chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMR
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: low titers/didn't have a response; This non-serious case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 48-year-old female patient who received MMR (Priorix) for prophylaxis.   Concomitant products included aciclovir sodium (Acyclovir).   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced therapy non-responder (Verbatim: low titers/didn't have a response). The outcome of the therapy non-responder was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-MAR-2025 Reporter stated that a patient who was currently on Acyclovir had gotten a dose of Priorix back in 2020 no exact date shared, and did not have a response, reporter mentioned that this patient had a titer test and showed low titers.
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: received a dose of Bexsero after a temperature excursion of 68 °F to 72 °F for 15 hours.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 24-year-old female patient who received Men B NVS (Bexsero) (batch number DD72H, expiry date 30-NOV-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: received a dose of Bexsero after a temperature excursion of 68 °F to 72 °F for 15 hours.). The outcome of the incorrect storage of drug was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-MAR-2025 The pharmacist reported that they administered Bexsero to a patient after a temperature excursion and Bexsero vaccine was exposed to 68 degree Fahrenit to 72 degree Fahrenit for 15 hours, which led to incorrect storage of drug.  The reporter asked do they have extended stability data for this vaccine.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number PZ75H, expiry date 28-FEB-2025) for prophylaxis.   On 04-MAR-2025, the patient received Menveo. On 04-MAR-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Administration of expired dose). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 12-MAR-2025 Licensed practical nurse mentioned that administered a dose of Menveo 1 vial to a patient on 04th March 2025 and the dose expired on 28th February 2025 which led to expired vaccine use. Wanted to know if they should repeat the dose?
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique/only administered the diluent; Inappropriate Reconstitution Technique/only administered the diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received MMR (Priorix) for prophylaxis.   On 11-MAR-2025, the patient received Priorix. On 11-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique/only administered the diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique/only administered the diluent). 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: 12-MAR-2025 The pharmacist reported that a patient who was only administered the diluent component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 12-MAR-2025 The reporter stated that she had a patient who received 2 doses of Shingrix and still got a severe case of shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Ocular discomfort, Swelling face
Clinical narrative: Swelling on her face; Red cheeks; Pressure on the left eye; This non-serious case was reported by a other health professional via call center representative and described the occurrence of facial swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced facial swelling (Verbatim: Swelling on her face), red face (Verbatim: Red cheeks) and sensation of pressure in eye (Verbatim: Pressure on the left eye). The patient was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the facial swelling, red face and sensation of pressure in eye were resolved (duration 12 hrs).   It was unknown if the reporter considered the facial swelling, red face and sensation of pressure in eye to be related to Shingrix.     It was unknown if the company considered the facial swelling, red face and sensation of pressure in eye to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-MAR-2025 The reporter reported that he/she had a patient, after her 1st shot, she got swelling on her face, red cheeks and pressure on her left eye, which only lasted 12 hours, and she took Benadryl.  Could she get the 2nd dose or not.
Vaccine: COVID19
Symptoms: Radiculitis brachial
Clinical narrative: Severe Brachial neuritis; This spontaneous report received from a patient concerned a patient of unspecified age and sex. Received via J and J managed social media. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose and frequency not reported, administered on 09-Oct-2021, additional dosage information included: dose number in series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up.  No concomitant medications were reported.  The patient left arm/ hand remained at 50 percent function since 5 days post Janssen covid vaccine.   On an unspecified date, the patient experienced severe brachial neuritis. (dose series 1). The action taken with janssen covid-19 vaccine was not applicable.  The outcome of severe brachial neuritis was not reported.  This report was serious (other medically important condition).; Sender's Comments: V0; brachial neuritis; The event has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Vaccine: COVID19
Symptoms: COVID-19, Coronary artery occlusion, Ophthalmoplegia, SARS-CoV-2 test
