chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Hypersomnia, Hypertension, Paraesthesia
Clinical narrative: heart murmur has gotten worse (echogram done and it got worse); heart murmur has gotten worse (echogram done and it got worse); I could feel it in my stomach right away but that went away; chills; anxiety attack; One day I slept all day; One day of the prickly feeling but that went away; High blood pressure; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 97-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient could feel it in her stomach right away but that went away. She had chills, anxiety attack during the night. One day, she slept all day. One day of the prickly feeling but that went away. High blood pressure, heart murmur has gotten worse (echogram done and it got worse). How strong was the 2nd shot, is it the same or different and what was the efficacy of one dose. She wanted to know should she get the 2nd one. The seriousness of the events was reported as non-serious. The patient underwent lab tests and procedures which included echogram: heart murmur has gotten worse on an unknown date. The outcome of high blood pressure, one day I slept all day, anxiety attack, chills was unknown; heart murmur has gotten worse (echogram done and it got worse) was not resolved and I could feel it in my stomach right away but that went away, one day of the prickly feeling but that went away was resolved on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Blood test, Eosinophil count decreased, Neutrophil count decreased, White blood cell count increased
Clinical narrative: Slight increase the white cell; The neutrophils 0.5 below 70 mark; Eosinophils 7 to 8 tenths below 0-5 percentage; His cholesterol increased; This is a spontaneous report from Pfizer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient took historical Vaccine BNT162B2 Dose 1 COVID-19 immunization. On 30Mar2021 Caller mentions that he got the 2 doses of the Pfizer covid vaccine. He received the second dose like a month and a half ago and today he had the results of his latest bloodwork and he noted a slight increase the white cell: the neutrophils 0.5 below 70 mark and the eosinophils 7 to 8 tenths below 0-5 percentage. He wants to know if this could be caused by the vaccine.  He mentioned also that his cholesterol increased. Caller wanted to know if the vaccine could increase his cholesterol. The patient underwent lab tests and procedures which included blood test: slight increase the white cell   on 2021 Slight increases the white cell: the neutrophils 0.5 below 70 mark and the eosinophils 7 to 8 tenths below 0-5 percentage, Cholesterol increased. Outcome of events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Provider heart failure and COPD as medical condition; red marks but does not state that these are hives; red marks but does not state that these are hives; itching in various parts of my body; This is a spontaneous report from a contactable consumer (patient himself). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Lot Number: ER8733), via an unspecified route of administration, administered in left deltoid (left shoulder) on 28Mar2021 (age at vaccination: 78 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing heart failure, ongoing chronic obstructive pulmonary disease, cardiac pacemaker insertion, stated he has been diagnosed about 4 to 5 years ago. He says heart failure and COPD as medical condition and that's the worst of it. On 30Mar2021, itching in various parts of body; on an unknown date, red marks but does not state that these are hives. The reporter would like to know if this is possibly a side effect of the vaccine. He was unsure if he needs to see his family doctor about this. He states that on Monday he was fine, but today it started to itch. He doesn't know if it is a reaction to the shot. He also mentioned it doesn't itch where he got the shot, and that area doesn't bother him. It was itching on other parts of his body. The reporter states that he had concomitant medication prior to two weeks before the symptom started, but states it has it is not relevant to this report. The outcome of prutitis was not recovered and outcome of all the other events were unknown. There was no product quality complaint (PQC) present.   Follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Panic reaction, Product administered at inappropriate site
Clinical narrative: I just don't know if this from the vaccine or if they hit a nerve; She is in a bit of a panic; I have had some numbness, more like how it feels when it your blood pressure taken and thing pumps up around your arm and the rest of the arm feels numb.; This is a spontaneous report from a contactable consumer (patient herself). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, in left arm on an unspecified date (age at vaccination: 61-years) as dose 1, single for covid-19 immunisation. Patient had her second dose of vaccination today (unspecified date). Patients medical history and concomitant medications were not reported. On 10Mar2021, she had some numbness, more like how it feels when it your blood pressure taken and thing pumps up around your arm and the rest of the arm feels numb. She thought the numbness had to do with where they injected the vaccine, maybe they hit a nerve. It was a strange numbness where the injection was, the numbness went down near her wrist. It felt like a strange pulsing type of thing. Like how they pumped up her arm, and the cuff got tighter. It was a little different than numbing feeling. She clarified that the numbness started from her injection site to her wrist, and it had been the same momentary thing all together. It was stronger up by her injection site. She did not put it down, she did not do the little whatever on the scan. She has had a symptom and thought it would go away by now. She was wondering. She was due to receive her second dose of the covid vaccine today. She was wondering if she should get her second dose of the covid vaccine in her other arm. She had a little bit of time to complete a report with safety. She had to leave soon. She did not have her patient record card with her at that time. While on the call, she was trying to send an email out to other teachers. She went to send it to 38 other teachers and it did not save. Now she had to start all the way over. She was in a bit of a panic on an unspecified date. She really just wanted to know if she should get the second dose of the covid vaccine in the same arm. If this is a reaction of the vaccine, she does not want to get the second dose of the covid vaccine in her other arm, and then have both arms tingling. The outcome of event for numbness of upper extremities was not recovered and for panic reaction it was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Feeling abnormal, Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: She states that's weird; left foot went numb/ leg, arm, and half of face felt numb/ leg, arm, and half of face felt numb; feeling dizzy; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 28-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 11Mar2021 15:00 (at the age of 28-years-old) as dose1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Mar2021 15:15, Immediately after receiving the first dose of vaccine, the patient experienced left foot went numb/ leg, arm, and half of face felt numb/ leg, arm, and half of face felt numb. It was reported that her left foot went numb, then her leg, arm, and half of face felt numb. She felt a bit dizzy immediately after the vaccine. She stated that was weird. The clinical details of the events as follows: Immediately after receiving the first dose she started feeling numb in first her left foot, while also feeling dizzy. when she left the facility, she clearly also felt numb in her left leg, then her left arm. At that point she walked back to the facility, they checked her blood-pressure which looked normal. Later, the same day she felt the numbness in the left side of her face as well. The numbness was gone the next day (12Mar2021) and coming back for shorter times for few times Within the week after. She stated that she felt numb in half of her body after the vaccine. She stated that was not on the list of side effects. Her doctor was unsure whether she can receive the second dose or not and suggested her to call Pfizer. The patient wanted to know if this was a severe reaction or not and she can receive the second dose or wait. She asked has Pfizer seen anyone else have that reaction. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. On 23Mar2021, post vaccination, the patient underwent COVID-19 PCR test (nasal swab) which was Negative. The patient outcome of the events was resolved on an unspecified date in 2021, while the outcome of the event Weird feeling was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Decreased appetite, Fatigue, Hypoaesthesia oral, Pain
Clinical narrative: numbness in her lip; lack of appetite; fatigued; body pain; canker sores; had a fever yesterday of 100.2; This is a spontaneous report in response to mail trail sent regarding confirmation of the first Pfizer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. Medical history included, patient has fibromyalgia and arthritis and the pain was bad. Concomitant medication was not reported. It was mentioned that, to report an adverse side effect that was told to me by a family member that received the 2nd dose of the COVID-19 vaccination. Patient (My aunt) received the 2nd dose, last week. Talked to patient on the phone last night and patient told that after received the vaccine, for approximately 2-3 days, the patient experienced numbness in lip, lack of appetite, fatigued, body pain, canker sores. On 31Mar2021 it was reported that, patient had a fever yesterday of 100.2 and patient was 1 week post second dose. The outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: numbness in her lip; lack of appetite; fatigued; body pain; canker sores; had a fever yesterday of 100.2; This is a spontaneous report in response to mail trail sent regarding confirmation of the first Pfizer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. Medical history included, patient has fibromyalgia and arthritis and the pain was bad. Concomitant medication was not reported. It was mentioned that, to report an adverse side effect that was told to me by a family member that received the 2nd dose of the COVID-19 vaccination. Patient (My aunt) received the 2nd dose, last week. Talked to patient on the phone last night and patient told that after received the vaccine, for approximately 2-3 days, the patient experienced numbness in lip, lack of