chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Wrong schedule
Clinical narrative: Covid positive; Covid positive; Is scheduled for the second shot on 03May.; This is a spontaneous report from a contactable consumer. This consumer reported for his 67-year-old patient (wife) that, she received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown) via an unspecified route of administration on 28Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The Reporter has a question regarding second shot for Covid. He and his wife got the first shot of Pfizer on 28Jan and stated that doctor checked them and found out they were Covid positive. The reporter stated that they were sent to the hospital and infused with monoclonal antibody, now they were fine and relieved. He reported that the nurse said not to have the shot until about 90 days. The reporter wanted to know if they should have shot at 90 days and if have any information about this. Is scheduled for the second shot on 03May. The outcome of the events reported as unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid19; tested positive for Covid19; This is a spontaneous report from contactable consumer. This consumer reported similar events for two patients (wife and daughter). This is 1st of 2 reports and refers to reporter's wife.   A female patient (age not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on unknown date (Lot number not provided) as single dose for COVID-19 immunisation and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, in Jan2021 (Lot number not provided) as single dose  for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient has recently tested positive for COVID19. It was unknown if the patient received treatments for the events. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446811 Same reporter/drug/event, different patient
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had couples of days of bad symptoms thought had COVID but had no fever; had couples of days of bad symptoms thought had COVID but had no fever; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced had couples of days of bad symptoms thought had covid but had no fever. The patient underwent lab tests and procedures which included body temperature: normal on but had no fever, sars-cov-2 test: positive on friend around 40 years old had couples of days of bad symptoms thought had COVID but had no fever. The outcome of event was unknown. Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid symptoms; Covid Symptoms; This is a spontaneous report received from a contactable consumer (patient). This is one of the 2 report from same patient. A 73-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6208) dose 2, via intramuscular route of administration on upper left arm on 11Mar2021 15:00 at single dose for COVID-19 immunization. On 01Jul2020 to 09Jul2021 the patient medical history included, Positive Covid 19, Fever, Chills, No appetite, diarrhea, body headache. The patient concomitant medications were not reported. The patient received bnt162b2, (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6201) dose 1 via Intramuscular route of administration on upper left arm on 18Feb2021 15:00 at single dose for COVID-19 immunization and experienced Covid Symptoms on 19Feb2021 03:30, received treatment (Tylenol) for adverse event. On 11Mar2021 12:00 the patient experienced covid symptoms after second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: Positive on unknown date in 2021. The patient received treatment (Tylenol) for adverse event. The patient recovered from the events on 13Mar2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever above 101.2
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Fatigue, Full blood count, Injection site pain
Clinical narrative: Pain and soreness at injection site x48 hours, onset 3 hours after injection Fatigue, aches, chills, fever x36 hours, onset 3 hours after injection Bruising and itching to legs x4 days, onset 12 hours after injection, ongoing
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, Pain, Pruritus, Pyrexia
Clinical narrative: Pain and soreness at injection site x48 hours, onset 3 hours after injection Fatigue, aches, chills, fever x36 hours, onset 3 hours after injection Bruising and itching to legs x4 days, onset 12 hours after injection, ongoing
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: My feet and right hand were progressively getting more painful and hard to move after the first shot. And now after the second shot my right hand and left hand hace gotten progressively worse in stiffness and pain and my right foot is always in pain in the morning. And I suffer through the day at it gets a little better but never normal.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Headache, Insomnia, Lymph node pain, Malaise
Clinical narrative: cold sweats (skin very hot, I assume I had a fever, though was too sick to check it) sleeplessness aches all over body,  pain not quellable with Tylenol headache sensitive glands     all lasting about 12 hours      this was my 2nd dose, first dose had no effects except for site soreness
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin warm
Clinical narrative: cold sweats (skin very hot, I assume I had a fever, though was too sick to check it) sleeplessness aches all over body,  pain not quellable with Tylenol headache sensitive glands     all lasting about 12 hours      this was my 2nd dose, first dose had no effects except for site soreness
