chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Illness, SARS-CoV-2 test
Clinical narrative: 2nd shot- Extreme illness, missing 1 week of work; 3 weeks later Congestive Heart Failure, requiring 2 hospitalizations, and currently waiting on a CRT-D Implant for CHF; This is a spontaneous report from a contactable consumer. This case is for the second dose.  A 43-year-old female patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 13Apr2021 at 09:00 (Batch/Lot Number: ER8737) as DOSE 2, SINGLE for covid-19 immunization. Medical history included Hyperthyroidism, Migraines, Glaucoma, IBS (Inflammatory bowel disease), Anxiety, Eating Disorder, Gallbladder Disease, Pancreatitis and Known allergies: Sulfa (Sulfonamide allergy). Concomitant medications included levothyroxine (LEVOTHYROXINE), escitalopram oxalate (LEXAPRO) and buspirone (BUSPIRONE) all taken for unspecified indications, start and stop dates were not reported. The patient previously took Ceclor and Augmentin [amoxicillin;clavulanic acid] and experienced drug hypersensitivity. The patient experienced 2nd shot- extreme illness, missing 1 week of work and 3 weeks later congestive heart failure, requiring 2 hospitalizations, and currently waiting on a crt-d implant for chf on 14May2021 at 13:00. Seriousness of the events includes hospitalization, disability, life threatening. The patient was hospitalized for the events for 6 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Jun2021 (Covid test type post vaccination: Nasal swab). Therapeutic measures were taken as a result of the events. Outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101048018 Same reporter/Drug, Different dose/event
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This prompted a COVID-19 test which came back positive.; This prompted a COVID-19 test which came back positive.; Patient felt aching in her bones similar to side effect following second dose of vaccine.; This is a spontaneous report from a contactable consumer or other non hcp. A 39-year-old female patient received second dose of bnt162b2 (Pfizer covid 19, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 39-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number and Expiration date 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, patient felt aching in her bones similar to side effect following second dose of vaccine. This prompted a COVID-19 test which came back positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Polymerase chain reaction positive
Clinical narrative: This is a spontaneous report from a contactable consumer. A 58-years-old female patient second dose of received bnt162b2 (Pfizer covid vaccine, formulation: solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 29Mar2021 (at the age of 57-years-old) as DOSE 2, SINGLE and first dose bnt162b2 (Pfizer covid vaccine, formulation: solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 08Mar2021 (at the age of 57-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications not reported. On 12Aug2021, the patient was diagnosed with COVID. The patient had symptoms prior to being diagnosed with COVID. The patient underwent lab tests and procedures which included (PCR test) polymerase chain reaction positive: covid on 12Aug2021. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Rash, Ultrasound abdomen
Clinical narrative: "Period" lasts for 10 days (6 days no bleeding)/Bleeding for 49 days (12 days no bleeding)/bleeding for 3 days (3 days no bleeding)/Bleeding for 5 days (8 days no bleeding); Rash develops all over arms, legs, and stomach.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old, non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Er8730, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 23Mar2021 14:00 (at the age of 33-year-old) as dose 1, single for COVID-19 immunization in pharmacy or drug store. No other vaccine was administered in four weeks. The patient did not have any known allergies. The patient did not have Covid prior vaccination. The patient was not tested for Covid post vaccination. Medical history was none, and concomitant medications were not reported. On 29Mar2021, the patient experienced rash develops all over arms, legs, and stomach. The patient had not eaten anything different or been outside to catch a rash from anything. On 06Apr2021, the patient experienced period lasts for 10 days (6 days no bleeding)/bleeding for 49 days (12 days no bleeding)/bleeding for 3 days (3 days no bleeding)/bleeding for 5 days (8 days no bleeding). On 06Apr2021: Patient went to dermatologist for the rash, given an oral cream and a steroid shot. Dermatologist told this could be from the COVID vaccine and she should still get a second dose, this was not considered severe. Rash starts to clear up a few days after this. It was reported that, from 06Apr2021- 15Apr2021: Period lasts for 10 days (6 days no bleeding), 22Apr2021 - 09Jun2021: bleeding for 49 days (12 days no bleeding), 22Jun2021-24Jun2021 bleeding for 3 days (3 days no bleeding), 28Jun2021 - 02Jul2021: bleeding for 5 days (heavy thought this was a real period) (9 days no bleeding), 12Jul2021- 16Jul2021: bleeding for 5 days (8 days no bleeding), 25Jul2021- 29Jul2021: bleeding for 5 days (8 days no bleeding), 07Aug2021- 12Aug2021: bleeding for 5 days. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included ultrasound: unknown results on an unspecified date. Therapeutic measures were taken as a result of the events with ultrasound, oral cream and a steroid shot. The outcome of the events was recovered with sequelae on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest pain, Dyspnoea, Feeling abnormal, Feeling of relaxation
