chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Hypoaesthesia, Joint swelling, Paraesthesia
Clinical narrative: Extreme joint pain all over body and swelling; Extreme joint pain all over body and swelling; Severe hair loss-comes out in bunches; numbness in neck radiating down arms into hands, right arm and hand are still tingling and numb; right arm and hand are still tingling and numb; This is a spontaneous report from a contactable consumer, the patient. This 65-year-old non-pregnant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0196) via unspecified route in the left arm on 20Jul2021 at 15:00 (at the age of 65-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, diabetes, COVID, and allergies to sulfa and penicillin. There were no other vaccines received within four weeks of the COVID vaccine. Concomitant medications received within two weeks of the vaccine included metformin, sitagliptin phosphate (JANUVIA), metoprolol, valsartan. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0181) via unspecified route in the left arm on 29Jun2021 at 15:00 (at the age of 65-years-old) as a single dose for COVID-19 immunization. On 21Jul2021 at 02:00, patient experienced extreme joint pain all over body and swelling, numbness in neck radiating down arms into hands, right arm and hand are still tingling and numb, severe hair loss-comes out in bunches. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment included unspecified medication to reduce pain. The outcome of the events was not recovered. The patient was not tested for COVID post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Raised red bumps, very itchy.; Raised red bumps, very itchy.; This is a spontaneous report from a contactable consumer, the patient. This 60-year-old  non-pregnant female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: ER8727) on 27Mar2021 at 10:45 (at the age of 59-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: ER8731), both in the left arm via unspecified route as single doses for COVID-19 immunization. Patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. Patient reported hyper reaction to topical gel product (store brand) in May2021 and then hyper-reaction (same type) to facial after having same products used pre-vaccine (Aug2021). Raised red bumps, very itchy. First time all over right upper body back and front; second time on face (jawline to forehead hairline and across to before ears). The onset date of the events was reported as 11Aug2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment for events included prednisone oral/cream for first reaction; oral second reaction. The outcome of the events was recovering. Since the vaccination, the patient has not been tested for COVID-19.   Follow-up (25Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Chest pain
Clinical narrative: bad chest pain; her heart is really tight; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 11Aug2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported she received the first dose on 11Aug2021 and since then she had been experiencing really bad chest pain and her heart was really tight. The patient inquired what she should do. The clinical outcomes of the events were not recovered.  The lot number for the vaccine was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cluster headache
Clinical narrative: cluster headaches; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Fa7484), via an unspecified route of administration in left arm on 23Jul2021 (at the age of 44-years-old) as dose 2, single for COVID-19 immunization. Medical history included hypertension and hypercholestremia. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient was not having any known allergies and was not pregnant. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Ew0181), via an unspecified route of administration in left arm on 03Jul2021 11:00 (at the age of 44-years-old) as dose 1, single for COVID-19 immunization. The patient experienced cluster headaches on 27Jul2021 16:00. The event resulted in emergency room or department or urgent care visit. The patient was treated with Oxygen and sumatriptan. Since the vaccination, patient has not been tested for COVID-19. Outcome of event was not resolved.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: Stroke; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150), unknown dose via an unspecified route of administration, administered in Arm Left on 14Apr2021(at the age of 36-years-old), as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 since the vaccination. Facility where the most recent COVID-19 vaccine was administered was other. Patient had taken Blood thinners and statin for reported events. Patient visited to emergency room/department or urgent care. On 30Jul2021 at 08:30 AM, the patient experienced stroke. The patient was hospitalized for stroke for 3 days. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab) was negative on 19Jul2021, sars-cov-2 test (Nasal Swab) was negative on 26Jul2021, and sars-cov-2 test (Nasal Swab) was negative on 31Jul2021. The outcome of the event was recovering.  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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus, Rash
Clinical narrative: Itching; rash; trouble breathe; This is a spontaneous report from a contactable consumer (patient reported for self). A 55-years-old (non-pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in left arm on 11Aug2021 11:00 (at the age of 55-years-old) as dose number unknown, single for COVID-19 immunisation (Reason why batch/lot is Unknown: Unable to locate or read the details). Medical history included sulfa allergy. The patient's concomitant medications were not reported. The patient previously received Shingles vaccine (Lot Number: not reported). Prior to the 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. On 13Aug2021 22:30, patient experienced itching, rash and trouble breathe. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of adverse events, treatment: Benadryl. Outcome of the events was reported as not recovered.  Device Date: 14Aug2021   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Dizziness, Dyspnoea, Nausea, Palpitations