Clinical narrative: coronary artery occlusion; internuclear ophthalmoplegia; Covid-19 spike protein levels from 3385 arbitrary units per milliliter (AU/ml) at presentation to 2699 AU/ml; This spontaneous case was reported by a non-health professional and describes the occurrence of CORONARY ARTERY OCCLUSION (coronary artery occlusion) and OPHTHALMOPLEGIA (internuclear ophthalmoplegia) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 CORONARY ARTERY OCCLUSION (coronary artery occlusion) (seriousness criterion medically significant), OPHTHALMOPLEGIA (internuclear ophthalmoplegia) (seriousness criterion medically significant) and COVID-19 (Covid-19 spike protein levels from 3385 arbitrary units per milliliter (AU/ml) at presentation to 2699 AU/ml). The patient was treated with Ivermectin at a dose of more than 4 months. At the time of the report, CORONARY ARTERY OCCLUSION (coronary artery occlusion), OPHTHALMOPLEGIA (internuclear ophthalmoplegia) and COVID-19 (Covid-19 spike protein levels from 3385 arbitrary units per milliliter (AU/ml) at presentation to 2699 AU/ml) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: 3385 arbitrary unit per millilitre and 2699 arbitrary unit per millilitre.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medication was not reported. It was reported that, patient had coronary artery occlusion and internuclear ophthalmoplegia after administration of Moderna COVID-19 mRNA vaccine. Administration of Ivermectin for more than four months led to notable improvements in the patient's symptoms, with a documented reduction in COVID-19 spike protein levels from 3385 arbitrary units per milliliter (AU/ml) at presentation to 2699 AU/ml.   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2025: Live non-significant follow-up was received. Reference ID was added.; Reporter's Comments: Concurrent COVID-19 might be a confounder given that Coronary artery occlusion and Ophthalmoplegia are complications that have been observed in patients who experienced this infection. The benefit-risk relationship of the product is not affected by this report.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid started 2/20/25. Symptoms: headache, sore throat, muscle aches, ear ache and fatigue; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid started 2/20/25. Symptoms: headache, sore throat, muscle aches, ear ache and fatigue) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication.    Previously administered products included for Drug use for unknown indication: Penicillin, erythromycin and Sulfa. Past adverse reactions to the above products included Allergy with Penicillin, Sulfa and erythromycin. Concurrent medical conditions included GERD, Sleep apnea, Depression, Penicillin allergy, Drug allergy (Allergy to sulfa) and Allergy to antibiotic (Allergy to erythromycin).   On 08-Oct-2024, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and first dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 20-Feb-2025, the patient experienced COVID-19 (Covid started 2/20/25. Symptoms: headache, sore throat, muscle aches, ear ache and fatigue). At the time of the report, COVID-19 (Covid started 2/20/25. Symptoms: headache, sore throat, muscle aches, ear ache and fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2025, SARS-CoV-2 test: Positive. On 28-Feb-2025, SARS-CoV-2 test: Negative. On 10-Mar-2025, SARS-CoV-2 test: Positive.         Covid began on 20-Feb-2025, presenting symptoms such as headache, sore throat, muscle aches, ear pain, and fatigue. The initial symptoms were noted on 23-Feb-2025 and resolved by 26-Feb-2025. A test was conducted on 28-Feb-2025. A rebound case of Covid emerged on 9-Mar-2025, with a positive test result on 10-Mar-2025, accompanied by symptoms including fatigue, headache, muscle pain, and fever. No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: slightly indurated; warm to the touch; soreness she experienced was at the injection site; red mark on the injection site; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 57-year-old female patient (unknown if pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 08Mar2025 as dose 1, single (Lot number: LJ5281, Expiration Date: 30Mar2026) at the age of 57 years, in arm for immunisation. The patient's relevant medical history included: "allergy to sulfa" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 13Mar2025, outcome "unknown", described as "red mark on the injection site"; VACCINATION SITE PAIN (non-serious) with onset 13Mar2025, outcome "recovered" (13Mar2025), described as "soreness she experienced was at the injection site "; VACCINATION SITE INDURATION (non-serious), outcome "unknown", described as "slightly indurated"; VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "warm to the touch". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site induration, vaccination site warmth.  Additional information: She has no additional medical conditions to provide and states she is a pretty healthy person. The patient didn't receive any other vaccines on the same date as the Pfizer vaccine or within 4 weeks prior to the first administration of the suspect vaccine. Caller had a reaction after receiving the Prevnar 20 vaccine. The caller would like to inquire if Prevnar 20 contains sulfa because she is allergic to it and she had a reaction after receiving the vaccine. The patient read over every document prior to that and she did not see any mention of sulfa in the product and she had the pharmacist double check and he did not see anything and saw no interaction with the medications she takes. She got the injection and a for couple days she was sore and yesterday (13Mar2025) she noticed a quarter or a half dollar sized red mark on the injection site and kind of dismissed it and her initial thought was that she slept on something and this morning she got up and it is like if you cup your hand on your arm and is that size and it is red, slightly indurated and warm to the touch. Clarified the soreness she experienced was at the injection site and it began on 13Mar2025 and the soreness resolved after the 1st day like the norm after getting an injection. The red mark on her arm is now larger and it is the size of putting your hand over the arm and she does not know how to describe it. She is hoping the Benadryl is going to help and at the moment she took some Benadryl to see if that will calm it down. Right at the moment, she is trying Benadryl because this morning (14Mar2025) it got worse so she is trying Benadryl to see if that counteracts what is going on as she was not expecting any of this.
