chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles very bad; 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 very bad). 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: 27-MAY-2025 This case was reported by a patient via interactive digital media.  Patient took both shingles vaccine and still got shingles very bad. Patient wished someone could have told them that the drugs they were on could have cancelled out the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; 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(Dose 1 & 2).
Sex: M
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: only a diluent was given; only a diluent was given; This non-serious case was reported by a physician via interactive digital media and described the occurrence of inappropriate preparation of medication in a male patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: only a diluent was given) and inappropriate dose of vaccine administered (Verbatim: only a diluent was given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine 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: 23-MAY-2025 This case was reported via (Chatbot) interactive digital media. The healthcare professional reported that the patient was given only the diluent of the Priorix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Vaccine: RVX
Symptoms: Mycoplasma infection, Pain in extremity
Clinical narrative: leg pains are unbearable/it gave me the micro plasma; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mycoplasma infection in a 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 mycoplasma infection (Verbatim: leg pains are unbearable/it gave me the micro plasma). The outcome of the mycoplasma infection was not reported.   It was unknown if the reporter considered the mycoplasma infection to be related to RSV vaccine.     It was unknown if the company considered the mycoplasma infection to be related to RSV vaccine.   Additional Information: GSK receipt date: 23-MAY-2025 This case was reported by a patient via interactive digital media. The truth was that ever since he/she received the vaccines, the leg pain had become unbearable. He/she developed a mycoplasma infection afterward, and it was worse than anything he/she had experienced before. He/she had never had lung issues or cataracts prior to this. Since the vaccination, the symptoms had been horrible. However, he/she did not blame the vaccines themselves.
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: I'M STILL 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 (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 sickness (Verbatim: I'M STILL SICK). The outcome of the sickness was not resolved.   The reporter considered the sickness to be related to Shingrix.     The company considered the sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-MAY-2025 The reporter stated that he/she was not taking because he/she was still sick from the first one.
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: got inadequate dose; This non-serious case was reported by a consumer via sales rep and described the occurrence of underdose 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 underdose (Verbatim: got inadequate dose). The outcome of the underdose was not applicable.   Additional Information: GSK Receipt Date: 27-MAY-2025 Reporter stated that essentially someone got an inadequate dose and cannot figure out what patient it was.  Also asked are there recs on re-vaccinating with not knowing what patient it was. They narrowed it down to about 10 patients, no more data was provided. Patient received inadequate dose, which led to underdose.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration at inappropriate age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-month-old female patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis.   On 27-MAY-2025, the patient received Kinrix. On 27-MAY-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration at inappropriate age). 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: 28-MAY-2025 The nurse informed that they gave a Kinrix to a 16 month old child (patient), which led to an inappropriate age ta vaccine administration. The vaccine administration facility was the same as primary reporter.
