappropriate dose of vaccine administered (Verbatim: accidentally administered the liquid part only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 18-FEB-2025 The certified medical assistant called to report that a nurse yesterday (day before reporting) accidentally administered the liquid part only, instead of a full complete dose with the powder to the patient, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. Certified medical assistant wanted to know what safety concerns they have to address to the patient.  The vaccine administration facility was the same as primary reporter.
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patients were late for their second dose after COVID years ago/ interval longer; 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 an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patients were late for their second dose after COVID years ago/ interval longer). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 18-FEB-2025 Pharmacist stated various patients were late for their second dose after Covid years ago. Pharmacist stated no further information was available regarding number of patients (maybe 2 a year but unknown) and no further details were available. The patients received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 4.0
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: received first dose of a Kinrix vaccine to 4 year old patient; some of the vaccine was left inside the syringe; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 4-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: received first dose of a Kinrix vaccine to 4 year old patient) and incomplete dose administered (Verbatim: some of the vaccine was left inside the syringe). The outcome of the inappropriate schedule of vaccine administered and incomplete dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-FEB-2025 The reporter reported that the patient that was administered a 1st dose of Kinrix vaccine and some of the vaccine was left inside the syringe, which led to inappropriate schedule of vaccine administered and incomplete dose administered.  The reporter asked if they have to revaccinate a four year old
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late 2nd dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in July 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: Late 2nd dose.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-FEB-2025 The pharmacist called to inform that a patient that had received the first dose of Shingrix back in July 2024 had not received the 2nd dose yet. The reporter also mentioned that the patient doctor had advised to restart the series. the vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: accidentally administered Bexsero instead of MenQuadfi; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis.   On 31-JAN-2025, the patient received the 1st dose of Bexsero. On an unknown date, the patient received Menquadfi. On 31-JAN-2025, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: accidentally administered Bexsero instead of MenQuadfi). The outcome of the wrong vaccine 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: 21-FEB-2025 Other HCP they accidentally administered Bexsero instead of MenQuadfi to an 11 year old patient on January 31st 2025. This was the first dose of a Meningitis B vaccine for the patient. Patient receive Bexsero instead of MenQuafi which led to wrong vaccine administered.
Age: 70.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive, did get the flu and covid vaccine back at the beginning of oct; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive, did get the flu and covid vaccine back at the beginning of oct) in a 70-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine for an unknown indication.    The patient's past medical history included COVID-19 (About 2 years ago). Previously administered products included for COVID-19: paxlovid (About 2 years ago). Past adverse reactions to the above products included No adverse effect with paxlovid.   In October 2024, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On 18-Oct-2024, the patient received first dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 50 microgram. In January 2025, the patient experienced COVID-19 (tested positive, did get the flu and covid vaccine back at the beginning of oct). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) ongoing from January 2025 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive, did get the flu and covid vaccine back at the beginning of oct) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2025, SARS-CoV-2 test: Positive.         No concomitant medication was reported.  It was unknown if the patient had previously received Pfizer vaccine.  The reporter stated about 2 years ago she thought, she had tested positive and took it Paxlovid, and then just recently, and reporter had surprised that she and her husband tested positive, both did get the flu and covid vaccine back at the beginning of October. The reporter stated they have not had any problems, taking it, but noticed the metallic taste but had more of a bad sore throat and the sore throat seemed to be abating quickly but have still congestion but she only taken two doses so far.   This case was linked to US-MODERNATX, INC.-MOD-2025-782516 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-782516:Husband case
Vaccine: PNC20
Symptoms: Device connection issue