Clinical narrative: my heart began to pound in my chest, beat out of rhythm, race/tachycardia; my heart began to pound in my chest, beat out of rhythm, race/tachycardia; my heart began to pound in my chest, beat out of rhythm, race/tachycardia; Dizziness; nausea; shortness of breath; fingers and toes went tingly and cold; fingers and toes went tingly and cold; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 39-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0198, Expiry date: unknown, at the age of 39-year-old), dose 1 via an unspecified route of administration, administered in Arm Left on 10Jul2021 03:00 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication. The patient previously took fentanyl for drug hypersensitivity and experienced drug hypersensitivity (known allergies: Fentanyl). No covid prior to vaccination or tested covid post vaccination. Patient did not receive any other vaccine in four weeks. The patient reported that within 2 min of vaccination my heart began to pound in my chest, beat out of rhythm, race/tachycardia on 10Jul2021 15:15. The patient experienced dizziness, nausea, shortness of breath. on 10Jul2021. The patient reported that her fingers and toes went tingly and cold on 10Jul2021. Patient sat for 30 plus minutes trying to regulate my breathing pattern and prevent passing out. Patient remained seated as instructed by the pharmacist. The event arrhythmia was reported as medically significant. It was reported that patient did not receive any treatment. The clinical outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral coldness, Tachycardia
Clinical narrative: my heart began to pound in my chest, beat out of rhythm, race/tachycardia; my heart began to pound in my chest, beat out of rhythm, race/tachycardia; my heart began to pound in my chest, beat out of rhythm, race/tachycardia; Dizziness; nausea; shortness of breath; fingers and toes went tingly and cold; fingers and toes went tingly and cold; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 39-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0198, Expiry date: unknown, at the age of 39-year-old), dose 1 via an unspecified route of administration, administered in Arm Left on 10Jul2021 03:00 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication. The patient previously took fentanyl for drug hypersensitivity and experienced drug hypersensitivity (known allergies: Fentanyl). No covid prior to vaccination or tested covid post vaccination. Patient did not receive any other vaccine in four weeks. The patient reported that within 2 min of vaccination my heart began to pound in my chest, beat out of rhythm, race/tachycardia on 10Jul2021 15:15. The patient experienced dizziness, nausea, shortness of breath. on 10Jul2021. The patient reported that her fingers and toes went tingly and cold on 10Jul2021. Patient sat for 30 plus minutes trying to regulate my breathing pattern and prevent passing out. Patient remained seated as instructed by the pharmacist. The event arrhythmia was reported as medically significant. It was reported that patient did not receive any treatment. The clinical outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Hospitalized for sever seizure; This is a spontaneous report from a contactable consumer. This 50-year-old male consumer (patient himself) reported received first dose of bnt162b2 (BNT162B2, Formulation was Solution for injection, Lot Number EW0162), dose 1 via unspecified route on an unspecified date in Apr2021 as dose 1, single and received second dose of bnt162b2 (BNT162B2, Formulation was Solution for injection, Lot Number EW0172), dose 2 via unspecified route on an unspecified date in May2021 as dose 2, single for COVID-19 immunization (age at time of vaccination 50 years). The patient medical history was none, and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient was not tested for COVID-19. On 22May2021 the patient was Hospitalized for sever seizure. The patient treatment received for the adverse event such as many tests, anti-seizure medication. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis allergic
Clinical narrative: Has had an allergic skin reaction on her face; This is a spontaneous report from a contactable nurse, the patient. This 62-year-old female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) on 15Mar2021 (at the age of 62-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECT COVID-19 mRNA VACCINE, Lot number: unknown) on 05Apr2021 (at the age of 62-years-old); both via unspecified route as single doses for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient reported she had Pfizer vaccine 15Mar and 05Apr. Since then patient has had an allergic skin reaction on face (2021). She had been treated with prednisone and antibiotics. Every time that she was done with the medicine the reaction flared up again. Patient clarified that this started after first dose and it got better. She decided to get the second dose and then it got really bad. The outcome of the event was not recovered.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information provided a contributory role of BNT162B2 to the event allergic skin reaction 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: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, SARS-CoV-2 test, Skin irritation
