chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Thrombosis
Clinical narrative: Stroke due to a large blood clot to the brain; Stroke due to a large blood clot to the brain; Widespread blood clots in both of her arms; This is a spontaneous report from a contactable consumer (daughter).   A 67-year-old female patient received the 2nd single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in the left arm, on 17Mar2021 (at the age of 67 years old, not pregnant at time of vaccination) (Lot number was unavailable since unable to locate or read the details), for COVID-19 immunisation. The patient's medical history included ongoing atrial fibrillation, high blood pressure, and scoliosis. Concomitant medications included ongoing acetylsalicylic acid (ASPIRIN) for atrial fibrillation, naproxen, pregabalin, tramadol, and metoprolol. The patient never had a history of blood clots. There were no allergies to report. The patient had not received any other vaccines in the four weeks prior to receiving BNT162b2. The patient had received the first single dose of BNT162b2 on an unspecified date, in the left arm. The patient's daughter stated that her mother suffered a stroke due to a large blood clot to the brain on 25Mar2021 at 12:30 am, requiring hospitalization. During hospitalization, a surgery to remove blood clot from the brain was needed. Hospitalzation lasted 12 days. The reporter added that in the week prior to the reporting, the mother 'passed' (as reported) but had widespread blood clots in both of her arms. The patient required unspecified treatment due to the events and had not recovered at the time of the reporting. The events were considered also serious since life threatening and due to disability. The patient did not have COVID-19 prior to the vaccination and had not tested positive post vaccination.  Information on lot/batch number has been requested.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 94-year-old female patient (reporter's mother) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient passed away on an unspecified date. It was unknown if an autopsy was performed. The reporter said that patient died because she is 94 years old and not with the vaccine.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, this female patient death is attributed to her advanced age  (94 years old) and assessed unrelated to BNT162B2 vaccine.; Reported Cause(s) of Death: passed away
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: Fever; loss of appetite; headaches; fatigue all day; nausea; This is a spontaneous report from a contactable consumer. A 79-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 20Feb2021 (Batch/Lot Number: EN6200) at single dose for covid-19 immunisation. Medical history included Non-Hodgkin's lymphoma (4 years ago). Historical vaccine included BNT162B2, dose 1 intramuscularly, administered in Arm Right on 31Jan2021 14:00 (Batch/Lot Number: EL9265) at single dose. The concomitant medications were not reported. On 21Feb2021, the patient experienced fever, loss of appetite, headaches, fatigue all day and nausea. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included covid-19 negative on Jan2021. The outcome of events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; loss of appetite; headaches; fatigue all day; nausea; This is a spontaneous report from a contactable consumer. A 79-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 20Feb2021 (Batch/Lot Number: EN6200) at single dose for covid-19 immunisation. Medical history included Non-Hodgkin's lymphoma (4 years ago). Historical vaccine included BNT162B2, dose 1 intramuscularly, administered in Arm Right on 31Jan2021 14:00 (Batch/Lot Number: EL9265) at single dose. The concomitant medications were not reported. On 21Feb2021, the patient experienced fever, loss of appetite, headaches, fatigue all day and nausea. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included covid-19 negative on Jan2021. The outcome of events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID 19 after receiving 1st Pfizer vaccine dose and diagnosed with COVID-19 on 30Mar21; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient received her 1st Pfizer vaccine dose on 27Mar2021, and her 2nd dose was scheduled on 17Apr2021. She was diagnosed with COVID-19 on 30Mar21. Patient questioned was it ok for her to get her 2nd vaccine dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in 2021. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Oropharyngeal discomfort, Pain, Pruritus
Clinical narrative: 1 hour after shot, throat felt slightly off. 22 hours after shot began to experience headaches and head fog. Following day had extreme body aches (especially on sides), headaches, head fog, and fever.  Very lathargic. Throat felt normal again.  Following day most body aches were gone, but also received periodic headaches and still had some body aches and soreness. Began to feel itchy. Itchiness location wandered throughout day - began in groin, moved to legs, moved to chest, then to head. Following day still have itchiness but primarily on head and to some extent on feet. In the evening, upper lip also became very swollen. This is current status of side effects felt.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Exposure during pregnancy, Palpitations
