chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Vaccination site pain
Clinical narrative: feel like in a fog; severe headache/all over the top of my head and throbbing; chills; anxious; could not relax or sleep; Soreness at the injection site; Diarrhea for 3 hours; exhausting/fatigue; This is a spontaneous report from a contactable consumer (patient).  A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 24May2021 (Batch/Lot Number: ER8735) (at the age of 50-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history included COVID-19 prior to vaccination. Concomitant medications included fluoxetine; mirabegron (MYRBETRIQ); propranolol and lithium; all taken for an unspecified indication, start and stop date were not reported.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER8735) on 03May2021 (at the age of 50-years-old) in the right arm for COVID-19 immunisation. Patient had vaccine number 2 in the afternoon. On 24May2021 at 23:00, patient began to experience a severe headache. It was all over the top of her head and throbbing. Patient had the chills, anxious and could not relax or sleep.  Patient was unsteady on her feet. Patient had soreness at the injection site and diarrhea for 3 hours. It was exhausting. This morning (date unspecified), she still have not had any sleep.  She had a slight headache and fatigued. She felt like she was in a fog. No treatment was given to the patient. Since the vaccination, patient has not been tested for COVID-19. Outcome of headache was recovering, diarrhea was recovered on 25May2021, while remaining events was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Tremor
Clinical narrative: tremors; could not walk the next day; This is a spontaneous report from a contactable consumer (patient himself). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Apr2021 (Batch/Lot number and Expiration date were unknown) as the 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient could not walk next day (10Apr2021), was in the hospital and had tremors on an unspecified date, and was using a walker at the time of the report. The patient wanted to know if he should get the 2nd vaccine the day after the report (26May2021). The events led to hospitalization on an unspecified date. Therapeutic measures were taken as a result of the event "could not walk the next day." The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient received Pfizer Vaccine approx 2 months ago. Was diagnosed as COVID positive; Patient received Pfizer Vaccine approx 2 months ago. Was diagnosed as COVID positive/loss of smell and nasal congestion; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on Mar2021 (reported as approximately 2 months ago) (Batch/Lot number was not reported) as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received Pfizer Vaccine approximately 2 months ago (Mar2021). The patient was diagnosed as COVID positive today (25May2021) after experiencing loss of smell and nasal congestion. Nurse Practitioner was aware as the test was completed at MD office. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Dyspnoea, Peripheral swelling, Thrombosis
Clinical narrative: Sharp chest pain; Shortness of breath; Multiple occlusive thrombus in right leg(distal femoral, and popliteal vein with nonocclusive in right mid femoral vein); Right leg swelling; This is a spontaneous report from a contactable Other Health Professional. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as unknown, single dose for COVID-19 immunisation. Medical history included Acute cholecystitis without obstruction from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had not been diagnosed with covid-19 prior vaccination. It was unknown if patient had been tested for covid-19 post vaccination. He had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced multiple occlusive thrombus in right leg(distal femoral, and popliteal vein with nonocclusive in right mid femoral vein) and right leg swelling on 13Apr2021; shortness of breath on 17Apr2021 and sharp chest pain on 18Apr2021, all with outcome of Recovered/Resolved with Sequel. Further events description stated that on 13Apr2021 the patient developed right leg swelling; on 17Apr2021 developed shortness of breath; on 18Apr2021 he woke with sharp chest pain. He went to ER and found to have multiple occlusive thrombus in right leg (distal femoral, and popliteal vein with nonocclusive in right mid femoral vein). CT Chest in Apr2021 revealed emboli in bilateral lower lobes, right middle and right upper lobes. The patient was hospitalized for the events for 3 days. Therapeutic measures were taken as a result of the events. The patient had heparin drip and ELIQUIS. The events resulted to 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 events recovered with lasting effects on an unspecified date.  Information about Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Blindness, Cold sweat, Malaise
Clinical narrative: can't see; sick; Clammy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 18May2021 as an unknown dose number, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know if the vaccine can make the eyes go blurry. On 22May2021, Saturday, the patient has been sick and clammy and the patient can't see, it was a mess. The patient did not know whether he needs to go to the emergency room or not. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Deformity, Investigation