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate schedule of DTap series.; Kinrix administered too early in the series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Inappropriate schedule of DTap series.) and inappropriate age at vaccine administration (Verbatim: Kinrix administered too early in the series). The outcome of the inappropriate schedule of vaccine administered 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:28-MAY-2025 A pharmacy director called to inform that for Kinrix. It was administered too early in the series, before it should, which led to inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. There were multiple patients. Reporter mentioned that there were 31 patients, no details about each of the patients were provided, as well as lot numbers. However, healthcare professional agreed to follow-up by Safety team to provide additional details.  The Vaccine Administration Facility was same as Primary Reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient didn't get COVID, but eventually got it but just last year; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient didn't get COVID, but eventually got it but just last year) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2024, the patient experienced COVID-19 (Patient didn't get COVID, but eventually got it but just last year). At the time of the report, COVID-19 (Patient didn't get COVID, but eventually got it but just last year) outcome was unknown.            Concomitant product use was not provided by the reporter. The reporter stated that her mom, her dad and her whole family got the Moderna COVID vaccine and almost all of them did not get sick. They didn't get COVID, but her parents eventually got it but just last year. Her parents had received Moderna since the beginning. The reporter refused to provide initials and DOB for her parents. No other details provided. Treatment information was not provided. Reporter causality was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-786994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-786994:Reporter father case
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: They didn't get COVID, but my parents eventually got it but just last year; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (They didn't get COVID, but my parents eventually got it but just last year) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2024, the patient experienced COVID-19 (They didn't get COVID, but my parents eventually got it but just last year). At the time of the report, COVID-19 (They didn't get COVID, but my parents eventually got it but just last year) outcome was unknown.            Concomitant product use was not provided by the reporter. The reporter stated that her mom got the Moderna COVID vaccine and she did not get sick. She didn't get COVID but got it but just last year. She received Moderna since the beginning. The reporter refused to provide initials and DOB for her parents. No other details provided. Treatment information was not provided. Reporter causality was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-786994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-786994:Reporter mother case
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient just recently got COVID 2 months ago, but she also had her shots; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient just recently got COVID 2 months ago, but she also had her shots) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse effect with Pfizer.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In March 2025, the patient experienced COVID-19 (Patient just recently got COVID 2 months ago, but she also had her shots). At the time of the report, COVID-19 (Patient just recently got COVID 2 months ago, but she also had her shots) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient just recently got COVID, 2 months ago, but she also had her shots. The patient got Pfizer at the beginning and then Moderna after. The reporter stated that none of her family gets sick after their COVID vaccines. Treatment information was not provided. Reporter causality was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-786994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-786994:Reporter sister case
Sex: M
Vaccine: COVID19
Symptoms: Cranial nerve disorder
Clinical narrative: from the vaccination would have any medical issues with the cranial 3 nerve; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CRANIAL NERVE DISORDER (from the vaccination would have any medical issues with the cranial 3 nerve) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced CRANIAL NERVE DISORDER (from the vaccination would have any medical issues with the cranial 3 nerve). At the time of the report, CRANIAL NERVE DISORDER (from the vaccination would have any medical issues with the cranial 3 nerve) outcome was unknown.      The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   No concomitant medications were reported.  It was reported that the reporter was checking if any side effects from the vaccination would have caused any medical issues related to the cranial 3 nerve. Reporter's husband was experiencing recurring problems. Reporter also enquired if anyone else also experienced the same problem.  It was unknown if the patient experienced any additional symptoms or events  No treatment medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Condition aggravated
