chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Hypersensitivity
Clinical narrative: His eyes were swollen. He couldn't even go outside.; After he got vaccine, his seasonal allergies were acting up; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A 74-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04May2021 as 2nd dose single for COVID-19 immunization. Historical vaccine of BNT162B2 was given as a first dose 3 weeks before the 2nd dose. Medical history included ongoing seasonal allergy from an unspecified date. Patient has seasonal allergies and he was advised by his doctor to wait for 3 months before taking Depo-Medrol/corticosteroids. He got swollen eyes and serious allergies because he cannot take any steroid shots - Asking for medication to take for treatment of his allergies - Patient is very frustrated and provided limited information only, he does not want to make any safety report  Potential Duplicate AE Report E transmit. The patient's concomitant medications were not reported. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized (except for participants in Phase 1 see exclusion criterion 14), intra-articular, intra bursal, or topical (skin or eyes) corticosteroids are permitted. On an unspecified date patient experienced his eyes were swollen, he couldn't even go outside and after he got vaccine, his seasonal allergies were acting up. After he got vaccine, his seasonal allergies were acting up. He went to his doctor to get Depo-Medrol. They did not administer Depo-Medrol due to COVID vaccine. He was told he needed to wait 3 months. His eyes were swollen. He couldn't even go outside. Caller wants to know if there is anything else he can take. Caller said he usually gets his allergy shot in April or May. It was delayed since he got the COVID shot. After that cleared up, he was able to get his first shot, and after that cleared up, he was able to get his second shot. After that he went to the doctor, who was not aware, and because it's a steroid, he couldn't do it. He could not get Depo-Medrol because it was a steroid. Also stated that his allergies were so bad that he wanted to rip his eyes out of his head. The outcome of the events was unknown.  Follow-up(21May2021): This is a Follow-up spontaneous report from a Pfizer sponsored program COVAX US Support. No new significant information was provided.    Warm transferred caller to Pfizer, Caller not provided with phone number or hours prior to transfer, in the event of disconnection, due to caller getting frustrated and saying goodbye.  Information about Lot/Batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood count, Computerised tomogram, Headache
Clinical narrative: First dose: headaches; This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, ( Batch/Lot Number: EW0150), via an unspecified route of administration in Arm Left on 06Apr2021 15:00 as 1st dose, single dose and received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection,( lot# EW0172, NDC/Expiry not known) via unspecified route of administration in the left arm on 27Apr2021 as 2nd dose, single dose for COVID-19 immunisation. Medical history included ongoing migraine verbatim: migraines. Concomitant medications included tylenol, excedrin, sumatriptan, reyvow taken for an unspecified indication, start and stop date were not reported. The patient experienced after first dose headaches on unspecified date Apr2021. The event was assessed as non-serious. Therapeutic measures were taken as a result of first dose: headaches.The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room visit. On 19May2021 the patient underwent lab tests and procedures which included blood count: unknown and computerized tomogram: negative. The patient received the second Covid 19 vaccine on 27Apr2021 and she started getting headaches probably the next day on 28Apr2021 and the headaches just keep going on. They are pretty much staying the same. They are pretty much staying the same. The headaches do get better with medication. She's fine in the morning but by lunchtime she has a full blown headache. She says it's positional. When asked to clarify she reports it gets better when she's laying down but she's also taking medication so she doesn't know if the laying down is helping or the medication is helping. Her headaches are very cyclical. She does report a history of migraines. She was diagnosed around this time last year in 2020. She had had migraines undiagnosed prior. She reports her migraines are well controlled. She was in contact with her neurologist on 05May2021 or 06May2021. She was seen by her neurologist on 10May2021, 11May2021, and 17May2021. Her neurologist instructed her to go to the emergency room yesterday, on 19May2021. She had a CT scan of her head done yesterday and blood work. At her neurologists office she had an injection in her skull. She doesn't know the name of the medication used. She was given a cocktail of generic Toradol, Benadryl, and Zofran. The outcome of the event was recovered.  Follow up (20May2021): This is a follow up spontaneous report from a contactable consumer. This 59 year-old female consumer (patient) reported that: Pfizer Suspect Vaccine and Vaccination Details ( Dates for first and second dose), Medical history and Concomitant medication, Clinical information added.
