chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 09-Jul-2024 at 11:46 AM, the patient was vaccinated with an improperly storage dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X0114411, expiration date expiration date was not reported, however upon internal validation determined as 19-Apr-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided).   Administered dose of vaccine was exposed to the temperature excursion of 9.2 degrees Celsius for 13 minutes (product storage error). No previous temperature excursion occurred. There were no additional adverse events reported (no adverse event).   This is one of several reports received from the same reporter.; Reporter's Comments:
Age: 1.0
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a 1-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 13-Jan-2025 at 02:48 PM, the patient was vaccinated with an improperly storage dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X0114411, expiration date expiration date was not reported, however upon internal validation determined as 19-Apr-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided).   Administered dose of vaccine was exposed to the temperature excursion of 12.3 degrees Celsius for 6 hours and 23 minutes (product storage error). No previous temperature excursion occurred. There were no additional adverse events reported (no adverse event).   This is one of several reports received from the same reporter.; Reporter's Comments:
Age: 4.0
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 04-NOV-2024 at 11:42 AM, the patient was vaccinated with an improperly storage dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X0114411, expiration date expiration date was not reported, however upon internal validation determined as 19-Apr-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided).   Administered dose of vaccine was exposed to the temperature excursion of 12.3 degrees Celsius for 6 hours and 23 minutes (product storage error). No previous temperature excursion occurred. There were no additional adverse events reported (no adverse event).   This is one of several reports received from the same reporter.; Reporter's Comments:
Age: 1.0
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 24-Sep-2024 at 10:07 AM, the patient was vaccinated with an improperly storage dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X0114411, expiration date expiration date was not reported, however upon internal validation determined as 19-Apr-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided).   Administered dose of vaccine was exposed to the temperature excursion of 12.3 degrees Celsius for 6 hours and 23 minutes (product storage error). No previous temperature excursion occurred. There were no additional adverse events reported (no adverse event).   This is one of several reports received from the same reporter.; Reporter's Comments:
Age: 62.0
Sex: M
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site pain
Clinical narrative: Soreness at injection site; The patient has not yet received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Influenza vaccine inact split 4v (Fluzone quadrivalent) for prophylaxis.   On 25-NOV-2019, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 25-NOV-2019, the patient received Fluzone quadrivalent (unknown arm). On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain (Verbatim: Soreness at injection site) and incomplete course of vaccination (Verbatim: The patient has not yet received the second dose). The outcome of the injection site pain was unknown and the outcome of the incomplete course of vaccination was not applicable.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-MAR-2025 The patient self-reported this case for himself. The patient received the first dose of Shingrix and had not yet received the second dose till the time of reporting, which led to an incomplete course of vaccination. The patient also received Fluzone Quad vaccine at the same time. The patient believed the vaccines were given in different arms. The patient had soreness at the injection site after receiving Shingrix. No other conditions were provided. It was unknown if the reporter considered the injection site pain to be related to Fluzone Quad vaccine.
Age: 66.0
Sex: M
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 66-year-old male patient who received MMR (Priorix) (batch number xx9n4) for prophylaxis.   Concurrent medical conditions included diabetes (Diabetes).   On 07-MAR-2025, the patient received the 1st dose of Priorix. On 07-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the inappropriate age at vaccine administration 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: 18-MAR-2025 The consumer was the reporter. The reporter stated that he received his first dose of Priorix on 07th March 2025 and the patient was 66 years old which led to inappropriate age at vaccine administration. The patient was born in and did not think he was vaccinated in his country. Due to increased cases of , in the where was resides, he was contacted by his pharmacy and advised he should be vaccinated. The patient was unable to provide the street address, zip code, phone number for the pharmacy. The patient stated that he has a diagnosis of Type 2 diabetes. No further information was obtained/provided.
Sex: M
Vaccine: VARZOS
Symptoms: Illness, Pyrexia
Clinical narrative: had fever; illness; This non-serious case was reported by a other health professional via sales rep and described the occurrence of fever 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, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: had fever) and illness (Verbatim: illness). The outcome of the fever and illness were resolved (duration 1 week).   It was unknown if the reporter considered the fever and illness to be related to Shingrix.     It was unknown if the company considered the fever and illness to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-MAR-2025 The other health professional reported that the patient had side effects after dose 1 of Shingrix.  The patient had fever and illness for a week.
