chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: right arm he has two fingers that have been numb for 3 weeks; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, NDC number and Expiry Date were not provided), via an unspecified route of administration, administered in Left arm on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Investigation Assessment was not provided. The Reporter was calling about the Pfizer covid vaccine. The patient had the vaccine on his left arm but his right arm, he has two fingers that have been numb for 3 weeks on an unspecified date. The second dose was supposed to be this Friday. The reporter asked, what should he do? Should he get the second dose? His doctor said to call Pfizer? The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: ill; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program.  A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC 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 taking both doses of the Pfizer COVID 19 vaccine, patient became ill; went to the doctor and was in the hospital. Patient was seeking compensation. 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, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID 19 test after first dose of vaccination; positive COVID 19 test after first dose of vaccination; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date patient experienced positive covid 19 test after first dose of vaccination. It was reported that, patient stated that patient and a few of her coworkers all tested positive after they already had the first dose of the Pfizer COVID 19 vaccination. Patient and one other coworker have both tested negative now. Patient would like to know if she needs to start the series over again or if she can receive her second dose of the vaccine today. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (She states that she and a few of her coworkers all tested positive after they had already had the first dose of the Pfizer COVID 19 vaccination) on unspecified date and sars-cov-2 test: negative (She and one other coworker have both tested negative now) on unspecified date.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Vaginal haemorrhage
Clinical narrative: She stated it was most likely due to the COVID shot messing up my menstrual cycle and causing excessive bleeding; vaginal bleeding was out of control/causing excessive bleeding; This is a spontaneous report from a contactable consumer. This 43-year-old female consumer (Patient) reported.  A 43-year-old (non-pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in arm right on 10Jun2021 09:00 (at the age of 43-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date (at the age of 43-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After the vaccination, the patient did not have a menstrual cycle the rest of the month or most of July. Then on Sat. 31Jul2021 7:00 AM patient started bleeding bright red blood vaginally and Sunday 01Aug2021 she was rushed to the Emergency Room because the vaginal bleeding was out of control. she went to her Doctor on 04Aug2021 and was tested for everything. Nothing came back abnormal. She stated it was most likely due to the COVID shot messing up my menstrual cycle and causing excessive bleeding. The patient was not diagnosed with covid prior vaccination and patient didn't test for covid post vaccination. No allergies reported. The outcome of the events was recovering.  No follow-up attempts possible. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Heart rate increased, Hypertension, Lip swelling, Palpitations
Clinical narrative: Had a rash; Hives; Iching from Mid waiste to top of head; High Blood pressure; Ponding Heart; Rasing Heart; Vision was effected; Anxious felt like I was in a cloud; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; This is a spontaneous report from a contactable other healthcare professional (Patient). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8727), first dose via an unspecified route of administration, administered in left arm on 29Mar2021 at 10:45 (at the age of 53-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/(privacy) administration facility. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing, menopause from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took propofol and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient also administered with Other Vaccine (lot number=EW0161) on 29Mar2021 in Left arm as dose 2 single. On an unspecified date in Mar2021 at 10:45, had a rash, Hives, Itching from Mid waist to top of head. High blood pressure, Ponding Heart, Raising Heart. Vision was affected, Anxious felt like I was in a cloud. Her tongue lips and throat started to tingle and swell. Told many providers trying to figure out what was going on. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability, or permanent damage.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug bnt162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pharyngeal paraesthesia, Pharyngeal swelling, Pruritus, Rash