Age: 57.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Skin warm
Clinical narrative: slightly indurated; warm to the touch; soreness she experienced was at the injection site; red mark on the injection site; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 57-year-old female patient (unknown if pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 08Mar2025 as dose 1, single (Lot number: LJ5281, Expiration Date: 30Mar2026) at the age of 57 years, in arm for immunisation. The patient's relevant medical history included: "allergy to sulfa" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 13Mar2025, outcome "unknown", described as "red mark on the injection site"; VACCINATION SITE PAIN (non-serious) with onset 13Mar2025, outcome "recovered" (13Mar2025), described as "soreness she experienced was at the injection site "; VACCINATION SITE INDURATION (non-serious), outcome "unknown", described as "slightly indurated"; VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "warm to the touch". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site induration, vaccination site warmth.  Additional information: She has no additional medical conditions to provide and states she is a pretty healthy person. The patient didn't receive any other vaccines on the same date as the Pfizer vaccine or within 4 weeks prior to the first administration of the suspect vaccine. Caller had a reaction after receiving the Prevnar 20 vaccine. The caller would like to inquire if Prevnar 20 contains sulfa because she is allergic to it and she had a reaction after receiving the vaccine. The patient read over every document prior to that and she did not see any mention of sulfa in the product and she had the pharmacist double check and he did not see anything and saw no interaction with the medications she takes. She got the injection and a for couple days she was sore and yesterday (13Mar2025) she noticed a quarter or a half dollar sized red mark on the injection site and kind of dismissed it and her initial thought was that she slept on something and this morning she got up and it is like if you cup your hand on your arm and is that size and it is red, slightly indurated and warm to the touch. Clarified the soreness she experienced was at the injection site and it began on 13Mar2025 and the soreness resolved after the 1st day like the norm after getting an injection. The red mark on her arm is now larger and it is the size of putting your hand over the arm and she does not know how to describe it. She is hoping the Benadryl is going to help and at the moment she took some Benadryl to see if that will calm it down. Right at the moment, she is trying Benadryl because this morning (14Mar2025) it got worse so she is trying Benadryl to see if that counteracts what is going on as she was not expecting any of this.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  An adult 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 nos (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "Chest pain"; Bnt162b2 nos (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "Chest pain"; Bnt162b2 nos (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "Chest pain". The following information was reported: CHEST PAIN (non-serious), outcome "recovered". Therapeutic measures were not taken as a result of chest pain.  Additional information: Chest pain following vaccination. Patient reported stated he had received 4 doses of the Pfizer Covid vaccine. He said the only side effect was chest pain. He could not recall whether he experience it with every dose or just the most recent dose(s).  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-202500058266 same reporter/patient/event, different dose;US-PFIZER INC-202500058268 same reporter/patient/event, different dose;US-PFIZER INC-202500058267 same reporter/patient/event, different dose;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: He said that he had Covid about a week ago despite having to have Pfizer vaccine every time it goes out. He was also able to share that it also happened last two years ago.; He said that he had Covid about a week ago despite having to have Pfizer vaccine every time it goes out. He was also able to share that it also happened last two years ago.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "He said that he had Covid about a week ago despite having to have Pfizer vaccine every time it goes out. He was also able to share that it also happened last two years ago.". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The reporter mentioned that he wrote a letter to CEO of Pfizer because of the cost of Paxlovid. He said that he had Covid about a week ago despite having to have Pfizer vaccine every time it goes out. He was also able to share that it also happened last two years ago. He said that he was shocked to know that the cost of Paxlovid is (Withheld).   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-PV202500031625 same patient, drug, event; different dose;
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure, Weight
Clinical narrative: The patient was diagnosed with covid; The patient was diagnosed with covid; This is a spontaneous report received from a Consumer or other non HCP.  An 81-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Aug2024 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "COPD", start date: 2020 (unspecified if ongoing); "hospitalized" (unspecified if ongoing); "bronchitis" (unspecified if ongoing); "ear infection" (unspecified if ongoing). Concomitant medication(s) included: TOBRAMYCIN. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE; up to date.), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Mar2025, outcome "unknown" and all described as "The patient was diagnosed with covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Feb2025) Positive; (10Mar2025) Positive, notes: Unit: Not Provided; Weight: (unspecified date) 185 lbs. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course:  The reporter, who is the patient's wife, mentioned that the patient is on his third day of Paxlovid. The doctor prescribed Ciprofloxacin 500mg for an ear infection that the patient had before contracting COVID-19 and starting Paxlovid. The patient had previously been treated with an antibiotic for the ear infection, then contracted COVID-19, and now needs Ciprofloxacin again. The reporter confirmed that the patient has not yet started Ciprofloxacin and wanted to ensure there were no interactions with Paxlovid, especially since the patient is 81 years old and she wanted to avoid any medical emergencies. The patient is currently out picking up his prescription, and the reporter advised him to ask the pharmacist. Both the reporter and her husband have received all the Pfizer COVID-19 vaccines and recently visited urgent care. The patient tested positive for COVID-19 on 10Mar2025, using a test kit that was four months past its expiration date, but the urgent care confirmed the test was still valid. The reporter tested negative for COVID-19. The patient was diagnosed with an ear infection about three weeks ago and seems to have it again. He takes Paxlovid twice daily, at 7:00 AM and 7:00 PM. The patient has COPD, diagnosed about five years ago when he was hospitalized for bronchitis. The reporter confirmed that the patient's COPD, hospitalization, and bronchitis occurred before the Pfizer COVID-19 vaccines were available. The doctor wants to see the patient in two weeks.  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: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  An adult male patient received BNT162b2 (BNT162B2 NOS), 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: CHEST PAIN (non-serious), outcome "recovered". Therapeutic measures were not taken as a result of chest pain.  Additional information: Chest pain following vaccination. Patient reported stated he had received 4 doses of the Pfizer Covid vaccine. He said the only side effect was chest pain. He could not recall whether he experience it with every dose or just the most recent dose(s).  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-202500057704 same reporter/patient/event, different dose;US-PFIZER INC-202500058267 same reporter/patient/event, different dose;US-PFIZER INC-202500058268 same reporter/patient/event, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  An adult male patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "recovered". Therapeutic measures were not taken as a result of chest pain.  Additional information: Chest pain following vaccination. Patient reported stated he had received 4 doses of the Pfizer Covid vaccine. He said the only side effect was chest pain. He could not recall whether he experience it with every dose or just the most recent dose(s).  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-202500057704 same reporter/patient/event, different dose;US-PFIZER INC-202500058266 same reporter/patient/event, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  An adult male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), 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): "Chest pain"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "Chest pain". The following information was reported: CHEST PAIN (non-serious), outcome "recovered". Therapeutic measures were not taken as a result of chest pain.  Additional information: Chest pain following vaccination. Patient reported stated he had received 4 doses of the Pfizer Covid vaccine. He said the only side effect was chest pain. He could not recall whether he experience it with every dose or just the most recent dose(s).     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-202500057704 same reporter/patient/event, different dose;US-PFIZER INC-202500058266 same reporter/patient/event, different dose;
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Illness
Clinical narrative: gets sick for two days after every COVID and Flu vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "gets sick for two days after every COVID and Flu vaccine".  Additional information: The patient informed she only gets Pfizer COVID vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, FLUX, RSV
Symptoms: Malaise, Pain in extremity
Clinical narrative: pain in arm; was sick; This is a spontaneous report received from a Consumer or other non HCP, Program ID: 205309.  A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE), in Sep2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (DOSE NUMBER UNKNOWN, patient got sick for two days after every COVID-19 vaccine), for COVID-19 immunization, reaction(s): "sick"; Flu vaccine (DOSE NUMBER UNKNOWN, patient got sick for two days after every Flu vaccine), for Immunization, reaction(s): "sick". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2024, outcome "recovered" (2024), described as "pain in arm"; MALAISE (non-serious) with onset 2024, outcome "recovered" (2024), described as "was sick".  Additional information: she experienced pain in arm and was sick for two days after getting COVID-19, RSV, and Flu vaccines all at once.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had Covid about a week ago despite having to have Pfizer vaccine every time it goes out.; had Covid about a week ago despite having to have Pfizer vaccine every time it goes out.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  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 NUMBER UNKNOWN, SINGLE; had COVID two years ago), for Covid-19 immunization, reaction(s): "Covid". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2025, outcome "unknown" and all described as "had Covid about a week ago despite having to have Pfizer vaccine every time it goes out.".  Clinical course: The reporter mentioned that he wrote a letter to CEO of Pfizer because of the cost of Paxlovid. He said that he had Covid about a week ago despite having to have Pfizer vaccine every time it goes out. He was also able to share that it also happened last two years ago. He said that he was shocked to know that the cost of Paxlovid is (Withheld).   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-202500057931 same patient, product, event; different dose;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19/tested positive; COVID-19/tested positive; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 40-year-old male 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 included: "COVID-19", start date: 2022 (unspecified if ongoing), notes: test COVID two years back after vaccination. The patient's concomitant medications were not reported. Past drug history included: Paxlovid, start date: 2022, for COVID-19 treatment. 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) all with onset 03Jul2024, outcome "unknown" and all described as "COVID-19/tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: two years back; after vaccination; (03Jul2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient and his wife took Pfizer vaccines. Saturday (29Jun2024), patient's wife got diagnosed with COVID. On 03Jul2024, patient was told to have tested positive and had been prescribed Paxlovid for COVID-19. Patient tested COVID two years back after vaccination and Paxlovid was never expensive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500032273 same reporter/product/event, different patient;US-PFIZER INC-202500059466 same reporter/patient/product/event, different dose;
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: positive Covid test; positive Covid test; 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: Covid-19 vaccine (Dose number unknown, single; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive Covid test". The event "positive covid test" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was vaccinated and boosted and "everything else". Patient had a positive Covid test and the doctor prescribed Paxlovid.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP and a Nurse, Program ID.  A 75-year-old male 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 included: "Diabetic" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "Cancer" (unspecified if ongoing); "Pain" (unspecified if ongoing); "operation" (unspecified if ongoing); "operation" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN (ongoing); GABAPENTIN (ongoing). The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (Dose number unknown, single; unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Apr2024, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Apr2024) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (prescribed Paxlovid). Clinical course: The patient was in rehab. Patient was diabetic and everything went downhill; patient got cancer, and everything was being covered (insurance). Patient was fine as far as he knows. Patient has gone through cancer and everything else, the last few years everything was being taken care of (insurance). Patient tested positive for Covid just yesterday (03Apr2024). Patient had all his shots, had all the boosters, and felt fine. He might ask them to give him another test because sometimes these tests provide false positive. It seemed that everybody was sick in the whole place where the patient was staying (rehab center). The patient stated there was nothing wrong with him and he felt quite fine. They got him locked up for 5 days in his room. Patient was not on anything special and just took his regular meds every day: Metformin for diabetes, pain killer, some vitamins, Gabapentin, meds for cholesterol, and meds for blood pressure - been taking those for years. Patient have gone through chemo and everything else and had two operations.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Investigation, Thrombosis with thrombocytopenia syndrome
Clinical narrative: ITP; VIITP; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Jan2023 as dose 4 (booster), single (Lot number: G36665) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Unknown manufacturer), for Covid-19 Immunization. The following information was reported: IMMUNE THROMBOCYTOPENIA (hospitalization, medically significant), outcome "unknown", described as "ITP"; THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (medically significant), outcome "unknown", described as "VIITP". Clinical course was reported as follows: On 03Jan2023, I received my 4th dose of Pfizer COVID vaccine (2nd booster) Lot # G36665. A few days later, I was admitted to the hospital,  and was diagnosed with ITP. Tested for numerous malfunctions of my system, given several platelet transfusions and after 3 days in the hospital, I was released back to my home. I was ultimately diagnosed with VIITP.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itch from head to toe; This is a spontaneous report received from a Consumer or other non HCP from License Party.  An elderly male 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: PRURITUS (non-serious), outcome "unknown", described as "itch from head to toe".  Additional information: The patient had a COVID shot and it triggered something that made him itch from head to toe.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 0.5
Vaccine: FLU3
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2nd dose given before 4 week mark with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old and unknown gender patient who received 2nd dose of influenza quadrival A-B multidose vaccine preserved [Fluzone] before 4 week mark with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Jan-2025, the patient received an unknown dose 1 of influenza quadrival A-B multidose vaccine preserved Suspension for injection (strength, expiry date and lot number not reported) via intramuscular route in unknown administration site for influenza protection (Influenza immunisation).  On 31-Jan-2025 patient also received an unknown dose 2 of same vaccine with an unknown batch number via intramuscular route in unknown administration site for Influenza immunization before 4-week mark with no reported adverse event (inappropriate schedule of product administration) (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.
