chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness transient
Clinical narrative: Temporary loss of eyesight left eye.; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, in the left arm on 26Feb2021 10:15 at a single dose (at the age of 68-years-old) for COVID-19 immunisation. Medical history included atrial fibrillation (A-fib) and gout. The patient has no known allergies. Concomitant medication included allopurinol and acetylsalicylic acid (ASPIRIN (E.C.). The patient received the first dose of BNT162B2 (lot number was not reported) in the left arm on 29Jan2021 10:15 (at the age of 68-years-old) for COVID-19 immunisation. No other vaccines were administered within four weeks. No COIVD prior vaccination. On 27Feb2021 at 11:00, the patient experienced temporary loss of eyesight left eye. The patient did not receive treatment for the event. No COVID tested post vaccination. The patient recovered from the event in Feb2021.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: arm was very sore when she got up it was swollen and red and hurt terribly; arm was very sore when she got up it was swollen and red and hurt terribly; arm was very sore when she got up it was swollen and red and hurt terribly; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 59 years of age), via an unspecified route of administration in the left arm on 25Feb2021 14:15 (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunisation. Medical history included chronic blood clot in left leg from an unknown date and unknown if ongoing and environmental allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks prior to covid vaccine. She was not pregnant. The patient had not had covid prior vaccination and she had not been tested post vaccination. It was reported that during the night of 25Feb2021 at 11:00 PM, the patient's arm was very sore when she got up it was swollen and red and hurt terribly. So she went to the ER because she had a chronic blood clot in her left leg; there was no clot in her arm but it was still swollen, red and it hurts. She added that she have very bad environment allergies and queried if she should get the second shot. No treatment received for the events. The outcome of the events was unknown; the events resulted to emergency room visit.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling abnormal, Flushing, Rash
Clinical narrative: severe upper abdominal pain/very bad stomach ache; flush through her body; rash/flush through her body; she felt a little weird; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. About 30-35 minutes after receiving the injection, in Feb2021, the patient developed severe upper abdominal pain/very bad stomachache. She also experienced a rash/flush through her body in Feb2021 and she felt like she was going to die. After experiencing that, she felt a little weird for a minute or so. Then the flush/rash happened again but not as bad as the initial flush. The stomachache lasted for 2 hours then it stopped. The patient had recovered from severe upper abdominal pain/very bad stomachache and she felt a little weird in Feb2021, the outcome of the other events was unknown.   Information on about lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose increased, Blood pressure measurement, Condition aggravated, Thyroid function test
Clinical narrative: When probed for are the events worsened improved or still persisting consumer stated "Worsened"; Blood Sugar went up; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration on 28Jan2021 at single dose, and second dose (lot number: EN6200, expiry date not reported), via an unspecified route of administration on 19Feb2021 at single dose for COVID-19 immunization. Medical history included blood pressure measurement, hypothyroidism (low thyroid), and diabetes mellitus. Concomitant medications included thyroid (ARMOUR THYROID) for hypothyroidism and liothyronine. The patient's blood sugar went up on 02Feb2021. When probed if the event worsened improved or still persisting,  the consumer stated "worsened" on an unspecified date. On an unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement:high and thyroid function test: low. Clinical outcome of blood sugar went up was not recovered while unknown for the other event.  Information about lot/batch number has been obtained.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: When probed for are the events worsened improved or still persisting consumer stated "Worsened"; Blood Sugar went up; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration on 28Jan2021 at single dose, and second dose (lot number: EN6200, expiry date not reported), via an unspecified route of administration on 19Feb2021 at single dose for COVID-19 immunization. Medical history included blood pressure measurement, hypothyroidism (low thyroid), and diabetes mellitus. Concomitant medications included thyroid (ARMOUR THYROID) for hypothyroidism and liothyronine. The patient's blood sugar went up on 02Feb2021. When probed if the event worsened improved or still persisting,  the consumer stated "worsened" on an unspecified date. On an unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement:high and thyroid function test: low. Clinical outcome of blood sugar went up was not recovered while unknown for the other event.  Information about lot/batch number has been obtained.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Femur fracture, Lethargy, Memory impairment, Pyrexia
