chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; Just came down with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox at young age).   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: Just came down with 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 and shingles to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAY-2025 This case was reported by a patient via interactive digital media. The patient stated he/she got both (Shingles) vaccination shots 4 years ago (from the date of reporting). The patient stated he/she just came down with shingles. The patient's physician said it was very early and mild case, but they sting and itch bad.  The patient enquired why did he/she got them. 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, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine."
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus
Clinical narrative: My arm hurts so much; and was so itchy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: My arm hurts so much) and pruritus (Verbatim: and was so itchy). The outcome of the pain in arm and pruritus were not reported.   It was unknown if the reporter considered the pain in arm and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAY-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she was just vaccinated.  And his/her arm hurts so much, and it was so itchy.  Reporter mentioned that was going to delay getting the second shot. The follow-up could not be possible as no contact details were available.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles weeks 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 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: still got shingles weeks later). 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 and shingles to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAY-2025 This case was reported by a patient via interactive digital media. The patient took both series of Shingle shots and still got shingles weeks later. 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, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. "
Vaccine: DTAP
Symptoms: Death
Clinical narrative: infant died within 10 days of Infanrix vaccination; This serious case was reported by a other health professional via interactive digital media and described the occurrence of unknown cause of death in a infant patient who received DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, 10 days after receiving Infanrix, the patient experienced unknown cause of death (Verbatim: infant died within 10 days of Infanrix vaccination) (serious criteria death and GSK medically significant). The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death to be related to Infanrix and Infanrix Pre-Filled Syringe Device.     The company considered the unknown cause of death to be unrelated to Infanrix and Infanrix 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: 30-APR-2025 This case was reported by the reporter via interactive digital media. It was reported that sixty-nine infants (patients) died after received Infanrix vaccine out of those sixty-seven died within 10 days of vaccination. This was 1 of 69 linked cases reported by same reporter.; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK vaccine Infanrix and Infanrix PRE-FILLED SYRINGE DEVICE.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site pain, Pyrexia
Clinical narrative: patient experienced injection site pain; fever; felt like crap; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a adult 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, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: patient experienced injection site pain), fever (Verbatim: fever) and feeling abnormal (Verbatim: felt like crap). The outcome of the injection site pain, fever and feeling abnormal were resolved (duration 36 hrs).   It was unknown if the reporter considered the injection site pain, fever and feeling abnormal to be related to Shingrix.     It was unknown if the company considered the injection site pain, fever and feeling abnormal to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAY-2025 Patient was approximately 60 years old. Patient had been vaccinated with Shingrix and a few hours after the injections the patient experienced injection site pain, within a few hours experienced fever and "felt like crap". The symptoms lasted about 36 hours and patient is fully recovered.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site swelling, Pyrexia
Clinical narrative: swelling around the injection site /made a motion of about a 6 inch circle on her arm; Fever; Fatigue; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling around the injection site /made a motion of about a 6 inch circle on her arm), fever (Verbatim: Fever) and fatigue (Verbatim: Fatigue). The outcome of the injection site swelling was not reported and the outcome of the fever and fatigue were resolved (duration 1 day).   It was unknown if the reporter considered the injection site swelling, fever and fatigue to be related to Shingrix.     It was unknown if the company considered the injection site swelling, fever and fatigue to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR061338   Additional Information: GSK Receipt Date: 09-MAY-2025 A female patient, approximately 55 years old, received both doses of the Shingrix vaccine. After each dose the patient experienced swelling around the injections site and made a motion of about a 6 inch circle on her arm. She also experienced fever, fatigue that lasted about a day each time. For tolerance to second dose, refer case US2025AMR061338.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have it again for the second time; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and upadacitinib (Rinvoq) for product used for unknown indication.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and Rinvoq. 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: I have it again for the second time). The action taken with Rinvoq was unknown. 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: 12-MAY-2025 The case was received from the patient via interactive digital media. The reporter reported that had it again for the second time.  It was so bad after the first time that he/she had the two vaccines so he/she would not get it again.  Find out it was from Rinvoq that caused it this time.  No more vaccines for him/her. It was unknown if the reporter considered the vaccination failure and shingles to be related to Rinvoq.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2)
