chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Headache, Herpes zoster, Rash
Clinical narrative: Missed dose of the Vaccine; shingles on her face including around the eyes; Shingles, rash, on her face, on her eyebrow near her; Ear bothering her; Persistent headaches; This is a spontaneous report from a contactable consumer. A 41-years-old female patient received first dose of bnt162b2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot: number  EN6207), via an unspecified route of administration, administered in Arm Left on 17Mar2021 as 1st dose, single dose for covid-19 immunization. The patient did not had any medical history. Concomitant medication(s) included vitamins nos (MULTIVITAMIN [VITAMINS NOS]) started taking about 5 years ago for good health, prenatal and general women's health vitamin. There was no prior Vaccinations within 4 weeks.On 01Apr2021, in the morning patient experienced persistent headaches, on 03Apr2021, early evening around 5 or 6 PM patient had ear issue started, ear started bothering her the pain started, patient thought she had an ear infection or something. On  06Apr2021, when patient woke up in the morning she had Shingles, rash, on her face, on her eyebrow near her eye. It was reported that patient got first Pfizer covid-19 vaccine injection on 17Mar2021 but then developed shingles 2 weeks later.  She was wondering when she can get second injection, It has been about 7 weeks since the first. She had blisters that opened and then they scabbed. They are not visible but, she can still see what is left of them. It was a week or two ago they started to go away she believes.  She went to Urgent Care and received an antiviral as treatment and was prescribed Valtrex as treatment and she is finished taking Valtrex. The eye doctor she went to see since she had the shingles on her face including around the eyes, told her to wait about 2-3 months to give her body time to heal and her immune system strong again before receiving her second Pfizer covid-19 injection. The patient reported that she needs to make a decision on whether she should get the next dose or not. The outcome of the event ear bothering her was resolved on 10Apr2021, persistent headaches resolved on 14Apr202 and event shingles on her face including, shingles, rash, on her face, on her eyebrow near her resolved on 21Apr2021 and outcome for missed dose of the vaccine was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: he had a fever of 102 that rose to 103.5F; He also has muscle aches; This is a spontaneous report from a contactable consumer (patient's fiance). A 42-year-old male patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration yesterday (08May2021) at 14:00 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date and experienced similar symptoms but not as severe. On 09May2021 at 02:00, the patient experienced a fever of 102 that rose to 103.5 degrees Fahrenheit (F). He also had muscle aches. The patient was treated with paracetamol (TYLENOL). The outcomes of fever and muscle aches were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test
Clinical narrative: random episodes of dizziness about once per week; This is a spontaneous report from a non-contactable consumer (patient).  A 23-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Apr2021 at single dose in arm left for COVID-19 immunisation. Medical history included allergy to pumpkin. Concomitant medications included generic oral contraceptives. The patient experienced random episodes of dizziness about once per week since 16Apr2021. The patient was not treated for the event. On 19Apr2021, 26Apr2021 and 03May2021, rapid sars-cov-2 test resulted negative. The patient did not recover from the event. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: I feel like crap/I do not feel right; I can hardly breath; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: unspecified) via unspecified route, as 2nd dose, single dose on 27Apr2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date patient stated, patient had a big problem with the vaccine, '20' patient was vaccinated, 2 weeks ago and patient felt like crap. Patient went to the emergency room, doctor said that patient had COVID, they did the testing for the COVID. Patient got the Pfizer COVID 'flu' testing, nothing appears wrong but does not feel right, patient could hardly breath, patient need help. The clinical outcome for the events was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: Felt really bad; Strange tingling in fingertips and hands; Her hand goes numb. It is like a tingling feeling; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: UNKNOWN), via an unspecified route of administration on 01May2021, as 2nd dose, single dose, for COVID-19 immunization and co-suspect drug included celecoxib (CELEBREX; Capsule, hard; Lot Number: Unknown) for arthritis. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: UNKNOWN), via an unspecified route of administration on 02Apr2021, as single dose for COVID-19 immunization. On 01May2021 at night, after the second shot, the patient experienced a strange tingling in her fingertips and hands, which continued. Patient wondered if it was a side effect and does not know if it improved, persisted or worsened. Patient had no prescribing doctor and she went to pharmacy. Patient felt really bad and had not moved around a lot. It started off with her fingers, and then her hand gone numb. It was like a tingling feeling, as if she laid on it , or slept on it. The clinical outcome of the event strange tingling in fingertips and hands was not resolved. The clinical outcome of all other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: high fever (103F)/ fever for so many days; a lot of bone aches; fatigue; This is a spontaneous report from a contactable consumer (patient). 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 1st dose, single dose for COVID-19 immunization. Medical history included the patient had COVID on Oct2020. The patient's concomitant medications were not reported. It will be two weeks "tomorrow" since her first dose of the vaccine. On an unspecified date in 2021, patient was having COVID-like symptoms and she has been to the doctor twice and all tests have came back negative. They do not know what was wrong. The patient experienced high fever (103 F) for 5-6 days now, a lot of bone aches, and she has been in the bed for days. She had fatigue in the beginning. This reminds patient of when she had COVID. She has had a fever for so many days. Patient is about to go to the emergency room. The patient was asking if there's something she can read or if someone can tell her if it is normal to have reactions a week later (7 days) after receiving the COVID vaccine, instead of a few days later. Outcome of the events were unknown.   Information about lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numbness in my tongue, in gums & cheeks; Numbness in my tongue, in gums & cheeks; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received BNT162B2(COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection Batch/Lot Number: EM6208, Expiration Date: not reported), via an unspecified route of administration on 19Mar2021 (at the age of 70 years old) as second dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: EL9267), via an unspecified route of administration on 26Feb2021 (at the age of 70 years old) as single, for COVID-19 immunisation. On an unspecified date in Mar2021, reported to be nearly third week of Mar2021, the patient experienced numbness in tongue, in gums & cheeks. Seriousness of the events were unspecified. No treatment was received for the adverse event. Outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache
Clinical narrative: fatigue; headache; feeling very bad; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (UNSPECIFIED TRADE NAME), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue, headache, and feeling very bad for several days. Events took place after use of product. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Epistaxis
Clinical narrative: a couple of nosebleeds here and there 3 weeks after receiving the second dose of the Pfizer Biontech Covid-19 Vaccine; cough every now and then; This is a spontaneous report received from a contactable consumer (the patient). A 26-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he seemed to be having a couple of nosebleeds here and there 3 weeks after receiving the second dose of the Pfizer Biontech COVID-19 Vaccine. He seemed to also be experiencing cough every now and then. He suspected that wearing the surgical mask with wire lining could be the cause but wanted to get more information from Pfizer. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: loss of sense of smell; This is a spontaneous report from a Pfizer sponsored program, Pfizer COVID-19 Vaccine call center. This is a spontaneous report from a contactable consumer (68-year-old male) or other non hcp. A 55-year-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 06Feb2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced loss of sense of smell on Feb2021. Caller stated that wife loss of sense of smell around the same time he was diagnosed with Covid 19, although she never was tested. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Dysmenorrhoea, Nausea, Pain
Clinical narrative: severe abdominal/ period cramps lasting approx 1 (1 week after dose); severe abdominal/ period cramps lasting approx 1 (1 week after dose); diarrhea pm approx 12 hours after dose; slight nausea am next day after dose; intermittent abdominal aches/ sharp body pains (never had at this frequency); This is a spontaneous report from a contactable consumer. This 43-year-old female consumer (patient) reported for herself that. A 43-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0176), via an unspecified route of administration, administered in Arm Left on 06May2021 10:15 as 1st dose, single dose for covid-19 immunisation. The patient was 43 years old and non-pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On May2021 the patient experienced severe abdominal/ period cramps lasting approx 1 (1 week after dose), diarrhea pm approx 12 hours after dose, slight nausea am next day after dose and intermittent abdominal aches/ sharp body pains (never had at this frequency). Treatment received for the adverse event was ibuprofen. Therapeutic measures were taken as a result of severe abdominal/ period cramps lasting approx 1 (1 week after dose), diarrhea pm approx 12 hours after dose, slight nausea am next day after dose. The outcome for the events severe abdominal/ period cramps lasting approx 1 (1 week after dose), diarrhea pm approx 12 hours after dose, slight nausea am next day after dose was resolved on May2021, for the event intermittent abdominal aches/ sharp body pains (never had at this frequency) the outcome was unknown. No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Intraocular pressure increased, Neck pain, Vaccination site joint movement impairment
