chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Vascular pain
Clinical narrative: feeling small shock like pain in my thighs; feeling small shock like pain in my thighs. Ever since it's moved to random places all over my body; Like piercing stabbing pain in muscles; feels sometimes like in my veins; This is a spontaneous report from a contactable consumer (the patient). A 52-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, (Batch/Lot number unknown due to unable to locate or read the details) via an unspecified route of administration, administered in Arm Left on 14Aug2021 15:45 at age of 52-year-old at single dose for COVID-19 immunisation. Medical history included Sjogrens, penicillin allergy and sulfa drugs allergy. The patient had no COVID-19 prior vaccination. No COVID tested post vaccination. Concomitant medications included unspecified drugs. It reported the patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. As she walked out she began feeling small shock like pain in her thighs. Ever since it's moved to random places all over her body. Like piercing stabbing pain in muscles and felt sometimes like in her veins. The events onset date was reported as 14Aug2021 15:45. No treatment received for the events. The outcome of the events was not recovered.   The lot number for BNT162B was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Oxygen saturation decreased, Paraesthesia
Clinical narrative: Total body numbness; Fave and tongue numb and tingly; Fave and tongue numb and tingly; Fave and tongue numb and tingly; Fave and tongue numb and tingly; Severe left sided head pain; Low oxygen; This is a spontaneous report from a contactable other hcp (patient). A 47-years-old female non-pregnant patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 23Aug2021 10:30 (at the age of 48 years), (Batch/Lot Number: Fc3183) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously took sulfonamides and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Aug2021 10:45, the patient experienced total body numbness, fave and tongue numb and tingly, severe left sided head pain, low oxygen. The events resulted in visit to Emergency room/department or urgent care. The treatment received for the events was unknown. Device Date was 24Aug2021. The clinical outcome of the events was not recovered at the time of report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Total body numbness; Fave and tongue numb and tingly; Fave and tongue numb and tingly; Fave and tongue numb and tingly; Fave and tongue numb and tingly; Severe left sided head pain; Low oxygen; This is a spontaneous report from a contactable other hcp (patient). A 47-years-old female non-pregnant patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 23Aug2021 10:30 (at the age of 48 years), (Batch/Lot Number: Fc3183) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously took sulfonamides and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Aug2021 10:45, the patient experienced total body numbness, fave and tongue numb and tingly, severe left sided head pain, low oxygen. The events resulted in visit to Emergency room/department or urgent care. The treatment received for the events was unknown. Device Date was 24Aug2021. The clinical outcome of the events was not recovered at the time of report.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Platelet count decreased, SARS-CoV-2 test negative
Clinical narrative: Was being monitored for low but stable platelets, after receiving both doses of vaccine, platelets dropped by 15%; Was being monitored for low but stable platelets, after receiving both doses of vaccine, platelets dropped by 15%; This is a spontaneous report from a non-contactable consumer (patient) received via COVAES. A 53-year-old male patient received BNT162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on Jun2021 (Batch/Lot number was not reported) (at the age of 53-years-old) as dose 2, single; and via an unspecified route of administration, administered in right arm on Apr2021 (Batch/Lot number was not reported) (at the age of 53-years-old) as dose 1, single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered in a school or student health clinic. Medical history included low platelet count Immune thrombocytopenic purpura (ITP). The patient has no relevant past drug history. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. In Jul2021, the patient was being monitored for low but stable platelets, after receiving both doses of vaccine, platelets dropped by 15%. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. There was no hospitalization prolonged and no treatment received. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included nasal swab test with result: negative in Aug2021. The outcome of the event was not recovered/not resolved.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Loss of personal independence in daily activities, Nasal disorder, Respiratory disorder
Clinical narrative: obstructing my breathing at night; upper respiratory/severe nasal problems; upper respiratory/severe nasal problems; has progressively worsened to the point that it is now obstructing my breathing at night; restricting my day to day activities; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received bnt162b2 (BNT162B2, also reported Product=COVID 19 vaccine, lot unknown), via an unspecified route of administration on an unspecified date in Mar2021 as dose 2, single for Covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Two weeks after receiving the 2nd dose (17Mar2021), the patient started having upper respiratory/severe nasal problems. It has progressively worsened to the point that it was obstructing breathing at night and restricting the day to day activities. At this point nothing has helped. The patient still tried to do nasal rinses every hour to gain very minimal relief but this cannot be a long term solution. The event, obstructing breathing at night, was reported serious medically significant. The patient had to do clinic visit to a Doctor or other healthcare professional office. The patient underwent laboratory test which included Sars-cov-2 test: negative on unspecified date.  