chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Breast pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Small bumps directly around lymph nodes with intense itching which feels like it's on the inside sometimes; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 18Mar2021 12:00 as single dose for COVID-19 immunization. Medical history included SAPHO syndrome, vasculitis, gout, arthritis, carpal tunnel syndrome, hot peppers and garlic sensitivity, and seasonal rhinitis allergy, all from an unknown date. The patient has no COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included ibuprofen; pregabalin (LYRICA); methotrexate; omeprazole; and paracetamol (TYLENOL), all taken for an unspecified indication. The patient previously took Biaxin and Bactrim and experienced allergies. On 20Mar2021, 04:00, the patient experienced pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, and upper back. Onset was intense aching pain two days post injection. Small bumps directly around lymph nodes with intense itching which felt like it's on the inside sometimes was reported. It was a Monday night of 22Apr2021 at 9:55 PM and symptoms were static, not worsening not improving. No treatment was received for the events. The outcome of the events was not recovered.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Small bumps directly around lymph nodes with intense itching which feels like it's on the inside sometimes; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 18Mar2021 12:00 as single dose for COVID-19 immunization. Medical history included SAPHO syndrome, vasculitis, gout, arthritis, carpal tunnel syndrome, hot peppers and garlic sensitivity, and seasonal rhinitis allergy, all from an unknown date. The patient has no COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included ibuprofen; pregabalin (LYRICA); methotrexate; omeprazole; and paracetamol (TYLENOL), all taken for an unspecified indication. The patient previously took Biaxin and Bactrim and experienced allergies. On 20Mar2021, 04:00, the patient experienced pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, and upper back. Onset was intense aching pain two days post injection. Small bumps directly around lymph nodes with intense itching which felt like it's on the inside sometimes was reported. It was a Monday night of 22Apr2021 at 9:55 PM and symptoms were static, not worsening not improving. No treatment was received for the events. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Caffeine consumption, Dysgeusia, Electric shock sensation, Pain in extremity
Clinical narrative: she was "shocking people" when she touched them, like static shock/I started shocking people and myself; when she pushes down on her arm it hurts.; she "could taste it when he gave it to me" talking about the vaccine.; she couldn't stop drinking coffee. She normally drinks 2 cups a day, but after receiving her vaccine, she dray 10 cups of coffee; This is a spontaneous report from a contactable consumer (patient)  A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Mar2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose with no problem. She said she only knows that she "got a needle" because when she pushes down on her arm it hurts. Her concern, however, was that for the rest of the day after the shot she couldn't stop drinking coffee. She normally drinks 2 cups a day, but after receiving her vaccine, she dray 10 cups of coffee, didn't feel jittery, and went to sleep that night with no problem, and slept well. She wanted to know if this is normal. Should she get a large coffee before going to get her second dose. The patient also reported that she was "shocking people" when she touched them, like static shock. She also stated she "could taste it when he gave it to me" talking about the vaccine. She would like to know when she would get the "normal" symptoms. The patient further stated, "I had the vaccination yesterday- no problems and teeny concern of mine - after I got it I started shocking people and myself - I could taste it when he gave it to me. My concern was it made me drink a significant amount of coffee - 10 cups of coffee - didn't feel over caffeinated. Laid down and went to sleep. No ailments, don't feel bad - Had to have a cup of coffee every hour. 2 cups everyday and Pepsi. When I push in my arm is the only way that I knew I got a needle. Pfizer was my choice of vaccine from the beginning. Thank you are my heroes." The patient was informed that there was no information about avoiding caffeine around vaccination.  Cannot make a recommendation about coffee consumption, that would be a personal decision. Patient stated that she did not feel fatigued. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Ocular hyperaemia, Visual impairment
Clinical narrative: eyes feel hot/burning and also states she sees 'sparklers'; eyes feel hot/burning and also states she sees 'sparklers'; developed red eyes with  red veins in her eyes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 19Mar2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient developed red eyes with red veins in her eyes; eyes feel hot/burning and also stated she sees 'sparklers'. It was unclear from the patient when she developed these side effects. She was wanting to know if these have been reported and if so how long will it last. Clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Headache, Oropharyngeal pain
Clinical narrative: He has covid; He started having a fever of 100-101 range; Sore throat; Stomach ache; Headache; Chills; This is a spontaneous report from a contactable consumer. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received his first Pfizer vaccine on Tuesday 15Mar2021, and starting on Friday on 19Mar2021 he started having a fever of 100-101 range, sore throat, stomachache, headache, chills, and chills was still going on today. The patient and his girlfriend were saying he had COVID. The patient made an appointment for a COVID test. The patient has not recovered from chills. Outcome of the rest of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Suspected COVID-19