Clinical narrative: sharp chest pain; deformation; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EWQ175) via an unspecified route of administration, administered into left arm on 29Apr2021 12:00 (at the age of 41-year-old) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EWQ150) administered into left arm on 08Apr2021 12:00 PM (at the age of 41-year-old) for COVID-19 immunization. On 02May2021, patient experienced sharp chest pain. Patient went to the emergency room and they found that it was not a heart attack but something else. Patient underwent chest exams on 02May2021 which ruled out any blockage or tearing but there was a deformation for no known reason. The events required emergency room visit, caused hospitalization on 02May2021 and patient was treated with blood thinners. Outcome of events was recovering. Patient was sure that the events were an adverse effect of the vaccine.  Follow up attempts are needed. Further information has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: Paralyzed; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration in the right high shoulder (right deltoid) on 27Mar2021 at 10:03 at the age of 47 years old (Batch/Lot Number: ERZ613 OR ER2613) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), at the age of 47 years old, batch number: EN6205 on 06Mar2021 at 10:11AM or 09:11AM given in her right high shoulder as an injection for COVID-19 immunisation. The patient was calling about the COVID 19 vaccination that she received. She stated that with the first dose, she did not feel anything, and she is calling to report on the second dose. She has spoken with Pfizer before, but she had questions and she was told how to go about it. She stated she received the vaccine and the symptom started exactly 8 hours after. She got the vaccine at 10:05AM or 10:03AM and it was about 9:03PM when the symptom started. She stated she got the vaccine probably at 10:03AM on 27Mar2021 and she was paralyzed. She stated picture someone laying there, it went into the right arm and then went into left and paralyzed there then it came down from the top to across her chest and shot straight down and missed the breast area and went into the ribs then it paralyzed her left leg and shot right across and paralyzed her whole right thigh and all she knows was that she could not move. She was paralyzed, and it shot into her and came across and then straight down. She stated it just did it at the moment exactly 8 hours and it started at around 9:08pm. She clarified, well it started actually 11 hours after the vaccine and not 8 hours. She wanted to say it lasted for 2 minutes where she could not move for a while and it was strange. The exact time was maybe 2 minutes after it started was when it stopped. She clarified and stated, well actually it lasted a couple of hours and stopped at 11:08PM. She stated she is not sure if she has recovered completely from this. The event outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: patient bled a lot more than usual after getting the Pfizer COVID Vaccine/the site was bandaged but, it was still bleeding pretty good; This is a spontaneous report from a contactable pharmacist. A 14-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reports patient bled a lot more than usual after getting the pfizer covid vaccine/the site was bandaged but, it was still bleeding pretty good on an unspecified date. Pharmacist reports that the patient received first dose of the Pfizer COVID Vaccine and it bleed a lot more than usual. Reports using a 1 inch needle giving the shot and the site was bandaged but, it was still bleeding pretty good. The outcome of the event was unknown.  Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient getting covid symptoms after getting covid vaccine; Patient getting covid symptoms after getting covid vaccine; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient (also reported as 41-year-old) received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was getting covid symptoms after getting covid vaccine on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Heart rate, Pain
Clinical narrative: She had a little pain, but that was nothing; This is a spontaneous report from a contactable consumer (reporting for herself).  A 75 year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm, at age 75 years, on 07Apr2021 (Batch/Lot Number: EP7533) as 1ST DOSE,SINGLE DOSE for COVID-19 immunisation. Medical history included ongoing slow thyroid  and high blood pressure. She has never been in the hospital. She has never had surgeries. She doesn't have diabetes. She is a healthy woman. She is a hiker, and usually hikes 4-5 miles a day,  She tries to make sure her heart goes to 128. She didn't have any problems getting there. Concomitant medication included levothyroxine 75 ug taken for slow thyroid, start and stop date were not reported; valsartan (DIOVAN) 160-12.5 mg taken for high blood pressure, start and stop date were not reported. The patient previously took Centrum but usually stops it a month before her blood test to see how normal her blood test is. So she hasn't taken the Centrum since Mar2021. The first dose was given on 07Apr2021, with lot number EP7533 in her left arm. She had a little pain, but that was nothing on an unspecified date in 2021. She had no reaction on her arm. She was so happy not to have side effects. She had no rash or shortness of breath. She was so happy. Last year (2020), she had an electrocardiogram done, and everything was normal with no problems. She doesn't have diabetes or any illness. ECG done everything normal no problems. She gets a blood test every year to see if everything is normal. The outcome of the event was recovered. Patient had her second dose was on 28Apr2021.   Information on lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Diarrhoea, Dyspnoea, Flatulence, Laboratory test