Clinical narrative: Heart palpitations, including strong, rapid heartbeat. Chest fluttering and sensation of skipped or rapid succession beats with chest tightness. Fluttering sensation will often force a cough out. Strongest day of, and whereas existed over the past five days seems to be strongest on day five. Currently 15 weeks pregnant. First time mom. Estimated due date 10/08/2021.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: swollen lymph node (and slight pain) on the left collarbone (same side of the injection)
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: General fatigue about 24 hours after vaccination. Went to bed and felt fine the next day after sleeping 10 hours. While not a major reaction to the vaccine, I am reporting this minor reaction nevertheless for statistical purposes. Thank you.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Headache, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: High fever of 102 degrees.  Took 2 caplets of Tylenol at 9pm on 04/09/2021 that had little to no effect.  At 3am on 04/10/2021 took 2 gel caplets of Advil hoping to do better.  The Advil brought the fever down to 100-101 for several hours but the fever went right back up.  Arm was sore and had headache.  My fever went down to 99 degrees 48 hours after taking the shot on 04/11/2021 at 3pm. Later on 04/11/2021 around 9pm my temperature went back to normal including any pain or swelling at the injection site.  I had to re-hydrate myself but felt better.  Overall I would do it again to protect my family from this virus.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vomiting
Clinical narrative: chills; vomiting; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, (Batch/Lot number was not reported) via an unspecified route of administration on 08Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller (mother of the patient) calling on the behalf of her daughter and reported chills and vomiting. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Heart rate increased, Lymphadenopathy, Panic reaction
Clinical narrative: weakness, rapid heart rate, and panic five minutes after receiving vaccine. went away on its own after a couple of minutes swelling and soreness of axillary lymph nodes five days after the vaccine, currently ongoing
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Injection site pain
Clinical narrative: Extreme Fatigue 12 hours after shot lasting about 36 hours Diarrhea starting about 24 hours after shot  Pain at shot location
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: My period started on the 14th of April as expected.  I usually have cramping on the 2nd or third day.  It's now my 5th day and I'm experiencing debilitating cramping more than my normal.  It's quite worry, because I'm thinking I should be in the emergency room.  Also experiencing heavier than my normal flow.  I've had to stay in bed for the past 2 days, unable to get any relief.  All this is very concerning, usually my cramping would cease at day 2 or 3.  This isn't normal for me to experience this level and duration of pain
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Pain, Pain in extremity, Vomiting
Clinical narrative: 4/9/21- pain in left arm 4/10/21 to 4/13/21 - body aches and sore 4/13/21 to  4/15/21 - body aches went away, started diarrhea. Eating was normal around 4/13/21 and then ate less because of the diarrhea and stomach aches/cramp increasing 4/15/21 (evening) - ate a bit of sushi, instant diarrhea and vomitting. Vomitted 4 times and 12 times of diarrhea from 18:00 to the next morning. 4/16/21 - vomitting stopped and not really nauseous but still diarrhea. Ate a half banana at night and drank water 4/17/21 - ate half a banana in the morning made me super nauseous but didn?t vomit. Ate a lipton soup for diner, drank water and apple just during the day. Night: slept good from 22:30 to 2:30 and then diarrhea every hour.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 lastApril 3; tested positive for Covid-19 lastApril 3; This is a spontaneous report via Pfizer- sponsored program from contactable consumer (patient). A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 21Mar2021 at single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that patient had his 1st dose last March 21, 2021 and he was due for his 2nd dose on April 11, 2021. He mentioned that he was tested positive for Covid-19 last April 3, 2021. He wanted to know if how he could reschedule his 2nd dose and he also wanted to ask if how he will proceed given his condition. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 lastApril 3; tested positive for Covid-19 lastApril 3; This is a spontaneous report via Pfizer- sponsored program from contactable consumer (patient). A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 21Mar2021 at single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that patient had his 1st dose last March 21, 2021 and he was due for his 2nd dose on April 11, 2021. He mentioned that he was tested positive for Covid-19 last April 3, 2021. He wanted to know if how he could reschedule his 2nd dose and he also wanted to ask if how he will proceed given his condition. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe Tinnitus