Clinical narrative: Had a rash; Hives; Iching from Mid waiste to top of head; High Blood pressure; Ponding Heart; Rasing Heart; Vision was effected; Anxious felt like I was in a cloud; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; This is a spontaneous report from a contactable other healthcare professional (Patient). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8727), first dose via an unspecified route of administration, administered in left arm on 29Mar2021 at 10:45 (at the age of 53-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/(privacy) administration facility. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing, menopause from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took propofol and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient also administered with Other Vaccine (lot number=EW0161) on 29Mar2021 in Left arm as dose 2 single. On an unspecified date in Mar2021 at 10:45, had a rash, Hives, Itching from Mid waist to top of head. High blood pressure, Ponding Heart, Raising Heart. Vision was affected, Anxious felt like I was in a cloud. Her tongue lips and throat started to tingle and swell. Told many providers trying to figure out what was going on. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability, or permanent damage.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug bnt162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Urticaria, Visual impairment
Clinical narrative: Had a rash; Hives; Iching from Mid waiste to top of head; High Blood pressure; Ponding Heart; Rasing Heart; Vision was effected; Anxious felt like I was in a cloud; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; This is a spontaneous report from a contactable other healthcare professional (Patient). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8727), first dose via an unspecified route of administration, administered in left arm on 29Mar2021 at 10:45 (at the age of 53-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/(privacy) administration facility. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing, menopause from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took propofol and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient also administered with Other Vaccine (lot number=EW0161) on 29Mar2021 in Left arm as dose 2 single. On an unspecified date in Mar2021 at 10:45, had a rash, Hives, Itching from Mid waist to top of head. High blood pressure, Ponding Heart, Raising Heart. Vision was affected, Anxious felt like I was in a cloud. Her tongue lips and throat started to tingle and swell. Told many providers trying to figure out what was going on. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability, or permanent damage.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug bnt162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Body temperature, Body temperature decreased, Chest pain, Cough
Clinical narrative: Bad cough; Chest still hurts; Heart beating fast and kind of hurt; Only got a couple hours of sleep; Heart beating fast and kind of hurt; Stuffy; Low temp; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 30-year-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Aug2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced heart beating fast and kind of hurt leading to angina pectoris, stuffy leading to nasal congestion, low temp leading to body temperature decreased, bad cough, chest still hurts leading to chest pain, heart beating fast and kind of hurt leading to heart rate increased and she only got a couple hours of sleep leading to insomnia on Aug2021. The patient underwent lab tests and procedures which included body temperature at 97.5 Fahrenheit, she is usually 97.5 but running 99.5 , sars-cov-2 test: negative on 26Aug2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Insomnia, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Bad cough; Chest still hurts; Heart beating fast and kind of hurt; Only got a couple hours of sleep; Heart beating fast and kind of hurt; Stuffy; Low temp; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 30-year-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Aug2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced heart beating fast and kind of hurt leading to angina pectoris, stuffy leading to nasal congestion, low temp leading to body temperature decreased, bad cough, chest still hurts leading to chest pain, heart beating fast and kind of hurt leading to heart rate increased and she only got a couple hours of sleep leading to insomnia on Aug2021. The patient underwent lab tests and procedures which included body temperature at 97.5 Fahrenheit, she is usually 97.5 but running 99.5 , sars-cov-2 test: negative on 26Aug2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: HV 2 flare up ( previously undiagnosed) in August; This is a spontaneous report from a contactable consumer or other non hcp (male patient). A 60-years-old male patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported), via an unspecified route of administration, administered in Arm Left on 05Apr2021 11:00 as 2nddose, single for COVID-19 immunisation (Age at vaccination was 60 years). Historical vaccine was a 60-years-old male patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported), via an unspecified route of administration, administered in Arm Left on 15Mar2021 as 1st dose, single for COVID-19 immunisation. Medical history included (High blood pressure) hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included amlodipine besilate (AMLODIPINE BESILATE) taken for an unspecified indication, start and stop date were not reported; prazosin (PRAZOSIN) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; pravastatin (PRAVASTATIN) taken for an unspecified indication, start and stop date were not reported.  The patient experienced hv 2 flare up (previously undiagnosed) in august on 07Aug2021.Patient must visit the physician office. Outcome of the event was recovered with sequelae.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy for 3-5 weeks; This is a spontaneous report from a contactable consumer. An adult male patient received BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: Unknown), dose 1 via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Post-vaccination, patient experienced Bell's palsy for 3-5 weeks. The clinical outcome of the event was unknown.   Information about batch/Lot number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmological examination, Retinal detachment, Vitreous floaters