Clinical narrative: She also is diabetic and has high eye pressure.; The pain is going to her neck and does not let her raise her arm. She also mentions that she also have a sharp pain in her belly and she did not have it before.; Feeling that her shoulder is killing her.; The pain is going to her neck and does not let her raise her arm. She also mentions that she also have a sharp pain in her belly and she did not have it before.; she also have a sharp pain in her belly; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 30Apr2021 as a single dose for covid-19 immunization. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) via unspecified route on an unspecified date. The patient's medical history included diabetes. The patient's concomitant medications were not reported as single dose. It was reported that the patient felt that her shoulder was killing her. The patient stated that the pain was up to her neck and does not let her raise her arm. The patient also stated that she also had a sharp pain in her belly which did not had it ever before all on 19May2021. The patient also stated that she was also a diabetic and has high eye pressure. Patient called her doctor this morning and could not find him so she she left a message. Patient did not want to go to the ER and she wanted to know why she was having these adverse reactions after 20 days of taking the vaccine. The patient was explained about the reports of muscle pain and pain in the injection site, the possible duration and being more intense after the second dose. The patient was recommended to consult her physician to determine the cause of her pain. Therapeutic measures were not taken as result of AE. The outcome of the events was unknown.  Information on lot number/batch number was requested.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient) reported for a patient of unspecified age and gender received bnt162b2 (BNT162B2, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced vomiting. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast tenderness, Ovulation disorder, Postmenopausal haemorrhage
Clinical narrative: started her period, it was lite; started to ovulate; breasts were sore and tender; breasts were sore and tender; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot Number: EL9261) as 2nd dose, single for Covid-19 immunization. The patient received the first dose of BNT162B2 on 21Jan2021 (at the age of 55years) for Covid-19 immunization. Medical history included menopause from Jul2019, and fibromyalgia from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included duloxetine (DULOXETINE); cyanocobalamin (B12); ergocalciferol (VIT D); sambucus nigra (ELDERBERRY); zinc (ZINC), and Vitamins (unspecified); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she has not had a period since Jul2019. She received her second Pfizer Covid shot on 12Feb2021. Then 7 weeks later, she started to ovulate, 1 week later her breasts were sore and tender, and then a week later she started her period, it was lite. It was just like her normal cycle used to be. The patient asked, "Are the vaccines causing menopausal women to start their cycle again after receiving their Covid vaccines?" There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovered on an unspecified date.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Ear discomfort, Groin pain
Clinical narrative: headache; ears very clogged; both thighs very painful; her left arm was very painful; lower back very painful; I wanted her to rule out pericarditis before having full cardiac workup; sharp left-sided chest pain began with increased pain in groin and left hip; sharp left-sided chest pain began with increased pain in groin and left hip; sharp left-sided chest pain began with increased pain in groin and left hip; this pain in chest, especially when taking a deep breath; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in left arm on 11May2021 18:00 (Lot Number: EW0185) as 1st dose, single dose for covid-19 immunisation. Medical history included had pericarditis a number of years ago (unknown date) that lasted one year then went away and rheumatic fever at age 7 (unknown year). The patient was very healthy and felt perfectly fine prior to vaccine. The patient was not diagnosed with Covid-19. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamins nos (VITAMINS NOS reported as vitamins) and supplements. The patient received the most recent COVID-19 vaccine from a pharmacy or drug store. The patient reported that 4 hours after she got the shot (11May2021), her left arm, lower back, and both thighs very painful. The next morning (12May2021), she had headache, ears very clogged, and lower back and thighs were very painful. It was reported that 7 days later (May2021), the patient experienced a sharp left-sided chest pain began with increased pain in groin and left hip. These symptoms are still continuing to this date. The patient reported that she had pericarditis in past and this pain in chest, especially when taking a deep breath, is very similar (May2021). She called her primary care physician (PCP) to try to get appointment to see her, but she was told to go to ER. The patient did not want to get to the ER due to the deductible to meet before her insurance kicks in. She wanted to rule out pericarditis before having full cardiac workup. All symptoms were still continuing, however chest pain is not as severe. The patient does not plan to get second shot. The patient considered the events was non-serious. The patient has not been tested for COVID-19 since vaccination. The patient did not received treatments for the adverse events. The outcome of the events was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Painful respiration, Pericarditis, Vaccination site pain
Clinical narrative: headache; ears very clogged; both thighs very painful; her left arm was very painful; lower back very painful; I wanted her to rule out pericarditis before having full cardiac workup; sharp left-sided chest pain began with increased pain in groin and left hip; sharp left-sided chest pain began with increased pain in groin and left hip; sharp left-sided chest pain began with increased pain in groin and left hip; this pain in chest, especially when taking a deep breath; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in left arm on 11May2021 18:00 (Lot Number: EW0185) as 1st dose, single dose for covid-19 immunisation. Medical history included had pericarditis a number of years ago (unknown date) that lasted one year then went away and rheumatic fever at age 7 (unknown year). The patient was very healthy and felt perfectly fine prior to vaccine. The patient was not diagnosed with Covid-19. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamins nos (VITAMINS NOS reported as vitamins) and supplements. The patient received the most recent COVID-19 vaccine from a pharmacy or drug store. The patient reported that 4 hours after she got the shot (11May2021), her left arm, lower back, and both thighs very painful. The next morning (12May2021), she had headache, ears very clogged, and lower back and thighs were very painful. It was reported that 7 days later (May2021), the patient experienced a sharp left-sided chest pain began with increased pain in groin and left hip. These symptoms are still continuing to this date. The patient reported that she had pericarditis in past and this pain in chest, especially when taking a deep breath, is very similar (May2021). She called her primary care physician (PCP) to try to get appointment to see her, but she was told to go to ER. The patient did not want to get to the ER due to the deductible to meet before her insurance kicks in. She wanted to rule out pericarditis before having full cardiac workup. All symptoms were still continuing, however chest pain is not as severe. The patient does not plan to get second shot. The patient considered the events was non-serious. The patient has not been tested for COVID-19 since vaccination. The patient did not received treatments for the adverse events. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives after ~48 hours on both arms.  Hives continue to spread after 72 hours covering 30% of back area and 25% of arms.  Benadryl 25 mg PO appears to be controlling the hives now.; This is a spontaneous report from a contactable consumer. A 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 20May2021 08:00 (Batch/Lot Number: EW0168) as 1st dose, single for covid-19 immunization. The patient has no medical history and concomitant medications. The patient has no known allergies. On 22May2021 at 08:00, the patient experienced hives after 48 hours on both arms. Hives continue to spread after 72 hours covering 30% of back area and 25% of arms. Benadryl 25 mg P.O appears to be controlling the hives now. The outcome of the events was recovering.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Apr2021 16:30 (at age 62-year-old) (Batch/Lot Number: EP7533) as 1st dose, single dose for covid-19 immunisation. Medical history included neurofibromatosis from an unknown date and unknown if ongoing. There were no concomitant medications and no other vaccines received in four weeks. The patient experienced Bell's palsy on 23May2021 08:00. Prednisone and Valtrex was given was treatment. Outcome of the event was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fall, Inappropriate schedule of product administration, Malaise