Clinical narrative: hub broke off; This is a spontaneous report received from a Nurse from product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LK6651, Expiration Date: 30Jun2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "hub broke off".  The reporter considered "hub broke off" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "hub broke off" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: Unexpected therapeutic effect; very good for asthma; 2nd dose: Date: About 6 months later; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "very good for asthma", "Unexpected therapeutic effect". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Unexpected therapeutic effect"; PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown", described as "very good for asthma"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "2nd dose: Date: About 6 months later".  Additional information: Calling to let know caller got the COVID-19 shot from Pfizer two times and caller was suffering with asthma for a long time, many years, for 15 or 18 years. Confirmed asthma was prior to caller getting any of the Pfizer COVID-19 shots. After caller got the shot, hasn't for a long time, has no need for asthma medicine anymore. Usually by Spring time caller was not even able to go outside, after got the shot for the last 3 years feeling good. Confirmed both doses were the Pfizer COVID-19 shot. First dose date was unknown, doesn't remember, in Spring time, but does not have card at time of call to provide information. Patient received second dose, about 6 months later.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: was suffering from asthma, after got the Pfizer COVID-19 shot, is feeling a lot better; was suffering from asthma, after got the Pfizer COVID-19 shot, is feeling a lot better; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (ongoing), notes: used to get hospitalized every month. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown" and all described as "was suffering from asthma, after got the Pfizer COVID-19 shot, is feeling a lot better".  Additional information: reporter friend was suffering from asthma, and reporter friend used to get hospitalized every month. After reporter friend got the Pfizer COVID-19 shot, reporter friend was feeling a lot better. Confirmed had asthma prior to getting the Pfizer COVID-19 shot. reporter stated Pfizer had the best reputation, and then reporter got the second shot because was very good for asthma, which was the same for reporter friend who was worse, reporter was with reporter friend last night.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 41.0
Sex: F
Vaccine: FLUX, PNC20
Symptoms: Cellulitis, Erythema, Infection
Clinical narrative: redness over 13cm in diameters; cellulitis; infection; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 41-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Feb2025 as dose number unknown, single (Lot number: LJ5284, Expiration Date: 30Jun2025) at the age of 41 years, in left arm for immunisation; influenza vaccine (INFLUENZA VACCINE), from 12Feb2025) to 12Feb2025 at single (dose number unknown, single) for immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (ongoing), notes: Ankylosing spondylitis is a autoimmune. Concomitant medication(s) included: SIMPONI taken for ankylosing spondylitis; LEVOTHYROXINE taken for thyroid disorder; KEFLEX [CEFALEXIN]. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "redness over 13cm in diameters"; CELLULITIS (non-serious), outcome "unknown"; INFECTION (non-serious), outcome "unknown". Therapeutic measures were taken as a result of erythema, cellulitis, infection.  Additional Information: Caller, a 41-year-old patient, was injected with pneumococcal vaccine. When asked for the name of the vaccine, caller stated that it's from REDACTED. She received the vaccine and it cost her to have an infection, redness over 13cm in diameters. According to the doctors it was cellulitis and they are not taking responsibility. Consumer was unaware of the dose of vaccination. Consumer stated, Yes, she had taken Simponi (50 mg), and she had taken it for Ankylosing spondylitis and that is why she went her physician and that is why they gave her the vaccine. Other concomitant medication was taken consumer stated, Levothyroxine, 100 mg for thyroid. Vaccine administered on same date with the Pfizer vaccine was yes it was another vaccine in the off the arms and that the flu vaccine.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiomegaly, Loss of consciousness
Clinical narrative: Pfizer COVID vaccine created large hearts/have a pacemaker for an enlarged heart; passing out; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 19-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: EW0153) and in 2021 as dose 2, single (Lot number: EW0171) at the age of 18 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIOMEGALY (medically significant) with onset 2021, outcome "unknown", described as "Pfizer COVID vaccine created large hearts/have a pacemaker for an enlarged heart"; LOSS OF CONSCIOUSNESS (medically significant) with onset 2021, outcome "unknown", described as "passing out". The events "pfizer covid vaccine created large hearts/have a pacemaker for an enlarged heart" and "passing out" required physician office visit. Therapeutic measures were taken as a result of cardiomegaly, loss of consciousness. Additional information: The patient previously had no medical issues, a healthy football player had to have a pacemaker. The patient was not on Pacemakers before receiving the Pfizer COVID vaccine, he was playing football, baseball and basketball and every other sport that could possibly think of, until he was told he had to take the vaccine to be able to go to school. The patient's mother reached out to a doctor in 2021 back when patient had his pacemakers put in and the doctor "don't know anything". The patient has a job in life and he just has a pacemaker. The patient was a healthy 18-year-old kid took the Vaccine and now, he has pacemaker enlarged heart, an 18-year-old healthy boy but then had to have a pacemaker for an enlarged heart. He had to have a pacemaker because of the vaccine. He got the vaccine (Pfizer COVID-19 Vaccine) and then started having symptoms which then required him to have a pacemaker installed. "They tried medication for him because he was passing out and they gave the option of putting in a pacemaker at that time but caller thought that was a little extreme, so did not do it and then, the medication did not really do the tricks, so then caller had to go in and get the pacemaker." No prior vaccination. No investigations.