Clinical narrative: She then states that 2 weeks after the first COVID vaccine she took in February 2021 her hair started falling "in bunches"; She then states that 2 weeks after the first COVID vaccine she took in February 2021 her hair started falling "in bunches"; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (She then states that 2 weeks after the first COVID vaccine she took in February 2021 her hair started falling "in bunches") and CONDITION AGGRAVATED (She then states that 2 weeks after the first COVID vaccine she took in February 2021 her hair started falling "in bunches") in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L208) for COVID-19 prophylaxis.     Concurrent medical conditions included Hair loss (patient on Finasteride for hair fall).    On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, the patient experienced ALOPECIA (She then states that 2 weeks after the first COVID vaccine she took in February 2021 her hair started falling "in bunches") and CONDITION AGGRAVATED (She then states that 2 weeks after the first COVID vaccine she took in February 2021 her hair started falling "in bunches"). The patient was treated with Finasteride for Hair loss, at an unspecified dose and frequency. At the time of the report, ALOPECIA (She then states that 2 weeks after the first COVID vaccine she took in February 2021 her hair started falling "in bunches") and CONDITION AGGRAVATED (She then states that 2 weeks after the first COVID vaccine she took in February 2021 her hair started falling "in bunches") had not resolved.            No concomitant medication was reported. It was reported that 2 weeks after the first COVID vaccine she took in Feb-2021 her hair started falling in bunches. She took other doses later, and she regrets doing so because she did not know how it would affect her, and she should not have done it.  She took vaccine doses on 2-Nov-2021 with lot 016MZ0A, then on 15-Aug-2022 with lot 088021 and then on 28-Oct-2022 with lot 013h22a. It was unknown if the patient experienced any additional symptoms or events.   This case was linked to US-MODERNATX, INC.-MOD-2025-786999 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-786999:Invalid case
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Carpal tunnel syndrome, Gait disturbance, Pain, Pyrexia
Clinical narrative: body pains; low grade fever (100'F); she cannot walk; she has carpal tunnel; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body pains), PYREXIA (low grade fever (100'F)), GAIT DISTURBANCE (she cannot walk) and CARPAL TUNNEL SYNDROME (she has carpal tunnel) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 203523A) for COVID-19 prophylaxis.     No Medical History information was reported.   In July 2024, the patient received seventh dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to .5 milliliter. On an unknown date, the patient received sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (body pains), PYREXIA (low grade fever (100'F)), GAIT DISTURBANCE (she cannot walk) and CARPAL TUNNEL SYNDROME (she has carpal tunnel). At the time of the report, PAIN (body pains) and PYREXIA (low grade fever (100'F)) had resolved and GAIT DISTURBANCE (she cannot walk) and CARPAL TUNNEL SYNDROME (she has carpal tunnel) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 Farad. On an unknown date, SARS-CoV-2 test: Negative.         No concomitant medication was reported. She had received 7 Moderna COVID-19 vaccines, and she was the only one that didn't get sick (COVID) and she got vaccines consistently. If she got a runny nose, she would test for COVID consistently and was always negative. The reporter stated that with every shot, except for her last one in July 2024 with lot number 203523A she experienced body pains, like she cannot walk for 24 hours, and a low-grade fever (100'F) that starts within 6 hours and goes away after about 12-24 hours. She had carpal tunnel.  She was not diagnosed it before any COVID shots. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-786996, US-MODERNATX, INC.-MOD-2025-786997, US-MODERNATX, INC.-MOD-2025-786998 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-786998:Reporter sister case US-MODERNATX, INC.-MOD-2025-786997:Reporter mother case US-MODERNATX, INC.-MOD-2025-786996:Reporter father case
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: body pains; low grade fever (100'F); she cannot walk; she has carpal tunnel; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body pains), PYREXIA (low grade fever (100'F)), GAIT DISTURBANCE (she cannot walk) and CARPAL TUNNEL SYNDROME (she has carpal tunnel) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 203523A) for COVID-19 prophylaxis.     No Medical History information was reported.   In July 2024, the patient received seventh dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to .5 milliliter. On an unknown date, the patient received sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (body pains), PYREXIA (low grade fever (100'F)), GAIT DISTURBANCE (she cannot walk) and CARPAL TUNNEL SYNDROME (she has carpal tunnel). At the time of the report, PAIN (body pains) and PYREXIA (low grade fever (100'F)) had resolved and GAIT DISTURBANCE (she cannot walk) and CARPAL TUNNEL SYNDROME (she has carpal tunnel) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 Farad. On an unknown date, SARS-CoV-2 test: Negative.         