chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: interval between two doses were 18 days; interval between two doses were 18 days; Tested Positive for COVID; Covid-19 test result was positive; Taste of coffee was different; Stuffy nose; This is a spontaneous report from a contactable consumer. A 49-year-old patient of an unspecified gender received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, formulation: solution for injection) via an unspecified route of administration on 02Feb2021 (Lot Number: EL9264) as single dose for covid-19 immunisation. Historical vaccination included patient received first dose of BNT162B2, Lot Number: EL8982 on 15Jan2021 for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included Covid-19 test result was positive on 20Mar2021. On an unspecified date, the patient tested positive for covid, interval between two doses were 18 days, stuffy nose on 18Mar2021 and taste of coffee was different on 19Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: Red blood in stool after 2nd dose of vaccine; This is a spontaneous report from a contactable consumer (patient himself). A 51-year-old male gender patient started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021 at 15:00 (at the age of 51-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took BNT162B2(lot number: EN6955) via an unspecified route of administration in the left arm on 06Mar2021 15:00 at single dose for COVID-19 immunization. The patient experienced Red blood in stool after 2nd dose of vaccine on 27Mar2021. Patient did not receive any treatment. The outcome of event was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: fever; Feeling Unwell; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient's wife) reported a male patient of an unspecified age received first and second dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown, Expiry Date: unknown), via an unspecified route of administration on 01Mar2021 and 22Mar2021 respectively at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever and feeling unwell. The reporter stated her husband got both of the doses for COVID 19 vaccine and he was experiencing an adverse event like fever and feeling unwell. His first dose was taken last 01Mar2021 and the second dose took last 22Mar2021. She also mentioned that if her husband can take Tylenol. The outcome of event was unknown.  Follow-up activities have been completed and Information related to lot/batch no. has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Very heavy menstrual bleeding; lots of blood clotting; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 22Mar2021 at 05:45 PM (17:45), at a single dose, for COVID-19 immunization. The patient's medical history included allergies to penicillin. The patient's concomitant medications included collagen, krill oil, and ethinylestradiol/ etonogestrel (NUVARING). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a pharmacy or drug store. On 26Mar2021, the patient had a very heavy menstrual bleeding which she had never experienced prior; there was no cramping but lots of blood clotting. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Hypoaesthesia
Clinical narrative: numbness of the left heel within two days of the shot; This is a spontaneous report from a contactable consumer (patient).   A 67-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 21Mar2021 08:45 (Batch/Lot Number: EP7534), at the age of 67-years at vaccination, as SINGLE DOSE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received dose 1 of the vaccine on Feb2021 on left arm (lot number: EN6202). It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. On 23Mar2021 10:00, the patient experienced numbness of the left heel within two days of the shot (disability).  The patient underwent lab tests and procedures which included blood work: unknown result on 26Mar2021.  The outcome of the evet was not recovered. Therapeutic measures were taken as a result of the event. Since the vaccination, the patient has not been tested for COVID-19.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Thrombosis, Ultrasound scan
Clinical narrative: they had a ultrasound done and found out I had a number of clots in that position; a sore Leg, Upper part of the left calf 2 inches below the knee on the backside; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 15:00 (Batch/Lot Number: En6207) as SINGLE DOSE for covid-19 immunisation. Medical history included Treatable Acid reflex, anxiety and mild depression. Concomitant medications included omeprazole, buspirone and alprazolam for unspecified indication. Patient had the Covid shot on 18Mar2021 at about 3 PM the next morning (on 19Mar2021 06:00) patient woke up with a sore Leg, Upper part of the left calf 2 inches below the knee on the backside. After it did not go away, he went to the doctor then they had a ultrasound done and found out he had a number of clots in that position. Treatment received for the adverse event includes they put patient on a blood thinner. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, the patient has been tested for COVID-19. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Mar2021. Covid test post vaccination done via nasal Swab, They had the results in 15 minutes, covid test result Negative, ultrasound scan: clots in that position on 19Mar2021 found out, had a number of clots in that position. Outcome of the events was recovering.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cognitive disorder, Confusional state, Dizziness, Feeling abnormal
Clinical narrative: feeling almost to pass out; lightheaded/dizzy; extreme confusion; cognitive issues (more than 'brain fog'); cognitive issues (more than 'brain fog'); nausea; weak to the point of needing to sit down often; break out in sweat a couple of times daily; arm hurt; I am not confident to drive and am having difficulty performing my dailing routine; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient (Patient was not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unknown route on 18Mar2021 at 13:30 PM (at the age of 64-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history included neutropenia. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported.  The patient was perfectly well prior to vaccine administration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not receive any other medications within 2 weeks of vaccination. On 19Mar2021 at 14:30 PM, she has been lightheaded and dizzy to the point of feeling almost to pass out. She had extreme confusion/cognitive issues (more than brain fog) and nausea. She was weak to the point of needing to sit down often and break out in sweat a couple of times daily. Her arm hurt for a couple of days but that has resolved.  She was not confident to drive and having difficulty performing her dailing routine. The patient was concerned about ever recovering and receiving the second dose. No treatments were given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The outcome of the event arm hurt was recovered in Mar2021 while the outcome of the remaining events was not recovered.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Loss of personal independence in daily activities, Nausea, Pain in extremity
Clinical narrative: feeling almost to pass out; lightheaded/dizzy; extreme confusion; cognitive issues (more than 'brain fog'); cognitive issues (more than 'brain fog'); nausea; weak to the point of needing to sit down often; break out in sweat a couple of times daily; arm hurt; I am not confident to drive and am having difficulty performing my dailing routine; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient (Patient was not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unknown route on 18Mar2021 at 13:30 PM (at the age of 64-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history included neutropenia. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported.  The patient was perfectly well prior to vaccine administration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not receive any other medications within 2 weeks of vaccination. On 19Mar2021 at 14:30 PM, she has been lightheaded and dizzy to the point of feeling almost to pass out. She had extreme confusion/cognitive issues (more than brain fog) and nausea. She was weak to the point of needing to sit down often and break out in sweat a couple of times daily. Her arm hurt for a couple of days but that has resolved.  She was not confident to drive and having difficulty performing her dailing routine. The patient was concerned about ever recovering and receiving the second dose. No treatments were given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The outcome of the event arm hurt was recovered in Mar2021 while the outcome of the remaining events was not recovered.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Malaise, Pain, Pyrexia
Clinical narrative: Evening of second shot, developed fever of 101/I had a low grade fever; body aches/body aches during the entire time.; overall feeling ill; dry cough; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number was en6202) via an unspecified route of administration, administered in left arm on 06Mar2021 at 15:45 (at the age of 56-years-old) at a single dose for COVID-19 immunization. Medical history included glaucoma and hypertension. The patient's concomitant medications were not reported.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications within 2 weeks of vaccination. Patient had no allergies to medications, food or other products; Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was en601) administered on left arm on 13Feb2021 at 15:45, single dose for COVID-19 immunization. The patient reported that on the evening of second shot, on 06Mar2021, he developed fever of 101, body aches, and overall feeling ill. This went on for two weeks. He had a low grade fever and body aches during the entire time. There were days that he spent in bed. The patient also mentioned that he developed a dry cough. No treatment was received for the events. The outcome of the events was recovered with lasting effects (recovered with sequel).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable female consumer(patient) via Pfizer Sponsored Program. A female patient of an unspecified age received bnt162b2 (BNT162B2), 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. Medical history included asthma. The patient's concomitant medications were not reported. The patient tested positive for covid-19 on an unspecified date and experienced drug ineffective. She was wondering if she should still take the Covid-19 vaccine 2nd shot scheduled next day. She had her 1st dose of the vaccine 3 weeks ago. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on  unknown date. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got the first shot, I had COVID and I got like a severe reaction almost like COVID again; I got the first shot, I had COVID and I got like a severe reaction almost like COVID again; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6204, expiry date Jun2021), via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history included Blood pressure high, diagnosed with COVID-19 earlier since 23Dec2020. Concomitant medications were not reported. Patient stated, "I just have a question I do not sure you could even answer, I got the first shot, I had COVID and I got like a severe reaction almost like COVID again (on 08Mar2021), I was wondering you know I have been reading maybe you do not need second vaccination if you had a strong antibody reaction." Due date of second shot was reported as 29Mar2021. Treatment for the event included taking Tylenol at 325mg. The outcome of the event was resolved in Mar2021.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Developed Left lower extremity DVT 24 hours after vaccine; This is a spontaneous report from a non-contactable Physician.   A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route, on 24Mar2021 (at the age of 59-year-old) at a single dose for COVID-19 immunisation. Relevant medical history included hypertension (HTN), diabetes mellitus (DM) and hyperlipidemia (HLD). The patient did not have history of deep vein thrombosis (DVT) and no other risk factors. The patient was not diagnosed with COVID-19 before vaccination. No relevant concomitant medications were provided. She developed left lower extremity DVT 24 hours after vaccine, on 25Mar2021. The event required emergency room visit. The patient was treated with an anticoagulation therapy. Post vaccination COVID-19 test was not done. 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 the information currently available, the event deep vein thrombosis was most likely due to the patient's underlying hypertension, diabetes mellitus and hyperlipidemia. However a possible contributory role of vaccine BNT162B2 to the event can not be totally excluded. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient) via the Pfizer sponsored program. A female patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She just got her shot at 2 o' clock and she was still bleeding around 5:00 on an unspecified date with outcome of unknown. Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: loss of hearing in one ear; This is a spontaneous report from a non-contactable consumer. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), 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, the patient experienced Loss of hearing in one ear. The patient received treatment for the event: Steroid. The patient was not diagnosed with COVID-19 prior to vaccination. The outcome of the event was not recovered.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac function test, Cardiac stress test, Echocardiogram, Electrocardiogram
Clinical narrative: heart palpitations and a rapid irregular pulse. Per pulse oximeter, heart rate was 133 beats/minute. In the emergency room an electrocardiogram showed atrial fibrillation; This is a spontaneous report from a non-contactable consumer (patient). A 70-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 07:45 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. Medical history included allergies to medications of Clindamycin, Penicillin, Amoxicillin, Statins and hypertension (controlled on medication), type 2 diabetes (diet controlled), obesity, obstructive sleep apnea, thyroid nodules benign. Concomitant medication(s) included metoprolol (METOPROLOL), fosinopril (FOSINOPRIL, furosemide (LASIX [FUROSEMIDE]), niacin (NIACIN) and bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 07:45 (Batch/Lot Number: EN5318) as single dose for covid-19 immunisation. On 20Mar2021 18:00, the patient started to have heart palpitations and a rapid irregular pulse. Per pulse oximeter, heart rate was 133 beats/minute. In the emergency room an electrocardiogram showed atrial fibrillation. Cardiac, thyroid and all other labs were normal. Atrial fibrillation resolved in the emergency room without treatment. Discharged to home, appointment in clinic on 23Mar2021 with a cardiologist, who ordered Cartia XT (started 23Mar2021) and Eliquis (started 23Mar2021 after stress test). On 24Mar2021 a cardiac echo and a myocardial profusion imaging stress test were completed and results on both tests were reported as being normal. There was no past diagnosis of atrial fibrillation or of the above symptoms of heart palpitations and rapid irregular heartbeat. The symptoms have not been experienced since the initial episode on 20Mar2021. Plans are to remain on Cardia XT and Eliquis, and to be seen on 23Jun2021 in the cardiology clinic for an electrocardiogram and an appointment with the cardiologist. Therapeutic measures (Cartia XT 120mg per day, Eliquis 5mg two times a day) were taken as a result of the event. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date in Mar2021 the event was recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Laboratory test, Thyroid function test
Clinical narrative: heart palpitations and a rapid irregular pulse. Per pulse oximeter, heart rate was 133 beats/minute. In the emergency room an electrocardiogram showed atrial fibrillation; This is a spontaneous report from a non-contactable consumer (patient). A 70-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 07:45 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. Medical history included allergies to medications of Clindamycin, Penicillin, Amoxicillin, Statins and hypertension (controlled on medication), type 2 diabetes (diet controlled), obesity, obstructive sleep apnea, thyroid nodules benign. Concomitant medication(s) included metoprolol (METOPROLOL), fosinopril (FOSINOPRIL, furosemide (LASIX [FUROSEMIDE]), niacin (NIACIN) and bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 07:45 (Batch/Lot Number: EN5318) as single dose for covid-19 immunisation. On 20Mar2021 18:00, the patient started to have heart palpitations and a rapid irregular pulse. Per pulse oximeter, heart rate was 133 beats/minute. In the emergency room an electrocardiogram showed atrial fibrillation. Cardiac, thyroid and all other labs were normal. Atrial fibrillation resolved in the emergency room without treatment. Discharged to home, appointment in clinic on 23Mar2021 with a cardiologist, who ordered Cartia XT (started 23Mar2021) and Eliquis (started 23Mar2021 after stress test). On 24Mar2021 a cardiac echo and a myocardial profusion imaging stress test were completed and results on both tests were reported as being normal. There was no past diagnosis of atrial fibrillation or of the above symptoms of heart palpitations and rapid irregular heartbeat. The symptoms have not been experienced since the initial episode on 20Mar2021. Plans are to remain on Cardia XT and Eliquis, and to be seen on 23Jun2021 in the cardiology clinic for an electrocardiogram and an appointment with the cardiologist. Therapeutic measures (Cartia XT 120mg per day, Eliquis 5mg two times a day) were taken as a result of the event. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date in Mar2021 the event was recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Melanoma recurrent
Clinical narrative: The melanoma is limited to my right armpit and the timing of the melanoma recurrence in conjunction with the vaccination; noticed the lump in my right armpit grew much faster and I had a reaction (swollen nodes) in my left armpit as well; This is a spontaneous report from a contactable consumer (patient).   A 37-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Batch/Lot Number: EN9810) as single dose for covid-19 immunisation.  Medical history included stage 1b melanoma from 2014 to an unknown date , skin lesion removal in 2014.  The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 for COVID-19 immunisation on 29Jan2021 13:00 on left arm and experienced small marble-sized lump in right armpit. The patient stated that, "I had a stage 1b malignant melanoma lesion removed from my right shoulder in 2014 and had completed all required follow-up. About a week after receiving the first dose (left arm), I noticed a small marble-sized lump in my right armpit. The lump continued to grow rapidly and I went to the doctor, after a biopsy and scans it was confirmed to be metastatic melanoma, most likely a recurrence from the 2014 melanoma. I received the second dose on 18 February (left arm) and noticed the lump in my right armpit grew much faster and I had a reaction (swollen nodes) in my left armpit as well. The melanoma is limited to my right armpit. We are reporting the event because of the timing of the melanoma recurrence in conjunction with the vaccination and because the (institute name withheld) is investigating the biopsy/pathology of the tumor in the right axilla as there are features they have never seen before in melanoma." The adverse event result in Doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included Immunotherapy. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was not resolved.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: DVT L leg, possible PE; DVT L leg, possible PE; This is a spontaneous report from a contactable physician. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 09Mar2021 (at the age of 76 years old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took NSAIDS. The patient experienced DVT L leg, possible PE on 12Mar2021. Treatment given included Eliquis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was recovering.  Information on the batch/lot number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events deep vein thrombosis and possible pulmonary embolism occurred in a plausible temporal relationship.  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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dizziness, Dyspnoea, Fatigue, Motor dysfunction
Clinical narrative: atrial fib; Short of breath; fatigue; Nausea; Dizziness; Unable to function; discolored; This is a spontaneous report from a contactable consumer(patient himself). A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided), via an unspecified route of administration, at Right Arm on 24Mar2021 12:30 (at age of 61 years old) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Short of breath, atrial fib, fatigue, nausea, discolored, dizziness, unable to function, all on 24Mar2021 14:00. Adverse event result in Emergency room/department or urgent care. No treatment received for the adverse event. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Skin discolouration
Clinical narrative: atrial fib; Short of breath; fatigue; Nausea; Dizziness; Unable to function; discolored; This is a spontaneous report from a contactable consumer(patient himself). A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided), via an unspecified route of administration, at Right Arm on 24Mar2021 12:30 (at age of 61 years old) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Short of breath, atrial fib, fatigue, nausea, discolored, dizziness, unable to function, all on 24Mar2021 14:00. Adverse event result in Emergency room/department or urgent care. No treatment received for the adverse event. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she tested positive last Monday (22Mar); This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine, batch/Lot number was not reported), dose 1 via an unspecified route of administration on 11Mar2021 as single dose for covid-19 immunisation and scheduled on 01Apr for the 2nd dose. The patient medical history and concomitant medications were not reported. Patient said that she tested positive last Monday (22Mar2021). Patient was asking if she can receive the 2nd dose or should she wait. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Myocarditis, Nausea, Platelet count, Thrombocytopenia
Clinical narrative: nausea; vomiting; chest pain; myocarditis; thrombocytopenia; This is a Literature-spontaneous report 2021, 1-4; entitled Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination. A 44-year-old woman was hospitalized for nausea, vomiting and chest pain on the day that she received the Pfizer vaccine (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number unknown) at single dose (at 44-year-old) for COVID-19 immunization. Her laboratory values included a platelet count of 85 x 109/L and a peak troponin level of 4 ng/mL (normal < = 0.04 ng/mL). The patient was diagnosed with myocarditis but did not require treatment for thrombocytopenia. Her platelets were 61 x 109/L on discharge, but subsequent platelet counts were not reported. The outcome of the events was unknown.  No follow-up attempts are needed. Information on Lot/batch number cannot be obtained.; Sender's Comments: The causal association cannot be excluded between the reported events and BNT162B2 vaccine use. 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 AE. 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin, Vomiting
Clinical narrative: nausea; vomiting; chest pain; myocarditis; thrombocytopenia; This is a Literature-spontaneous report 2021, 1-4; entitled Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination. A 44-year-old woman was hospitalized for nausea, vomiting and chest pain on the day that she received the Pfizer vaccine (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number unknown) at single dose (at 44-year-old) for COVID-19 immunization. Her laboratory values included a platelet count of 85 x 109/L and a peak troponin level of 4 ng/mL (normal < = 0.04 ng/mL). The patient was diagnosed with myocarditis but did not require treatment for thrombocytopenia. Her platelets were 61 x 109/L on discharge, but subsequent platelet counts were not reported. The outcome of the events was unknown.  No follow-up attempts are needed. Information on Lot/batch number cannot be obtained.; Sender's Comments: The causal association cannot be excluded between the reported events and BNT162B2 vaccine use. 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 AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: slight pain in their arm; This is a spontaneous report received from Pfizer-sponsored program. A contactable female consumer (Patient) reported that she received Pfizer Covid-19 Vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: not provided), via an unspecified route of administration 18Mar2021 at as single dose for COVID-19 immunisation. The patient's medical history and concomitant was not reported. Patient reported that she, her mother, and her husband got the first dose last Thursday. Patient would like to know the timeframe of getting the second dose and said she wishes to get her second dose later (22 days or 25 days) so that she can take care of her 90-year-old mother in case she gets any side effects. Reporter stated that they have experienced slight pain in their arm after the first dose. The outcome of the event was unknown.  Follow-up (24Mar2021): This is a follow-up spontaneous report from a contactable consumer. No new information was added in the follow-up.  -Attempted to cold transfer to service unit due to long waiting time, the caller refused -Created and submit AE form:
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: she felt a little tightness in her chest; This is a spontaneous report from the Pfizer sponsored program. A contactable consumer (Patient) reported that a female patient of an unspecified age received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 23Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously had an BNT162b2 (First dose) for COVID-19 immunization on 05Mar2021. Patient stated that she had her second shot of the vaccine yesterday (23Mar2021). She said it seems okay, but she felt a little tightness in her chest. She called in to ask if it is normal. Outcome of the event was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Initial insomnia, Nightmare
Clinical narrative: having nightmares; having trouble falling asleep; This is a spontaneous report from the Pfizer Sponsored Program. A contactable consumer (patient) reported that a female patient of an unspecified age received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 06Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously had an BNT162b2 (First dose) for COVID-19 immunization. Patient stated that she received her 2nd dose of 06Mar2021 then started having nightmares and having trouble falling asleep. Outcome of both events were unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received a positive test; received a positive test; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 11Mar2021 (Lot Number: UNKNOWN) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that he received his first dose of the vaccine on 11Mar2021 and was scheduled to receive his second dose of the vaccine on 01Apr2021. He stated that last Tuesday he started having symptoms of COVID-19 and took a rapid test that came back negative in Mar2021, but then received a positive test on Thursday 25Mar2021. The patient would like to know if he was still able to take the second dose of the vaccine on Friday. The patient would like to know if there is any information on the quarantining timeline since he has received a positive COVID-19 vaccine. He stated that his wife and children were also tested but came back negative for COVID-9 but did not know if the same quarantining guidelines would apply to them. The patient underwent lab tests and procedures which included COVID-19 virus test which showed negative on Mar2021 and positive on 25Mar2021.The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Has patient who had 1st dose of covid vaccine. Has tested positive for covid virus; Has patient who had 1st dose of covid vaccine. Has tested positive for covid virus; This is a spontaneous report from a contactable consumer via a Pfizer-Sponsored Program. A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. On an unspecified date, the patient had tested positive for covid virus. The patient was supposed to get second dose end of this week. The patient enquired about what we recommend as far as quarantine and 2nd dose appointment. Lab data included SARS-CoV-2 test positive on an unspecified date. The outcome was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: After the Pfizer vaccine she got more headaches; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. Medical history included stroke patient and headache from an unknown date. After the Pfizer vaccine she got more headaches. Inquiring if she should take the second covid vaccine. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Has growth on arm; This is a spontaneous report from a non-contactable consumer or other non hcp (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient had growth on arm and was worried she did not get the vax correctly into the deltoid muscle. She was wondering if she should get another one. She has HCP appointment today to determine is vaccine given in the right area. Outcome of the event was unknown.  No follow-up attempts are possible; Information on the lot/batch number could not be requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Axillary pain, Chest pain, Dizziness, Dyspnoea
Clinical narrative: chest pain; pain under arm pits; pain under arm pits, up neck, and down her arms; dizziness; pain is now in hands, elbows; pain is now in face; Pain in neck and throat; pain is now in upper pallet; different taste in her mouth; lips, tongue, and mouth numbness; tingling; shortness of breath; pain in her joints/elbows; This is a spontaneous report received from a contactable other HCP (Nurse, patient). This female patient of unspecified age reported that she received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 11Jan2021 as a single dose for COVID-19 vaccination. The Patient was completely healthy before this with no history. The concomitant medications included zoloft, steroids, tylenol and protonix. On 9Feb2021 she began having the following symptoms: chest pain, pain under arm pits, up neck, and down her arms. She had visited the physician several times and everything was normal. symptoms got worse with dizziness, pain is now in hands, elbows, face, upper pallet, neck and throat. It did not go away. She has a different taste in her mouth. She has lips, tongue, and mouth numbness and tingling that comes and goes. She has shortness of breath and pain in her joints. At one point she was admitted to the hospital for 6 days- all labs, scans, xrays, MRI's were normal. She would see a rheumatologist and getting out lab tests done. She said her Rheumatologist was treating another nurse that now has paralysis due to the vaccine. The patient receive treatment for the events. The outcomes of events are unknown.  Information on Batch number/Lot number can not be obtained.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the events cannot be completely excluded.  This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Hypoaesthesia oral, Magnetic resonance imaging normal, Neck pain, Oral pain
Clinical narrative: chest pain; pain under arm pits; pain under arm pits, up neck, and down her arms; dizziness; pain is now in hands, elbows; pain is now in face; Pain in neck and throat; pain is now in upper pallet; different taste in her mouth; lips, tongue, and mouth numbness; tingling; shortness of breath; pain in her joints/elbows; This is a spontaneous report received from a contactable other HCP (Nurse, patient). This female patient of unspecified age reported that she received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 11Jan2021 as a single dose for COVID-19 vaccination. The Patient was completely healthy before this with no history. The concomitant medications included zoloft, steroids, tylenol and protonix. On 9Feb2021 she began having the following symptoms: chest pain, pain under arm pits, up neck, and down her arms. She had visited the physician several times and everything was normal. symptoms got worse with dizziness, pain is now in hands, elbows, face, upper pallet, neck and throat. It did not go away. She has a different taste in her mouth. She has lips, tongue, and mouth numbness and tingling that comes and goes. She has shortness of breath and pain in her joints. At one point she was admitted to the hospital for 6 days- all labs, scans, xrays, MRI's were normal. She would see a rheumatologist and getting out lab tests done. She said her Rheumatologist was treating another nurse that now has paralysis due to the vaccine. The patient receive treatment for the events. The outcomes of events are unknown.  Information on Batch number/Lot number can not be obtained.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the events cannot be completely excluded.  This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.