Clinical narrative: broken femur; early morning fall (maybe related); lethargy; memory issues (beyond normal for her); low grade fever; This is a spontaneous report from a contactable consumer. An 88-years-old (non-pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). Concomitant medications included atorvastatin (ATORVASTATIN), gabapentin (GABAPENTIN), lorazepam (LORAZEPAM), losartan (LOSARTAN), metoprolol succinate (METOPROLOL SUCCINATE), pantoprazole (PANTOPRAZOLE), paroxetine (PAROXETINE), and zolpidem (ZOLPIDEM). The patient had no other vaccines in four weeks. The patient had no COVID prior vaccination. On 20Feb2021 at 12:00, the patient had a low-grade fever for 2 days, followed by lethargy and memory issues (beyond normal for her) on the 3rd day (23Feb2021). Finally, on the 4th day (24Feb2021), by early morning, the patient had a fall (maybe related) and a broken femur. The events resulted in emergency room/department or urgent care, hospitalization as the patient was hospitalized for two days due to the events. Treatment for the events was unknown. The patient underwent lab tests and procedures which included Blood test/viral RNA: Negative on 26Feb2021. The events had not resolved.   Information on the batch/lot number has been requested.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: broken femur; early morning fall (maybe related); lethargy; memory issues (beyond normal for her); low grade fever; This is a spontaneous report from a contactable consumer. An 88-years-old (non-pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). Concomitant medications included atorvastatin (ATORVASTATIN), gabapentin (GABAPENTIN), lorazepam (LORAZEPAM), losartan (LOSARTAN), metoprolol succinate (METOPROLOL SUCCINATE), pantoprazole (PANTOPRAZOLE), paroxetine (PAROXETINE), and zolpidem (ZOLPIDEM). The patient had no other vaccines in four weeks. The patient had no COVID prior vaccination. On 20Feb2021 at 12:00, the patient had a low-grade fever for 2 days, followed by lethargy and memory issues (beyond normal for her) on the 3rd day (23Feb2021). Finally, on the 4th day (24Feb2021), by early morning, the patient had a fall (maybe related) and a broken femur. The events resulted in emergency room/department or urgent care, hospitalization as the patient was hospitalized for two days due to the events. Treatment for the events was unknown. The patient underwent lab tests and procedures which included Blood test/viral RNA: Negative on 26Feb2021. The events had not resolved.   Information on the batch/lot number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Tinnitus, Weight, Weight decreased
Clinical narrative: he has lost also since he got that shot he had lost 8 pounds in like 4 days. He weighs not like a 117-118 pounds; Headache; His arm was hurting; It is the ringing in the ear; felt like a siren was going both of his ears; This is a spontaneous report from a contactable consumer (parent). A 38-year-old male patient (son) received first dose of BNT162B2 on 05Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. When he received the first one he felt headache a little bit and his arm was hurting and all of a sudden he suffers from tinnitus, It is the ringing in the ear. He is about 5' 9 and he has lost also since he got that shot he had lost 8 pounds in like 4 days. He weighs not like a 117-118 pounds. The outcome of the events was unknown.  Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: So much pain that she could not move her left arm; So much pain that she could not move her left arm (the arm that was injected)/ moved to her right arm; This is a spontaneous report from a contactable consumer (patient).  A 78-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9266), via an unspecified route of administration on the arm on 13Feb2021 at a SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported.  She had the shot on the 13Feb2021 and was fine, but reported that a week and 2 days later (22Feb2021) she was in so much pain that she could not move her left arm (the arm that was injected) and 2-3 days later this moved to her right arm. The patient spoke to her healthcare professional regarding this and was prescribed a muscle relaxant. Outcome of the events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Chills, Movement disorder, Seizure
Clinical narrative: seizure; couldn't move and speak; couldn't move and speak; chills; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age (age: 77, unit: unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 24Feb2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced seizure, couldn't move and speak and chills on 26Feb2021. The patient received first dose of Pfizer on 24Feb2021, and experienced a seizure 48 hours later.  She was experiencing severe chills, then during the night, woke up with a seizure, couldn't move and speak, didn't go to the ER, no history of seizure, already filed safety report. She wants to know if she can receive the second vaccine. The outcome of the events was unknown.   Information on the Lot/Batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Nausea, Pain in extremity, Vomiting
