chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Paraesthesia, Vision blurred, Vitreous floaters
Clinical narrative: Blurred vision/focus issues/can't focus visually/couldn't see right; floaters; left arm and leg went numb; Both arms and legs tingly; felt disoriented; cold chills; Legs and arm felt heavy; my eyes are now having esophoria convergence Excess or vergance dysfunction; my eyes are now having esophoria convergence Excess or vergance dysfunction; my eyes are now having esophoria convergence Excess or vergance dysfunction; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 18Mar2021 11:45 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included allergies to Penicillin and no other medical history. The patient had no COVID prior vaccination. The patient was no pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ALLERTEC); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); ascorbic acid (VITAMIN C); ergocalciferol (VITAMIN D). There was no vaccine in four weeks. The patient stated that right after she drove off, Blurred vision/floaters, left arm and leg went numb. Both arms and legs tingly, felt disoriented, cold chills, had to pull the car over because she couldn't see right. Legs and arm felt heavy. Blurred vision & focus issues had continued and the eye doctor said her eyes were now having esophoria convergence Excess or vergance dysfunction. She still can't focus visually since she drove off from the vaccine. She had to go to the doctor today & they were going to schedule a neurologist appointment to make sure she didn't have a mini stroke. It had been extremely scary since she received it. All events occurred on 18Mar2021 12:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment received for the events and she needed glasses with a prism and neurologist appointment. The patient had no COVID tested post vaccination. The outcome of the events was not recovered.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Loss of consciousness
Clinical narrative: passed out/unconscious; feel weak; dizzy; not normal; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in arm left on 26Mar2021 09:45AM (Lot Number: ER8730) as single dose for COVID-19 immunisation. The patient had COVID prior vaccination. The patient had no other medical history or known allergies. The patient's concomitant medications were reported as none. The patient did not have COVID test post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After taking the vaccine the patient waited for 15 minutes prior to departing the facility in order to make sure there was no adverse reactions. At approximately 10:15 10:30 AM the patient drove back home. After driving for about five minutes while stopped at a traffic light the patient completely passed out at 10:45, he was unconscious for approximately 2 to 3 minutes, almost crashed his car and EMT support had to be called. The patient regained his conscience but it took him over a half hour to feel 50% better. Until 8:30 PM 26Mar2021, the patient still felt weak and dizzy and not normal. No treatment was received for events. The outcome of events was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Disturbance in attention, Eye movement disorder, Fatigue, Gait disturbance
Clinical narrative: Seizure like events; Began sputtering; My shoulder and neck seized up; Eyes rolled back in her head and she had no control over it; Did not remember some of it; Confused; Unable to focus with her eyes; Extreme fatigue; Walking is unsteady; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 59267-1000-03), via an unspecified route of administration, administered in left arm on 24Mar2021 16:45 as single dose for COVID-19 immunization. Medical history included asthma, bronchitis, anxiety, allergy to Aspirin, NSAIDs, agave, soy, and dairy. The patient has no history of COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not COVID tested post vaccination. Concomitant medications included venlafaxine and progesterone taken for an unspecified indication. On 24Mar2021, 19:30, the patient experienced seizure like events. She began sputtering, her shoulder and neck seized up, eyes rolled back in her head and she had no control over it and did not remember some of it. It happened twice in a row. She had been confused, unable to focus with her eyes, extreme fatigue, and her walking was unsteady. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment for the events. The patient was requested for testing and referral for neurologist for MRI. The patient has not recovered from the events.  Follow up attempts are possible. Further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Musculoskeletal stiffness, Seizure, Speech sound disorder