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; 2nd time I had shingles/3rd time I got them it was a very light case/4th time having them and the pictures speak for themselves; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 2nd time I had shingles/3rd time I got them it was a very light case/4th time having them and the pictures speak for themselves). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 12-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that they had received the vaccine after the second time they had shingles. The third time they had shingles, it was a very light case. They were now experiencing their fourth episode, which was described as awful, with accompanying pictures. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Breast pain, Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; am currently suffering from shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: am currently suffering from shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that she was vaccinated a year ago. The patient was currently suffering from shingles. The patient guesses the jab did not work. The pain in my back and right breast was unbearable at times. Praying it goes away soon. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: it was very painful for 5 days; 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 (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 pain (Verbatim: it was very painful for 5 days). The outcome of the pain was resolved (duration 5 days).   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 13-MAY-2025 This case was reported by a patient via interactive digital media. The reporter stated that it was very painful for 5 days.  He/she did not know if he/she would get the 2nd dose or now.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: had a very painful episode of 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.   The patient's past medical history included shingles.   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: had a very painful episode of 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: 10-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that someone yesterday who was under 50 and not eligible for the Shingle Vaccine but has had Shingles, this needs to change.  Even if you have had the one Shot 1st generation Shingles Vaccine you really need the two Shot 2nd generation Shingles Vaccine.  Reporter had the one shot 1st generation Shingles Vaccine and had a very painful episode of Shingles that lasted for several months.
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: got my 1st shot and a week later got 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, 1 week after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got my 1st shot and a week later got 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: 11-MAY-2025 This case was reported by a patient via interactive digital media. Patient got the first shot and a week later got shingles, it was a mild case got into doctor right away. Also stated that never did get second shot.
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: raised redness around the injection site; very sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site erythema (Verbatim: raised redness around the injection site) and pain in arm (Verbatim: very sore arm). The patient was treated with paracetamol (Tylenol). The outcome of the injection site erythema and pain in arm were not reported.   It was unknown if the reporter considered the injection site erythema and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the injection site erythema and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAY-2025 This case was reported by a patient via interactive digital media. The patient stated that he/she just had a very sore arm with some raised redness around the injection site.  The patient stated that the Tylenol and ice helped but nothing compared to a shingles outbreak.  The patient asked others to get that shot.
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pediatric dose administered to adult patient; Pediatric dose administered to adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Pediatric dose administered to adult patient) and underdose (Verbatim: Pediatric dose administered to adult patient). 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: 02-MAY-2025 Other Health Professional reported that he/she administered a pediatric dose of the Engerix-B Hepatitis B to an adult patient, which led to adult use of a child product and underdose. And reporter wants to just trying to see how to advice in  if can just administered another dose or if  just need to administered an adult dose. No more details were left by reporter in the voicemail.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: a 12 year old female patient was accidentally administered an expired dose of Priorix on 05/06/2025; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old female patient who received MMR (Priorix) (batch number 342rc, expiry date 01-MAY-2025) for prophylaxis.   On 06-MAY-2025, the patient received the 2nd dose of Priorix. On 06-MAY-2025, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: a 12 year old female patient was accidentally administered an expired dose of Priorix on 05/06/2025). The outcome of the expired vaccine used 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 : 06-MAY-2025 A medical assistant called in to report that a 12 year old female patient was accidentally administered an expired dose of Priorix on 6th May 2025 which led to expired vaccine used.
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a teenager was accidentally given the shingrix vaccuine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 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 inappropriate age at vaccine administration (Verbatim: a teenager was accidentally given the shingrix vaccuine). The outcome of the inappropriate age at vaccine administration was not applicable.   Additional Information: GSK receipt date: 06-MAY-2025 On 06/May/2025, a healthcare professional started a chat and informed that what do I need to look out for if a teenager was accidentally given the shingrix vaccine this led to Inappropriate age at vaccine administration. After that message, reporter ended the chat on their end, so no additional details could be collected.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Shingrix - Subcutaneous injection; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 74-year-old male patient who received Herpes zoster (Shingrix) (batch number TS525, expiry date 10-MAR-2027) for prophylaxis.   On 07-MAY-2025, the patient received Shingrix (subcutaneous). On 07-MAY-2025, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Shingrix - Subcutaneous injection). The outcome of the intramuscular formulation administered by other route was not applicable.   Additional Information: GSK receipt date: 07-MAY-2025 A pharmacist reported the administration of Shingrix via subcutaneous injection instead of intramuscular injection, which led to intramuscular formulation administered by other route. The pharmacist asked if the dose should be repeated.
