chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Temporary partial blindness; ringing in right ear; pale skin; sweating; dizziness.; This is a spontaneous report from a contactable consumer (patient).  A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Sep2021 15:30 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Prior to vaccination, was the patient diagnosed with COVID-19, known allergies: numerous foods and environmental substances like trees and grass all from an unknown date and unknown if ongoing.  Since the vaccination, has the patient been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. There were no concomitant medications. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: unknown) on 27Aug2021 12:00 PM at the left arm for COVID-19 immunization. It was reported that the patient experienced Temporary partial blindness, ringing in right ear, pale skin, sweating, dizziness on 18Sep2021 03:30 PM. The patient underwent laboratory procedure which includes covid test post vaccination (unknown covid test type), which was negative in 2021. The outcome of the events was recovered on 27Sep2021 12:00 PM.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Pain in extremity
Clinical narrative: He had soreness in the arm after receiving the 1st, 2nd, and 3rd dose; He already received 3 doses of the Pfizer-BioNTech Covid-19 Vaccine; he already received 3 doses of the Pfizer-BioNTech Covid-19 Vaccine; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 76 year old male patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3,SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness in the arm after receiving the 1st, 2nd, and 3rd dose causing pain in extremity on an unspecified date with outcome of unknown, he already received 3 doses of the pfizer-biontech covid-19 vaccine leading to off label use and extra dose administered on an unspecified date with outcome of unknown. He wants to know if he should still receive booster dose.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abscess, Crohn's disease, Device issue
Clinical narrative: Abscess; Crohn's disease; Device issue; This is a solicited report based on the information received by Pfizer from agency (Manufacturer Control No: 21K-163-4081454-00).   Solicited report from by a contactable 24-year-old female patient with events of might have Crohn's instead of ulcerative colitis due to abscesses and non-serious might have Crohn's instead of ulcerative colitis due to abscesses and pen misfire with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced might have Crohn's instead of ulcerative colitis due to abscesses and pen misfire. Pfizer biontech COVID-19 vaccine (Tozinameran) was also considered suspect. The patient was in hospital for abscesses. She thought that she might have Crohn's instead of ulcerative colitis due to abscesses. She had pen misfire. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On 23May2021, patient received 1st dose COVID-19 vaccine manufactured by Pfizer. Primary reporter did not have the lot number information, because the packaging was discarded. The reporter's causality for the event(s) of might have Crohn's instead of ulcerative colitis due to abscesses unknown onset with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of might have Crohn's instead of ulcerative colitis due to abscesses unknown onset and pen misfire was not provided. Agency's opinion is that there is no reasonable possibility that the events of might have Crohn's instead of ulcerative colitis due to abscesses unknown onset, might have Crohn's instead of ulcerative colitis due to abscesses unknown onset and pen misfire are related to Humira (Adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Reported events of Abscess and Crohn's' disease are most likely intercurrent conditions and unrelated to BNT162B2 vaccine. Pen misfire was related to co-suspect medication Humira (Adalimumab). Case will be reassessed upon receipt of additional information.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Dyspnoea, Eye pruritus, Fatigue, Headache
Clinical narrative: her nose feeling stuffed and clogged; trouble breathing; heart palpitates; headache; fatigue; body aches; bumps on her face and body; bones hurt; throat hurts; her eye is red and itching; her eye is red and itching; She experienced an allergic reaction throughout her body; This is a spontaneous report from a contactable consumer via medical information team. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunization. Medical history included she went through COVID very bad last year from 2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date in 2021 the patient experienced her nose felt stuffed and clogged, trouble breathing, heart palpitates, this has been going on for 3 weeks, headache, fatigue, body aches, bumps on her face and body, bones hurt, throat hurts, her eye is red and itching, she experienced an allergic reaction throughout her body. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Milia, Nasal congestion, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: her nose feeling stuffed and clogged; trouble breathing; heart palpitates; headache; fatigue; body aches; bumps on her face and body; bones hurt; throat hurts; her eye is red and itching; her eye is red and itching; She experienced an allergic reaction throughout her body; This is a spontaneous report from a contactable consumer via medical information team. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunization. Medical history included she went through COVID very bad last year from 2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date in 2021 the patient experienced her nose felt stuffed and clogged, trouble breathing, heart palpitates, this has been going on for 3 weeks, headache, fatigue, body aches, bumps on her face and body, bones hurt, throat hurts, her eye is red and itching, she experienced an allergic reaction throughout her body. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations
Clinical narrative: her nose feeling stuffed and clogged; trouble breathing; heart palpitates; headache; fatigue; body aches; bumps on her face and body; bones hurt; throat hurts; her eye is red and itching; her eye is red and itching; She experienced an allergic reaction throughout her body; This is a spontaneous report from a contactable consumer via medical information team. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunization. Medical history included she went through COVID very bad last year from 2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date in 2021 the patient experienced her nose felt stuffed and clogged, trouble breathing, heart palpitates, this has been going on for 3 weeks, headache, fatigue, body aches, bumps on her face and body, bones hurt, throat hurts, her eye is red and itching, she experienced an allergic reaction throughout her body. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Neuralgia, Reading disorder, Thrombosis
Clinical narrative: deep thrombosis on both of her legs; "made her nerve shot"; diarrhea; can see but little hard to read small prints; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm in Apr2021 (batch/lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. Caller (patient) said that she was on a blood thinner and has been for 2 years and they never mentioned anything about it when they gave her the vaccine. On her first shot of bnt162b2, she experienced increased heart rate (reached 133) and stomach ache. Caller also stated that her arm went sore but was not indicated whether it was on her first or second shot. On her second shot, she experienced deep thrombosis on both of her legs, diarrhea that comes and goes, "can see but little hard to read small prints", "made her nerve shot" in 2021. Patient also wanted to confirm if it would be advisable to administer the vaccine on the other arm if there is a cancer on one arm but did not state if she has this condition. Outcome of events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Positive COVID-19 test via PCR 14Sep2021; COVID-like symptoms 10Sep2021; This is a spontaneous report from a contactable consumer or other non hcp ). A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 17Feb2021 11:00 (at the age of 35-year-old) (Batch/Lot Number: EN5318) as dose 2, single, dose 1 intramuscular, administered in Arm Left on 28Jan2021 11:00 (at the age of 35-year-old) (Batch/Lot Number: EN5318) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Sep2021 16:00, the patient had COVID-like symptoms.On 14Sep2021, the patient had positive COVID-19 test via PCR. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Sep2021 Nasal Swab. No treatment received for the events. The adverse events were result in Doctor or other healthcare professional office/clinic visit. The clinical outcome of the events were not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: lymph node swelling; pain in left armpit and a little above my left boob; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number : FE3592 and Expiry date: Unknown), dose 2 via an unspecified route of administration on 17Sep2021 12:00 as DOSE 2, SINGLE for Covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.On 18Sep2021 the patient experienced lymph node swelling , pain in left armpit and a little above my left boob.The outcome of event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Arthralgia, Chest pain, Limb discomfort, Lymphadenopathy
Clinical narrative: swelling towards the arm pit, chest, slowly moving to the rib cage and stomach/ I'm actually swollen/ abnormal retention in the area/ Puffiness; swelling towards the arm pit, chest, slowly moving to the rib cage and stomach; The pain moved from my arm, chest/sore arm; The pain moved from my arm, chest; Drowsiness; Shoulder pain; Hard to set my arm to the side of my body; May be effecting Multiple lymph nodes, puffiness that can be seen; This is a spontaneous report from a contactable consumer. A 25-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14Sep2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Sep2021, consumer experienced swelling towards the arm pit, chest, slowly moving to the rib cage and stomach. Consumer stated, He had initial swelling. He was a body builder. He has developed muscles. He noticed in the definition of his chest muscles. The pain moved from my arm, chest. He was actually swollen. Hard to set my arm to the side of my body. The swelling moves around. It's an abnormal retention in the area. (maybe affecting) Multiple lymph nodes; puffiness that can be seen. Previous to the vaccine everything was ok. There was swelling now. Pain in arm,  lymphadenopathy from  document "how long side effects last: Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, was likely to have resulted from a robust vaccine-elicited immune response. from VR no information on puffiness/abnormal retention that was moving from arms to chest, rib and stomach. Consumer stated that he was still experiencing. Added he did feel the typical sore arm; he noticed when he was working out, he was drowsy before lifting; he has some shoulder pain; then he noticed a swelling going toward his armpit and chest; now it was slowly moving to his ribcage and stomach. Adds he was fairly lean so maybe he can just see it; but he was asking is this normal? Therapeutic measures were taken as a result of all events. The outcome of events was not recovered.  lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Swelling
Clinical narrative: swelling towards the arm pit, chest, slowly moving to the rib cage and stomach/ I'm actually swollen/ abnormal retention in the area/ Puffiness; swelling towards the arm pit, chest, slowly moving to the rib cage and stomach; The pain moved from my arm, chest/sore arm; The pain moved from my arm, chest; Drowsiness; Shoulder pain; Hard to set my arm to the side of my body; May be effecting Multiple lymph nodes, puffiness that can be seen; This is a spontaneous report from a contactable consumer. A 25-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14Sep2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Sep2021, consumer experienced swelling towards the arm pit, chest, slowly moving to the rib cage and stomach. Consumer stated, He had initial swelling. He was a body builder. He has developed muscles. He noticed in the definition of his chest muscles. The pain moved from my arm, chest. He was actually swollen. Hard to set my arm to the side of my body. The swelling moves around. It's an abnormal retention in the area. (maybe affecting) Multiple lymph nodes; puffiness that can be seen. Previous to the vaccine everything was ok. There was swelling now. Pain in arm,  lymphadenopathy from  document "how long side effects last: Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, was likely to have resulted from a robust vaccine-elicited immune response. from VR no information on puffiness/abnormal retention that was moving from arms to chest, rib and stomach. Consumer stated that he was still experiencing. Added he did feel the typical sore arm; he noticed when he was working out, he was drowsy before lifting; he has some shoulder pain; then he noticed a swelling going toward his armpit and chest; now it was slowly moving to his ribcage and stomach. Adds he was fairly lean so maybe he can just see it; but he was asking is this normal? Therapeutic measures were taken as a result of all events. The outcome of events was not recovered.  lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First dose: Sore left arm; This is a spontaneous report from a contactable 34-years-old female consumer(patient).  A 34-year-old female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 23Aug2021 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 23Aug2021, after the vaccination, the patient experienced a sore left arm right away. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (23Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Drug ineffective, Parosmia
Clinical narrative: thought he had Covid earlier; thought he had Covid earlier; lost sense of smell. has regained some of it for some smells, but indicated his full sense of smell has not returned.; can smell some things like petroleum products; This is a spontaneous report from a contactable consumer(employee).A male patient of an unspecified age received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: Not reported) via unspecified route of administration, on unknown date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient had not received any other vaccine within 4 weeks. Patient had no known diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patients medical history and concomitant medications were not reported. No history of Additional Vaccines Administered on Same Date of the Pfizer Suspect.Pfizer employee stated he was not able to report this online for some reason, but he had a friend over this weekend who shared some information about the Comirnaty vaccine and he wanted to report it.  On an unknown date the reporter stated that the patient had lost sense of smell, has regained some of it for some smells, but indicated his full sense of smell has not returned, can smell some things like petroleum products, thought he had Covid earlier. Reporter also stated that he thought he had Covid earlier but does not provide if it was before or after the vaccine administration and Pfizer employee unable to provide. No further details provided. The outcome of the event for can smell some things like petroleum products was not resolved. The outcome of the event for lost sense of smell. has regained some of it for some smells, but indicated his full sense of smell has not returned was recovering. And the outcome for the event thought he had Covid earlier was unknown.   Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Chest pain, Colon cancer stage IV
Clinical narrative: Experienced Chest pains; enlarged heart, a stent put in; Found out has stage 4 colon cancer; This is a spontaneous report from a Pfizer-sponsored program. A contactable Consumer reported for a female patient (neighbour). A female patient in her 70's received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on an unspecified date and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 2, single on an unspecified date for covid-19 immunization. Medical history included overweight (as reported little fat, happens when you age) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Caller stated patient received first dose of vaccine a year ago and second dose was received 28 days after the first dose. Patient did not receive any other products (at the time report). Reporter stated that he did not go with the patient to receive the Pfizer Covid Vaccine. On unspecified date, the patient experienced chest pains after received Pfizer Covid Vaccine and went to the doctor with enlarged heart and had a stent put in. On unspecified date, patient found out now she had stage 4 colon cancer and now on chemotherapy. Caller visited the patient every day and could not see any more until and patient was safe to be around. Therapeutic measures were taken as a result of event stage 4 colon cancer with chemotherapy. At the time of this report, the outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (22Sep2021): New information received from a same contactable consumer in response to Non-HCP letter sent via telephonic activity: consumer stated, 'you are working for a company who is giving out a vaccine like Moderna, your vaccine is not a vaccine, is not FDA approved, Consumer states 'is a poison, a depopulation media'  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable male Pharmacist (patient). A male patient of unspecified age received unknown dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: unknown, Expiry date: Not provided), via an unspecified route on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient had diarrhea for the last two days. He had the shot nine days ago. He wants to know if this is a listed side effect. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Immunisation, Off label use
Clinical narrative: Off label use; Booster; I was out sick with the 3rd Covid Pfizer shot; This is a spontaneous report from a contactable consumer or other non-health care professional re-ported for a male consumer(patient). A male patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose and second dose of BNT162B2 for COVID-19 immunization. It was unknown that the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced off label use, booster and i was out sick with the 3rd covid pfizer shot. The clinical outcome for all the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Head discomfort, Headache, Off label use
Clinical narrative: Received the first, second and third dose of the Pfizer Comirnaty vaccine; Received the first, second and third dose of the Pfizer Comirnaty vaccine; Pressure on her head; Headache; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 66-years-old female patient received BNT162B2 (, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunizations. The patient medical history and concomitant medications were not reported.  The patient experienced pressure on her head from horrific headache that lasted 9 days, received the first, second and third dose of the pfizer comirnaty vaccine.  Caller wanted to know if this is a common side effect of the third dose. Caller stated that she feels better now and that her HCP has recommended treatment for her headache. The event outcome was unknown for off label use and extra dose administered and recovered for headache and Pressure on her head.  Response: Spoke from attached document PI Table 4: Study 2  Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose  Participants 56 Years of Age and Older.  From an independent report in 99 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) the adverse event profile was like that after the second dose."  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Vaccination site pain
Clinical narrative: it hurt my arm where I got the shot; have a low white blood cell count; I have back pain; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer-sponsored program COVAX US support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm on an unspecified date at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced it hurt my arm where i got the shot, have a low white blood cell count, i have back pain. Question: Reporter is a consumer calling to ask about interaction between Celecoxib and the Pfizer Covid vaccine. Is there a test that I can take to see if the vaccine worked on me, I have a low white blood cell count, and because when I took the shot it hurt my arm where I got the shot, but that was it. my sister on the other hand was in bed for 2 days. Question: My doctor prescribed Celecoxib 200mg capsule, because I have back pain, and I want to know if taking it will affect the vaccine, since the medication is an anti-inflammatory. Can i use fever-reducing drugs or pain relievers before or after getting the vaccine. Question: When does the vaccine start to protect me after taking the second dose. The patient underwent lab tests and procedures which included white blood cell count: low on an unspecified date. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient tested positive for C-19 on 16Sep2021; Patient tested positive for C-19 on 16Sep2021/mild cough and scratchy throat for 2-3 days; This is a spontaneous report from a contactable Pharmacist. A 14-years-old non pregnant female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot Number: FA6780, Expiry date: unknown), via unspecified route of administration on 29Jul2021 (age at vaccination 14 years and non-pregnant at the time of vaccination) as DOSE 2, SINGLE and first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot Number: FA6780, Expiry date: unknown), via intramuscular, administered in arm right on 08Jul2021 (age at vaccination 14 years and non-pregnant at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included known allergies seasonal allergies, pet dander. The patient's concomitant medications were not reported. Hospital was facility where the most recent COVID-19 vaccine was administered. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. It was reported that the patient received both doses of PFE covid vaccine (08Jul2021-lot FA6780, 29Jul2021 lot FA6780). Patient tested positive for C-19 on 16Sep2021 with mild cough, scratchy throat for 2-3 days. Patient was fine now. The patient underwent covid test post vaccination (nasal Swab, covid test date on16Sep2021, covid test result was positive). The patient did not receive any treatment for the events. The outcome of event was recovered in 2021.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I got sick after receiving my 2 Covid shots; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for self). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced I got sick after receiving my 2 covid shots. Patient got sick after receiving 2 Covid shots and now I want to know if I am immunized enough against the Covid. Am I protected against someone who is not vaccinated. Why should I take the booster shot. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Feeling abnormal, Nasal congestion, Nasopharyngitis
