chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count decreased
Clinical narrative: I can't be standing for more than a few minutes; My legs begin to cramp up; Muscle aches; Sore throat; Couldn't get out of bed all weekend; White blood and platelets count abnormally low; White blood and platelets count abnormally low; Mononucleosis; Cough; Dizziness; Muscle weakness; Fever; Headache; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in left arm on 15Apr2021 10:00 as single dose for Covid-19 immunization. Medical history included gastritis and sensitive stomach from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination. Concomitant medications included drospirenone, ethinylestradiol (NIKKI); pantoprazole sodium sesquihydrate (PROTONIX); and an unspecified vitamin, all taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for Covid-19 immunization. The patient received her second dose on 15Apr2021, Thursday, and on 16Apr2021, Friday night, she got a mild headache. Beginning 17Apr2021 09:00, Saturday, she got severe headache, dizziness, muscle weakness, and a fever. Symptoms worsened throughout the days. On 19Apr2021, Monday, she also got a sore throat. She couldn't get out of bed all weekend. She went to the hospital and they found that her white blood and platelets count were abnormally low, among other low things (white blood at 1.8). She was hospitalized until 20Apr2021, Tuesday, and was found to have mononucleosis. Cough developed and ended Tuesday, 20Apr2021. Beginning 20Apr2021 onward, the muscle aches were the biggest complaint, she can't be standing for more than a few minutes or her legs begin to cramp up. Headaches and dizziness continued. Sore throat stopped, and fever began to subside. On 19Apr2021, the patient underwent lab tests and procedures which included platelet count: abnormally low, Nasal Swab/PCR: negative, and white blood cell count: 1.8. The events resulted in Doctor or healthcare professional office/clinic visit, Emergency room/department or urgent care, and events from 19Apr2021 caused hospitalization until 20Apr2021. Treatment for the events included Tylenol and IV fluids. The outcome of sore throat recovered in Apr2021, cough resolved on 20Apr2021, fever was recovering and for other events was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Brown-Sequard syndrome, Condition aggravated, Inflammation, Joint swelling, Limb discomfort
Clinical narrative: Got really inflamed and everything again; Brown-Sequard syndrome; Brown-Sequard syndrome; Tingling in both legs; legs getting swollen; whole left side of body swelling only from under the breast down; muscles tightening on the whole left side of body only from under the breast down; continued discomfort in left leg; Swelling makes it to where her joints can't like she can't bend her knee really well; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 48-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 01Apr2021 at 10:15 (Lot Number: EN6201), as single dose, for COVID-19 immunisation. Medical history included ongoing Brown-Sequard syndrome, ongoing diabetes mellitus, COVID-19 from 14Feb2021 to 2021 (for about 3 weeks), ongoing immunodeficiency. Concomitant medication included semaglutide (OZEMPIC) for diabetes mellitus. The patient experienced Brown-Sequard syndrome exacerbation (medically significant) on 01Apr2021 with outcome of unknown, tingling in both legs (non-serious) on 01Apr2021 with outcome of unknown, legs getting swollen (non-serious) on 01Apr2021 with outcome of unknown, whole left side of body swelling only from under the breast down (non-serious) on 01Apr2021 with outcome of unknown, muscles tightening on the whole left side of body only from under the breast down (non-serious) on 01Apr2021 with outcome of unknown, continued discomfort in left leg (non-serious) on 01Apr2021 with outcome of unknown, swelling makes it to where her joints can't like she can't bend her knee really well (non-serious) on 01Apr2021 with outcome of unknown, got really inflamed and everything again (non-serious) on 21Apr2021 with outcome of unknown. Patient reported that had swelling in the areas that normally, like the left side of her back, her stomach, all the sites that basically the Brown-Sequard Syndrome that she has problems with, it just exacerbated it.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Paraesthesia, Peripheral swelling, Swelling
