chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Syncope
Clinical narrative: syncope; Soreness overnight in left arm; expanding pain to left shoulder; Strong Fever/low fever; body pain; headache; felt uneasy; nausea/Felt like throwing up; dizzy/lightheaded; Profuse sweating; EKG showed low heart rate, blood pressure; EKG showed low heart rate, blood pressure; feeling weak; could not stand; Feeling worse; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included Cholesterol (blood cholesterol abnormal) from an unknown date. There were no concomitant medications. The patient previously received first dose of BNT162B2 for covid-19 immunisation on 24Mar2021. The patient also previously received naproxen and experienced allergies. The patient experienced syncope, soreness overnight in left arm, expanding pain to left shoulder, strong fever/low fever, body pain, headache, felt uneasy, nausea/felt like throwing up, dizzy/lightheaded, profuse sweating, ekg showed low heart rate, blood pressure, feeling weak, could not stand and feeling worse all on 15Apr2021 at 13:00. All the reported events caused hospitalization for 1 day. It was reported that After receiving Pfizer vaccine at 4pm developed Soreness overnight in left arm, expanding pain to left shoulder. Strong Fever and body pain in morning. Feeling worse throughout morning after breakfast of tea and fruits. While having lunch at 1.30 pm felt uneasy and nausea and could not complete lunch. Felt like throwing up and got up feeling dizzy and lightheaded. Experienced syncope and had to lie down on kitchen floor. Tried to get up with help from family members but could not stand and had to lie down again on floor. Profuse sweating. Wife called 911 and ambulance who arrived and checked pulse, EKG showed low heart rate, blood pressure. Taken by ambulance and paramedics to hospital Emergency where IV fluids were given to stabilize and discharged after 4 hours of observation. Still feeling weak, headache, low fever. Taking Tylenol and fluids while recovering. Adverse event start date: 15Apr2021. Adverse event start time: 01:00 PM. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement): low on 15Apr2021, EKG (electrocardiogram): showed low heart rate, blood pressure on 15Apr2021 and pulse/heart rate (heart rate): low on 15Apr2021. Therapeutic measures were taken as a result of all the events which includes IV fluids and Tylenol. Outcome of all the events was recovering  Information on batch/lot number was requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: body ache; chills; fever; bad Headache; This is a spontaneous report from a contactable reporter (patient's husband). A 41-year-old female patient (wife) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration on 15Apr2021, as single dose for COVID-19 immunisation. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration, on an unknown date, as single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. On 15Apr2021, the patient experienced body ache, chills, fever, a bad headache. Caller stated that his wife received the second dose of the Pfizer Covid-19 vaccine yesterday morning and by noon until now she has felt like she was run over with a truck, she has a strong body ache, chills, fever, a bad headache and it has been going back and forth. Would like to consult when will these side effects will pass. Outcome of the events were unknown.  No follow up activities required as no further information can be expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Delusional disorder, unspecified type, Diplopia, Feeling abnormal, Headache
Clinical narrative: very delusional; Can't remember; Severe headache; Double vision; Still not feeling right; Cold chills; This is a spontaneous report from a contactable consumer (patient's daughter). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 at single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had a severe reaction 2 days later on 10Apr2021 and was still not feeling right. The patient was experiencing cold chills, severe headache, she's like out of her head, she can't remember, especially at nighttime it's worse, double vision and she's very delusional. The reporter wanted to know what to do. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: very delusional; Can't remember; Severe headache; Double vision; Still not feeling right; Cold chills; This is a spontaneous report from a contactable consumer (patient's daughter). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 at single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had a severe reaction 2 days later on 10Apr2021 and was still not feeling right. The patient was experiencing cold chills, severe headache, she's like out of her head, she can't remember, especially at nighttime it's worse, double vision and she's very delusional. The reporter wanted to know what to do. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypophagia, Nausea