Sex: F
Vaccine: COVID19
Symptoms: Leukaemia
Clinical narrative: Leukemia developed after second shot; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route on unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. It was unknown if the patient was diagnosed with COVID-19 since the vaccination. The patient previously took 1st COVID-19 vaccine shot and got lymph nodes swelled. On unspecified date, the patient experienced leukemia after second shot. The outcome of the event was unknown.  follow-up attempts are possible. further information is expected
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: lower back pain for last 2 weeks since taking vaccine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 06May2021 at 14:00 (Lot Number: er8736) as single dose for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy and barretts esophagus. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Known allergies was none. Concomitant medication was reported as: The patient received the list of any other medications within 2 weeks of vaccination. On 11May2021, the patient experienced lower back pain for last 2 weeks since taking vaccine. The patient aware of no other activity or event that would be a cause. No treatment received. The outcome of event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Flank pain, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: bilateral subsegmental PTEs; right flank pain under ribs; This is a spontaneous report received from a contactable HCP.  A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0153), via an unknown route, on 30Apr2021 (at the age of 64-year-old) at single dose for COVID-19 immunisation, administered at Pharmacy/drug store. The patient was not diagnosed with COVID-19 before vaccination. Relevant medical history included hypertension (HTN), gout and osteochondritis dissecans (OCD). No relevant concomitant medications were provided. The patient did not have allergies. No other vaccine was received in four weeks. The patient presented to the emergency room (ER) with right flank pain under ribs. Found to have bilateral subsegmental pulmonary thromboembolisms (PTEs). The onset date of the events was provided as 20May2021. Both events were reported serious because requiring hospitalization for 3 days (admission date not provided) and as life-threatening conditions. The patient was treated with enoxaparin then apixaban. Nasal swab was done on 21May2021 and resulted negative. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0172) on 21May2021 for COVID-19 immunisation. The patient was treated with enoxaparin then apixaban. The patient was recovering from the events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of all reported events cannot be totally 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.
Sex: U
Vaccine: COVID19
Symptoms: Blindness, Ocular ischaemic syndrome, Visual impairment, Vitreous floaters
Clinical narrative: Ocular ischemia that the blood flow into my eyes; Told me I am going to go blind; I could wake up blind or gradually go blind, that I was going to lose my sight; Black spots and a bunch of floaters; Black spots and a bunch of floaters; This is a spontaneous report from a contactable consumer or other non hcp.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID  19 mRNA VACCINE; formulation: Solution for injection), dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported. It was reported that patient just want to ask about some side effects from having the vaccine. He/she had the first Vaccine on 02Apr2021 and that was the Friday and the following Friday patient had to scramble for an emergency eye appointment. He/she woke up with some black spots and a bunch of floaters and by the time everything was done they told he/she had ocular ischemia that the blood flow into my eyes, it was kind of (incomplete sentence). He/she did not had the comorbid for the diagnosis, people who have that usually have high cholesterol or uncontrollable sugar and things like that but patient did not. And he/she was wondering if this was something that Pfizer has seen because basically they told him/her that he/she going to go blind. By the time patient got out successfully and everything they told him/her that he/she had ocular ischemia. And he/she did not have the comorbidity for the disease process. And frankly patient had been a little scared to take the second one because they told he/she could wake up blind or gradually go blind, that he/she was going to lose his/her sight and that was a huge change in life here. He/she did not know if it has occurred in other patients as well or had vaccinated or not. It was also reported that patient was supposed to be on the same day when he/she saw that specialist about his/her eye which was the 20th of, the 23rd and he kept him/her all day long, he/she am not kidding he kept him/her in his office from 8:45 till 16:30, he/she was all day long he was running test after test on me. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Hallucination, Illness, Movement disorder, Pain
Clinical narrative: hallucinations; very sick; unable to move/unable to get out of bed; pain throughout my entire body; Vomiting; swelling; lost of appetite for 2 days; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0182), at the age of 36 years old, in left arm on 20May2021 10:15 at single dose for covid-19 immunisation. The patient medical history was none. The patient had no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (lot number: EW0170), at the age of 36 years old, in left arm on 29Apr2021 10:15 at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient became very sick, unable to move, unable to get out of bed, incredible pain throughout his entire body, vomiting, swelling, hallucinations and lost of appetite for 2 days on 20May2021 23:00. The patient had not been tested for covid-19 since the vaccination. The treatment for events was unknown. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Vomiting