Clinical narrative: Has had an allergic skin reaction on her face; This is a spontaneous report from a contactable nurse, the patient. This 62-year-old female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) on 15Mar2021 (at the age of 62-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECT COVID-19 mRNA VACCINE, Lot number: unknown) on 05Apr2021 (at the age of 62-years-old); both via unspecified route as single doses for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient reported she had Pfizer vaccine 15Mar and 05Apr. Since then patient has had an allergic skin reaction on face (2021). She had been treated with prednisone and antibiotics. Every time that she was done with the medicine the reaction flared up again. Patient clarified that this started after first dose and it got better. She decided to get the second dose and then it got really bad. The outcome of the event was not recovered.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information provided a contributory role of BNT162B2 to the event allergic skin reaction 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: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Loss of consciousness, Menstrual disorder, Pain, SARS-CoV-2 test
Clinical narrative: The cramping is unbearable and cause me to pass out.; Periods every 10 days and last for at least 9 days.; The cramping is unbearable and cause me to pass out.; I have never felt worse pain in my life and it hasn't gone away since I got the vaccine; This is a spontaneous report from a non-contactable consumer (Patient herself). A 20-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; Lot number was not reported), via intramuscular route, administered in left arm on 04May2021 (at the age of 20 years) as dose 2, single for covid-19 immunisation. Medical history included allergies to mold and allergies to Azithromycin. The patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. Patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number was not reported) dose 1, single for covid-19 immunisation. The patient reported that she got her periods every 10 days and last for at least 9 days. The cramping was unbearable and cause her to pass out. She has never felt worse pain in her life, and it hasn't gone away since she got the vaccine on 11May2021. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab test which included covid test post vaccination which was negative on an unknown date. Patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: patient tested positive for COVID; patient tested positive for COVID; This is a spontaneous report from a contactable consumer. A 47-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via unspecified route of administration, on 11Mar2021 (at the age of 47-year-old), as single dose and received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via unspecified route of administration, on 01Apr2021 (at the age of 47-year-old), as single dose, both for COVID-19 immunization. The patient's medical history was not reported. Patient received the other medication in two weeks included cetirizine hydrochloride (ZYRTEC). On 16Aug2021 at 08:00, patient tested positive for COVID. No treatment received for the events. No covid prior vaccination. The patient underwent the lab tests and procedure which included the Covid test result was positive on 16Aug2021 and Nasal swab result was Negative on 13Aug2021. Outcome of the event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Rash macular, Vaccination site erythema
Clinical narrative: blotchiness; redness; diarrhea; little bit of congestion with her breathing; This is a spontaneous report from a contactable pharmacist via Team. A 19-years-old female patient received first dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, Solution for injection, Batch/Lot Number: FC3180, Expiry Date, NDC number, UPC number: unknown) via an unspecified route of administration on an unknown date in 2021 (last week) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that 2 days after the patient took her first dose she had redness and blotchiness on her arm where she received the injection (on an unspecified date in 2021) and also on other parts of her body. The patient also experienced diarrhea (on an unspecified date in 2021) and a little bit of congestion with her breathing (on an unspecified date in 2021). The patient was evaluated at an urgent care and was advised not to receive a second dose of the Pfizer COVID-19 vaccine. The patient does not currently have a Primary Care Provider. The patient and her mother came back to speak with the reporter on Friday (unspecified date) and asked if she thought the patient should receive a second dose of the vaccine or not. The patient was not treated with any medications by the urgent care provider. The event blotchiness was considered as serious (Medically Significant). The reporter stated that that the patient's symptoms have improved. The outcome of all events was recovering.; Sender's Comments: Based on temporal relationship the causal association between the event blotchiness and the usage of the vaccine cannot be excluded. The case will be reassessed when there is additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Blood test, Electrocardiogram, Investigation, Pyrexia
