chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Wound
Clinical narrative: Approximately 6 months after taking her last HPV vaccine dose, my daughter began seeing blood in her stools accompanied by bouts of exhaustion. She was diagnosed with Ulcerative Colitis and her health has deteriorated since then. Even after trying numerous medications, GI doctors have not been able to bring her into remission since March 2020. She had an ileostomy in Aug of 2020 which ended up worsening her colitis and causing worsening symptoms. She also got perianal disease at this time, which was treated with multiple procedures and a skin flap surgery July 2021, but none of them worked. The surgery left her with wounds around and inside her anus that still have not healed to this day. The anal pain is so intense during the 8-12 stools she has per day that she requires narcotics to get her through them. The past few years have been consumed with pain, sickness, extended hospital stays, and emotional trauma caused by the relentless and unresolved nature of her illness. She missed her entire senior year of high school last year, attempted to return this fall only to repeatedly become sick causing her to take another medical leave. We are not anti-vaxxers. As there is no family history of IBD, we are still baffled by what could have triggered this reaction a once healthy girl. Because the HPV vaccine was the only thing new in her life, we want to be able to warn others in the event it may have had anything to do with this tragic outcome. my daughter has had numerous testing since her diagnosis in 2019. I cannot list them all here but can provide release of her medical records if it would help.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product label issue
Clinical narrative: Monovalent pfizer 12+ labelled as bivalent and given when patient was to receive bivalent, not monovalent
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent pfizer 5-11 vaccine reconstituted and labelled as bivalent. Given to patient when they should have received bivalent not monovalent.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV
Symptoms: Urticaria
Clinical narrative: Hives generalized starting 11/17/22 am.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Gait inability, Hypergammaglobulinaemia benign monoclonal, Muscle twitching, Myalgia
Clinical narrative: Six days following the Janssen covid vaccine, all of my joints started popping and burning. All my muscles became tight and painful to the point that I could not walk or rise from sitting. I have been diagnosed with POTS, postural orthostatic tachycardia syndrome.  My neck became painful with cervical instability and nerve pain.  I have suffered POTS symptoms of high heart rate/ low blood pressure, balance issues, skin problems, GI tract pain, pelvic pain, lower back pain, tinnitus as well as calf/ankle/foot/wrist pain. My vision was at times is blurry with spots and double vision. I am not able to take care of myself, and walk with a walker.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheelchair user
Clinical narrative: Six days following the Janssen covid vaccine, all of my joints started popping and burning. All my muscles became tight and painful to the point that I could not walk or rise from sitting. I have been diagnosed with POTS, postural orthostatic tachycardia syndrome.  My neck became painful with cervical instability and nerve pain.  I have suffered POTS symptoms of high heart rate/ low blood pressure, balance issues, skin problems, GI tract pain, pelvic pain, lower back pain, tinnitus as well as calf/ankle/foot/wrist pain. My vision was at times is blurry with spots and double vision. I am not able to take care of myself, and walk with a walker.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Balance disorder, Blood immunoglobulin A increased, Diplopia
Clinical narrative: Six days following the Janssen covid vaccine, all of my joints started popping and burning. All my muscles became tight and painful to the point that I could not walk or rise from sitting. I have been diagnosed with POTS, postural orthostatic tachycardia syndrome.  My neck became painful with cervical instability and nerve pain.  I have suffered POTS symptoms of high heart rate/ low blood pressure, balance issues, skin problems, GI tract pain, pelvic pain, lower back pain, tinnitus as well as calf/ankle/foot/wrist pain. My vision was at times is blurry with spots and double vision. I am not able to take care of myself, and walk with a walker.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Gait inability, Gastrointestinal pain, Heart rate increased, Hypergammaglobulinaemia benign monoclonal
Clinical narrative: Six days following the Janssen covid vaccine, all of my joints started popping and burning. All my muscles became tight and painful to the point that I could not walk or rise from sitting. I have been diagnosed with POTS, postural orthostatic tachycardia syndrome.  My neck became painful with cervical instability and nerve pain.  I have suffered POTS symptoms of high heart rate/ low blood pressure, balance issues, skin problems, GI tract pain, pelvic pain, lower back pain, tinnitus as well as calf/ankle/foot/wrist pain. My vision was at times is blurry with spots and double vision. I am not able to take care of myself, and walk with a walker.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Joint noise, Laboratory test, Loss of personal independence in daily activities, Magnetic resonance imaging head