Clinical narrative: Got really inflamed and everything again; Brown-Sequard syndrome; Brown-Sequard syndrome; Tingling in both legs; legs getting swollen; whole left side of body swelling only from under the breast down; muscles tightening on the whole left side of body only from under the breast down; continued discomfort in left leg; Swelling makes it to where her joints can't like she can't bend her knee really well; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 48-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 01Apr2021 at 10:15 (Lot Number: EN6201), as single dose, for COVID-19 immunisation. Medical history included ongoing Brown-Sequard syndrome, ongoing diabetes mellitus, COVID-19 from 14Feb2021 to 2021 (for about 3 weeks), ongoing immunodeficiency. Concomitant medication included semaglutide (OZEMPIC) for diabetes mellitus. The patient experienced Brown-Sequard syndrome exacerbation (medically significant) on 01Apr2021 with outcome of unknown, tingling in both legs (non-serious) on 01Apr2021 with outcome of unknown, legs getting swollen (non-serious) on 01Apr2021 with outcome of unknown, whole left side of body swelling only from under the breast down (non-serious) on 01Apr2021 with outcome of unknown, muscles tightening on the whole left side of body only from under the breast down (non-serious) on 01Apr2021 with outcome of unknown, continued discomfort in left leg (non-serious) on 01Apr2021 with outcome of unknown, swelling makes it to where her joints can't like she can't bend her knee really well (non-serious) on 01Apr2021 with outcome of unknown, got really inflamed and everything again (non-serious) on 21Apr2021 with outcome of unknown. Patient reported that had swelling in the areas that normally, like the left side of her back, her stomach, all the sites that basically the Brown-Sequard Syndrome that she has problems with, it just exacerbated it.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Hypoacusis, Loss of personal independence in daily activities, Stress, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for the daughter.   A 41-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as single dose maybe the right arm (reporter was unsure) at the age of 41-year-old for COVID-19 immunisation, administered through hospital.  Medical history was none.  There were no concomitant medications.   In Apr2201 the patient experienced she can't hear right now and it won't go away, ringing in ears, she is extremely stressed out and this is affecting her life, she was so upset. The course of events was as follows: She has had ringing in her ears from this, started some time after the shot. She was extremely stressed out and this was affecting her life. She can't live like this. She recently divorced with 2 kids and trying to work. Went to the doctor twice and they sent her to ENT department. This is destroying her life. It was very stressful. Patient was having a severe problem. She had been to the doctor twice, including this week in Apr2021 and once the end of last week in Apr2021. They looked at her medications and sent her to counseling, to therapy. She had definitely not gotten better, has been persistent. She did not know on like a graph scale where it was. She received no treatment for ringing in ears. She was trying to take something for stress because this was horrible. She cannot hear right now and it won't go away. This is a serious problem. Reporter did not want her daughter to go deaf. She received a message from hospital, regarding her being scheduled for the second vaccine on Saturday and she said she was not going for that she wished she had not gotten the first one. Reporter stated she has a good friend who's daughter was a PA whom she has been corresponding to about this and she sent them links of how the Covid vaccine is linked to tinnitus. She has never had anyone report this. She sent it to her daughter and her daughter said can't read this, there is blogs with responses and she just said she can't read this, she was so upset that she can't hear right because of this with this ringing that won't go away. She had gotten a call from the Hospital Department stating that she was ready for the second shot. She was not getting the second shot and was sorry that she got the first one. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Hypoacusis
Clinical narrative: clogged ears, loss of hearing acuity. Sudden onset.; clogged ears, loss of hearing acuity. Sudden onset.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot ER8735), via an unspecified route of administration, administered in left arm on 19Apr2021 14:00 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no other vaccine in 4 weeks and no other medications in 2 weeks. On 22Apr2021 20:30, the patient experienced clogged ears and loss of hearing acuity, sudden onset. There was no therapy for the events. The patient had no Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was not recovered.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Investigation, Myocardial infarction, Pulmonary oedema