appetite, fatigued, body pain, canker sores. On 31Mar2021 it was reported that, patient had a fever yesterday of 100.2 and patient was 1 week post second dose. The outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Right side of right leg was numb, it is no longer numb; Toes began to tingle, feeling in my toes is back; This is a spontaneous report from a contactable consumer (patient himself). A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number e206; Expiration Date: 17Mar2021) via an unspecified route of administration on 09Mar2021 (at age of 71-year-old) as single dose for COVID-19 immunization. Medical history included fungal skin infection, hypoaesthesia and head injury from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced right side of right leg was numb, it is no longer numb and toes began to tingle, feeling in my toes is back. It was reported that, patient had a very exciting and wonderful news. On 09Mar2021, he had received first injection, on 24Mar2021, he had a very radical changes in body. He had a toe fungus that he have been living with for 15 years. His toes were numb for the last 10 years, could not feel them. Last on the 24th in the middle of the night his toes began to tingle and woke him up. The feeling in his toes was back. Many years ago when he was in his 30's he had a head injury so my right side of right leg was numb, it was no longer numb. Patient's diet has not changed, nothing has changed except the COVID vaccine. All he knew it that since the injection the absolute numbness of my toes was almost gone, he can feel the movement of toes and on the right side of my right leg the numbness was gone. For him it was a whole lot. Till now patient did not received second shot of vaccine. The patient did not receive any treatment for adverse event. Outcome of both the events was recovered on 24Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Elevated heart rate, it is slightly elevated like adding them is overall hundred but it would be in the low, in the mid 90s; Heart rate is increased like in 90 like 91, 92, 93 like that mid to low 90s; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer Covid-19 vaccine, Solution for injection, Batch/Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration on an unspecified date as Dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced elevated heart rate, it is slightly elevated like adding them is overall hundred but it would be in the low, in the mid 90s; heart rate is increased like in 90 like 91, 92, 93 like that mid to low 90s on an unspecified date. When asked about the concern, consumer stated, the heart rate is increased like in 90 like 91, 92, 93 like that mid to low 90s. Patient just wanted to know is that something that other people have reported. Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department and provided with the number and website link as (website withheld). Further probing couldn't be done because consumer was unwilling to further answer any questions. Reason of delay was spike of incoming calls due to COVID19 vaccine. The patient underwent lab tests and procedures which included heart rate: elevated heart rate. I felt like elevated heart rate, it is slightly elevated like adding them is overall hundred but it would be in the low, in the mid 90s, which is usually not resting. This is usually not for me, it went up to like 90 and my heart rate is usually in the high 70s and 80s."The heart rate is increased like in 90 like 91, 92, 93 like that mid to low 90s. The patient received treatment reported as unknown. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Capillary fragility
Clinical narrative: Broken capillaries on the underside of left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 (Batch/Lot Number: ER2613 expiry date was not reported) via intramuscular route of administration at arm left on 23Mar2021 09:00 (at the age of 30-years-old) as a single dose for covid-19 immunisation. The patients medical history included thyroid cancer from an unknown date, thyroidectomy was done in 2016 on an unspecified date and Thyroid was removed, other relevant medical history including but not limited to these conditions: diagnosed allergies(Unspecified), compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Thyroid cancer in 2016. Concomitant medications included levothyroxine dosage text - 100mcg daily taken for hormone replacement therapy from 2016 to an unspecified stop date. She wanted to know if she was having a normal side effect. On 25-MAR-2021 21:00 the patient experienced broken capillaries on the underside of her left arm. It was not at injection site, but on the underside. There was maybe a dozen of broken capillaries in spots like a tiger stripe. The patient did not had any other vaccinations within four weeks prior to this. The outcome of events was recovering.    No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Hypoaesthesia, Hypoaesthesia eye, Hypoaesthesia oral, Paraesthesia