Vaccine: VARZOS, VARZOS
Symptoms: Dermatitis contact, Rash erythematous
Clinical narrative: early red rash was poison ivy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of red rash 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 red rash (Verbatim: early red rash was poison ivy). The outcome of the red rash was not reported.   It was unknown if the reporter considered the red rash to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the red rash to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2025 The case was received from the patient via interactive digital media. The reporter reported that he/she actually think did both shots.  At first the reporter thought the early red rash was poison ivy, until he/she thought why does not it itch. So the reporter looked it up online (on a Saturday) and when he/she saw it might be shingles and having it near your eye could cause blindness. The reporter got to an emergency room as soon as possible. They checked the reporter's eye with some kind of ultra violet thing and said he/she was fine but called the other docs in to see it. The reporter was so thankful. he/she feel the vaccine kept it from being painful or hurting my eye (Though, since it was around Halloween, it was a great zombie look).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: still get the stabbing pains every now and then; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: still get the stabbing pains every now and then). The outcome of the pain was not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-MAR-2025 This case was reported by a patient via interactive digital media. The patient was about 55 only had a few patches on right side.  It cleared up but every blue moon right side where the patches of shingles were feels like been stabbed with a knife and it can last anywhere from 1 to 3 days each episode.  The patient believe the shingles were living on the nerves inside body.  The patient did get the Shingrix shot and, still get the stabbing pains every now and then.
Vaccine: VARZOS, VARZOS
Symptoms: Ophthalmic herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; which went into my eye; got the shingles anyway, which went into my eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingrix and Shingles vaccine. On an unknown date, an unknown time after receiving Shingrix and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: which went into my eye) (serious criteria GSK medically significant) and shingles (Verbatim: got the shingles anyway, which went into my eye). The patient was treated with gabapentin and paracetamol (Tylenol). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster and shingles were not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix and Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingrix and Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the shingles vaccine and the Shingrix vaccine and got the shingles anyway, which went into eye, and still suffering with after effects of itching and stabbing pains in the area.  The patient on 300 microgram gabapentin three times a day, which helps a little, use ice packs and anti-itch cream and Tylenol.  This case was considered as suspected vaccination failure since the details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix and Shingles vaccine. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix and Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: getting them every couple of months; hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult 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 shingles (Verbatim: getting them every couple of months) and pain (Verbatim: hurt). The outcome of the shingles and pain were resolved.   The reporter considered the shingles and pain to be related to Shingrix.     The company considered the shingles and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported would be them mildly, but they still hurt. The patient did get one shot of Shingrix but could not continue them because of the bad reaction. The patient was getting shingles every couple of months and tried every trick in the book.  The reporter reported well she did the fast and never got a breakout until broke fast. So now the patient pretty much only eat fruit and veggies, it's been so nice.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; And I still got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: And I still got them). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 6 weeks).   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: 19-MAR-2025 The case was received from the patient via interactive digital media. The reporter self-reported this case foe himself/herself. The reporter had the vaccine and still got them.  The reporter reported that but, he/she was sure that they were not as bad for taking the vaccine.  They lasted 6 weeks. 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: Herpes zoster
Clinical narrative: got the shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got the 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: 19-MAR-2025 This case was reported by a reporter via interactive digital media. The reporter knew of several people (patients) who got the Shingles shot and within the week got the shingles.
