chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (nurse). The reporter is the patient.  A 68-year-old female patient received bnt162b2 (bnt162b2), as dose 1, single (batch/lot number: unknown), as dose 2, single (batch/lot number: unknown) and in sep2021 as dose 3 (booster), single (batch/lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: pain in extremity (non-serious), outcome "unknown", described as "sore arm".  Additional information: caller declines to make a report. She doesn't want to get anyone in trouble. Reporter details: caller states she was an lpn 40-year-ago. Caller states she trusts the product and will take vaccines every week so long as she can get on an airplane. States she had dose 1, 2, and 3 and she had a sore arm and came home after the 1st one and it was 90 minutes of go lay down a minute and nothing extreme.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Extreme pain and swelling in left arm for a week after each dose.; Extreme pain and swelling in left arm for a week after each dose.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6205), in left arm and on 01Apr2021 as dose 2, single (Lot number: EN6205) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 2021, outcome "not recovered" and all described as "Extreme pain and swelling in left arm for a week after each dose.". The events "extreme pain and swelling in left arm for a week after each dose." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling.  Additional Information: No other vaccine in four weeks. Multi vitamins medications was in two weeks. No COVID prior vaccination. Prior to vaccination, the patient has not diagnosed with COVID. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Hyperhidrosis, Inflammation
Clinical narrative: serious rash with inflammation; serious rash with inflammation; very itchy to the point skin is burning; very itchy to the point skin is burning; started out with headache; chills; sweats; fever; blisters on lip; swelling in knuckles and hands; swelling in knuckles and hands; rash on extremity; neck shoulders legs feat quite red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for Covid-19 immunization. The following information was reported: RASH (non-serious), INFLAMMATION (non-serious), outcome "unknown" and all described as "serious rash with inflammation"; PRURITUS (non-serious), SKIN BURNING SENSATION (non-serious), outcome "unknown" and all described as "very itchy to the point skin is burning"; HEADACHE (non-serious), outcome "unknown", described as "started out with headache"; CHILLS (non-serious), outcome "unknown"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweats"; PYREXIA (non-serious), outcome "unknown", described as "fever"; LIP BLISTER (non-serious), outcome "unknown", described as "blisters on lip"; PERIPHERAL SWELLING (non-serious), JOINT SWELLING (non-serious), outcome "unknown" and all described as "swelling in knuckles and hands"; RASH (non-serious), outcome "unknown", described as "rash on extremity"; ERYTHEMA (non-serious), outcome "unknown", described as "neck shoulders legs feat quite red". Therapeutic measures were taken as a result of rash, inflammation, pruritus, skin burning sensation.  Additional Information: Forwarded as an Adverse Event by the medical team on 12Apr2022. Reporter provided verification of contact address on 11Apr2022. Customer Verbatim: Did second booster now for a week Have a serious rash with inflammation on prednisone, five day regimen very itchy to the point skin is burning did take antihistamine also I Tve used several lotions snd sprays bactracine, hydacortizone 10 ,silver sulphinate cream tricilotion ointment started out with headache then chills sweats fever blisters on lip then swelling in knuckles and hands rash on extremity Ts neck shoulders legs feat quite red and nothing is helping can you advise symptoms if docume,  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Joint swelling, Lip blister, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: serious rash with inflammation; serious rash with inflammation; very itchy to the point skin is burning; very itchy to the point skin is burning; started out with headache; chills; sweats; fever; blisters on lip; swelling in knuckles and hands; swelling in knuckles and hands; rash on extremity; neck shoulders legs feat quite red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for Covid-19 immunization. The following information was reported: RASH (non-serious), INFLAMMATION (non-serious), outcome "unknown" and all described as "serious rash with inflammation"; PRURITUS (non-serious), SKIN BURNING SENSATION (non-serious), outcome "unknown" and all described as "very itchy to the point skin is burning"; HEADACHE (non-serious), outcome "unknown", described as "started out with headache"; CHILLS (non-serious), outcome "unknown"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweats"; PYREXIA (non-serious), outcome "unknown", described as "fever"; LIP BLISTER (non-serious), outcome "unknown", described as "blisters on lip"; PERIPHERAL SWELLING (non-serious), JOINT SWELLING (non-serious), outcome "unknown" and all described as "swelling in knuckles and hands"; RASH (non-serious), outcome "unknown", described as "rash on extremity"; ERYTHEMA (non-serious), outcome "unknown", described as "neck shoulders legs feat quite red". Therapeutic measures were taken as a result of rash, inflammation, pruritus, skin burning sensation.  