chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Inappropriate schedule of product administration
Clinical narrative: Date of start of drug: 25Jan2021, Dose Number: 1; Date of start of drug: 18Mar2021, Dose Number: 2; Miscarriage; This is a spontaneous report from a contactable consumer (patient) reported herself. A 26-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 18Mar2021 01:00 PM (Batch/Lot Number: EN6203) as 2ND DOSE, SINGLE for covid-19 immunisation, at the age at vaccination date of 26 years old.  Patient was not pregnant. Medical history reported as no. The patient's concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. No known allergies. Historical vaccine included first dose of BNT162B2 (lot number: En6203) on  25Jan2021 01:00 PM at left arm.  The patient experienced miscarriage (medically significant) on 26Apr2021 with outcome of recovered, date of start of drug: 25jan2021, dose number: 1; date of start of drug: 18mar2021, dose number: 2 (non-serious) on an unspecified date with outcome of unknown. The event miscarriage resulted in Doctor or other healthcare professional office/clinic visit. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19/ Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts completed. No further information expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular vascular disorder, Pain in extremity
Clinical narrative: Red blood clot in left eye; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 12May2021 (lot number: EW0182; expiration date: 31Aug2021), as 1st dose, single dose, at age 25 years old, for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine taken for an unspecified indication, start and stop dates were not reported. On 12May2021, the patient had sore arm. On 13May2021, when the patient woke up, she had a red blood clot in her left eye. Treatment for sore arm included Tylenol. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood disorder, Thrombosis
Clinical narrative: I have a blood clot in hurry I have blood clots regularly; Blood is way too thick so he give triple dose; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on 01May2021 (batch/lot number and expiration date not reported) as UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated, "I received COVID 19 vaccination on 01May2021 at my Doctor's Office and yesterday (12May2021), I went to see my Oncologist. I am on blood thinners, its Coumadin. I get Warfarin which is you know (incomplete sentence, thus, not clarified and was not captured). Anyway, I take Coumadin, my blood is way too thick, so he gave triple dose and I went back today, and it is still bad, and I am taking another triple dose tonight and going back. What are the safety issues in getting Coumadin and getting that vaccination?" When probed for follow up, consumer stated, "Yes, it be great if they did. I need to find something we need to correct because I have a blood clot in hurry. I have blood clots regularly if I do not keep my blood thin." Patient stated, "Have you heard other people reporting this problem or was it the concern in the beginning or what can be done in other words?" Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Immobile, Tinnitus
Clinical narrative: tinnitus; immobile literally for  6 days; This is a spontaneous report from a contactable consumer (patient).   A 60-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 were not reported.  The patient experienced immobile literally for 6 days and ended up at the specialist and the ER, the consumer also asked if tinnitus was a side effect or an allergic reaction, patient received the first dose of Pfizer 5 weeks ago yesterday as of report, and stated that couldn't get the second shot for medical reasons patient was having. Outcome for events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Portal vein thrombosis
Clinical narrative: portal vein thrombosis; This is a spontaneous report received from a contactable physician. A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) as unknown single for covid-19 immunisation. Medical history included on hormone replacement therapy (HRT). No known allergies. The patient's concomitant medications were not reported. The patient experienced portal vein thrombosis (seriousness criteria: medically significant) on an unspecified date. The adverse event resulted in doctor or other healthcare professional office/clinic visit. AE treatment including lovenox. No covid prior vaccination. Unknown if covid tested post vaccination. The event outcome was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of portal vein thrombosis due to temporal relationship.  Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: 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 contactable consumer (patient) via a Pfizer-sponsored program, COVAX support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 12Feb2021 (lot number was not reported), as 2nd dose, single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the 2nd dose of COVID-19 vaccine on 12Feb2021 and tested positive for COVID on 09May2021 (reported as "this past Sunday"). Treatment included antibody infusion which the patient received on 11May2021. The outcome of the event was unknown.  