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness (Verbatim: Sick). The outcome of the sickness was not resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2025 The patient said sorry if he/she came across as too gruff, he/she sick right now. The patient said if they know there were alternative cures for cancer. Research the Tippins protocol. Patient would never get any big pharma therapies personally. His/her own choice as done so much research on big pharma. He/she done deep dives on statins, most vaccines, and, of course, all the medications that take. His/her rheumatologist has farmed over to a psoriatic arthritis because would not take any of their fancy infusion therapies that have fetal cell lines in them. Mostly keep him/herself healthy by diet and taking ivermectin prophylaxis when in a crowd.; Sender's Comments:  US-GSK-US2025AMR035772:Same reporter
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 3 days after vaccine, pateint broke out with 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 Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: 3 days after vaccine, pateint broke out with 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: 18-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine at the hospital the patient worked at and 3 days later broke out with shingles.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; vaccine did not work for me; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: vaccine did not work for me). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAR-2025 This case was reported by a patient via interactive digital media. The reporter stated that the vaccine did not work for him/her, but they said that the small pox vaccine helps. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: F
Vaccine: RVX
Symptoms: Product contamination, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Going thru it now/Respiratory syncytial virus infection; it was contaminated; Got vaccine, but it was contaminated; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: Going thru it now/Respiratory syncytial virus infection), product contamination (Verbatim: it was contaminated) and poor quality vaccine administered (Verbatim: Got vaccine, but it was contaminated). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was not resolved and the outcome of the product contamination and poor quality vaccine administered were not applicable.   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: 18-MAR-2025 This case was reported by a patient via interactive digital media. The patient received the RSV vaccine and was going through it (Respiratory syncytial virus infection) now.  The patient received the contaminated vaccine and got letter 2 days before he/she got it. The patient reported it to be awful and requested to get vaccinated.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for Respiratory syncytial virus infection 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 RSV vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Had them on neck and face; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of herpes zoster 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 herpes zoster (Verbatim: Had them on neck and face). The outcome of the herpes zoster was not reported.   It was unknown if the reporter considered the herpes zoster to be related to Shingles vaccine.     It was unknown if the company considered the herpes zoster to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported to  have a high pain tolerance but told would rather have three more kids than have shingles again.  The patient  reported it was the most painful thing he/she have ever had. The patient had shingles on face and neck and that was after having the first shingle vaccine.  The patient stated would better believed she/he will get the vaccine that is out now.
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Dialysis after first dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of dialysis in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31-OCT-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced dialysis (Verbatim: Dialysis after first dose of Shingrix). The outcome of the dialysis was unknown.   It was unknown if the reporter considered the dialysis to be related to Shingrix.     It was unknown if the company considered the dialysis to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-MAR-2025 Pharmacist called to report about a patient who received the Shingrix and before getting the second dose, The pharmacist stated, He was not a dialysis patient and he is undergoing dialysis patient with three times a week .  The pharmacist enquired if there was any contraindication for getting the vaccine. Patient was undergoing dialysis and Health Care Professional was looking if it was safe to complete the schedule of Shingrix.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose of Engerix-B; 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 19-year-old female patient who received HBV (Engerix B) (batch number X527B, expiry date 17-MAR-2025) for prophylaxis.   On 18-MAR-2025, the patient received Engerix B. On 18-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: administration of an expired dose of Engerix-B). 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: 19-MAR-2025 The healthcare professional called in to request data about the administration of an expired dose of Engerix-B.  They stated the dose expired on March 17th, 2025, and was administered on March 18th, 2025, which led to expired vaccine used. They asked and doubled down on their wish to remain anonymous, but did consent to receive follow-up. The Vaccine Administration Facility is the same as Primary Reporter.
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: Severe Neurological Reaction; This spontaneous case was reported by a non-health professional and describes the occurrence of NERVOUS SYSTEM DISORDER (Severe Neurological Reaction) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (Severe Neurological Reaction) (seriousness criterion medically significant). At the time of the report, NERVOUS SYSTEM DISORDER (Severe Neurological Reaction) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732177 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732177:S-R
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Graves' disease
Clinical narrative: Grave's disease; they noticed symptoms/have an allergy to ingredient in COVID-19 vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 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. Vaccination history included: Bnt162b2 (DOSE 1, single), for COVID-19 immunization, reaction(s): "allergy to ingredient in COVID-19 vaccine"; Bnt162b2 (DOSE 2, single), for COVID-19 immunization, reaction(s): "allergy to ingredient in COVID-19 vaccine". The following information was reported: GRAVES' DISEASE (medically significant), outcome "unknown", described as "Grave's disease"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "they noticed symptoms/have an allergy to ingredient in COVID-19 vaccine". Clinical course: The patient received 3 doses. The patient had an allergy to ingredient in COVID-19 vaccine, clarified a PEG, 3350 or something, allergy, an allergy to Miralax. Said the ingredient in Miralax was also in the vaccine. The patient was after 3rd dose and had Grave's disease, confirmed spelling with caller, hyperthyroid. The patient was given medicine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she has Covid; she has Covid; This is a spontaneous report and received from Consumer or other non HCPs, Program ID.  A 42-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (not ongoing), notes: has taken Paxlovid 2 years ago; within five days cured. The patient's concomitant medications were not reported. Past drug history included: Paxlovid, start date: 2023, stop date: 2023, for COVID-19 immunization. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she has Covid".  Clinical course: Reporter states that the patient had COVID and has taken Paxlovid 2 years ago. Patient is 42 years old but has a mind at the fourth-grade level. During an inbound call for financial assistance, patient's father stated that he was calling for his daughter who is developmentally disabled. Patient was prescribed with Paxlovid. Later in the call patient's mother stated, "...she has Covid, and we have to get that medicine, and we have Covid too." The patient's mother stated she never had trouble getting medication for her but "since they gave her # (unspecified) all the sudden they won't pay for it." Later in the call, patient's mother stated, "We had, we had it in the past, we had Covid, couple years ago and we all got Paxlovid then...it was great, within five days we were cured, you know..." When asked if this was the second time getting Covid, patient's mother said "Yes" and when asked if this was the second time getting Paxlovid, patient's mother said "Yes, yes". When asked how long did the patient have Covid, patient's mother responded, "...It was about two years ago", Later In the call, patient's mother stated, "You know, I just want you to know a part from my daughter being mentally disabled, she is physically very healthy, she has no medical, physical yes she has no Physical problems whatsoever, it's just mentally". Towards the end of the call, patient's mother stated, "She had all the vaccinations too, she had all the Pfizer uh, Pfizer ones, she was fully vaccinated..."