Vaccine: TDAP
Symptoms: Injection site swelling, Pain
Clinical narrative: R deltoid swelling + persistent pain w ROM after 6 wks (given 1/27/25)
Age: 44.0
Sex: F
Vaccine: PNC20
Symptoms: Product substitution error
Clinical narrative: PCV-20 from VFC given to Adult Patient.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive Covid by about 48 hours ago maybe a little less/which I have taken in the past; I tested positive Covid by about 48 hours ago maybe a little less/which I have taken in the past; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 45-year-old 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2025, outcome "unknown" and all described as "I tested positive Covid by about 48 hours ago maybe a little less/which I have taken in the past". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2025) positive.  Clinical course: During an inbound call for financial assistance, the patient said that he/she tested positive Covid by about 48 hours ago maybe a little less. Later in the call, the patient said that  it seemed crazy to him/her that they will personally give these shots away that are supposed to muscle the symptoms of covid if you get it, which he/she had taken in the past but then there's something that actually really works and they make it unobtainable for most people to even purchase. When explaining to the patient how the voucher information will be provided, then the patient realized that he/she had to do all of this while having covid and he/she can even hardly think straight right now.
Sex: F
Vaccine: COVID19
Symptoms: Eye injury
Clinical narrative: eye injury; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Jan2022 at 18:00 as dose number unknown (booster), single (Lot number: Fk9896), in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunisation. The following information was reported: EYE INJURY (disability) with onset 01Feb2022, outcome "not recovered". It was unknown if therapeutic measures were taken as a result of eye injury.  Additional information: eye injury, ever since receiving the Covid-19 Booster vaccine. This had tremendously affected patient's ability to operate her daily activities. Just need appropriate and specialized treatments which were covered by public insurance. The patient did not receive any other vaccines on the same date as the vaccine(s) for which you are reporting. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. The patient was not taking any other medications within 2 weeks of the event starting.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: 2X2 RED RASH AROUND INJECTION SITE, NOT RAISED, ITCHY OR PAINFUL, PATIENT NOTICED 2 DAYS AFTER VACCINE WHILE DRESSING
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Vomiting projectile
Clinical narrative: Pt projected vomited twice after receiving vaccine; first time approx 7 mins after vaccine and second time five mins later
Age: 59.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Limb mass, Pain in extremity
Clinical narrative: Patient stated they still had soreness in left arm and a bump from the vaccines 6 months later.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Injection site pruritus, Pain in extremity, Pruritus
Clinical narrative: Days 2 thru 4, I experienced lots of pain in my left arm, but then by Day 5. I experienced itching over my entire body and especially over the injection site.  By the next morning, things had died down.  The pain was gone and I thought I was okay.  I went to exercise and after 10 minutes of doing my Healthrider, I experienced intense itching again and had mild difficulty breathing which lasted most of the day and I contacted my family doctor.  Then, the symptoms died down again, and a week later, the itching came back again, and I am also left with mild pain in my arm that feels like I sprained it.   I again contacted my doctor and was advised that it was a reaction to the injection and that if it flared up again to come in or go to the nearest Urgent Care and I was given info about the shot.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Laboratory test, Personality change, Social avoidant behaviour
Clinical narrative: Patient's personality has changed.  She has become withdrawn and anxious.  She struggles in social situations.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Social problem
Clinical narrative: Patient's personality has changed.  She has become withdrawn and anxious.  She struggles in social situations.