Clinical narrative: headache; chest pain; felt like he was not getting any oxygen and also had a rash; his heart is "fluttering", felt like he was not getting any oxygen; felt like he was not getting any oxygen and also had a rash; whole body "slowed up" that he could not even put his clothes on; calmness and relaxation; not necessarily a bad thing but it was different/everything went crazy; swelling of the whole body; This is a spontaneous report from a contactable consumer (reported himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on 22Jul2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient wants guidance on receiving second dose after he experienced some adverse events after receipt of the first dose of the Pfizer Biontech COVID19 vaccine on 22Jul2021. On an unknown date Jul2021, the patient experienced three days of "calmness and relaxation" and that like someone had given him a drug, which the patient described as "not necessarily a bad thing but it was different." On 26Jul2021 (fourth day), the patient stated that "everything went crazy" and that his whole body "slowed up" that he could not even put his clothes on. The patient also had a headache, chest pain and that his heart is "fluttering", felt like he was not getting any oxygen and also had a rash. On an unknown date Jul2021, the patient also had swelling of the whole body. The patient stated that the event expect swelling of the whole body was only lasted for 6-8 hours then it completely resolved on an unknown date Jul2021. The outcome of the event swelling of the whole was unknown   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Loss of personal independence in daily activities, Rash, Swelling
Clinical narrative: headache; chest pain; felt like he was not getting any oxygen and also had a rash; his heart is "fluttering", felt like he was not getting any oxygen; felt like he was not getting any oxygen and also had a rash; whole body "slowed up" that he could not even put his clothes on; calmness and relaxation; not necessarily a bad thing but it was different/everything went crazy; swelling of the whole body; This is a spontaneous report from a contactable consumer (reported himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on 22Jul2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient wants guidance on receiving second dose after he experienced some adverse events after receipt of the first dose of the Pfizer Biontech COVID19 vaccine on 22Jul2021. On an unknown date Jul2021, the patient experienced three days of "calmness and relaxation" and that like someone had given him a drug, which the patient described as "not necessarily a bad thing but it was different." On 26Jul2021 (fourth day), the patient stated that "everything went crazy" and that his whole body "slowed up" that he could not even put his clothes on. The patient also had a headache, chest pain and that his heart is "fluttering", felt like he was not getting any oxygen and also had a rash. On an unknown date Jul2021, the patient also had swelling of the whole body. The patient stated that the event expect swelling of the whole body was only lasted for 6-8 hours then it completely resolved on an unknown date Jul2021. The outcome of the event swelling of the whole was unknown   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: rash on both arms from the wrist up to the elbows; Some days the rash is red and some days it's not; it itches; This is a spontaneous report from a contactable consumer (patient).    A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  On 06Aug2021, the patient experienced rash on both arms from the wrist up to the elbows, some days the rash is red and some days it's not, it itches. The outcome of the events was unknown. Therapeutic measures were taken as a result of the events included Benadryl and cream. The clinical course was reported as follows: Patient reports on 01Aug2021 she got the first COVID vaccine and is going to say 5 days later she got this rash on both arms from the wrist up to the elbows and it comes and goes. Some days it's red and some other days you can hardly see it, but it itches. Went to the pharmacy just the other day because she couldn't' stand it anymore. So she bought Benadryl and cream and was told to take 2 tablets that night, this all happened at night and she put on the cream. Some days the rash is red and some days it's not.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: lost hearing in his right ear; he was a little achy and his arm was sore; his arm was sore; This is a spontaneous report from a contactable consumer. A 30-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm at the age of 30 years old on 11Aug2021 (Batch/Lot Number: FC3181; Expiration Date: 01Oct2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from 1991 and ongoing. There were no concomitant medications. The patient reported getting his first vaccine 11Aug2021 at noon and stated that by 8 o'clock he lost hearing in his right ear. He wanted to know if this is a reported side effect of the vaccine, if it is a known occurrence or a coincidence. He stated that this is not ringing in the ear, if he was to put the phone up to the right ear he would only hear about 50 percent of the sound. He stated it is not ringing and not pressure, it is a loss of everything especially on the right side. He stated he got his shot at noon and by 8 o'clock he noticed a change in his hearing. He stated he was a little achy and his arm was sore, but it has really been his right ear. No treatment was received. The outcome of the event lost hearing in his right ear was not recovered. The outcome of other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Procedural complication