Clinical narrative: severe nausea; she is having a hard time drinking tea or anything; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates: unknown), via an unspecified route of administration, on 14Apr2021, as single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient reported that on an unknown date in Apr2021, after receiving the first dose of the vaccine, patient had severe nausea. Patient stated that, this was the third day, and she was having a hard time drinking tea or anything. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received her first dose on 21Jan2021/contracted Covid illness/tested positive for COVID; This is a spontaneous report from a contactable other healthcare professional (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiration date not provided) via an unspecified route of administration, administered in the left arm on 20Jan2021 as a single dose for COVID-19 immunisation. The patient has no medical history and there were no concomitant medications. The patient did not receive any other vaccine within 4 weeks and no adverse events following prior vaccinations. The patient stated that she got the COVID vaccine in the middle of Jan (20Jan2021) and later got COVID. She stated a couple days after getting COVID, she got the monoclonal antibody infusion and was told to wait until the first of May to get the vaccine but they did not tell her if she should start over again. She stated that she tested positive on 01Feb2021 and 2 to 3 weeks later, on an unspecified date in Feb2021, she tested negative. She stated that symptoms she had was mainly fatigue and a wet productive cough when she was positive with COVID. She stated that fatigue and wet productive cough started around 01Feb2021 and lasted about 3 weeks so probably ended on 21Feb2021 but she has recovered completely from the symptoms. She received a monoclonal antibody infusion and the medications she tooks were Zpack and Ivermectin. The outcome of the event was recovered on an unspecified date in Feb2021.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program . A female patient of unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via unknown route of administration on 13Apr2021 as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On 13Apr2021, the patient had sore arm. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Her arm at the injection site is still swollen; Her arm at the injection hot and itchy.; injection site is  red; This is a spontaneous report from a contactable consumer (patient).. A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number and expiry date were not provided), via an unspecified route of administration, in arm, on 06Apr2021 (at the age of 22-years-old) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had experienced the injection site is still swollen, red, hot and itchy. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: arm soreness; fever; chills; felty achy; she felt tired; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 09Apr2021 as single dose for covid-19 immunization. Medical history included covid-19 from 13Jan2021 to an unknown date. The patient's concomitant medications were not reported. The patient waited 90 days before getting the first dose because she got Covid-19 last 13Jan2021. She experienced side effects after the first dose. First, she experienced arm soreness and took Tylenol. She also had fever, chills, felty achy and the following day she felt tired. She was not scheduled for her second dose yet. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Constipation, Fatigue, Headache
Clinical narrative: cold painful stuff in my arm; feeling chills; fever; nauseated; began feeling sick; Headache; felt very weak and tired; felt very weak and tired; I've been constipated since; burning painful; all that night hard time sleep; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration on 13Mar2021 at 07:50 (Lot number : not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included historical vaccine received first dose of bnt162b2,Inoperable lung cancer from 2010 to an unknown date stage 3B lung cancer, metastases to lymph nodes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter stated that she felt the second one "immediately, like the solution hit a nerve or something. I said out loud, "ouch", felt like a cold painful stuff in my arm and immediately my arm started to get pain, and during the time we had to wait afterward, my arm got very sore, hard to pick up my arm. When I got home, I began feeling sick, chills, fever, legs felt like 100 pound weights on them. nauseated felt like lumps in the back of my head. Headache, fever, chills, nauseated, ached all over. I don't know if this is part of it, but my bowels, she have been constipated since, and normally have no issue having bowel movements. she felt very weak and tired. She states that she could