chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Immunisation, Off label use, Rheumatoid arthritis
Clinical narrative: off label use; In Aug2021, patient received booster dose COVID-19 Vaccine; Rheumatoid arthritis flare; Humira not working; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer from regulatory authority (manufacturer control number: 21K-163-4106524-00) from a contactable consumer (patient herself). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: not reported, expiration date: not reported) intramuscular on 02Feb2021 (age at vaccination: 53 years) as dose 1, single and dose 2 intramuscular on 28Feb2021 (Lot number: not reported) as single, dose 3 intramuscular on an unspecified date in Aug2021 (Lot number: not reported) as dose 3 (booster), single for COVID-19 immunization; adalimumab (HUMIRA, formulation: Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Lot number was not reported) to an unspecified date, at dosage of CF for Moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. On an unknown date in Aug2021, the patient experienced rheumatoid arthritis flare, patient received booster dose covid-19 vaccine, humira not working on an unspecified date in 2021. Rheumatoid arthritis was marked as medically significant. The reporter's causality for the event(s) of Humira not working and Rheumatoid arthritis flare was not provided for Humira and possible for PFIZER-BIONTECH COVID-19 mRNA VACCINE. Clinical outcome of the event drug ineffective was reported as recovering and unknown for rest of the events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available in narrative the reported  events of rheumatoid arthritis flare , drug ineffective, Immunization and off label use are  assessed as related to suspected vaccine BNT162B2
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Facial spasm, Hyperkinesia, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: hyperkinetic movement/movement that was uncontrollable and involuntary; facial spasm; tremors; This is a spontaneous report from a contactable consumer (patient's daughter). An 84-year-old female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiry date unknown), via an unspecified route of administration on Sep2021 as dose 2, single for covid-19 immunisation.  Medical history included highly allergic to medications. The patient was previously vaccinated with the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, lot number unknown) on an unspecified date for covid-19 immunisation. Concomitant medication included influenza vaccine (FLU VACCINE VII) taken for immunisation on Sep2021. The reporter informed that her mother, the patient, was now experiencing hyperkinetic (also reported as hypokinetic) movement on Sep2021 (seriousness: hospitalization from Oct2021 (either 05Oct or 06Oct) and ongoing) which was progressing and starting to get worse. The patient also experienced facial spasm and tremors on an unspecified date in 2021. She stated that according to a journalism narrative from (privacy), there was a piece on neurology, and it was explaining that the COVID vaccine can precipitate a functional neurological disorder, it was not actually a functional neurological disorder, but it looks like it through movements and tremors and facial spams. She was just trying to get information because at this point the patient was in the hospital and they have done an MRI, a CAT scan and a spinal tap on an unspecified date in 2021 and nothing was coming up. She added that she was unsure if what the patient has been experiencing was from the Pfizer COVID vaccine, and that was what they were trying to figure out and see what they were looking at. All she can say was that after the 2nd shot, the patient noticed that she started having this movement that was uncontrollable and involuntary. She doesn't know 100% if it was due to Pfizer, at this point they were just investigating. The patient had the vaccine at the end of Sep2021 and this was when that had all started. She asked for information if anyone had neurologic symptoms after receiving the vaccine. The outcome of event hyperkinetic movement was not recovered. The outcome of the other remaining events was unknown.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: hyperkinetic movement/movement that was uncontrollable and involuntary; facial spasm; tremors; This is a spontaneous report from a contactable consumer (patient's daughter). An 84-year-old female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiry date unknown), via an unspecified route of administration on Sep2021 as dose 2, single for covid-19 immunisation.  