Clinical narrative: Its lessened, intermittent, she will be fine for a few days and then feel winded.; diarrhea; shortness of breath; palpitations; had a weird rash on her leg; itching all over her body; nausea; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0172), via an unspecified route of administration on 24Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Vaccine was not administered at military facility. The patient received her first Pfizer Covid vaccine on 24Apr2021 and she went to the ER on the 25Apr2021 because she had a weird rash on her leg, shortness of breath and palpitations. She wanted to make sure it wasn't a blood clot. Her labs and chest x-ray came back normal and ER doctor said to check back with her primary care physician. She had the rash and itching all over her body on 25Apr2021. She also had nausea on 25Apr2021 and diarrhea on 26Apr2021. Its lessened, intermittent, she will be fine for a few days and then feel winded on an unspecified date. Therapeutic measures were taken as a result of shortness of breath and had a weird rash on her leg and included treatment with Benadryl. The outcome of the events shortness of breath and palpitations were recovering, the outcome of the event had a weird rash on her leg was recovered on an unspecified date, and the outcome of the other events were unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Pruritus, Rash
Clinical narrative: Its lessened, intermittent, she will be fine for a few days and then feel winded.; diarrhea; shortness of breath; palpitations; had a weird rash on her leg; itching all over her body; nausea; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0172), via an unspecified route of administration on 24Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Vaccine was not administered at military facility. The patient received her first Pfizer Covid vaccine on 24Apr2021 and she went to the ER on the 25Apr2021 because she had a weird rash on her leg, shortness of breath and palpitations. She wanted to make sure it wasn't a blood clot. Her labs and chest x-ray came back normal and ER doctor said to check back with her primary care physician. She had the rash and itching all over her body on 25Apr2021. She also had nausea on 25Apr2021 and diarrhea on 26Apr2021. Its lessened, intermittent, she will be fine for a few days and then feel winded on an unspecified date. Therapeutic measures were taken as a result of shortness of breath and had a weird rash on her leg and included treatment with Benadryl. The outcome of the events shortness of breath and palpitations were recovering, the outcome of the event had a weird rash on her leg was recovered on an unspecified date, and the outcome of the other events were unknown.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pain in extremity, SARS-CoV-2 test, Skin disorder
Clinical narrative: wrist and ankle pain; heel pain; bump re appeared however only on ankle and heel; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on 28Apr2021 (at the age of 19-years-old) at 2nd dose, single dose for COVID-19 immunization. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Past drug history was reported as none. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration in left arm on 01Apr2021 at 11:15 (at the age of 19-years-old) at 1st dose, single dose for COVID-19 immunization. On 06-08Apr2021 after the first dose, he experienced low grade fever, chills, and body ache. On 14Apr2021, he began to complain about chest pain. He went to a hospital in which he was told he has environmental pneumonia on right lung and was given antibiotics. On 17Apr2021, he went to the emergency room due fever at 104.3 and chills which were high, and he had difficulty breathing. He was admitted to a hospital and was eventually transferred. He was given antibiotics (ZITHROMAX) and IV fluids. The patient was discharged on 21Apr2021. Later that night, they noticed bumps that hurt in front of his legs. He went to the doctor and they indicated he had erythema nodosum and was prescribed prednisone 2 a day for 5 days. He took an X-ray that showed he had hilar lymphadenopathy on Apr2021, and they will go and see a pulmonary specialist. The patient was told it was ok to take the second dose of the Pfizer vaccine. He received the second dose on 28Apr2021 and on 01May2021, bump re-appeared however, it was only on his ankle and heel. On 15May2021, new symptoms he experienced were wrist, ankle, and heel pain. He was waiting to see a specialist. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient underwent lab tests and procedures which included nasal swab for COVID-19: negative on 12Apr2021, 15Apr2021, and 17Apr2021; body temperature: 104.3 on 17Apr2021; and X-ray: hilar lymphadenopathy on Apr2021. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: wrist and ankle pain; heel pain; bump re appeared however only on ankle and heel; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on 28Apr2021 (at the age of 19-years-old) at 2nd dose, single dose for COVID-19 immunization. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Past drug history was reported as none. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration in left arm on 01Apr2021 at 11:15 (at the age of 19-years-old) at 1st dose, single dose for COVID-19 immunization. On 06-08Apr2021 after the first dose, he experienced low grade fever, chills, and body ache. On 14Apr2021, he began to complain about chest pain. He went to a hospital in which he was told he has environmental pneumonia on right lung and was given antibiotics. On 17Apr2021, he went to the emergency room due fever at 104.3 and chills which were high, and he had difficulty breathing. He was admitted to a hospital and was eventually transferred. He was given antibiotics (ZITHROMAX) and IV fluids. The patient was discharged on 21Apr2021. Later that night, they noticed bumps that hurt in front of his legs. He went to the doctor and they indicated he had erythema nodosum and was prescribed prednisone 2 a day for 5 days. He took an X-ray that showed he had hilar lymphadenopathy on Apr2021, and they will go and see a pulmonary specialist. The patient was told it was ok to take the second dose of the Pfizer vaccine. He received the second dose on 28Apr2021 and on 01May2021, bump re-appeared however, it was only on his ankle and heel. On 15May2021, new symptoms he experienced were wrist, ankle, and heel pain. He was waiting to see a specialist. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient underwent lab tests and procedures which included nasal swab for COVID-19: negative on 12Apr2021, 15Apr2021, and 17Apr2021; body temperature: 104.3 on 17Apr2021; and X-ray: hilar lymphadenopathy on Apr2021. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Nausea, Pain in extremity
Clinical narrative: nausea; Headache; Fatigue; different feeling than what he normally feels; His arm was sore; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 23Feb2021 14:02 (at the age of 76-year-old) (Batch/Lot Number: EN6202; Expiration Date: 30Jun2021) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included diabetes from 1996. The patient's concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN9264) administered in the right arm on 02Feb2021 (at the age of 76-year-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunization where patient also experienced his arm was sore. On 24Feb2021, the patient experienced nausea, headache, fatigue, different feeling than what he normally feels, and his arm was sore. The onset time for the events headache and nausea was at 09:00. The patient was admitted to the hospital due to the events nausea, headache, fatigue, and different feeling than what he normally feels. The events did not require emergency room and physician office visit. There was no treatment received for all events. On an unspecified date, the patient recovered from all events.  Follow-up attempts are needed. Further information has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Magnetic resonance imaging, Product use issue, Thrombosis
Clinical narrative: Blood clot caused stroke on right side of the body 4 weeks after the 2nd dose of vaccination; Blood clot caused stroke on right side of the body 4 weeks after the 2nd dose of vaccination; The patient also received the first dose of other vaccine on 18Apr2021.; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 76 years old, in left arm on 18Apr2021 14:30 at single dose for covid-19 immunisation.  Medical history included high blood pressure. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with covid-19 prior to vaccination. The patient received high blood pressure medicine within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient previously received the first dose of BNT162B2 (lot number: unknown), at the age of 76 years old, in left arm on 28Mar2021 14:30 at single dose for covid-19 immunisation. The patient also received the first dose of other vaccine on 18Apr2021. The patient experienced blood clot caused stroke on right side of the body 4 weeks after the second dose of vaccination on 15May2021 20:00. The patient was hospitalized for the events blood clot caused stroke on right side of the body for 14 days. The events blood clot caused stroke on right side of the body caused disability. The patient had not been tested for covid-19 since the vaccination. Therapeutic measures were taken as a result of blood clot caused stroke on right side of the body 4 weeks and included treatment with tissue plasminogen activator (TPA) shot, magnetic resonance imaging (MRI) and therapy. The outcome of events blood clot caused stroke was recovering. The outcome of event received other vaccine on 18Apr2021 was unknown.  Information on the batch/lot number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Vomiting
Clinical narrative: Constant throwing up and went into a stroke; Constant throwing up and went into a stroke; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EWO151), at the age of 80 years old, in right arm on 02Apr2021 12:45 at single dose for covid-19 immunisation.  Medical history included chronic obstructive pulmonary disease (COPD). The patient was not pregnant at time of vaccination. The patient was not diagnosed with covid-19 prior to vaccination. The patient received any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient experienced constant throwing up and went into a stroke on 01May2021 10:00. The patient was hospitalized due to the events. The patient had not been tested for covid-19 since the vaccination. Therapeutic measures were taken as a result of constant throwing up and went into a stroke. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fracture, Road traffic accident