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: feeling achy; This is a spontaneous report from a non-contactable consumer (patient) via medical information team. A 26-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know if it was okay to take Tylenol or ibuprofen after the vaccine as she was feeling achy on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information about batch/lot number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bradycardia, Headache, Inappropriate schedule of product administration, Neck pain, Off label use
Clinical narrative: bradycardia; fainting; Head and neck ache; Head and neck ache; first dose received on 09Mar2021; second dose received on 15Mar2021; first dose received on 09Mar2021; second dose received on 15Mar2021; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the right arm, on 15Mar2021 15:00, as single dose, for COVID-19 immunisation.  Medical history included psoriasis, high blood pressure, scoliosis and low thyroid. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); sertraline; sertraline hydrochloride (ZOLOFT); and levothyroxine sodium (LEVOTHYROXINE), all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported) received at age 67 years, via an unspecified route of administration in the right arm, on 09Mar2021 14:45, for COVID-19 immunisation. On 15Mar2021, the patient experienced bradycardia, was fainting, and had head and neck ache. One week after the second vaccine, in Mar2021, the patient was taken to the hospital due to the events. Treatment for the events included "had to have a pacemaker put in". The patient reported that she never had heart problems before, and she was curious if these could have ben side effects from the vaccine. The events resulted to physician office and emergency room visits, and hospitalization. The duration of the hospitalization was reported as 4 days. The events were reported as life-threatening illnesses. The patient was recovering from the events.  Information about Batch/Lot number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: bradycardia; fainting; Head and neck ache; Head and neck ache; first dose received on 09Mar2021; second dose received on 15Mar2021; first dose received on 09Mar2021; second dose received on 15Mar2021; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the right arm, on 15Mar2021 15:00, as single dose, for COVID-19 immunisation.  Medical history included psoriasis, high blood pressure, scoliosis and low thyroid. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); sertraline; sertraline hydrochloride (ZOLOFT); and levothyroxine sodium (LEVOTHYROXINE), all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported) received at age 67 years, via an unspecified route of administration in the right arm, on 09Mar2021 14:45, for COVID-19 immunisation. On 15Mar2021, the patient experienced bradycardia, was fainting, and had head and neck ache. One week after the second vaccine, in Mar2021, the patient was taken to the hospital due to the events. Treatment for the events included "had to have a pacemaker put in". The patient reported that she never had heart problems before, and she was curious if these could have ben side effects from the vaccine. The events resulted to physician office and emergency room visits, and hospitalization. The duration of the hospitalization was reported as 4 days. The events were reported as life-threatening illnesses. The patient was recovering from the events.  Information about Batch/Lot number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrioventricular block, Syncope
Clinical narrative: bradycardia; fainting; Head and neck ache; Head and neck ache; first dose received on 09Mar2021; second dose received on 15Mar2021; first dose received on 09Mar2021; second dose received on 15Mar2021; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the right arm, on 15Mar2021 15:00, as single dose, for COVID-19 immunisation.  Medical history included psoriasis, high blood pressure, scoliosis and low thyroid. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); sertraline; sertraline hydrochloride (ZOLOFT); and levothyroxine sodium (LEVOTHYROXINE), all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported) received at age 67 years, via an unspecified route of administration in the right arm, on 09Mar2021 14:45, for COVID-19 immunisation. On 15Mar2021, the patient experienced bradycardia, was fainting, and had head and neck ache. One week after the second vaccine, in Mar2021, the patient was taken to the hospital due to the events. Treatment for the events included "had to have a pacemaker put in". The patient reported that she never had heart problems before, and she was curious if these could have ben side effects from the vaccine. The events resulted to physician office and emergency room visits, and hospitalization. The duration of the hospitalization was reported as 4 days. The events were reported as life-threatening illnesses. The patient was recovering from the events.  