Clinical narrative: hallucinations; very sick; unable to move/unable to get out of bed; pain throughout my entire body; Vomiting; swelling; lost of appetite for 2 days; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0182), at the age of 36 years old, in left arm on 20May2021 10:15 at single dose for covid-19 immunisation. The patient medical history was none. The patient had no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (lot number: EW0170), at the age of 36 years old, in left arm on 29Apr2021 10:15 at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient became very sick, unable to move, unable to get out of bed, incredible pain throughout his entire body, vomiting, swelling, hallucinations and lost of appetite for 2 days on 20May2021 23:00. The patient had not been tested for covid-19 since the vaccination. The treatment for events was unknown. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got COVID, he tested for COVID; He has (COVID) but he has no symptoms; Got COVID, he tested for COVID; He has (COVID) but he has no symptoms; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that, got COVID, he tested for COVID; he has (COVID) but he has no symptoms (as reported) on an unknown date. The patient underwent lab tests and procedures which included COVID-19 test resulted positive on an unknown date. The reporter questioned about the working manner of vaccine. The reporter wanted to know the composition of vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received first dose, then tested positive for covid, wants to know if getting second dose is appropriate. The outcome of the events was unknown.  No follow-up attempts are possible; no further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Leg swollen; Foot swelling; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in Arm Right on 18May2021 (Batch/Lot Number: ER8736, Expiry Date: 31Aug2021) as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. NDC and UPC number of vaccines is unknown. On 20May2021 patient experienced leg swollen- peripheral swelling, foot swelling 2 days after taking shot. The outcome of the events was unknown. The outcome of events unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Asked if he could take medicine for his headache; This is a spontaneous report from a Pfizer- sponsored program Covax US Support. A non-contactable male consumer (patient) of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 20May2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Medical questions addressed by this program were not forwarded/referred to medical information. The patient was asked if he could take medicine for his headache. The patient was received the 1st dose of Pfizer COVID-19 vaccine a few hours ago (20May2021). Customer and/or medical inquiry was not forwarded or referred to MI. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site pain
Clinical narrative: soreness in arm of injection; headache; nausea; This is a spontaneous report from a contactable consumer. This 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 14May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unknown date, the patient experienced soreness in arm of injection and a headache. The patient stated last week, and past 2 days complains of nausea and was wondering if she was still would be having this. Outcome of the events was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Symptomatic of Sars-COV-2; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 12Apr2021 (age at vaccination 62-year-old) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that she received first dose 12Apr2021 and 11 days later became symptomatic of Sars-COV-2 on 23Apr2021. She was tested on 27Apr2021. She was asking for recommendation on receiving second dose. The patient underwent lab tests and procedures which included sars-cov-2 test showed unknown results on 27Apr2021. The outcome of event was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: He experienced a burst blood vessel in his eye 3 day later; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported for himself.  A male patient of an unspecified age received bnt162b2 (BNT162B2 solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation  .  The patient medical history and concomitant medications was not reported. It was reported that on an unspecified date the patient had a burst blood vessel in his eye 3 day later after administration of vaccine. Outcome of the event was unknown.  Information about lot/batch number was not available. Further information expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 25Apr2021 at 12:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation, administered at the pharmacy or drug store. Medical history included diagnosed with COVID-19 prior to vaccination. Historical vaccine included first dose of bnt162b2 in the left arm for covid-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient developed shingles the day after the second dose (26Apr2021 at 12:00). The patient received treatment for the event which included anti-viral medication. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome of the event was not recovered.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site reaction