Clinical narrative: bad fall/fractures from her fall; bad fall/fractures from her fall; car accident; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 29Mar2021 (batch/lot number was not reported), as 1st dose, single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had her first dose and then got in a car accident on an unspecified date. She missed her second dose. It was also reported that the patient had a bad fall due to other reasons and was in the hospital (unspecified date) to have a surgery because of fractures from her fall. The reporter asked if the patient should get the second dose even though it was almost 4 weeks since her first dose of should the patient start over. The outcome of the events was unknown.  Information about lot/batch number has been requested. Additional information has been expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19
Clinical narrative: had all the symptoms of covid noting he lost his sense of taste and smell; had all the symptoms of covid noting he lost his sense of taste and smell; symptoms of covid; This is a spontaneous report received from the Pfizer Sponsor Program. A contactable consumer reported for a 37-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date as 1st dose single for covid-19 immunisation  .  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient received the first dose of the Pfizer covid 19 vaccine and eight days later had all the symptoms of covid noting he lost his sense of taste and smell on an unspecified date with outcome of unknown.  Patient was not tested for Covid but caller knows the patient has Covid.   Information on the lot/batch number has been requested.  The events Smell loss, Taste loss, and COVID-19 occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: experienced a seizure after vaccination; This is a spontaneous report from a contactable nurse. A 72-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date as SINGLE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced a seizure after vaccination on an unspecified date with outcome of unknown.  They took patient to the Emergency Room (ER).  Information on the lot/batch number has been requested.; Sender's Comments: Current information is limited and does not allow a full medical assessment.  Relevant medical history and concomitant drugs are not reported.  Case will be reassessed once receiving additional information. 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 agency as appropriate.,Linked Report(s) : US-PFIZER INC-2021610416 Same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Aneurysm, Cerebrovascular accident, Clumsiness, Computerised tomogram, Dysarthria
Clinical narrative: CT scan showed positive for stroke and aneurysm; CT scan showed positive for stroke and aneurysm; left side drooping in face; slurred speech; left arm clumsy; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer representative. This consumer reported the same events under the same suspect product for three patients. This is the first of three reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6263) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received 2nd Pfizer Covid vaccine on 26Feb2021. Approximately 48 hours later patient experienced slurred speech, left side drooping in face, unable to text on phone, left arm clumsy, went to ER (emergency room) Monday morning, CT (computed tomography) scan showed positive for stroke and aneurysm. Patient admitted and hospital gave heparin and daily aspirin. MRI (on Magnetic resonance imaging) Tuesday - unknown results. Symptoms subsided a few days later. The outcome of events was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021606116 Same reporter and drug, similar events, different patients;US-PFIZER INC-2021606117 Same reporter and drug, similar events, different patients
Sex: U
Vaccine: COVID19
Symptoms: Facial paralysis, Magnetic resonance imaging
Clinical narrative: CT scan showed positive for stroke and aneurysm; CT scan showed positive for stroke and aneurysm; left side drooping in face; slurred speech; left arm clumsy; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer representative. This consumer reported the same events under the same suspect product for three patients. This is the first of three reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6263) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received 2nd Pfizer Covid vaccine on 26Feb2021. Approximately 48 hours later patient experienced slurred speech, left side drooping in face, unable to text on phone, left arm clumsy, went to ER (emergency room) Monday morning, CT (computed tomography) scan showed positive for stroke and aneurysm. Patient admitted and hospital gave heparin and daily aspirin. MRI (on Magnetic resonance imaging) Tuesday - unknown results. Symptoms subsided a few days later. The outcome of events was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021606116 Same reporter and drug, similar events, different patients;US-PFIZER INC-2021606117 Same reporter and drug, similar events, different patients
Sex: U