Clinical narrative: He has covid; He started having a fever of 100-101 range; Sore throat; Stomach ache; Headache; Chills; This is a spontaneous report from a contactable consumer. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received his first Pfizer vaccine on Tuesday 15Mar2021, and starting on Friday on 19Mar2021 he started having a fever of 100-101 range, sore throat, stomachache, headache, chills, and chills was still going on today. The patient and his girlfriend were saying he had COVID. The patient made an appointment for a COVID test. The patient has not recovered from chills. Outcome of the rest of the events was unknown.   Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Dizziness, Dyspnoea, Headache
Clinical narrative: tightness in chest; Headache; dizziness; shortness of breath; nausea; itching; severe pain in both knees; numbness in both thighs; This is a spontaneous report from a contactable consumer (patient). A 60-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 Right on 21Mar2021 14:30 (Batch/Lot number was not reported) at the age of 60 years old, as single dose for covid-19 immunization. Medical history included sleep apnea, history of breast cancer left side lumpectomy, chemotherapy, radiation, asthma, osteoarthritis, vestibular disorder, allergies to unspecified medications and food, and GERD (gastrooesophageal reflux disease). The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included lisinopril (LISINOPRIL); hydrochlorothiazide; hydroxyzine; and meloxicam (MELOX); 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 21Mar2021 03:00, the patient experienced tightness in chest, headache, dizziness, shortness of breath, nausea, itching, severe pain in both knees, and numbness in both thighs. The events resulted in: doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The events were treated with Benadryl, solution medrol pf, sodium chloride. The patient has not recovered from the events. The patient has not been tested for COVID post vaccination. The events were reported as non-serious.   Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nausea, Pruritus
Clinical narrative: tightness in chest; Headache; dizziness; shortness of breath; nausea; itching; severe pain in both knees; numbness in both thighs; This is a spontaneous report from a contactable consumer (patient). A 60-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 Right on 21Mar2021 14:30 (Batch/Lot number was not reported) at the age of 60 years old, as single dose for covid-19 immunization. Medical history included sleep apnea, history of breast cancer left side lumpectomy, chemotherapy, radiation, asthma, osteoarthritis, vestibular disorder, allergies to unspecified medications and food, and GERD (gastrooesophageal reflux disease). The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included lisinopril (LISINOPRIL); hydrochlorothiazide; hydroxyzine; and meloxicam (MELOX); 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 21Mar2021 03:00, the patient experienced tightness in chest, headache, dizziness, shortness of breath, nausea, itching, severe pain in both knees, and numbness in both thighs. The events resulted in: doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The events were treated with Benadryl, solution medrol pf, sodium chloride. The patient has not recovered from the events. The patient has not been tested for COVID post vaccination. The events were reported as non-serious.   Information on the lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dyspnoea, Heart rate increased
Clinical narrative: Afib symptoms; short breath just walking doing simplest little things; Rapid heartbeat again; This is a spontaneous report from a contactable consumer.   A 61-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 21Mar2021 12:30 (Batch/Lot Number: EN6208), at the age of 61-years at vaccination, as SINGLE DOSE for covid-19 immunisation.  Medical history included Ankylosing spondylitis/psoriasis, cardiac ablation from Jan2017.  The patient received dose 1 of vaccination on 28-FEB-2021 12:30 PM and was feeling small symptoms sometimes.   Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient started feeling small symptoms after the second dose, the next day, 22-MAR-2021 15:00, the patient definitely was having the Afib symptoms again, short breath just walking doing simplest little things and having rapid heartbeat again.  The patient stated he had no problems before Pfizer vaccination. The outcome of the events was unknown. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Fear, Headache
Clinical narrative: not being able to catch her breath/breathing issues; lung issues like she couldn't catch her breath; body aches; Chest discomfort; got sick from it for 4 days; she is scared to take the second shot; fatigue/Tiredness; slight headache; muscles aches; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 11Mar2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got her first Pfizer Covid vaccine dose on 11Mar2021 and "right away" experienced  fatigue, slight headache, muscles aches on 11Mar2021. It was reported that later" she experienced not being able to catch her breath/breathing issues, lung issues like she couldn't catch her breath, body aches, chest discomfort, tiredness, got sick from it for 4 days, she was scared to take the second shot. Patient wanted know other people have experienced these side effects after the first dose. If so, did they get the second dose and did they experience the same side effects or was it worse. She asked it was more important to her to make sure the second shot is safe to take than to make a report. Outcome of the all events was unknown.  Information about the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lung disorder, Myalgia, Pain