Information about Batch/Lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: the client died yesterday; This is a spontaneous report from a non-contactable other healthcare professional (hcp) from a Pfizer-sponsored program. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient died on 08Apr2021.  The cause of death was unknown. It was unknown if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes.     The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: the client died yesterday
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test
Clinical narrative: a bit of cough; The caller got her first dose on 18Mar2021 and then on the 19Mar2021 she was diagnosed with covid; This is a spontaneous report from a Pfizer-sponsored program. A 50-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6208; Expiry Date: Unknown), via an unspecified route of administration at left arm on 18Mar2021 as single dose for COVID-19 immunization. Patient's medical history and concomitant medication were not reported. The patient stated that her first dose of the vaccine on 18Mar2021 and tested positive for covid and wanted to know if it's okay to take second dose of the covid vaccine. The patient got her first dose on 18Mar2021 and then on the 19Mar2021 she was diagnosed with covid. The patient still had a bit of a cough and her second dose was supposed to be on Friday 09Apr2021.The patient's covid symptoms started on 19Mar2021. Product complaint was reported. The patient underwent lab test and procedure which included COVID-19 virus test was positive. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: vision very blurry; This is a spontaneous report from contactable male consumer (patient). A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER2613), via an intramuscular route of administration in left arm on 02Apr2021 09:30 at single dose for COVID-19 immunization. Medical history included allergies, compromised immune status, respiratory Illness, geentic/chromosoaml abnormalities, endrocrine abnormalities, diabetes and obesity. The patient's concomitant medications were not reported. The patient did not receive prior vaccinations within 4 weeks. On 03Apr2021, at 08:30-09:00, the patient had very blurry vision. This was for 4-5 hours. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Daughter took covid test today and tested positive with no symptoms/may have been exposed; This is a spontaneous report received from a contactable consumer (Patient). This female consumer reported for her husband (Patient). A male patient of an unspecified age received first dose of 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 was not reported. The husband and her got 1st Pfizer dose on Monday. Daughter took covid test today and tested positive with no symptoms. Was with them outdoors on Friday, may have been exposed. Daughters schedule this afternoon to get the vaccine. Will the COVID test come up positive because we took the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Death, Malaise, Oropharyngeal discomfort
Clinical narrative: My uncle died three days after taking the vaccine; he felt strange and he felt like something was in his throat; he felt like he wasn't doing well; This is a spontaneous report from a contactable nurse reporting for her uncle.    A 73-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  Medical history included psoriasis , cardiac pacemaker insertion on an unknown date (He recently had a pacemaker implanted several months ago) , hypertension from an unknown date.      The patient  died three days after taking the vaccine  on 09Apr2021 , he felt strange and he felt like something was in his throat on 09Apr2021 with outcome of unknown.  The patient underwent lab tests and procedures which included blood pressure measurement: 150/90   on  09Apr2021.    It was not reported if an autopsy was performed.  Course of the event: The reporter's uncle died three days after taking the vaccine. He was at home getting ready to watch a basketball game with the reporter's aunt when he began to complain that he felt strange and he felt like something was in his throat. Both the patient and the reporter's aunt are also RN's. My aunt checked his BP and the first time it was 150/90. His BP was taken a second time but the reporter cannot remember what  the 2nd reading was. He then said he was going to the bathroom and asked her to call # because he felt like he wasn't doing well.  The reporter's aunt  called #, and assisted the reporter's uncle to lay down in bed. She remained on the phone with #who arrived at the scene shortly thereafter. They performed CPR at the scene and he was transported to the hospital. The reporter  believes the patient was pronounced dead at home. The patient was about 5"10, heavy set stature. He recently had a pacemaker implanted several months ago and has a history of psoriasis and HTN. There is additional concomitant medical history I will have to confirm.   Information about lot/batch has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment for the reported patient's sudden death. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: My uncle died three days after taking the vaccine