Clinical narrative: having a heart attack; couldn't breath; lungs were filled-up with fluid; felt like a pin cushion; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN9581), via an unspecified route of administration on 06Feb2021 as single dose for COVID-19 immunization. Medical history included breast cancer/her breast cancer had came back in the same place from 2006, both breasts removed on 2006. Concomitant medication included palbociclib (IBRANCE) taken for breast cancer female from 24Jun2020 to 04Feb2021 then from 01Apr2021 and ongoing. The patient previously received the first dose of bnt162b2 (lot number: EL3248) on 17Jan2021 for COVID-19 immunization and experienced acute bronchitis. On 14Feb2021, the patient was taken by an ambulance and was hospitalized because she couldn't breath, they thought she was having a heart attack, her lungs were filled-up with fluid. The doctors had her on oxygen while she was in the hospital, and did heart and lung tests on her on an unspecified date in 2021. While in the hospital, the patient felt like a pin cushion on an unspecified date. The patient left the hospital on 17Feb2021. The patient was tested for COVID-19 three times on unspecified dates all with negative results. the patient was hospitalized again on 25Feb2021 to 01Mar2021 for reasons not reported. The outcome of the events she couldn't breath, thought she was having a heart attack, her lungs were filled-up with fluid was recovered on 17Feb2021, while for the event felt like a pin cushion was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: having a heart attack; couldn't breath; lungs were filled-up with fluid; felt like a pin cushion; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN9581), via an unspecified route of administration on 06Feb2021 as single dose for COVID-19 immunization. Medical history included breast cancer/her breast cancer had came back in the same place from 2006, both breasts removed on 2006. Concomitant medication included palbociclib (IBRANCE) taken for breast cancer female from 24Jun2020 to 04Feb2021 then from 01Apr2021 and ongoing. The patient previously received the first dose of bnt162b2 (lot number: EL3248) on 17Jan2021 for COVID-19 immunization and experienced acute bronchitis. On 14Feb2021, the patient was taken by an ambulance and was hospitalized because she couldn't breath, they thought she was having a heart attack, her lungs were filled-up with fluid. The doctors had her on oxygen while she was in the hospital, and did heart and lung tests on her on an unspecified date in 2021. While in the hospital, the patient felt like a pin cushion on an unspecified date. The patient left the hospital on 17Feb2021. The patient was tested for COVID-19 three times on unspecified dates all with negative results. the patient was hospitalized again on 25Feb2021 to 01Mar2021 for reasons not reported. The outcome of the events she couldn't breath, thought she was having a heart attack, her lungs were filled-up with fluid was recovered on 17Feb2021, while for the event felt like a pin cushion was unknown.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid19 PCR test on 14Apr2021, after receiving the first dose of the Covid19 vaccine on 2Apr2021; symptoms started on 8Apr2021 with a negative Covid19 rapid test that day.; This is a spontaneous report from a contactable consumer (patient).   A 47-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 02Apr2021 19:00 (Batch/Lot Number: ER8732) as single dose at the age of 47-year-old for COVID-19 immunisation.  The patient medical history and concomitant medications were none.  No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). No events following prior vaccinations. The patient he got COVID in between the two doses: COVID-19 symptoms started on 08Apr2021 with a negative COVID-19 rapid test on 08Apr2021 and was tested positive for COVID19 PCR test on 14apr2021, after receiving the first dose of the COVID-19 vaccine. The events did not require a visit to Emergency Room? Or Physician Office. He received treatment with Tylenol. On 20Apr2021 he stopped the medication and he was feeling better now. The events were considered medically significant. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive on 14Apr2021, Sars-cov-2 test negative: negative on 08Apr2021. The outcome of event was unknown. This report was note related to a study or program. His second dose was scheduled for 23Apr2021. Caller was asking if he was still safe to get the vaccine or should he wait. A Product Complaint was filed.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Chest X-ray, Computerised tomogram head, Echocardiogram, Magnetic resonance imaging head