Clinical narrative: Six days following the Janssen covid vaccine, all of my joints started popping and burning. All my muscles became tight and painful to the point that I could not walk or rise from sitting. I have been diagnosed with POTS, postural orthostatic tachycardia syndrome.  My neck became painful with cervical instability and nerve pain.  I have suffered POTS symptoms of high heart rate/ low blood pressure, balance issues, skin problems, GI tract pain, pelvic pain, lower back pain, tinnitus as well as calf/ankle/foot/wrist pain. My vision was at times is blurry with spots and double vision. I am not able to take care of myself, and walk with a walker.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal, Monoclonal immunoglobulin present, Muscle tightness, Myalgia, Neck pain
Clinical narrative: Six days following the Janssen covid vaccine, all of my joints started popping and burning. All my muscles became tight and painful to the point that I could not walk or rise from sitting. I have been diagnosed with POTS, postural orthostatic tachycardia syndrome.  My neck became painful with cervical instability and nerve pain.  I have suffered POTS symptoms of high heart rate/ low blood pressure, balance issues, skin problems, GI tract pain, pelvic pain, lower back pain, tinnitus as well as calf/ankle/foot/wrist pain. My vision was at times is blurry with spots and double vision. I am not able to take care of myself, and walk with a walker.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuralgia, Pain in extremity, Pelvic pain, Skin disorder, Spinal instability
Clinical narrative: Six days following the Janssen covid vaccine, all of my joints started popping and burning. All my muscles became tight and painful to the point that I could not walk or rise from sitting. I have been diagnosed with POTS, postural orthostatic tachycardia syndrome.  My neck became painful with cervical instability and nerve pain.  I have suffered POTS symptoms of high heart rate/ low blood pressure, balance issues, skin problems, GI tract pain, pelvic pain, lower back pain, tinnitus as well as calf/ankle/foot/wrist pain. My vision was at times is blurry with spots and double vision. I am not able to take care of myself, and walk with a walker.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Vision blurred, Walking aid user
Clinical narrative: Six days following the Janssen covid vaccine, all of my joints started popping and burning. All my muscles became tight and painful to the point that I could not walk or rise from sitting. I have been diagnosed with POTS, postural orthostatic tachycardia syndrome.  My neck became painful with cervical instability and nerve pain.  I have suffered POTS symptoms of high heart rate/ low blood pressure, balance issues, skin problems, GI tract pain, pelvic pain, lower back pain, tinnitus as well as calf/ankle/foot/wrist pain. My vision was at times is blurry with spots and double vision. I am not able to take care of myself, and walk with a walker.
Age: 64.0
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Eye pain, Headache
Clinical narrative: Eye pain; Headache; This spontaneous case was retrieved on 04-Nov-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number 2484497-1), reported by other healthcare professional, and concerned a 64-year-old, female patient.  The patient's concurrent conditions included diabetes, hypothyroidism, obesity, asthma, and allergy to codeine (reported as 'codiene'). The patient's concomitant medications were not reported.  It was reported that on 03-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 'one', route of administration: intramuscular; anatomical location: left arm; indication: not reported). The batch number reported was P100468911. The reported batch number was identified by Seqirus to be linked to suspect product Afluria Quadrivalent (Influenza vaccine inact split 4v) instead of reported suspect product Fluad Quadrivalent. Based on the reported batch number, the suspect product was changed to Afluria Quadrivalent.  On 04-Oct-2022, one day after receiving Afluria Quadrivalent, the patient experienced headache and eye pain. The patient visited emergency room and physician office.  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 64-year-old female patient experienced headache and eye pain one day after receiving the suspect Afluria Quadrivalent vaccine. Reportedly, the patient visited emergency room and physician office. The patient's relevant concurrent conditions included diabetes and hypothyroidism. The patient's concomitant medications were not reported. Information regarding the related diagnostic findings was not provided. Causality is assessed as possibly related to the suspect vaccine based on plausible time relationship.; Sender's Comments: A 64-year-old female patient experienced headache and eye pain one day after receiving the suspect Afluria Quadrivalent vaccine. Reportedly, the patient visited emergency room and physician office. The patient's relevant concurrent conditions included diabetes and hypothyroidism. The patient's concomitant medications were not reported. Information regarding the related diagnostic findings was not provided. Causality is assessed as possibly related to the suspect vaccine based on plausible time relationship.