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: I had emergency surgery to remove a femoral blood clot from my groin to the bottom of my left leg; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 17Mar2021 12:00 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation at a Pharmacy or Drug Store. Medical history included known allergies to sulfa drugs, latex, animal dander, dairy, wheat, mold, mildew, ragweed and other wildflowers; and clot once before in the same leg-left inner thigh in 1974. Concomitant medications included thyroid (ARMOUR THYROID) and apixaban (ELIQUIS). The patient previously had a pneumonia vaccine on 24Feb2021 in the left arm. The patient does not know if her first dose of Pfizer vaccine caused this, but on "04Mar2010" (as reported) she had an emergency surgery to remove a femoral blood clot from her groin to the bottom of her left leg which started on 03Apr2021 at 12 AM (as reported). The event resulted in emergency room/department or urgent care visit, hospitalization for 2 days and was considered life threatening illness (immediate risk of death from the event). She had a clot once before in the same leg-left inner thigh in 1974. The patient was on Eliquis 5 mg 2 pills 2 X day for two more days, then 1 pill in am and 1 pill in evening for rest of her life. The patient had the second dose of BNT162B2 (lot: ER8732) on 07Apr2021 in the left arm. The patient has no covid prior vaccination and was not tested for covid  post vaccination. The event recovered with lasting effects.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: DVT; PE; This is a spontaneous report from a contactable consumer (patient). This adult male patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Mar2021, lot EP6955, in right arm, for COVID-19 immunization. No other vaccine was received in 4 weeks. Medical history and concomitant medications were not reported. On 03Apr2021 the patient experienced DVT and PE. The events resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Events treatment included dabigatran (PRADAXA). The events were resolving at the time of report. COVID was not tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: unknown) via an unspecified route of administration on 23Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) on 29Jan2021 at single dose for COVID-19 immunization. Patient stated that she got tested positive 2 times for 3 months. She mentioned that she got the 1st vaccine last 29Jan2021 and got the 2nd dose 23Feb2021 (More than 21 days). She stated that they need to reschedule the date due to bad weather. On the 28Feb2021, the caller was tested positive for Covid. Caller then had another test and was again tested positive. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Hyperhidrosis, Insomnia
Clinical narrative: I am dying I have never felt that; if it gets worse I will just write it out or I will go ahead and die or whatever; Sweating real bad; I am doing everything in slow motion; Sleepy but could not sleep; Every joint on me ached; Where the shot was, that was sore it was first time that I have been getting these side effects; Slight headache; I don't feel like getting up. I don't even want to get out of bed, I ache so bad. I don't want to do anything else; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8734) at single dose, on 05Apr2021 at 02:15, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient previously, on 12Mar2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) for COVID-19 immunisation. On 05Apr2021, the patient experienced feeling abnormal ("I am dying I have never felt that; if it gets worse I will just write it out or I will go ahead and die or whatever"), sweating ("Sweating real bad"), mobility decreased ("I am doing everything in slow motion"), Sleep difficult ("Sleepy but could not sleep"), joint ache ("Every joint on me ached"), pain in extremity ("Where the shot was, that was sore it was first time that I have been getting these side effects"), slight headache and patient was feeling unwell ("I don't feel like getting up. I don't even want to get out of bed, I ache so bad. I don't want to do anything else"). The patient did not have fever. Clinical outcome of the events was unknown at time of this report.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Mobility decreased, Pain in extremity