No concomitant medication was reported. She had received 7 Moderna COVID-19 vaccines, and she was the only one that didn't get sick (COVID) and she got vaccines consistently. If she got a runny nose, she would test for COVID consistently and was always negative. The reporter stated that with every shot, except for her last one in July 2024 with lot number 203523A she experienced body pains, like she cannot walk for 24 hours, and a low-grade fever (100'F) that starts within 6 hours and goes away after about 12-24 hours. She had carpal tunnel.  She was not diagnosed it before any COVID shots. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-786996, US-MODERNATX, INC.-MOD-2025-786997, US-MODERNATX, INC.-MOD-2025-786998 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-786998:Reporter sister case US-MODERNATX, INC.-MOD-2025-786997:Reporter mother case US-MODERNATX, INC.-MOD-2025-786996:Reporter father case
Sex: M
Vaccine: COVID19
Symptoms: Aortic valve replacement, Cardiac pacemaker insertion
Clinical narrative: Asked if the caller has any comorbidities  or immunocompromised, caller stated that he has a pace maker, TAVR aortic valve replacement; Asked if the caller has any comorbidities  or immunocompromised, caller stated that he has a pace maker, TAVR aortic valve replacement; This is a spontaneous report received from a Physician from medical information team, Program ID.  A 75-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 27Aug2024 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: comirnaty (DOSE 5 (BOOSTER), SINGLE), administration date: 03Apr2022, for COVID-19 immunization; BNT162b2 (DOSE 6 (BOOSTER), SINGLE), administration date: 14Sep2023, for COVID-19 immunization; Moderna (DOSE 1, SINGLE), administration date: Jan2021, for COVID-19 immunization; Moderna (DOSE 2, SINGLE), administration date: Feb2021, for COVID-19 immunization; Moderna (DOSE 3 (BOOSTER), SINGLE), administration date: Aug2021, for COVID-19 immunization; Comirnaty (DOSE 4 (BOOSTER), SINGLE), administration date: Mar2022, for COVID-19 immunization. The following information was reported: AORTIC VALVE REPLACEMENT (medically significant), CARDIAC PACEMAKER INSERTION (medically significant), outcome "unknown" and all described as "Asked if the caller has any comorbidities  or immunocompromised, caller stated that he has a pace maker, TAVR aortic valve replacement".  Clinical course: Caller is a HCP and a patient, confirmed above inquiry. His last dose of COVID-19 vaccine was on 27Aug2024 which was the Comirnaty 12 plus. Asked if the caller has any comorbidities  or immunocompromised, caller stated that he has a pace maker, (withheld) valve replacement. Caller also stated that he had a total of 7 covid-19 vaccinations. He is 75 years old turning 76.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Based on known nature of the events and limited information available, the events are assessed as not related to BNT162b2 omicron (kp.2), and more likely due to underlying medical conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus
Clinical narrative: git a Glucose spike/Diabetic; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "not recovered", described as "git a Glucose spike/Diabetic". The patient underwent the following laboratory tests and procedures: Blood glucose: Spike, notes: He states he has talked to 2 other friends and they git a Glucose spike, one went from 100 to 267 and another went up to 460.  Clinical information: Caller states he has gotten so many problems from the Pfizer Covid 19 Vaccine. Caller states he just got his Glucose tested and it went from 100 to 402 and he is passing out. Caller states his doctor said it was from the Covid Vaccine. He states he has talked to 2 other friends and they git a Glucose spike, one went from 100 to 267 and another went up to 460 and his sister's went up to 367. What is the deal with the Covid Vaccine spiking Glucose that you guys said it was safe and effective? Caller states they are Diabetic now, everybody is Diabetic now. Caller states his Doctor said he has shortened his life by 5 years, 5-10 years. Caller states 3 other friends got the same glucose spike that he just talked to.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Bone cancer
Clinical narrative: one guy got a super cancer in his spine; 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. The following information was reported: BONE CANCER (medically significant), outcome "unknown", described as "one guy got a super cancer in his spine".  Clinical course: Caller stated one guy got a super cancer in his spine.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: why did the covid shots mess up my sense of taste; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TASTE DISORDER (non-serious), outcome "unknown", described as "why did the covid shots mess up my sense of taste".  Additional information: The reporter asked why did the covid shots mess up my sense of taste.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Thrombosis