Clinical narrative: couple of falls/slid off her bed; contusion; hadn't been feeling well; patient missed her second dose of the COVID vaccine which was supposed to be given 24Mar2021/She didn't get the second dose because she had had a couple of falls; This is a spontaneous report from a Pfizer sponsored program received from a contactable nurse (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 03Mar2021 (at the age of 74-year-old) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient missed her second dose of the COVID vaccine which was supposed to be given 24Mar2021. She asked if she can still get the second dose. The patient didn't have a prescribing doctor. She registered online, and they called her and told her they would have shots available, so she went and got it. She hadn't been feeling well on unspecified date so she is just now getting around to calling about it. She didn't get the second dose because she had had a couple of falls. She slid off her bed and had a contusion. That was the last part of Mar2021. She was in the hospital for observation for 2-3 days, and then she was in rehab for 3 weeks. She was in the hospital from 30Mar2021 to 02Apr2021. She was then transferred to physical therapy until 27Apr2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The events fall and contusion are most like accidents, unrelated to BNT162B2.  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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for the Covid virus a week later/she was asymptomatic; This is a spontaneous report received from a contactable healthcare professional (patient) via a Pfizer-sponsored program. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in left arm on 16Apr2021 08:00 (at the age of 40-year-old) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient received the first dose of the Pfizer Covid-19 vaccine and tested positive for the Covid virus on 23Apr2021. She was scheduled to receive her second dose on 07May2021, and they said because she was asymptomatic, some people said she would be fine, some people said wait, nobody gave her a straight answer. She is asking when she can receive her second dose. She is a little apprehensive and wasn't sure on when to receive the second dose due to hearing numerous things. She plans to receive the second dose this week. On 23Apr2021, the patient tested positive for COVID. The patient recovered from the event on unspecified date.  Information on the lot/batch number has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on stomach, hand, face and neck; This is a spontaneous report from a contactable consumer (patient). A 16-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: Ew0171), via an unspecified route of administration, administered in the left arm on 12May2021 at 17:15 as a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 21May2021, the patient developed rash on stomach, hand, face and neck. The patient received Benadryl and cortizone-10 as treatment for the event. The outcome of the event was not recovered. The event was reported as non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Swelling face, Urticaria
Clinical narrative: Hives over 90% of body; swollen face; difficulty breathing; This is a spontaneous report from a contactable consumer (reported for herself). A 29-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the left arm, at age 29 years, on 21May2021 18:00 (Batch/Lot Number: EW0186) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included endometriosis from an unknown date and unknown if ongoing. Patient had no known allergies. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol;norethisterone acetate taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historically took first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EW0179) at age 29 years on 30Apr2021 05:00 PM on the left arm for COVID-19 immunisation. On 21May2021 at 21:00, the patient experienced hives over 90% of body, swollen face and difficulty breathing. Patient was hospitalized in May2021 for 1 day. Patient was treated with dexamethasone 12mg for the events. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was other. The outcome of the events was recovering.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Heart rate, Heart rate irregular, Inappropriate schedule of product administration, Off label use
Clinical narrative: I felt my heart beat in an irregular pattern (AFib) and even it detected  by Watch.; I felt my heart beat in an irregular pattern (AFib) and even it detected  by Watch.; Date of start of drug: 01May2021, Dose Number: 1; Date of start of drug: 01May2021, Dose Number: 2; Date of start of drug: 01May2021, Dose Number: 1; Date of start of drug: 01May2021, Dose Number: 2; This is a spontaneous report from a contactable female consumer reported for herself. A 32-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0171, Expiration date: unknown), via unspecified route, administered in left arm on 01May2021 at 11:15 AM (at the age of 32-year-old) as 1st dose, single dose for COVID-19 immunisation. On the same day(01May2021), the patient received another dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0179, Expiration date: unknown), via unspecified route, administered in left arm on 01May2021 at (at the age of 32-year-old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no history of allergies. No other vaccines were received within 4 weeks prior to Covid vaccine. Prior or post vaccination the patient has not been tested or diagnosed with covid 19. On 23May2021, at 11:45 am, 22 days after the vaccination, the patient experienced heartbeat in irregular pattern (AFib) and even it detected by her watch. The lab data includes heart rate monitoring on 23May2021. No treatment options were used for the event. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Computerised tomogram, Deafness, Disorientation, Dizziness