Clinical narrative: I am dying I have never felt that; if it gets worse I will just write it out or I will go ahead and die or whatever; Sweating real bad; I am doing everything in slow motion; Sleepy but could not sleep; Every joint on me ached; Where the shot was, that was sore it was first time that I have been getting these side effects; Slight headache; I don't feel like getting up. I don't even want to get out of bed, I ache so bad. I don't want to do anything else; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8734) at single dose, on 05Apr2021 at 02:15, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient previously, on 12Mar2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) for COVID-19 immunisation. On 05Apr2021, the patient experienced feeling abnormal ("I am dying I have never felt that; if it gets worse I will just write it out or I will go ahead and die or whatever"), sweating ("Sweating real bad"), mobility decreased ("I am doing everything in slow motion"), Sleep difficult ("Sleepy but could not sleep"), joint ache ("Every joint on me ached"), pain in extremity ("Where the shot was, that was sore it was first time that I have been getting these side effects"), slight headache and patient was feeling unwell ("I don't feel like getting up. I don't even want to get out of bed, I ache so bad. I don't want to do anything else"). The patient did not have fever. Clinical outcome of the events was unknown at time of this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Head discomfort, Headache, Nervousness, Suicidal ideation
Clinical narrative: Headache; Suicidal; weird feeling, bad feeling in her head that was getting worse; Anxious; Nervous; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 19Mar2021 11:00 (Batch/Lot Number: EP7534) as SINGLE DOSE for COVID-19 immunization at the pharmacy. Medical history included ongoing dilated pulmonary artery diagnosed 2-3 years ago. Concomitant medications were not reported. The patient received the vaccine on 19Mar2021 11:00.  After 5 hours, she had a weird feeling, bad feeling in her head that was getting worse. She was completely suicidal the next day (20Mar2021) and the day after that that lasted for like 3 days maybe. She also had a headache on 26Mar2021 that has lasted for 2 weeks. She was not suicidal anymore, but still felt anxious. She did not treat her symptoms in any way, but finally got alprazolam (XANAX) from her doctor. She was due for second one and was a little nervous. The patient recovered with sequlae from suicidal on 23Mar2021; recovered from headache on 09Apr2021; unknown for nervousness while not recovered from the remaining events  No follow-up attempts are possible. No information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: allergic reaction; hives; trouble breathing; itchy; This is a spontaneous report from a non-contactable consumer or other non hcp (patient).   A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced allergic reaction, hives, trouble breathing and itchy on an unspecified date.  Course of events was as follows: She had an allergic reaction to the Pfizer Covid vaccine. It gave her hives, and trouble breathing. She had hives and they were itchy all over. She went to the hospital. They had to give her Epipen 0.3 mg injection at an unknown dose and frequency via unknown route for allergic reaction. The outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 12.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A dose at age 11 and an accidental 2nd dose at age 12 with no AE; Initial information received on 19-Mar-2021 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional.  This case involves a 12 year old patient who received a dose at age 11 and an accidental second dose at age 12 (Extra dose administered), while patient received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE Solution for injection [lot number and expiry date no reported] via an intramuscular route at an unknown administration site for prophylactic vaccination.  This was a case of actual medication error due to extra dose administered (latency was on same day).  It was reported that, patient received previous shot at age 11. It was advised her to call -800-vaccine to find out what needs to be done but patient also wanted to report this information here. It was unknown if patient's physician provided consent to be contacted.  At the time of report, no adverse event reported (It was unknown if the patient experienced any additional symptoms/events).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: MEN
Symptoms: Rash
Clinical narrative: had a bad skin break out post meningitis vaccine; Initial information was received on 19-Mar-2021 regarding an unsolicited valid non-serious received from a consumer/non-healthcare professional.  This case involves a 17-year-old female patient who experienced had a bad skin break out post MENINGOCOCCAL VACCINE (meningitis) (rash), while treated with DUPILUMAB [DUPIXENT].  Medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It is unknown if the patient had any concomitant disease or risk factor.  At the time of report the patient had Atopic dermatitis.  On 20-Jul-2020, the patient started taking DUPIXENT (DUPILUMAB) 300 mg via subcutaneous route (with an unknown formulation, batch number and expiry date) for Atopic dermatitis.