Information related to batch/lot no. was requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: I am feeling a clot in my left  armpit after 1 day of having 2nd dose of COVID19 Pfizer; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 35-years, on 11May2021 18:00 (Lot Number: EW0179) as single dose for covid-19 immunization. The patient medical history was not reported. The patient was not pregnant at time of vaccination. Concomitant medications were none (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. Historical vaccine included the first dose of BNT162B2 on an unknown date for covid-19 immunization. The patient reported that she was feeling a clot in her left armpit at 08:00 on 13May2021 (reported as after 1 day of having 2nd dose of COVID19 Pfizer). The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Event outcome was not recovered.  No follow-up attempts needed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Mixed connective tissue disease
Clinical narrative: mixed connective tissue disease; This is a spontaneous report from a contactable Nurse (patient) reported for herself from a Pfizer sponsored program. A 71-years-old female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 (Batch/Lot Number: EM9810) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 71 years old.  Medical history included ongoing immune thrombocytopenia (ITP) diagnosed probably 10 or 15 years ago. The patient's concomitant medications were not reported. Historical vaccine included first dose of Pfizer Covid Vaccine on 18Jan2021 (LOT: EL3249) at left arm for covid-19 immunization. The patient experienced mixed connective tissue disease (medically significant) on 08Apr2021 with outcome of not recovered.  Therapeutic measures were taken as a result of mixed connective tissue disease. Reported patient recently diagnosed with mixed connective tissue disease on 08Apr2021, in the past month. She currently has been placed on prednisone and  Plaquenil and wanted to know if that will affect her vaccine. Caller stated she started medications this Month in May. She received both of the Pfizer vaccines in Jan and Feb of 2021.  Information about lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Mixed connective tissue disease  . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Epstein-Barr virus infection
Clinical narrative: I have Epstein Barr Virus and my symptoms flared after both shots. It was just 2 days of symptoms after the first shot, but 3 weeks of symptoms after the second shot.; I have Epstein Barr Virus and my symptoms flared after both shots. It was just 2 days of symptoms after the first shot, but 3 weeks of symptoms after the second shot.; This is a spontaneous report from a contactable consumer (patient).   A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Mar2021 12:00 PM, at age of 49 years old (Batch/Lot Number: Unknown) as 1st dose, single; dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 03:00 PM (at age of 50 years old), (Batch/Lot Number: Unknown) as 2nd dose single, for covid-19 immunisation.  The patient was not pregnant at time of vaccination. Medical history included Epstein Barr, allergies: Penicillin.  The patient's concomitant medications received within 2 weeks of vaccination: fluoxetine hydrochloride (PROZAC). Adverse event reported that: "I have Epstein Barr Virus and my symptoms flared after both shots. It was just 2 days of symptoms after the first shot, but 3 weeks of symptoms after the second shot." Adverse event start date was 20Mar2021 08:00 AM. No treatment received for adverse events. Outcome for events was unknown.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest; This is a spontaneous report from a contactable consumer (patients Son-in-Law). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. It was reported that week 1/2 after 1st vaccine the patient went into cardiac arrest. In hospital in (withheld). The outcome of the event was unknown.   Follow up needed, Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: light headedness/dizziness; This is a non-interventional study report from the marketing program received from a contactable consumer (patient). This consumer reported information received by Pfizer from Abbvie (manufacturer control number: 21K-163-3889347-00).  