Clinical narrative: Detached Retina left eye; experiencing dark floaters; This is a spontaneous serious report from a contactable consumer (patient herself).  A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jul2021 (Batch/Lot Number: EW0180) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration, administered in Arm Left on 09Aug2021, at noon (Batch/Lot Number: GN0191) as DOSE 2, SINGLE, (age at vaccination was 51 years old) for covid-19 immunisation. Medical history included broken thumb from 07Aug2021 to an unknown date. The patient's concomitant medications included allergy shot, current frequency every 3 weeks for allergy (last dose was on 29Jul2021, has received on and off for the last decade). Patient reported receiving second dose of Pfizer covid vaccine 09Aug2021 and a couple of days after (unspecified date in Aug2021) she started experiencing dark floaters. She developed a detached retina of the left eye with 2 tears. She had an eye exam on 17Aug2021 and was referred to a specialist. She had surgery that same day due to having the detached retina with 2 tears. The events required a visit to Physician Office. She had no AE(s) following prior vaccination (first dose). Patient stated she has not had any trauma to her eye at all prior to this. She would like to report this experience. Unable to provide outcome of event for dark floaters. She is still is unable to see out of her left eye. Patient adds that she read where others have reported this and ocular issues. Details are unknown to her. One was a science article. She forgot where she read the other one. They were different articles but with the same issues. She is unsure if this has been reported. The patient underwent lab tests and procedures which included eye exam (ophthalmological examination): two tears and a detached retina left eye on 17Aug2021. Treatment for the events was eyesurgery performed on 17Aug2021. The outcome of detached retina left eye was recovered/resolved with Sequel on 17Aug2021 and outcome for experiencing dark floaters in eye was unknown.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate, Heart rate increased, Hyperhidrosis
Clinical narrative: Heart Rate 170 for 2 hrs; vaccine is administered outside the range19 - 42 days after the first dose; Insomnia; Fever; Sweets; Chills; Headache; This is a spontaneous report from a non-contactable consumer (Patient). A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on 22Apr2021 10:15 (at the age of 31-year-old) as single dose for covid-19 immunisation. The patient medical history was reported as none. Concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on 25Feb2021 10:15 as single dose for covid-19 immunisation. On 22Apr2021 23:00, the patient experienced heart rate 170 for 2 hrs, vaccine is administered outside the range19 - 42 days after the first dose, insomnia, fever, sweets, chills and headache. The patient underwent lab tests and procedures which included heart rate: 170 for 2 hrs. No treatment was received to treat this adverse event. The events insomnia, heart Rate 170 for 2 hrs, fever, sweets, chills, headache were recovered on an unspecified date in 2021 and outcome of vaccine is administered outside the range19 - 42 days after the first dose was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Insomnia, Pyrexia
Clinical narrative: Heart Rate 170 for 2 hrs; vaccine is administered outside the range19 - 42 days after the first dose; Insomnia; Fever; Sweets; Chills; Headache; This is a spontaneous report from a non-contactable consumer (Patient). A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on 22Apr2021 10:15 (at the age of 31-year-old) as single dose for covid-19 immunisation. The patient medical history was reported as none. Concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on 25Feb2021 10:15 as single dose for covid-19 immunisation. On 22Apr2021 23:00, the patient experienced heart rate 170 for 2 hrs, vaccine is administered outside the range19 - 42 days after the first dose, insomnia, fever, sweets, chills and headache. The patient underwent lab tests and procedures which included heart rate: 170 for 2 hrs. No treatment was received to treat this adverse event. The events insomnia, heart Rate 170 for 2 hrs, fever, sweets, chills, headache were recovered on an unspecified date in 2021 and outcome of vaccine is administered outside the range19 - 42 days after the first dose was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Condition aggravated, Neuropathy peripheral, Paraesthesia, SARS-CoV-2 test