Clinical narrative: Fainted; Fever; Blindness; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received second dose of bnt162b2 (COMIRNATY COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 15Aug2021 05:45 PM (Batch/Lot number was not reported) as single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 25Jul2021 05:45 PM as single dose for COVID-19 immunization. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 16Aug2021, at 07:30 AM the patient experienced Fever, fainted, blindness, complete loss of vision for about 15 minutes. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment for the events with some Examinations, EKG, blood work. The patient underwent lab tests and procedures which included blood test: unknown results, electrocardiogram: unknown results, investigation: unknown results on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted; Fever; Blindness; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received second dose of bnt162b2 (COMIRNATY COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 15Aug2021 05:45 PM (Batch/Lot number was not reported) as single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 25Jul2021 05:45 PM as single dose for COVID-19 immunization. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 16Aug2021, at 07:30 AM the patient experienced Fever, fainted, blindness, complete loss of vision for about 15 minutes. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment for the events with some Examinations, EKG, blood work. The patient underwent lab tests and procedures which included blood test: unknown results, electrocardiogram: unknown results, investigation: unknown results on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Retinal vein occlusion
Clinical narrative: Had a Retinal Vein Occlusion in left eye within 30 days of second dose.; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for himself that a 39-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0176), via an unspecified route of administration, administered in Arm Left on Apr2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included bupropion hydrochloride (WELLBUTRIN); fluticasone propionate, salmeterol xinafoate (ADVAIR) and salbutamol (VENTOLINE). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number : EW0153), via an unknown route of administration on Apr2021 (Age at vaccination 39 years) as single dose for COVID-19 immunisation. On 04Jun2021 09:00, the patient experienced had a retinal vein occlusion in left eye within 30 days of second dose. Patient was received injection as treatment for event. Facility type Vaccine was pharmacy or drug Store. Patient was visited to emergency room and physician office, Disability or permanent damage. 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. Since the vaccination, patient has been not tested for COVID-19. The clinical outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Lung neoplasm malignant
Clinical narrative: lung cancer; This is a spontaneous report from a contactable consumer or other non hcp.     A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3246), via an unspecified route of administration, administered in Arm Right on 27Jan2021 (at the age of 67-year-old) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included ongoing asthma (Verbatim: Asthma allergy), non-tobacco user (second hand smoke from her parents). There were no concomitant medications.  Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3246, Expiry date: unknown), via unspecified route of administration on 08Jan2021 (at the age of 67-year-old) in left arm for COVID-19 immunization. The patient experienced lung cancer on 19Feb2021.  The patient underwent lab tests and procedures which included CT Scan (computerised tomogram): unknown results (calcium score). Patient completed her Pfizer Covid 19 vaccine series in January. Patient developed lung cancer in February, has surgery with part of lung removed and reports being immunocompromised. unable to assess causality of developing cancer after receiving Pfizer Covid 19 vaccine series. Patient got her first two Pfizer COVID vaccines. She has questions about a booster and if she needs to get it.She was diagnosed with lung cancer after the vaccine. Her cancer was an incidental finding. It was lung cancer, and they took part of her lung out. Caller did not have a prescribing doctor. She got it at the hospital incase of a reaction. She got it at the (name). Her surgery was the 23Mar2021 to remove the cancer. She is sure its not related to the vaccine because it was right after. Her cancer was stage 1b. Therapeutic measures were taken with surgery on 23Mar2021 as a result of lung cancer. The outcome of event was recovered on unspecified date.  Follow-up (19Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Loss of consciousness, Malaise
Clinical narrative: Not feeling good, feeling awful, after first vaccine; Passed out after first vaccine; Tested positive for Covid virus, after first vaccine; Tested positive for Covid virus, after first vaccine; This is a spontaneous report from a contactable consumer. A 69-year-old male patient (reporter's Brother) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 03Aug2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Aug2021, after first vaccination, patient was not feeling good and was taken to the hospital by ambulance on 06Aug2021. Patient Passed out. And when he was in the emergency room, they tested him for COVID and he tested positive. It was reported that patient had an appointment last Friday (on an unspecified date), to see a primary doctor because he wasn't feeling good. Event malaise resulted in emergency room and physician office visit. The patient underwent lab tests and procedures which included sars-cov-2 test resulted positive on an unspecified date in Aug2021. Reporter wanted to know can the Pfizer shot, give patient COVID, and states that she got the shot the same week as patient and she was reading her information sheet that was provided about the side effects, her brother has all of them, and was feeling awful. Reporter asked, when can patient take another Covid test to see if he was still positive, should he get the second vaccine within the 21 days or wait. Report does not relate to a study or programme. The clinical outcome for events was unknown.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Throat tightness