Clinical narrative: my face my whole right side, face is numbing and I am in so much pain; my face my whole right side, face is numbing and I am in so much pain; the numbness is going up my feet, up my eye, up my forehead, up my lips, the middle of my head, it's numbness and tingling; the numbness is going up my feet, up my eye, up my forehead, up my lips, the middle of my head, it's numbness and tingling; the numbness is going up my feet, up my eye, up my forehead, up my lips, the middle of my head, it's numbness and tingling; the numbness is going up my feet, up my eye, up my forehead, up my lips, the middle of my head, it's numbness and tingling; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 45-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 45-years-old) for COVID-19 immunization. Patient medical history was not reported. Patient received concomitant medications. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient stated that she had a severe reaction to the Pfizer vaccine the first one and it was very severe and worsened and they advised her to take the second one and she had the reference number and she took the second one and her face, her whole right side, face was numbing and she was in so much pain. She further stated that, it was getting worse the numbness was going up her feet, up her eye, up her forehead, up her lips, the middle of her head, it was numbness and tingling. The patient also stated that her weight was 205, something like that so she needed to know if that was side effect do people feel that. The patient underwent lab tests and procedures which included weight as weight was 205 (unit: unknown) on an unspecified date. The patient stated that she took Advil, Tylenol and Benadryl as treatment. The outcome of the events my face my whole right side, face is numbing and was in so much pain and the numbness is going up my feet, up my eye, up my forehead, up my lips, the middle of my head, it's numbness and tingling was unknown while that of the other events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: my face my whole right side, face is numbing and I am in so much pain; my face my whole right side, face is numbing and I am in so much pain; the numbness is going up my feet, up my eye, up my forehead, up my lips, the middle of my head, it's numbness and tingling; the numbness is going up my feet, up my eye, up my forehead, up my lips, the middle of my head, it's numbness and tingling; the numbness is going up my feet, up my eye, up my forehead, up my lips, the middle of my head, it's numbness and tingling; the numbness is going up my feet, up my eye, up my forehead, up my lips, the middle of my head, it's numbness and tingling; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 45-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 45-years-old) for COVID-19 immunization. Patient medical history was not reported. Patient received concomitant medications. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient stated that she had a severe reaction to the Pfizer vaccine the first one and it was very severe and worsened and they advised her to take the second one and she had the reference number and she took the second one and her face, her whole right side, face was numbing and she was in so much pain. She further stated that, it was getting worse the numbness was going up her feet, up her eye, up her forehead, up her lips, the middle of her head, it was numbness and tingling. The patient also stated that her weight was 205, something like that so she needed to know if that was side effect do people feel that. The patient underwent lab tests and procedures which included weight as weight was 205 (unit: unknown) on an unspecified date. The patient stated that she took Advil, Tylenol and Benadryl as treatment. The outcome of the events my face my whole right side, face is numbing and was in so much pain and the numbness is going up my feet, up my eye, up my forehead, up my lips, the middle of my head, it's numbness and tingling was unknown while that of the other events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: I had numbness on left side of my cheek; This is a spontaneous report from a contactable Nurse. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date caller reports that she "received the COVID shot at 5pm and within an hour after leaving "she had numbness on left side of her cheek". She reports that her left cheek feels like it would if Novocain was injected into it. She reports having taken Tylenol in the morning and plans to see her doctor but was advised to call and report this symptom. Outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased
Clinical narrative: numbness on the right side of my face; My SED rate is elevated; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had her both Pfizer vaccine. On an unspecified date, the patient was experiencing numbness on the right side of her face. The first numbness was about an hour after the injection and again on holiday. She asked what she need to know or tell her doctor. On an unspecified date, her sedimentation rate (SED) rate was elevated. They have ruled out a stroke and she see a neurologist on 4/13. The outcome of the events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: her knee cap was numb; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 31Mar2021 as dose 1 single (at the age of 58-year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller stated her grandma received the first dose of the Pfizer COVID vaccine today. Patient had side effects to include her knee cap was numb on 31Mar2021. Caller would like to know if she can use ibuprofen on it. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Maternal exposure during pregnancy, Rash pruritic