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Priorix possible administration after being exposed to freezing temperatures; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a specified number of patients who received MMR (Priorix) for prophylaxis.   On an unknown date, the patients received Priorix. On an unknown date, an unknown time after receiving Priorix, the patients experienced incorrect storage of drug (Verbatim: Priorix possible administration after being exposed to freezing temperatures). 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: 07-MAY-2025 Nurse called to report Priorix vaccines were stored in the facility freezer at lowest of minus 11.6 degree Fahrenheits probably since shipment was received on 4th February.  Two vaccines were no longer in the box, so nurse suspects they were administered but did not have specific patient information yet, which led incorrect storage of drug. The reporter mentioned that the vaccines were administered to two different patients but when asking more details about the event she explained no report with information was made yet, so no more information was available at moment of call. During the call the reporter mentioned that the vaccines were not frozen at the moment of administration.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Extra dose administered
Clinical narrative: Late 2nd and 3rd dose/received 1st dose on 13-Nov-2024, 2nd one not until 26-Apr-2025; 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 40-year-old female patient who received HAB (Twinrix) (batch number M4B34) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 13th November 2024 of lot number H7RF2).   On 26-APR-2025, the patient received the 2nd dose of Twinrix. On 26-APR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd and 3rd dose/received 1st dose on 13-Nov-2024, 2nd one not until 26-Apr-2025). 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: 07-MAY-2025 A registered pharmacist called and reported a question on the Twinrix vaccine dosing schedule, so the patient received her 1st dose on 13th November 2024, her 2nd one not until 26th April 2025, so the reporter was unsure about when she needs her 3rd dose. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix instead of Infanrix administration; Infanrix second dose out of the recommended age administration; Infanrix first dose out of the recommended age administration/Infanrix second dose out of the recommended age administration/Boostrix out of the recommended age administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3ZH27, expiry date 25-JAN-2027) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis, DTPa (Infanrix) for prophylaxis and DTPa (Infanrix) for prophylaxis.   On 02-MAY-2025, the patient received Boostrix. On an unknown date, the patient did not receive the 3rd dose of Infanrix. In JUL-2024, the patient received the 2nd dose of Infanrix. In DEC-2023, the patient received the 1st dose of Infanrix. In DEC-2023, not applicable after receiving Boostrix, Infanrix and Infanrix and an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix first dose out of the recommended age administration/Infanrix second dose out of the recommended age administration/Boostrix out of the recommended age administration). In JUL-2024, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix second dose out of the recommended age administration). On 02-MAY-2025, the patient experienced wrong vaccine administered (Verbatim: Boostrix instead of Infanrix administration). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate age at vaccine administration 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: 08-MAY-2025 Medical Assistant wanted to know if there would be any harm to a 2-year-old patient that received Boostrix instead of Infanrix as a third dose in the diphtheria, tetanus and pertussis immunization scheme which led to wrong vaccine administered. Also, it was reported that when the patient received the first and second dose of Infanrix, both being also given out of the recommended age of administration (first dose in December 2023 and second in July 2024, when the patient was over 1 year of age) which led to inappropriate age at vaccine administration. The Vaccine Administration Facility is the same as Primary Reporter. Consented to follow up.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Engerix-B inadvertent 20mcg dose to 19 year old; Engerix-B inadvertent 20mcg dose to 19 year old; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 19-year-old female patient who received HBV (Engerix B adult) (batch number CT2Z7) for prophylaxis.   On 08-APR-2025, the patient received Engerix B adult. On 08-APR-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Engerix-B inadvertent 20mcg dose to 19 year old) and overdose (Verbatim: Engerix-B inadvertent 20mcg dose to 19 year old). The outcome of the adult product administered to child and overdose 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: 08-MAY-2025 Pharmacist calls today on 08th May 2025 to report 19 years and 2-month-old patient received the adult dose inadvertently on 08th April 2025 which led to adult product administered to child and overdose. The Vaccine Administration Facility is the same as Primary Reporter.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: possible expired dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received HBV (Engerix B) (batch number H3O74) and (batch number H3074) for prophylaxis.   On 08-MAR-2025, the patient received Engerix B. On 08-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: possible expired dose). The outcome of the expired vaccine used 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: 09-MAY-2025 Reporter stated that a nurse have administered a vaccine (Engerix-B), and the expiration date that they discharged , if that was the correct expiration date, it will be expired at the time of the administration. The patient received expired vaccine, which led to expired vaccine used.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, Underdose