Vaccine: COVID19
Symptoms: Clumsiness, Dysarthria, Facial paralysis
Clinical narrative: drooping in face; slurred speech; left arm clumsy; This is a spontaneous report from a contactable consumer received via Pfizer sales representative. This consumer reported the same events under the same suspect product for three patients. This is one of three reports. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced (left side) drooping in face, slurred speech and left arm clumsy. Outcome of events were unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021606004 Same reporter, drug and events; different patient;US-PFIZER INC-2021606117 Same reporter, drug and events; different patient
Sex: U
Vaccine: COVID19
Symptoms: Clumsiness, Dysarthria, Facial paralysis
Clinical narrative: Slurred speech; left arm clumsy; drooping in face; This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. This consumer reported the same events under the same suspect product for three patients. This is one of three reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced drooping in face, slurred speech and left arm clumsy, all on an unspecified date with outcome of unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021606116 Same reporter, drug and events; different patient;US-PFIZER INC-2021606004 Same reporter, drug and events; different patient
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dysgeusia, Hot flush, Malaise, Oxygen saturation
Clinical narrative: Came down with COVID after receiving the first shot; Oxygen level down to 50; Food tasted terrible; Running 103 fever; Not feeling that good today; Hot flash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05May2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient medical history included Kidney transplant from Aug2018 and ongoing. Concomitant medications were not reported. Caller states she got the first shot on 05May2021 and came down with COVID on 08May2021. She was  hospitalized, and is now out of the hospital. She wants to know how soon can she get the second shot. It is  scheduled for 27May2021. Caller clarified that she is referring to the Pfizer biotech COVID vaccine. Caller states she got it at (facility name). Caller states they told her when she got out of the hospital to call where she got the injection, and they would be able to tell her what to do. Caller states she needs to get dental work done, and she needs to get this cleared up. Caller states she knew she had COVID because food tasted terrible, and she was running a 103 fever. She was in-home tested and at the hospital they tested her too. She was immediately placed in quarantine. Caller states an ambulance had to come get her from the house because her oxygen level got down to 50. Caller states she would prefer to transfer because she is not feeling that good that day (25May2021). Caller states you guys make this really hard, you promote how easy it is to get this shot, but it's not. States she had a good experience getting the first shot, there was no line, and everyone was so nice. Caller states the thing is right now she has three follow up appointments with a pulmonary therapist, cardiac and kidney doctor, cardiologist and respiratory therapist. Caller states she reached out to her physician, and she was told to contact Pfizer. They wanted to know if she can get the vaccine. Caller wants to know if she should ask her other doctors if she should get the vaccine? Caller states the thing is her primary care doctor is on maternity leave. Caller declines transfer and states she needs to end the call because she is having a hot flash (25May2021). Caller abruptly disconnected the call. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pyrexia, Suspected COVID-19
Clinical narrative: Came down with COVID after receiving the first shot; Oxygen level down to 50; Food tasted terrible; Running 103 fever; Not feeling that good today; Hot flash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05May2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient medical history included Kidney transplant from Aug2018 and ongoing. Concomitant medications were not reported. Caller states she got the first shot on 05May2021 and came down with COVID on 08May2021. She was  hospitalized, and is now out of the hospital. She wants to know how soon can she get the second shot. It is  scheduled for 27May2021. Caller clarified that she is referring to the Pfizer biotech COVID vaccine. Caller states she got it at (facility name). Caller states they told her when she got out of the hospital to call where she got the injection, and they would be able to tell her what to do. Caller states she needs to get dental work done, and she needs to get this cleared up. Caller states she knew she had COVID because food tasted terrible, and she was running a 103 fever. She was in-home tested and at the hospital they tested her too. She was immediately placed in quarantine. Caller states an ambulance had to come get her from the house because her oxygen level got down to 50. Caller states she would prefer to transfer because she is not feeling that good that day (25May2021). Caller states you guys make this really hard, you promote how easy it is to get this shot, but it's not. States she had a good experience getting the first shot, there was no line, and everyone was so nice. Caller states the thing is right now she has three follow up appointments with a pulmonary therapist, cardiac and kidney doctor, cardiologist and respiratory therapist. Caller states she reached out to her physician, and she was told to contact Pfizer. They wanted to know if she can get the vaccine. Caller wants to know if she should ask her other doctors if she should get the vaccine? Caller states the thing is her primary care doctor is on maternity leave. Caller declines transfer and states she needs to end the call because she is having a hot flash (25May2021). Caller abruptly disconnected the call. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cardiomyopathy, Chest discomfort, Dyspnoea, Myocardial infarction, Troponin