Clinical narrative: bad complication after the after cosmetic surgery (liposuction) and needed a blood transfusion; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 13Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report. A contactable consumer (patient) reported that a 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 19Apr2021 (Batch/Lot number was not reported) as dose 1, single (at the age of 38 years old) for COVID-19 immunisation.  The medical history and concomitant medications were not reported.  The patient experienced a bad complication after the after cosmetic surgery (liposuction) and needed a blood transfusion on an unspecified date. It has been about 4 months since her first vaccine.  The outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 4 days later tested positive for covid; This is a spontaneous report received from a contactable pharmacist. A 52-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 23Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the 1st dose of the vaccine and 4 days later on an unspecified date tested positive for covid. As per pharmacist, the patient has completed quarantine, and was asymptomatic. Reporter had concern, can the patient receive the second dose of the vaccine and wanted to know packaging sealed and intact. Vaccination of people with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and they had met criteria to discontinue isolation. This recommendation applied to people who experience SARS-CoV-2 infection before receiving any vaccine dose and those who experience SARS-CoV-2 infection after the first dose of an mRNA vaccine but before receipt of the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unknown date. The outcome of the events was reported as unknown.  Description of complaint: Pharmacist calling since there was a patient that received the covid vaccine first dose and four days later tested positive for covid. Asking if the patient should receive the second dose. He declined to complete report. He does not have lot number to provide.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Dyspnoea, Palpitations
Clinical narrative: heart arrhythmias; shortness of breath; heart palpitations; This is a spontaneous report from a contactable consumer.   A 58-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications. The patient previously took first dose of bnt162b2 via an unspecified route of administration, on unspecified date (Batch/Lot Number: not reported) as for covid-19 immunization. On an unspecified date, after his 2nd dose, the patient was having shortness of breath, heart palpitations, and heart arrhythmias, not still experiencing them, but experienced after the vaccine. The patient was asking had there been any data or studies on whether to get another or a different vaccine as a booster. Caller states, there will be a time limit on how long these vaccines will be effective. He was concerned about taking a booster shot. The outcome of events was recovered on unspecified date.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Ejection fraction, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis, SARS-CoV-2 test
Clinical narrative: myocarditis following SARS-CoV-2 vaccination; This is a literature report. This author reported similar events for five patients. This is the third of five reports.  An adult male patient (age range 20-25 years) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have an infectious prodrome. The patient developed severe chest pain and elevated troponin I. The patient developed CMR-proven myocarditis shortly after vaccination. The patient experienced myocarditis following sars-cov-2 vaccination, 2 days after the second vaccination. Lag between vaccination and presentation: 2 days. Symptoms at presentation included non-positional chest pain radiating to back; myalgia and; malaise. The patient had fever on presentation. Electrocardiogram showed sinus rhythm with diffuse ST elevation and PR depression; non-sustained ventricular tachycardia. Peak cardiac troponin 1 was 13.4 ng/mL. Ejection fraction (normal >55%) was 48%. The patient had negative nasopharyngeal SARS-CoV-2 PCR testing. CMR revealed patchy midmyocardial increased T2 signal with corresponding late gadolinium enhancement consistent with the acute inflammation of myocarditis. The patient did not develop any other complications and was discharged home. The outcome of the event was unknown.   Although the clinical presentation, CMR findings, and temporal association strongly suggest the possibility of vaccine associated myocarditis in the patient, the authors cannot conclude definitively that COVID-19 vaccine was causative or that other etiologies for myocarditis can be definitively excluded in the patient. Nevertheless, clinicians should be suspicious of myocarditis in recently vaccinated patients with symptoms consistent with this diagnosis.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event, a possible contribution of the drug to the event cannot be excluded.  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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202100999284 same article/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Troponin I
Clinical narrative: myocarditis following SARS-CoV-2 vaccination; This is a literature report. This author reported similar events for five patients. This is the third of five reports.  An adult male patient (age range 20-25 years) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have an infectious prodrome. The patient developed severe chest pain and elevated troponin I. The patient developed CMR-proven myocarditis shortly after vaccination. The patient experienced myocarditis following sars-cov-2 vaccination, 2 days after the second vaccination. Lag between vaccination and presentation: 2 days. Symptoms at presentation included non-positional chest pain radiating to back; myalgia and; malaise. The patient had fever on presentation. Electrocardiogram showed sinus rhythm with diffuse ST elevation and PR depression; non-sustained ventricular tachycardia. Peak cardiac troponin 1 was 13.4 ng/mL. Ejection fraction (normal >55%) was 48%. The patient had negative nasopharyngeal SARS-CoV-2 PCR testing. CMR revealed patchy midmyocardial increased T2 signal with corresponding late gadolinium enhancement consistent with the acute inflammation of myocarditis. The patient did not develop any other complications and was discharged home. The outcome of the event was unknown.   