Clinical narrative: Patient felt like going to pass out and she did then, she was probably out less than in a minute; Severe headache; Nauseous; Throwing up/Vomiting; Sore arm; This is a spontaneous report from a contactable consumer (patient).  A 65-years-old female patient (weight: 81.65 kg, height 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6201) at single dose, on 22Feb2021, for COVID-19 immunisation. Relevant medical history included thyroid disorder form an unspecified date. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder. On 22Feb2021, the patient experienced sore arm. On 25Feb2021, the patient developed severe headache, nauseous, and vomiting (throwing up) and the patient felt like going to pass out and she did then, she was probably out less than in a minute. The patient described as following: so, on 25Feb2021, the headache increased throughout the day and her nauseousness continued throughout the day and in the afternoon with the pain of the headache she thought she passed out, she vomited that gave her little bit of relief but then she took "two (not clarified) Advil and went to bed". Clinical outcome of the adverse events was unknown at time of this report. Patient asked if should be expected the same kind of reaction when she got her second shot.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Computerised tomogram abdomen, Laboratory test
Clinical narrative: confirmed appendicitis; This is a spontaneous report from a contactable Physician. A 34-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9269), via an unspecified route of administration on 04Feb2021 17:30 at SINGLE DOSE for covid-19 immunisation. Medical history was reported as none.  Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1.5/30), bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10) and folic acid.  The reporter stated that abdominal pain that began at center of abdomen upon waking up at 8 am on 07Feb2021 and progressively got worse throughout the day. Developed nausea and multiple episodes of vomiting around 15:00. Abdominal pain then moved to RLQ, was persistent, dull and achy, worsened with movement (on 07Feb2021, 8:00). Pain was still present throughout the night and the next day, went to the ER for evaluation. There was concern for appendicitis. Labs were overall normal, CT abdomen was equivocal, abdominal and transvaginal ultrasound were normal but examination was concerning. Laparoscopic surgery was performed and confirmed appendicitis on an unspecified date. The patient was hospitalized for the event on an unspecified day. Outcome of the event was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable healthcare professional.  A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, administered in left arm on 26Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bell's palsy on 01Mar2021. The event was reported to have resulted in emergency room/department or urgent care visit. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association, the known safety profile of the COVID-19 vaccine, and lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported bell's palsy and the suspect administration.   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 RA, IEC, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pneumonia, Sepsis
Clinical narrative: double pneumonia and sepsis; double pneumonia and sepsis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 30Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history was chronic obstructive pulmonary disease (COPD). The patient previously took prednisone for COPD. She has a history of COPD and prior to getting her first Pfizer vaccine, she was on prednisone and antibiotics and was not feeling well. Concomitant medications were not reported. When she got her first vaccine on 30Jan2021, she started having problems breathing and a high fever and thought it was related to the vaccine. She was admitted to the hospital last Tuesday and was diagnosed with double pneumonia and sepsis. The doctor said it was not related to the vaccine. She got out of the hospital on Saturday. She is still on prednisone and antibiotics and now on oxygen all the time. She is getting mixed messages from her doctors on whether or not to get her second vaccine tomorrow. Some say yes, others no. She has not felt well for the last 5 weeks. The patient underwent lab tests and procedures which included body temperature: high fever on an unspecified date. The outcome of the events was unknown.; Sender's Comments: Based on the information available the reported events are considered not related to suspect drug.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Sepsis
Clinical narrative: double pneumonia and sepsis; double pneumonia and sepsis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 30Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history was chronic obstructive pulmonary disease (COPD). The patient previously took prednisone for COPD. She has a history of COPD and prior to getting her first Pfizer vaccine, she was on prednisone and antibiotics and was not feeling well. Concomitant medications were not reported. When she got her first vaccine on 30Jan2021, she started having problems breathing and a high fever and thought it was related to the vaccine. She was admitted to the hospital last Tuesday and was diagnosed with double pneumonia and sepsis. The doctor said it was not related to the vaccine. She got out of the hospital on Saturday. She is still on prednisone and antibiotics and now on oxygen all the time. She is getting mixed messages from her doctors on whether or not to get her second vaccine tomorrow. Some say yes, others no. She has not felt well for the last 5 weeks. The patient underwent lab tests and procedures which included body temperature: high fever on an unspecified date. The outcome of the events was unknown.; Sender's Comments: Based on the information available the reported events are considered not related to suspect drug.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pneumonia, Sepsis