Clinical narrative: diagnosed with cardiomyopathy; heart attack; difficulty breathing and chest pressure; difficulty breathing and chest pressure; This is a spontaneous report from a contactable consumer.  A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Event took place after use of product. The patient was in great health and fitness. The patient received the 1st dose of Pfizer COVID vaccine and within 48 hours, he was having difficulty breathing and chest pressure. The patient was admitted to the Emergency Room (ER) with a heart attack. He was diagnosed with cardiomyopathy and admitted to hospital for 7 days. Troponin level was between 9-10 for 2 days straight. The patient will not be getting the 2nd dose of vaccine. The outcome of the events was unknown.  Information about batch/Lot number has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspnoea, Laboratory test
Clinical narrative: HEART...  SUDDEN DEATH 20 DAYS AFTER; BREATHING ISSUES; This is a spontaneous report from a contactable consumer (patient). An 85-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL1284, expiry date not provided) via an unspecified route of administration, administered in left arm on 02Feb2021 as first dose, single dose for covid-19 immunisation. Medical history included diabetes, bipolar, seizure disorder and COPD (chronic obstructive pulmonary disease), all from an unknown date and unknown if ongoing. The patient's concomitant medications included unspecified medications reported as patient received within 2 weeks of vaccination. The patient previously took buproprion hydrochloride (WELLBUTRIN). Patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. Prior to vaccination, the patient was diagnosed with COVID-19. On 10Feb2021 10:00, the patient experienced heart (also reported as sudden death 20 days after), and immediately had breathing issues, no arrhythmia, no adverse defibrillator reading recorded. Family saw decline immediately after injection, did not request autopsy and adverse medical decline reported to doctor following injection. The events resulted to doctor or other healthcare professional office/clinic visit. Treatment receive in response to the events and treated with cardiologist. The patient died on 10Feb2021.  The causes of death were heart (heart disorder) and breathing issues. An autopsy was not performed. Since the vaccination, the patient has been tested for COVID-19.; Reported Cause(s) of Death: HEART...  SUDDEN DEATH 20 DAYS AFTER; BREATHING ISSUES
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Computerised tomogram, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Guillain Barre Syndrome (tingling, heat, sharp electrical-like pains started in both feet in the morning); Pains eventually attacked my lower stomach; This a spontaneous report from a contactable consumer (patient herself).   This 46-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0173), via an unknown route of administration in the left arm, on 08May2021 09:30 AM (at the age of 46-year-old female) at single dose for COVID-19 immunisation, administered at Pharmacy/drug store. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0153), via an unknown route in the left arm, on 17Apr2021 09:30 AM (at the age of 46-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. The patient did not have relevant medical history and concomitant medications. On 13May2021 07:00 AM, she had tingling, heat, and sharp electrical-like pains started in both feet. By afternoon it had traveled up both legs. It eventually attacked both legs and her lower stomach. The patient visited the emergency room (ER) where doctor diagnosed Guillain Barre Syndrome. The patient was treated with gabapentin and pain meds. In May2021, computerized tomogram (CT) scans and lumbar puncture were done but results were not provided. The patient is currently recovering from the events.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Pharyngeal swelling, Urticaria
Clinical narrative: shortness of breath; hives on nouth; throat swelling; dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 1 via an unspecified route of administration, administered in Arm Left on 19May2021 (Batch/Lot Number: ew0177) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included asthma. Concomitant medication included fluticasone propionate (FLOVENT); montelukast sodium (SINGULAIR); and cetirizine hydrochloride (ZYRTEC) and METHYLPHINATE. The patient previously took peanut, tree nut, coconut. The patient experienced shortness of breath, hives on mouth, throat swelling, and dizziness all on 19May2021 14:00 with outcome of recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment antihistamine was received for the adverse event. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.