feel it Immediately going in my arm, she told the nurse after first, you were good. After the second, It was burning painful, going in on the second dose. (the vaccination provider) " she have never felt an injection to feel that solution to feel painful going in." Caller states, We had gotten ours 7:50am 13Mar2021, I immediately felt it, as soon as she got home, started getting sick, all that night hard time sleep, next day 14Mar2021 all day all night, same feeling, Yesterday, when she got awake it was better. The events were considered as non-serious. The outcome of the event all that night hard time sleep was reported as recovered on 14Mar2021 and other events were reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Pain, Pyrexia, Sleep disorder
Clinical narrative: cold painful stuff in my arm; feeling chills; fever; nauseated; began feeling sick; Headache; felt very weak and tired; felt very weak and tired; I've been constipated since; burning painful; all that night hard time sleep; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration on 13Mar2021 at 07:50 (Lot number : not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included historical vaccine received first dose of bnt162b2,Inoperable lung cancer from 2010 to an unknown date stage 3B lung cancer, metastases to lymph nodes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter stated that she felt the second one "immediately, like the solution hit a nerve or something. I said out loud, "ouch", felt like a cold painful stuff in my arm and immediately my arm started to get pain, and during the time we had to wait afterward, my arm got very sore, hard to pick up my arm. When I got home, I began feeling sick, chills, fever, legs felt like 100 pound weights on them. nauseated felt like lumps in the back of my head. Headache, fever, chills, nauseated, ached all over. I don't know if this is part of it, but my bowels, she have been constipated since, and normally have no issue having bowel movements. she felt very weak and tired. She states that she could feel it Immediately going in my arm, she told the nurse after first, you were good. After the second, It was burning painful, going in on the second dose. (the vaccination provider) " she have never felt an injection to feel that solution to feel painful going in." Caller states, We had gotten ours 7:50am 13Mar2021, I immediately felt it, as soon as she got home, started getting sick, all that night hard time sleep, next day 14Mar2021 all day all night, same feeling, Yesterday, when she got awake it was better. The events were considered as non-serious. The outcome of the event all that night hard time sleep was reported as recovered on 14Mar2021 and other events were reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: cold painful stuff in my arm; feeling chills; fever; nauseated; began feeling sick; Headache; felt very weak and tired; felt very weak and tired; I've been constipated since; burning painful; all that night hard time sleep; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration on 13Mar2021 at 07:50 (Lot number : not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included historical vaccine received first dose of bnt162b2,Inoperable lung cancer from 2010 to an unknown date stage 3B lung cancer, metastases to lymph nodes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter stated that she felt the second one "immediately, like the solution hit a nerve or something. I said out loud, "ouch", felt like a cold painful stuff in my arm and immediately my arm started to get pain, and during the time we had to wait afterward, my arm got very sore, hard to pick up my arm. When I got home, I began feeling sick, chills, fever, legs felt like 100 pound weights on them. nauseated felt like lumps in the back of my head. Headache, fever, chills, nauseated, ached all over. I don't know if this is part of it, but my bowels, she have been constipated since, and normally have no issue having bowel movements. she felt very weak and tired. She states that she could feel it Immediately going in my arm, she told the nurse after first, you were good. After the second, It was burning painful, going in on the second dose. (the vaccination provider) " she have never felt an injection to feel that solution to feel painful going in." Caller states, We had gotten ours 7:50am 13Mar2021, I immediately felt it, as soon as she got home, started getting sick, all that night hard time sleep, next day 14Mar2021 all day all night, same feeling, Yesterday, when she got awake it was better. The events were considered as non-serious. The outcome of the event all that night hard time sleep was reported as recovered on 14Mar2021 and other events were reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Haemorrhage, Headache, Pain in extremity, Pruritus