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), intramuscular on 17Feb2021 (at the age of 66-years-old) as 1st dose, single dose for COVID-19 immunisation; adalimumab (HUMIRA, Batch/Lot number was not reported), subcutaneous from Jan2019 and ongoing, at 40 mg, weekly for an unspecified indication. Medical history included recurrent difficulty in sleeping from 1971 and unknown if ongoing, joint pain from an unknown date and unknown if ongoing, elevated cholesterol level from 2005 and unknown if ongoing, rheumatoid arthritis from an unknown date and unknown if ongoing, tobacco user (One pack of cigarettes) from 1966 to 2016, alcohol use (one glass of wine a glass of bourbon) from 1972 and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)) and clopidogrel taken for cardiac disorder; metoprolol tartrate and lisinopril taken for hypertension; atorvastatin calcium taken for blood cholesterol; clobetasol taken for an unspecified indication; folic acid taken for supplementation therapy; ascorbic acid;chondroitin sulfate;glucosamine hydrochloride taken for chondropathy; ibuprofen taken for an unspecified indication; levothyroxine sodium taken for thyroid disorder; omeprazole taken for an unspecified indication; naproxen taken for anxiety; vitamin d3 taken for supplementation therapy; all start and stop dates were not reported. The patient experienced light headedness/dizziness on 17Feb2021. The action taken in response to the event for adalimumab was unknown. The outcome of the event was recovered on 19Feb2021.  The reporter's causality for the events of light headedness/dizziness with humira 40mg/0.4ml (Adalimumab) was no reasonable possibility.    No follow-up attempts are needed. No further information is expected.  The reporters assessment of the causal relationship of the event with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: Based on the temporal association, the event light headedness/dizziness is considered as related to the use of BNT162B2. 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: M
Vaccine: COVID19
Symptoms: Dysphagia, Pharyngitis streptococcal, Streptococcus test positive, Tonsillar hypertrophy
Clinical narrative: tonsils were swollen, enlarged/ tonsils were touching each other; couldn't swallow; did a strep test and it was positive; This is a spontaneous report from a contactable consumer (patient's mother) via Pfizer Sponsored Program. A 18-year old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route of administration on 09Apr2021 at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 10Apr2021 he was taken to urgent care because his tonsils were swollen, enlarged, he couldn't swallow and his tonsils were touching each other. In the urgent care a strep test was made and it was positive so they prescribed him amoxicillin and he finished the course of antibiotics and then on 04May2021 his tonsils were swollen again and he went to convenient care and he was prescribed azithromycin (ZITHROMYCIN) and methylprednisolone. He finished the course of those antibiotics and medications as well. The patient had not had any other symptoms such as a cough, fever, or tiredness. He is a healthy student athlete with no underlying conditions and no history of having tonsillitis or strep. The consumer stated that this issue has been going on for a month. The consumer stated: "I have not provided her any information that can help him and hopefully he doesn't die she will just have to figure it out." The outcome of the events was unknown.   Information about lot/batch number has been requested requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021550844 Same patient, different vaccine dose number and different event.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Drug ineffective, Suspected COVID-19
Clinical narrative: the patient had been experiencing cough hoarse throat and fever as high as 104.9 F/the patient thought he may have covid-19 disease; the patient had been experiencing cough hoarse throat and fever as high as 104.9 F/the patient thought he may have covid-19 disease; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date in Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that he received his first injection of the Pfizer COVID-19 vaccine about 3 weeks ago (in Apr2021). For the past 8 days (in May2021), the patient had been experiencing cough hoarse throat and fever as high as 104.9 F. The patient thought he may have covid-19 disease but he had not been tested. The patient asked that if he should cancel his second Pfizer covid-19 vaccine or not since he may have covid-19 infection. Events outcome was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, Ultrasound scan
Clinical narrative: she experienced pain in her right leg and had DVT; she experienced pain in her right leg and had DVT; This is a spontaneous report from a Pfizer sponsored program.. A 61-year-old contactable female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 05Apr2021 (at 61years old) (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The second dose is scheduled on 26Apr2021 (correct dosing schedule). Patient missed her second dose because she had 2 ultrasounds after her first dose. In addition, she experienced pain in her right leg and had DVT on unspecified dates. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Cerebral haemorrhage, Chills, Cognitive disorder, Dizziness