Clinical narrative: Itching and skin redness from head to toe; Itching and skin redness from head to toe; Didn't want throat to close, took a couple Benadryl; This is a follow up spontaneous report from a pfizer sponsored program. A 60-years-old female contactable consumer or other non hcp (patient)received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: solution for injection, Lot Number ER8727, expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 26Mar2021 (time of vaccination was later morning) (at age of 60-year-old) as DOSE 1, SINGLE for covid-19 immunization at Big Tent Facility in the parking lot (60 year when vaccinated). Medical history included multiple sclerosis from 1995 and ongoing, also the patient is immune compromised due to which the vaccine may protect her only 30 to 40%. Patient did not take concomitant medications (No other products). No additional vaccines administered on same date of the Pfizer suspect. No AE (adverse event) following prior vaccinations. No Prior Vaccinations (within 4 weeks). No family medical history relevant to AE. Flu shot, arm will get sore and itch. No further details provided. On 26Mar2021, 2-3 hours post vaccination the patient developed Itching all over Skin, head to toe Itching really bad and got red. On an unknown date in 2021, the patient also reported that she doesn't want to close the throat. As hours went by, skin was coming back to natural colour wasn't itching as much. The patient did not visit the doctor not admitted to emergency room due to the events. The patient was asked to delay the second dose of vaccination as that could cause her to admit in the emergency room because of she is on a drug that suppresses her immune system. The patient was scheduled to receive her second dose on 16Apr2021, but she did not do the vaccination. The patient also reported that as she doesn't want her throat to close, she took Benadryl. There was no investigation assessment. There was Product Complaint. No relevant tests. The outcome of the events was reported as unknown, while for the event throat constriction it was reported as recovered.   Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: Breakthrough case of Covid-19 infection after Covid-19 vaccination.; Breakthrough case of Covid-19 infection after Covid-19 vaccination.; This is a spontaneous report from a contactable physician. A 66-year-old male patient received second dose of bnt162b2 (BNT162B2), intramuscular on 02Mar2021 (Lot number was not reported) as single dose, first dose intramuscular on 03Feb2021 (Lot number was not reported) as single dose for covid-19 immunisation, age at vaccination 66-year-old. Medical history and concomitant medications were not reported. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 13Aug2021 patient experienced covid-19 infection after covid-19 vaccination (reported as breakthrough case of Covid-19 infection after Covid-19 vaccination). Event resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. Since the vaccination, the patient has been tested for COVID-19. The patient underwent laboratory tests and procedures which included Polymerase chain reaction (PCR) Nasal Swab positive on 15Aug2021. Patient had not recovered from the event, at the time of the report.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had the breakthrough infections had had two doses of the Pfizer vaccine; had the breakthrough infections had had two doses of the Pfizer vaccine; This is a spontaneous report from a contactable physician reporting same events under the same suspect product for 10 total number patients. This is one of 10 reports.  A patient of unspecified age and gender received two doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported ten patients had breakthrough infections. Local pharmacies in their area giving booster dose and the patients that had had the breakthrough infections had had two doses of the Pfizer vaccine on an unspecified date with outcome of unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID  infections  based on the known safety profile.,Linked Report(s) : US-PFIZER INC-202101100913 same reporter/SD/AE, different patient;US-PFIZER INC-202101100917 same reporter/SD/AE, different patient;US-PFIZER INC-202101100916 same reporter/SD/AE, different patient;US-PFIZER INC-202101100920 same reporter/SD/AE, different patient;US-PFIZER INC-202101100915 same reporter/SD/AE, different patient;US-PFIZER INC-202101100918 same reporter/SD/AE, different patient;US-PFIZER INC-202101100122 same reporter/SD/AE, different patient;US-PFIZER INC-202101100914 same reporter/SD/AE, different patient;US-PFIZER INC-202101100919 same reporter/SD/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She went in to get tested and it came back positive.; She went in to get tested and it came back positive.; This is a spontaneous report from a contactable consumer or other non hcp. An adult nonpregnant female patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on Mar2021 as dose 2, single for COVID-19 immunization. Previously the patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient's medical history and concomitant medications were not reported. The reporter reported that the patient went out for a small bachelorette party with 4 other friends the first week of August. All wore masks and very healthy. All had been vaccinated and they were mostly outdoors the whole weekend. The patient came home on 09Aug2021. Again, on 10Aug2021, the patient went back and since 12Aug2021, the was feeling sick with covid-Symptoms. The patient then went for SarS-cov-2 infection test and the results came positive. The patient was not treated for the events. The outcome of the events was reported as recovering for covid-19 and unknown for vaccination failure.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: This is a Spontaneous report from PFIZER Sponsored program from a contactable consumer (Patient's wife). A male patient of an unspecified age received BNT162B2, dose 1 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a stroke (medically significant) on 2021 with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: after the 1st dose had a stroke; This is a spontaneous report from a non contactable consumer (Patient's wife)  A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient after the 1st dose had a stroke (medically significant) on an unspecified date with outcome of unknown.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Carditis