Age: 18.0
Sex: M
Vaccine: UNK, MENB
Symptoms: Computerised tomogram head normal, Full blood count normal, Generalised tonic-clonic seizure, Metabolic function test normal
Clinical narrative: grand mal seizure 6 hours after vaccination of the meningococcal B vaccine
Age: 18.0
Sex: M
Vaccine: UNK, MENB
Symptoms: Computerised tomogram head normal, Generalised tonic-clonic seizure
Clinical narrative: grand mal seizure 6 hours after vaccination of the meningococcal B vaccine
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Balance disorder, Body temperature, Cerebrovascular accident, Dizziness, Ear discomfort
Clinical narrative: Covid test result: Positive; Covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FJ5683), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Nov2022, outcome "unknown" and all described as "Covid test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Nov2022) Positive, notes: Nasal Swab.  Course of events: No covid prior vaccination. No known allergies. No other vaccine in fourweeks. Patient got the Pfizer bivalent shot on noon 08Nov2022 at Pharmacy or Drug Store. She developed fever and headache the next day in the 38.5 C and pain and pressure in her ears like ear fullness felt like her ears inside will explode from pressure inside both ears. The second day the fever went away never came back, but she was dizzy and it got worse the third day Friday 11Nov2022 in the morning she had a severe dizzy spell and was resting all day but at 10 pm Friday 11Nov2022 she had severe vertigo lost ability to walk or stay on her feet so she was so scared she was having a stroke could not get up from lying position. She could not turn her head or move if she did it was scary like she was being moved violently like thrown away left or right totally lost coordination balance ability to walk and her ears and head were full under pressure even on 15Nov2022 day 7 she felt pressure. Saturday 7 am 11Nov2022 she called emergency to take her to the hospital manage on the floor to drag herself to open the door and they took me to Emergency.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, the pandemic and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ear pain, Gait disturbance, Head discomfort, Headache, Inappropriate schedule of product administration
Clinical narrative: Covid test result: Positive; Covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FJ5683), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Nov2022, outcome "unknown" and all described as "Covid test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Nov2022) Positive, notes: Nasal Swab.  Course of events: No covid prior vaccination. No known allergies. No other vaccine in fourweeks. Patient got the Pfizer bivalent shot on noon 08Nov2022 at Pharmacy or Drug Store. She developed fever and headache the next day in the 38.5 C and pain and pressure in her ears like ear fullness felt like her ears inside will explode from pressure inside both ears. The second day the fever went away never came back, but she was dizzy and it got worse the third day Friday 11Nov2022 in the morning she had a severe dizzy spell and was resting all day but at 10 pm Friday 11Nov2022 she had severe vertigo lost ability to walk or stay on her feet so she was so scared she was having a stroke could not get up from lying position. She could not turn her head or move if she did it was scary like she was being moved violently like thrown away left or right totally lost coordination balance ability to walk and her ears and head were full under pressure even on 15Nov2022 day 7 she felt pressure. Saturday 7 am 11Nov2022 she called emergency to take her to the hospital manage on the floor to drag herself to open the door and they took me to Emergency.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, the pandemic and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vertigo
Clinical narrative: Covid test result: Positive; Covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FJ5683), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Nov2022, outcome "unknown" and all described as "Covid test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Nov2022) Positive, notes: Nasal Swab.  Course of events: No covid prior vaccination. No known allergies. No other vaccine in fourweeks. Patient got the Pfizer bivalent shot on noon 08Nov2022 at Pharmacy or Drug Store. She developed fever and headache the next day in the 38.5 C and pain and pressure in her ears like ear fullness felt like her ears inside will explode from pressure inside both ears. The second day the fever went away never came back, but she was dizzy and it got worse the third day Friday 11Nov2022 in the morning she had a severe dizzy spell and was resting all day but at 10 pm Friday 11Nov2022 she had severe vertigo lost ability to walk or stay on her feet so she was so scared she was having a stroke could not get up from lying position. She could not turn her head or move if she did it was scary like she was being moved violently like thrown away left or right totally lost coordination balance ability to walk and her ears and head were full under pressure even on 15Nov2022 day 7 she felt pressure. Saturday 7 am 11Nov2022 she called emergency to take her to the hospital manage on the floor to drag herself to open the door and they took me to Emergency.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, the pandemic and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid test result: Positive; Covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FJ5683), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Nov2022, outcome "unknown" and all described as "Covid test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Nov2022) Positive, notes: Nasal Swab.  