Clinical narrative: Pregnant at the time of vaccination?: Yes; dermatitis rash on back of left shoulder; dispersed itchy rash in multiple locations (face, hands, and torso); This is a spontaneous report from a contactable consumer (Patient). A 34-year-old pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: ENG199 and Expiration date was not reported), via an unspecified route of administration in right arm on 09Mar2021 at 18:00 (at the age of 34-year-old ) as dose 1, single for Covid-19 Immunisation. The patient medical history was not reported. The patient had allergies to medications, food, or other products: Augmentin, Telfa bandages. The patient received concomitant medications within 2 weeks of vaccination included prenatal vitamins, probiotics, Colace. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021, the patient had experienced dermatitis rash on back of left shoulder, not directly at the vaccine site, followed by dispersed itchy rash in multiple locations (face, hands, and torso). Gestation period when reaction or event was observed in the fetus/unit: 28 weeks. Patient last menstrual period date on 22Aug2020. Pregnancy Due Date or delivery date on 29May2021. Adverse events resulted in doctor or other healthcare professional office or clinic visit. The patient received treatment which included antihistamines, steroid cream, oral steroids. The outcome of events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Maternal exposure during pregnancy, Somnolence, Vaccination site bruising, Vaccination site pain
Clinical narrative: Four days later was exhausted; napped all day.; Bruise at the sight for a few days; arm sore at injection site; Maternal exposure during pregnancy (6 months); This is a spontaneous report received from a contactable consumer (patient). A 30-year-old pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 04:15 PM (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient did not have any allergies to food products, medications and others. The patient last menstrual date reported as 13Sep2020 and delivery date was reported as 20Jun2021. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021, the patient experienced with bruise at the sight for a few days, arm sore at injection site for a day or two and four days later was exhausted and napped all day. On 24Mar2021, the patient received first dose of vaccine (Maternal exposure during second trimester-6 months). The patient did not visit physician office and other healthcare professional clinic. The patient received treatment for events was unknown. On an unspecified date in Mar2021, the clinical outcome of the event bruise at the sight, arm sore at injection site, exhausted and napped all day were recovered. The clinical outcome of the event maternal exposure during second trimester-6 months was unknown.   Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia
Clinical narrative: upper lips is slightly swollen and tingly just a lit bit; upper lips is slightly swollen and tingly just a lit bit; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot: number: unknown) via an unspecified route of administration in arm left on 31Mar2021 12:00 PM (Age at vaccination was 56 Years and patient was not pregnant at the time of vaccination) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vitamins C and D and multi vitamin are the list of other medications the patient received within 2 weeks of vaccination. No allergies to medications, food, or other products. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot: number: unknown) via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 Immunisation. Consumer Stated, I got the Pfizer Covid vaccine yesterday my second one. The first one I just had the sore arm and the only questions I have was today it's been 24 hours since my second one and my upper lips is slightly swollen and tingly just a lit bit on 01Apr2021. I was wondering if I can take Benadryl, was it okay to take Benadryl. The outcome of the events was unknown.   No follow-up attempts were needed. Information about lot/batch number could not be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Flushing, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: throat constriction; heart racing; feeling flushed; buzzing sensation in body; tremors; GI distress daily; Weight loss; right arm pain; This is a spontaneous report from a contactable Nurse. A 59-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL9262) via an unspecified route of administration, administered in Arm Right on 03Feb2021, SINGLE (at the age of 59-years-old) for COVID-19 immunisation. The patient's medical history included Hashimoto disease, allergic rhinitis and vitamin d deficiency. The patient's concomitant medications included fexofenadine hydrochloride (ALLEGRA); famotidine; thyroid (ARMOUR THYROID); mesalazine (LIALDA); valaciclovir hydrochloride (VALTREX S) all taken for unspecified start date for unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL3248) via an unspecified route of administration, administered in left Arm on 12Jan2021 at 05:30 PM for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. It was reported that,on 03Feb2021 at 05:45 pm, within 10 min of second injection patient had throat constriction, heart racing and feeling flushed. Patient experienced buzzing sensation in body and tremors, GI distress daily, and occasional heart racing at times, weight loss and felt like on edge of allergic reaction all the time. It was reported that, right arm pain continued since shot. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 26Feb2021 and weight: loss on 03Feb2021. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Throat tightness, Tremor, Weight, Weight decreased