Clinical narrative: Sepsis; double pneumonia; This is a spontaneous report from a contactable consumer (patient's daughter).  A 78-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included COPD from an unknown date. The patient's concomitant medications were not reported. Patient on tuesday (assessed as 2021) was hospitalized with double pneumonia and sepsis then was in the hospital until Saturday(assessed as 2021), when she was released. Patient is still on a breathing machine, which is not normal for her, and reporter is not sure if she should get the second dose of the vaccine which is scheduled for tomorrow since patient is still on antibiotics and Prednisone (assessed as treatment for sepsis and pneumonia). The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Sepsis
Clinical narrative: Sepsis; double pneumonia; This is a spontaneous report from a contactable consumer (patient's daughter).  A 78-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included COPD from an unknown date. The patient's concomitant medications were not reported. Patient on tuesday (assessed as 2021) was hospitalized with double pneumonia and sepsis then was in the hospital until Saturday(assessed as 2021), when she was released. Patient is still on a breathing machine, which is not normal for her, and reporter is not sure if she should get the second dose of the vaccine which is scheduled for tomorrow since patient is still on antibiotics and Prednisone (assessed as treatment for sepsis and pneumonia). The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Contusion, Haemorrhage, Pain
Clinical narrative: Bleeding; Pain; burning; Bruising; This is a spontaneous report from a Non-contactable consumer reporting for herself.    A 53-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine,  via an unspecified route of administration, administered in right arm on Feb2021 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation  .  The patient medical history  and  concomitant medications were not reported.  The patient experienced bleeding  on Feb2021 with outcome of recovered , pain  on Feb2021 with outcome of recovered with sequelae , burning sensation  on Feb2021 with outcome of recovered with sequelae , bruising on Feb2021 with outcome of recovered with sequelae.    Bleeding was considered an Important Medical Event. Course of the event: Pain, burning and bleeding immediately after injection. Bleeding stopped right away with a band-aid. Burning subsided within a few hours. Pain went away after 72 hours except it continues to hurt when sleeping on that side (right side). Bruising started about 3 days after the injection and took approximately 10 days to resolve.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Lethargy, Pneumonia, Pulmonary oedema
Clinical narrative: Fluid buildup in lungs. Than pneumonia set in.; Fluid buildup in lungs. Than pneumonia set in.; Weakness; lethargic; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) taken for an unspecified indication, start and stop date were not reported. The patient experienced fluid buildup in lungs. than pneumonia set in, weakness and lethargic on 15Feb2021. Therapeutic measures were taken as a result of all the events which includes Medicine and breathing treatments. Outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Dyspepsia, Fatigue, Migraine
Clinical narrative: headache/migraine; shoulder and neck pain; shoulder and neck pain; feeling tired; her stomach was not in the best shape; Digestive distress; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: unknown, via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history Guillain-Barre syndrome. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for COVID-19 immunization and experienced 3 "rough days." The patient wanted information on some "residual" side effects that she is experiencing after receiving the COVID-19 vaccine, she received the second dose of the vaccine and presented the following side effects: headache/migraine that is diminishing, feeling tired, shoulder and neck pain or headache-type of reaction, her stomach was not in the best shape but she was tolerating food. She had been checked by two doctors and they can't find anything that could be causing this, she does not have a fever. The reporter is a patient with Guillain-Barre syndrome. She tried taking paracetamol (TYLENOL) but it did not make too much except for making blisters. She was a little concerned about her situation and stated that she wanted to make sure that she will be alright. During the call, she mentioned that one nurse told her that after receiving the vaccine she was on bed for 3 days and that other colleague of her was "not right" 6 days after receiving the vaccine she also knows that there are people who have some digestive distress after receiving the vaccine and she believes that her migraine/headache was causing her to have a digestive distress. She mentioned that after receiving the first shot of the vaccine she had 3 "rough days." The patient was recovering from the headache/migraine; while unknown for the rest of the events.