Course of events: No covid prior vaccination. No known allergies. No other vaccine in fourweeks. Patient got the Pfizer bivalent shot on noon 08Nov2022 at Pharmacy or Drug Store. She developed fever and headache the next day in the 38.5 C and pain and pressure in her ears like ear fullness felt like her ears inside will explode from pressure inside both ears. The second day the fever went away never came back, but she was dizzy and it got worse the third day Friday 11Nov2022 in the morning she had a severe dizzy spell and was resting all day but at 10 pm Friday 11Nov2022 she had severe vertigo lost ability to walk or stay on her feet so she was so scared she was having a stroke could not get up from lying position. She could not turn her head or move if she did it was scary like she was being moved violently like thrown away left or right totally lost coordination balance ability to walk and her ears and head were full under pressure even on 15Nov2022 day 7 she felt pressure. Saturday 7 am 11Nov2022 she called emergency to take her to the hospital manage on the floor to drag herself to open the door and they took me to Emergency.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, the pandemic and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Hypoaesthesia
Clinical narrative: we got the virus this year; we got the virus this year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 85-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), on 19Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 24Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 84 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high. Concomitant medication(s) included: AMLODIPINE taken for hypertension; TELMISARTAN; CARVEDILOL. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "we got the virus this year". The patient underwent the following laboratory tests and procedures: Antibody test: (2022) unknown result; SARS-CoV-2 test: (2022) Unknown Result. It was reported that now they got over that. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201304866 same product/event, different patients;
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: we got the virus this year; we got the virus this year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 85-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), on 19Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 24Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 84 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high. Concomitant medication(s) included: AMLODIPINE taken for hypertension; TELMISARTAN; CARVEDILOL. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "we got the virus this year". The patient underwent the following laboratory tests and procedures: Antibody test: (2022) unknown result; SARS-CoV-2 test: (2022) Unknown Result. It was reported that now they got over that. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201304866 same product/event, different patients;
Age: 48.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pharmacist called and reported that a 48 year old female received the first dose of GARDASIL-9 a few months ago. No additional AE reported. No PQC reported. No additional information provided.; Pharmacist called and reported that a 48 year old female received the first dose of GARDASIL-9 a few months ago. No additional AE reported. No PQC reported. No additional information provided.; This spontaneous report was received from a pharmacist and referred to a 48-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date reported as "a few months ago",  the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, dose number, frequency, route, anatomical location, lot number, and expiration date were not reported), for prophylaxis (product administered to patient of inappropriate age); no adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: have had 3 shots; shingles; vaccination failure; This spontaneous report was received from a patient of unknown age and gender reporting on himself via Glaxosmithkline.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates, the patient received 3 doses of zoster vaccine live (ZOSTAVAX) subcutaneous injection, administered as prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) (reported as shingles vaccine). The first dose was years ago, when it became available and very expensive. In unknown dates in the last 3 years, the patient received the 2 series vaccine (Extra dose administered).   On an unknown date in March 2022 (reported as "this spring") , the patient developed shingles (Herpes zoster) (vaccination failure). The outcome of the events of herpes zoster and vaccination failure was not reported.    The causal relationship between herpes zoster and zoster vaccine live (ZOSTAVAX) was not reported. The event of vaccination failure was determined to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; adult patient received 2 pediatric doses of RECOMBIVAX HB instead of 1 adult dose of RECOMBIVAX HB.; This spontaneous report has been received from a Registered nurse referring to an adult patient of unspecified age and gender. Information of concurrent condition, medical history, concomitant medication and drug reactions/allergies was not reported.  On an unknown date in 2015, due to a shortage of the adult formulation of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (Captured in MARRS 2211USA005182), The patient was vaccinated with 2 doses of the pediatric formulation of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (dose, frequency, Route and location of administration were unknown) which had a valid lot # L016427 with expiration date on 13-APR-2017 for prophylaxis (Product administered to patient of inappropriate age). No additional AE details were provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2211USA005182:MSD