Clinical narrative: not being able to catch her breath/breathing issues; lung issues like she couldn't catch her breath; body aches; Chest discomfort; got sick from it for 4 days; she is scared to take the second shot; fatigue/Tiredness; slight headache; muscles aches; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 11Mar2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got her first Pfizer Covid vaccine dose on 11Mar2021 and "right away" experienced  fatigue, slight headache, muscles aches on 11Mar2021. It was reported that later" she experienced not being able to catch her breath/breathing issues, lung issues like she couldn't catch her breath, body aches, chest discomfort, tiredness, got sick from it for 4 days, she was scared to take the second shot. Patient wanted know other people have experienced these side effects after the first dose. If so, did they get the second dose and did they experience the same side effects or was it worse. She asked it was more important to her to make sure the second shot is safe to take than to make a report. Outcome of the all events was unknown.  Information about the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiokeratoma, Body height decreased, Dizziness
Clinical narrative: condition on bottom of my scrotum that seems to be angiokeratoma; lightheaded; Caller mentioned he guesses he's shrinking/they've got him down to 5'8" now.; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient (age at vaccination: 70-year-old) received the second dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration in left arm on 16Mar2021 10:00 as SINGLE DOSE for Covid-19 immunisation. Medical history included hives basically on thighs and legs, sometimes in arms and lip (Feb2021), thyroid disorder and blood cholesterol. She had her first dose of bnt162b2 (Lot: EN6201) in left upper arm on 23Feb2021. Concomitant medications included levothyroxine sodium for thyroid disorder and fenofibrate for blood cholesterol. On 21Mar2021, the patient experienced a condition on bottom of his scrotum that seemed to be angiokeratoma and was reported as worsened with itching and was getting very painful. He informed that his in a condition in which small dark spots occur on the skin but they can become very painful and are prone to bleed. He went to the doctor and gave him some steroid cream: Betamethasone Valerate for condition. He had lightheaded on 17Mar2021. He also mentioned he guessed he's shrinking/they've got him down to 5'8" now (Mar2021). The outcome of angiokeratoma was not recovered; for other events was unknown.  The following information on the batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood immunoglobulin G normal, Herpes simplex test negative, Pain, Scrotal dermatitis
Clinical narrative: condition on bottom of my scrotum that seems to be angiokeratoma; lightheaded; Caller mentioned he guesses he's shrinking/they've got him down to 5'8" now.; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient (age at vaccination: 70-year-old) received the second dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration in left arm on 16Mar2021 10:00 as SINGLE DOSE for Covid-19 immunisation. Medical history included hives basically on thighs and legs, sometimes in arms and lip (Feb2021), thyroid disorder and blood cholesterol. She had her first dose of bnt162b2 (Lot: EN6201) in left upper arm on 23Feb2021. Concomitant medications included levothyroxine sodium for thyroid disorder and fenofibrate for blood cholesterol. On 21Mar2021, the patient experienced a condition on bottom of his scrotum that seemed to be angiokeratoma and was reported as worsened with itching and was getting very painful. He informed that his in a condition in which small dark spots occur on the skin but they can become very painful and are prone to bleed. He went to the doctor and gave him some steroid cream: Betamethasone Valerate for condition. He had lightheaded on 17Mar2021. He also mentioned he guessed he's shrinking/they've got him down to 5'8" now (Mar2021). The outcome of angiokeratoma was not recovered; for other events was unknown.  The following information on the batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caller got already the 2 doses of the Pfizer covid vaccine and tested positive for Covid 19 afterwards.; Caller got already the 2 doses of the Pfizer covid vaccine and tested positive for Covid 19 afterwards.; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 on 03Jan2021 in the afternoon (lot number: EJ1685) at the age of 45 years old, dose 2 on 24Jan2021 11:15 (Lot Number: EJ168) at the age of 45 years old , both via an unspecified route of administration as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No Family Medical History Relevant to AE(s). No History of all previous immunization with the Pfizer vaccine considered as suspect. No additional administered vaccines. No Prior Vaccinations (within 4 weeks). Caller wanted to know if it could be possible that she tested positive to Covid 19 and she got a variant. Caller got already the 2 doses of the Pfizer covid vaccine and tested positive for Covid 19 afterwards. She wanted to know about the research statics of the people that fully vaccinated tested positive for Covid 19 after receiving vaccine. Caller wanted to know if she went again to test, she would test positive. Caller wanted to know if the Institute had reported cases where patients tested positive after being vaccinated. Vaccine Administered at Military Facility: No. Caller stated she was calling about the COVID 19 vaccine and was wondering if the department of health notifies Pfizer if a patient got both vaccinations and tested positive for Covid. Caller stated she tested positive and got the test on 16Mar2021 and emailed results on 17Mar2021 to tell her she was positive. Caller stated she had not been to the doctor because