Clinical narrative: got a lump in her leg that was a blood clot; got a lump in her leg that was a blood clot; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), LIMB MASS (non-serious), outcome "unknown" and all described as "got a lump in her leg that was a blood clot". Clinical course: The reporter mentioned that her neighbor got the Covid-19 shot and she got a lump in her leg that was a blood clot.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: the patient also had some reaction to the Paxlovid medication; the patient also had some reaction to the Paxlovid medication; This is a spontaneous report received from an Other HCP.  A 62-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "the patient also had some reaction to the Paxlovid medication". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with BNT162b2 NOS can not be fully excluded.,Linked Report(s) : US-PFIZER INC-202300011455 same patient, different dose/event;
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Headache; severe fatigue; chills; This is a spontaneous report received from a Nurse.  A 76-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 27May2025 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Lichens planopilaris" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "OAB" (unspecified if ongoing); "Adhesive tape allergy" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE, start date: 06Sep2006. Past drug history included: Anticholinergics, reaction(s): "Drug hypersensitivity"; Fosamax, reaction(s): "Drug hypersensitivity"; Lisinopril, reaction(s): "Drug hypersensitivity". The patient did not receive other vaccines on the same date as the vaccine(s) reported. The patient did not receive other vaccines within 4 weeks prior to the vaccine(s) reported. The following information was reported: HEADACHE (non-serious) with onset 28May2025, outcome "unknown"; CHILLS (non-serious) with onset 28May2025, outcome "unknown"; FATIGUE (non-serious) with onset 28May2025, outcome "unknown", described as "severe fatigue". Therapeutic measures were taken as a result of headache, fatigue, chills. Treatment received for the adverse event included Tylenol and rest.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I am positive for COVID, and I was on the Pfizer vaccination trial as well; I am positive for COVID, and I was on the Pfizer vaccination trial as well; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 46-year-old 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I am positive for COVID, and I was on the Pfizer vaccination trial as well". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I am positive for COVID.  Clinical information: During an inbound call for financial assistance, the patient, Name withheld, stated that patient needed some assistance in getting a prescription for Paxlovid. The patient was then unemployed and did not have access to health insurance. The patient did not even have access to a doctor at the moment, but the patient was positive for COVID, and patient was on the Pfizer vaccination trial as well." When discussing the cost of seeing a doctor, Name withheld stated,". The patient had to spend a bunch of money patient did not have because patient was sick." When offered to transfer to the Drug and Safety department, Name withheld stated, "Probably after patient recover, the patient did not had the patience for that to be honest, sorry."  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Goitre, Pancreatic cyst, Uterine leiomyoma, Vaginal haemorrhage
Clinical narrative: Cyst on her Pancreas; Enlarged Thyroid; Vaginal Bleeding; Fibroid; This is a spontaneous report received from a Pharmacist from medical information team, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PANCREATIC CYST (non-serious), outcome "unknown", described as "Cyst on her Pancreas"; GOITRE (non-serious), outcome "unknown", described as "Enlarged Thyroid"; VAGINAL HAEMORRHAGE (non-serious), outcome "unknown", described as "Vaginal Bleeding"; UTERINE LEIOMYOMA (non-serious), outcome "unknown", described as "Fibroid".  Additional information: pharmacist wanted to know how frequent the adverse effect of Pfizer Covid-19 vaccine is and how they can manage those effects because they have a patient who got adverse effects. She would like to see if there is any information on the things the patient is experiencing and how they can manage those side effects. Caller states the patient has a cyst on her pancreas, enlarged thyroid, vaginal bleeding that she believes is from a fibroid that started after the Pfizer Covid vaccine and it has been happening for 2 years.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 1.25
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: nurse reconstituted the hib powder portion of pentacel with an unknown liquid to two patients. liquid dtap/ipv portion not administered with no reported ae; nurse reconstituted the hib powder portion of pentacel with an unknown liquid to two patients. liquid dtap/ipv portion not administered with no reported ae; Initial information received on 20-May-2025 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (non-healthcare professional).   This case was linked with US-SA-2025SA154169.  This case involves a 15 months old patient with unknown gender for whom nurse reconstituted the hib powder portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] with an unknown liquid and liquid dtap/ipv portion not administered with no reported adverse event.   Reportedly, there was no parental drug exposure. The patient have unknown medical history/condition, concomitant disease and risk factor or lab tests.  Reporter reported that the suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot number, expiry date and strength not reported) for Immunization for patient 15 months old (Immunisation) and nurse reconstituted the hib powder portion of pentacel with an unknown liquid to two patients. liquid dtap/ipv portion not administered with no reported adverse event (single component of a two-component product administered), (product preparation error) (latency same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  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.; Sender's Comments:  US-SA-2025SA154169:
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome; This spontaneous case, initially received on 28-May-2025, was reported by a non health professional and concerns an adult female patient.  Relevant History and concomitant medication were reported as unknown.  Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for influenza prophylaxis, Dose regimen: not reported, Route of administration: not reported, Anatomical location: not reported, Lot number: Not reported and requested upon follow-up.   No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Guillain-Barre Syndrome (Medically Significant, outcome: Recovering/resolving).  Case was upgraded to serious upon company assessment of the reported event's clinical significance.  An adverse event related to the administration of Flucelvax was reported. Physician informed that one of his patients had experienced an adverse event after receiving the vaccine. The patient was an adult female who developed Guillain-Barré Syndrome following her vaccination with Flucelvax. Doctor recognized the adverse event promptly and provided the necessary care, which improved the patient's outcome  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the causality and seriousness of the event Guillain-Barre Syndrome as unknown; Reporter's Comments: Causality: Due to the spontaneous nature of the case, the event is considered related for reporting purposes. Related considering biological plausibility, however there is insufficient information about precise event latency, therapy details, clinical course, medical history and concomitant medication which precludes a sound medical assessment. According to the Brighton Collaboration criteria, the case meets Level 4 diagnostic certainty for the event of Guillain-Barre Syndrome (there is lack of sufficient information to meet any level of case diagnostic criteria)
Sex: F
Vaccine: HEP, HIBV
Symptoms: Extra dose administered
Clinical narrative: No other AE/No PQC; Patient did have all childhood vaccinations at the time that they were due when she was a child so this PEDVAXHIB is an extra dose; This spontaneous report was received from a nurse regarding to a 22-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 28-MAY-2025, the patient was vaccinated with haemophilus b Conjugate Vaccine (meningococcal protein conjugate) (LIQUID PEDVAX HIB) at a dose of 0.5 mL (strength, route of administration, anatomical injection site, lot # and expiration date were not reported), for prophylaxis; and with hepatitis b vaccine rHBsAg (yeast) (ENGERIX B) (strength, dose, route of administration, anatomical injection site, lot #, expiration date and indication were not reported).  The reporter  stated that patient was inadvertently given haemophilus b Conjugate Vaccine (meningococcal protein conjugate) (LIQUID PEDVAX HIB) that was not due. The patient was also vaccinated with hepatitis b vaccine rHBsAg (yeast) (ENGERIX B) at the same time as the haemophilus b Conjugate Vaccine (meningococcal protein conjugate) (LIQUID PEDVAX HIB). Hepatitis b vaccine rHBsAg (yeast) (ENGERIX B) was due and was given appropriately. Patient did have all childhood vaccinations at the time that they were due when she was a child so this haemophilus b Conjugate Vaccine (meningococcal protein conjugate) (LIQUID PEDVAX HIB) was an extra dose. No other information provided. No other AE/No PQC.  Lot # is being requested and will be submitted if received.
Age: 73.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Limb mass, Pruritus
Clinical narrative: pt called saying he had a total of 9 raised bumps total on both arms and they itched.  shot was given mid morning and he called about 5pm same day
Age: 66.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: Priorix antigen was not reconstituted with diluent prior to administration. Patient only received diluent.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient was due for Tdap and HPV. I gave Meningococcal by mistake. I notified my provider and supervisor and reported it to all the appropriate people. Patient did not show any signs of adverse reactions.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: Patient complained about having mild swelling, pain and numbness at the injection site.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Carditis, Catheterisation cardiac, Computerised tomogram, Electrocardiogram
Clinical narrative: Heart inflammation
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Ultrasound scan
Clinical narrative: Heart inflammation
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient reported that she couldn't move her arm the day after the vaccine. Her whole arm was in pain up to her hand.