Clinical narrative: An adult patient received a pediatric dose of Engerix-B; An adult patient received a pediatric dose of Engerix-B; An adult patient received a pediatric dose of Engerix-B that was expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 57-year-old female patient who received HBV (Engerix B) (batch number 92DJ3, expiry date 03-MAY-2025) for prophylaxis.   On 12-MAY-2025, the patient received Engerix B. On 12-MAY-2025, an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: An adult patient received a pediatric dose of Engerix-B), underdose (Verbatim: An adult patient received a pediatric dose of Engerix-B) and expired vaccine used (Verbatim: An adult patient received a pediatric dose of Engerix-B that was expired). The outcome of the adult use of a child product, underdose and expired vaccine used 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: 12-MAY-2025 On 12th May 2025, a medical assistant called to report that they had administered a pediatric dose of Engerix-B to an adult female patient (57 years old), but it had expired on 3rd May 2025, which led to Adult use of a child product, Underdose and Expired vaccine used. The dose had been administered on 12th May 2025.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: wrong vaccine administered; a patient received a fourth dose of Pediarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 1-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number TC47K, expiry date 29-MAR-2026) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Pediarix and did not receive Infanrix. On an unknown date, an unknown time after receiving Pediarix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: wrong vaccine administered) and extra dose administered (Verbatim: a patient received a fourth dose of Pediarix). The outcome of the wrong vaccine administered and extra dose administered 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: 13-MAY-2025 The registered nurse reported a patient received a fourth dose of Pediarix instead of a dose of Infanrix which led to wrong vaccine administered and extra dose administration.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Her husband is now diagnosed with myocarditis too; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDITIS (Her husband is now diagnosed with myocarditis too) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Her husband is now diagnosed with myocarditis too) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Her husband is now diagnosed with myocarditis too) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   No vaccines within the past 4 weeks prior to the Moderna vaccine was reported.  No concomitant medications were reported.  The reporter inquired about methods for removing the COVID spike protein from the body of someone who had received the Moderna COVID vaccine. The reporter stated that the patient had been diagnosed with myocarditis despite never having contracted COVID.  It was reported that for some people, the spike protein naturally dissipates, but for others, it remains and causes ongoing health issues. She reported that doctors had not devised a treatment plan, and she criticized claims that myocarditis primarily affects men aged 19 to 30, asserting that individuals up to the age of 80 had reported similar issues. She sought answers regarding the removal of the spike protein.  She confirmed that neither her daughter nor son-in-law had experienced any other side effects.  She reported that Moderna had known that myocarditis could result from the vaccine but failed to disclose it properly. She mentioned clinical trials she saw on TV, saying that myocarditis had been documented but was reportedly considered a temporary issue in young people. The reporter reiterated that Moderna had known that myocarditis would result from it. The reporter questioned whether the company had a plan to treat vaccine-induced myocarditis, and she also found it strange that both her daughter and her husband had developed the condition.  It is unknown if the patient experienced any additional symptoms or events.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-786196 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-786196:same reporter different patient
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Extrasystoles, Fatigue