Clinical narrative: Seizure like events; Began sputtering; My shoulder and neck seized up; Eyes rolled back in her head and she had no control over it; Did not remember some of it; Confused; Unable to focus with her eyes; Extreme fatigue; Walking is unsteady; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 59267-1000-03), via an unspecified route of administration, administered in left arm on 24Mar2021 16:45 as single dose for COVID-19 immunization. Medical history included asthma, bronchitis, anxiety, allergy to Aspirin, NSAIDs, agave, soy, and dairy. The patient has no history of COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not COVID tested post vaccination. Concomitant medications included venlafaxine and progesterone taken for an unspecified indication. On 24Mar2021, 19:30, the patient experienced seizure like events. She began sputtering, her shoulder and neck seized up, eyes rolled back in her head and she had no control over it and did not remember some of it. It happened twice in a row. She had been confused, unable to focus with her eyes, extreme fatigue, and her walking was unsteady. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment for the events. The patient was requested for testing and referral for neurologist for MRI. The patient has not recovered from the events.  Follow up attempts are possible. Further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness
Clinical narrative: Dizziness; upset stomach; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 23Mar2021 at 07:30 (at the age of 40-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medications included losartan, metoprolol, omeprazole (PROTONIX) and citalopram. The patient previously received Keflex and experienced allergies. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced dizziness and upset stomach on 24Mar2021 at 06:00. No treatment was given for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Product administered at inappropriate site, SARS-CoV-2 test
Clinical narrative: Bell's Palsy; administered in the left leg; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727, expiry date: unknown), via an unspecified route of administration, administered in the left leg, on 21Mar2021 09:45, as single dose, for COVID-19 immunization. The patient medical history was not reported. The patient did not have COVID-19 prior to vaccination. There were no concomitant medications (no other medications in two weeks). The patient did not receive other vaccines in four weeks. On 22Mar2021, the patient experienced Bell's palsy. This event required hospitalization for 2 days (unspecified dates). Treatment included steroids. The patient underwent COVID Nasal Swab and tested negative on 22Mar2021. The outcome of the event Bell's palsy was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pruritus, Eye pruritus, Flushing, Heart rate increased
Clinical narrative: decreased hearing; Allergic reaction which included hives; Mild vasovagal reaction; itchy throat; Allergic reaction which included hives, itchy throat, eyes, nose, and ears, and hives; fast heart rate; flushing; lightheaded; itchy throat, eyes, nose, and ears; itchy throat, eyes, nose, and ears; itchy throat, eyes, nose, and ears; This is a spontaneous report from a contactable other HCP (patient).   A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 39-year-old via an unspecified route of administration, administered in Arm Left on 26Mar2021 17:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included asthma, allergies, inflammatory bowel disease. There was no COVID prior vaccination, no other vaccine within 4 weeks prior to the COVID vaccine, and no COVID tested post vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); lisdexamfetamine mesilate (VYVANSE); breo all within 2 weeks of vaccination.  The patient experienced allergic reaction which included hives, itchy throat, eyes, nose, and ears; mild vasovagal reaction which included flushing, fast heart rate, lightheaded, and decreased hearing all on 26Mar2021 17:15 and resulted in Doctor or other healthcare professional office/clinic visit. Treatments included antihistamines and steroids. The events outcome was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association and profile of the product  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the contributory role of the suspect product is possible.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoacusis, Nasal pruritus, Presyncope, Throat irritation
Clinical narrative: decreased hearing; Allergic reaction which included hives; Mild vasovagal reaction; itchy throat; Allergic reaction which included hives, itchy throat, eyes, nose, and ears, and hives; fast heart rate; flushing; lightheaded; itchy throat, eyes, nose, and ears; itchy throat, eyes, nose, and ears; itchy throat, eyes, nose, and ears; This is a spontaneous report from a contactable other HCP (patient).   A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 39-year-old via an unspecified route of administration, administered in Arm Left on 26Mar2021 17:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included asthma, allergies, inflammatory bowel disease. There was no COVID prior vaccination, no other vaccine within 4 weeks prior to the COVID vaccine, and no COVID tested post vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); lisdexamfetamine mesilate (VYVANSE); breo all within 2 weeks of vaccination.  