The outcome of events was not recovered.  Information on the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: obstructing my breathing at night; upper respiratory/severe nasal problems; upper respiratory/severe nasal problems; has progressively worsened to the point that it is now obstructing my breathing at night; restricting my day to day activities; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received bnt162b2 (BNT162B2, also reported Product=COVID 19 vaccine, lot unknown), via an unspecified route of administration on an unspecified date in Mar2021 as dose 2, single for Covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Two weeks after receiving the 2nd dose (17Mar2021), the patient started having upper respiratory/severe nasal problems. It has progressively worsened to the point that it was obstructing breathing at night and restricting the day to day activities. At this point nothing has helped. The patient still tried to do nasal rinses every hour to gain very minimal relief but this cannot be a long term solution. The event, obstructing breathing at night, was reported serious medically significant. The patient had to do clinic visit to a Doctor or other healthcare professional office. The patient underwent laboratory test which included Sars-cov-2 test: negative on unspecified date.  The outcome of events was not recovered.  Information on the Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: contracted Covid; contracted Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration on 31Mar2021 as dose 2, single, and received first dose of BNT162B2 (Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration on 03Mar2021 as dose 1, single; both for COVID-19 immunization. Medical history and concomitant medications were not reported. for COVID-19 immunization. On 02Aug2021, Patient contracted COVID. Patient stated, that patient unblinded in order to know vaccine status (placebo) and subsequently received the Pfizer vaccine. Lab test included sars-cov-2 test reported as contracted COVID (COVID positive status). The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm that she couldn't lift above her head for a day or so; This is a spontaneous report from a contactable consumer reported for a patient. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller mentioned that someone he knew had their first dose of the vaccine and had no side effects other than a sore arm that she couldn't lift above her head for a day or so on an unspecified date. The outcome of the event was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: Lupus; This is a spontaneous report from a contactable Nurse (patient).  A 52-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 19Aug2021 at 15:01 as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported.  Previously on an unspecified date, patient had the first dose of the vaccine for covid-19 immunisation.Patient had a booster shot on 19Aug2021 at 15:01. The patient experienced lupus on an unspecified date in 2021 with outcome of unknown.The lot number for 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   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: A lot of blood clots in his left leg; This is a spontaneous report from a Pfizer Sponsored Program via Regulatory Authority Support from a contactable consumer (patient).  A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA 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 and the patient's concomitant medications were not reported. on unknown date the patient had blood clots, a lot of blood clots in his left leg. He had surgery before second dose was scheduled. The outcome of the evens was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Diabetes mellitus
Clinical narrative: become a diabetic/ raise your sugar level; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer stated, "I just have one question for you. I don't wanna give my information. I received Pfizer injection about a week ago and I have a question." Consumer was informed about the Pfizer Medical information department and consumer stated, "No, it is nothing like that. I want to know if taking the second part of the Pfizer injection. Do you get, if you are not diabetic become a diabetic with this injection? Does it raise your sugar level?" Consumer hung up the call abruptly. The outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Illness, Loss of consciousness, Nausea
Clinical narrative: almost passed out after vaccination/Still feels like he has to pass out; sick; throw uppy/feeling like he has to throw up but he can't/feeling like have to vomit; He is sleeping, napping during the day 4 to 6 hours, sleeps 9 hours at night; wakes up feels nauseous; achy; he feels this bad; heart racing; headachy; he is pale; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer. A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Aug2021 (Batch/Lot Number: FC 3180) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jul2021 for Covid-19 Immunisation and experienced got really sick, heart racing, feeling like have to vomit, nauseous and headache. And He spent 3 to 4 days in nursing quarters, sleeping. After the second dose got even sicker. heart racing, feeling like have to vomit, she is concerned that he is having an adverse event. After his 2nd dose he is still sick, almost passed out after vaccination, the pharmacist thought they would have to call an ambulance, but did not call the ambulance. "He is sleeping, napping during the day 4 to 6 hours, sleeps 9 hours at night, wakes up feels nauseous, achy and headachy and throw uppy, not just being teenage lazy, feeling like he has to throw up but he can't he is pale and still aches. Still feels like he has to pass out, he asks to sleep with us, because he feels this bad.She called the Doctor "can't get us in until Thursday. The nurse said he probably had covid when he got his vaccine. They want to test his white, red blood cell hemoglobin and something else and another covid test. "Call back 24Aug2021 at 2:54PM - Left voice mail with telephone number and extension due to call disconnected while on hold.Outcome of achy was not recovered, of others was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100909916 same pt, different dose/event