Clinical narrative: Stroke; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 22Mar2021 09:00 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure, bleeding ulcer and helicobacter pylori infection both from 15Feb2021, and ongoing tumor on his heart. Concomitant medication included lisinopril taken for high blood pressure. The patient previously took the first dose of bnt162b2 in the left arm on 26Feb2021 (lot number: EN6203) for COVID-19 immunisation. Right before he had his first shot, he was in the hospital on 15Feb2021 with a bleeding ulcer and a helicobacter pylori infection. He had been in the hospital and isn't sure what all they gave him then. The patient started lisinopril 4 or 5 years ago when he was diagnosed with high blood pressure. His blood pressure was under control with the lisinopril but the patient is no longer on it. The patient's father had a stroke when he was 42 but he had high blood pressure and didn't get it treated. The patient got up around 07:00 in the morning on 27Mar2021. The patient's wife got up at 08:30 when she realized something was wrong. The patient said when he got up around 07:00, he experienced his right side being numb. The patient went to the emergency room and was treated there. He had a stroke. The patient was hospitalized from 27Mar2021 to 30Mar2021. The patient's wife doesn't know if it has anything to do with the shot. After his stroke, they put him on "carvilo". When the patient was in the hospital for the stroke, they found other issues. He has a tumor in his heart that's a pretty good size and the doctor said it had been there for awhile. So, they put her husband on "carvilo" to help with his blood pressure and his heart. She doesn't think the tumor had anything to do with the shot because the doctor did say the size of the tumor was as big as it was because it had been there a while. They found the tumor while trying to find out why he had the stroke. They still haven't found a reason as to why he had the stroke. The tumor is on the right side of his heart and they said they didn't think that had anything to do with the stroke. The tumor was found on 28Mar2021. They did an MRI and a CT scan on his head when he was in the emergency room (ER) on 27Mar2021. They also did an ultrasound on his heart, chest, and abdomen. Since he's been out, they did an MRI on his heart. They also did X-rays on his lungs. He is getting ready to go back to the hospital for open heart surgery on 07May2021. Outcome of the event was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Ultrasound abdomen, Ultrasound chest
Clinical narrative: Stroke; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 22Mar2021 09:00 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure, bleeding ulcer and helicobacter pylori infection both from 15Feb2021, and ongoing tumor on his heart. Concomitant medication included lisinopril taken for high blood pressure. The patient previously took the first dose of bnt162b2 in the left arm on 26Feb2021 (lot number: EN6203) for COVID-19 immunisation. Right before he had his first shot, he was in the hospital on 15Feb2021 with a bleeding ulcer and a helicobacter pylori infection. He had been in the hospital and isn't sure what all they gave him then. The patient started lisinopril 4 or 5 years ago when he was diagnosed with high blood pressure. His blood pressure was under control with the lisinopril but the patient is no longer on it. The patient's father had a stroke when he was 42 but he had high blood pressure and didn't get it treated. The patient got up around 07:00 in the morning on 27Mar2021. The patient's wife got up at 08:30 when she realized something was wrong. The patient said when he got up around 07:00, he experienced his right side being numb. The patient went to the emergency room and was treated there. He had a stroke. The patient was hospitalized from 27Mar2021 to 30Mar2021. The patient's wife doesn't know if it has anything to do with the shot. After his stroke, they put him on "carvilo". When the patient was in the hospital for the stroke, they found other issues. He has a tumor in his heart that's a pretty good size and the doctor said it had been there for awhile. So, they put her husband on "carvilo" to help with his blood pressure and his heart. She doesn't think the tumor had anything to do with the shot because the doctor did say the size of the tumor was as big as it was because it had been there a while. They found the tumor while trying to find out why he had the stroke. They still haven't found a reason as to why he had the stroke. The tumor is on the right side of his heart and they said they didn't think that had anything to do with the stroke. The tumor was found on 28Mar2021. They did an MRI and a CT scan on his head when he was in the emergency room (ER) on 27Mar2021. They also did an ultrasound on his heart, chest, and abdomen. Since he's been out, they did an MRI on his heart. They also did X-rays on his lungs. He is getting ready to go back to the hospital for open heart surgery on 07May2021. Outcome of the event was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: DVT and PE, 2 weeks after first vaccine; DVT and PE, 2 weeks after first vaccine; This is a spontaneous report from a contactable physician. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) at the age of 57-years-old as single dose for covid-19 immunisation. Medical history included hypertension and hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included lisinopril; levothyroxine; amlodipine all taken for an unspecified indication, start and stop date were not reported. The patient experienced DVT (deep vein thrombosis) and PE (pulmonary embolism), 2 weeks after first vaccine on 08Apr2021. The patient was hospitalized due to the events for 1 day. Therapeutic measures were taken as a result of the events. The patient recovered from the events on an unspecified date in Apr2021.  Information on lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between events DVT (deep vein thrombosis) and PE (pulmonary embolism) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Chills, Dizziness, Pain
Clinical narrative: Fever 103; total and severe body ache; chills; vomiting; swelling of hands; dizziness; terrible and constant abdominal pain; This is a spontaneous report from a contactable consumer. A 50-year-old 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 07Apr2021 15:00 (at the age of 50-years-old) (Batch/Lot Number: ew0169) as SINGLE DOSE for covid-19 immunisation. Medical history included weight abnormal, Pituitary tumor extracted, known allergies_PCN. Concomitant medications included omeprazole. The patient received first dose of BNT162B2 for Covid-19 immunisation on 30Mar2021 at 50-years-old. (Product: Covid 19, Brand: Pfizer, Lot Number: ER8727, Lot unknown: False, Administration Date: 30Mar2021, Administration time: 01:00PM, Vaccine location: Left arm, Dose Number: 1). On 08Apr2021 16:45, the patient experienced Fever 103, total and severe body ache, chills, vomiting, swelling of hands, dizziness, terrible and constant, abdominal pain. I have O Negative Blood and high percentages of Neanderthal DNA (more than 97% of population). The events were assessed as serious (disability). The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included body temperature: normal on 08Apr2021 Fever 103. The outcome of the events was not recovered. The patient did not have COVID prior vaccination, and was not covid tested post vaccination.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Fever 103; total and severe body ache; chills; vomiting; swelling of hands; dizziness; terrible and constant abdominal pain; This is a spontaneous report from a contactable consumer. A 50-year-old 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 07Apr2021 15:00 (at the age of 50-years-old) (Batch/Lot Number: ew0169) as SINGLE DOSE for covid-19 immunisation. Medical history included weight abnormal, Pituitary tumor extracted, known allergies_PCN. Concomitant medications included omeprazole. The patient received first dose of BNT162B2 for Covid-19 immunisation on 30Mar2021 at 50-years-old. (Product: Covid 19, Brand: Pfizer, Lot Number: ER8727, Lot unknown: False, Administration Date: 30Mar2021, Administration time: 01:00PM, Vaccine location: Left arm, Dose Number: 1). On 08Apr2021 16:45, the patient experienced Fever 103, total and severe body ache, chills, vomiting, swelling of hands, dizziness, terrible and constant, abdominal pain. I have O Negative Blood and high percentages of Neanderthal DNA (more than 97% of population). The events were assessed as serious (disability). The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included body temperature: normal on 08Apr2021 Fever 103. The outcome of the events was not recovered. The patient did not have COVID prior vaccination, and was not covid tested post vaccination.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable physician and consumer (receptionist). A 55-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccines received on four weeks. Patient was not pregnant. The patient experienced bell's palsy on Apr2021 which caused hospitalization. Prednisone was given as treatment. Outcome of the event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Bell's palsy due to temporal relationship and current known drug safety profile.  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.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Cerebrovascular accident, Magnetic resonance imaging, Muscular weakness, Neurological symptom
Clinical narrative: stroke; developed neurological symptoms; developed left sided symptoms of weakness in left arm and leg, unsteadiness, left hand tremor.; developed left sided symptoms of weakness in left arm and leg, unsteadiness, left hand tremor.; developed left sided symptoms of weakness in left arm and leg, unsteadiness, left hand tremor.; This is a spontaneous report from a non-contactable consumer. An elderly female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced stroke, developed neurological symptoms and developed left sided symptoms of weakness in left arm and leg, unsteadiness, left hand tremor. It was reported that the events resulted in hospitalization. It was reported that the patient developed neurological symptoms following the first dose of the Pfizer vaccine. Thereafter she was hospitalized and diagnosed with a stroke and is now home. She received the shot in her right arm and later developed left sided symptoms of weakness in left arm and leg, unsteadiness, left hand tremor. She saw her doctor who thought she had had a stroke and send her for an MRI and to see a neurologist who confirmed after the image she had a stroke. The patient underwent lab tests and procedures which included magnetic resonance imaging: stroke on an unspecified date (neurologist who confirmed after the image she had a stroke). Outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: stroke; developed neurological symptoms; developed left sided symptoms of weakness in left arm and leg, unsteadiness, left hand tremor.; developed left sided symptoms of weakness in left arm and leg, unsteadiness, left hand tremor.; developed left sided symptoms of weakness in left arm and leg, unsteadiness, left hand tremor.; This is a spontaneous report from a non-contactable consumer. An elderly female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced stroke, developed neurological symptoms and developed left sided symptoms of weakness in left arm and leg, unsteadiness, left hand tremor. It was reported that the events resulted in hospitalization. It was reported that the patient developed neurological symptoms following the first dose of the Pfizer vaccine. Thereafter she was hospitalized and diagnosed with a stroke and is now home. She received the shot in her right arm and later developed left sided symptoms of weakness in left arm and leg, unsteadiness, left hand tremor. She saw her doctor who thought she had had a stroke and send her for an MRI and to see a neurologist who confirmed after the image she had a stroke. The patient underwent lab tests and procedures which included magnetic resonance imaging: stroke on an unspecified date (neurologist who confirmed after the image she had a stroke). Outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Epilepsy, Memory impairment, SARS-CoV-2 test, Seizure
Clinical narrative: Seizures; Memory issues; Epilepsy; This is a spontaneous report from a contactable nurse (patient).  A 32-year-old non-pregnant (including at the time of the vaccination) female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 19Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at the physician's office.  Medical history included depression and anxiety. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication and therapy dates. She had no COVID-19 prior to vaccination. The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 29Dec2020 01:30 PM (Batch/Lot number was not reported) on the right arm as COVID-19 immunization. Then, received the 2nd dose on 19Jan2021. The patient was then diagnosed with epilepsy in Feb2021 a month after getting 2nd dose. On 08Mar2021 10:30, the patient had seizure and memory issues. The patient was brought to the emergency room/department or urgent care due to the events. Then was admitted in the hospital on 08Mar2021. The patient had nasopharyngeal swab on 05Mar2021 and showed negative. The patient received an unspecified treatment for the events but not yet recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Epilepsy.,seizures, memory impairment. The case will be reassessed once new information is available. 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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: I fainted; This is a spontaneous report from a non-contactable consumer (patient). A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration, administered in left arm on 21Apr2021 12:45 as a single dose for COVID-19 immunisation. Medical history included allergies to Penicillin. The patient was not pregnant at the time of vaccination. The patient has not had COVID prior to vaccination. Concomitant medication included etonogestrel (NEXPLANON). The patient has not had any other vaccine in four weeks. The patient fainted on 21Apr2021 17:00. No treatment was given in response to the event. The outcome of the event was recovering. The patient was not tested for COVID post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: As of 22Apr2021 patient was trying to get the second dose Pfizer Vaccine; patient was tested positive for the COVID Virus on 08Apr2021; patient was tested positive for the COVID Virus on 08Apr2021; This is a spontaneous report from a contactable consumer (patient).   A 73-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm on 10Mar2021 (Batch/Lot Number: EN6208) as single dose in arm/ shoulder at the age of 73-year-old for covid-19 immunisation, administered at home (someone came out and gave the patient the first dose).  