The patient experienced allergic reaction which included hives, itchy throat, eyes, nose, and ears; mild vasovagal reaction which included flushing, fast heart rate, lightheaded, and decreased hearing all on 26Mar2021 17:15 and resulted in Doctor or other healthcare professional office/clinic visit. Treatments included antihistamines and steroids. The events outcome was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association and profile of the product  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the contributory role of the suspect product is possible.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: decreased hearing; Allergic reaction which included hives; Mild vasovagal reaction; itchy throat; Allergic reaction which included hives, itchy throat, eyes, nose, and ears, and hives; fast heart rate; flushing; lightheaded; itchy throat, eyes, nose, and ears; itchy throat, eyes, nose, and ears; itchy throat, eyes, nose, and ears; This is a spontaneous report from a contactable other HCP (patient).   A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 39-year-old via an unspecified route of administration, administered in Arm Left on 26Mar2021 17:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included asthma, allergies, inflammatory bowel disease. There was no COVID prior vaccination, no other vaccine within 4 weeks prior to the COVID vaccine, and no COVID tested post vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); lisdexamfetamine mesilate (VYVANSE); breo all within 2 weeks of vaccination.  The patient experienced allergic reaction which included hives, itchy throat, eyes, nose, and ears; mild vasovagal reaction which included flushing, fast heart rate, lightheaded, and decreased hearing all on 26Mar2021 17:15 and resulted in Doctor or other healthcare professional office/clinic visit. Treatments included antihistamines and steroids. The events outcome was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association and profile of the product  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the contributory role of the suspect product is possible.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive; This is a spontaneous report received from contactable consumer. A 66-years old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch EN6198 and expiry date: Unknown) via an unspecified route of administration on 08Mar2021 for covid-19 immunisation. Relevant medical history and concurrent conditions included Pre-diabetic and Blood pressure high from unknown date and ongoing is unknown. Concomitant medication included proprietary medicinal product name: Unspecified medication for Blood pressure. On 15Mar2021 patient tested positive for covid after taking the first shot of the Covid19 vaccine. Reporter wanted to know whether the next dose cane be taken or not as per scheduled date which was on the 28 of March. The events outcome was unknown.   Follow up letter has been generated information on batch/lot number was available.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: Woke up on 3rd morning with excruciating hip pain, unable to bend; Woke up on 3rd morning with excruciating hip pain, unable to bend; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 2) via an unspecified route of administration, administered in left arm on 23Mar2021,15:00 (batch/lot number: unknown) at 62 years old as SINGLE DOSE for COVID-19 immunization. The vaccine was administered in Other vaccination facility. The patient's medical history included MGUS (Monoclonal gammopathy of undetermined significance), Ehlers Danlis syndrome 3, and iodine allergy; all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Concomitant medications included clarithromycin (CLARI), estradiol (ESTROGEN), progesterone (PROGESTERONE), methylphenidate hydrochloride (RITALIN), and testosterone (TESTOSTERONE); therapy dates and indications for all were unspecified. The patient previously received the first dose of the BNT162B2 via an unspecified route of administration, administered in left arm on 02Mar2021 17:00 (batch/lot number: unknown) at 62 years old as single dose for COVID-19 immunization. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 26Mar2021 07:00, the patient woke up on 3rd morning with excruciating hip pain, unable to bend. It was unknown if patient received treatment as a result of the event. The patient has not recovered from the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID after first dose of the vaccine; got COVID after first dose of the vaccine; This is a spontaneous report received from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on 17Jan2021 (Batch/Lot Number: EM0477) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer COVID-19 vaccine on 17Jan2021, then she got COVID on an unspecified date after the vaccine and has not received second dose at this time. She wanted to know where she can get the second dose, she knows she is over due for the second dose, was supposed to be received on 15Mar2021. Patient wanted to know if she can have her second dose after 6 weeks, local system is impossible because she got her first dose abroad. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Coronavirus test positive; This is a spontaneous report received from a contactable consumer (reported for herself) via the Pfizer sponsored program. A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6198, expiry date not reported), via an unspecified route of administration on 08Mar2021 as single dose for covid-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient's concomitant medications included unspecified medication; patient mentioned as taking concomitant products as yes, as patient have hypothyroidism. The patient was tested positive after taking the first shot of the Covid19 vaccine. Patient was just wondering if she will get the next dose on 28Mar2021. Patient was tested positive (Covid test) on the 17Mar2021; also reported as Coronavirus test positive. The outcome of the event was unknown.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Melanoma recurrent, Scan