Additional Information: Forwarded as an Adverse Event by the medical team on 12Apr2022. Reporter provided verification of contact address on 11Apr2022. Customer Verbatim: Did second booster now for a week Have a serious rash with inflammation on prednisone, five day regimen very itchy to the point skin is burning did take antihistamine also I Tve used several lotions snd sprays bactracine, hydacortizone 10 ,silver sulphinate cream tricilotion ointment started out with headache then chills sweats fever blisters on lip then swelling in knuckles and hands rash on extremity Ts neck shoulders legs feat quite red and nothing is helping can you advise symptoms if docume,  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Skin burning sensation
Clinical narrative: serious rash with inflammation; serious rash with inflammation; very itchy to the point skin is burning; very itchy to the point skin is burning; started out with headache; chills; sweats; fever; blisters on lip; swelling in knuckles and hands; swelling in knuckles and hands; rash on extremity; neck shoulders legs feat quite red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for Covid-19 immunization. The following information was reported: RASH (non-serious), INFLAMMATION (non-serious), outcome "unknown" and all described as "serious rash with inflammation"; PRURITUS (non-serious), SKIN BURNING SENSATION (non-serious), outcome "unknown" and all described as "very itchy to the point skin is burning"; HEADACHE (non-serious), outcome "unknown", described as "started out with headache"; CHILLS (non-serious), outcome "unknown"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweats"; PYREXIA (non-serious), outcome "unknown", described as "fever"; LIP BLISTER (non-serious), outcome "unknown", described as "blisters on lip"; PERIPHERAL SWELLING (non-serious), JOINT SWELLING (non-serious), outcome "unknown" and all described as "swelling in knuckles and hands"; RASH (non-serious), outcome "unknown", described as "rash on extremity"; ERYTHEMA (non-serious), outcome "unknown", described as "neck shoulders legs feat quite red". Therapeutic measures were taken as a result of rash, inflammation, pruritus, skin burning sensation.  Additional Information: Forwarded as an Adverse Event by the medical team on 12Apr2022. Reporter provided verification of contact address on 11Apr2022. Customer Verbatim: Did second booster now for a week Have a serious rash with inflammation on prednisone, five day regimen very itchy to the point skin is burning did take antihistamine also I Tve used several lotions snd sprays bactracine, hydacortizone 10 ,silver sulphinate cream tricilotion ointment started out with headache then chills sweats fever blisters on lip then swelling in knuckles and hands rash on extremity Ts neck shoulders legs feat quite red and nothing is helping can you advise symptoms if docume,  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Peripheral swelling
Clinical narrative: soreness, swelling in the same arm right below the injection site; soreness, swelling in the same arm right below the injection site; He reported having chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 3, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "soreness, swelling in the same arm right below the injection site"; CHILLS (non-serious), outcome "unknown", described as "He reported having chills".  Additional information: Consumer stated, "I got a question about the Pfizer booster shot (clarified as Pfizer Covid-19 vaccine) number 2. I took the booster shot number 2 which would be my 4th vaccination, I took it at Saturday which would have been the 9th this year.IHe reported having chills, soreness at injection site and swelling underneath the left armpit right below where the hair is in the underarm. He mentioned he read a possible side effect is swelling at the injection site, and wants to know if swelling under the armpit in the same arm the injection was administered has been reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (12Apr2022): This is a Follow-up spontaneous report from a Contactable consumer. Updated information included: New reporter info added, New events added. Patient's age was captured.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations, Weight, Weight increased
Clinical narrative: My heart is pounding out of my chest; I gained 20 pounds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "My heart is pounding out of my chest"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "I gained 20 pounds". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Customer reported that his/her heart was pounding out of chest and he/she gained 20 pounds since vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Histamine intolerance