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thrombosis
Clinical narrative: Big Blood Clot in left leg; This is a spontaneous report from a non-contactable consumer (Patient). A 80-years-old female patient (Non-pregnant) received bnt162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection), via an unspecified route of administration on 28Mar2021 11:00 as single dose for COVID-19 immunisation. The patient medical history included allergies to Demerol. The patient's concomitant medications were not reported. On 17Apr2021 21:30 patient experienced big blood clot in left leg. Patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included Nasal swab test results negative on 16Apr2021. Treatment received for the adverse event was blood thinners. The outcome of event was Not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Fatigue, Hypoaesthesia oral, Pain
Clinical narrative: I had my 2nd Moderna Covid vaccination on Monday at 11. By the time I got home Monday night, I was having rigors and severe pain throughout my body. Tuesday, I continued having the pain, extreme fatigue and started having itching, burning and hypersensitive skin everywhere.  Finally took Benadryl around 2000 Tuesday evening when my lips and tongue started getting numb and tingling. 5/4/2021- The pain subsided, but I continue to have the itching and hypersensitivity.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pruritus, Sensitive skin
Clinical narrative: I had my 2nd Moderna Covid vaccination on Monday at 11. By the time I got home Monday night, I was having rigors and severe pain throughout my body. Tuesday, I continued having the pain, extreme fatigue and started having itching, burning and hypersensitive skin everywhere.  Finally took Benadryl around 2000 Tuesday evening when my lips and tongue started getting numb and tingling. 5/4/2021- The pain subsided, but I continue to have the itching and hypersensitivity.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bruxism, Chills, Decreased appetite, Dizziness, Dry mouth
Clinical narrative: Sudden onset of muscle spasms approximately 16 hours after 2nd Moderna Vaccine for COVID-19 followed by: ?Low-Midgrade fever,Dizziness, Dry Mouth,  Muscle Pain, Injection Site Pain, Difficulty Swallowing, Chills, Skin Sensitivity, Teeth Grinding,  Loss of Appetite,  Loss of Sense of Time,  Feral Hallucinations,  Feelings of Regret.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Feeling guilty, Hallucination, Injection site pain, Muscle spasms
Clinical narrative: Sudden onset of muscle spasms approximately 16 hours after 2nd Moderna Vaccine for COVID-19 followed by: ?Low-Midgrade fever,Dizziness, Dry Mouth,  Muscle Pain, Injection Site Pain, Difficulty Swallowing, Chills, Skin Sensitivity, Teeth Grinding,  Loss of Appetite,  Loss of Sense of Time,  Feral Hallucinations,  Feelings of Regret.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia, Skin sensitisation, Time perception altered
Clinical narrative: Sudden onset of muscle spasms approximately 16 hours after 2nd Moderna Vaccine for COVID-19 followed by: ?Low-Midgrade fever,Dizziness, Dry Mouth,  Muscle Pain, Injection Site Pain, Difficulty Swallowing, Chills, Skin Sensitivity, Teeth Grinding,  Loss of Appetite,  Loss of Sense of Time,  Feral Hallucinations,  Feelings of Regret.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Chest pain, Chills
Clinical narrative: Approximately 12 hours after I received my second Moderna vaccine dose (around 4:30am EST), I began having chills, fever, body aches, nausea, moderate chest pain/discomfort, vomiting, and shortness of breath. I called 911 and asked for an ambulance because of difficulty breathing. Arrived at Hospital Center ER around 5:00am, given oxygen and several tests (blood, urine, EKG) and also IV fluids in my left arm. Vomited a second time around 8:00am. Continued difficulty breathing until around 11:00am and chest pain improved somewhat. Got chest x rays done and monitored until I could breathe more regularly without oxygen. Discharged around 12:26pm. Heartbeat was abnormally fast for this whole duration and did not return to resting heart rate until about 5:00pm later that evening, 24 hours after vaccine. All symptoms subsided within 48 hours. Diagnosis was nonspecific chest pain and UTI.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram abnormal, Heart rate increased, Nausea, Pain
Clinical narrative: Approximately 12 hours after I received my second Moderna vaccine dose (around 4:30am EST), I began having chills, fever, body aches, nausea, moderate chest pain/discomfort, vomiting, and shortness of breath. I called 911 and asked for an ambulance because of difficulty breathing. Arrived at Hospital Center ER around 5:00am, given oxygen and several tests (blood, urine, EKG) and also IV fluids in my left arm. Vomited a second time around 8:00am. Continued difficulty breathing until around 11:00am and chest pain improved somewhat. Got chest x rays done and monitored until I could breathe more regularly without oxygen. Discharged around 12:26pm. Heartbeat was abnormally fast for this whole duration and did not return to resting heart rate until about 5:00pm later that evening, 24 hours after vaccine. All symptoms subsided within 48 hours. Diagnosis was nonspecific chest pain and UTI.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Urinary tract infection, Urine analysis abnormal, Vomiting
Clinical narrative: Approximately 12 hours after I received my second Moderna vaccine dose (around 4:30am EST), I began having chills, fever, body aches, nausea, moderate chest pain/discomfort, vomiting, and shortness of breath. I called 911 and asked for an ambulance because of difficulty breathing. Arrived at Hospital Center ER around 5:00am, given oxygen and several tests (blood, urine, EKG) and also IV fluids in my left arm. Vomited a second time around 8:00am. Continued difficulty breathing until around 11:00am and chest pain improved somewhat. Got chest x rays done and monitored until I could breathe more regularly without oxygen. Discharged around 12:26pm. Heartbeat was abnormally fast for this whole duration and did not return to resting heart rate until about 5:00pm later that evening, 24 hours after vaccine. All symptoms subsided within 48 hours. Diagnosis was nonspecific chest pain and UTI.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased, Palpitations, Troponin I increased
Clinical narrative: short of breath  extremely fast heart palpitations fast pulse chest discomfort
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: PATIENT RECIEVED PFIZER 1/8/2021. HE COMPLETED SERIES WITH MODERNA ON 4/30/2021. LOCATION DOES NOT OFFER PFIZER.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: One week after receiving the first Moderna vaccine a raised square rash appeared at the site of injection. Rash appeared raised for about 2 days before becoming flat. The rash is red and still spreading down the arm at least 6 days later. The rash is mildly itchy.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling of body temperature change, Headache, Injection site pain
Clinical narrative: A rash appeared on entire back. hot cold flashes, headaches that come and go, foggy brain, fatigued but cant sleep. Nine days into the first injection, my right arm (around injection sight ) approx 4 inch x 4 inch rash and major swelling of my upper arm.  Seems to be getting worse. Very itchy, warm to the touch , and hurts. Rash on the back has not gone away either.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth, Rash
Clinical narrative: A rash appeared on entire back. hot cold flashes, headaches that come and go, foggy brain, fatigued but cant sleep. Nine days into the first injection, my right arm (around injection sight ) approx 4 inch x 4 inch rash and major swelling of my upper arm.  Seems to be getting worse. Very itchy, warm to the touch , and hurts. Rash on the back has not gone away either.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: A rash appeared on entire back. hot cold flashes, headaches that come and go, foggy brain, fatigued but cant sleep. Nine days into the first injection, my right arm (around injection sight ) approx 4 inch x 4 inch rash and major swelling of my upper arm.  Seems to be getting worse. Very itchy, warm to the touch , and hurts. Rash on the back has not gone away either.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: red itchy rash inside elbow, red itch bumps on a couple fingers and on inside of right wrist
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia, Paraesthesia, Swelling face
Clinical narrative: Bell's Palsy; Mild tingling in the left arm; swelling on my left cheek; musculature changes in the left jaw, left cheek and facial nerve regions of left cheek (described as feeling similar to getting an injection at the dentist to numb your mouth).; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: 03461), via an unspecified route of administration in the left arm on 19Apr2021 at 15:45 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none and the patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included loratadine/pseudoephedrine sulfate (CLARITIN- D), fish oil, and a multi-vitamin (unspecified). On 19Apr2021, within 5 minutes of the vaccination, the patient experienced mild tingling in the left arm. On 19Apr2021, the patient experienced a feeling of musculature changes in the left jaw, left cheek, and facial nerve regions of left cheek (feeling similar to getting an injection at the dentist to numb your mouth). The patient was concerned it was Bell's Palsy however only noticed swelling on the left cheek. The symptoms remained the same for 2 hours without worsening, then subsided a little. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of Bell's Palsy, mild tingling in the left arm, "swelling on my left cheek", "musculature changes in the left jaw, left cheek and facial nerve regions of left cheek (described as feeling similar to getting an injection at the dentist to numb your mouth)" was resolving.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Vaccination site haemorrhage
Clinical narrative: jabbed her or inserted the needle, blood spewed out of her arm/ She was bleeding bleeding bleeding; she didn't know if the medicine from the vaccine actually had a chance to go into her arm, and into the tissues it was supposed to; This is a spontaneous report from a contactable consumer (the patient). A 64-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EW153), via an unspecified route of administration in the right arm on 18Apr2021 (at the age of 64-years-old) as a single dose for COVID-19 immunization. The patient had no medical history and no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number ER8330 or ER8730), via an unspecified route of administration in the left arm on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient received the second COVID shot and as soon as they jabbed her or inserted the needle, blood spewed out of her arm. She was bleeding, bleeding, bleeding. She was concerned, because she didn't know if the medicine from the vaccine actually had a chance to go into her arm, and into the tissues it was supposed to. Her arm was bleeding as soon as the needle went in. She wanted to know if there was a way to know if she got the medicine. The outcome of the events was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Peau d'orange, Peripheral swelling, Rash
Clinical narrative: I have ha-mrsa and the skin had a rash; Left arm swollen and red; Left arm swollen and red; I have ha-mrsa and the skin had a rash; Cellulite looking swelling and now skin extremely flaky and dry; Cellulite looking swelling and now skin extremely flaky and dry; Cellulite looking swelling and now skin extremely flaky and dry; This is a spontaneous report from a contactable consumer reporting for herself. A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 09Apr2021 at 17:30 (at the age of 49 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 17Mar2021 at 04:30 PM (at the age of 49 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included HA-MRSA/asthma, and had known allergies: sulfa. The patient was not pregnant at the time of vaccination. Concomitant medication included amoxicillin and doxycycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:00, the patient reported she has ha-mrsa and the skin had a rash, Left arm swollen and red, Cellulite looking swelling and now skin extremely flaky and dry. The patient did not receive treatment for these events. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation, Staphylococcal infection
Clinical narrative: I have ha-mrsa and the skin had a rash; Left arm swollen and red; Left arm swollen and red; I have ha-mrsa and the skin had a rash; Cellulite looking swelling and now skin extremely flaky and dry; Cellulite looking swelling and now skin extremely flaky and dry; Cellulite looking swelling and now skin extremely flaky and dry; This is a spontaneous report from a contactable consumer reporting for herself. A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 09Apr2021 at 17:30 (at the age of 49 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 17Mar2021 at 04:30 PM (at the age of 49 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included HA-MRSA/asthma, and had known allergies: sulfa. The patient was not pregnant at the time of vaccination. Concomitant medication included amoxicillin and doxycycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:00, the patient reported she has ha-mrsa and the skin had a rash, Left arm swollen and red, Cellulite looking swelling and now skin extremely flaky and dry. The patient did not receive treatment for these events. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Vaccination site pain
Clinical narrative: when she woke up this morning her left eye had a blood spot on the white part of the eye; soreness at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date for COVID-19 immunisation. On 23Apr2021, patient reported that when she woke up this morning her left eye had a blood spot on the white part of the eye and denied any injury or change in vision. The only other symptom reported was soreness at the injection site on an unknown date in Apr2021. The patient also reported that her husband and everyone I talk to has a sore arm after getting their injection. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Potentiating drug interaction, Urinary tract infection
Clinical narrative: UTI; Is okay to Cipro at this time; This is a spontaneous report from a contactable consumer (patient) via medical information team. An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8733), dose 1 via an unspecified route of administration on 07Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got her first dose of the Pfizer BioNTech COVID-19 vaccine on 07Apr2021 and reports that her second doe was coming up. However, her doctor has put her on Cipro 250mg to take twice a day for 7 days for a UTI in 2021, and caller would like to know if it was okay to take this at this time in 2021. She was worried about the medication affecting the effectiveness of the vaccine. The outcome for the events were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Oxygen saturation, Pneumonia, SARS-CoV-2 test
Clinical narrative: BP and oxygen all over; 06Apr went to ER been in and out of ICU battling covid/ pneumonia as they say; 06Apr went to ER been in and out of ICU battling covid/ pneumonia as they say; day one normal tenderness at injection site; This is a spontaneous report from a contactable consumer (patient).  A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 11Mar2021 10:00 (Batch/Lot Number: EN6204) (at the age of 68-years-old) as single dose for Covid-19 immunisation.  Medical history included chronic obstructive pulmonary disease (COPD) and weak immune system. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination. The patient underwent nasal swab COVID test on 10feb2021 with negative result, nasal swab rapid PCR COVID test on 15Feb2021 with negative result. On day one (12Mar2021), patient experienced normal tenderness at injection site, by day 3 (14Mar2021), got sick, had daughter call in LEVAQUIN 7 days worth. The patient experienced continuing chest pain from continuous coughing, BP and oxygen all over, over next 2 weeks less physical activity. On 06Apr2021, patient went to ER, had been in and out of ICU battling COVID/ pneumonia as they say. He received plasma from recovered COVID patient and Remdesivir. The patient stayed so isolated in his home; his daughter did all his shopping meds everything. Her family had been tested and was tested several times. The patient stated that he was afraid his COPD and weak immune system couldn't handle the vaccine. The events required a visit to the Doctor or other healthcare professional office/clinic, Emergency room/department or urgent care and led to prolongation of hospitalization (as the vaccine was received during existing hospitalization (as reported)). The events were assessed by the reporter as life-threatening (immediate risk of death from the event). The patient was hospitalized for 21 days. The outcome of the events was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination site pain
Clinical narrative: BP and oxygen all over; 06Apr went to ER been in and out of ICU battling covid/ pneumonia as they say; 06Apr went to ER been in and out of ICU battling covid/ pneumonia as they say; day one normal tenderness at injection site; This is a spontaneous report from a contactable consumer (patient).  A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 11Mar2021 10:00 (Batch/Lot Number: EN6204) (at the age of 68-years-old) as single dose for Covid-19 immunisation.  Medical history included chronic obstructive pulmonary disease (COPD) and weak immune system. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination. The patient underwent nasal swab COVID test on 10feb2021 with negative result, nasal swab rapid PCR COVID test on 15Feb2021 with negative result. On day one (12Mar2021), patient experienced normal tenderness at injection site, by day 3 (14Mar2021), got sick, had daughter call in LEVAQUIN 7 days worth. The patient experienced continuing chest pain from continuous coughing, BP and oxygen all over, over next 2 weeks less physical activity. On 06Apr2021, patient went to ER, had been in and out of ICU battling COVID/ pneumonia as they say. He received plasma from recovered COVID patient and Remdesivir. The patient stayed so isolated in his home; his daughter did all his shopping meds everything. Her family had been tested and was tested several times. The patient stated that he was afraid his COPD and weak immune system couldn't handle the vaccine. The events required a visit to the Doctor or other healthcare professional office/clinic, Emergency room/department or urgent care and led to prolongation of hospitalization (as the vaccine was received during existing hospitalization (as reported)). The events were assessed by the reporter as life-threatening (immediate risk of death from the event). The patient was hospitalized for 21 days. The outcome of the events was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal haemorrhage, Nausea, Pulseless electrical activity, SARS-CoV-2 test
Clinical narrative: nausea; vomiting; diarrhea; large GI bleed; PEA (Pulseless electrical activity); This is a spontaneous report from a contactable physician. A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Apr2021 (Lot Number: EW0158) as single dose for covid-19 immunisation. Medical history included coronary artery disease (CAD), cardiomyopathy, hyperlipidemia, and hypertension. The patient had no covid prior vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN EC); atorvastatin (LIPITOR [ATORVASTATIN]); carvedilol (COREG); fluocinonide (LIDEX-E); sacubitril valsartan sodium hydrate (ENTRESTO); and warfarin sodium (COUMADIN). The patient had nausea, vomiting and diarrhea since getting the vaccine which progressed to a large GI bleed, had PEA (Pulseless electrical activity), was resuscitated and was currently in the ICU intubated. The events occurred on 14Apr2021 and all events resulted in hospitalization, considered as life threatening illness (immediate risk of death from the event). The patient received treatment for the events which included transfusions, resuscitation, and current intubation. The patient underwent lab test which included Roche cobas SARS-CoV-2 assay: negative on 19Apr2021. Outcome of the events was not recovered.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be completely excluded considering the temporal association. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: nausea; vomiting; diarrhea; large GI bleed; PEA (Pulseless electrical activity); This is a spontaneous report from a contactable physician. A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Apr2021 (Lot Number: EW0158) as single dose for covid-19 immunisation. Medical history included coronary artery disease (CAD), cardiomyopathy, hyperlipidemia, and hypertension. The patient had no covid prior vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN EC); atorvastatin (LIPITOR [ATORVASTATIN]); carvedilol (COREG); fluocinonide (LIDEX-E); sacubitril valsartan sodium hydrate (ENTRESTO); and warfarin sodium (COUMADIN). The patient had nausea, vomiting and diarrhea since getting the vaccine which progressed to a large GI bleed, had PEA (Pulseless electrical activity), was resuscitated and was currently in the ICU intubated. The events occurred on 14Apr2021 and all events resulted in hospitalization, considered as life threatening illness (immediate risk of death from the event). The patient received treatment for the events which included transfusions, resuscitation, and current intubation. The patient underwent lab test which included Roche cobas SARS-CoV-2 assay: negative on 19Apr2021. Outcome of the events was not recovered.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be completely excluded considering the temporal association. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Loss of personal independence in daily activities, SARS-CoV-2 test, Speech disorder
Clinical narrative: I had a Stroke; Blood clot travelled to my brain; effected left side of my body; ability to speak; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: ER 8729), via an unspecified route of administration in left arm on 10Apr2021 (at the age of 46-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a pharmacy/drug store. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not have covid prior vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had a stroke. Blood clot travelled to his brain and effected left side of his body and ability to speak on 15Apr2021 at 17:30. The events resulted to emergency room/department or urgent care, hospitalization for 3 days, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received unspecified treatments for the event. Covid test post vaccination on 15Apr2021 with result of negative. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: received the first covax then 5 days after tested positive for the virus; received the first covax then 5 days after tested positive for the virus; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received a first dose of BNT162B2 (batch/Lot number and expiration date: not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, she received the first covax then 5 days after tested positive for the virus. Further, she was asking what she should do about the second covax. The patient's laboratory investigation included she was tested (SARS-CoV-2 antibody test) as positive for virus on an unknown date. The outcome of the event was unknown at the time of the report.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, COVID-19, SARS-CoV-2 test positive
Clinical narrative: received the first covax then 5 days after tested positive for the virus; received the first covax then 5 days after tested positive for the virus; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received a first dose of BNT162B2 (batch/Lot number and expiration date: not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, she received the first covax then 5 days after tested positive for the virus. Further, she was asking what she should do about the second covax. The patient's laboratory investigation included she was tested (SARS-CoV-2 antibody test) as positive for virus on an unknown date. The outcome of the event was unknown at the time of the report.   Information on the lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Myocardial infarction, Thrombosis
Clinical narrative: 5-6 Blood clots, blood clots were present; heart attack; This is a spontaneous report from a contactable consumer reporting for himself. A 54-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Mar2021 12:00 on left arm at single dose for COVID-19 immunization. Facility type vaccine was at Pharmacy or Drug Store. Medical history included high blood pressure, high cholesterol. Concomitant medications included atorvastatin (LIPITOR), amlodipine besilate (NORVASC). Historical Vaccine included first dose of BNT162B2 on 08Mar2021 12:00 on left arm for COVID-19 immunization. The patient experienced 5-6 Blood clots, had heart attack and blood clots were present on 14Apr2021 13:00. The events were resulted in Emergency Room Visit, Hospitalization, Life threatening illness (immediate risk of death from the event). Treatment was received for the events included Stent. The outcome of the events were resolving. Information on Lot/Batch number has been requested.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis, SARS-CoV-2 test
Clinical narrative: small blood clot in brain; This is a spontaneous report from a contactable consumer (patient). A 86-year-old male patient received the second dose of bnt162b2, via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Type two diabetes b, covid prior vaccination in 2021, blood clot in lung. Concomitant medication included exenatide (BYETTA). The patient previously received the first dose of bnt162b2, via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient experienced small blood clot in brain on 09Apr2021. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (4 days), Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient received the treatment Heparin for event. Covid test post vaccination (Blood test) was negative on 12Apr2021. The outcome of the event was not recovered.  Information on Lot/Batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Arterial stenosis, Artery dissection, Chills
Clinical narrative: fibromuscular dysplasia; 3 artery dissections; narrowing of other arteries; chills; aches; fever 101; left neck and chest swollen lymph nodes; stomach aches; abdominal pain; It also affected a renal artery, causing lack of blood to my left kidney, causing part of that kidney to die; heart attack; left flank pain; This is a spontaneous report from a non-contactable consumer (patient). A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on left arm on 19Jan2021 (Batch/Lot Number: EL3249) as SINGLE DOSE for covid-19 immunisation. Medical history included post-partum hypothyroidism. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK9231) via an unspecified route of administration on left arm on 29Dec2020 for covid-19 immunisation. The patient stated "The day after second vaccine and that week, I had chills, aches, fever 101, left neck and chest swollen lymph nodes, stomach aches. 28Jan2021, I started having severe left flank pain and abdominal pain. On 04Feb2021, I had a heart attack, was in V-fib arrest, and subsequently found to have fibromuscular dysplasia (FMD), which caused 3 artery dissections and narrowing of other arteries. Did not know I had FMD prior to the heart attack. Most people who have FMD never show signs or symptoms and don't know they have it. Others with FMD have it affect maybe one artery. Something caused my FMD to go into overdrive, affecting 3 arteries. It also affected a renal artery, causing lack of blood to my left kidney, causing part of that kidney to die - that was my 28Jan2021 pain. Coincidental my FMD acted up this way a little over a week after receiving the second Pfizer shot?" Events were reported as serious and 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 hospitalization for 9 days. Treatment received for all events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): negative on an unknown date (Covid test post vaccination). The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromuscular dysplasia, Flank pain, Lymphadenopathy, Myocardial infarction, Pain
Clinical narrative: fibromuscular dysplasia; 3 artery dissections; narrowing of other arteries; chills; aches; fever 101; left neck and chest swollen lymph nodes; stomach aches; abdominal pain; It also affected a renal artery, causing lack of blood to my left kidney, causing part of that kidney to die; heart attack; left flank pain; This is a spontaneous report from a non-contactable consumer (patient). A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on left arm on 19Jan2021 (Batch/Lot Number: EL3249) as SINGLE DOSE for covid-19 immunisation. Medical history included post-partum hypothyroidism. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK9231) via an unspecified route of administration on left arm on 29Dec2020 for covid-19 immunisation. The patient stated "The day after second vaccine and that week, I had chills, aches, fever 101, left neck and chest swollen lymph nodes, stomach aches. 28Jan2021, I started having severe left flank pain and abdominal pain. On 04Feb2021, I had a heart attack, was in V-fib arrest, and subsequently found to have fibromuscular dysplasia (FMD), which caused 3 artery dissections and narrowing of other arteries. Did not know I had FMD prior to the heart attack. Most people who have FMD never show signs or symptoms and don't know they have it. Others with FMD have it affect maybe one artery. Something caused my FMD to go into overdrive, affecting 3 arteries. It also affected a renal artery, causing lack of blood to my left kidney, causing part of that kidney to die - that was my 28Jan2021 pain. Coincidental my FMD acted up this way a little over a week after receiving the second Pfizer shot?" Events were reported as serious and 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 hospitalization for 9 days. Treatment received for all events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): negative on an unknown date (Covid test post vaccination). The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Renal disorder, SARS-CoV-2 test
Clinical narrative: fibromuscular dysplasia; 3 artery dissections; narrowing of other arteries; chills; aches; fever 101; left neck and chest swollen lymph nodes; stomach aches; abdominal pain; It also affected a renal artery, causing lack of blood to my left kidney, causing part of that kidney to die; heart attack; left flank pain; This is a spontaneous report from a non-contactable consumer (patient). A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on left arm on 19Jan2021 (Batch/Lot Number: EL3249) as SINGLE DOSE for covid-19 immunisation. Medical history included post-partum hypothyroidism. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK9231) via an unspecified route of administration on left arm on 29Dec2020 for covid-19 immunisation. The patient stated "The day after second vaccine and that week, I had chills, aches, fever 101, left neck and chest swollen lymph nodes, stomach aches. 28Jan2021, I started having severe left flank pain and abdominal pain. On 04Feb2021, I had a heart attack, was in V-fib arrest, and subsequently found to have fibromuscular dysplasia (FMD), which caused 3 artery dissections and narrowing of other arteries. Did not know I had FMD prior to the heart attack. Most people who have FMD never show signs or symptoms and don't know they have it. Others with FMD have it affect maybe one artery. Something caused my FMD to go into overdrive, affecting 3 arteries. It also affected a renal artery, causing lack of blood to my left kidney, causing part of that kidney to die - that was my 28Jan2021 pain. Coincidental my FMD acted up this way a little over a week after receiving the second Pfizer shot?" Events were reported as serious and 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 hospitalization for 9 days. Treatment received for all events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): negative on an unknown date (Covid test post vaccination). The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.