she has been in quarantine and caller declined to provide HCP email. Caller tested positive on 16Mar2021 and when asked if the caller was still positive the caller responded if she should get another COVID test. The caller stated that she had not got that far to call the doctor. Caller stated that it had worsened. Caller stated she received the vaccine at the clinic at Hospital in a suite room area for healthcare providers. Treatment inlcuded Tylenol. The events did not require a visit to Emergency Room and Physician Office. Caller asked so far in research what was the statistics that someone has been fully vaccinated and tested positive for COVID. Caller stated she was just curious how many people test positive as the general public seems to think one should not test positive after receiving the vaccine and she should have been protected more. The report was serious per the reporter. The outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ischaemic, Dizziness, Ear pain, Headache, Malaise
Clinical narrative: ischemic colitis; sore throat; constant headaches; ears hurt; dizzy; generally not feeling well; This is a spontaneous report from a contactable healthcare professional (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 65-year-old, via an unspecified route of administration, administered in left arm on 04Feb2021 (Lot Number: EL3246) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included the patient having known allergies (unspecified). Concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: EL0140) at the age of 65-year-old, via an unspecified route of administration at the left arm on 14Jan2021 at 04:00 PM for Covid-19 immunization. On 01Mar2021, the patient experienced ischemic colitis, constant headaches, ears hurt, dizzy, generally not feeling well, and sore throat. The patient was hospitalized on an unspecified date due to the events for 5 days. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered.  Information on the batch/lot number has been requested.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of ischemic colitis, which may  likely represent intercurrent medical condition.   Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the other reported events  due to temporal relationship   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: ischemic colitis; sore throat; constant headaches; ears hurt; dizzy; generally not feeling well; This is a spontaneous report from a contactable healthcare professional (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 65-year-old, via an unspecified route of administration, administered in left arm on 04Feb2021 (Lot Number: EL3246) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included the patient having known allergies (unspecified). Concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: EL0140) at the age of 65-year-old, via an unspecified route of administration at the left arm on 14Jan2021 at 04:00 PM for Covid-19 immunization. On 01Mar2021, the patient experienced ischemic colitis, constant headaches, ears hurt, dizzy, generally not feeling well, and sore throat. The patient was hospitalized on an unspecified date due to the events for 5 days. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered.  Information on the batch/lot number has been requested.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of ischemic colitis, which may  likely represent intercurrent medical condition.   Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the other reported events  due to temporal relationship   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot
Clinical narrative: dizziness; hot; This is a spontaneous report received from a non-contactable other healthcare professional. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205) via an unspecified route of administration on 24Mar2021 as single dose for COVID-19 immunisation. Medical history included multiple sclerosis and complained of a weakness in her legs that she experiences during her flares. She does mention having to be on 2L oxygen at times when she has a flare. The patient's concomitant medications were not reported. On 24Mar2021, patient began to experience dizziness and hot. She was treated with water and lying in trendelenburg position. Outcome of events was unknown.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Epistaxis, Hypersensitivity
Clinical narrative: Allergies; experience bleeding (she reports "a lot") from his nose a lot; This is a spontaneous report from a contactable consumer. An 86-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 02Mar2021 at single dose for COVID-19 immunization and rivaroxaban (XARELTO VASCULAR) via an unspecified route of administration from unspecified date for atrial fibrillation. Medical history included atrial fibrillation. The patient's concomitant medications was not reported.  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Feb2021 for COVID-19 immunization. He received his first Pfizer Covid vaccine dose on 09Feb2021 and his second on 02Mar2021. On 03Mar2021 he started to experience bleeding (she reports "a lot") from his nose a lot then stopped for 10-15 mins, then 04Mar2021 same thing occurred in the morning. On 06Mar2021, she took him to emergency room. He is on Xarelto for atrial fibrillation. The bleeding stopped and they told them to put vaseline in his nose. He was treated by his PCP 09Mar2021 - and was told this was not a side effect of the vaccine but could possibly be allergies and was prescribed allergy medication. She states that after 2 days the bleeding returned. She was instructed by the MD that if the bleeding comes back then XARELTO needs to be stopped, which he did, then he restarted it because is worried about having a stroke. Now the bleeding has returned. The action taken of rivaroxaban in response to events was unknown. The outcome of the event bleeding (she reports "a lot") from his nose a lot was not recovered and the outcome of the event allergies was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Mental impairment