Clinical narrative: tingling in hands and feet, which progressively got worse, to burning all over body within one week. 4 months later, still burning. Diagnosed with small fiber neuropathy.; tingling in hands and feet, which progressively got worse, to burning all over body within one week. 4 months later, still burning. Diagnosed with small fiber neuropathy.; tingling in hands and feet, which progressively got worse, to burning all over body within one week. 4 months later, still burning. Diagnosed with small fiber neuropathy.; tingling in hands and feet, which progressively got worse, to burning all over body within one week. 4 months later, still burning. Diagnosed with small fiber neuropathy.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 54-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left, administration time was 11:00 am on an unspecified date at dose 1, single for covid-19 immunisation. Medical history included covid-19 (if covid prior vaccination: Yes) and Known allergies: penicillin, Ceftin. Concomitant medications were not reported. Patient did not receive other vaccine in four weeks and other medications in two weeks. On 28Mar2021 the patient experienced tingling in hands and feet, which progressively got worse, to burning all over body within one week. 4 months later, still burning. Diagnosed with small fiber neuropathy. Otherwise, healthy with no underlying conditions. Events led to doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included (Nasal Swab) sars-cov-2 test: negative on 13Aug2021 (If COVID tested post vaccination: Yes). Patient received treatment with Gabapentin, minocycline for the adverse events. Outcome of the events was not resolved.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Headache, Pain, Pyrexia
Clinical narrative: loss of appetite; Fever of 99.4,; body aches; headache with sharp stings in back of head; This is a spontaneous report from a non-contactable consumer. This 15-year-old female consumer reported that: A 15-year-old female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, Lot number ew0165) via an unspecified route of administration in right arm on 24Aug2021 03:30PM (at the age of 15-year-old) for COVID-19 immunisation. The patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, Lot number ew0179) via an unspecified route of administration in right arm on 03Aug2021 (at the age of 60-year-old) for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination and was not tested post vaccination. On 25Aug2021 the patient had fever of 99.4, body aches, headache with sharp stings in back of head and loss of appetite. The patient was treated with pain relief pills. Events resolved on an unspecified date.   No follow up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: I have been post menapausel for 20 years and 8 days after receiving this I started to have spotting and light bleeding I have never had this in 20 years, I have had to go through many painful procedur; This is a spontaneous report from a contactable other hcp and nurse (patient). A 65-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EW0187) via an unspecified route of administration, administered in left arm on 03Aug2021 16:45 (at the age of 65-years-old) as single dose for covid-19 immunization. The patient's medical history included HTN Seizures from an unknown date and unknown if ongoing. The patient previously took percocet and experienced vomiting. The patient's concomitant medications were not reported. On 13Aug2021 04:00, the patient has been post menapausel for 20 years and 8 days after receiving this she started to have spotting and light bleeding she never had this in 20 years, she have had to go through many painful procedure. The patient was hospitalized for 1 day and therapeutic measures were taken as a result of the adverse event. Treatment reported that uterine bx and scheduled d&c. The outcome of the event was recovered on unspecified date.; 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 reported event 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Postural orthostatic tachycardia syndrome
Clinical narrative: She was diagnosed with the POPS syndrome, Postal tachycardia syndrome.; This is a spontaneous report from a contactable consumer (patient's husband). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172) via an unspecified route of administration, administered in Arm Left on 29Apr2021 at age of 27-year-old at single dose for COVID-19 immunisation. Medical history included birth control. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) taken for contraception. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: "EW0158.") on 08Apr2021 at age of 27-year-old at left arm for COVID-19 Immunisation. The reporter reported the adverse effect from the Pfizer vaccine do to with the patient so, she was usually vaccinated. She had a first dose on 08Apr2021 and second on 29Apr2021 so, after her second dose between 29 within 1-2 minutes of getting the vaccine on 29Apr2021, she lost her vision, had severe headache, dizziness and that subsided and about 30 minutes after that, it came back and didn't go away. Quite a few day they had to go to emergency room, she was admitted by the night. Some of them were shorten since then, she had been in emergency room four times, undergoing medical treatments with medical doctors, cardiologists, neurologist and medical doctors, then they saw to specialist and she diagnosed with POPS syndrome by the result of the Pfizer vaccine. The reporter stated the doctor believed for the vaccine so just wanted to