Clinical narrative: she knows of a young gentleman who took the shot of the vaccine and developed carditis; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter state that" she knows of a young gentleman who took the shot of the vaccine and developed carditis" on an unspecified date with outcome of unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: Patient was deadly ill for a week, she ran a fever and everything; Patient was deadly ill for a week, she ran a fever and everything; This is a spontaneous report from a contactable consumer and other health professional. A female patient of an unspecified age received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient was deadly ill for a week, she ran a fever and everything (medically significant) on an unspecified date with outcome of recovered after 1 week.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Seizure
Clinical narrative: He passed out; He was convulsing on the floor; This is a spontaneous report from a contactable consumer (patient's wife). A 36-year-old male patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 16Aug2021 at 14:00 (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. Not even a minute after vaccination the patient passed out (medically significant) on 16Aug2021 with outcome of unknown, he was convulsing on the floor (medically significant) on 16Aug2021 with outcome of unknown. Emergency number was called. No therapeutic measures were taken.   The lot number for bnt162b2 was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Cataract
Clinical narrative: misplaced their vaccination cards which are needed for their cataract surgery; This is a spontaneous report from a Non contactable consumer via Pfizer-sponsored program.  A patient of unknown age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On unknown date, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient misplaced vaccination card which was needed for cataract surgery. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She does actively have Covid but they are not treating her for Covid; She does actively have Covid but they are not treating her for Covid; This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 14Mar2021 (Lot number was not reported) as single dose, and dose 1 via an unspecified route of administration on 14Feb2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included immunosuppression. Concomitant medications were not reported. On an unknown date in 2021 patient actively had covid but they were not treating her for covid. Pharmacist calling on behalf of a patient, asking about getting a third dose or booster shot. The patient did get a blood transfusion 10 days before the time of the report. They were asking if they can provide a third dose to the patient. It was reported that patient is immunosuppressed and falls in the categories that would make her eligible for a third dose or booster dose. The patient did get a whole blood transfusion, not related to covid, and it was not concentrated Covid antibodies. In the 90 day waiting period, post blood sample from whole blood transfusion, does that make her wait 90 days because of the treatment. She will continue to get regular whole blood transfusions because of her immune status. She does actively have Covid but they are not treating her for Covid. Patient needs a blood transfusion for how sick she was. She was getting whole blood. There is more of a problem with those with active, live vaccines. Pharmacist wanted to make sure there was enough spacing limitations. Clarified that the caller was referring to the Pfizer Covid-19 vaccine. The first dose was given 14Feb2021 and the second dose was 14Mar2021. The day of the report would be the third dose and would be out of the 28 day spacing required after the second dose. Pharmacist did not know if they screen blood for Covid antibodies or not, she guessed they don't. When giving therapy for Covid with convalescent plasma, she knows they would space it out 90 days. Reporter wanted to know if she needs a waiting period for whole blood. The patient is immunosuppressed and is exposing everyone by doing so. Reporter clarified that the patient does not actively have Covid (as reported). Outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective , COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive to COVID after being vaccinate in March and April/runny nose; Tested positive to COVID after being vaccinate in March and April/runny nose; This is a spontaneous report from a contactable consumer (patient). A 17-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 26Mar2021 (at the age of 17-years-old) (Batch/Lot Number: EP6955) as dose 1, single then intramuscular, administered in the left arm on 16Apr2021 (Batch/Lot Number: EP6955) as dose 2, single for COVID-19 immunization. Medical history included allergies: penicillin. Concomitant medications were not reported. On 15Aug2021, the patient experienced runny nose. The patient had a nasal swab on 16Aug2021 that resulted positive. The patient tested positive to COVID after being vaccinate in March and April. The events were considered non-serious by the consumer. The patient was recovering from the events and had no treatment.  No follow-up attempts are possible. No further information is expected.