Although the clinical presentation, CMR findings, and temporal association strongly suggest the possibility of vaccine associated myocarditis in the patient, the authors cannot conclude definitively that COVID-19 vaccine was causative or that other etiologies for myocarditis can be definitively excluded in the patient. Nevertheless, clinicians should be suspicious of myocarditis in recently vaccinated patients with symptoms consistent with this diagnosis.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event, a possible contribution of the drug to the event cannot be excluded.  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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202100999284 same article/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Caller received both doses of the Pfizer Covid-19 vaccine FEB2021 and started having complaints of itching that persists to this day; This is a spontaneous report from a contactable consumer. This 90-year-old female consumer (patient) reported for herself that she 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 in Feb2021 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 in Feb2021 as dose 2, single for COVID-19 immunization. The medical history of the patient included allergy to penicillin and previously had to go the hospital due to having a reaction to penicillin. The patient's concomitant medications were not reported. On an unknown date the patient reported complaints of itching with the Pfizer Covid-19 vaccine. The event outcome was unknown. Caller asked if she should get the third dose of the Pfizer Covid-19 vaccine.  The lot number for the vaccine, [enter generic Pfizer vaccine name], was not provided and would be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: pain around her heart; shortness of breath; This is a spontaneous report received from a contactable consumer or other non hcp. A 75-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 06Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain around her heart and shortness of breath on an unspecified date. Outcome of the events was unknown. PQC Details: Product: Pfizer-Biontech Covid-19 Vaccine. Question: Does the Pfizer BioNTech Covid 19 vaccine cause any heart issues? Response: spoke as per doc attached and referred back to HCP. Product: Pfizer-Biontech Covid-19 Vaccine, Question: Transfer from Agent in DSU NTID CHILDA09 REP: 0L7OP1U2 (duplicate AE etransmitted incase additional information was conveyed during call. Caller, female, aged 75, received both doses of the Pfizer BioNTech Covid 19 vaccine on 13Feb2021 and 6Mar2021. She is still experiencing shortness of breath and pain around her heart. She is concerned after hearing that the creator of the original mRNA vaccine is no longer involved with making the vaccines and has warned not to give the vaccine to children under the age of 12 for at least two years, and that the mRNA technology is not working the way he had initially thought it would. She wants to know if there are any known fertility issues with the vaccine? She has several nieces and nephews as well as a grandson who are in their childbearing years. Response: spoke as per Infertility CONS attached and referred back to HCP.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itching; hives; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  Medical history included systemic lupus erythematosus (SLE) and the patient reported that he was allergic to penicillin, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 12Aug2021 (about 8 hours later after the injection), the patient experienced itching and hives. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL. The patient outcome of the events was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: currently having dental issues; This is a spontaneous report from a Pfizer sponsored program Support. A contactable consumer reported for a male patient (reporter's husband) that a male patient of an unspecified age received bnt162b2 (BNT162B2 Solution for injection), dose 1 via an unspecified route of administration on 28Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced currently having dental issues on Aug2021.  received his 1st dose 28Jul and has been having dental issues may need to start antibiotics. The caller wants to know if there are contraindicatios  bewteen the vaccine and antibiotics. Will Fax AE for dental issues after the 1st dose. Relayed PMI and transferred to PMI withheld for more information. Support CEP. The outcome of the event was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Migraine, Paraesthesia
Clinical narrative: numbness in my leg; pins and needles in my legs from the knees down; had something neurological migraine; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer reported for herself. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 10Apr2021 as dose 2, single for COVID-19 immunisation. Medical history included psoriasis she has a history of psoriasis, stroke from Feb2016 to an unknown date. She was placed on warfarin daily because she has atrial fibrillation. Concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, after the vaccination she developed pins and needles in my legs from the knees down, it got bad for a while. Caller asked because of insurance, if is there a specific type of doctor she should go to. It was reported that I still had the numbness in my leg and had something neurological migraine. I had pins and needles, never had this experience before, I had this second shot. My first shot does not gave me any of that but when I had my second shot I live with this, its not constant but right now it's been going on since 3:30 pm and I still had the numbness in my leg. Just merely strong pins of needles feeling in my leg and I had never called to let anyone know that happened it was right after the shot I had it. Now that's been several months now, and I still get it like I thought it will go away, but it is still, every other day several times a week it comes back to me. So, I dont know I am on blood thinners. Somebody said something about maybe it's a prerequisite to stroke that I already had a stroke in the past that didn't had anything like that. I had something neurological, migraine. I dont know if this is affecting my blood vessels in my legs so I am having this experience all the time and asked what she do to prevent it. I do take Warfarin so because of my stroke and I had AFib but that this is totally different. The clinical outcome of the event numbness in my leg, pins and needles in my legs from the knees down was not resolved and the event had something neurological migraine was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101050574 same reporter/drug/AE with different patient(s).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Migraine, Neuralgia, Vaccination site pain
Clinical narrative: Migraine Headaches, Severe Nerve Pain in the Left Arm at injection site.; Migraine Headaches, Severe Nerve Pain in the Left Arm at injection site.; Migraine Headaches, Severe Nerve Pain in the Left Arm at injection site.; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8734), as dose 1, single and dose 2, single (Lot number: ER8735), both via unspecified routes of administration, in left arm on 07Apr2021 (at the age of 67-years-old), for COVID-19 immunization. Medical history included chronic lower back pain due to osteoarthritis and codeine allergy. Concomitant medications included atorvastatin, clonazepam, tadalafil (CIALIS) and fluticasone propionate (FLUTICASON). No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced migraine headaches, severe nerve pain in the left arm at injection site on 07Apr2021. Both the doses were reported to be given on the same date. The event resulted in doctor/ other healthcare professional office visit and disability or permanent damage. The patient received treatment for the event which included Imitrex and Neurontin. The outcome of all events was not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Angiogram, Colitis ischaemic, Colonoscopy, Magnetic resonance imaging
Clinical narrative: iagnosed with Ischemic Colitis; then began to have frank blood coming from my rectum.; severe abdominal pain; swelling to area; This is a spontaneous report from a contactable Nurse reporting for herself. This 32-year old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number 6H9899) via unspecified route of administration on the right arm on 16Dec2020 at 03:15 PM (at the age of 32-year old) at single dose for COVID-19 immunization at hospital. Relevant medical history included hypothyroidism. There no known history of drug allergy and no concomitant medications. On 16Dec2020 after vaccination the patient experienced swelling to area. On 18Dec2020 at about 08:30 PM the patient began to have severe abdominal pain, then frank blood coming from her rectum. She went to the hospital and was admitted for 2.5 days and diagnosed with ischemic colitis after after CTA of abdomen, MRI of abdomen and then finally an EGD and Colonoscopy. Treatment of events was reported to be CTA, MRI, EGD, Colonoscopy, Medications. The events resulted in emergency room/department or urgent care and hospitalization. The outcome of the events was recovered.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (Ischemic colitis, Rectal hemorrhage, Abdominal pain) and the administration of the vaccine cannot be excluded.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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Oesophagogastroduodenoscopy, Rectal haemorrhage, Swelling
Clinical narrative: iagnosed with Ischemic Colitis; then began to have frank blood coming from my rectum.; severe abdominal pain; swelling to area; This is a spontaneous report from a contactable Nurse reporting for herself. This 32-year old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number 6H9899) via unspecified route of administration on the right arm on 16Dec2020 at 03:15 PM (at the age of 32-year old) at single dose for COVID-19 immunization at hospital. Relevant medical history included hypothyroidism. There no known history of drug allergy and no concomitant medications. On 16Dec2020 after vaccination the patient experienced swelling to area. On 18Dec2020 at about 08:30 PM the patient began to have severe abdominal pain, then frank blood coming from her rectum. She went to the hospital and was admitted for 2.5 days and diagnosed with ischemic colitis after after CTA of abdomen, MRI of abdomen and then finally an EGD and Colonoscopy. Treatment of events was reported to be CTA, MRI, EGD, Colonoscopy, Medications. The events resulted in emergency room/department or urgent care and hospitalization. The outcome of the events was recovered.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (Ischemic colitis, Rectal hemorrhage, Abdominal pain) and the administration of the vaccine cannot be excluded.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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Menstruation irregular