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pallor, Palpitations, Somnolence, Vomiting
Clinical narrative: almost passed out after vaccination/Still feels like he has to pass out; sick; throw uppy/feeling like he has to throw up but he can't/feeling like have to vomit; He is sleeping, napping during the day 4 to 6 hours, sleeps 9 hours at night; wakes up feels nauseous; achy; he feels this bad; heart racing; headachy; he is pale; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer. A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Aug2021 (Batch/Lot Number: FC 3180) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jul2021 for Covid-19 Immunisation and experienced got really sick, heart racing, feeling like have to vomit, nauseous and headache. And He spent 3 to 4 days in nursing quarters, sleeping. After the second dose got even sicker. heart racing, feeling like have to vomit, she is concerned that he is having an adverse event. After his 2nd dose he is still sick, almost passed out after vaccination, the pharmacist thought they would have to call an ambulance, but did not call the ambulance. "He is sleeping, napping during the day 4 to 6 hours, sleeps 9 hours at night, wakes up feels nauseous, achy and headachy and throw uppy, not just being teenage lazy, feeling like he has to throw up but he can't he is pale and still aches. Still feels like he has to pass out, he asks to sleep with us, because he feels this bad.She called the Doctor "can't get us in until Thursday. The nurse said he probably had covid when he got his vaccine. They want to test his white, red blood cell hemoglobin and something else and another covid test. "Call back 24Aug2021 at 2:54PM - Left voice mail with telephone number and extension due to call disconnected while on hold.Outcome of achy was not recovered, of others was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100909916 same pt, different dose/event
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Electric shock sensation, Headache, Hypoaesthesia
Clinical narrative: This is a spontaneous report received from a noncontactable consumer (patient). A 54-year-old female (non-pregnant) patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; solution for injection; batch/lot# EW0173 or EW0158; expiry date not reported), at the age of 54, via an unspecified route of administration, on unknown date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient did not have COVID-19 prior to vaccination and was not tested post vaccination. The patient experienced tinnitus, numbness and tingling in all extremities. She felt like electricity pulsing through her body. She got headaches and ringing in ears for months after shot. The patient had bloodwork, CT, MRI and nerve conduction test (all normal). The patient did not receive treatment in response to the events. All events lead to emergency room visit and physician office visit. The outcome of the events: not recovered (at the time of the report). No follow-up attempts possible. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Nerve conduction studies, Paraesthesia, Tinnitus
Clinical narrative: This is a spontaneous report received from a noncontactable consumer (patient). A 54-year-old female (non-pregnant) patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; solution for injection; batch/lot# EW0173 or EW0158; expiry date not reported), at the age of 54, via an unspecified route of administration, on unknown date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient did not have COVID-19 prior to vaccination and was not tested post vaccination. The patient experienced tinnitus, numbness and tingling in all extremities. She felt like electricity pulsing through her body. She got headaches and ringing in ears for months after shot. The patient had bloodwork, CT, MRI and nerve conduction test (all normal). The patient did not receive treatment in response to the events. All events lead to emergency room visit and physician office visit. The outcome of the events: not recovered (at the time of the report). No follow-up attempts possible. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Pain in extremity
Clinical narrative: sore arm for a couple of hours; Nosebleed; This is a spontaneous report from a 71 years old contactable consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Feb2021 (lot number EL9269), at 71 years old, as the second single dose, for COVID-19 immunization. No other vaccine was administered on the same date or within 4 weeks. Medical history included ongoing hereditary hemorrhagic telangiectasia (this was a life-long condition, she was born with it, her father also had it). The patient previously received the first dose of BNT162B2 vaccine on 15Jan2021 (lot number EL8982) experiencing epistaxis, sore arm, headache and blood pressure was 60/32. Concomitant medications included tamoxifen ongoing for about 4 years, at 20 mg twice a day for nosebleed suppression and an unspecified thyroid pill. On an unspecified date in Feb2021, 2-3 days after the second dose, the patient experienced epistaxis and on 05Feb2021 she experienced sore arm (no big deal). The nosebleed occurred after the second vaccination was a bad nosebleed, but she was able to stop it. The patient received also a third dose of vaccine on 19Aug2021. After each vaccine dose the patient experienced a nosebleed a couple of days after and sore arm for a couple of hours. She got nosebleeds periodically anyway. She had a history of hereditary hemorrhagic telangiectasia (HHT) and she stated that it caused nosebleed because the blood vessels in the nose were deformed so they break and bled. Nosebleed required ER visit and physician office visit. Nosebleed resolved on an unspecified date in Feb2021. Sore arm resolved on 05Feb2021. She denied any labs, testing, or treatments relevant to events. She had an appointment with her hematologist and they will check her hemoglobin.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101098025 Same patient, different vaccine dose, similar events;US-PFIZER INC-202101100937 Same patient, different vaccine dose, similar events
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: terrible tinnitus after receiving your vaccine; This is a spontaneous report from a contactable consumer. This consumer reported same event in two patients. This is the first of two reports. A male patient of an unspecified age reported that received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknow date in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. After receiving the vaccine the patient experienced terrible tinnitus in 2021. The patient has been to the doctor 3 times including an ENT visit. The reporter told CDC and they don't care. The doctors just shrug. It's now been 5 months with no improvement. Actually the event has worsened.  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) :PFIZER INC-202101102283 Same drug/AE, different patient
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Colitis microscopic, SARS-CoV-2 test
Clinical narrative: developed diarrhea, stomach cramps, and bloating/diagnosed with lymphocytic colitis; This is spontaneous report from a contactable consume (patient). A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 12Mar2021 10:30 (Lot Number: EN6206) as dose 1, single (at age of 43-years-old) for covid-19 immunisation. No pregnant at time of vaccination. No other vaccine in four weeks. Medical history included Idiopathic hypersomnia, irritable bowel syndrome (IBS), subclinical hypothyroidism. No known allergies. No COVID prior vaccination. Concomitant medications included levothyroxine sodium; melatonin; DHEA; docosahexaenoic acid (DHA); ubidecarenone (COQ10); vitamin D NOS (VIT D); acetylcysteine (NAC). On 18Mar2021 07:00 (also reported as 6 days after the first dose of the Pfizer Covid19 vaccine), she developed diarrhea, stomach cramps, and bloating. These symptoms worsened and became chronic for 12+ weeks, at which time she finally underwent a colonoscopy. A biopsy was taken during the procedure through which she was diagnosed with lymphocytic colitis. Although she has a history of IBS, which is effectively managed with dietary restrictions, she has never had episodes of colitis prior to this time. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment (prescribed a 5 week regimen of Budesonide). The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 02Apr2021 10:30 (Lot Number: ER8733) as dose 2, single for covid-19 immunisation. The patient underwent lab tests and procedures which included biopsy: lymphocytic colitis, colonoscopy: unknown results, Saliva test by PCR - Accurate Diagnostic Labs: negative on 08Jun2021. Outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Infection, SARS-CoV-2 test positive
Clinical narrative: Typical signs of infection, individual tested positive for Covid with a rapid test.; Typical signs of infection, individual tested positive for Covid with a rapid test; Breakthrough infection 4 months after second dose.; This is a spontaneous report from a contactable consumer. A 51-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date in Apr2021 (at the age of 51-years-old) as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if other vaccine in four weeks. No covid prior vaccination. Covid tested post vaccination was yes. On an unspecified date in Aug2021, breakthrough infection 4 months after second dose. Typical signs of infection, individual tested positive for Covid with a rapid test. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with REGEN-COV. The patient underwent lab tests and procedures which included sars-cov-2 test positive (nasal swab): positive on an unspecified date in Aug2021. The outcome of events was recovering.  Information on the lot/batch number has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Partial seizures, Seizure
Clinical narrative: New onset seizure activity diagnosed in month of July while patient at home with family.; EEG demonstrated "focal" seizure activity.; This is a spontaneous report from a contactable physician. A 85-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: IR8731)via intramuscular, route of administration, administered in left arm on 01Apr2021 at 10:00  as Dose 1,Single for COVID-19 immunization. Medical history included high blood pressure, a fib (Atrial fibrillation), high cholesterol, TVAR (Transcatheter aortic valve implantation), hx CHF (cardiac failure congestive), seizures and anxiety from an unknown date and unknown if ongoing. Concomitant medications included metoprolol (METOPROLOL), diltiazem hydrochloride (CARDIAZEM (AVENTIS)), rosuvastatin calcium (CRESTOR), celecoxib (CELEXA [CELECOXIB]), furosemide (LASIX [FUROSEMIDE]), potassium chloride (POTASSIUM CHLORIDE) and apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. The patient previously took Bactrim and flourecin contrast and experienced known allergies for bactrim and flourecin contrast. The patient experienced new onset seizure activity diagnosed in month of july while patient at home with family and EEG demonstrated focal seizure activity on 06Jul2021 at 19:00. The patient received treatment for the events. The patient was hospitalized for eeg demonstrated focal seizure activity (partial seizures) for 5 days. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Someone right now that is in the hospital with heart conditions with the shot; This is a spontaneous report from a non-contactable consumer via Medical Information Team. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as a dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she was concerned about the safety of the vaccine when there had not be a 5-6 year review/study and that it was approved so quickly by the FDA. She was just wondering. She heard yesterday that the Pfizer shot was not FDA approved yet just which was an emergency basis, based on the fact that it hasn't done enough reviews, for a long enough time. She knew a lot of people who have serious side effects to this shot. People are having terrible side effects to it. These are people's lives they are messing with. These are people who want to live, they don't want to have serious consequences. For something to be FDA approved in such a short time was very scary to parents and comprehension. That's not long enough to said something was going into her body that had been reviewed to 6 months. That just doesn't seem logical. She know someone right now that was in the hospital with heart conditions with the shot, so she questioned it. She remain anonymous and declined to share any information about herself. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Chest pain, Fatigue, Headache, Pyrexia
Clinical narrative: possible stroke; Seizure; Fever; chest pain; headache; extreme fatigue.; This is a spontaneous report from a contactable consumer. This 54-year-old non-pregnant female consumer (patient) reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EWO168, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 16Aug2021 at 10:15 AM (at the age of 54 years) as dose 2, single for covid-19 immunisation. Medical history included known allergies (unspecified). Concomitant medications in two weeks included Fluvoxamine, Estradiol, Trazadone, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EWO168, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 26Jul2021 at 12:15 PM (at the age of 54 years) as dose 1, single for covid-19 immunisation. No other vaccine in four weeks. No covid test prior vaccination. Facility type vaccine was public health clinic/veterans administration facility. Covid test performed post vaccination. The patient experienced fever, chest pain, headache. Seizure, possible stroke, extreme fatigue on 16Aug2021 at 13:00. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received. The patient underwent lab tests and procedures which included Nasal swab: negative on 21Aug2021. The outcome of event was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Seizure
Clinical narrative: possible stroke; Seizure; Fever; chest pain; headache; extreme fatigue.; This is a spontaneous report from a contactable consumer. This 54-year-old non-pregnant female consumer (patient) reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EWO168, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 16Aug2021 at 10:15 AM (at the age of 54 years) as dose 2, single for covid-19 immunisation. Medical history included known allergies (unspecified). Concomitant medications in two weeks included Fluvoxamine, Estradiol, Trazadone, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EWO168, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 26Jul2021 at 12:15 PM (at the age of 54 years) as dose 1, single for covid-19 immunisation. No other vaccine in four weeks. No covid test prior vaccination. Facility type vaccine was public health clinic/veterans administration facility. Covid test performed post vaccination. The patient experienced fever, chest pain, headache. Seizure, possible stroke, extreme fatigue on 16Aug2021 at 13:00. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received. The patient underwent lab tests and procedures which included Nasal swab: negative on 21Aug2021. The outcome of event was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 5 months after their 2nd dose, they both tested positive for Covid; 5 months after their 2nd dose, they both tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program regulatory authority Support via contactable nurse (patient) via medical information team . A 61-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 61 years old, Batch/lot number, NDC number, Expiry Date: Not provided) as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 61 years old, Batch/lot number, NDC number, Expiry Date: Not provided) as dose 2, single both taken for COVID-19 immunisation. The patient medical history and other products were not provided. The patient stated yesterday, 5 months after their 2nd dose, they both; she and her husband tested positive for COVID (24Aug2021), she was a nurse, and spent some years in research and data collection, she went to get a rapid COVID test, her doctor told her that the only information they report to the county was a positive test, they do not report a person's vaccination status, she questioned how was Pfizer gathering data in terms of immune response, and efficacy of the vaccine, if none of this information was being collected on the local level, how can the vaccine be improved to further benefit the patient, they were not testing for variants on the local level, how Pfizer was approaching new variants that are developing, on a local level, they were not doing genomic type testing to differentiate the variants, how Pfizer was getting the information on the variants and she explained information about the flu vaccine for each season. She wanted to know how Pfizer was getting information about the different variants coming out, how Pfizer was following breakthrough cases, how they are gathering information about it, and how Pfizer was keeping the vaccine up to date moving forward. The patient further stated that if local health professionals are not capturing data, how can the pharmaceutical companies move forward with improving their vaccines, she had no adverse events with the vaccine, she wanted to know if there was a 2nd breakthrough susceptibility even after people have been fully vaccinated and are COVID positive and they forward her question to someone from their team so that they can research about it further. The patient underwent lab tests and procedures which included rapid COVID test: positive on 24Aug2021. The outcome of the events 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 information available in the case, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: Erectile dysfunction.  Inability to gain a full erection; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient reported that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 01Jun2021 at 15:45 (at the age of 19 years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. No COVID prior vaccination and no COVID tested post vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 11May2021 at 15:45 (at the age of 19 years) as dose 1, single for covid-19 immunisation. The patient experienced erectile dysfunction and inability to gain a full erection on 03Jun2021. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of event was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101103163 similar report from same reporter
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: Issues with getting a full penile erection.  Erectile Dysfunction.My 19-year-old son experienced the same thing 2 days after receiving the Pfizer vaccine 2nd does.; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection via an unspecified route of administration, administered in Arm Left on 23Apr2021 16:00 (at the age of 55-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. 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. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 02Apr2021 16:00 (at the age of 55-year-old) as single dose for covid-19 immunisation. On 28Apr2021, the patient experienced issues with getting a full penile erection. Erectile dysfunction. His 19-year-old son experienced the same thing 2 days after receiving the pfizer vaccine 2nd dose. No treatment was received to treat this adverse event. The outcome of event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-202101103077 similar report from same reporter
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rectal haemorrhage, Thrombosis, Vaginal haemorrhage
Clinical narrative: The rectal bleeding is not that much; Bleeding with a lot of clots; she started to bleed vaginally; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 50 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (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 experienced the rectal bleeding on an unspecified date with outcome of unknown, bleeding with a lot of clots leading to thrombosis on an unspecified date with outcome of unknown also she started to bleed vaginally leading to vaginal haemorrhage on an unspecified date with outcome of unknown.  No follow-up attempts are possible. No further information is expected.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Sperm concentration, Sperm concentration decreased
Clinical narrative: Since vaccination, sperm count has dropped approximately 80 percent; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0182), via an unspecified route of administration on arm right on 13May2021 10:30 AM (age at vaccination: 39 years) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history and known allergies was reported as none. Device Date was reported as 25Aug2021.The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient Concomitant medications within 2 weeks of vaccination included Zinc Glycinate taken for unspecified indication from an unknown date and Multivitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0170), via an unspecified route of administration on arm left on 22Apr2021 11:00 AM (at the age: 39 years) as dose 1, single for COVID-19 immunization. On 17Jun2021, the patient experienced Since vaccination, sperm count has dropped approximately 80%. It was reported that Sperm count before vaccination averaged 78 million, concentration 23 million/mL. Sperm count after vaccination has averaged 16 million, concentration 6 million/mL. This was across 6 semen analyses over 5 months, 2 before vaccination, 4 after vaccination. The adverse event resulted in Doctor or other healthcare professional office/clinic visit/ Disability or permanent damage. The lab test included Sperm concentration: averaged 78 million, concentration 23 million/ml (Before vaccination 2 semen analysis) and Sperm concentration: averaged 16 million, concentration 6 million/ml (After vaccination 4 semen analysis) on an unknown date in 2021. The treatment received for the events was reported as no. The outcome of event was unknown.  Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: Cancer; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for herself.  An unknown age female patient received her 2nd dose of the Pfizer BioNtech Covid 19 Vaccine BNT162B2 in Jun2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. She later noticed she developed something on her breast, and after testing she was diagnosed with cancer. Outcome of the event was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.