Medical history included highly allergic to medications. The patient was previously vaccinated with the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, lot number unknown) on an unspecified date for covid-19 immunisation. Concomitant medication included influenza vaccine (FLU VACCINE VII) taken for immunisation on Sep2021. The reporter informed that her mother, the patient, was now experiencing hyperkinetic (also reported as hypokinetic) movement on Sep2021 (seriousness: hospitalization from Oct2021 (either 05Oct or 06Oct) and ongoing) which was progressing and starting to get worse. The patient also experienced facial spasm and tremors on an unspecified date in 2021. She stated that according to a journalism narrative from (privacy), there was a piece on neurology, and it was explaining that the COVID vaccine can precipitate a functional neurological disorder, it was not actually a functional neurological disorder, but it looks like it through movements and tremors and facial spams. She was just trying to get information because at this point the patient was in the hospital and they have done an MRI, a CAT scan and a spinal tap on an unspecified date in 2021 and nothing was coming up. She added that she was unsure if what the patient has been experiencing was from the Pfizer COVID vaccine, and that was what they were trying to figure out and see what they were looking at. All she can say was that after the 2nd shot, the patient noticed that she started having this movement that was uncontrollable and involuntary. She doesn't know 100% if it was due to Pfizer, at this point they were just investigating. The patient had the vaccine at the end of Sep2021 and this was when that had all started. She asked for information if anyone had neurologic symptoms after receiving the vaccine. The outcome of event hyperkinetic movement was not recovered. The outcome of the other remaining events was unknown.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination failure
Clinical narrative: Sore arm; COVID-19 Virus; COVID-19 Virus; This is a spontaneous report from a Pfizer sponsored regulatory authority. A contactable consumer reported for herself that a 79-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in upper left arm on 27Jan2021 11:00 (Lot Number: EL9262) at the age of 79 years as single dose and the first dose of bnt162b2 via an unspecified route of administration administered in upper left arm on 06Jan2021 (Lot Number: EL3246) at the age of 79 years as single dose for covid-19 immunisation. Medical history included heart surgery. Concomitant medication included paracetamol (TYLENOL) around the dates of vaccination. Patient experienced COVID-19 Virus on 09Sep2021. Contracted COVID-19 virus 30 days ago, a month ago. She wanted to know how long, when can she receive the COVID-19 vaccine booster shot. Clarified she had a very mild case of COVID-19 virus. As soon as she got the COVID-19 virus, her physician sent her to a local hospital to have an antibody infusion. Asked the hospital when she should get the booster. Hospital stated they are getting conflicting information. She was 30 days out from having COVID-19 virus. She was going to be leaving the country. Needed to be sure and wanted the maximum protection. Treatment: 10Sep2021 received the antibody infusion. She knew how she contracted COVID-19 virus. In contact with an infected person. Stated that was how she got it. Tested positive on 09Sep2021. Patient did not go to Emergency Room. Went to hospital for outpatient antibody infusion. Was not admitted to the hospital. Patient had sore arm following prior vaccinations, but didn't think that qualified, so no. Heart surgery after receiving both COVID-19 Vaccines. She tested positive for Covid on 09Sep2021, and wanted to know when can she take the booster shot. She was given convalescent antibody therapy at the hospital, it had been 30 days since she received it, and had found conflicting information about when she should be able to get the vaccine. She was advised by the hospital to call Pfizer for this information. Patient is also pressed for time, as she was going to be traveling out of the country, and needed to be vaccinated prior. Outcome of events were unknown.
Age: 40.0
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 from a contactable consumer. A 41year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) intramuscular, in the left arm, at the age of 40-year-old on 30Apr2021, as  dose 1, single then BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on unknown date, as  dose 2,single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and had undergone PCR test. On 12Oct2021(also reported as 08Oct2021, the patient experienced Covid-19.The patient underwent lab test and procedures which include nasal swab(PCR) on 12Oct2021 which showed positive result.  The prednisone/atarax were given as a therapeutic measure. The outcome of the event was recovering at the time of report. The event was assessed was consumer by non serious.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: clots in the patient's system; This is a spontaneous report from contactable consumer via a company representative.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.The  patient was admitted to the hospital within 12 hours of receiving the first dose of the Pfizer COVID-19 vaccine. Hematologist reported two major clots in the patient's system who had to undergo four transfusions.Physicians determined that the Pfizer COVID-19 vaccine was responsible for these clots in the patient.Patient has since recovered, and reported this occurrence only with the Pfizer vaccine.The outcome of the event was recovered on unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Arterial clots in legs; This is a spontaneous report from a contactable consumer reported for self A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arterial clots in legs in Apr2021 with outcome of unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got covid; who have received vaccine and then got covid; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced got covid and drug ineffective and who have received vaccine and then got covid on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: got covid on unspecified date. The clinical outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Just a little fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not reported, Expiry Date: Not Reported), via an unspecified route of administration on 11Oct2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Oct2021 the patient experienced just a little fever. The reporter was asking booster dose, what was recommended for a fever. The reporter was asking if the she can take a Tylenol. She had just a little fever tonight. The patient asked what dose as the patient had not taken Tylenol or ibuprofen for many years. In response disclaimer was indicated asked to refer HCP. The outcome of the event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Neck pain
Clinical narrative: pain fluttering in the neck behind the ear that comes and goes away; Little pain on the neck; This is a spontaneous report from a contactable consumer (Patient). A 79-year-old female patient received bnt162b2 (BNT162B2 Formulation; solution for injection, Lot Number: 301558A; Expiration Date: 31Dec2021), dose 3 via an unspecified route of administration, administered in Arm Left on 11Oct2021 as DOSE 3 (BOOSTER), SINGLE (at the age of 79-year-old) for COVID-19 immunisation. Medical history included heart beat and all that (on unspecified heart medications) from an unknown date and unknown if ongoing. There were no concomitant medications (no other product). Historical vaccine included first dose of bnt162b2 06Feb2021 (Batch/lot number: EL9265, right arm) and second dose of bnt162b2 on 02Mar2021 (Batch/lot number: EN6200, right arm) (at the age of 78 -year-old) for covid-19 immunisation. It was reported that the patient did so good after first two shots. The patient experienced pain fluttering in the neck behind the ear that comes and goes away and little pain on the neck, behind the ears, but down a little bit on 12Oct2021 (about an hour or two ago). The patient stated it would come again in a little bit, but it has been doing that for a couple of hours. The caller wanted to know what she should do about the side effects she experienced after getting the Pfizer vaccine. The patient had a little fluttering pain which only lasts about 30 seconds. At the time of this report, the patient not experiencing fluttering pain. The patient stated since it started it comes and goes. The outcome of events reported as not recovered.  Follow-up activities closed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Had two strokes, unspecified, after both vaccines; This is a spontaneous report from a contactable consumer (reporter's wife) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 15:00 (Lot number: EN6207) as DOSE 2, SINGLE for COVID-19 immunization and experienced stroke, could not walk, could not talk/Her voice went out, seizures, headaches, migraine, urinary tract infection, she got sick, high blood pressure, collapsed and did not know anything that happened, felt odd. The patient experienced strokes, unspecified, after second dose of vaccine on an unspecified date. The outcome of event was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Infertility female
Clinical narrative: two pregnant women lost their baby and can no longer have children.; two pregnant women lost their baby and can no longer have children.; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is the second of 2 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (dose number unknown) for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced miscarriage and she can no longer have children. The outcome of the events was unknown. The reporting consumer stated that "two pregnant women lost their baby and can no longer have children".  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101352584 Same reporter, drug and events, different patient
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Contusion, Localised infection, Pain, Pain in extremity
Clinical narrative: diagnosed her with either cellulitis or an infection as a result of the vaccine; diagnosed her with either cellulitis or an infection as a result of the vaccine; terrible arm pain; diffuse red mark along her arm and in the middle there is like a triangular black and blue spot; It is (Pain) now getting worse over the past few days; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (Parent).    A 26-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/ Lot number: FF8841) via an unspecified route of administration on 09Oct2021 (age at vaccination 26 years old) as dose 3 (booster), single for covid-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch No. /Lot Number: not reported) administered via an unspecified route on an unspecified date as dose 1 and dose 2 both as single for covid-19 immunization. It was reported that caller daughter had the booster dose of the COVID vaccine on 09Oct2021. On 09Oct201, patient has had terrible arm pain started at night since then, by next day it was full blown, now getting worse over the past few days and also has a diffuse red mark along her arm and in the middle, there was like a triangular black and blue spot. Parent confirmed that the marks that her daughter developed on her arm developed on that same day as well on 09Oct2021. Patient has had two virtual emergency room visits the past two nights because it has gotten that bad. It got worse so her daughter also went to urgent care and on an unknown date patient was diagnosed with either cellulitis or an infection as a result of the vaccine. The Investigation assessment is reported as No. Therapeutic measures taken for the events diagnosed as cellulitis or an infection as a result of the vaccine which included as patient was now on antibiotics. Outcome of the events terrible arm pain and diffuse red mark along her arm and in the middle, there is like a triangular black and blue spot was reported was not recovered and cellulitis or an infection as a result of the vaccine, it was (Pain) now getting worse over the past few days was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Breast pain, Vaccination site discomfort, Vaccination site pain
Clinical narrative: severe back pain; also under her breast and armpit on the same side as the injection; also under her breast and armpit on the same side as the injection; soreness at the injection site; she had tightness at the injection site; This is a spontaneous report from a contactable consumer. This 67-year-old female consumer (patient) reported for herself that. A 67-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: FF8841), via an unspecified route of administration, administered in Arm Left on 10Oct2021 14:00 as DOSE 3 (BOOSTER), single for covid-19 immunization. The patient medical history included hip arthroplasty from an unknown date and unknown if ongoing hip replacement about 12 years ago. Concomitant medications included influenza vaccine (FLU VACCINE VII) taken for an unspecified indication, start and stop date were not reported. The patient previously received Historical vaccine bnt162b2 (formulation: Solution for injection, Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on an 01Mar2021 as DOSE 1, SINGLE, received second dose bnt162b2 (formulation: Solution for injection, Lot Number: ER8730), via an unspecified route of administration, administered in Arm Left on an 22Mar2021 as DOSE 2, SINGLE for covid-19 immunization. All she had with the first two shots was sore arm and After receiving the booster dose, the patient felt tight at the injection site started pretty much right away on Sunday, 10Oct2021. She had read about the lymph node problem and thought that was a normal side effect, so she did not call her primary care about that. She was trying to wait this out a day or two to see if it gets better. she had tightness and soreness at the injection site, and also under her breast and armpit on the same side as the injection. The patient started soreness under arm and breast started late Monday,11Oct2021. Today (13Oct2021) the patient had severe back pain. The patient reported that she never had back pain before. The patient reported that she walks every day and was in good shape. She was healthy and had no underlying conditions. She can barely move without pain. She took Ibuprofen 200 mg tablet Lot: P111343, Expiry: Jul2021and it had not done anything. The patient's arm was totally better. The arm pit and breast was getting much better. Her back was horrible. The patient was asking if it was reported before and asked if she get a bad batch. She was very upset and hopes it was not permanent. The clinical outcome of the events was she had tightness and soreness at the injection site, also under her breast and armpit on the same side as the injection was recovering and another event severe back pain was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No follow-up attempts are possible.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, International normalised ratio, Pulmonary embolism
Clinical narrative: pulmonary embolism diagnosed on 23Sep2021; Patient diagnosed with DVT left leg on 21Sep2021 (left peroneal and left popliteal)/She then had a new DVT diagnosis right leg (right popliteal ) on 03Oct2021; This is a spontaneous report from a contactable physician. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 10Jul2021 (Batch/Lot Number: EW0180) (at the age of 50-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient had no covid prior to vaccination and was not covid tested post vaccination. Medical history included obesity, fibroids, hypertension (HTN), asthma, type 2 diabetes mellitus (DM), gastritis, sleep apnea; and known allergies to seafood, dust mites, cats, dogs, rabbits, birds, mold, and grass. The patient's concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 19Jun2021 (Batch/Lot Number: EX0198) (at the age of 50-year-old) for covid-19 immunization. Patient diagnosed with deep vein thrombosis (DVT) left leg on 21Sep2021 (left peroneal and left popliteal) and started Eliquis, then pulmonary embolism diagnosed on 23Sep2021 and switched to Warfarin. She then had a new DVT diagnosis right leg (right popliteal) on 03Oct2021 while on warfarin which was therapeutic international normalised ratio (INR) 3.2. Prior to COVID vaccination she never had a DVT or PE. She has a risk factor for DVT which was obesity. The events resulted to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The events were life-threatening and caused hospitalization for 3 days. The events were treated with anticoagulation. On unspecified date, the patient recovered from the events.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  deep vein thrombosis, pulmonary embolism . The case will be reassessed once new information is 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
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient came down with COVID; patient came down with COVID; This is a spontaneous report received from a non-contactable consumer from a Pfizer-sponsored program, regulatory authority. This consumer reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot numbers and expiry dates were reported) dose 1, single and dose 2, single; both via unspecified routes of administration, on unknown dates, for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter was trying to make booster shot appointment but the patient came down with COVID on an unspecified date. The outcome of the events was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101368206 same reporter, same drug, same events, different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient came down with COVID; patient came down with COVID; This is a spontaneous report received from a non-contactable consumer from a Pfizer-sponsored program, regulatory authority. This consumer reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot numbers and expiry dates were reported) dose 1, single and dose 2, single; both via unspecified routes of administration, on unknown dates, for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter was trying to make booster shot appointment, but the patient came down with COVID on an unspecified date. The outcome of the events was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101368205 same reporter, same drug, same events, different patients
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pruritus, Rash, Sleep disorder
Clinical narrative: Got sick for a week; Rashes all over her body; Itching for more than 24 hours; Wakes her up at night; This is a spontaneous report from a non-contactable consumer(patient). A 76-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient had a serious reaction after receiving the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine. The patient got sick for a week. Another 2 weeks have passed, and now patient has rashes all over her body, and patient has been itching for more than 24 hours. The patient said the itchiness wakes her up at night and it is so bad. The patient said her symptoms lasted 3 weeks and that she currently still has them. The patient already went to the doctor twice, and was prescribed with Prednisone for 2 weeks. The medication did nothing. The outcome of events was not recovered.  No follow-up attempts possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Drug ineffective, Fatigue, Influenza
Clinical narrative: Weakness; I got like I had flu and cold, chills whatever you talk chill problem; I got like I had flu and cold, chills whatever you talk chill problem; I got like I had flu and cold, chills whatever you talk chill problem; Tired; Sleepy; I had both Covid vaccination dosage and I had Covid infection; I took this bad things and I was ill; I had both Covid vaccination dosage and I had Covid infection; I took this bad things and I was ill; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 07Apr2021 (Lot Number: EN6207) as dose 2, single and dose 1 via an unspecified route of administration on 15Mar2021 (Lot Number: EN6201) as dose 1, single for COVID-19 immunization (at the age of 60-year-old). The patient medical history and concomitant medications were not reported. The patient reported that he had both COVID vaccination dosage and had COVID infection; he took this bad things and he was ill (medically significant) and developed weakness, got like he had flu and cold, chills whatever you talk chill problem, tired and sleepy. On an unspecified date, the patient underwent lab tests and procedures which included COVID-19 test: unknown. The patient was treated with unspecified medication as a therapeutic measure of had both COVID vaccination dosage and had COVID infection; he took this bad things and he was ill. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test, Somnolence, Suspected COVID-19
Clinical narrative: Weakness; I got like I had flu and cold, chills whatever you talk chill problem; I got like I had flu and cold, chills whatever you talk chill problem; I got like I had flu and cold, chills whatever you talk chill problem; Tired; Sleepy; I had both Covid vaccination dosage and I had Covid infection; I took this bad things and I was ill; I had both Covid vaccination dosage and I had Covid infection; I took this bad things and I was ill; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 07Apr2021 (Lot Number: EN6207) as dose 2, single and dose 1 via an unspecified route of administration on 15Mar2021 (Lot Number: EN6201) as dose 1, single for COVID-19 immunization (at the age of 60-year-old). The patient medical history and concomitant medications were not reported. The patient reported that he had both COVID vaccination dosage and had COVID infection; he took this bad things and he was ill (medically significant) and developed weakness, got like he had flu and cold, chills whatever you talk chill problem, tired and sleepy. On an unspecified date, the patient underwent lab tests and procedures which included COVID-19 test: unknown. The patient was treated with unspecified medication as a therapeutic measure of had both COVID vaccination dosage and had COVID infection; he took this bad things and he was ill. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicectomy
Clinical narrative: emergency appendectomy; This is a spontaneous report from a contactable consumer or other non hcp.  A 17-years-old male patient received bnt162b2 (BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 29Mar2021 (Batch/Lot Number: ER8732) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Reporter stated that his son, withheld is a 17-year-old athlete that competes in High school track & Field and Cross-Country Running. He had his 1st Pfizer Vaccine on 29Mar2021 (Vaccine Proof enclosed). Immediately after this Pfizer Vaccine his son had an Emergency Appendectomy. From the input of physicians and other medical experts, it has been studied and verified that the Pfizer Covid-19 Vaccine may have played a significant role in this Acute Appendectomy from the side effect profile listed for the Pfizer Vaccine. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable consumer. An 86-year-old male patient received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Healthy man in (country) received the Pfizer COVID-19 vaccine and 15-16 days later (in 2021), went to the emergency room (ER), had complaints of extreme diarrhea, tested negative for COVID-19 initially when admitted to the hospital but 3 days later, moved to the COVID ward and tested positive for Covid-19 and died a couple days afterwards. The patient died on an unspecified date. An autopsy was performed that revealed spiked protein in every organ of his body.  The event occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: tested positive for Covid-19; tested positive for Covid-19; Autopsy-determined Cause(s) of Death: spiked protein in every organ of his body
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Feeling abnormal, Pain, SARS-CoV-2 test
Clinical narrative: just diagnosed with covid, breakthrough cases; just diagnosed with covid, breakthrough cases; some lingering fatigue; feel lousy; achy; This is a spontaneous report received from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number EL9269, Expiration: unknown) via an unspecified route of administration in arm left on 10Feb2021 in the morning (age at vaccination: 69 years) as single dose and first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number EL8982, Expiration: unknown) via an unspecified route of administration in arm left on 20Jan2021 in the morning (age at vaccination: 69 years) as single dose for covid-19 immunisation. The patient's medical history included when querying other medications and medical conditions, reports she takes a couple allergy pills and does not think this was significant, there was no family Medical History Relevant to AE. Her husband and her were both vaccinated with the second shot on 10Feb2021. There was no vaccine administered at military facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. There were no additional vaccines administered on same Date of the Pfizer Suspect. AE did not require a visit to emergency room. There were no prior vaccinations (within 4 weeks). There was no AE following prior vaccinations. On 10Oct2021, the patient just diagnosed with covid, breakthrough cases, vaccination failure. She came down with symptoms the day after her husband did, her symptoms started on 02Oct2021. She was called and asked to get tested and her positive test result came in on 10Oct2021. After the second dose of covid vac-cine she did feel lousy, fatigued and achy and needed to take Tylenol. She thinks both doses were in her left arm since she is righthanded. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 10Oct2021 her positive test result came in on 10Oct2021. Treatment included home therapy such as Tylenol. The outcome of events was recovered for COVID-19, feel lousy, achy, not recovered for some lingering fatigue and unknown for vaccination failure.  Follow-up attempts are completed. No further information was expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: just diagnosed with covid, breakthrough cases; just diagnosed with covid, breakthrough cases; some lingering fatigue; feel lousy; achy; This is a spontaneous report received from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number EL9269, Expiration: unknown) via an unspecified route of administration in arm left on 10Feb2021 in the morning (age at vaccination: 69 years) as single dose and first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number EL8982, Expiration: unknown) via an unspecified route of administration in arm left on 20Jan2021 in the morning (age at vaccination: 69 years) as single dose for covid-19 immunisation. The patient's medical history included when querying other medications and medical conditions, reports she takes a couple allergy pills and does not think this was significant, there was no family Medical History Relevant to AE. Her husband and her were both vaccinated with the second shot on 10Feb2021. There was no vaccine administered at military facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. There were no additional vaccines administered on same Date of the Pfizer Suspect. AE did not require a visit to emergency room. There were no prior vaccinations (within 4 weeks). There was no AE following prior vaccinations. On 10Oct2021, the patient just diagnosed with covid, breakthrough cases, vaccination failure. She came down with symptoms the day after her husband did, her symptoms started on 02Oct2021. She was called and asked to get tested and her positive test result came in on 10Oct2021. After the second dose of covid vac-cine she did feel lousy, fatigued and achy and needed to take Tylenol. She thinks both doses were in her left arm since she is righthanded. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 10Oct2021 her positive test result came in on 10Oct2021. Treatment included home therapy such as Tylenol. The outcome of events was recovered for COVID-19, feel lousy, achy, not recovered for some lingering fatigue and unknown for vaccination failure.  Follow-up attempts are completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Cerebrovascular accident, Disorientation
Clinical narrative: stroke; super disoriented and his body pulls to the right; has no taste in his mouth; This is a spontaneous report from a contactable consumer (patient's wife). A 28-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller reported that her husband had a stroke during the weekend on an unspecified date. He was released from the hospital yesterday (unspecified date). He does therapy at home. He was super disoriented, and his body pulls to the right. He also had no taste in his mouth, has a difficult time differentiating taste. The patient was scheduled to get his second dose of Pfizer vaccine however he does not know he should proceed. The patient was hospitalized for stroke (cerebrovascular accident) from an unknown date to 13Oct2021 for 3 days. The outcome of all events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: possibly cause my appendicitis; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: er8734) via an unspecified route of administration, administered in Arm Right on 15Apr2021 14:15 (at 49-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included asthma, diverticulosis, obesity, hypertension, depression, benign prostatic hyperplasia, latex allergy. Covid prior vaccination was No. Other medications in two weeks: Yes, however, not specified. The patient previously took bnt162b2 DOSE 1, SINGLE (Lot No: ep7534) on 25Mar2021 02:15 PM at Left arm for covid-19 immunisation and allergies to tobrex. The patient reported that the bnt162b2 possibly cause his appendicitis from Jun2021. AE resulted in: Emergency room/department or urgent care, Hospitalization for 3 days, Life threatening illness (immediate risk of death from the event). Treatment for the event included Appendectomy. Covid tested post vaccination via Nasal Swab result=Negative. The outcome of the event was recovered.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is 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.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got COVID positive test result on 14Oct2021; Got COVID positive test result on 14Oct2021; This is a spontaneous report from a contactable consumer. This consumer reported for a 16-year-old female patient that:  A 16-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), intramuscular, administered in Arm Right on 12Apr2021 (At the age of 16 Years) as DOSE 2, SINGLE for covid-19 immunisation. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), intramuscular, administered in Arm Right on 22Mar2021 (At the age of 16 Years) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 13Oct2021 Nasal Swab. The patient got covid positive test result and vaccination failure on 14oct2021. No, treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Yes, patient covid tested post vaccination. The outcome of the events were recovering.  Follow-up attempts completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Body aches; flu like symptoms; fatigue; slight fever; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number : FD8448 and expiry date was not reported) via an unspecified route of administration, in the right arm, at the age of 69-year-old, on 08Oct2021 16:00, as  dose 3 (booster), single for covid-19 immunisation in a pharmacy or drug store. The patient medical history included hypertension and hyperlipidemia. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19 and was not tested for Covid-19. The patient's concomitant medications include influenza vaccine inact sag 4v (FLUAD QUADRIVALENT) on 29Sep2021 for immunization, atenolol, enalapril, and atorvastatin.  Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EM9810 and expiry dates was not reported) on 04Feb2021 13:00, as dose 1, single and (lot number: EN6203 and expiry dates was not reported) on 27Feb2021 14:00, as dose 2, single; both given via an unspecified route of administration, in the left arm, at the age of 69-year-old, for covid-19 immunisation. On 09Oct2021 08:00, the patient experienced Body aches, flu like symptoms, fatigue, and slight fever for 2 days. The patient didn't receive any treatment in response to the event. The outcome of the event fever was recovered on 11Oct2021 while the other events recovered in Oct2021. The events were assessed by the consumer as non-serious.  Follow-up attempts are completed. No further information is expected.