Clinical narrative: breathlessness; fatigue; exacerbated a preexisting intermittent ectopic heartbeat; it exacerbated a preexisting intermittent ectopic heartbeat; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (breathlessness) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ectopic heartbeats (Intermittent ectopic heartbeat).    On 10-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (breathlessness) (seriousness criterion medically significant), FATIGUE (fatigue) (seriousness criterion medically significant), EXTRASYSTOLES (exacerbated a preexisting intermittent ectopic heartbeat) and CONDITION AGGRAVATED (it exacerbated a preexisting intermittent ectopic heartbeat). At the time of the report, DYSPNOEA (breathlessness), FATIGUE (fatigue), EXTRASYSTOLES (exacerbated a preexisting intermittent ectopic heartbeat) and CONDITION AGGRAVATED (it exacerbated a preexisting intermittent ectopic heartbeat) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.       Concomitant medications were not reported.  It was reported that usually the patient had pretty much all the side effects which resolved after a week. It was reported that the patient had exacerbated a pre-existing intermittent ectopic heartbeat.  It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not reported.; Reporter's Comments: Company comment: The medical history of Intermittent ectopic heartbeat is considered as a confounder. The benefit-risk relationship of product is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Post-acute COVID-19 syndrome
Clinical narrative: bad headaches; long covid symptoms; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 30May2021 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, SINGLE), administration date: 09May2021, for Covid-19 Immunization, reaction(s): "headaches", "chills", "insomnia". The following information was reported: HEADACHE (life threatening), outcome "unknown", described as "bad headaches"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long covid symptoms".  Clinical course: The patient had side effects like headaches, chills, insomnia & many other side effects. The patient had previously received the unspecified Pfizer vaccine "RM" (as reported) and experienced coughing, insomnia, shortness of breath, headaches, depression, anxiety (severe). It was reported that the patient bad headaches, as a result of taking the covid vaccines. The patient also had long covid symptoms because of the shots.  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-PV202500034218 same patient, different vaccine dose/event;US-PFIZER INC-202500099734 same patient, different vaccine dose/event;
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large, red, swollen location, warm to touch, 3-4 inches across, at the injection site; Large, red, swollen location, warm to touch, 3-4 inches across, at the injection site; Large, red, swollen location, warm to touch, 3-4 inches across, at the injection site; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 14May2025 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in right arm for immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 14May2025 at 10:00, outcome "recovering" and all described as "Large, red, swollen location, warm to touch, 3-4 inches across, at the injection site". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site warmth, vaccination site swelling.  Additional information: As of 14May2025, facility where vaccine was administered was doctor's office/urgent care. The patient did not receive any other vaccines on the same date as the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. It was unknown whether the patient was taking any other medications within 2 weeks of the event starting.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Pain
Clinical narrative: Pain all over body; This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 28Apr2025 at 11:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 80 years, in left arm for immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 28Apr2025, outcome "recovered" (01May2025), described as "Pain all over body". Therapeutic measures were taken as a result of pain.  Additional information: Facility where vaccine was administered was doctor's office/urgent care. The patient did not receive any other vaccines on the same date as the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not taking any other medications within 2 weeks of the event starting. The patient had pain all over body, could not get out of bed to go to bathroom. Husband had to help to get out of bed and walk her to the bathroom. Started taking Tylenol and Advil was resting at home for 2 days.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: RSV
Symptoms: Death
Clinical narrative: killed from a botched RSV vaccine developed and produced by Pfizer; This is a spontaneous report received from a Lawyer from legal division.  A male patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "killed from a botched RSV vaccine developed and produced by Pfizer". The date and cause of death for the patient were unknown.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: killed from a botched RSV vaccine developed and produced by Pfizer
Sex: M
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: Asked if I knew a great class action lawyer he thinks he got MS from the Covid Vaccine.; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NUS2025US060768 (Novartis Pharmaceuticals Corporation).  A 41-year-old male 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: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "Asked if I knew a great class action lawyer he thinks he got MS from the Covid Vaccine.".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : NUS2025US060768 Novartis Pharmaceuticals Corporation;
Age: 48.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Asthenia, Fatigue, Flushing
Clinical narrative: Imz given at 10:30. Received a call from patient asking if it was normal to feel flush throughout her body. She thought it was due to the TDaP. She said she also felt weak and tired. I encouraged her to go to the Emergency Room to be evaluated.
Age: 66.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None noted