Clinical narrative: throat constriction; heart racing; feeling flushed; buzzing sensation in body; tremors; GI distress daily; Weight loss; right arm pain; This is a spontaneous report from a contactable Nurse. A 59-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL9262) via an unspecified route of administration, administered in Arm Right on 03Feb2021, SINGLE (at the age of 59-years-old) for COVID-19 immunisation. The patient's medical history included Hashimoto disease, allergic rhinitis and vitamin d deficiency. The patient's concomitant medications included fexofenadine hydrochloride (ALLEGRA); famotidine; thyroid (ARMOUR THYROID); mesalazine (LIALDA); valaciclovir hydrochloride (VALTREX S) all taken for unspecified start date for unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL3248) via an unspecified route of administration, administered in left Arm on 12Jan2021 at 05:30 PM for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. It was reported that,on 03Feb2021 at 05:45 pm, within 10 min of second injection patient had throat constriction, heart racing and feeling flushed. Patient experienced buzzing sensation in body and tremors, GI distress daily, and occasional heart racing at times, weight loss and felt like on edge of allergic reaction all the time. It was reported that, right arm pain continued since shot. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 26Feb2021 and weight: loss on 03Feb2021. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dizziness, Fall, Fatigue
Clinical narrative: on the 2nd day;he had a little cold; On the 1st day, he felt Chest pain; passed out; feeling like I'm going to faint; stuffy nose; feel hot; Tachycardia; I felt like I was going to fade/last night he was feeling dizziness; hit my head on the wall and my back, it felt like I went into a black hole. I don't know for how long I was on the ground; nausea; He is experiencing blurry vision; headache; cough; Fatigue; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,  Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on 21Mar2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. He got the vaccine, the first Pfizer Covid vaccine he took on 21Mar2021 and at the moment he had to wait 15-20 minutes in that department. From there, he returned to his house and when he came home he began to feel hot, tachycardia, stuffy nose, he felt like he was going to fade, a lot of nausea, then he passed out and hit his head on the wall and his back, it felt like he went into a black hole. He did not know for how long he was on the ground, he then tried to get on the bed again. On the 1st day, he also felt chest pain and on the 2nd day, he had a little cold. He had cough, fatigue, nausea and blurry vision on unspecified date. They called medical facility, he went to a specialized doctor, he had me under observation for 2 days. Patient asked about the Pfizer's policy/recommendation regarding whether he should get the second shot or not. His second dose was scheduled for 13Apr2021. He continued with headaches and tachycardias, less frequent, as well as feeling like he was going to faint when he got up. Therapeutic measures were taken as a result of event "last night he was feeling dizziness". The outcome of headache, tachycardia and presyncope was not recovered and outcome of other events was unknown.  No follow up attempts are needed. No further information is expected.  Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Loss of consciousness, Nasal congestion, Nasopharyngitis
Clinical narrative: on the 2nd day;he had a little cold; On the 1st day, he felt Chest pain; passed out; feeling like I'm going to faint; stuffy nose; feel hot; Tachycardia; I felt like I was going to fade/last night he was feeling dizziness; hit my head on the wall and my back, it felt like I went into a black hole. I don't know for how long I was on the ground; nausea; He is experiencing blurry vision; headache; cough; Fatigue; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,  Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on 21Mar2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. He got the vaccine, the first Pfizer Covid vaccine he took on 21Mar2021 and at the moment he had to wait 15-20 minutes in that department. From there, he returned to his house and when he came home he began to feel hot, tachycardia, stuffy nose, he felt like he was going to fade, a lot of nausea, then he passed out and hit his head on the wall and his back, it felt like he went into a black hole. He did not know for how long he was on the ground, he then tried to get on the bed again. On the 1st day, he also felt chest pain and on the 2nd day, he had a little cold. He had cough, fatigue, nausea and blurry vision on unspecified date. They called medical facility, he went to a specialized doctor, he had me under observation for 2 days. Patient asked about the Pfizer's policy/recommendation regarding whether he should get the second shot or not. His second dose was scheduled for 13Apr2021. He continued with headaches and tachycardias, less frequent, as well as feeling like he was going to faint when he got up. Therapeutic measures were taken as a result of event "last night he was feeling dizziness". The outcome of headache, tachycardia and presyncope was not recovered and outcome of other events was unknown.  No follow up attempts are needed. No further information is expected.  Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Presyncope, Tachycardia, Vision blurred