Clinical narrative: chills; fever; injection site reaction; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Not reported), via an unspecified route of administration on an unspecified date, as first dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date of 2021, the patient experienced chills, fever and injection site reaction, but chills well after second dose which was on 28Apr2021. The outcome was recovered for chills on an unspecified date of 2021 and unknown for rest of the events.  Information about Lot/Batch number has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, SARS-CoV-2 test
Clinical narrative: Myocarditis; This is a spontaneous report from a contactable pharmacist. A 15-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW1077), at the age of 15 years old, intramuscularly on 17May2021 at single dose for covid-19 immunisation. The patient medical history was reported as none. The patient had no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient experienced myocarditis on 21May2021. The event resulted in hospitalization for 2 days. The patient was currently still in hospital. The patient had been tested for covid-19 since the vaccination. The patient underwent lab tests and procedures, which included covid-19 test: negative on 22May2021 by nasal swab. Therapeutic measures were taken as a result of myocarditis and included treatment with analgesic. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment. 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: arm numbness and tingling; arm numbness and tingling; This is a spontaneous report from a contactable other hcp. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EP6955), via intramuscular, administered in Deltoid Left on 26Mar2021 15:09 as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing iron deficiency anaemia Prior to Jun2020 and burning sensation from Oct2020 to an unknown date. The patient's concomitant medications were not reported. Patient did not take other vaccine prior to COVID-19 vaccination. After 1st Covid-19 vaccine on 26Mar2021, she developed numbness and tingling down her entire let arm which resolved within about 48 hours. The events were reported as serious (important medical event). No treatment was received for events. The outcome of the event was reported as recovered in Mar2021.  No follow-up attempts are needed. No further information is expected; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of numbness and tingling cannot be excluded.But also consider medical history of burning sensation and iron deficiency anaemia.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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pyrexia, Vomiting
Clinical narrative: stomach bug; fever; vomiting; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported for herself.  A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Concomitant medication included tofacitinib citrate (XELJANZ XR), oral from an unspecified date at 11 mg, daily for Rheumatoid arthritis. The patient's concomitant medications were not reported. Patient was still taking xeljanx XR but missed the doses due to covid vaccine and after vaccine patient had a "stomach bug" which included fever and vomiting. The outcome of the events was resolved. PT also reports a general side effects of Xeljanz of fatigue.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: My white blood count went down when I got my Covid shot; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration, on 11Jun2019 (as reported), at the age of 66 year old, as unknown dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included palbociclib (IBRANCE). It was reported that the patient's white blood count went down when she got her COVID shot. The outcome of the event was unknown.   Information about batch/ lot number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Moderate pain in her arm; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. An 80-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 24May2021 (at the age of 80-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant mediations were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. It was reported that, caller, female, aged 80, received her second dose of the Pfizer BioNTech Covid 19 vaccine yesterday on 24May2021. She was now (on an unspecified date in May2021) having moderate pain in her arm and was wondering how long it might last. The event was considered as non-serious by the consumer. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Burning sensation, Computerised tomogram, Electrocardiogram
Clinical narrative: Numbness from the knees down, numbness from the elbows down; burning sensation in his joints; burning and tingling sensation in his face; burning and tingling sensation in his face; exhaustion; really bad headache; This is a spontaneous report from a contactable 36-year-old male consumer reported for himself. A 36-years-old male patient received bnt162b2 (BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown, via unspecified route, on 13May2021 (at 36-years age) as 1 st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. In May2021 the patient had experienced numbness from the knees down, numbness from the elbows down, burning sensation in his joints, burning and tingling sensation in his face. All these effects come and goes. He also experienced exhaustion and a really bad headache 1 night. He had already gone to the ER twice. The patient underwent lab tests and procedures which included several blood test, CAT Scan (computerized tomogram), EKG(Electrocardiogram) which all came back normal, and he was perfectly fine. He had consulted with his neurologist and orthopedic doctors and both had no findings for him. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness from the knees down, numbness from the elbows down; burning sensation in his joints; burning and tingling sensation in his face; burning and tingling sensation in his face; exhaustion; really bad headache; This is a spontaneous report from a contactable 36-year-old male consumer reported for himself. A 36-years-old male patient received bnt162b2 (BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown, via unspecified route, on 13May2021 (at 36-years age) as 1 st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. In May2021 the patient had experienced numbness from the knees down, numbness from the elbows down, burning sensation in his joints, burning and tingling sensation in his face. All these effects come and goes. He also experienced exhaustion and a really bad headache 1 night. He had already gone to the ER twice. The patient underwent lab tests and procedures which included several blood test, CAT Scan (computerized tomogram), EKG(Electrocardiogram) which all came back normal, and he was perfectly fine. He had consulted with his neurologist and orthopedic doctors and both had no findings for him. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over his body including his eyes/rash all over his body including his eyes/still there on his toes; This is a spontaneous report from a contactable consumer (mother) via medical team. A 13-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: not reported) dose 1 via unspecified route of administration on 13May2021 as a single dose for COVID-19 immunisation (age at vaccination was 13 years). Caller was asking for guidance regarding getting the second vaccine dose after having a side effect following the first dose. She reports that her son received his first vaccine dose on 13May2021 and 4 days later on 17May2021 he began having a rash all over his body including his eyes. She reports that the rash lasted for about 6 days and is still there on his toes. She reports concern about what he may experience after getting the second dose, which is scheduled for 03Jun2021, and asks for guidance on if it will be safe for him to get it or not. Patient had a side effect after the first dose of the vaccine. Should get the second dose? Caller talking about her 13-year-old son, asking how much protection will my son get or what is the efficacy following 1 dose of the Pfizer covid vaccine? The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: have swelling of the heart muscle after getting vaccinated.; This is a spontaneous report from a contactable consumer.   A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient experienced swelling of the heart muscle after getting vaccinated. The clinical outcome of swelling of the heart muscle after getting vaccinated was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.      Amendment: This follow-up report is being submitted to amend previously report: patient initials updated.   Follow-up attempts are completed; information about lot number cannot be obtained.          Follow-up (25May2021): This is a follow-up report to notify that the case 2021475747 and case 2021600303 are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 2021600303.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Paraesthesia
Clinical narrative: chest pain; Tingling in right hand; tingling left hand and leg; This is a spontaneous report from a contactable physician. A 18-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number was not reported) via an unspecified route of administration on 03May2021 as first dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, in May2021, the patient experienced chest pain, tingling in right hand; tingling left hand and leg. Patient went to emergency room and underwent lab tests and procedures which included electrocardiogram: normal. Symptoms resolved within 24-36 hours. Outcome of the events was recovered on an unknown date.   Provider wants to know if okay to administer 2nd dose, He can administer second dose which is due 31May2021.  Information about lot/batch number has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphocyte count, Lymphocyte count increased
Clinical narrative: lymphocyte is elevated; This is a spontaneous report from a contactable consumer (Patient). An 85-year-old male patient received second dose of BNT162B2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Historical Vaccination included Patient already received first dose of BNT162B2 for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced elevated lymphocyte levels after the second dose of the vaccination. The patient stated that the vaccine activates the B cells, so he didn't know if that has something to do with it. The patient also stated he had no information on elevated lymphocyte levels after vaccination and referred to HCP. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: chills; fever; very tired; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient had the first dose of the Pfizer covid 19 vaccine the last Friday in December. Patient reported that she had a bad reaction reporting chills, fever and very tired on unspecified date. The outcome of events was unknown.  Information on the lot/batch number has been requested
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she was diagnosed with Covid; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 27Apr2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, on 07May2021, she was diagnosed with COVID and the pharmacist told her to wait 90 days to get her second dose. Her second dose was scheduled for 19May2021. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Haemorrhage, Headache
Clinical narrative: red blood bleeding; gastrointestinal upset; diarrhea; chills; headache; This is a spontaneous report from a contactable consumer(patient). A 79-year-old female patient received first dose of bnt162b2(BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date (at the age of 79-years-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that, after the first dose of the vaccine she had side effects that included red blood bleeding during the 3-4 days that she had gastrointestinal upset, diarrhea, chills, and headache. The patient stated, the bleeding stopped, and she was doing better now but she was just upset and concerned with the bleeding. She did not know if she should receive the second dose. She would like to know should she receive the second dose after having this side effect. The Pfizer team responded as the patient should not get the Pfizer-BioNTech COVID-19 Vaccine if patient had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. The Pfizer team referred patient to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The outcome of the events red blood bleeding was recovering, and the outcome of the events gastrointestinal upset, diarrhea, chills, and headache was unknown. Information on the lot/batch number has been requested.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Blackouts; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Batch/Lot number: Unknown, Expiration date: Unknown), via an unspecified route on an unknown date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced blackouts. Patient wanted to know if event has been reported as side-effect. It was unknown if the patient received any treatment for the events. The clinical outcome of blackouts was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Thrombosis
Clinical narrative: I didn't know if this could be a blood clot forming as result of the vaccination or this just regard could still be a blood clot.; I have too swelling in my lower left leg just below the knee; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0162; NDC / UPC number of COVID Vaccine: Unknown; Expiration Date: 31Jul2021), via an unspecified route of administration on 20Apr2021 as 2nd dose, single for covid-19 immunisation. Medical history included blood clot and stated as I do have blood clot in my past case history. My mother died at blood clot to the heart. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Lot Number: ER8734; Expiration date: 31Jul2021) for COVID-19 immunisation. On 24May2021, the patient experienced i didn't know if this could be a blood clot forming as result of the vaccination or this just regard could still be a blood clot and i have too swelling in my lower left leg just below the knee. Additional Context was received as, I was calling in regard to my vaccination did I had. The first shot I had on 30Mar2021 and then the second one was on 20Apr2021. Further patient stated, that's what I am really not sure about I am not sure of this, if this is a COVID related vaccine issue or not. I have swelling too in my lower left leg just below the knee. I noticed this first time yesterday and notice this again today few minutes ago looking better and I didn't know if this could be a blood clot forming as result of the vaccination or this just regard could still be a blood clot and I wasn't sure if there was any relation to the vaccine. Patient stated, I am going to try to see my doctor tomorrow, helps to get into see him tomorrow. Like I said I am trying to see my doctor tomorrow. I am trying to see him hopefully he will able to help me. I have concerned about the swelling because I do have blood clot in my past case history. My mother died at blood clot to the heart I had in never and stroke and that is why I concerned. So that's why I go to the doctor tomorrow. Outcome of the events was recovering.  Further probing could not be done as consumer was not willing to complete the report. Hence limited information available over the call.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal distension, Diarrhoea, Eructation, Ultrasound abdomen normal
Clinical narrative: bloating; burping; a little diarrhea; Ethylene Glycol is an ingredient and it is Miralax.; This is a spontaneous report from a contactable physician. 2 female patients, both are about 50 years old. This case is for the first female patient out of two. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration was not reported) via unspecified route of administration on 25Apr2021 as 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration was not reported) via unspecified route of administration as 1st dose, single dose for COVID-19 immunization. It was reported that both patient received their 2nd Pfizer vaccine dose on 25Apr2021. Since their 2nd dose both have been experiencing bloating, burping and a little diarrhea for over a month now. They have no pain, and their abdominal ultrasound was normal. HCP stated if that continued, will do a CT scan in a couple weeks, but really thought it was related to the vaccine. Ethylene Glycol was an ingredient, and it was Miralax. So, all made sense. The lab test and procedure which included abdominal ultrasound was normal on unspecified date. The outcome of the events was not recovered and outcome of the event reaction to excipient was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021607602 same reporter/drug/AE with different patient
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Nausea
Clinical narrative: experience excruciating stomach pain that feels like a knot. He says it radiates to his back; experience excruciating stomach pain that feels like a knot. He says it radiates to his back; "a little bit" of nausea; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration on 22May2021, as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 22May2021, that evening patient experienced excruciating stomach pain that feels like a knot, it radiated to his back and had a little bit of nausea. Asking that this was normal. The outcome of the events was unknown.  Information on the lot/batch number has been requested.