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: you can still get Covid, even though you've gotten your boosters and flu shots, second another booster, another booster; you can still get Covid, even though you've gotten your boosters and flu shots, second another booster, another booster; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 70-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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. Vaccination history included: Flu shots, for Covid-19 Immunization; Bnt162b2 (Primary immunization series complete), for Covid-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 Immunization; Pneumonia shots. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "you can still get Covid, even though you've gotten your boosters and flu shots, second another booster, another booster". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis; This is a spontaneous report received from an Other HCP.  A male patient received BNT162b2 (COMIRNATY), in 2020 as dose number unknown, 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: PSORIASIS (non-serious), outcome "unknown".  Additional information: A Pfizer vaccine sales representative was talking to a physician assistant that shared that he personally experienced a side effect with the Covid vaccine and he wanted to report that incident. He experienced Psoriasis, a very severe case of Psoriasis. The patient got the vaccine many years ago, like 2020. He just shared it with the Pfizer vaccine sales representative.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vitiligo
Clinical narrative: Vitiligo; the whole area itches/Itching was on the left upper arm where got the vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Melanoma" (unspecified if ongoing), notes: Melanoma was 13 years ago. The patient's concomitant medications were not reported. Vaccination history included: Pfizer covid vaccine (DOSE 1; SINGLE), for Covid-19 immunization. The following information was reported: VITILIGO (non-serious), outcome "not recovered"; VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "the whole area itches/Itching was on the left upper arm where got the vaccine". The events "vitiligo" and "the whole area itches/itching was on the left upper arm where got the vaccine" required physician office visit. Therapeutic measures were not taken as a result of vitiligo.  Additional information: The patient was not allergic to any previous vaccination, medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The AEs did not require a visit to the Emergency Room. The patient called about second vaccine, for covid. This is the Pfizer Covid Vaccine. Had severe reaction to it. She ended up getting vitiligo. She explained she started to first notice spots. She noticed spot on arm and then the next morning there were more spots. When she started breaking out she did not know what was going on so she went to the dermatologist. That was when she called the dermatologist and saw dermatologist 9 days later after getting the second vaccine. She clarified that she noticed the spots on both the left and right arm. She later added, since she received the second dose of the Pfizer Covid Vaccine the whole area itched. It was not constant, but it woke up at night from scratching the arm. This itching was on the left upper arm where got the vaccine.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out in a rash; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown, 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: RASH (non-serious), outcome "unknown", described as "Broke out in a rash".  Additional information: Reporter stated that his husband got a COVID-19 vaccination back in 2022 and since then he broke out in a rash and they had gone to Dermatologist, gone to allergy doctor, nothing to get rid of it. Reporter wondered if the Pfizer vaccine could have cause it.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Folliculitis
Clinical narrative: developed folliculitis under her scalp; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization, reaction(s): "folliculitis". The following information was reported: FOLLICULITIS (non-serious), outcome "not recovered", described as "developed folliculitis under her scalp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of folliculitis. Additional information: After taking the 5 Pfizer COVID-19 vaccines between 2021 and 2022 she experienced folliculitis. Caller states that first time the vaccine came out she got it and it started on her scalp. Ended up in clinic and they were not able to help her either and nothing happened because all of the prescription that was given to her did not work, she even had shots in her scalp but did not work, had special medications made in the special pharmacy but did not work. Folliculitis is very painful and nothing could have been done. It started on the scalp and it moved under the scalp now. Had 3 biopsies done by different clinics. Had some outside on her scalp but she used to have a lot on the beginning when it started. Was taking the medications, had shots and she had a lot of different things, it went inside her scalp now. It's no longer 100% on top of the scalp, patient some but not many but most of the spots right now are inside the scalp. When patient touches scalp, feels bumps with the size of a little rice. It started it was like little pimples with little 'pops' on top of it and a lot of them. The thing developed when patient started having this is that it hurts a lot and it itches a lot. Feels like has a rash and has to scratch her head because it bother her. Lost a lot of hair and whenever drives, have the window rolled down, just the air touching her hair, it hurts her. It's painful. It burns a lot. Was specifically diagnosed with 'Folliculitis'.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500038076 same patient, different vaccine doses;