report that. When probed treatment for adverse events: Reporter stated, nitially, When taken her in emergency room and admitted, she was given migraine cocktail through IV, she had severe migraine since she got her vaccine, that was cleared about 50%, then she was diagnosed with the POPS syndrome, postal tachycardia syndrome (as reported), that was medical person, diagnosed with professional at doctor office which result from the Pfizer vaccine, since then she was diagnosed with undergone treatments to health people, Involves. She was having IV therapy. She was taking puncture black supplement (not further clarify) magnesium Albertine, she was having soft pills for blood pressure which was very very low. She took some pain killer for headache, that has not gone away since that day. She took NAD, injections. She also a therapist to her Cardiovascular health and exercise. Reporter stated, "Well help her some medical dose." Lab test information included she had full blood worked on, She was actually like tested everything(not further clarified). The outcome of the event(s) was recovering.  Follow-up (30Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: The site where shot is the red and swollen and tender; The site where shot is the red and swollen and tender; The site where shot is the red and swollen and tender; had the COVID vaccine her third COVID shot; had the COVID vaccine her third COVID shot; This is a spontaneous report from a contactable consumer (reported for wife). A female patient of an unspecified age received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 3, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown) on an unspecified date as single dose for COVID-19 immunization. It was reported that, the wife of reporter "had the COVID vaccine her third COVID shot" (yesterday) and "the site where shot is the red and swollen and tender" on an unspecified date. It was reported that, the patient took the third shot, she took the booster. The reporter was asking if anything could be put on her arm to help with the swelling, and the redness and the tenderness. Reporter was informed about the role of Pfizer Drug Safety. Further probing could not be done as the reporter hung up the call abruptly. Hence limited information available over the call. The outcome of the events was unknown.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: tingling feet; Experiencing sore arm; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer sponsored program COVAX US support.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported; Expiry Date: Not Provided), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced tingling feet and experiencing sore arm. The patient reported she has no doctor or no insurance as also their ER is full with unvaccinated people. Told (withheld) that a nurse or Pharmacist could also call Pfizer regarding this concern. She did not want to provide any further information. She just wanted to know if the events were normal and if they have any report on sore arm and tingling feet. She denied providing her birth date, address and email. Reporter seriousness for the events were unspecified. Outcome of the events were unknown.  Follow-up (26Aug2021): This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable female consumer (patient) reported for herself included clinical information.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2].
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: The day after the shot I went to a cardio exercise class and fainted after 1/2 hr.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 73-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Aug2021 (at the age of 73-year-old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not take other vaccine in four weeks and did not took other medications in two weeks. The patient not had covid prior vaccination and not tested for covid post vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on an unknown date (at the age of 73-year-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. On 26Aug2021 10:00AM, the day after the shot the patient went to a cardio exercise class and fainted after 1/2 hr. The patient not received any treatment for the event. The clinical outcome of the event was recovered on 26Aug2021.  No follow-up attempts are possible; information about lot/batch numbe cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dementia, Pneumonia
Clinical narrative: Pneumonia; Dementia; This is a spontaneous report from a non-contactable consumer reporting for patient (Reporter's aunt). An elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included dementia and Coagulation disorder from an unknown date. Concomitant medications included warfarin sodium (COUMADIN SODIUM) taken as blood thinner, start and stop date were not reported; warfarin sodium (WARFARIN SODIUM) taken as blood thinner, start and stop date were not reported. The reporter stated that her elderly aunt was not told about the blood thinners. She stated that her aunt was on coumadin and warfarin and had dementia. The reporter stated her aunt got both of the Pfizer covid 19 vaccines and developed pneumonia in the hospital and complete dementia after on an unspecified date. The reporter asked, is bleeding disorder/been on blood thinners a contraindication. The reporter stated that there have been 1000s and 1000s of cases among all ages noting especially blood clots. She stated she wants to know it is passed and effective and be OK for everybody to take and nothing happens. She specified what she meant by nothing happens to mean nothing happens to people with blood disorder. The reporter stated she would love to provide the information to report her aunts experience but she does not trust anything going on and did not want to provide demographics for AE. She had questions about the Pfizer covid 19 vaccine. She asked if the vaccine is completely FDA approved, still under clinical trials or EUA. She wanted to know if the vaccine is through the clinical trials and can be given safely. She wanted to know if the vaccine is completely passed and 100 percent FDA approved. She stated the person she spoke to before said the clinical trials would end in 2023. She stated the person she spoke with earlier provided her the information about persons with medical conditions. She stated that one of the things on the list was having a bleeding disorder or on a blood thinner. The case was reported as non-serious. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: a friends sister was so freaked out, got the vaccine, and stroked out; This is a spontaneous report from a non-contactable consumer (friend).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  A friends sister was so freaked out, got the vaccine, and stroked out (medically significant) on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick; This is a spontaneous report from a contactable Consumer or other non-health care professional (Parent) reported for her daughter. A 43-years-old female bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; batch no/Lot number: not reported) via unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization and also received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; batch no/Lot number: not reported) via unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Patient medical history and concomitant medications were not reported. It was reported that patient had both doses and got severely hurt by Pfizer vaccine after first dose, and also stated fortunately she doesn't have long term effects. Caller stated she will not get the third shot definitely. She had the first one and had an adverse reaction that was when she really got sick, and she was warned but didn't pay attention to parent. She did not think it was severe enough to not get the second dose. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Electrocardiogram ambulatory abnormal, Palpitations, SARS-CoV-2 test
Clinical narrative: feel prolonged and intense palpitations; prescribed a 48 hour Holter monitor which showed 15% of the time was with PVCs; This is a spontaneous report received from a contactable consumer (Patient). A 44-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0181) via an unspecified route of administration in left arm on 19Jun2021 at 14:00 (at the age of 44-year-old) as dose 1, single for COVID-19 immunisation. Medical history included bee sting allergy and palpitations (I have had minimal palpitations for years) . The patient previously took sulfa [sulfanilamide] and experienced drug hypersensitivity. The patient was not pregnant at the time vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included daily multi vitamin. Patient did not have COVID prior to vaccination and it was yes covid tested post vaccination. It was reported that a few days after the first vaccine, I started to feel prolonged and intense palpitations. I have had minimal palpitations for years, but never the duration or intensity of these. About 2.5 weeks after dose 1, they hit the max intensity. My doctor prescribed a 48-hour Holter monitor which showed 15% of the time was with PVCs. The patient underwent lab tests and procedures which included Holter monitor (which showed 15% of the time was with PVCs) on Jun2021,sars-cov-2 test: negative on 01Aug2021 Nasal Swab, sars-cov-2 test: negative on 07Aug2021 Nasal Swab, sars-cov-2 test: negative on 28Jul2021 other (Saliva test). Patient did not receive any treatment for the events. Patient visits emergency room and physician office for the events. Outcome of all events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Fatigue, Feeling abnormal
Clinical narrative: covid test result=Positive; Covid test date=25Aug2021,covid test result=Positive; body aches.; fever, HA/fever last night; Coughing; Feels like " hit by truck"; Felt like she was super tired; Went into work because she thought she just didn't get enough sleep; This is a spontaneous report from a non-contactable nurse. A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248), dose 1 via an Intramuscular route of administration, on 28Jan2021 (age at vaccination: 61), in left arm as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 25Aug2021 the patient experienced covid test result as positive, body aches, fever, HA/fever last night, Coughing, feels like " hit by truck", felt like she was super tired, went into work because she thought she just didn't get enough sleep. Covid prior vaccination reported as unknown and post vaccination reported as yes. On 25Aug2021 the patient underwent lab test and procedure included SARS-CoV-2 test: positive. Treatment received reported as unknown. The patient had a physician office visit. The outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event COVID_19, Drug ineffective and suspect drug BNT162B2 cannot be excluded.