Clinical narrative: Irregular  high blood pressure; dizzy; disoriented; loss of balance; pain in neck left side; loss of hearing; impaired blurry vision; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 09Apr2021 at 10:45 as a single dose for COVID-19 immunization.  Medical history included Bell's palsy ebv (as reported) from an unknown date and unknown if ongoing. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included lisinopril (manufacturer unknown); clarithromycin (CLARITIN); ascorbic acid (VITAMINS C); colecalciferol (D3) and fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:30, the patient had an irregular high blood pressure, was dizzy and disoriented, had a loss of balance, pain in neck left side, loss of hearing and impaired blurry vision. The events resulted in a visit to the emergency room and hospitalization for 2 days. The patient had an MRI, CT scan, EKG and an echocardiogram (results unknown). The patient had a nasal swab COVID-19 test on 28Apr2021 with an unknown result. The outcome of the event was recovering.   Information about batch/lot has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Hypertension, Magnetic resonance imaging, Neck pain
Clinical narrative: Irregular  high blood pressure; dizzy; disoriented; loss of balance; pain in neck left side; loss of hearing; impaired blurry vision; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 09Apr2021 at 10:45 as a single dose for COVID-19 immunization.  Medical history included Bell's palsy ebv (as reported) from an unknown date and unknown if ongoing. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included lisinopril (manufacturer unknown); clarithromycin (CLARITIN); ascorbic acid (VITAMINS C); colecalciferol (D3) and fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:30, the patient had an irregular high blood pressure, was dizzy and disoriented, had a loss of balance, pain in neck left side, loss of hearing and impaired blurry vision. The events resulted in a visit to the emergency room and hospitalization for 2 days. The patient had an MRI, CT scan, EKG and an echocardiogram (results unknown). The patient had a nasal swab COVID-19 test on 28Apr2021 with an unknown result. The outcome of the event was recovering.   Information about batch/lot has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vision blurred
Clinical narrative: Irregular  high blood pressure; dizzy; disoriented; loss of balance; pain in neck left side; loss of hearing; impaired blurry vision; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 09Apr2021 at 10:45 as a single dose for COVID-19 immunization.  Medical history included Bell's palsy ebv (as reported) from an unknown date and unknown if ongoing. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included lisinopril (manufacturer unknown); clarithromycin (CLARITIN); ascorbic acid (VITAMINS C); colecalciferol (D3) and fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:30, the patient had an irregular high blood pressure, was dizzy and disoriented, had a loss of balance, pain in neck left side, loss of hearing and impaired blurry vision. The events resulted in a visit to the emergency room and hospitalization for 2 days. The patient had an MRI, CT scan, EKG and an echocardiogram (results unknown). The patient had a nasal swab COVID-19 test on 28Apr2021 with an unknown result. The outcome of the event was recovering.   Information about batch/lot has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arteriogram carotid normal, Balance disorder, Blood pressure increased, Burning sensation, Central nervous system inflammation
Clinical narrative: Irregular  high blood pressure; dizzy; disoriented; loss of balance; pain in neck left side; loss of hearing; impaired blurry vision; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 09Apr2021 at 10:45 as a single dose for COVID-19 immunization.  Medical history included Bell's palsy ebv (as reported) from an unknown date and unknown if ongoing. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included lisinopril (manufacturer unknown); clarithromycin (CLARITIN); ascorbic acid (VITAMINS C); colecalciferol (D3) and fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:30, the patient had an irregular high blood pressure, was dizzy and disoriented, had a loss of balance, pain in neck left side, loss of hearing and impaired blurry vision. The events resulted in a visit to the emergency room and hospitalization for 2 days. The patient had an MRI, CT scan, EKG and an echocardiogram (results unknown). The patient had a nasal swab COVID-19 test on 28Apr2021 with an unknown result. The outcome of the event was recovering.   Information about batch/lot has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Computerised tomogram normal, Deafness, Disturbance in attention, Dizziness