Clinical narrative: micro haemorrhaging in the brain; pneumonia/ fever/ difficulty breathing; dizzy; unable to walk without help; chills; standing asleep; incoherent unable to form sentences; incoherent unable to form sentences; did not know family; cognitive disabilities; This is a spontaneous report. A contactable consumer (patient's daughter) reported that female patient of unspecified age received dose 2 of BNT162B2, via an unspecified route of administration on 09Mar2021 as single dose for COVID-19 immunization. The patient previously took the dose 1 on an unspecified date. Medical history and concomitant medications were not reported. The patient received her 2nd dose of COVID vaccine on 09Mar2021. Immediately after 2nd dose (unknown date), dizzy and unable to walk without help 2-3 days after second dose chills, (4-5 days) standing asleep incoherent unable to form sentences. Admitted to hospital diagnosed micro haemorrhaging in the brain. Thursday fine, developed fever, as far as cognitive ability one week later relapsed after diagnosis fever. Friday night difficulty breathing, diagnosis pneumonia relapsed of cognitive disabilities. Went for brunch, did not know family. Clarified home but with home aide support. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Incoherent, Pneumonia, Somnolence, Speech disorder
Clinical narrative: micro haemorrhaging in the brain; pneumonia/ fever/ difficulty breathing; dizzy; unable to walk without help; chills; standing asleep; incoherent unable to form sentences; incoherent unable to form sentences; did not know family; cognitive disabilities; This is a spontaneous report. A contactable consumer (patient's daughter) reported that female patient of unspecified age received dose 2 of BNT162B2, via an unspecified route of administration on 09Mar2021 as single dose for COVID-19 immunization. The patient previously took the dose 1 on an unspecified date. Medical history and concomitant medications were not reported. The patient received her 2nd dose of COVID vaccine on 09Mar2021. Immediately after 2nd dose (unknown date), dizzy and unable to walk without help 2-3 days after second dose chills, (4-5 days) standing asleep incoherent unable to form sentences. Admitted to hospital diagnosed micro haemorrhaging in the brain. Thursday fine, developed fever, as far as cognitive ability one week later relapsed after diagnosis fever. Friday night difficulty breathing, diagnosis pneumonia relapsed of cognitive disabilities. Went for brunch, did not know family. Clarified home but with home aide support. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Rash
Clinical narrative: developed a rash; This is a spontaneous report from a contactable pharmacist (patient). A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 12Jan2021 (Batch/Lot Number: EJ1686) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 for covid-19 immunisation. The patient experienced rash after 6 days of vaccination on 18Jan2021 and kept coming back, even though it has responded to topical steroids, a few days later came back. The patient visited dermatologist and undergone biopsy of rash on an unknown date in 2021 and then consulted allergist who thought patient might be allergic to something because of the clinical symptom. The allergist highly suspected the rash to be caused by the vaccine, it should be out of patient system by now. The patient states that she has seen two dermatologist and an allergist, and they suspect her rash was from the Pfizer Covid Vaccine. The patient took topical steroids as a treatment for which the rash has responded but after a few days later came back. It was reported that the rash was for more than a few months. The outcome of the event rash was not resolved.  No follow-up attempts are needed. No further information expected.; Sender's Comments: Based on the information provided, A possible contributory role of the suspect product to the development of rash cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Back injury
Clinical narrative: Back injury; This is a spontaneous report from a consumer (patient) from a Pfizer-sponsored program . A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 22Jan2021 at 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient received both doses of the vaccine on 22Jan2021 for his first dose and his second dose on 19Feb2021 (4 weeks apart). He mentioned that he had a back injury in between the doses on an unspecified date in 2021, and he took anti-inflammatory and pain killers for 2 weeks. He stopped the medication 60 hours before taking the second dose. His main question was how these medications might affect the efficacy of the vaccine. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: her sister currently testing positive for COVID, despite getting the vaccine; her sister currently testing positive for COVID, despite getting the vaccine; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (sister) reported for a female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The patient experienced contracted covid after getting the first dose of vaccine 5 days prior. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Scheduled for 2nd dose of COVID Vaccine on 15May, but wanted to know if they should keep the appointment, with her sister currently testing positive for COVID, despite getting the vaccine. The reporter considered events as non-serious. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained .
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, SARS-CoV-2 test, Thrombosis
Clinical narrative: had a superficial blood clot in my left calf between the first and second vaccines; This is a spontaneous report from a contactable consumer (Patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 16:00 (Batch/Lot Number: ER8733) at the age of 51-years-old as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medication was none, patient did not received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a superficial blood clot in his left calf between the first and second vaccines on 16Apr2021. Event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the event included had a shot of enoxaparin sodium (LOVENOX) and am taking rivaroxaban (XARELTO). The patient underwent lab tests and procedures which included blood test: negative on 06May2021, Nasal swab covid-19 test: negative on 27Apr2021. The outcome of the event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Haemorrhage
Clinical narrative: blood running down from his shoulder to his biceps; left a dark bruise for 2 weeks afterwards; This is a spontaneous report received from a non-contactable consumer (patient). A 6-decade-old male patient (in his 50s) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient was getting his 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine, he saw blood running down from his shoulder to his biceps. He said that the vaccination provider wiped it out, and put pressure on it. It stopped bleeding, but left a dark bruise for 2 weeks afterwards. Since there was blood, he wanted to know if it was possible that the vaccine was injected into a blood vessel. He also wanted to know if there was a possibility that he did not receive enough dose, and the vaccine may not be as effective as it should be. He wanted to know if there was a standard procedure for when he suspects that he did not get a full dose. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Fatigue, Headache
Clinical narrative: Headache; Coughing; Fatigue/Tiredness; she doesn't have energy; Bacterial globules in her lungs; Tested positive for COVID; This is a spontaneous report from a contactable consumer reporting on behalf of the patient via a Pfizer sponsored program. A 47-year-old female patient (sister) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 24Apr2021 (at the age of 47 years old) (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included obesity (most likely 200 lbs) and hives. Concomitant medication included unspecified steroids for hives problem. The reporter stated that her sister got her first Pfizer COVID vaccine on 24Apr2021 and about days later, her sister tested positive for COVID on 30Apr2021 and schedule the get the second dose on 15May2021 this month and wanted to know if the patient should get it. The patient still has tiredness and she doesn't have energy to make a call. The reporter did not know if her sister has taken Tylenol or anything. The reporter know that the patient had headache, bacterial globules in her lungs, fatigue, and coughing.  The patient had lab test at her hospital where she works, she had one when tested negative and when she had second one tested positive on 30Apr2021. The patient had not yet recovered from fatigue/tiredness and she doesn't have energy, while outcome of the remaining events was unknown.   Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lower respiratory tract infection bacterial, SARS-CoV-2 test
Clinical narrative: Headache; Coughing; Fatigue/Tiredness; she doesn't have energy; Bacterial globules in her lungs; Tested positive for COVID; This is a spontaneous report from a contactable consumer reporting on behalf of the patient via a Pfizer sponsored program. A 47-year-old female patient (sister) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 24Apr2021 (at the age of 47 years old) (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included obesity (most likely 200 lbs) and hives. Concomitant medication included unspecified steroids for hives problem. The reporter stated that her sister got her first Pfizer COVID vaccine on 24Apr2021 and about days later, her sister tested positive for COVID on 30Apr2021 and schedule the get the second dose on 15May2021 this month and wanted to know if the patient should get it. The patient still has tiredness and she doesn't have energy to make a call. The reporter did not know if her sister has taken Tylenol or anything. The reporter know that the patient had headache, bacterial globules in her lungs, fatigue, and coughing.  The patient had lab test at her hospital where she works, she had one when tested negative and when she had second one tested positive on 30Apr2021. The patient had not yet recovered from fatigue/tiredness and she doesn't have energy, while outcome of the remaining events was unknown.   Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Disturbance in attention, Dysarthria, Gait disturbance, Paraesthesia