Clinical narrative: bleeding; Rash; itching; hives; pain in head, shoulders; pain in head, shoulders; pain in head, shoulders, arm; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Apr2021 at 15:30 (3:30 PM) (at the age of 41 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  Medical history included asthma, allergies, and anxiety. Concomitant medications included bupropion; diphenhydramine hydrochloride (BENADRYL), and unspecified supplements.  The patient previously took amoxicillin and experienced allergies.  The patient experienced rash, hives, itching, bleeding, and pain in head, shoulders, arm on 14Apr2021 at 17:00 (5:00 pm). The patient did not receive treatment for the events. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks.  The patient is recovering from the events.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: bleeding; Rash; itching; hives; pain in head, shoulders; pain in head, shoulders; pain in head, shoulders, arm; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Apr2021 at 15:30 (3:30 PM) (at the age of 41 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  Medical history included asthma, allergies, and anxiety. Concomitant medications included bupropion; diphenhydramine hydrochloride (BENADRYL), and unspecified supplements.  The patient previously took amoxicillin and experienced allergies.  The patient experienced rash, hives, itching, bleeding, and pain in head, shoulders, arm on 14Apr2021 at 17:00 (5:00 pm). The patient did not receive treatment for the events. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks.  The patient is recovering from the events.   Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Confusional state, Diplopia, Dizziness
Clinical narrative: confused/When talking to her she is talking out of her head/hought her condo was turned completely around; She is having headaches; muscle pain; chills; double vision; dizziness; her arm, and joint pain; her arm, and joint pain; extremely exhausted; This is a spontaneous report from a contactable consumer. A 68-year-old female patient (consumer's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 08Apr2021 (Batch/Lot number unknown as complainant does not have the product with them at the time of call) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter was calling about her mother. The patient was fine before she got this shot and no one can seem to help her. They had the vaccine on 08Apr2021 and her mom (patient) started having severe reactions to it on 10Apr2021. Patient had the chills, muscle aches, muscle pain, headache, dizziness, her arm, and joint pain. She did not have fever, but had chills. She had double vision now. The symptoms are not going away. They are getting worse. They took her mom to the ER. The patient was confused. When talking to her she was talking out of her head. The severity of confusion is she thought her condo was turned completely around. Patient was not getting better. Went to the doctor and the doctor was at a lost. Patient was extremely exhausted. Caller stated they all took the same shot on the same day and her mom was the only one to have a reaction. Patient was literally out of her mind. Caller's dad had to take patient to the store with him because he didn't want to leave her by herself. They live in a condo on the second floor. Her mom thought the condo was reversed. Her dad was worried to leave her mom by herself because he didn't want her to go out the wrong door and go over the balcony. Her mom was not like that prior to receiving COVID19 Vaccine. Reporter was asked if there was an antidote. They were told patient should see her doctor and that she need treatment but no one could give they something to antidote the vaccine. The outcome of events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: confused/When talking to her she is talking out of her head/hought her condo was turned completely around; She is having headaches; muscle pain; chills; double vision; dizziness; her arm, and joint pain; her arm, and joint pain; extremely exhausted; This is a spontaneous report from a contactable consumer. A 68-year-old female patient (consumer's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 08Apr2021 (Batch/Lot number unknown as complainant does not have the product with them at the time of call) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter was calling about her mother. The patient was fine before she got this shot and no one can seem to help her. They had the vaccine on 08Apr2021 and her mom (patient) started having severe reactions to it on 10Apr2021. Patient had the chills, muscle aches, muscle pain, headache, dizziness, her arm, and joint pain. She did not have fever, but had chills. She had double vision now. The symptoms are not going away. They are getting worse. They took her mom to the ER. The patient was confused. When talking to her she was talking out of her head. The severity of confusion is she thought her condo was turned completely around. Patient was not getting better. Went to the doctor and the doctor was at a lost. Patient was extremely exhausted. Caller stated they all took the same shot on the same day and her mom was the only one to have a reaction. Patient was literally out of her mind. Caller's dad had to take patient to the store with him because he didn't want to leave her by herself. They live in a condo on the second floor. Her mom thought the condo was reversed. Her dad was worried to leave her mom by herself because he didn't want her to go out the wrong door and go over the balcony. Her mom was not like that prior to receiving COVID19 Vaccine. Reporter was asked if there was an antidote. They were told patient should see her doctor and that she need treatment but no one could give they something to antidote the vaccine. The outcome of events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain in extremity
Clinical narrative: feeling achy in shoulders back and legs.; feeling achy in shoulders back and legs.; feeling achy in shoulders back and legs.; This is a spontaneous report from a contactable consumer(patient). A 72-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) second dose via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Reported that he has had the second dose 2 weeks ago and is feeling achy in shoulders back and legs. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Taste disorder
Clinical narrative: sneezing and tasting the after vaccine.; sneezing and tasting the after vaccine.; This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored Program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced symptoms like sneezing and tasting the after vaccine. She would like to get the guidance on whether she should receive the second dose after experiencing these symptoms. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.  No follow-up attempts are needed; Information related to batch/Lot number could not be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Flushing, Lower respiratory tract infection, Panic attack
Clinical narrative: cold feeling in chest; About 35 minutes post 2nd vaccine, I had a severe panic attack; Flushing feeling; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient (not pregnant, age at vaccination: 35-year-old) received the second dose of bnt162b2 (BNT162B2, lot EW0161), via an unspecified route of administration in the right arm, on 15Apr2021 as SINGLE DOSE for Covid-19 immunisation. The patient's medical history was not reported. She had her first dose of bnt162b2 (lot EN6204) on 18Mar2021, administered in the left arm. The patient previously took aspirin (acetylsalicylic acid) and experienced drug allergy. Concomitant medications included atenolol, hctz, hydrocodone, cyclobenzaprine hydrochloride (FLEXERIL) and gabapentin; taken for an unspecified indication, start and stop date were not reported. On 15Apr2021 19:45, she had panic attack, flushing feeling, shortness of breath and cold feeling in chest. These did not occur with the 1st dose of vaccine. As treatment, she was given with 3mg Ativan PO (oral). The outcome of events was recovering.  Information on the lot number was already obtained.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cerebellar stroke, Cerebrovascular accident, Chills, Echocardiogram
Clinical narrative: thrombotic strokes; right cerebellar stroke; vertebral artery dissection/ tore a vertebral artery in her neck; two sub acute strokes; vertigo; nausea; weakness; fatigue; sore arm; mild chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN5318) via an unspecified route of administration, administered in Arm Left, at the age of 37-year-old, on 04Feb2021 16:30, as SINGLE DOSE for covid-19 immunisation.  Medical history was not reported. The patient did not receive any other vaccines 4 weeks prior. Concomitant medication included ongoing drospirenone, ethinylestradiol (DROSPIRENONE/ETHINYLESTRADIOL) taken for contraception.  The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL3302) single dose, at the age of 37-year-old, on 14Jan2021 1500PM in the left arm, for covid-19 immunisation and experienced fatigue and a sore arm. On 05Feb2021, the patient experienced fatigue, sore arm, mild chills, and body aches. On 08Mar2021, the patient was hospitalized because of vertebral artery dissection after an intense workout that morning/ she tore a vertebral artery in her neck which she immediately clotted and led to her having a stroke. The patient had vertigo, nausea and weakness on 08Mar2021 and went to the ER and they found she had a thrombolytic stroke in the cerebellum as a result of the vertebral artery dissection. The patient was admitted to the hospital on 08Mar2021 then she was discharged 11Mar2021. While she was in the hospital, they did an MRI and found two sub-acute thrombolytic strokes or blood clots in her brain. The patient tore the artery in her neck which led to the right cerebellar stroke; her blood was really clotty but they could tell by the imaging that the two subacute blood clots that led to having the other two strokes were there approximately three weeks before but not much older than that (without exhibiting symptoms, so she had three thrombotic strokes in total). Since she was discharged she has been out of work and will be on FML for two to three months and going to physical therapy from the effects of the strokes. Adds while she was in the hospital they were trying to determine the cause of the two sub-acute strokes that were unrelated to the dissection. They did several tests including: EKG which was normal; TEE scope down her throat to look at her heart which was normal; and blood work to check for a clotting disorder which was also all normal.  So far nothing has been found. Outcome of mild chills, body aches, and sore arm was recovered on 06Mar2021; outcome of vertebral artery dissection and right cerebellar stroke was recovering; while it was unknown for the other events.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Fatigue, Imaging procedure, Investigation, Magnetic resonance imaging head
Clinical narrative: thrombotic strokes; right cerebellar stroke; vertebral artery dissection/ tore a vertebral artery in her neck; two sub acute strokes; vertigo; nausea; weakness; fatigue; sore arm; mild chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN5318) via an unspecified route of administration, administered in Arm Left, at the age of 37-year-old, on 04Feb2021 16:30, as SINGLE DOSE for covid-19 immunisation.  Medical history was not reported. The patient did not receive any other vaccines 4 weeks prior. Concomitant medication included ongoing drospirenone, ethinylestradiol (DROSPIRENONE/ETHINYLESTRADIOL) taken for contraception.  The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL3302) single dose, at the age of 37-year-old, on 14Jan2021 1500PM in the left arm, for covid-19 immunisation and experienced fatigue and a sore arm. On 05Feb2021, the patient experienced fatigue, sore arm, mild chills, and body aches. On 08Mar2021, the patient was hospitalized because of vertebral artery dissection after an intense workout that morning/ she tore a vertebral artery in her neck which she immediately clotted and led to her having a stroke. The patient had vertigo, nausea and weakness on 08Mar2021 and went to the ER and they found she had a thrombolytic stroke in the cerebellum as a result of the vertebral artery dissection. The patient was admitted to the hospital on 08Mar2021 then she was discharged 11Mar2021. While she was in the hospital, they did an MRI and found two sub-acute thrombolytic strokes or blood clots in her brain. The patient tore the artery in her neck which led to the right cerebellar stroke; her blood was really clotty but they could tell by the imaging that the two subacute blood clots that led to having the other two strokes were there approximately three weeks before but not much older than that (without exhibiting symptoms, so she had three thrombotic strokes in total). Since she was discharged she has been out of work and will be on FML for two to three months and going to physical therapy from the effects of the strokes. Adds while she was in the hospital they were trying to determine the cause of the two sub-acute strokes that were unrelated to the dissection. They did several tests including: EKG which was normal; TEE scope down her throat to look at her heart which was normal; and blood work to check for a clotting disorder which was also all normal.  So far nothing has been found. Outcome of mild chills, body aches, and sore arm was recovered on 06Mar2021; outcome of vertebral artery dissection and right cerebellar stroke was recovering; while it was unknown for the other events.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pain in extremity, Thrombotic stroke, Vertebral artery dissection
Clinical narrative: thrombotic strokes; right cerebellar stroke; vertebral artery dissection/ tore a vertebral artery in her neck; two sub acute strokes; vertigo; nausea; weakness; fatigue; sore arm; mild chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN5318) via an unspecified route of administration, administered in Arm Left, at the age of 37-year-old, on 04Feb2021 16:30, as SINGLE DOSE for covid-19 immunisation.  Medical history was not reported. The patient did not receive any other vaccines 4 weeks prior. Concomitant medication included ongoing drospirenone, ethinylestradiol (DROSPIRENONE/ETHINYLESTRADIOL) taken for contraception.  The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL3302) single dose, at the age of 37-year-old, on 14Jan2021 1500PM in the left arm, for covid-19 immunisation and experienced fatigue and a sore arm. On 05Feb2021, the patient experienced fatigue, sore arm, mild chills, and body aches. On 08Mar2021, the patient was hospitalized because of vertebral artery dissection after an intense workout that morning/ she tore a vertebral artery in her neck which she immediately clotted and led to her having a stroke. The patient had vertigo, nausea and weakness on 08Mar2021 and went to the ER and they found she had a thrombolytic stroke in the cerebellum as a result of the vertebral artery dissection. The patient was admitted to the hospital on 08Mar2021 then she was discharged 11Mar2021. While she was in the hospital, they did an MRI and found two sub-acute thrombolytic strokes or blood clots in her brain. The patient tore the artery in her neck which led to the right cerebellar stroke; her blood was really clotty but they could tell by the imaging that the two subacute blood clots that led to having the other two strokes were there approximately three weeks before but not much older than that (without exhibiting symptoms, so she had three thrombotic strokes in total). Since she was discharged she has been out of work and will be on FML for two to three months and going to physical therapy from the effects of the strokes. Adds while she was in the hospital they were trying to determine the cause of the two sub-acute strokes that were unrelated to the dissection. They did several tests including: EKG which was normal; TEE scope down her throat to look at her heart which was normal; and blood work to check for a clotting disorder which was also all normal.  So far nothing has been found. Outcome of mild chills, body aches, and sore arm was recovered on 06Mar2021; outcome of vertebral artery dissection and right cerebellar stroke was recovering; while it was unknown for the other events.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: thrombotic strokes; right cerebellar stroke; vertebral artery dissection/ tore a vertebral artery in her neck; two sub acute strokes; vertigo; nausea; weakness; fatigue; sore arm; mild chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN5318) via an unspecified route of administration, administered in Arm Left, at the age of 37-year-old, on 04Feb2021 16:30, as SINGLE DOSE for covid-19 immunisation.  Medical history was not reported. The patient did not receive any other vaccines 4 weeks prior. Concomitant medication included ongoing drospirenone, ethinylestradiol (DROSPIRENONE/ETHINYLESTRADIOL) taken for contraception.  The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL3302) single dose, at the age of 37-year-old, on 14Jan2021 1500PM in the left arm, for covid-19 immunisation and experienced fatigue and a sore arm. On 05Feb2021, the patient experienced fatigue, sore arm, mild chills, and body aches. On 08Mar2021, the patient was hospitalized because of vertebral artery dissection after an intense workout that morning/ she tore a vertebral artery in her neck which she immediately clotted and led to her having a stroke. The patient had vertigo, nausea and weakness on 08Mar2021 and went to the ER and they found she had a thrombolytic stroke in the cerebellum as a result of the vertebral artery dissection. The patient was admitted to the hospital on 08Mar2021 then she was discharged 11Mar2021. While she was in the hospital, they did an MRI and found two sub-acute thrombolytic strokes or blood clots in her brain. The patient tore the artery in her neck which led to the right cerebellar stroke; her blood was really clotty but they could tell by the imaging that the two subacute blood clots that led to having the other two strokes were there approximately three weeks before but not much older than that (without exhibiting symptoms, so she had three thrombotic strokes in total). Since she was discharged she has been out of work and will be on FML for two to three months and going to physical therapy from the effects of the strokes. Adds while she was in the hospital they were trying to determine the cause of the two sub-acute strokes that were unrelated to the dissection. They did several tests including: EKG which was normal; TEE scope down her throat to look at her heart which was normal; and blood work to check for a clotting disorder which was also all normal.  So far nothing has been found. Outcome of mild chills, body aches, and sore arm was recovered on 06Mar2021; outcome of vertebral artery dissection and right cerebellar stroke was recovering; while it was unknown for the other events.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Magnetic resonance imaging, Thrombotic stroke, Vertebral artery dissection
Clinical narrative: thrombotic strokes; right cerebellar stroke; vertebral artery dissection/ tore a vertebral artery in her neck; two sub acute strokes; vertigo; nausea; weakness; fatigue; sore arm; mild chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN5318) via an unspecified route of administration, administered in Arm Left, at the age of 37-year-old, on 04Feb2021 16:30, as SINGLE DOSE for covid-19 immunisation.  Medical history was not reported. The patient did not receive any other vaccines 4 weeks prior. Concomitant medication included ongoing drospirenone, ethinylestradiol (DROSPIRENONE/ETHINYLESTRADIOL) taken for contraception.  The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL3302) single dose, at the age of 37-year-old, on 14Jan2021 1500PM in the left arm, for covid-19 immunisation and experienced fatigue and a sore arm. On 05Feb2021, the patient experienced fatigue, sore arm, mild chills, and body aches. On 08Mar2021, the patient was hospitalized because of vertebral artery dissection after an intense workout that morning/ she tore a vertebral artery in her neck which she immediately clotted and led to her having a stroke. The patient had vertigo, nausea and weakness on 08Mar2021 and went to the ER and they found she had a thrombolytic stroke in the cerebellum as a result of the vertebral artery dissection. The patient was admitted to the hospital on 08Mar2021 then she was discharged 11Mar2021. While she was in the hospital, they did an MRI and found two sub-acute thrombolytic strokes or blood clots in her brain. The patient tore the artery in her neck which led to the right cerebellar stroke; her blood was really clotty but they could tell by the imaging that the two subacute blood clots that led to having the other two strokes were there approximately three weeks before but not much older than that (without exhibiting symptoms, so she had three thrombotic strokes in total). Since she was discharged she has been out of work and will be on FML for two to three months and going to physical therapy from the effects of the strokes. Adds while she was in the hospital they were trying to determine the cause of the two sub-acute strokes that were unrelated to the dissection. They did several tests including: EKG which was normal; TEE scope down her throat to look at her heart which was normal; and blood work to check for a clotting disorder which was also all normal.  So far nothing has been found. Outcome of mild chills, body aches, and sore arm was recovered on 06Mar2021; outcome of vertebral artery dissection and right cerebellar stroke was recovering; while it was unknown for the other events.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Deep vein thrombosis, Dyspnoea, Rash macular
Clinical narrative: short of breath; chest pain; she had a blood clot and was diagnosed with a blood clot/diagnosed with DVT; Red splotches on leg; This is a spontaneous report from a contactable Nurse. A 62-year-old female patient received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot Number: EW0150) as SINGLE DOSE for covid-19 immunization. Medical history included she had a blood clot after surgery 100 pounds ago, around 18 years ago, she had the heart attack at age 41 and thrombophlebitis from an unknown date and unknown if ongoing. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for cardiac disorder from an unspecified start date and ongoing.  The patient experienced she had a blood clot and was diagnosed with a blood clot/diagnosed with DVT on 10Apr2021 and red splotches on leg on 09Apr2021. She states she got the vaccine on Thursday 08Apr2021. She confirms that the painful red splotches showed up on 09Apr2021. The blood Clot was diagnosed on the 10Apr2021. She states that the doctors put her on Lovenox. She states that it is only significant if she gets short of breath and/or has chest pain. If it travels then it is significant. She states that her doctor said she had a good sized clot, but she didn't ask specifics. Outcome of the event was not recovered.; Sender's Comments: On the basis of the available information, the reported event DVT would seem most likely related to underlying medical conditions which is not related to BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Patient had bilateral pulmonary embolisms; This is a spontaneous report from a contactable physician. An elderly (also reported as 65+ years) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 02Apr2021 (Batch/Lot Number: EN6205) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient is not pregnant. The patient had no known allergies. Concomitant medication included apixaban (ELIQUIS); monascus purpureus (RED YEAST RICE); colecalciferol (VIT D3); calcium; all taken for an unspecified indication, start and stop date were not reported. The patient had bilateral pulmonary embolisms on 07Apr2021 and was hospitalized for 2 days. There are no other vaccines in four weeks, no prior vaccination and was not tested positive post vaccination. Anticoagulation therapy was given as treatment. The outcome of the event was recovering.; Sender's Comments: Considering a plausible temporal relation, a causal relationship between the reported event of Pulmonary embolism and suspect drug bnt162b2 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 Committees, and Investigators, as appropriate.