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported that, : Patient mom was counseled in regards to COVID Vaccine. She understands no drug-drug interaction [DDI].  Details of laboratory data were not reported.  On an unknown date, the patient developed non-serious had a bad skin break out post meningitis vaccine (rash) unknown latency following the administration of MENINGOCOCCAL VACCINE and 7 months 27 days from first and last dose intake of DUPILUMAB.  No action was taken with DUPILUMAB (DUPIXENT).  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome was unknown.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: red recurring every month at the same site; itchy/recurring every month at the same site; swollen/recurring every month at the same site; Initial information received on 22-Mar-2021 regarding an unsolicited valid non-serious case received from a physician.  This case involves child patient who had red recurring at the same site (erythema), itchy/recurring at the same site (pruritus) and swollen/recurring at the same site (swelling), while he/she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation: Pre filled syringe, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (every month), the patient developed a non-serious red recurring at the same site (erythema), itchy/recurring at the same site (pruritus) and swollen/recurring at the same site (swelling) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE..  The patient mother reported that ever since her child received the flu shot in November, every month at the same time in the exact same place as the flu shot and patient gets red, itchy and swollen. The patient mother said it happened a few weeks to a month after the flu shot but has been recurring every month at the same site.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: no adverse event; no adverse event  hence non-case
Sex: F
Vaccine: TTOX
Symptoms: Anaphylactic reaction, Eye swelling, Swelling face
Clinical narrative: anaphylactic reaction to Tetanus toxoid vaccine; face and eyes welled shut; face and eyes welled shut; Initial information was received on 06-Apr-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional via non-licensed partner This case involves a 6 year-old female patient who experienced anaphylactic reaction to tetanus toxoid vaccine (anaphylactic reaction) where her face and eyes welled shut (swelling face) and (eye swelling), after she received vaccine TETANUS TOXOID.  It was unknown if the patient had any medical history, concomitant disease or risk factor and the patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported   On an unknown date, the patient received a dose of suspect TETANUS TOXOID, produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious anaphylactic reaction to tetanus toxoid vaccine (anaphylactic reaction) where her face and eyes welled shut (swelling face) and (eye swelling) (Unknown latency) following the administration of TETANUS TOXOID. These events were assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events and she was then told never to receive tetanus toxoid again.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  Result of assessment was not reported.  There will be no information available on batch number for this case.; Sender's Comments: This case involves a 6 year-old female patient who experienced anaphylactic reaction, swelling face and eye swelling after vaccination with TETANUS TOXOID (unknown manufacturer). The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Rash, Rash pruritic, Urticaria
Clinical narrative: the rash was worse; torso very itchy for 1 week; scattered red spots urticaria; Initial information received on 15-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a 80 year old female patient who experienced the rash was worse (rash), torso very itchy for 1 week (pruritus) and scattered red spots urticarial (urticaria), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history included Rash.  Medical treatment, vaccination, concomitant medication and family history were not provided.  On 18-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ233AA and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious the rash was worse (rash), torso very itchy for one week (pruritus) and diagnosis scattered red spots urticaria (urticaria), (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was also reported that the nurse is calling today, because the patient son called the office and asked about the patient (his mom) getting the Covid (coronavirus diseases) Vaccine. During the call, the son of the patient mentioned that his mom had an allergic reaction to the Fluzone Quadrivalent vaccine and questioned if any of the ingredients of the Covid vaccine and the Fluzone Quadrivalent vaccine are the same. Reporter relationship: health care professional (HCP), Product used: Used First time product used: yes still using product: no Was Device Used: yes  Details of laboratory data not reported.   The patient was treated with BILASTINE (BLEXTEN) (anti-allergy medication).  At the time of reporting, the outcome of events was reported as unknown.