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: headache/migraine; shoulder and neck pain; shoulder and neck pain; feeling tired; her stomach was not in the best shape; Digestive distress; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: unknown, via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history Guillain-Barre syndrome. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for COVID-19 immunization and experienced 3 "rough days." The patient wanted information on some "residual" side effects that she is experiencing after receiving the COVID-19 vaccine, she received the second dose of the vaccine and presented the following side effects: headache/migraine that is diminishing, feeling tired, shoulder and neck pain or headache-type of reaction, her stomach was not in the best shape but she was tolerating food. She had been checked by two doctors and they can't find anything that could be causing this, she does not have a fever. The reporter is a patient with Guillain-Barre syndrome. She tried taking paracetamol (TYLENOL) but it did not make too much except for making blisters. She was a little concerned about her situation and stated that she wanted to make sure that she will be alright. During the call, she mentioned that one nurse told her that after receiving the vaccine she was on bed for 3 days and that other colleague of her was "not right" 6 days after receiving the vaccine she also knows that there are people who have some digestive distress after receiving the vaccine and she believes that her migraine/headache was causing her to have a digestive distress. She mentioned that after receiving the first shot of the vaccine she had 3 "rough days." The patient was recovering from the headache/migraine; while unknown for the rest of the events.   Information about lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: developed a rash in my back and groin that did not go away; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received the second dose of bnt162b2 (Lot number was not reported), via an unspecified route of administration in the left arm on 10Feb2021 09:30 AM (at the age of 67-year-old) at single dose for COVID-19 immunization. Medical history included anxiety and some lactose intolerance. Concomitant medications included venlafaxine; fluoxetine hydrochloride (PROZAC); azelastine hydrochloride, fluticasone propionate (DYMISTA); amlodipine; and atorvastatin calcium (ATORVAS).  The patient previously took lisinopril and experienced drug allergy. The patient previously received the first dose of bnt162b2 via an unspecified route of administration on the left arm on 22Jan2021 09:30 AM (at the age of 67-year-old) at single dose for COVID-19 immunization. Approximately 5 days after receiving the 2nd Covid 19 vaccine on 15Feb2021 12:00, the patient developed a rash in his back and groin that did not go away until 3 days ago when he was prescribed Prednisone 20 mg (2 a day) by an allergist. Prior to the Prednisone the rash was very persistent and increasing in intensity. The patient didnot know if it had to be with the vaccine, but five days later and did not respond to antihistamines or over the counter ointments for rash. No covid prior vaccination nor covid tested post vaccination. The event resulted in Emergency room/department or urgent care. The outcome of the event was unknown.    Information on Lot/Batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Facial bones fracture, Fatigue, Feeling cold, Investigation
Clinical narrative: Blacked out; fractured nose; fainting; very tired and cold; very tired and cold; light headed; thirsty; nausea; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9266), via an unspecified administered in the left arm on 13Feb2021 at 08:15 AM at SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Medical history included arthritis (No chronic health conditions besides arthritis). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), simvastatin, and colecalciferol (D3). The patient previously took cipro [ciprofloxacin hydrochloride] and experienced allergies. Historical vaccine includes first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 at 5:00 PM for COVID-19 immunisation. It was reported that for 2 days, patient was very tired and cold. At day 4 while at her trainer, the patient experienced light headed, thirsty, nausea, and had blacked out. All tests were normal at emergency room (ER), but have fractured nose. The patient wanted to understand if this fainting can be related to the second shot. Cardiologist said no problems in the heart. All events started on 17Feb2021. There was no treatment received for all events. The patient had COVID test post vaccination via nasal swab on 17Feb2021 which showed negative result. On an unspecified date in 2021, the patient recovered from all events.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, SARS-CoV-2 test, Syncope, Thirst
Clinical narrative: Blacked out; fractured nose; fainting; very tired and cold; very tired and cold; light headed; thirsty; nausea; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9266), via an unspecified administered in the left arm on 13Feb2021 at 08:15 AM at SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Medical history included arthritis (No chronic health conditions besides arthritis). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), simvastatin, and colecalciferol (D3). The patient previously took cipro [ciprofloxacin hydrochloride] and experienced allergies. Historical vaccine includes first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 at 5:00 PM for COVID-19 immunisation. It was reported that for 2 days, patient was very tired and cold. At day 4 while at her trainer, the patient experienced light headed, thirsty, nausea, and had blacked out. All tests were normal at emergency room (ER), but have fractured nose. The patient wanted to understand if this fainting can be related to the second shot. Cardiologist said no problems in the heart. All events started on 17Feb2021. There was no treatment received for all events. The patient had COVID test post vaccination via nasal swab on 17Feb2021 which showed negative result. On an unspecified date in 2021, the patient recovered from all events.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle discomfort, Nervous system disorder
Clinical narrative: My muscle and nerve on both side of my face (especial jawline area) are uncomfortable; My muscle and nerve on both side of my face (especial jawline area) are uncomfortable; This is a spontaneous report from a contactable Consumer. This 66-years-old female Consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/exp. date unknown), via an unspecified route of administration on 23Jan2021 11:45 AM at single dose on left arm for covid-19 immunisation at a Clinic/ Administration facility.  Medical history included diabetes mellitus from an unknown date and unknown if ongoing.  Patient had no known allergies. Patient did not have any other vaccine in four weeks. Concomitant medication included metformin, thiamine hydrochloride (VITAMIN B-1), cyanocobalamin (VITAMIN B-12).  After the 1st dose, her muscle and nerve on both side of her face (especial jawline area) are uncomfortable. The nerve of both of front elbows was uncomfortable "stronger" on an unspecified date with outcome of not recovered.  Patient has not tested post vaccination.   The lot number for the vaccine, BNT162B2, was not provided and has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Investigation
Clinical narrative: gradually increasing pain in upper chest, which became severe; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received BNT162B2 (BNT162B2; Batch/Lot number and expiry date was not reported) via an unspecified route of administration, administered in Arm Right on 25Feb2021 as SINGLE DOSE for covid-19 immunization. Medical history included diabetes mellitus. Concomitant medications included acarbose (ACARBOSE), sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]), metformin (METFORMIN) and losartan (LOSARTAN) all taken for unspecified indications, start and stop dates were not reported. The patient previously took denoral [risperidone] and darvon [betahistine mesilate] and experienced allergies. The patient experienced gradually increasing pain in upper chest, which became severe on 26Feb2021 at 20:00. It was reported that beginning in evening of day following vaccination: gradually increasing pain in upper chest, which became severe. Went to ER; tests there ruled out heart Involvement; referred to regular physician for follow-up (appointment booked for 03Mar2021). Pain slightly better when patient left ER, gradually subsided overnight and following day; pain gone on second following day. The patient underwent lab tests and procedures which included investigation: Test for heart involvement on an unspecified date (Tests there ruled out heart involvement). The outcome of the event was recovered.   Information about lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Disease recurrence
Clinical narrative: 6 hours of AFIB/taking a medication for AFIB and have not had AFIB for 3 years; 6 hours of AFIB/taking a medication for AFIB and have not had AFIB for 3 years; This is a spontaneous report from a non-contactable consumer (patient herself). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6203), via an unspecified route of administration on the left arm, on 26Feb2021 10:15, at a single dose, for covid-19 immunization. Medical history included allergies: bee stings and sulfa drugs, AFIB (not had AFIB for 3 years) and, had a confirmed case of COVID on Jan2021 (reported as 1 month before vaccination). Concomitant medication included unspecified medication for AFIB. The patient experienced 6 hours of AFIB on 27Feb2021 10:15, 24 hours after first dose. The patient was taking a medication for AFIB (concomitant medication) and have not had AFIB for 3 years. The patient recovered from the adverse event on 27Feb2021 16:15 with no treatment received for it. The patient was not covid-tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Haemorrhage
Clinical narrative: bleeding from ileostomy; abdominal pain; This is a spontaneous report from a non-contactable pharmacist. An 80-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), intramuscular on 28Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took Iodine, Levaquin and Morphine and experienced allergies. It was unknown if the patient received other vaccines in four weeks. The patient experienced abdominal pain and bleeding from ileostomy on 01Mar2021 at 11:00PM. The events resulted in emergency room/department or urgent care and hospitalization. The patient had no COVID prior vaccination and had not tested post vaccination. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Based on the information available the events abdominal pain and bleeding from ileostomy are attributed to intercurrent medical conditions that were not related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 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: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: hardness at injection site; has an area on her arm that is 3 inches in diameter that was red and swollen at the injection site.; has an area on her arm that is 3 inches in diameter that was red and swollen at the injection site; This is a spontaneous report from a contactable nurse reporting for her friend (patient). A 91-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration, administered in arm Right on 18Feb2021 14:00 at single dose for covid-19 immunisation. Medical history included stage 3 kidney disease, colon cancer, breast cancer and radiation from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced hardness at injection site and has an area on her arm that is 3 inches in diameter that was red and swollen at the injection site on 28Feb2021. The nurse reported that her friend got the first injection of the Covid-19 vaccine on 18Feb2021. She was fine and did not have any reactions. Yesterday she showed the nurse an area on her arm that was 3 inches in diameter that was red and swollen at the injection site. The nurse adds that she told her friend to apply ice to the area but she did not do that last night. Her friend said the area did not hurt. The nurse adds that it is strange that it appeared 10 days later. The patient did not recover from the events.  Information about lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship and known product safety profile, causality between reported vaccination site reactions and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Investigation, Laboratory test, Pancreatitis acute, SARS-CoV-2 test
Clinical narrative: Acute Pancreatitis; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9267), via an unspecified route of administration in the right arm on 23Feb2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. Patient had no known allergies. Concomitant medications included losartan, amlodipine and omeprazole. The patient was previously administered with the first dose of BNT162B2 (lot number: EN5318) on 26Jan2021 at 08:45 in the left arm for COVID-19 immunization. No other vaccine in four weeks. The patient experienced acute pancreatitis on 24Feb2021 07:00.  The patient was hospitalized for acute pancreatitis for 2 days. The patient self-admitted into ER and was admitted into hospital for observation. On unspecified date in 2021, patient underwent FMP, complete blood count (cbc) and chem-20 labwork which determined that no history to contribute to chief complaint and diagnosis. Treatment administered for the events included IV fluids and unknown medications. No covid prior vaccination. Covid test post vaccination included covid test type post vaccination: Nasal Swab on 27Feb2021 with negative result. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Blood sugar was extremely high; This is a spontaneous report from Support. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), on 22Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient and her husband got the second dose today (22Feb2021) and after the patient checked her blood sugar, it was extremely high. The patient's husband was asking if this is the effect of the vaccine. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Oropharyngeal pain, Pneumonia
Clinical narrative: pneumonia; congestion; coughing; sore throat; This is a spontaneous report from a contactable consumer. This consumer reported for a 97-year-old female patient (mother). This 97-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6200), dose 1 , single dose via an unspecified route of administration in the right arm on 18Feb2021 for COVID-19 vaccination. Medical history included COVID-19 on an unknown date in Oct2020, colon cancer, congestive heart failure and had a pacemaker.  Concomitant medications were not reported. On 24Feb2021  the patient had pneumonia, congestion, coughing and sore throat. She was on oxygen and does not use it all the time and guaifenesin (MUCINEX). Treatment was received for pneumonia, congestion, coughing and sore throat.  The clinical outcome of pneumonia, congestion, coughing and sore throat was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that a patient had an anaphylactic reaction following a single dose of the Pfizer BioNTech COVID-19 vaccine. Because it is contraindicated for the patient to take the second dose, she is finding the best way to protect the patient from COVID-19. She wants to know the duration of coverage of the vaccine. She said she knows that after a single dose, the vaccine is 92.6% effective. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known on available information and known drug profile, a possible causal relationship cannot be excluded between the suspect product and the event anaphylactic reaction. 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.