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: got the virus/ having the virus itself after getting the Pfizer shots and the booster; got the virus/ having the virus itself after getting the Pfizer shots and the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), on 19Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 24Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 79 years 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), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "got the virus/ having the virus itself after getting the Pfizer shots and the booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (2022) unknown results, notes: the lab work was for the doctor looking at the antibodies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201304927 same patient/suspect drug, different dose number/event;US-PFIZER INC-202201304867 same product/event, different patients;
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 17:00 as dose 4 (booster), single (Lot number: G56665) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing), notes: Other medical history: CLL; "Parkinson's disease" (unspecified if ongoing), notes: Other medical history: Parkinson's disease. Concomitant medication(s) included: ATORVASTATIN, start date: 01Nov2018, stop date: 01Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Nov2022) Negative, notes: Antigen test negative 07Nov and 09Nov2022; (09Nov2022) Negative, notes: Antigen test negative 07Nov and 09Nov2022. Therapeutic measures were taken as a result of covid-19.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Inappropriate schedule of product administration, SARS-CoV-2 test, Weight
Clinical narrative: I have always had normal Blood Pressure 124/78 I now have continual readings of 168/104; Pfizer Dose Number: 1 30Mar2021/ Pfizer Dose Number:2 14Apr2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot number: unknown, Vaccine location: Left arm, Vaccine administration time: 12:00 pm), administration date: 30Mar2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Apr2021 at 12:00, outcome "unknown", described as "Pfizer Dose Number: 1 30Mar2021/ Pfizer Dose Number:2 14Apr2021"; BLOOD PRESSURE INCREASED (disability, medically significant) with onset 10Oct2022 at 12:00, outcome "not recovered", described as "I have always had normal Blood Pressure 124/78 I now have continual readings of 168/104". The event "i have always had normal blood pressure 124/78 i now have continual readings of 168/104" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 168/104, notes: I now have continual readings of 168/104; (unspecified date) 124/78, notes: I have always had normal Blood Pressure 124/78; SARS-CoV-2 test: (20Jan2022) Positive, notes: Nasal Swab; Weight: (unspecified date) Normal, notes: I am normal weight and activity. Therapeutic measures were taken as a result of blood pressure increased.  Clinical course: The patient did not have any other medical history or known allergy. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient did not have COVID-19 prior vaccination. The patient was tested for COVID-19 post vaccination which included nasal swab. The patient has always had normal Blood Pressure 124/78. She now had continual readings of 168/104. She was normal weight and activity. This had to be what caused her new issue and need of medication. Now had to take blood pressure meds. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The case was reported as serious (Disabling/Incapacitating).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: uncomfortable and debilitating symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "uncomfortable and debilitating symptoms".  Additional information: The patient reported that, had a 4 month reaction to the Pfizer vaccine which the patient only took once at 3 of the patient's doctors suggested not to do again. Was there any hope for the patient to have a vaccine that did not cause months of uncomfortable and debilitating symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: high blood pressure; This is a spontaneous report received from contactable reporter(s) (Physician).  A female patient in her 80's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, ), for COVID-19 Immunization. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure". The event "high blood pressure" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient had no known history of high blood pressure. The patient's doctor would Iike to be followed up with by medical. The event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Pain in extremity, Peripheral swelling, Sunburn, Vaccination site pain
Clinical narrative: made my period 3 weeks late; sunburn; injection site pain; swelling in arm; Pain when lifting arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient received BNT162b2 (BNT162B2), on 29Aug2021 as dose 1, single (Lot number: FC3184) at the age of 27 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS", start date: 2017 (ongoing); "Migraines", start date: 2020 (ongoing); "GERD", start date: 2018 (ongoing); "absence of periods", start date: Aug2021 (ongoing); "Flu", start date: 2014 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MENSTRUATION DELAYED (non-serious), outcome "not recovered", described as "made my period 3 weeks late"; SUNBURN (non-serious), outcome "not recovered"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "injection site pain"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "swelling in arm"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Pain when lifting arm". Therapeutic measures were taken as a result of menstruation delayed, sunburn, vaccination site pain, peripheral swelling, pain in extremity.  Additional information:  Prior to vaccination, the patient did not received any other vaccination within the four weeks of vaccination. Therapeutic measures were taken as a result of adverse event MENSTRUATION DELAYED and included treatment with Provera pills (Start Date: Jan2022; Stop Date: Jan2022), to reduce menstrual cycle. The patient did not undergo anu relevant lab relevant test for Thromboembolic Events with Thrombocytopenia. The adverse events required the initiation of new medication, other treatment or procedure that included medication to induce menstrual cycle. The patient had sunburn only at injection site pain and swelling in arm. Pain when lifting arm. Made my period 3 weeks late. Periods were normal until 1st shot. The patient had flu 5 times since 2014 and the side effects from the vaccine were worse than any flu the patient have had. for reference the patient had normal periods. Had a period 28Jul2021-31Jul2021. 1st shot on 29Aug2021. Period 3 weeks late came on 13Sep2021-17Sep2021. 2nd shot on 20Sep2021. no period since had a period on 20Feb2022-26Feb2022 with the help of medication. After that period the patient haven't had a period as of 31Jul2022. So have not had a period without medication, naturally since 28Jul2021.; Sender's Comments: Linked Report(s) : PV202200027324 same reporter/patient, different dose/AE.;
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: broke out with severe psoriasis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: PSORIASIS (non-serious), outcome "unknown", described as "broke out with severe psoriasis".  Additional information: The patient broke out with severe psoriasis a few weeks after the 2nd vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Electric shock sensation, Pain
Clinical narrative: Experienced an "electrical fire or electric jolt" in the left shoulder to upper left quadrant of his chest; Feeling lasted about 6 hours, which was how long the achiness feeling lasted.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: ELECTRIC SHOCK SENSATION (non-serious), outcome "recovered", described as "Experienced an "electrical fire or electric jolt" in the left shoulder to upper left quadrant of his chest"; PAIN (non-serious), outcome "recovered", described as "Feeling lasted about 6 hours, which was how long the achiness feeling lasted.".  Additional information: This feeling lasted about 6 hours. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201307960 same reporter/AE/SD, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac disorder
Clinical narrative: They thought it was the heart at first, but they think it's a thinning vessel. It can create all kinds of stuff and cause issues and problems; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "They thought it was the heart at first, but they think it's a thinning vessel. It can create all kinds of stuff and cause issues and problems". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller wanted to discuss what she found out she has that she never had before the Covid vaccine. She declined to provide any further information. Caller clarified that she was a very healthy person. Yearly check-ups and blood work. Now, since she had the first and second vaccine and first booster, she has concerns that have gotten worse after she got the first vaccine. The doctor sent her, to all kinds of places to be checked out. They have found stuff that I have researched online that other people have had as well. They got never had issues after getting the vaccine that they before. They have found something that is totally similar to everyone else issue when they took the vaccine, which is very scary. What or how can be done. They though it was the heart at first, but they think it's a thinning vessel. It can create all kinds of stuff and cause issues and problems. She has had symptoms for about 2 years already. What can she do; if I can say it came from the vaccine, I want to know what Pfizer can do about it if I get sick or end up in the hospital. If it came from the vaccine, they may have to take care of my bill, was asking. She said that the booster was worse. She sais she will never take the second booster. She states she has spoken to someone at Pfizer already but has not gotten an answer. She states she has spoken to her attorney. She states she has spoken to someone at Pfizer already but hasn't gotten an answer. She says she will never take the second booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest painful; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the parent.  A female patient received BNT162b2 (COMIRNATY), 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: CHEST PAIN (non-serious), outcome "unknown", described as "chest painful".  Additional information: Nurse mentioned her daughter started to experience chest painful after having received comirnaty.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient passed away after receiving vaccine; This is a spontaneous report received from contactable reporter(s) (Nurse).  A female patient received BNT162b2 (BNT162B2), 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: DEATH (death, medically significant), outcome "fatal", described as "Patient passed away after receiving vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported event of death is considered related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The absence of clinical details precludes a more meaningful assessment. This case will be reassessed if additional information becomes available.    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.; Reported Cause(s) of Death: passed away