Clinical narrative: Irregular  high blood pressure; dizzy; disoriented; loss of balance; pain in neck left side; loss of hearing; impaired blurry vision; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 09Apr2021 at 10:45 as a single dose for COVID-19 immunization.  Medical history included Bell's palsy ebv (as reported) from an unknown date and unknown if ongoing. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included lisinopril (manufacturer unknown); clarithromycin (CLARITIN); ascorbic acid (VITAMINS C); colecalciferol (D3) and fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:30, the patient had an irregular high blood pressure, was dizzy and disoriented, had a loss of balance, pain in neck left side, loss of hearing and impaired blurry vision. The events resulted in a visit to the emergency room and hospitalization for 2 days. The patient had an MRI, CT scan, EKG and an echocardiogram (results unknown). The patient had a nasal swab COVID-19 test on 28Apr2021 with an unknown result. The outcome of the event was recovering.   Information about batch/lot has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram normal, Electrocardiogram ambulatory normal, Electrocardiogram normal, Feeling abnormal, Gait disturbance
Clinical narrative: Irregular  high blood pressure; dizzy; disoriented; loss of balance; pain in neck left side; loss of hearing; impaired blurry vision; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 09Apr2021 at 10:45 as a single dose for COVID-19 immunization.  Medical history included Bell's palsy ebv (as reported) from an unknown date and unknown if ongoing. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included lisinopril (manufacturer unknown); clarithromycin (CLARITIN); ascorbic acid (VITAMINS C); colecalciferol (D3) and fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:30, the patient had an irregular high blood pressure, was dizzy and disoriented, had a loss of balance, pain in neck left side, loss of hearing and impaired blurry vision. The events resulted in a visit to the emergency room and hospitalization for 2 days. The patient had an MRI, CT scan, EKG and an echocardiogram (results unknown). The patient had a nasal swab COVID-19 test on 28Apr2021 with an unknown result. The outcome of the event was recovering.   Information about batch/lot has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Magnetic resonance imaging head normal, Memory impairment, Muscle twitching, Nystagmus
Clinical narrative: Irregular  high blood pressure; dizzy; disoriented; loss of balance; pain in neck left side; loss of hearing; impaired blurry vision; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 09Apr2021 at 10:45 as a single dose for COVID-19 immunization.  Medical history included Bell's palsy ebv (as reported) from an unknown date and unknown if ongoing. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included lisinopril (manufacturer unknown); clarithromycin (CLARITIN); ascorbic acid (VITAMINS C); colecalciferol (D3) and fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:30, the patient had an irregular high blood pressure, was dizzy and disoriented, had a loss of balance, pain in neck left side, loss of hearing and impaired blurry vision. The events resulted in a visit to the emergency room and hospitalization for 2 days. The patient had an MRI, CT scan, EKG and an echocardiogram (results unknown). The patient had a nasal swab COVID-19 test on 28Apr2021 with an unknown result. The outcome of the event was recovering.   Information about batch/lot has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Presyncope, Pruritus, Scan with contrast
Clinical narrative: Irregular  high blood pressure; dizzy; disoriented; loss of balance; pain in neck left side; loss of hearing; impaired blurry vision; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 09Apr2021 at 10:45 as a single dose for COVID-19 immunization.  Medical history included Bell's palsy ebv (as reported) from an unknown date and unknown if ongoing. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included lisinopril (manufacturer unknown); clarithromycin (CLARITIN); ascorbic acid (VITAMINS C); colecalciferol (D3) and fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:30, the patient had an irregular high blood pressure, was dizzy and disoriented, had a loss of balance, pain in neck left side, loss of hearing and impaired blurry vision. The events resulted in a visit to the emergency room and hospitalization for 2 days. The patient had an MRI, CT scan, EKG and an echocardiogram (results unknown). The patient had a nasal swab COVID-19 test on 28Apr2021 with an unknown result. The outcome of the event was recovering.   Information about batch/lot has been requested.