Clinical narrative: Metastatic melanoma most likely a recurrence from the 2014; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration, administered in left arm on 29Jan2021 13:00 (at 37-year-old) at single dose for COVID-19 immunization. The vaccine was administered at military base. Medical history included stage 1b malignant melanoma lesion removed from right shoulder in 2014. The patient was not diagnosed with COVID-19 prior to vaccination. None known allergies to medications, food, or other products. Concomitant medications included multivitamins [VITAMINS NOS]; fish oil. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a stage 1b malignant melanoma lesion removed from his right shoulder in 2014 and had completed all required follow-up. On 06Feb2021 06:00 PM, about a week after receiving the first dose (left arm), patient noticed a small marble-sized lump in his right armpit. The lump continued to grow rapidly, and he went to the doctor, after a biopsy and scans it was confirmed to be metastatic melanoma, most likely a recurrence from the 2014 melanoma. The patient received the second dose on 18Feb2021 (left arm) and noticed the lump in his right armpit grew much faster and he had a reaction (swollen nodes) in his left armpit as well. The melanoma was limited to his right armpit. They were reporting the event because of the timing of the melanoma recurrence in conjunction with the vaccination and because they are  investigating the biopsy/pathology of the tumor in the right axilla as there were features, they had never seen before in melanoma. The event was reported as non-serious. It resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event included immunotherapy. The outcome of the event was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased
Clinical narrative: Blood pressure went up; Heart Rate exceeded 100 beats a minute five minutes after the injection; This is a spontaneous report from a contactable other hcp (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included asthmatic from an unknown date and unknown if ongoing. The patient don't have heart problems or blood pressure problems. The patient's concomitant medications were not reported.  The patient experienced heart rate exceeded 100 beats a minute five minutes after the injection and blood pressure went up on an unspecified date in Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was hospitalized for 1 day due to the events. Therapeutic measures were taken as a result of the events which included Heart monitor/ IV for flushing. The patient did not recover from the events.  Information about lot/batch has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events "Blood pressure went up" and "Heart Rate exceeded 100 beats a minute five minutes after the injection" cannot be completely excluded based on temporal association.  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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chest discomfort, Dyspnoea, Hypersensitivity
Clinical narrative: chest heaviness; having a hard time breathing; throat very scratchy; due to her allergies; lips swollen; "windpipe is shutting off" and "esophagus is closing; "windpipe is shutting off" and "esophagus is closing; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received bnt162b2 (BNT162B2), second dose via an unspecified route of administration on 15Mar2021 at single dose for COVID-19 immunization. Medical history included bronchitis in the past. The patient's concomitant medications were not reported. The patient  stated she "felt good" from that 15Mar2021 to 17Mar2021. She stated on 18Mar2021 she started experiencing heaviness in her chest and stated she was having a hard time breathing, and stated that on 26Mar2021 it was the same thing. She stated that her chest felt "Almost like bronchitis" as she stated she had bronchitis in the past. She reported that her throat was "very scratchy" and that it felt like her "windpipe was shutting off" and "esophagus was closing." The patient made a noise like she was clearing her throat and stated that that "helps it go away." She also reported that her lips are a little swollen, but stated this may be due to her allergies and stated she had taken a loratadine (CLARITIN) in the morning of 27Mar2021 for that. She reported that her head was fine, her temperature was 97.2, and her blood pressure was fine. She would like to know how long these side effects are expected to last. She spoke with her son who told her that these were side effects of the vaccine. She really did not want to go to the emergency room and reported she had tried to call her doctor but was on hold for a while. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Obstructive airways disorder, Oesophageal stenosis, Throat irritation
Clinical narrative: chest heaviness; having a hard time breathing; throat very scratchy; due to her allergies; lips swollen; "windpipe is shutting off" and "esophagus is closing; "windpipe is shutting off" and "esophagus is closing; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received bnt162b2 (BNT162B2), second dose via an unspecified route of administration on 15Mar2021 at single dose for COVID-19 immunization. Medical history included bronchitis in the past. The patient's concomitant medications were not reported. The patient  stated she "felt good" from that 15Mar2021 to 17Mar2021. She stated on 18Mar2021 she started experiencing heaviness in her chest and stated she was having a hard time breathing, and stated that on 26Mar2021 it was the same thing. She stated that her chest felt "Almost like bronchitis" as she stated she had bronchitis in the past. She reported that her throat was "very scratchy" and that it felt like her "windpipe was shutting off" and "esophagus was closing." The patient made a noise like she was clearing her throat and stated that that "helps it go away." She also reported that her lips are a little swollen, but stated this may be due to her allergies and stated she had taken a loratadine (CLARITIN) in the morning of 27Mar2021 for that. She reported that her head was fine, her temperature was 97.2, and her blood pressure was fine. She would like to know how long these side effects are expected to last. She spoke with her son who told her that these were side effects of the vaccine. She really did not want to go to the emergency room and reported she had tried to call her doctor but was on hold for a while. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure measurement, Blood test, Diffuse alopecia, SARS-CoV-2 test
Clinical narrative: losing hair pretty rapidly/ hair loss/ Telogen Effluvium; This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1,on 26Jan2021 14:15 (Batch/Lot number was not reported), dose 2 on 16Feb2021 (Batch/Lot number was not reported); both via an unspecified route of administration, administered in left arm at the age of 48 years old as single dose for covid-19 immunization. The facility type vaccine: Home/Facility. The patient medical history includes borderline HPB and borderline high blood sugar due to PCOS. The patient was not pregnant. No vaccines were given 4 weeks prior. The patient has no COVID-19 prior to vaccination. Concomitant medication included losartan and metformin. On 01Feb2021, the patient noticed that she was losing hair pretty rapidly. She went to her primary care physician and had bloodwork completed which all came back normal. She then went to a dermatologist who felt there may have been a link between the vaccine and her hair loss. The dermatologist diagnosed her with Telogen Effluvium on 25Mar2021. The event resulted to doctor or other healthcare professional office/clinic visit and no treatment was given. The event was reported to have caused disability or permanent damage. The patient had COVID-19 test PCR nasal swab on 23Mar2021 and the result was negative. The outcome of the event was recovering.  Information on about lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Condition aggravated, Dizziness, Eye haemorrhage, Feeling cold
Clinical narrative: eye had a hemorrhage - it got worse the next day; I feel light headed; head/face is tingly/cold; head/face is tingly/cold; eye had a hemorrhage - it got worse the next day; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female non-pregnant patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Mar2021 at 08:30 AM (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included gastric bypass from Jul2018, high blood pressure prior to gastric bypass but has had regular BP (blood pressure) since then, and allergy to penicillin. The patient's concomitant medications were not reported. The patient previously received the first dose of the same vaccine in left arm on 03Mar2021 at 08:30 AM for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 05:00 PM, a day after she received the Pfizer vaccine (2nd dose), her eye had a hemorrhage - it got worse the next day (26Mar2021). She felt light headed and head/face was tingly/cold. Took her blood pressure and it's in a normal range (109/77 111/77). She spoke with a relative that was a nurse practitioner and was advised hemorrhage could be related to vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the events was not resolved. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination.   Information about batch/Lot number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: eye had a hemorrhage - it got worse the next day; I feel light headed; head/face is tingly/cold; head/face is tingly/cold; eye had a hemorrhage - it got worse the next day; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female non-pregnant patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Mar2021 at 08:30 AM (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included gastric bypass from Jul2018, high blood pressure prior to gastric bypass but has had regular BP (blood pressure) since then, and allergy to penicillin. The patient's concomitant medications were not reported. The patient previously received the first dose of the same vaccine in left arm on 03Mar2021 at 08:30 AM for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 05:00 PM, a day after she received the Pfizer vaccine (2nd dose), her eye had a hemorrhage - it got worse the next day (26Mar2021). She felt light headed and head/face was tingly/cold. Took her blood pressure and it's in a normal range (109/77 111/77). She spoke with a relative that was a nurse practitioner and was advised hemorrhage could be related to vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the events was not resolved. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination.   Information about batch/Lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: peripheral neuropathy; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced peripheral neuropathy on an unspecified date with outcome of unknown. The patient received the 1st dose of the vaccine on 09Mar2021. He mentioned that he had peripheral neuropathy and had read on a website that people experienced new or worsened neuropathy after getting 2nd dose of the vaccine. He was scheduled for his 2nd dose on 30Mar2021 but was considering to not get it because of the articles he had read. He was asking for any live documentation on Neuropathy outside of the clinical trials. The case was assessed as non-serious.   No follow up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Hypoaesthesia, Neuropathy peripheral
Clinical narrative: peripheral neuropathy; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced peripheral neuropathy on an unspecified date with outcome of unknown. The patient received the 1st dose of the vaccine on 09Mar2021. He mentioned that he had peripheral neuropathy and had read on a website that people experienced new or worsened neuropathy after getting 2nd dose of the vaccine. He was scheduled for his 2nd dose on 30Mar2021 but was considering to not get it because of the articles he had read. He was asking for any live documentation on Neuropathy outside of the clinical trials. The case was assessed as non-serious.   No follow up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Bundle branch block left, Echocardiogram, Electrocardiogram, Neck pain
Clinical narrative: neck pain; arm pain; 3 troponin levels at 200/203/204; chronic LBBB; PAF; This is a spontaneous report from a contactable nurse (reporting for mother). A 92-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) dose 2 via an unspecified route of administration on 25Feb2021 as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 taken for COVID-19 immunisation. The patient was admitted to the hospital with neck/arm pain with 3 troponin levels at 200/203/204. Echo did not show wall motion abnormalities. Could she have had a delayed inflammatory process causing her symptoms? Myocarditis. There was no indication of an acute MI: EKG showed chronic left bundle branch block (LBBB). She did develop paroxysmal atrial fibrillation (PAF) on day 2, lasting only 12 hours. The outcome of events was unknown. Events were reported as non-serious.  Information about the Lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Troponin, Troponin increased
Clinical narrative: neck pain; arm pain; 3 troponin levels at 200/203/204; chronic LBBB; PAF; This is a spontaneous report from a contactable nurse (reporting for mother). A 92-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) dose 2 via an unspecified route of administration on 25Feb2021 as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 taken for COVID-19 immunisation. The patient was admitted to the hospital with neck/arm pain with 3 troponin levels at 200/203/204. Echo did not show wall motion abnormalities. Could she have had a delayed inflammatory process causing her symptoms? Myocarditis. There was no indication of an acute MI: EKG showed chronic left bundle branch block (LBBB). She did develop paroxysmal atrial fibrillation (PAF) on day 2, lasting only 12 hours. The outcome of events was unknown. Events were reported as non-serious.  Information about the Lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Nasal congestion
Clinical narrative: nasal and chest congestion; nasal and chest congestion; Severe dyspnea; tiredness; wheezing; coughing; headache; fever-like symptoms; injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration at arm left on 20Mar2021 at 14:00 at age of 25-year-old at single dose for COVID-19 immunisation. Medical history included severe asthma, rhinitis, allergies to grapseed, beans and legumes. Concomitant medications included budesonide, fluticasone propionate (FLOVENT), omeprazole, tiotropium bromide (SPIRIVA), levosalbutamol hydrochloride (XOPENEX). There was no other vaccine in four weeks. Patient experienced severe dyspnea, nasal and chest congestion, tiredness, wheezing, coughing, headache, fever-like symptoms, injection site soreness; all on 20Mar2021 at 02:45 PM. The events were reported as resulting in doctor or other healthcare professional office/clinic visit and disability or permanent damage. There was unspecified treatment for the events. Patient didn't have COVID prior vaccination. Patient was not tested COVID post vaccination. Outcome of the events was not recovered.  Information on batch/lot number was requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Vaccination site pain, Wheezing
Clinical narrative: nasal and chest congestion; nasal and chest congestion; Severe dyspnea; tiredness; wheezing; coughing; headache; fever-like symptoms; injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration at arm left on 20Mar2021 at 14:00 at age of 25-year-old at single dose for COVID-19 immunisation. Medical history included severe asthma, rhinitis, allergies to grapseed, beans and legumes. Concomitant medications included budesonide, fluticasone propionate (FLOVENT), omeprazole, tiotropium bromide (SPIRIVA), levosalbutamol hydrochloride (XOPENEX). There was no other vaccine in four weeks. Patient experienced severe dyspnea, nasal and chest congestion, tiredness, wheezing, coughing, headache, fever-like symptoms, injection site soreness; all on 20Mar2021 at 02:45 PM. The events were reported as resulting in doctor or other healthcare professional office/clinic visit and disability or permanent damage. There was unspecified treatment for the events. Patient didn't have COVID prior vaccination. Patient was not tested COVID post vaccination. Outcome of the events was not recovered.  Information on batch/lot number was requested.
Sex: M
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable other healthcare professional from a Pfizer-sponsored program. A male patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date as single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hives on an unspecified date with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Heart rate, Heart rate increased, Malaise
Clinical narrative: I fainted and my heart rate was 144 which is extremely high; I fainted and my heart rate was 144 which is extremely high; I had woken up in a sweat, had 103.6 fever.; I had woken up in a sweat, had 103.6 fever.; After fainting I threw up and continue to not feel good; After fainting I threw up and continue to not feel good; I also had a bad headache; This is a spontaneous report from a contactable consumer (patient).   A 23-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 23Mar2021 (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.  The patient stated that, "The 24th, the day after my shot. I had woken up in a sweat, had 103.6 fever. I fainted and my heart rate was 144 which is extremely high. After fainting I threw up and continue to not feel good. I also had a bad headache and continue to have one." The adverse event result in Doctor or other healthcare professional office/clinic visit. 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.   No follow-up attempts are needed. No further information is expected; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia, Syncope, Vomiting
Clinical narrative: I fainted and my heart rate was 144 which is extremely high; I fainted and my heart rate was 144 which is extremely high; I had woken up in a sweat, had 103.6 fever.; I had woken up in a sweat, had 103.6 fever.; After fainting I threw up and continue to not feel good; After fainting I threw up and continue to not feel good; I also had a bad headache; This is a spontaneous report from a contactable consumer (patient).   A 23-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 23Mar2021 (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.  The patient stated that, "The 24th, the day after my shot. I had woken up in a sweat, had 103.6 fever. I fainted and my heart rate was 144 which is extremely high. After fainting I threw up and continue to not feel good. I also had a bad headache and continue to have one." The adverse event result in Doctor or other healthcare professional office/clinic visit. 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.   No follow-up attempts are needed. No further information is expected; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Retinal vein occlusion
Clinical narrative: Central Retinal Vein Occlusion; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: El9261), via an unspecified route of administration administered in left arm on 01Feb2021 (at the age of 71-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Medical history included high blood pressure, premature ventricular contractions (PVC's), and cholesterol. The patient has a known allergy with meclizine. Concomitant medications included acebutolol, aspirin [acetylsalicylic acid] (ASPIRIN), atorvastatin, valsartan, and unspecified vitamin. On 04Feb2021, the patient experienced central retinal vein occlusion. Therapeutic measures were taken as a result of central retinal vein occlusion which included intravitreal avastin injection. The patient had not yet recovered from the event.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nasal congestion, Off label use, SARS-CoV-2 test positive, Taste disorder
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.