Clinical narrative: After receiving both initial Pfizer Covid-19 vaccines, I am having major issues with histamine intolerances; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HISTAMINE INTOLERANCE (non-serious), outcome "unknown", described as "After receiving both initial Pfizer Covid-19 vaccines, I am having major issues with histamine intolerances".  Additional information: Customer Verbatim: After receiving both initial Pfizer Covid-19 vaccines, the patient was having major issues with histamine intolerances, and had been for 12 months now. When the patient googled high histamine levels after, the search suggestions actually suggested after Covid-19vaccine and after vaccines, so it must be a popular search. Are any studies being done on this. Had any research been done on high histamine levels after the vaccines, are there any trials in progress. Possible antidote or treatments available.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Bladder cancer, Cardiac failure
Clinical narrative: bladder cancer; heart ejection fraction failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), for COVID-19 immunization; Bnt162b2 (Dose: 2nd), for COVID-19 immunization. The following information was reported: BLADDER CANCER (medically significant), outcome "unknown"; CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart ejection fraction failure". The patient underwent the following laboratory tests and procedures: Cardiac failure: 30-35 %. Customer Verbatim: I received the Pfizer covid vaccine and booster. In the past two months I have been diagnosed with heart ejection fraction failure @30-35(percent) then with cancer of the bladder. The bladder cancer appears to have been caught early and I am scheduled for surgery. The heart failure is a different matter and treatment is undertermined. Since we don't know any longterm effects of the vaccine, I thought it important to let you know. I have never been a smoker.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Bladder cancer, Computerised tomogram, Ejection fraction, Urine analysis
Clinical narrative: bladder cancer; heart ejection fraction failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), for COVID-19 immunization; Bnt162b2 (Dose: 2nd), for COVID-19 immunization. The following information was reported: BLADDER CANCER (medically significant), outcome "unknown"; CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart ejection fraction failure". The patient underwent the following laboratory tests and procedures: Cardiac failure: 30-35 %. Customer Verbatim: I received the Pfizer covid vaccine and booster. In the past two months I have been diagnosed with heart ejection fraction failure @30-35(percent) then with cancer of the bladder. The bladder cancer appears to have been caught early and I am scheduled for surgery. The heart failure is a different matter and treatment is undertermined. Since we don't know any longterm effects of the vaccine, I thought it important to let you know. I have never been a smoker.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: mild headache; achiness and stiffness through the whole body; achiness and stiffness through the whole body; slight chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 at 11:30 as dose 4 (booster), single (Lot number: fk9894) at the age of 79 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for covid 19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for covid 19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for covid 19 immunization. The following information was reported: PAIN (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 12Apr2022 at 08:00, outcome "not recovered" and all described as "achiness and stiffness through the whole body"; HEADACHE (non-serious) with onset 12Apr2022 at 08:00, outcome "not recovered", described as "mild headache"; CHILLS (non-serious) with onset 12Apr2022 at 08:00, outcome "not recovered", described as "slight chills". Therapeutic measures were not taken as a result of headache, pain, musculoskeletal stiffness, chills.  Additional Information: Reporter type: Patient. dose received More than 3. product: COVID 19. brand: Pfizer. lot number: fk9894, administration date: 11Apr2022. administration time: 11:30 AM. dose number: 4. vaccine location: Left arm. No other vaccine in four weeks. other medications in two weeks: Synthroid. adverse event: mild headache, achiness and stiffness through the whole body, slight chills. adverse event start date: 12Apr2022. adverse event start time: 08:00 AM. if patient recovered: Not recovered. No treatment ae. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Somnolence
Clinical narrative: Fever; Chills; Dull headache, which wasn't severe, like a London fog; Tried to sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing), notes: Caller states she has a history of cancer and just finished 6 chemotherapy treatments, and now she is taking a pill for treatment.; "chemotherapy treatments" (unspecified if ongoing), notes: history of cancer just finished 6 chemotherapy treatments, now taking a pill for treatment. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer: Unknown, Caller states she has never had any problems before with any vaccines.), for Covid-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer: Unknown, Caller states she has never had any problems before with any vaccines.), for Covid-19 immunization; Covid-19 vaccine (Dose 3; Manufacturer: Unknown (First booster), Caller states she has never had any problems before with any vaccines.), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset Oct2021, outcome "unknown"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "Dull headache, which wasn't severe, like a London fog"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "Fever"; SOMNOLENCE (non-serious) with onset Oct2021, outcome "unknown", described as "Tried to sleep".  