Clinical narrative: on the 2nd day;he had a little cold; On the 1st day, he felt Chest pain; passed out; feeling like I'm going to faint; stuffy nose; feel hot; Tachycardia; I felt like I was going to fade/last night he was feeling dizziness; hit my head on the wall and my back, it felt like I went into a black hole. I don't know for how long I was on the ground; nausea; He is experiencing blurry vision; headache; cough; Fatigue; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,  Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on 21Mar2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. He got the vaccine, the first Pfizer Covid vaccine he took on 21Mar2021 and at the moment he had to wait 15-20 minutes in that department. From there, he returned to his house and when he came home he began to feel hot, tachycardia, stuffy nose, he felt like he was going to fade, a lot of nausea, then he passed out and hit his head on the wall and his back, it felt like he went into a black hole. He did not know for how long he was on the ground, he then tried to get on the bed again. On the 1st day, he also felt chest pain and on the 2nd day, he had a little cold. He had cough, fatigue, nausea and blurry vision on unspecified date. They called medical facility, he went to a specialized doctor, he had me under observation for 2 days. Patient asked about the Pfizer's policy/recommendation regarding whether he should get the second shot or not. His second dose was scheduled for 13Apr2021. He continued with headaches and tachycardias, less frequent, as well as feeling like he was going to faint when he got up. Therapeutic measures were taken as a result of event "last night he was feeling dizziness". The outcome of headache, tachycardia and presyncope was not recovered and outcome of other events was unknown.  No follow up attempts are needed. No further information is expected.  Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Paraesthesia
Clinical narrative: she felt the vaccine go down the arm and had numbness and tingling in hands in the  hand and fingers; she felt the vaccine go down the arm and had numbness and tingling in hands in the  hand and fingers; she felt the vaccine go down the arm and had numbness and tingling in hands in the  hand and fingers; hand turned red; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection,Batch/Lot Number: ER8730), via an unspecified route of administration, administered in right arm on 30Mar2021 11:00 (at age of 37-year-old) as dose 1, single for covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No previous immunization with the Pfizer vaccine considered as suspect.She had a small reaction with the Whooping Cough vaccine once, She does not have any vaccine information since its been years and years ago. No additional vaccines administered on same date of the pfizer suspect.On 30Mar2021, immediately after receiving vaccine the patient experienced to feel the vaccine go down the arm and had numbness and tingling in hands in the hand and fingers and patient hand turned red. The patient received Benadryl as a treatment for the events.She wants to know if it is a normal reaction and should she get a second one or not because she had the reaction and she was worried about getting COVID with my asthma.The patient did not visit to emergency room. The outcome of the events was recovered on 30Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: hand on her opposite arm/pins and needles sensation/numbness; Tingling in her hand up to her forearm; This is a spontaneous report from a contactable consumer (patient). A 37-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8730), via an unspecified route of administration left arm on 01Apr2021 at 13:15 (at the age of 37-years) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Family medical history relevant to AE was reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced about 45 minutes after getting the vaccine, the hand on her opposite arm (right arm, she got injected on the left arm) experienced a pins and needles sensation, with accommodating numbness and tingling in her hand that went up to her forearm. It began only a few hours ago. It was in her hand and sometimes goes up a little bit. Patient stated that it's not awful, she was still able to do things. Otherwise she takes no medications. Patient did not visit to Emergency Room or Physician Office. She mentioned that it was not bad but enough to be noticeable. It had gone up to her forearm. She mentioned that it had been hours later that it was still not gone but it was not as bad. The outcome of the events was tingling in her hand up to her forearm was not resolved and other event was unknown.  No follow-up attempts are possible. No further information is expected.