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: only PENTACEL's DTap-IPV component was administered with no reported AE; Initial information received on 24-Mar-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age / gender patient who received only DTAP-IPV component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis a vaccine (Hepa); and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) both for Immunisation.  On 14-Mar-2025, the patient received 0.5 ml of dose 4 of DTAP-IPV component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength- standard, expiry date- 30-JUN-2025 and lot UK038AA) via intramuscular route in the left vastus lateralis for Immunization with no reported adverse event (single component of a two-component product administered) (latency- same day).  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: COVID19
Symptoms: Allergic reaction to excipient, Arthralgia, Erythema, Pain in extremity, Swelling
Clinical narrative: an allergy to ingredient in COVID-19 vaccine, clarified a PEG, or something; an allergic reaction (swelling, redness) as well as pain in both arms and legs; an allergic reaction (swelling, redness) as well as pain in both arms and legs; an allergic reaction (swelling, redness) as well as pain in both arms and legs; pain from left arm to leg, right arm to leg, shoulder; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Miralax, reaction(s): "allergy". The following information was reported: ALLERGIC REACTION TO EXCIPIENT (non-serious), outcome "unknown", described as "an allergy to ingredient in COVID-19 vaccine, clarified a PEG, or something"; SWELLING (non-serious), ERYTHEMA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "an allergic reaction (swelling, redness) as well as pain in both arms and legs"; ARTHRALGIA (non-serious), outcome "unknown", described as "pain from left arm to leg, right arm to leg, shoulder". The events "an allergy to ingredient in covid-19 vaccine, clarified a peg, or something", "an allergic reaction (swelling, redness) as well as pain in both arms and legs" and "pain from left arm to leg, right arm to leg, shoulder" required physician office visit. Therapeutic measures were not taken as a result of allergic reaction to excipient, swelling, erythema, pain in extremity, arthralgia.  Additional information: The patient has an allergy to ingredient in COVID-19 vaccine, clarified a PEG, or something. She said the ingredient in Miralax is also in the vaccine. She has something that feels like pain from left arm to leg, right arm to leg, shoulder, sometimes swollen and red like an allergic reaction. The patient and her son both have allergy to Miralax. The patient saw endocrinologist, did not do anything, told caller to obverse. Family does not have any thyroid problems. The events occurred after got the vaccine, she thinks not the only one case, other people have. She wants to check therapies, wants suggestion from doctor, wants to know how to treat, what do people do since was because of vaccine. She wants to know what treatment can be given. Confirmed received the Pfizer COVID-19 vaccine.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500062913 same reporter/patient, different vaccine dose/event;
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Laboratory test
Clinical narrative: Covid after Pfizer Shots; Covid after Pfizer Shots; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 78-year-old 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: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid after Pfizer Shots". The patient underwent the following laboratory tests and procedures: did a test: Unknown results. Clinical course: During an inbound call for financial assistance, towards the end of the conversation, the caller expressed concern about contracting COVID-19 again despite having received all their shots and boosters. In the background, someone mentioned they had received Pfizer shots. The caller confirmed, stating that Pfizer was the vaccine they had taken. When asked to clarify if this was their first or second time contracting COVID-19 (though the question was not specified), the caller explained that they had a mild case two years ago, which only required testing due to coughing symptoms and did not necessitate any medication. However, this time, the illness affected them more severely.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: skin reaction the day following her own COVID vaccine in 2021 to a diagnosis of Psoriasis; This is a spontaneous report received from a Physician.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PSORIASIS (non-serious), outcome "unknown", described as "skin reaction the day following her own COVID vaccine in 2021 to a diagnosis of Psoriasis".  Additional information: The reporter stated that a physician I met with stated she attributes a skin reaction the day following her own COVID vaccine in 2021 to a diagnosis of Psoriasis. She stated her vaccine was a Pfizer vaccine. Of note, she stated her Rheumatologist describes that after COVID infections, patients with Rheumatic diseases can no longer be managed with monotherapy immune modulation due to severity of immune disease.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received pediatric dose of Hep B instead of adult dose. Contacted patient for revaccination. No adverse events experienced.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received pediatric dose of Hep B. Contacted for revaccination. No adverse events
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Dizziness, Electrocardiogram normal, Hypertension, Nervousness
Clinical narrative: After 5-10 minutes of shingles vaccine he felt sharp pain retrosternal and dizzy and lightheaded His blood pressure was high not low, chest pain resolved after short time He says that he was nervous because he has PTSD of more and most of the time needle causing flashback of war and he gets nervous attack 911 came EKG was done no problem His vital sign came back to normal He declined to go to the ER and signed AMA
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: patient had soreness started in the arm and went away but not completely, she still feels sore sometimes, not sure related to vaccine, she will contact her PCP, no lunmps or bumps or rashes
Age: 19.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Underdose
Clinical narrative: Patient was given a pediatric dose instead of adult dose
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pt was given a pediatric dose instead of an adult dose.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse events.
Age: 73.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Immediate post-injection reaction, Inflammation, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Both Injections were placed in the left shoulder Bersa instead of the muscle tissue. This resulted in immediate high level of pain.  After pain continued for a couple of weeks medical attention was sought.  It was determined that the injections in the Bursa had resulted in considerable inflammation. The inflammation caused a high degree of pain during movement of the arm and limited use of the arm. Several visits were made to the Bone and Joint Clinic where cortisone was injected along with prednisone being prescribed' Once the prednisone ran it course the pain returned.  Every week that passed I kept hoping the arm would get better but it has not improved.  I still have limited use of my arm.
Age: 73.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Product administered at inappropriate site
Clinical narrative: Both Injections were placed in the left shoulder Bersa instead of the muscle tissue. This resulted in immediate high level of pain.  After pain continued for a couple of weeks medical attention was sought.  It was determined that the injections in the Bursa had resulted in considerable inflammation. The inflammation caused a high degree of pain during movement of the arm and limited use of the arm. Several visits were made to the Bone and Joint Clinic where cortisone was injected along with prednisone being prescribed' Once the prednisone ran it course the pain returned.  Every week that passed I kept hoping the arm would get better but it has not improved.  I still have limited use of my arm.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse events
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse events
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse events
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse events
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse events
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse events
Age: 74.0
Sex: M
Vaccine: TDAP
Symptoms: Gait inability, Limb discomfort
Clinical narrative: Per patient, he couldn't walk on the morning the day after the vaccine. Per patient his leg feel really heavy.
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two doses of abrysvo vaccine without any medical consequence or effect that was life threatening or other medical concern leading to immediate medical attention or further medical review. ACIP (Advisory Committee on Immunization Practices (ACIP)  guidelines did not specify harmful outcome related to duplicate dose of abrysvo.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site mass, Injection site pain, Nausea, Pain
Clinical narrative: Body aches/pain, nausea, headache, hard bump at injection site and pain surrounding it. These symptoms lasted multiple days.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVED A REDUDANT/DUPLICATE PPSV23 WHEN PNEUMONIA SERIES COMPLETED TWO YEARS PRIOR. PATIENT ALSO RECEIVED A FOURTH DOSE IN A 2-DOSE SERIES SHINGRIX (THE FIRST SERIES COMPLETED IN 2018) AND THE SECOND ROUND OF DOSES GIVEN 2/9/24 AND 7/24/24, RESPECTIVELY.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Erythema, Fatigue, Swelling face
Clinical narrative: patient woke up with red swollen face, loss of appetite, and tiredness. Patient has taken Benadryl and will follow up if no improvement in a few days. Patient will seek medical attention if any signs of anaphylaxis.