Clinical narrative: Right side of body tingling and heaviness; Right side of body tingling and heaviness; slurred speech; difficulty walking; difficulty concentrating; urinary incontinence; This is a spontaneous report from a contactable other health professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiration date not provided), via intramuscular, in right arm, on 05Feb2021 10:30 (at the age of 40-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included known allergies, and hypertension. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication was reported as "no". Patient did not receive other medications within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283 and expiration date not provided), via intramuscular, in right arm, on 15Jan2021 14:00  (at the age of 40-year-old), at single dose, for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Feb2021, the patient experienced right side of body tingling and heaviness, slurred speech, difficulty walking, difficulty concentrating, urinary incontinence. Patient was hospitalized for 2 days. Events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures after the vaccination, which included COVID-19 test (Nasal Swab) was negative on 12May2021. No treatment received for events. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the events of right side of body tingling and heaviness, slurred speech, difficulty walking, difficulty concentrating, urinary incontinence cannot be excluded completely. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to  Committees and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urinary incontinence
Clinical narrative: Right side of body tingling and heaviness; Right side of body tingling and heaviness; slurred speech; difficulty walking; difficulty concentrating; urinary incontinence; This is a spontaneous report from a contactable other health professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiration date not provided), via intramuscular, in right arm, on 05Feb2021 10:30 (at the age of 40-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included known allergies, and hypertension. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication was reported as "no". Patient did not receive other medications within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283 and expiration date not provided), via intramuscular, in right arm, on 15Jan2021 14:00  (at the age of 40-year-old), at single dose, for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Feb2021, the patient experienced right side of body tingling and heaviness, slurred speech, difficulty walking, difficulty concentrating, urinary incontinence. Patient was hospitalized for 2 days. Events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures after the vaccination, which included COVID-19 test (Nasal Swab) was negative on 12May2021. No treatment received for events. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the events of right side of body tingling and heaviness, slurred speech, difficulty walking, difficulty concentrating, urinary incontinence cannot be excluded completely. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to  Committees and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Coordination abnormal, Fall, Feeling abnormal
Clinical narrative: passing out/sort of out of body-ish awareness; Patient had never had a seizure, but it felt more like that than a faint; Felt heavy in upper arms/chest; Felt heavy in upper arms/chest; feeling uncoordinated walking through house; felt out of body; felt pain in knees/pain in right knee; joints seizing/cracking really hard; abrasions on both of knees; Moderate damage to L mcl; Must have fallen; stinging spot in the back of head; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0171) via an unspecified route of administration, administered in arm left on 01May2021 09:00 (at the age of 57-year-old) as single dose for COVID-19 immunization. Medical history included leukemia from 1998, breast cancer from 2001. No Known allergies. Concomitant medications were not reported. The patient previously received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0164) on 10Apr2021 08:00 AM (at the age of 56-year-old) in left arm for Covid-19 immunization, then experienced adrenal disorder and epinephrine increased. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Patient woke up Tues, 04May2021 08:00 AM. Felt heavy in upper arms/chest. Started feeling uncoordinated walking through house. Didn't remember actually passing out but felt out of body and felt pain in knees, and joints seizing/cracking really hard. sort of aware something was happening, but sort of out of body-ish awareness. Came back to awareness. abrasions on both of knees, moderate damage to L mcl. pain in right knee. must have fallen but no awareness of that - came to laying on back. Patient had never had a seizure, but it felt more like that than a faint. Also noticed a stinging spot in the back of head that seemed to travel up the back of skull for several days. Treatment was not received for the adverse event. Reporter assessed events were non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event "passing out/sort of out of body-ish awareness" was recovered in May2021, of other events was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Joint noise, Ligament injury, Limb discomfort, Loss of consciousness
Clinical narrative: passing out/sort of out of body-ish awareness; Patient had never had a seizure, but it felt more like that than a faint; Felt heavy in upper arms/chest; Felt heavy in upper arms/chest; feeling uncoordinated walking through house; felt out of body; felt pain in knees/pain in right knee; joints seizing/cracking really hard; abrasions on both of knees; Moderate damage to L mcl; Must have fallen; stinging spot in the back of head; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0171) via an unspecified route of administration, administered in arm left on 01May2021 09:00 (at the age of 57-year-old) as single dose for COVID-19 immunization. Medical history included leukemia from 1998, breast cancer from 2001. No Known allergies. Concomitant medications were not reported. The patient previously received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0164) on 10Apr2021 08:00 AM (at the age of 56-year-old) in left arm for Covid-19 immunization, then experienced adrenal disorder and epinephrine increased. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Patient woke up Tues, 04May2021 08:00 AM. Felt heavy in upper arms/chest. Started feeling uncoordinated walking through house. Didn't remember actually passing out but felt out of body and felt pain in knees, and joints seizing/cracking really hard. sort of aware something was happening, but sort of out of body-ish awareness. Came back to awareness. abrasions on both of knees, moderate damage to L mcl. pain in right knee. must have fallen but no awareness of that - came to laying on back. Patient had never had a seizure, but it felt more like that than a faint. Also noticed a stinging spot in the back of head that seemed to travel up the back of skull for several days. Treatment was not received for the adverse event. Reporter assessed events were non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event "passing out/sort of out of body-ish awareness" was recovered in May2021, of other events was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Skin abrasion
Clinical narrative: passing out/sort of out of body-ish awareness; Patient had never had a seizure, but it felt more like that than a faint; Felt heavy in upper arms/chest; Felt heavy in upper arms/chest; feeling uncoordinated walking through house; felt out of body; felt pain in knees/pain in right knee; joints seizing/cracking really hard; abrasions on both of knees; Moderate damage to L mcl; Must have fallen; stinging spot in the back of head; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0171) via an unspecified route of administration, administered in arm left on 01May2021 09:00 (at the age of 57-year-old) as single dose for COVID-19 immunization. Medical history included leukemia from 1998, breast cancer from 2001. No Known allergies. Concomitant medications were not reported. The patient previously received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0164) on 10Apr2021 08:00 AM (at the age of 56-year-old) in left arm for Covid-19 immunization, then experienced adrenal disorder and epinephrine increased. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Patient woke up Tues, 04May2021 08:00 AM. Felt heavy in upper arms/chest. Started feeling uncoordinated walking through house. Didn't remember actually passing out but felt out of body and felt pain in knees, and joints seizing/cracking really hard. sort of aware something was happening, but sort of out of body-ish awareness. Came back to awareness. abrasions on both of knees, moderate damage to L mcl. pain in right knee. must have fallen but no awareness of that - came to laying on back. Patient had never had a seizure, but it felt more like that than a faint. Also noticed a stinging spot in the back of head that seemed to travel up the back of skull for several days. Treatment was not received for the adverse event. Reporter assessed events were non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event "passing out/sort of out of body-ish awareness" was recovered in May2021, of other events was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Loss of consciousness, Nausea, Palpitations, Presyncope
Clinical narrative: Passed out if upright for too long; Nausea; Severe abdominal pains; Racing heart; Feeling like I was going to pass out; This is a spontaneous report from a contactable Other HCP (patient). A 39-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left, on 07May2021 16:00 (at the age of 39-year-old, not pregnant at time of vaccination) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included migraine, hypothyroidism. Concomitant medications included escitalopram oxalate (LEXAPRO); imipramine; levothyroxine; meloxicam.  The patient received them within 2 weeks of vaccination. The patient previously took topiramate (TOPAMAX), rizatriptan benzoate (MAXALT), flu vaccine, nitrofluorontin, neomycin, and had known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07May2021 16:15 (as reported), the patient experienced nausea, severe abdominal pains, racing heart and feeling like she was going to pass out when upright in the first 24hours post shot. Passed out if upright for too long. Racing heart would calm down after laying back down. No treatment received for all events. Events outcome was recovered in May2021.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of loss of consciousness and other. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate