chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Tongue eruption, Tremor
Clinical narrative: Flared- Autoimmune Disorder; Flared- Autoimmune Disorder; Extreme Fatigue; Fever; Headache; Body Aches; Muscle Tremors; Rash on Tongue and Lips; Rash on Tongue and Lips; This is a spontaneous report from a contactable consumer. This 49-year-old male consumer (patient) reported for himself that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration in right arm on 01Apr2021 12:00PM (at the age of 49-year-old) at single dose for COVID-19 immunisation. Relevant medical history included known allergies to mushrooms, latex and adhesive; mystenias Gravis (preliminary diagnosis) and autoimmune disorder (still in research). The patient had not COVID prior to vaccination. Concomitant medications were not reported. On 01Apr2021 12:00PM the patient experienced extreme fatigue, fever, headache, body aches, muscle tremors, rash on tongue and lips flared- autoimmune disorder (diagnosis still pending research - as reported) symptoms lasted for more than 4 days. The patient was tested for COVID post vaccination - no results reported. The events were resolving at the time of report.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Ocular vascular disorder, Pain in extremity, Retinal vein occlusion
Clinical narrative: Mini Stroke/blockage in left eye; Mini Stroke/blockage in left eye; Sore arm for 1 day after 1st dose; Diagnosed with CRVO of the eye; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN1199), via an unspecified route of administration, administered in left arm on 09Mar2021 12:30 (at the age of 33-years-old) as single dose for COVID-19 immunisation. The patient had no known allergy and no other medical history. The patient's concomitant medications were not reported. On 09Mar2021 the patient experienced sore arm for 1 day. She was diagnosed with CRVO of the eye. On 30Mar2021 she had mini stroke/blockage in left eye. Symptoms noticed about 1 week prior to 30Mar2021. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for events. The patient did not have COVID prior vaccination and she was not COVID tested post vaccination. The outcome of events was not recovered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: tinnitus and slightly hearing loss; tinnitus and slightly hearing loss; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER87 30), via an unspecified route of administration on 06Apr2021 (received at 24-years-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  The patient was not pregnant. She did not have COVID prior to vaccination. The patient experienced tinnitus and slightly hearing loss on 07Apr2021. The outcome of the events was not recovered. She was not tested for COVID post vaccination.   No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Haematochezia, Peripheral swelling, Platelet count, Platelet count decreased
Clinical narrative: Had blood with his stools like when he used the restroom he lost about half a water bottle of blood; Blood is still coming out; He has lost half of a water bottle of blood like 20 to 25 ml so far; Swollen arm; Tiredness; Had a low blood platelet count/his number is 167,000; This is a spontaneous report from a contactable consumer.  A 24-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734, expiration date was not reported), via an unspecified route of administration, administered in the left arm on 09Apr2021 17:30 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that within 48 hours after the consumer have no side effects but her boyfriend was feeling the typical side effects of swollen arm and the tiredness etc. Then in the morning on the third day, he had blood with his stools like when he used the restroom, he lost about half a water bottle of blood. Consumer read online with the signs and pictures and all that, in a very rare instances some people, their antibodies can attack their own blood platelet and lower the level. So, they went and had blood test ran and the normal number of blood platelets for his age and his gender male is 250,000 but his number is 167,000, which is about a 100,000 less and it was seventeen thousand away from a critical number of 150,000 blood platelets and the blood is still coming out. He was suffering from this on 11Apr2021 and he got the shot on 09Apr2021, he started showing blood on 11Apr2021 (not clarified further), this was his first shot. He went to the ER. They went to the hospital and they got the blood work done, he was admitted to the ER for 4 hours and based on the blood results they are sending him to see a specialist tomorrow (as reported) and monitoring his blood loss. They had a lab test ran on his blood work. The result was that he had a low blood platelet count. He has lost half of a water bottle of blood like 20 to 25 ml so far. Consumer stated that they were asking as if this maybe hemorrhoidal or something else but they didn't see anything like that. So, doctor in ER was not aware about the cases where people in very rare circumstances do have bleeding (further clarification unknown). Outcome of the events was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Lymphadenopathy, Pain in extremity, Peripheral swelling, Thrombosis
Clinical narrative: blood clot; lymphadenopathy; unable to walk without a cane; her left leg swelled up dramatically; painful leg; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (at the age of 69-years-old) as single dose for COVID-19 immunisation.  Medical history and concomitant medications were not reported. It was reported that patient received Pfizer shot a few weeks before reporting. Within 3 hours her left leg (she was inoculated on the left side) swelled up dramatically - - it was painful. Subsequently - a doctor discovered numerous blood clots in that leg; then a blood clot in one of her lungs. She was being treated but the lymphadenopathy has not subsided in her leg and she was now unable to walk without a cane. Lymphadenopathy was not resolved; the outcome of the other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood test, Cerebral disorder, Crying, Feeling abnormal
Clinical narrative: neuropathy in her left foot/ numb like tingling, a lot of tingling feeling/feel it every now and then throughout her body; numb like tingling, a lot of tingling feeling and she kind of feel it every now and then throughout her body; numb like tingling, a lot of tingling feeling and she kind of feel it every now and then throughout her body; felt weird; Iinterfering with her brain; makes her "like I want to cry."; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 01Apr2021 (lot number: ER8737) as single dose (at the age of 42-years-old) for COVID-19 immunisation. Medical history included temporomandibular joint syndrome (TMJ), headache and clench my teeth; from an unknown date and unknown if ongoing. Concomitant medication included butalbital, caffeine, paracetamol (BUTALBITAL, ACETAMINOPHEN & CAFFEINE) taken for "clench my teeth", start and stop date were not reported; the patient was also taking unspecified vitamins, supplements and an unspecified headache medication. The patient received the first shot of BNT162B2 for Covid-19 immunisation on an unspecified date. The patient had both the shots and was wondering because she was left with like this neuropathy in her left foot, it was kind of numb like tingling, a lot of tingling feeling and she kind of feel it every now and then throughout her body. It was like setting on her left foot and she got the shot on her left side. She got the last second shot and got it on Thursday (01Apr2021). She told her doctor right away the she saw this only after the last shot. She told the guy it was weird, it felt weird and then he said, you know it was a kind off to the side and was just "mental". But it has not gone away, it was like neuropathy, she doesn't remember if it was with the first shot because it was so quick in between. She wanted this to go away, it was really annoying. It was interfering with her brain, it was not good, it makes her "like I want to cry." The patient had a lab work done on Thursday morning (08Apr2021) and stated that her blood work was fine. They did a thyroid check, did her blood sugar and everything was fine; and her B12 to make sure her B12 wasn't low but everything was fine. The patient does not know the name of the tests. The patient wanted to know if the side effects she was experiencing was normal and was it going away. The outcome of the events was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuropathy peripheral, Paraesthesia, Thyroid function test, Vitamin B12
Clinical narrative: neuropathy in her left foot/ numb like tingling, a lot of tingling feeling/feel it every now and then throughout her body; numb like tingling, a lot of tingling feeling and she kind of feel it every now and then throughout her body; numb like tingling, a lot of tingling feeling and she kind of feel it every now and then throughout her body; felt weird; Iinterfering with her brain; makes her "like I want to cry."; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 01Apr2021 (lot number: ER8737) as single dose (at the age of 42-years-old) for COVID-19 immunisation. Medical history included temporomandibular joint syndrome (TMJ), headache and clench my teeth; from an unknown date and unknown if ongoing. Concomitant medication included butalbital, caffeine, paracetamol (BUTALBITAL, ACETAMINOPHEN & CAFFEINE) taken for "clench my teeth", start and stop date were not reported; the patient was also taking unspecified vitamins, supplements and an unspecified headache medication. The patient received the first shot of BNT162B2 for Covid-19 immunisation on an unspecified date. The patient had both the shots and was wondering because she was left with like this neuropathy in her left foot, it was kind of numb like tingling, a lot of tingling feeling and she kind of feel it every now and then throughout her body. It was like setting on her left foot and she got the shot on her left side. She got the last second shot and got it on Thursday (01Apr2021). She told her doctor right away the she saw this only after the last shot. She told the guy it was weird, it felt weird and then he said, you know it was a kind off to the side and was just "mental". But it has not gone away, it was like neuropathy, she doesn't remember if it was with the first shot because it was so quick in between. She wanted this to go away, it was really annoying. It was interfering with her brain, it was not good, it makes her "like I want to cry." The patient had a lab work done on Thursday morning (08Apr2021) and stated that her blood work was fine. They did a thyroid check, did her blood sugar and everything was fine; and her B12 to make sure her B12 wasn't low but everything was fine. The patient does not know the name of the tests. The patient wanted to know if the side effects she was experiencing was normal and was it going away. The outcome of the events was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: she was an epileptic and she do take anti-seizure meds. She have had 3 seizures in the last 24 hours; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER 8731), via an unspecified route of administration, administered in Arm Left on 09Apr2021 15:15 as [SINGLE DOSE] for covid-19 immunisation (Age at vaccination: 37 years). Medical history included epilepsy. Concomitant medications included lamotrigine and hyoscine butylbromisde (COLOSPAN). On 13Apr2021, 13:00 the patient stated that she was an epileptic and she do take anti-seizure meds. She have had 3 seizures in the last 24 hours. The patient was not pregnant. The patient did not have covid prior vaccination and was not test post vaccination. The patient did not received any treatment for the event. Outcome of the event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fall, Flatulence, Formication, Gait inability
Clinical narrative: fainted/blacked out; fainted/blacked out; skin felt like had spider and ants crawling all on skin; goosebumps; farted; fell backwards and hit the elbow, and thumb and back of head on the floor; fell backwards and hit the elbow, and thumb and back of head on the floor; fell backwards and hit the elbow, and thumb and back of head on the floor; fell backwards and hit the elbow, and thumb and back of head on the floor; could not walk; dizzy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (Lot Number: ER8737, unknown expiration) as a single dose for COVID-19 immunisation.  Medical history included COVID-19 disease from 06Jan2021 to an unknown date. The patient's concomitant medications were not reported.  The patient woke up in the middle of the night on 03Apr2021 at 02:00 AM, and the patient's skin felt like had spider and ants crawling all on skin and got goosebumps and had to get up to go to the restroom. The patient went to the restroom and urinated, and when he/she was ready to get up from the toilet he/she farted, the patient fainted/blacked out and fell backwards and hit the elbow, and thumb and back of head on the floor. The patient woke up, when that happened, it was a very hard crash. After that, the patient was unable, could not walk because when he/she tried, he/she got dizzy and had to crawl back to bed, with hands and knees back to bed. The patient asked if he/she should get the second shot. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Head injury, Joint injury, Limb injury, Loss of consciousness, Piloerection
Clinical narrative: fainted/blacked out; fainted/blacked out; skin felt like had spider and ants crawling all on skin; goosebumps; farted; fell backwards and hit the elbow, and thumb and back of head on the floor; fell backwards and hit the elbow, and thumb and back of head on the floor; fell backwards and hit the elbow, and thumb and back of head on the floor; fell backwards and hit the elbow, and thumb and back of head on the floor; could not walk; dizzy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (Lot Number: ER8737, unknown expiration) as a single dose for COVID-19 immunisation.  Medical history included COVID-19 disease from 06Jan2021 to an unknown date. The patient's concomitant medications were not reported.  The patient woke up in the middle of the night on 03Apr2021 at 02:00 AM, and the patient's skin felt like had spider and ants crawling all on skin and got goosebumps and had to get up to go to the restroom. The patient went to the restroom and urinated, and when he/she was ready to get up from the toilet he/she farted, the patient fainted/blacked out and fell backwards and hit the elbow, and thumb and back of head on the floor. The patient woke up, when that happened, it was a very hard crash. After that, the patient was unable, could not walk because when he/she tried, he/she got dizzy and had to crawl back to bed, with hands and knees back to bed. The patient asked if he/she should get the second shot. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: fainted/blacked out; fainted/blacked out; skin felt like had spider and ants crawling all on skin; goosebumps; farted; fell backwards and hit the elbow, and thumb and back of head on the floor; fell backwards and hit the elbow, and thumb and back of head on the floor; fell backwards and hit the elbow, and thumb and back of head on the floor; fell backwards and hit the elbow, and thumb and back of head on the floor; could not walk; dizzy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (Lot Number: ER8737, unknown expiration) as a single dose for COVID-19 immunisation.  Medical history included COVID-19 disease from 06Jan2021 to an unknown date. The patient's concomitant medications were not reported.  The patient woke up in the middle of the night on 03Apr2021 at 02:00 AM, and the patient's skin felt like had spider and ants crawling all on skin and got goosebumps and had to get up to go to the restroom. The patient went to the restroom and urinated, and when he/she was ready to get up from the toilet he/she farted, the patient fainted/blacked out and fell backwards and hit the elbow, and thumb and back of head on the floor. The patient woke up, when that happened, it was a very hard crash. After that, the patient was unable, could not walk because when he/she tried, he/she got dizzy and had to crawl back to bed, with hands and knees back to bed. The patient asked if he/she should get the second shot. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Kidney infection
Clinical narrative: kidney infection; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1, via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced kidney infection (medically significant) on an unspecified date. The 2nd dose will be on 15Apr2021. Last 08Apr2021, she was advised to take antibiotics for kidney infection. The patient would like to know if that will affect the vaccine. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bacterial pyelonephritis, Blood urine present, Cystitis bacterial, Urine analysis, Urine output decreased
Clinical narrative: kidney infection; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1, via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced kidney infection (medically significant) on an unspecified date. The 2nd dose will be on 15Apr2021. Last 08Apr2021, she was advised to take antibiotics for kidney infection. The patient would like to know if that will affect the vaccine. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: strokes signs; Two blood clots in the veins in legs; This is a spontaneous report from a contactable consumer.  A 64-year-old female consumer (patient) reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EN6199/EN6207 (as reported)) intramuscular into the left arm on 10Mar2021 (at the age of 64-years-old) at single dose for COVID-19 immunization. She received the second dose of BNT162B2 dose on 31Mar2021 (lot number unknown). Medical history included high blood pressure and GERD.     Concomitant drugs included Toprol  25mg, oral , twice a day  for blood pressure stated ''in Feb some time she don't know'' and Protonix 40mg,  oral twice a day for years for GERD. The consumer reported that 'she got her first vaccine and she has had the strokes signs''. Further she reported she got her first vaccine dose, then she had leg pain, she went to see the doctor and ordered a doppler.  She was put on blood thinners and three days later she got two blood clots in the veins of her legs, right. On 20Mar2021, her leg pain went pretty severe since I had the blood clot, when I got the second shot, it was still there. On 27Mar2021 she started treatment receiving Eliquis 5mg, twice a day for the blood clot and she did take a Physical therapy. When she got the second vaccine dose on 31Mar2021 she was on blood thinners. At the time of reporting the outcome of the event was reported as 'hasn't gotten better, it's the same not better not worse.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure decreased, Blood pressure measurement, Blood test, Loss of consciousness
Clinical narrative: Low grade fever; seizure; Passed out; syncope/ fainted; Blood pressure drop; Sore arm; This is a spontaneous report from a contactable consumer (patient's parent). A 28-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 28-years-old, via an unspecified route of administration in left arm on 07Apr2021 at single dose for COVID-19 immunization. Medical history included autism, being nervous, passed out, and anxiety. Concomitant medications included sertraline hydrochloride (ZOLOFT), quetiapine fumarate (SEROQUEL), gabapentin, bupropion hydrochloride (WELLBUTRIN), and lorazepam (ATIVAN) for being nervous. The patient received the Pfizer vaccine last Wednesday (07Apr2021) and immediately after that, at about 1:30 (unspecified), she just started having a seizure. They thought that it was more of a major response she was just having, fighting and was nervous about it, but it was kind of a different situation. The reporter has seen the patient passed out before. She did some blood test on 07Apr2021 and her sugars were fine. The reporter's concern was that they didn't know whether she should get the second one. The reporter didn't believe she got a seizure but was not sure about it. It's just that what immediately happened after she got the shot was that she passed out and they called the ambulance. After she passed out, she went to the emergency room and they did blood work on her. The reporter just did not know if they were going to let her go for the second dose because they couldn't relay if it was a seizure or a bizarre response where she just syncope and fainted. They were just thinking it was a bizarre response as it was just blood pressure drop but they were just not sure where to go from here. The patient was told to rest and intravenous fluid and something through the blood were given. The patient also experienced sore arm from 07Apr2021 for 2 days and had a low-grade fever the following day (08Apr2021). The outcome of the event sore arm was recovered on 09Apr2021 and recovered on Apr2021 for all other events.   Information about the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Seizure, Syncope
Clinical narrative: Low grade fever; seizure; Passed out; syncope/ fainted; Blood pressure drop; Sore arm; This is a spontaneous report from a contactable consumer (patient's parent). A 28-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 28-years-old, via an unspecified route of administration in left arm on 07Apr2021 at single dose for COVID-19 immunization. Medical history included autism, being nervous, passed out, and anxiety. Concomitant medications included sertraline hydrochloride (ZOLOFT), quetiapine fumarate (SEROQUEL), gabapentin, bupropion hydrochloride (WELLBUTRIN), and lorazepam (ATIVAN) for being nervous. The patient received the Pfizer vaccine last Wednesday (07Apr2021) and immediately after that, at about 1:30 (unspecified), she just started having a seizure. They thought that it was more of a major response she was just having, fighting and was nervous about it, but it was kind of a different situation. The reporter has seen the patient passed out before. She did some blood test on 07Apr2021 and her sugars were fine. The reporter's concern was that they didn't know whether she should get the second one. The reporter didn't believe she got a seizure but was not sure about it. It's just that what immediately happened after she got the shot was that she passed out and they called the ambulance. After she passed out, she went to the emergency room and they did blood work on her. The reporter just did not know if they were going to let her go for the second dose because they couldn't relay if it was a seizure or a bizarre response where she just syncope and fainted. They were just thinking it was a bizarre response as it was just blood pressure drop but they were just not sure where to go from here. The patient was told to rest and intravenous fluid and something through the blood were given. The patient also experienced sore arm from 07Apr2021 for 2 days and had a low-grade fever the following day (08Apr2021). The outcome of the event sore arm was recovered on 09Apr2021 and recovered on Apr2021 for all other events.   Information about the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Arthralgia, Depressed level of consciousness, Diarrhoea
Clinical narrative: Anaphylactic reaction; a lot of "brain fog"; Diarrhea; Her hip pain has gotten progressively worse; This is a spontaneous report from a contactable consumer via  Program.  The 46-years-old female consumer (patient) received BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown,) on 19Mar2021 via an unspecified route of administration as a single dose for COVID-19 immunization. The medical history and concomitant medication were not reported. The other medication included XELJANZ XR TAB 11MG since 28Jul2020. Patient reported that she had an anaphylactic reaction to her first Pfizer COVID-19 vaccine on 19Mar2021. Since this reaction she has had a lot of brain fog and diarrhea, that was not happening before the reaction. Patient also said that her hip pain has gotten progressively worse and affecting her ability to dress herself. Further patient explained she will miss 2 doses of Xeljanz before she receives the medication on 15Apr2021. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Schizophrenia
Clinical narrative: Schizophrenia; This is a spontaneous report received from Pfizer sponsored program. A contactable consumer reported that a 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiry date not reported), via an unspecified route of administration on 27Feb2021 as a single dose of COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter questions if patient can still receive the second dose as the patient is with schizophrenia and wanders off and sleeps at different locations. Outcome of the event was unknown.  Information about Lot/Batch number requested.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Joint swelling, Poisoning
Clinical narrative: My elbow is bigger than the golf ball on my left arm; That vaccine is poisonous; Sometimes it runs a temperature over 100 degrees over one spot, the rest of my body is cool; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient experienced that patient's elbow is bigger than the golf ball on left arm. Patient thinks that vaccine is poison. Sometimes patient runs a temperature over 100 degrees over one spot, the rest of the body is cool. Patient thinks that the vaccine is poisonous. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Ankle fracture, Product dose omission issue
Clinical narrative: miss the second dose on 17Mar2021; he fractured his ankle; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored program.  A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 24Feb2021 (at the age of 79-years) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Feb2021 (same day of vaccination), the patient fell down a flight of stairs and broke his ankle. The patient was scheduled to get the second dose on 17Mar2021 but unfortunately, he fractured his ankle which required him to undergo surgery and miss the second dose. Patient would like to know when to get the second dose of the vaccine and asks if he would need to restart the vaccination series due to the incident and if not, how long would he have in between the doses to receive the second vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pain
Clinical narrative: headache; shortness of breath; body pain; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199) via unspecified route on left arm single dose for COVID-19 immunization on 10Mar2021, 02:00 PM, at 58-year-old. Medical history included: high blood pressure, asthma, diabetes; allergies: ranitidine, metformin. Concomitant medication was not reported. The patient had headache, shortness of breath, body pain; doctor or other healthcare professional office/clinic visited and was reported as life threatening illness (immediate risk of death from the event). Treatment received as: betamethasone 6mg/ml 3ml, prednisone 40 mg x 4. Outcome of the event was resolving.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of the events headache, shortness of breath, body pain cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021445163 Same patient, different shot/event
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Dyspnoea, Gastric disorder, Headache, Pleural effusion
Clinical narrative: strong headache; a lot of shortness of breath; lungs full of fluids; stomach sickness; lost of smell; This is a spontaneous report from a contactable Nurse (patient). A 59-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Mar2021 14:00 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure, asthma, diabetes. Known allergies: ranitidine/metformin. No pregnant. The patient's concomitant medications were not reported. No covid prior vaccination.No other vaccine in four weeks. Historical Vaccine included first dose bnt162b2 at 58 year old for covid-19 immunisation, first dose lot number=EN6199, administration date=10Mar2021, administration time=02:00 PM, vaccine location=Left arm and experienced headache, shortness of breath and body pain. The patient experienced strong headache, a lot of shortness of breath, lungs full of fluids, stomach sickness, lost of smell on 05Apr2021 with outcome of recovering. The event was serious due to life threatening. AE resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Betamethasone 6mg/ml=3ml/ predinisone 40mg x 4. No covid tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021444473 Same patient, different shot/event
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dyspnoea, Gait disturbance, Myelitis transverse, SARS-CoV-2 test
Clinical narrative: Transverse Myelitis worsened; Transverse Myelitis worsened; I could not walk; trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunisation. Medical history was not provided. Patient was not pregnant, was not pregnant at time of vaccination. Concomitant medications included other medications in two weeks. No other vaccine in four weeks. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) at the age of 39-years, via an unspecified route of administration in right arm on 19Mar2021 14:00 at single dose for COVID-19 immunisation and experienced transverse myelitis; received zaleplon (SONATA) and experienced allergies. Less than 24 hours after receiving the second vaccination, the transverse myelitis worsened and patient could not walk and was beginning to have trouble breathing. Patient went to emergency room and was admitted and treated there for the following week for the condition transverse myelitis. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Days hospitalisation: 7. Patient received treatment for the events included among other meds, 5 day course of IV steroids . No covid prior vaccination, patient underwent covid test (Nasal Swab) post vaccination on 10Apr2021, covid test result was Negative. Outcome of the events was not recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myelitis transverse
Clinical narrative: Transverse Myelitis worsened; Transverse Myelitis worsened; I could not walk; trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunisation. Medical history was not provided. Patient was not pregnant, was not pregnant at time of vaccination. Concomitant medications included other medications in two weeks. No other vaccine in four weeks. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) at the age of 39-years, via an unspecified route of administration in right arm on 19Mar2021 14:00 at single dose for COVID-19 immunisation and experienced transverse myelitis; received zaleplon (SONATA) and experienced allergies. Less than 24 hours after receiving the second vaccination, the transverse myelitis worsened and patient could not walk and was beginning to have trouble breathing. Patient went to emergency room and was admitted and treated there for the following week for the condition transverse myelitis. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Days hospitalisation: 7. Patient received treatment for the events included among other meds, 5 day course of IV steroids . No covid prior vaccination, patient underwent covid test (Nasal Swab) post vaccination on 10Apr2021, covid test result was Negative. Outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report from a contactable consumer (patient herself).  This 60-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration in the right arm, on 06Mar2021 at 15:30 (Lot number EN6203) as single dose and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration in the left arm, on 27Mar2021 at 15:30 (Lot number EP7534) as single dose, for COVID-19 immunisation. Relevant medical history included allergy to nickel and latex). Past drug history included allergy to penicillin. Relevant concomitant medications included ezetimibe, chondroitin sulfate, glucosamine, biotin and vitamin (unspecified). No other vaccine was received in four weeks. The patient had a mild heart attack approximately two weeks after her first dose of the vaccine (untreated) in Mar2021 and a major heart attack 2 weeks to the day after her second dose (11Apr2021, at 02:00). The patient visited the emergency room and she was hospitalized for 5 days. The event was also considered serious as life-threatening. Therapeutic measures taken as result of the event includes angioplasty. The patient was recovering from the event.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis perforated, SARS-CoV-2 test
Clinical narrative: Appendicitis. Perforated appendix that started 6 days after vaccination; This is a spontaneous report from a contactable consumer. A 38-year-old male consumer (patient) reported that he received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration in left arm on 11Apr2021 10:00AM (at the age of 38-year-old) for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient had not COVID prior vaccination. On 17Apr2021, the patient had perforated appendix that started 6 days after vaccination. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for 6 days. Treatment included antibiotic and potential surgery upcoming. The patient was tested for COVID post vaccination (no results). The event was not resolved.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Major PE detected on CT Scan at an ER; This is a spontaneous report from a contactable consumer (patient).   A 74-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9810 ) on 09Feb2021 at 11:00 (at 74 years) at single dose in left arm for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Patient took the first dose of the vaccine (lot EL3247) in Jan2021 at 11:00 am  (at 74 years) in left arm for covid-19 immunisation. No COVID prior vaccination. On 31Mar2021 at 12:00 the patient experienced major pulmonary embolism (PE) detected on computerised tomogram (CT) Scan at an emergency room (ER). The event required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Event was serious duet to hospitalization and life threatening illness.Patient was hospitalized in 2021 for 4 days. Patient was treated with Heparin and Eliquis. Patient was tested post vaccination: Nasal Swab was done on 31Mar2021 and was negative. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hepatitis D
Clinical narrative: had Hepatitis D 3 days after First Pfizer Vaccine; This is a spontaneous report from a Pfizer sponsored program COVAX  support. This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) 1st dose via an unspecified route of administration on 12Mar2021 as SINGLE DOSE for COVID-19 immunization and hydrocortisone, neomycin sulfate, polymyxin b sulfate (CORTISPORIN). The patient medical history and concomitant medications were not reported. On Mar2021 the patient had hepatitis D 3 days after first Pfizer vaccine. It was reported that, second covid dose was given 03Apr2021. Caller was never asked about other injections at the time of the vaccine and was not supposed to get them so close together. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Gait inability, Pyrexia
Clinical narrative: fever; feeling weak; unable to walk independently; no appetite; This is a spontaneous report from a contactable consumer via social media. A 73-year-old male patient received the second dose of (lot number: EW2243), via an unspecified route of administration on 12Apr2021 09:45 (at the age of 73-years-old) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The other medications that the patient received within 2 weeks of vaccination were insulin and for blood pressure. Prior to vaccination, the patient was not diagnosed with Covid-19. The patient previously received the first dose of bnt162b2 (lot number: ER4812), via an unspecified route of administration on 16Mar2021 (at the age of 73-years-old) as a single dose for covid-19 immunisation. The patient's concomitant medications were not reported. On 16Apr2021, the patient experienced fever, feeling weak, unable to walk independently and had no appetite. The adverse events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received for the events. The outcome of the events was fatal. The patient died on 19Apr2021. Cause of death were fever, feeling weak, unable to walk independently and had no appetite. An autopsy was not performed. Since the vaccination, the patient hasn't been tested for covid-19.; Reported Cause(s) of Death: fever; feeling weak; unable to walk independently; no appetite
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thrombosis
Clinical narrative: Multiple blood clots in the left leg had to be submitted to the Emergency Room at the hospital for immediate treatment; This is a spontaneous report from a non-contactable consumer. A 40-years-old male patient received 1 dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE) lot number: ER2613 via an unspecified route of administration, in arm left on 12Apr2021 at the age of 40 years as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced multiple blood clots in the left leg and he had to be submitted to the emergency room at the hospital for immediate treatment on 16Apr2021 12:00 with outcome of recovering. The patient was hospitalized for 2 days and was treated with unspecified treatment. Covid test post vaccination: Nasal Swab on 20Apr2021 result Negative  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Had both vaccines and died from COVID-19 afterwards; Had both vaccines and died from COVID-19 afterwards; This is a spontaneous report from a contactable nurse. A 42-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 and dose 2; both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had both vaccines and died from COVID-19 afterwards on an unspecified date. The patient did not have any known underlying health conditions or issues. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Had both vaccines and died from COVID-19 afterwards; Had both vaccines and died from COVID-19 afterwards
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary embolism
Clinical narrative: pulmonary embolism; short of breath; This is a spontaneous report from a non-contactable consumer via Pfizer sales representative.  A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died of pulmonary embolism 2 days after 2nd vaccine dose. She had been short of breath the day after the shot, called the pharmacy where she'd received it, and they told her to go to ER. The reporter thought that she did not go to the ER, and then later died at home. It was unknown if an autopsy was performed. Outcome of the event short of breath at the time of death was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: pulmonary embolism