Medical history included disabled, she could not read and write. There were no concomitant medications.  The patient was tested positive for the COVID Virus on 08Apr2021 (medically significant) and as of 22Apr2021 patient was trying to get the second dose Pfizer Vaccine.  The course of events was as follows: When the person who administered dose one Pfizer Vaccine came back the patient had the COVID Virus.  After the first dose of the Pfizer COVID Vaccine, patient thought she had the virus, but they did not test her. Caller was sent to get tested and tested positive for the COVID Virus after receiving the first dose Pfizer Vaccine. Patient quarantined after being diagnosed with COVID. On 20Apr2021 someone called and wanted the patient to come in and get the second dose of Pfizer Vaccine. The patient told this person she is disabled and cannot come. This person was supposed to call back on 21Apr2012 and let caller know and no one called back. Patient could not read and write and was unable to provide address, phone number or email. As of 22Apr2021 patient was trying to get the second dose Pfizer Vaccine. Patient did not mind answer questions, wants somebody to help get second dose Pfizer Vaccine. Caller asked if the questions from Agent will help caller get second dose Pfizer Vaccine. This report was not related to a study or program. She has not received second dose.  A Product Complaint was filed.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Pyrexia, Renal function test, Renal impairment
Clinical narrative: slight temperature of 99; kidney function sky rocketed/kidney function: 1.21/kidney function increase; This is a spontaneous report received from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration, on 12Apr2021, as single dose, for COVID-19 immunisation. Medical history included lymphoma (large b cell), chronic obstructive pulmonary disease (COPD), blood pressure high, chronic back pain, and allergy. Concomitant medications included loratadine taken for hypersensitivity; and paracetamol (TYLENOL) taken for an unspecified indication, both start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at age 70 years, via an unspecified route of administration, on 18Mar2021, for COVID-19 immunisation. It was reported that the patient received the second dose of 12Apr2021 and had very minimal reactions (unspecified), she felt fine. On 21Apr2021, the patient underwent blood work and showed that her kidney function sky rocketed or increased. Prior to the vaccine, her kidney function was great. She reported that her kidney function prior to the vaccine was 0.69 and it was 1.21 on 21Apr2021 (a week after the second vaccine). She also reported she had a slight temperature of 99 (unspecified date) and this was nothing bad. The outcome of the event "kidney function sky rocketed/kidney function: 1.21/kidney function increase" was not recovered, while slight temperature was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dysmenorrhoea, Heavy menstrual bleeding, Irritability, SARS-CoV-2 test
Clinical narrative: period is extremely heavier than it's ever been, I have large blood clots; period is extremely heavier than it's ever been, I have large blood clots; cramping; irritability; premenstrual symptoms like cramping and irritability were the worst they've ever been; This is a spontaneous report from a contactable consumer, reporting for herself.   A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the right arm on 15Apr2021 (Batch/Lot Number: Er8729) as a single dose (at the age of 30 years old) for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, levonorgestrel (SEASONIQUE) taken for an unspecified indication, start and stop date were not reported; spironolactone taken for an unspecified indication, start and stop date were not reported; magnesium taken for an unspecified indication, start and stop date were not reported; polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported, and an unspecified multivitamin taken for an unspecified indication, start and stop date were not reported. Historical vaccine information included BNT162B2, dose 1 via an unspecified route of administration, administered in the right arm on 25Mar2021 at 12pm (Batch/Lot Number: Er8730) as a single dose (at the age of 29 years old) for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced period is extremely heavier than it's ever been, she has large blood clots on 21Apr2021 at 08:00 with outcome of not recovered, cramping on 21Apr2021 at 08:00 with outcome of not recovered, irritability on 21Apr2021 at 08:00 with outcome of not recovered, and premenstrual symptoms like cramping and irritability were the worst they've ever been on 21Apr2021 at 08:00 with outcome of not recovered.  The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative on 31Mar2021. Treatment was not received for the events.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: period is extremely heavier than it's ever been, I have large blood clots; period is extremely heavier than it's ever been, I have large blood clots; cramping; irritability; premenstrual symptoms like cramping and irritability were the worst they've ever been; This is a spontaneous report from a contactable consumer, reporting for herself.   A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the right arm on 15Apr2021 (Batch/Lot Number: Er8729) as a single dose (at the age of 30 years old) for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, levonorgestrel (SEASONIQUE) taken for an unspecified indication, start and stop date were not reported; spironolactone taken for an unspecified indication, start and stop date were not reported; magnesium taken for an unspecified indication, start and stop date were not reported; polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported, and an unspecified multivitamin taken for an unspecified indication, start and stop date were not reported. Historical vaccine information included BNT162B2, dose 1 via an unspecified route of administration, administered in the right arm on 25Mar2021 at 12pm (Batch/Lot Number: Er8730) as a single dose (at the age of 29 years old) for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced period is extremely heavier than it's ever been, she has large blood clots on 21Apr2021 at 08:00 with outcome of not recovered, cramping on 21Apr2021 at 08:00 with outcome of not recovered, irritability on 21Apr2021 at 08:00 with outcome of not recovered, and premenstrual symptoms like cramping and irritability were the worst they've ever been on 21Apr2021 at 08:00 with outcome of not recovered.  The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative on 31Mar2021. Treatment was not received for the events.
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Eye pain
Clinical narrative: vision loss; eye pain; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. It was unknown if the patient was pregnant at the time of vaccination. Medical history included Factor V Leiden, PCOS (Polycystic ovarian syndrome), and POTS (Postural orthostatic tachycardia syndrome), all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was unknown if the patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced eye pain and then vision loss on 20Mar2021, 2 days after vaccination. It was unknown if the patient received treatment for the adverse event. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. It was unknown if the patient has not been tested for COVID-19 since the vaccination. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Stevens-Johnson Syndrome; This is a spontaneous report from a contactable consumer, reporting for herself.   A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 31Mar2021 at 14:45 (Batch/Lot Number: ER8737) as a single dose (at the age of 57 years old) for covid-19 immunisation.  Medical history included pain from an unknown date and unknown if ongoing, and stevens-johnson syndrome from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included hydrocodone bitartrate, paracetamol (NORCO) taken for an unspecified indication, start and stop date were not reported; valaciclovir hydrochloride taken for an unspecified indication, start and stop date were not reported; calcium taken for an unspecified indication, start and stop date were not reported, and multivitamin taken for an unspecified indication, start and stop date were not reported.  The patient previously took sofosbuvir and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced stevens-johnson syndrome on 14Apr2021 with outcome of recovered on an unspecified date in Apr2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Eye discharge, Head discomfort, Headache, Impaired gastric emptying
Clinical narrative: her head is stopped up; feels really weak; has "gook" in her eyes; cold; headache; sore throat; nausea; feeling sick for the last week; She can't do anything; gastroparesis; sore arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 30Mar2021 (Batch/Lot Number: ER8733; Expiration Date: Jul2021) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. She reported having only a sore arm after getting the vaccine (in 2021) however she has had to cancel the appointment (twice) for her second dose on 20Apr2021. She was feeling sick for the last week (Apr2021) as her head was stopped up, has gastroparesis, felt really weak, has "gook" in her eyes, a real bad cold, headache, sore throat, and nausea.  She can't do anything and has stayed in her bed. Outcome of the events were unknown. She doesn't think the first shot caused it because she didn't get sick until days later.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on 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 RAs, Ethics Committees, and Investigators, as appropriate.