Clinical narrative: mental fog; Dizziness and unbalanced; Dizziness and unbalanced; This is a spontaneous report from a contactable consumer or other non hcp.    A 35-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration, administered in arm left on 15Mar2021 10:00 (Lot Number: EN6204) as single dose for covid-19 immunisation. Medical history included hypertension, hepatic fibrosis. No allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included tocopherol (VITAMIN E) taken for an unspecified indication, calcium carbonate taken for an unspecified indication, lisinopril taken for an unspecified indication, hctz taken for an unspecified indication. The patient experienced mental fog on 22Mar2021 13:00, dizziness and unbalanced on 22Mar2021 13:00. No treatment received for the adverse event. The events outcome was not recovered.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: received the first dose of the Pfizer covid vaccine on 08 MAR 2021/positive test on Thursday on 18 MAR 2021; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 08Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer covid vaccine on 08Mar2021, stated, "on the last week, I get the positive covid test, symptoms began, and Tuesday last week Mar 16th, positive test on Thursday on 18Mar2021. The patient wanted to know if she should get the second one, it should be next Monday 29Mar2021. Can I get it, or shouldn't take it I have it right now?" Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis
Clinical narrative: Patient developed colitis 3 days after first injection; This is a spontaneous case received from a contactable Physician. A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unknown date to an unknown date (at the age of 59-years-old) as single dose in the unknown anatomical location for COVID-19 immunization. The patient's medical history includes HTN, high cholesterol and chronic back pain. The patient's concomitant medications include HYDRALAZINE, ATORVASTATIN, paracetamol, tramadol hydrochloride (ULTRAM) and MAGNESIUM. On an unknown date, the patient developed colitis 3 days after first injection. The patient has received treatment for the event. The outcome of the event was recovering.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: The next morning was achy for 24 hours; Passing chills the night; This is a spontaneous report from the non-contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, lot number: ED6955) via unspecified route of administration in the left arm on 23Mar2021 at 09:00 am as a single dose for COVID-19 immunization. The patients medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 01Mar2021 09:00 am at left arm single for Covid-19 immunization (Lot number: EL3247). Patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced passing chills the night after the 2nd dose on 23Mar2021. The next morning was achy for 24 hours on 24Mar2021. No therapeutic measures were received for both the events. The outcome of events "chills" and "ache" were recovered on an unknown date in 2021.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Presyncope
Clinical narrative: almost blacked out; blood pressure was 185/127; This is a spontaneous report from a contactable consumer.   A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported)), dose 1 via an unspecified route of administration, administered in left arm on 21Mar2021, at 14:30  as single dose for covid-19 immunization.  Medical history included colon cancer from an unknown date, chemotherapy in 2017 to an unknown date. Concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) for immunization in 26Feb2021.  The patient previously took codeine and caffeine and experienced drug allergies.  On 21Mar2021, at  15:00 patient  experienced blood pressure was 185/127 and almost blacked out. The details were noted as follows:  after the injection as the patient was driving he almost blacked out. He parked his car and went back to the site; paramedics assisted him. His blood pressure was 185/127 on 21Mar2021 . He noted that he almost blacked out a second time. Doctor visits two days and three days after injection day was noted.  The outcome of events was recovering, with no noted treatments. No Covid test post vaccination was noted.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling sensation starting on my right feet, then right arm, then coming up on my body up to my face.; This is a spontaneous report from a contactable consumer (patient) via COVAES. A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN8730) via unspecified route of administration on 24Mar2021 12:45 PM at single dose for covid-19 immunization. The patients medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 on 03Mar2021 12:15 PM at left arm single dose for Covid-19 immunization (Lot number: EN6199). Within 10 minutes after the 2nd dose of the vaccine on 24Mar2021 at 01:00 PM patient felt tingling sensation starting on her right feet, then right arm, then coming up on my body up to my face. After 15 minutes of starting to feel those sensations, they stopped and I did not feel anything else so far it has been 8h approximately. No therapeutic measures were received for the event. The outcome of the event was recovered on 24Mar2021. Information on the suspect expiry date has been requested
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Gait disturbance, Tremor
Clinical narrative: suddenly began shaking horribly from head to feet/shaking of his hands; freezing; My walking is not as good as before; This is spontaneous report received from a contactable consumer (patient). A 79-year-old male patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration on 01Mar2021 at 12:45 (at the age of 79 years) at a single dose in the left arm for COVID-19 immunization. Medical history included stem cell transplant; then soon after GBS from an unknown date and was diagnosed with COVID-19 from an unknown date. No allergies to medications, food, or other products. Concomitant medications included levothyroxine; rosuvastatin; telmisartan; and metformin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) on 08Feb2021 at 12:45 pm in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Mar2021 at 21:30, patient was getting ready for bed but suddenly began shaking horribly from head to feet and was freezing. His wife put him in bed with six blankets but he was still freezing. His wife brought him to the ER. Upon arrival at the ER, it was noted that the shaking was gone but the shaking of his hands remain that he could not put a spoon of sugar in his coffee cup without spilling it and stated that his walking is not as good as before. The patient was hospitalized due to the events for 2 days. The events were considered serious for disability. Therapeutic measures were taken as a result of the events (needles were placed on both legs as reported) and MRI was performed. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequel on an unspecified date.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Illness, Nausea, Pain in extremity, Suspected COVID-19
Clinical narrative: not sure if she has Covid; not sure if she has Covid; she got sick; queasy stomach; hurting of her arm that she got the vaccine in; This is a spontaneous report received from a contactable consumer (Patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 13:00 (Batch/Lot Number: EN6206) at the age of 61-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered in parking lot. Not at Military Facility. The patient's medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historic vaccine included 23 years ago with her 1st flu shot she got sick but has not had any issues since. Patient stated she was scheduled for the 2nd Pfizer shot today and she got sick and was not sure if she has Covid on 23Mar2021. Stated she didn't want to get the 2nd shot and exacerbate her symptoms, states she got symptoms with her first shot. Patient was wondering if she can reschedule her shot in general as it was scheduled for today. Patient stated the symptoms after the 1st shot were not detrimental, she had a queasy stomach later that night and natural hurting of her arm that she got the vaccine in. Stated it started that night after 12 at night. Clarified she got the shot 03Mar2021 and the symptoms started after midnight making it 04Mar2021. Stated the symptoms didn't even last 24 hours and were gone by 05Mar2021. No Emergency Room and No Physician Office visit required. The outcome of the events 'hurting of her arm' and 'queasy stomach' was recovered on 05Mar2021 and the outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got Covid positive after receiving our first dose/ Had an active infection; Got Covid positive after receiving our first dose/ Had an active infection; This is a spontaneous report from a contactable pharmacist via a Pfizer sponsored program.  A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 07Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Covid-19 Vaccine and did not receive the second dose that is because that someone got Covid positive. This is a gentleman and older gentleman and he can't get around very well. He was in the facility when he got the first dose and he is no longer in that facility. the second dose that is because that someone got Covid positive. He also had Covid and he had an active infection previously as well. Obviously, it is like seventy or more days out from the first dose, it is beyond the recommended window. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (drug ineffective) with BNT162b2 can not be fully excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 antibody test, Urticaria
Clinical narrative: all over itching and hives; all over itching and hives; This is a spontaneous report from a contactable consumer (patient).  A 51-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 10Mar2021 18:30 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. Medical history included Hashimoto's disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient previously took biaxin and experienced allergy.  On 12Mar2021 14:15, the patient experienced all over itching and hives. The events were considered as serious requiring doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event).  The patient underwent lab tests and procedures on 18Mar2021 which included sars-cov-2 antibody test: negative. Therapeutic measures were taken as a result of all over itching and hives includes: EpiPen injection. Outcome of events was recovering.  Information on the lot/batch number has been requested.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.  Additional information received on 02Apr2021 to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain in extremity, Syncope
Clinical narrative: Fainted while sitting; Too much pain in hand; chills; Weakness; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received first dose of BNT162B2(Batch/Lot Number: Unknown), via an unspecified route of administration on 24Mar2021 18:15 at single dose in the left arm for COVID-19 immunization. Medical history included Known allergies: NSAID on an unknown date. The patient's concomitant medications were not reported. The patient previously took ibuprofen and experienced allergy. On 25Mar2021 03:00, the patient experienced fainted while sitting, too much pain in hand, chills and weakness. Therapeutic measures were taken as a result of all the events which included Tylenol. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any other medications within four weeks prior to the vaccination. 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 outcome of the events was not recovered.   The following information on the lot/batch number has been requested.