Additional information: Consumer stated she was calling about the Pfizer Covid vaccine, second booster. Consumer stated she wanted to report right away, her experiences after the second booster. Consumer stated she had fever, chills, and she tried to sleep. Consumer stated the next day she had a dull headache, which wasn't severe, like a London fog. Consumer stated her great nephew who works for Pfizer told her to report the event as soon as possible, so she was doing as he requested. Consumer stated she has never had any problems before with any vaccines. Consumer stated she has a history of cancer and just finished 6 chemotherapy treatments, and now she is taking a pill for treatment. Consumer does not provide the name of the medication or the product information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: IgA nephropathy
Clinical narrative: IgA nephropathy relapse following COVID-19 vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as unk, single (Batch/Lot number: unknown) for covid-19 immunization.The patient's relevant medical history included: "IgA nephropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IGA NEPHROPATHY (medically significant), outcome "unknown", described as "IgA nephropathy relapse following COVID-19 vaccination". Therapeutic measures were taken as a result of iga nephropathy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: she is still having effects in her left shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0168), as dose 2, single (Lot number: FJ1620) and as dose 3 (booster), single (Lot number: EW0169) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB INJURY (non-serious), outcome "unknown", described as "she is still having effects in her left shoulder".  Additional Information: Caller is a 60 year old patient who states that she got her everything done last year in Dec", and she is still having effects in her left shoulder, which is where she got both doses of the primary series of the Pfizer BioNTech Covid 19 vaccine, as well as her booster dose. She does not have a medical inquiry, she simply wants to report that it is ongoing.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral disorder
Clinical narrative: A woman dies of a rare brain disorder after second dose of Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 60-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 (Dose:1, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: CEREBRAL DISORDER (death), outcome "fatal", described as "A woman dies of a rare brain disorder after second dose of Pfizer". The patient date of death was Feb2021. Reported cause of death: "A woman dies of a rare brain disorder after second dose of Pfizer". It was not reported if an autopsy was performed.  Clinical course includes, We are sending you a piece of news that reached us this morning in case it is out of your area: A woman dies of a rare brain disorder after second dose of Pfizer withheld  a healthy withheld from withheld, died on Feb21, five months after receiving her second dose of Pfizer's COVID-19. The information published is all the information we have.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: A woman dies of a rare brain disorder after second dose of Pfizer
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, Nasal congestion, Nausea, Suspected COVID-19
Clinical narrative: contracted Cov-19 despite having 3 vaccine shots.; contracted Cov-19 despite having 3 vaccine shots.; Experiencing nausea; tiredness; congestion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 48-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted Cov-19 despite having 3 vaccine shots."; NAUSEA (non-serious), outcome "unknown", described as "Experiencing nausea"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion". Covid 19 booster patient contracted Cov-19 despite having 3 vaccine shots. Experiencing nausea, tiredness, congestion. Patient was a healthy 48 year old woman with a demanding job that requires her to travel extensively throughout the country. No underlying diseases or chronic illnesses in medical history. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: she and her Husband got a common cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: Unknown; Manufacturer: Unknown), for COVID-19 immunization.  The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "she and her Husband got a common cold".  Additional information: Caller (Name withheld) would like to cancel their appointment for the 2nd booster dose of the vaccine. Because she mentioned that she and her Husband got a common cold.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: she and her Husband got a common cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: Unknown; , Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "she and her Husband got a common cold".  Additional Information: The reporter would like to cancel their appointment for the 2nd booster dose of the vaccine. Because the patient mentioned that she and her Husband got a common cold.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: extensive menstruation, 3 plus months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 01Jan2022, outcome "recovered" (30Mar2022), described as "extensive menstruation, 3 plus months". Therapeutic measures were taken as a result of heavy menstrual bleeding.  Additional Information: Adverse event: Sixteen year old female with extensive menstruation, 3 plus months. Family physician advised possible cause Pfizer Covid Vaccine, however, did not confirm. After three months, female was seen by a gynecologist, where in different treatment was offered, and successful, but also indicated possible cause may be related to the Pfizer Covid vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart stopped and was resuscitated by neighbors until ambulance came; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 84-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) other for covid-19 immunisation.The patient's relevant medical history included: "Muscular dystrophy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Unknown, reaction(s): "Allergy". Vaccination history included: Covid 19 vaccine (Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: CARDIAC DISORDER (hospitalization), outcome "recovered", described as "heart stopped and was resuscitated by neighbors until ambulance came". It was unknown if therapeutic measures were taken as a result of cardiac disorder.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms for 1 day (no date given) day after covid booster; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like symptoms for 1 day (no date given) day after covid booster". Additional information: Patient took Xeljanz 5mg once daily, Oral from May2021 to current for rheumatoid arthritis per MD instructions, differs from manufacturer recommended 5mg twice daily. MD aware. Patient reported flu like symptoms for 1 day (no date given) day after covid booster. Patient agreed that it was hard to cope with rheumatoid arthritis and sometimes felt discouraged/depressed (no dates given). Unsure if md aware. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Palpitations
Clinical narrative: had a lot of heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "had a lot of heart palpitations". The event "had a lot of heart palpitations" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Consumer stated she was calling about the Pfizer vaccine for coronavirus and stated for her 2nd dose that she had, she had a lot of heart palpitations and did not report this and called the doctor office and they had her come in the following day and she did an EKG and she assumed the doctor's office reported this and she finally saw the doctor and the doctor told her that the vaccine pushes the immune system and affects the body all over and she does not believe the doctor's office reported this about her.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Excessive Hair Loss; fever; body aches; headache; dizziness; fatigue; pain in arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: FJ8762) at the age of 38 years, on 13Jan2021 as dose 2, single (Lot number: EK9231) and on 15Dec2021 as dose 3 (booster), single (Lot number: EK9231) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious) with onset 24Dec2020, outcome "recovered with sequelae", described as "Excessive Hair Loss"; PAIN (non-serious) with onset 24Dec2020, outcome "recovered with sequelae", described as "body aches"; DIZZINESS (non-serious) with onset 24Dec2020, outcome "recovered with sequelae"; FATIGUE (non-serious) with onset 24Dec2020, outcome "recovered with sequelae"; PYREXIA (non-serious) with onset 24Dec2020, outcome "recovered with sequelae", described as "fever"; HEADACHE (non-serious) with onset 24Dec2020, outcome "recovered with sequelae"; PAIN IN EXTREMITY (non-serious) with onset 24Dec2020, outcome "recovered with sequelae", described as "pain in arm". The events "excessive hair loss", "fever", "body aches", "headache", "dizziness", "fatigue" and "pain in arm" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia, pyrexia, pain, headache, dizziness, fatigue, pain in extremity.  Additional information: Adverse event Excessive Hair Loss over the course of 6 months-1 year, fever/body aches/headache/dizziness/fatigue/pain in arm starting day after each injection and lasting about 48hrs. Adverse event start date 24Dec2020. Ae resulted in [Doctor or other healthcare professional office/clinic visit], patient recovered with lasting effects with no treatment, no covid prior vaccination, patient was covid tested post vaccination, there were no known allergies and other medical history.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Excessive Hair Loss; fever; body aches; headache; dizziness; fatigue; pain in arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: FJ8762) at the age of 38 years, on 13Jan2021 as dose 2, single (Lot number: EK9231) and on 15Dec2021 as dose 3 (booster), single (Lot number: EK9231) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious) with onset 24Dec2020, outcome "recovered with sequelae", described as "Excessive Hair Loss"; PAIN (non-serious) with onset 24Dec2020, outcome "recovered with sequelae", described as "body aches"; DIZZINESS (non-serious) with onset 24Dec2020, outcome "recovered with sequelae"; FATIGUE (non-serious) with onset 24Dec2020, outcome "recovered with sequelae"; PYREXIA (non-serious) with onset 24Dec2020, outcome "recovered with sequelae", described as "fever"; HEADACHE (non-serious) with onset 24Dec2020, outcome "recovered with sequelae"; PAIN IN EXTREMITY (non-serious) with onset 24Dec2020, outcome "recovered with sequelae", described as "pain in arm". The events "excessive hair loss", "fever", "body aches", "headache", "dizziness", "fatigue" and "pain in arm" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia, pyrexia, pain, headache, dizziness, fatigue, pain in extremity.  Additional information: Adverse event Excessive Hair Loss over the course of 6 months-1 year, fever/body aches/headache/dizziness/fatigue/pain in arm starting day after each injection and lasting about 48hrs. Adverse event start date 24Dec2020. Ae resulted in [Doctor or other healthcare professional office/clinic visit], patient recovered with lasting effects with no treatment, no covid prior vaccination, patient was covid tested post vaccination, there were no known allergies and other medical history.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood pressure measurement, Body temperature, Dizziness, Oxygen saturation
Clinical narrative: Still dizzy/lightheaded; Unsteady; He felt the room was spinning; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 85-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FJ9441) at the age of 85 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Lot Number: EK4176, Location of injection: Arm Left, Vaccine Administration Time: 04:30 PM), administration date: 11Jan2021, when the patient was 84-year-old, for Covid-19 immunization, reaction(s): "None"; BNT162b2 (Dose 2, Single, Lot Number: EC3247, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 01Feb2021, when the patient was 84-year-old, for Covid-19 immunization, reaction(s): "None"; BNT162b2 (Dose 3, Single, Lot Number: FO3448, Location of injection: Arm Left, Vaccine Administration Time: 02:00 AM), administration date: 28Aug2021, when the patient was 85-year-old, for Covid-19 immunization, reaction(s): "None". The following information was reported: VERTIGO (non-serious) with onset 10Apr2022, outcome "not recovered", described as "He felt the room was spinning"; BALANCE DISORDER (non-serious) with onset 11Apr2022, outcome "not recovered", described as "Unsteady"; DIZZINESS (non-serious) with onset 12Apr2022, outcome "not recovered", described as "Still dizzy/lightheaded". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo, balance disorder, dizziness.  Additional information: Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. No known allergies. No other medical history.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: Still dizzy/lightheaded; Unsteady; He felt the room was spinning; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 85-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FJ9441) at the age of 85 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Lot Number: EK4176, Location of injection: Arm Left, Vaccine Administration Time: 04:30 PM), administration date: 11Jan2021, when the patient was 84-year-old, for Covid-19 immunization, reaction(s): "None"; BNT162b2 (Dose 2, Single, Lot Number: EC3247, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 01Feb2021, when the patient was 84-year-old, for Covid-19 immunization, reaction(s): "None"; BNT162b2 (Dose 3, Single, Lot Number: FO3448, Location of injection: Arm Left, Vaccine Administration Time: 02:00 AM), administration date: 28Aug2021, when the patient was 85-year-old, for Covid-19 immunization, reaction(s): "None". The following information was reported: VERTIGO (non-serious) with onset 10Apr2022, outcome "not recovered", described as "He felt the room was spinning"; BALANCE DISORDER (non-serious) with onset 11Apr2022, outcome "not recovered", described as "Unsteady"; DIZZINESS (non-serious) with onset 12Apr2022, outcome "not recovered", described as "Still dizzy/lightheaded". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo, balance disorder, dizziness.  Additional information: Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. No known allergies. No other medical history.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: AE(s) following prior vaccinations: No, just tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "AE(s) following prior vaccinations: No, just tiredness".  Additional information: Route, Anatomical Location: Shoulders, left and right she would rotate. Concomitant Medications: No, she just takes her normal medications. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): none.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Wheezing; Shortness of Breath; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2022 at 12:15 as dose 1, single (Lot number: FK9895) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "If covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DYSPNOEA (non-serious) with onset 21Feb2022 at 15:30, outcome "unknown", described as "Shortness of Breath"; WHEEZING (non-serious) with onset 21Feb2022 at 15:30, outcome "unknown". Therapeutic measures were taken as a result of wheezing, dyspnoea.  Additional information: The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No other medications in two weeks. Received treatment with Rescue Inhaler. The patient had covid prior vaccination. The patient was not tested for covid post vaccination. Known allergies: NKDA. Other medical history included: Asthma  No follow-up attempts are possible. No further information is expected.