Clinical narrative: taste and smell went away; taste and smell went away; Feeling bad; Nasal congestion; had a cold; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a 32-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01May2021 (at the age of 32-years-old) (Lot Number: EW0164; Expiration Date: Aug2021, NDC number: unknown) as DOSE 2, SINGLE for covid-19 immunisation. There were no patient medical history and concomitant medications. No adverse event following prior vaccinations. Patient previously took first dose of bnt162b2 (Lot number: ER8732; Expiration Date: Jul2021) administered in right arm on 10Apr2021 (at age of 32-year-old) for covid-19 immunisation. The patient was feeling bad on Thursday 09Sep2021. To clarified feeling bad he had no fever, no body chills, and no aches. He only had nasal congestion. That lasted from ninth, tenth, eleventh, and twelfth. On 13Sep2021, his taste and smell went away. That only lasted until 15Sep2021. Everything came back on 15Sep2021. He only had nasal congestion, no cough. His taste completely went away on 13Sep2021 and by 15Sep2021 he was able to smell and taste again. The patient had a cold on an unspecified date in Sep2021. None of additional vaccines administered on same date of the Pfizer Suspect. Patient did not require Emergency Room and Physician Office for the events. The patient underwent lab tests and procedures which included COVID test: unknown results (he is awaiting the results) on an unspecified date in 2021. It was reported that he valued human life. He was doing his part to protect himself and make sure he was not infecting other people in case he gets it. There were a lot of people that are immune suppressed. There were kids out there and old people who could be sick at any point and time by touching a countertop. Outcome of event Nasal congestion was recovered on 12Sep2021. Outcome of events feeling bad and had a cold were unknown while taste and smell went away were recovered on 15Sep2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101244374 same reporter/product, different patient / event.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: taste and smell went away; taste and smell went away; Feeling bad; Nasal congestion; had a cold; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a 32-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01May2021 (at the age of 32-years-old) (Lot Number: EW0164; Expiration Date: Aug2021, NDC number: unknown) as DOSE 2, SINGLE for covid-19 immunisation. There were no patient medical history and concomitant medications. No adverse event following prior vaccinations. Patient previously took first dose of bnt162b2 (Lot number: ER8732; Expiration Date: Jul2021) administered in right arm on 10Apr2021 (at age of 32-year-old) for covid-19 immunisation. The patient was feeling bad on Thursday 09Sep2021. To clarified feeling bad he had no fever, no body chills, and no aches. He only had nasal congestion. That lasted from ninth, tenth, eleventh, and twelfth. On 13Sep2021, his taste and smell went away. That only lasted until 15Sep2021. Everything came back on 15Sep2021. He only had nasal congestion, no cough. His taste completely went away on 13Sep2021 and by 15Sep2021 he was able to smell and taste again. The patient had a cold on an unspecified date in Sep2021. None of additional vaccines administered on same date of the Pfizer Suspect. Patient did not require Emergency Room and Physician Office for the events. The patient underwent lab tests and procedures which included COVID test: unknown results (he is awaiting the results) on an unspecified date in 2021. It was reported that he valued human life. He was doing his part to protect himself and make sure he was not infecting other people in case he gets it. There were a lot of people that are immune suppressed. There were kids out there and old people who could be sick at any point and time by touching a countertop. Outcome of event Nasal congestion was recovered on 12Sep2021. Outcome of events feeling bad and had a cold were unknown while taste and smell went away were recovered on 15Sep2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101244374 same reporter/product, different patient / event.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: my sister on the other hand was in bed for 2 days.; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer (Patient's sister) reported that a female patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced my sister on the other hand was in bed for 2 days. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: lost all of my body hair; This is a spontaneous report from a contactable consumer. This male consumer (patient) of unknown age reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 24Mar2021 the patient lost all of his body hair. He had questions about the third vaccine shot and asked if reported side effect and if those individuals who have reported had received the third dose. The event outcome was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101253532 Pfizer
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration
Clinical narrative: COVID 19 infection was confirmed on 22Sep2021; COVID 19 infection was confirmed on 22Sep2021/scratchy throat/cough; other vaccine same date vaccine date=01Apr2021; This is a spontaneous report from a contactable Pfizer colleague. A 39-years-old non pregnant female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number ER2613, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 01Apr2021 (age at vaccination: 39 years non pregnant at the time of vaccination) as DOSE 2, SINGLE, and received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number ER8734, Expiry date: unknown), via Intramuscular, administered in Arm Left on 01Apr2021 (age at vaccination: 39 years non pregnant at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. There was no medical history. Concomitant medication/ List of any other medications the patient received within 2 weeks of vaccination included ethinylestradiol, norethisterone acetate (Junel) taken for an unspecified indication. No known allergies were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine administered was workplace clinic. On 19Sep2021, the patient started to experience symptoms of scratchy throat and cough. Since the vaccination, patient has been tested for COVID-19. Covid test post vaccination Nasal Swab on 21Sep2021, covid test result was Positive. COVID 19 infection was confirmed on 22Sep2021. No treatment was received for events. Outcome of events drug ineffective and Covid-19 was recovering and unknown for other event.  Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got covid19 virus from someone at work.; got covid19 virus from someone at work.; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on 31Jul2021 as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced got covid19 virus from someone at work. (COVID-19) on an unspecified date. patient was asking when she can receive the second dose of the vaccine. she said one of her doctors told her 20 days after recovered while her other doctor said 1 month and the other 3 months. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Headache, Joint stiffness, Lyme disease
Clinical narrative: neuropathy in my hands and feet; had an old Lyme disease infection(probably a year old); general ache and pain; joint stiffness; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Apr2021 (at age of 52 years old, Lot Number: ER8729) as a single dose for covid-19 immunization. The patient medical history was not reported. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took the first dos of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), on 19Mar2021 (at age of 52 years old, Lot Number: ER6201) for covid-19 immunization. After getting the second dose of the COVID-19 vaccine, on 10Apr2021 the patient experienced general ache and pain, joint stiffness, fatigue, headache, and neuropathy in his hands and feet, which, per the guidelines, were normal side effects of the vaccine. However, when these symptoms still did not disappear after two weeks, he went to the Urgent Care on 26Apr2021. Blood test taken at the Urgent Care showed that he had an old Lyme disease infection (probably a year old). He was treated with Doxycycline for 3 weeks, but his condition never improved and the symptoms persists to this day. Since the Urgent Care visit, he had been evaluated by a neurologist, a hematologist/oncologist, an infectious disease specialist, a rheumatologist; none of them found any problem. He had done numerous blood tests and a full MRI of the spinal column and the brain. All of the tests came back normal. The patient underwent lab tests and procedures which included covid test type post vaccination, Blood test on 26Jul2021: Negative, Nasal Swab PCR on 26Aug2021: Negative. The patient was not received treatment (except Doxycycline for Lyme disease infection). The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The outcome of the events was not recovered.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head, Neuropathy peripheral, Pain, SARS-CoV-2 test
Clinical narrative: neuropathy in my hands and feet; had an old Lyme disease infection(probably a year old); general ache and pain; joint stiffness; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Apr2021 (at age of 52 years old, Lot Number: ER8729) as a single dose for covid-19 immunization. The patient medical history was not reported. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took the first dos of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), on 19Mar2021 (at age of 52 years old, Lot Number: ER6201) for covid-19 immunization. After getting the second dose of the COVID-19 vaccine, on 10Apr2021 the patient experienced general ache and pain, joint stiffness, fatigue, headache, and neuropathy in his hands and feet, which, per the guidelines, were normal side effects of the vaccine. However, when these symptoms still did not disappear after two weeks, he went to the Urgent Care on 26Apr2021. Blood test taken at the Urgent Care showed that he had an old Lyme disease infection (probably a year old). He was treated with Doxycycline for 3 weeks, but his condition never improved and the symptoms persists to this day. Since the Urgent Care visit, he had been evaluated by a neurologist, a hematologist/oncologist, an infectious disease specialist, a rheumatologist; none of them found any problem. He had done numerous blood tests and a full MRI of the spinal column and the brain. All of the tests came back normal. The patient underwent lab tests and procedures which included covid test type post vaccination, Blood test on 26Jul2021: Negative, Nasal Swab PCR on 26Aug2021: Negative. The patient was not received treatment (except Doxycycline for Lyme disease infection). The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: paralyzed feeding tube, pitch tube; This is a spontaneous report from a contactable consumer. A 12-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, batch/lot number and expiry date: 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. on an unspecified date, the patient experienced paralyzed feeding tube, pitch tube (paralysis). The reporter reported that, paralyzed, feeding tube, pitch tube. Pfizer said it was anxiety and tried to have her committed to a mental hospital and Pfizer is censoring her story. Pfizer destroyed her and her family, this is destroying our country and our children. The patient had Bell's Palsy from another vaccine. Out come of the event was unknown.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2