Age: 10.0
Sex: F
Vaccine: YF
Symptoms: Syncope
Clinical narrative: PATIENT FAINTED AFTER RECEIVING VACCINE
Age: 54.0
Sex: M
Vaccine: PNC21, VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The arm where he had the pneumonia shot swelled up to softball size, was red and painful. He also noted that he experienced side effects of fever, chills, headache, racing heart.  Patient called and informed us 4 days after the vaccine so it is not clear exactly when his symptoms began. he did not seek medical evaluation.
Age: 54.0
Sex: M
Vaccine: PNC21, VARZOS
Symptoms: Palpitations, Pyrexia
Clinical narrative: The arm where he had the pneumonia shot swelled up to softball size, was red and painful. He also noted that he experienced side effects of fever, chills, headache, racing heart.  Patient called and informed us 4 days after the vaccine so it is not clear exactly when his symptoms began. he did not seek medical evaluation.
Age: 31.0
Sex: F
Vaccine: CHIK, YF
Symptoms: Blood test, Chills, Dyspnoea, Fatigue, Lymphadenopathy
Clinical narrative: 5/23: Fever, chills, body aches, fatigue, 5/24 - 5/30 (date reporting): swollen lymph nodes, severe body aches, fatigue, shortness of breath
Age: 31.0
Sex: F
Vaccine: CHIK, YF
Symptoms: Pain, Pyrexia
Clinical narrative: 5/23: Fever, chills, body aches, fatigue, 5/24 - 5/30 (date reporting): swollen lymph nodes, severe body aches, fatigue, shortness of breath
Age: 70.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Contusion, Muscle spasms
Clinical narrative: Right arm hand had a severe cramp at thumb  5 minutes after injection.  Bruised thumb pad of lower hand .
Age: 70.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Muscle spasms, Pain, Skin discolouration
Clinical narrative: Right arm hand had a severe cramp at thumb  5 minutes after injection.  Bruised thumb pad of lower hand .
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: She had no signs or symptoms.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccination was expired at time of administration.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccination was expired at time of administration.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient's mother came in requesting Varicella vaccine for her daughter in addition to the scheduled Tdap appointment. Pharmacist proceeded to look up on database whether patient is eligible to receive Varicella. Per database, patient was overdue for Varicella, so pharmacist continued to process and administer vaccine. After injection, patient's mother handed pharmacist the vaccination yellow card to fill out. Upon reviewing the yellow card, pharmacist sees that patient already completed their Varicella series.
Age: 21.0
Sex: F
Vaccine: IPV
Symptoms: Syncope
Clinical narrative: A few minutes after the patient was given the shot they fainted. Patient was with her mother and father who are aware of her history of fainting (has happened with blood draws in the past). Patient was monitored closely for about 20 min and recovered. Patient did not report any harm as a result of fainting
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Ongoing pain after the initial vaccination. That was Moderna. My next 3 vaccine boosters have been phizer.  My shoulder site of vaccine either aches or stings periodically still 5 years later.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1, DTPPVHBHPB, PNC20
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash macular, Rash maculo-papular
Clinical narrative: Diffuse erythematous maculopapular rash began about two hours after injection, on face, back, chest / abdomen, upper arms and legs, sparing palms/soles. Annular erythematous macules over bilateral injection sites. No vomiting, diarrhea, fussiness, facial/oral swelling, difficulty breathing, fever, lethargy.  5/30/2025 Update information: Attempted to contact parents and no answer to obtain updates on health status. A voice mail was left in parent's phone to contact clinic for any updates and also instructed to go to Emergency Room if any shortness of breath, swelling, fever.