Clinical narrative: irregular vaginal bleeding/ period should not start for another two weeks, the period started within 36 hours after the vaccination; Dose 1 (31Mar2021)/Dose 2 (09Aug2021); This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 09Aug2021 18:00 (at the age of 33-years-old) as dose 2, single for covid-19 immunization in a Pharmacy or Drug Store.  Patient had no relevant medical history or known allergies.  The patient is not pregnant at the time of vaccination. Concomitant medication included regular birth control pills (unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 31Mar2021 10:00 at a dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks. Since the vaccination, has the patient has not been tested for COVID-19. On 11Aug2021 12 am, the patient experienced irregular vaginal bleeding described as the period should not start for another two weeks however the period started within 36 hours after (as reported) the vaccination. Treatment was not taken for the event. The outcome of the event was reported as recovering at the time of the report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest discomfort, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Heart flutters; dizziness; shortness of breath; headaches; chest pressure; fatigue; This is a spontaneous report from a contactable consumer (reported herself). A 49-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration, administered in arm left on 04Apr2021 12:00 (age at vaccination 49-year-old) as dose number unknown, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Medical history included heart problems from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced heart flutters, dizziness, shortness of breath, headaches, chest pressure, fatigue on an unknown date of 2021 12:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment medication was received for the events. Since the vaccination, the patient was not tested for COVID-19. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Heart flutters; dizziness; shortness of breath; headaches; chest pressure; fatigue; This is a spontaneous report from a contactable consumer (reported herself). A 49-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration, administered in arm left on 04Apr2021 12:00 (age at vaccination 49-year-old) as dose number unknown, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Medical history included heart problems from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced heart flutters, dizziness, shortness of breath, headaches, chest pressure, fatigue on an unknown date of 2021 12:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment medication was received for the events. Since the vaccination, the patient was not tested for COVID-19. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate irregular, Lymphadenopathy, Neck pain
Clinical narrative: irregular heart rhythm; heaviness feeling in neck; swollen lymph nodes in left neck and breast since my first dose; fatigue; This is a spontaneous report from a contactable other HCP (patient). A 29-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 21Jun2021 (at the age of 29-years-old) as dose 1, single for covid-19 immunization. The patient was not pregnant at time of vaccination. The patient medical history was not reported. The patient was no known allergies. Concomitant medications included amitriptyline, received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 22Jun2021, the patient had not felt right since vaccine, which clarified that patient had swollen lymph nodes in left neck and breast since her first dose. The patient had been very fatigue and also have been experiencing a heaviness feeling in neck ever since as well. The patient have noticed a irregular heart rhythm too. The adverse events resulted in [Doctor or other healthcare professional office/clinic visit]. The patient did not received treatment for the events. The outcome of the events was reported as not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event Arrythmia cannot be completely excluded.The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Mental impairment
Clinical narrative: Significantly reduced mental clarity, or "brain fog"; Significantly reduced mental clarity, or "brain fog"; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Lot Number: EW0183)), dose 1 via an unspecified route of administration, administered in the left arm on 07May2021 (age at the time of vaccination was 26-year-old) and dose 2 via an unspecified route of administration on 28May2021 (Lot Number: EW0191); both as single dose for COVID-19 immunization. The patient's medical history included Sulfa drugs allergy. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergy. 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. Since the vaccination, the patient has not been tested for COVID-19. On 07May2021, the patient experienced significantly reduced mental clarity, or "brain fog". He felt these effects started immediately upon both doses and has lingered on for the past 3 months. The outcome of the events was not resolved.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable Other HCP. This 69-year-old female Other HCP reported for herself that: A 69-year-old female patient received second 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 14Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included first 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 (at the age of 69-year-old) as single dose for covid-19 immunisation. Patient reported I am immunocompromised, and I have Antiphospholipid syndrome, I took the first two doses. I don't have cancer and I don't take steroids. I had a reaction to the second dose I know it's the same. Should I even attempt to take the third dose. I don't think I will have a reaction when asked what reactions she experienced patient stated the typical reactions fever and chills. It was the second dose I took on 14Feb. It's been so long ago I don't even remember. This agent confirmed with the caller that she is speaking of the Pfizer Covid 19 Vaccine. This case assessed as non-serious by the reporter. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested