chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Pharyngitis streptococcal, Renal disorder, Urine analysis
Clinical narrative: bad strep throat; got a really bad high blood pressure for 3 weeks; kidney was hurting; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number EL3247, Expiration date: May2021) via an unspecified route of administration in Arm Left on 02Mar2021 (at the age of 69-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included she was sensitive to chemicals, but did not specify any from an unknown date and unknown if ongoing. Concomitant medication included lisinopril taken for blood pressure abnormal from an unknown start date. On 05Mar2021, the patient got a really bad high blood pressure for 3 weeks, kidney was hurting and bad strep throat on an unspecified date. She was scared to get the 2nd shot. She had bad strep throat when it came to get the second vaccine. She didn't get her second dose. She asked what do I do to become fully vaccinated and if it was too late to get the second shot. Can I switch over to Moderna. Description of complaint included, she got the Pfizer COVID shot on 02Mar2021. After the shot she had high blood pressure and her kidneys hurt for 3.5 weeks. This high blood pressure and kidney pain started 3 days after the shot on 05Mar2021. She was afraid she was going to have a stroke because her blood pressure medicine wouldn't bring down her blood pressure. She was on Lisinopril. She didn't have the NDC/lot/expiration for the Lisinopril. The doctor increased the mg from 20mg to 40mg. She was back on 20 mg now. After the 3.5 weeks, it just stopped. Her kidneys and her blood pressure went back to normal. She got her urine tested and it was fine. The patient underwent lab tests and procedures which included blood pressure measurement: normal on After the 3.5 weeks, it just stopped. Her kidneys and her blood pressure went back to normal, blood pressure measurement: high on 05Mar2021, urine analysis: fine on an unknown date. The outcome of the events was recovered and bad strep throat was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Seizure, Syncope
Clinical narrative: Had a little seizure; Fainted; This is a spontaneous report from a contactable physician (pediatrician). A 20-year-old male patient received meningococcal group b rlp2086 (TRUMENBA), intramuscular, administered in deltoid left on 21Jul2021 (lot number: DW3000; expiration date: Jun2023; NDC number of Trumenba: 0005-0100-10; UPC number of Trumenba: 300050100102) at the age of 20-years-old, as dose number unknown, single for immunization. The patient had no relevant medical history. The patient was not taking concomitant medications. On 21Jul2021, the patient fainted and had a little seizure after receiving TRUMENBA. The vaccine was administered in the physician's office. Patient is going to college admission and it's required. The physician woke him up then gave him some water to drink and some cookie to eat. Physician stated that he did not eat lunch. The events lasted in less than 10 seconds. The patient recovered from the events on 21Jul2021. The physician considered causal relationship as very possible because events occurred in less than 5 seconds after the shot, like after 2-3 seconds. The physician wanted to know if there's any component in the Trumenba that can cause seizure.; Sender's Comments: Based on the close temporal relationship, the association between the events "patient fainted and had a little seizure" with TRUMENBA use can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: blood sugar shot up real high/went to 540 and that was extremely high; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 21Jul2021 09:30 (at the age of 61-years-old) at dose 1, single in the left arm for COVID-19 immunisation. Medical history included heart troubles (for about 10 years) and diabetes mellitus (15 to 18 years ago). The patient's concomitant medications were not reported. The patient reported that after the vaccination, the patient had errands to do. Then he came home and found that his sugar was extremely high on 21Jul2021 12:00. The patient hasn't eaten anything, so that was not the problem. It seemed that after the vaccination, his blood sugar shot up real high. It went to 540 and that was extremely high. The patient's blood sugar never goes that high. The patient had to take an extra insulin to get it back down. The patient's blood sugar returned to normal on 21Jul2021. The patient underwent blood sugar reading on 21Jul2021 12:00 with result "540 (extremely high)". Outcome of the event was recovered on 21Jul2021.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Inappropriate schedule of product administration
Clinical narrative: Approx 15 to 20 minutes of receiving vaccine - became SOB; The patient received the first dose of BNT162B2 on 08Mar2021 and the second dose on 22Jul2021; This is a spontaneous report from a contactable nurse. A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly, administered in the left arm at a hospital, on 22Jul2021 09:45am (batch/lot number: ER8729) at 65 years old, as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history included asthma/factor 11 from an unknown date. The patient was not diagnosed with COVID-19 prior to vaccination and was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 intramuscularly on 08Mar2021 (batch/lot number: EN6203) at 65 years old, as DOSE 1, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 on 08Mar2021 and the second dose on 22Jul2021. On 22Jul2021 10:15am (reported as approximately 15 to 20 minutes of receiving vaccine), the patient became SOB. The adverse event resulted in Emergency room/department or urgent care visit and patient received treatment. The outcome of the event SOB was not reported. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the event SOB cannot be excluded. The case will be reassessed once more information become 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.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Palpitations, Pericarditis, SARS-CoV-2 test
Clinical narrative: pericarditis; trouble breathing; chest pain; wheezing; palpitations; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 10Jun2021 at 13:15 (Lot Number: EW0182, unknown expiration) as dose 1, single; and on 01Jul2021 at 13:15 (Batch/Lot number was not reported) as dose 2, single, both via unspecified routes of administration in left arm at the age of 43 years old for COVID-19 immunisation.  Medical history and concomitant medications reported as none.  No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive medications within 2 weeks of vaccination. The patient experienced trouble breathing, chest pain, wheezing, palpitations - pericarditis on unspecified dates.  The events resulted in emergency room department/urgent care and doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 via nasal swab since the vaccination with negative result on 02Jul2021.  The patient had not yet recovered from the events.   Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: pericarditis; trouble breathing; chest pain; wheezing; palpitations; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 10Jun2021 at 13:15 (Lot Number: EW0182, unknown expiration) as dose 1, single; and on 01Jul2021 at 13:15 (Batch/Lot number was not reported) as dose 2, single, both via unspecified routes of administration in left arm at the age of 43 years old for COVID-19 immunisation.  Medical history and concomitant medications reported as none.  No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive medications within 2 weeks of vaccination. The patient experienced trouble breathing, chest pain, wheezing, palpitations - pericarditis on unspecified dates.  The events resulted in emergency room department/urgent care and doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 via nasal swab since the vaccination with negative result on 02Jul2021.  The patient had not yet recovered from the events.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cerebral palsy, Discomfort, Eye disorder, Facial paralysis
Clinical narrative: saw reports of Cerebral Palsy and feels she is heading in that direction; Face not completely drooping yet, but feels heavy/since the vaccine she has developed drooping of the face; Face is heavy on right side; severe migraine; Shoulder pain; Difficulty keeping right eye open; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on Jun2021 at 16:00 as dose 1, single for COVID-19 immunization at a pharmacy. The patient has no medical history, family history relevant to the events, and concomitant medications. No other vaccines taken 4 weeks prior to vaccination and on the same day with bnt162b2 vaccine. On an unspecified date, the patient reported that since the vaccine she has developed drooping of the face and severe migraines. The patient added that her face is not completely drooping yet, but has felt heavy on the right side of about the last 4 days, feels a lot of shoulder pain where she got the injection, and finding it hard to keep her right eye open in the evenings. She states that these symptoms have worsened, it is getting worse as it was also happening in the evenings and it now happening earlier in the day. The patient had a telehealth appointment with a physician but the doctor is not able to help her and wants to know if Pfizer is responsible. The patient added that she may go to the emergency room once she finishes talking to call handler. She saw reports of Cerebral Palsy and feels she is heading in that direction and states the doctor mentioned she might need steroids in her face if it is cerebral palsy. She would like some assurance that she is not going to end up with like a 3000 dollar bill for doing what she was supposed to do. States she has read articles about side effects and assumes that they would not be left high and dry. The outcome of the events was not recovered at the time of reporting.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: saw reports of Cerebral Palsy and feels she is heading in that direction; Face not completely drooping yet, but feels heavy/since the vaccine she has developed drooping of the face; Face is heavy on right side; severe migraine; Shoulder pain; Difficulty keeping right eye open; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on Jun2021 at 16:00 as dose 1, single for COVID-19 immunization at a pharmacy. The patient has no medical history, family history relevant to the events, and concomitant medications. No other vaccines taken 4 weeks prior to vaccination and on the same day with bnt162b2 vaccine. On an unspecified date, the patient reported that since the vaccine she has developed drooping of the face and severe migraines. The patient added that her face is not completely drooping yet, but has felt heavy on the right side of about the last 4 days, feels a lot of shoulder pain where she got the injection, and finding it hard to keep her right eye open in the evenings. She states that these symptoms have worsened, it is getting worse as it was also happening in the evenings and it now happening earlier in the day. The patient had a telehealth appointment with a physician but the doctor is not able to help her and wants to know if Pfizer is responsible. The patient added that she may go to the emergency room once she finishes talking to call handler. She saw reports of Cerebral Palsy and feels she is heading in that direction and states the doctor mentioned she might need steroids in her face if it is cerebral palsy. She would like some assurance that she is not going to end up with like a 3000 dollar bill for doing what she was supposed to do. States she has read articles about side effects and assumes that they would not be left high and dry. The outcome of the events was not recovered at the time of reporting.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for covid; I tested positive for covid; This is a spontaneous report from a contactable consumer or other non hcp.     A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: EP-6955) as dose number unknown, single dose for covid-19 immunisation at Workplace clinic.  The patient medical history was not reported with no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any medication within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. The patient stated i tested positive for covid on 21Jul2021 after being in contact with someone who tested positive days earlier. They did not know they had contracted covid until 2 days after I saw them. Therapeutic measures were taken as no for events. The patient underwent lab tests and procedures which included PCR Test (sars-cov-2 test): positive on 07Jul2021 (Nasal Swab). The outcome of events was not recovered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Gastrointestinal pain, Intestinal obstruction, Nausea, SARS-CoV-2 test
Clinical narrative: Resulted in ER visit due to concerns of bowel obstruction; GI symptoms  (nausea; vomiting; severe pain/cramps; constipation) after 1st dose; GI symptoms  (nausea; vomiting; severe pain/cramps; constipation) after 1st dose; GI symptoms  (nausea; vomiting; severe pain/cramps; constipation) after 1st dose; GI symptoms  (nausea; vomiting; severe pain/cramps; constipation) after 1st dose; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 27Feb2021 at 10:15 (at the age of 44-years-old) as dose 1, single for COVID-19 immunisation. Medical history included asthma, endometriosis, food sensitivity to eggs and wheat, all from an unknown date. Concomitant medications included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop dates were not reported and an unspecified birth control pill. In Mar2021, the patient experienced gastrointestinal (GI) symptoms (nausea; vomiting; severe pain/cramps; constipation) after the 1st dose. Resulted in emergency room (ER) visit due to concerns of bowel obstruction. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization. The patient was hospitalized for all events for 5 days. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 03Mar2021, 11Mar2021, 13Mar2021, Mar2021, 02Apr2021, 05Apr2021, 21Apr2021, 24Apr2021, Jul2021 and Jul2021. Therapeutic measures were taken as a result of all events. The outcome of the events was not recovered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Resulted in ER visit due to concerns of bowel obstruction; GI symptoms  (nausea; vomiting; severe pain/cramps; constipation) after 1st dose; GI symptoms  (nausea; vomiting; severe pain/cramps; constipation) after 1st dose; GI symptoms  (nausea; vomiting; severe pain/cramps; constipation) after 1st dose; GI symptoms  (nausea; vomiting; severe pain/cramps; constipation) after 1st dose; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 27Feb2021 at 10:15 (at the age of 44-years-old) as dose 1, single for COVID-19 immunisation. Medical history included asthma, endometriosis, food sensitivity to eggs and wheat, all from an unknown date. Concomitant medications included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop dates were not reported and an unspecified birth control pill. In Mar2021, the patient experienced gastrointestinal (GI) symptoms (nausea; vomiting; severe pain/cramps; constipation) after the 1st dose. Resulted in emergency room (ER) visit due to concerns of bowel obstruction. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization. The patient was hospitalized for all events for 5 days. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 03Mar2021, 11Mar2021, 13Mar2021, Mar2021, 02Apr2021, 05Apr2021, 21Apr2021, 24Apr2021, Jul2021 and Jul2021. Therapeutic measures were taken as a result of all events. The outcome of the events was not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Head discomfort, Headache, Syncope
Clinical narrative: Strong headache makes her faint; Strong headache makes her faint; Head was going to explode; Too hot; feeling really bad; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 11Jun2021 (Batch/Lot Number: EM0181; Expiration Date: 02Jul2021) (at the age of 42-years-old) as dose 1, single; and via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were none. The patient reported that she had strong headache that makes her faint on an unspecified date in 2021. Patient said she had second dose on unspecified date in 2021. She got her first dose on 11Jun2021. Regarding the second dose, the patient answered twice that her son and herself have the same number (as reported). She said that it was her that has the headache and it wasn't bad. She clarified that yesterday she was in bed all day due to the headache. She said that her head was going to explode, it was too hot, and it hurts, and she doesn't know if she should go to the hospital because she was feeling really bad. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100935715 Same reporter/drug/events, different patients
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Rash
Clinical narrative: Menses stopped immediately; Skin rash on upper and lower extremities; This is a spontaneous report from a contactable healthcare professional (patient herself). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 02Apr2021 11:30 (Batch/Lot number was not reported) at the age of 52-years as dose 2, single for COVID-19 immunisation. Medical history included intermittent migraines which I take preventive medication. Patient had no other health issues, no known allergies. Concomitant medication included topiramate taken for migraine received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 11:30 AM on the left arm at the age of 52 years as dose 1 for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that "menses stopped immediately." She had skin rash on upper and lower extremities. Never had a skin issue ever and never went to see a dermatologist in her life. Rash appeared a few days after the vaccination and she was in her home not around gardens, parks, grass, etc. She had no pets and lived alone working remotely. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included prescribed cream for rash, but rash has not diminished. Outcome of the events was not recovered. The case was reported as serious. The patient had not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal association there is possibility of causal association between the event amenorrhea and the suspect drug BNT162B2. 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
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery dissection, Myocardial infarction
Clinical narrative: Heart attack a week later; Heart attack a week later; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm in a hospital facility on 04Mar2021 12:00 (Batch/Lot number was not reported) (at the age of 46-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no covid prior to vaccination and has not been tested for covid-19 since the vaccination. The patient was not pregnant at the time of vaccination. Medical history included high platelets. Concomitant medications included hydroxyurea and multivitamin. On 11Mar2021, the patient experienced heart attack a week later. The patient was hospitalized for the event for 5 days. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder, Musculoskeletal stiffness, Neoplasm malignant, Stomatitis, Stress
Clinical narrative: he got a mouth sores or the cancer; He got a mouth sore; Couldn't eat nothing; the vaccine gave him like immunity stress or something; my shoulder stiff or something; This is a spontaneous report from a contactable consumer.   A male patient of an unspecified age received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number not provided), via an unspecified route of administration on 29Apr2021, as a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for Covid-19 immunization. On an unspecified date, the patient got a mouth sores or the cancer, couldn't eat nothing, the vaccine gave him like immunity stress or something, shoulder stiff or something. Reporter stated that We both complete our 'immunity' (Further clarification was unknown), the second dose was on 29Apr2021, it was stated that of course he had some like side effect but the main thing was after like a week, five days to seven days, he got a mouth sores or the cancer, which he never get before, the reporter don't know if this was related to the vaccine or not. It's like so stressful, like the first month he couldn't eat nothing, it was stated that had to make the food like very soft and then the doctor put him on the antivirus medicines (Further clarification was unknown) and it's getting little better, so he could eat right, after completing the medication after a week, it came back again, he couldn't eat nothing, now it's getting better but some-times like (voice not clear) and 'here and there' they don't know what's wrong, he never had this in his life so reporter wanted to know is this related to the vaccine or maybe the vaccine gave him like immunity stress or something. His (incomprehensible voice), looked like a cancer (Since reporter was unsure, hence cancer was not captured as event). Anyway, they put him on an antiviral medication (treatment) or whatever. The doctor came out helpful that is why reporter felt like a (in-complete sentence). The event Neoplasm malignant was considered as serious (Medically significant). The outcome of the events was unknown.   No further information was provided.
Sex: U
Vaccine: MENB
Symptoms: Seizure
Clinical narrative: seizure; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunisation. The patient medical history and concomitant medications were not reported. According to the physician, the patient received a dose of TRUMENBA and the patient had a seizure. Event took place after use of product. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event seizure based on the temporal association  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.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Heart rate, Heart rate increased
Clinical narrative: his blood pressure, at first it was93 and the second time it was 32; fast heartbeat; This is a spontaneous report from a contactable consumer (patient mother) via Pfizer-sponsored program.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date (lot/batch not provided) as COVID-19 immunization. Then, the 2nd dose on 22Jul2021. In 2021, the patient experienced had blood pressure which at first it was 93 and the second time it was 32 and had a fast heartbeat. Outcome of the events were unknown.   Information regarding the batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dementia, Joint swelling, Pityriasis rosea
Clinical narrative: some dementia; Rash on his legs and back that his dermatologist diagnosed as Pityriasis Rosea; significant swelling in his ankles; anxiety; This is a spontaneous report from a contactable consumer (patient) via a sales repsentative. An 81-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE; dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included heart disease and significant allergic reactions to many different things. The patient has had significant heart disease for years and is currently under the care of a cardiologist. The patient also has significant allergic reactions to many different things over the course of his 81 years. Concomitant medications included unspecified medications for heart disease. The patient is on many different medication for heart disease. Following two doses of the Pfizer vaccine: the patient has been experiencing for many months a rash on his legs and back that his dermatologist diagnosed as Pityriasis Rosea. The patient was also experiencing significant swelling in his ankles. The patient's family believes that there is some dementia and anxiety being experienced by the patient. He has been treated recently with steroids for the rash that he is experiencing without much improvement. Outcome of the event Pityriasis Rosea was not recovered, while outcome of other events was unknown.   Information on the Batch/lot number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Ear pain, Electrocardiogram, Laboratory test, Myocardial infarction
Clinical narrative: I was having a heart attack; having problems with pain in my left lung; my having a left ear ache; cold going on in my left lung; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP7534), via an unspecified route of administration, administered in arm right on 25Mar2021 at 14:15 (at the age of 59-years-old) as single for COVID-19 immunisation. The patient medical history was none. Concomitant medications includes unspecified medications (not other than her normal medications) received within 2 weeks of vaccination. The patient previously took the first dose of bnt162b2 on an unspecified date for COVID-19 immunisation. Patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient reported that on 29Mar2021, he started "having problems with pain in my left lung" and "my having a left earache". He really did not think much about it. He just thought he had a "cold going on in my left lung" and it was going up into his left ear. This went on for a long time. Finally, on 06May2021, he had lab work at the unspecified administration and talked to the nurse about his ear and left lung. She looked at his ear and told it looked fine and sent him to the hospital for chest X-rays. The X-rays came out clear. So, he had an appointment with his doctor on 10May2021 and she did an EKG and sent him to the ER. They told the patient that "I was having a heart attack". So nothing had changed from 29Mar2021 till 10May2021. He was having a heart attack all that time and never knew it. So the second shot was what made him have the heart attack because he had no heart problems before that time. The patient underwent lab test and procedure which included chest X ray: came out clear on an unspecified date, EKG: unknown results on 10May2021, lab work: unknown result on 06May2021 and nasal swab: unknown results on an unspecified date. The outcome of the events was resolving.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pulmonary pain, SARS-CoV-2 test
Clinical narrative: I was having a heart attack; having problems with pain in my left lung; my having a left ear ache; cold going on in my left lung; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP7534), via an unspecified route of administration, administered in arm right on 25Mar2021 at 14:15 (at the age of 59-years-old) as single for COVID-19 immunisation. The patient medical history was none. Concomitant medications includes unspecified medications (not other than her normal medications) received within 2 weeks of vaccination. The patient previously took the first dose of bnt162b2 on an unspecified date for COVID-19 immunisation. Patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient reported that on 29Mar2021, he started "having problems with pain in my left lung" and "my having a left earache". He really did not think much about it. He just thought he had a "cold going on in my left lung" and it was going up into his left ear. This went on for a long time. Finally, on 06May2021, he had lab work at the unspecified administration and talked to the nurse about his ear and left lung. She looked at his ear and told it looked fine and sent him to the hospital for chest X-rays. The X-rays came out clear. So, he had an appointment with his doctor on 10May2021 and she did an EKG and sent him to the ER. They told the patient that "I was having a heart attack". So nothing had changed from 29Mar2021 till 10May2021. He was having a heart attack all that time and never knew it. So the second shot was what made him have the heart attack because he had no heart problems before that time. The patient underwent lab test and procedure which included chest X ray: came out clear on an unspecified date, EKG: unknown results on 10May2021, lab work: unknown result on 06May2021 and nasal swab: unknown results on an unspecified date. The outcome of the events was resolving.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid on April 14; Tested positive for Covid on April 14; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered in left arm on 05Apr2021 13:30 (at the 62-year-old) as single dose for COVID-19 immunization and it was administered in hospital. Medical history was not reported and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. Concomitant medication in two weeks included citalopram. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered in left arm on 15Mar2021 13:45 as single dose for COVID-19 immunization and had contracted COVID. On 14Apr2021 at 09:00, patient tested positive for COVID. The patient underwent lab tests and procedures which included nasal swab as positive on 14Apr2021 and negative on 12May2021. It was unknown if the patient received any treatment for adverse event. The outcome of event COVID-19 was recovered on unspecified date in 2021.  Information about batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Severe anaphylactic reaction; This is a spontaneous report from a contactable physician (patient's husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization; and influenza vaccine (INFLUENZA VACCINE, unknown manufacturer), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunisation. Medical history included ongoing allergy to iodine and penicillin. The patient's concomitant medications were not reported. Historical vaccine includes influenza vaccine for immunization where patient previously had a severe anaphylactic reaction. On an unknown date, the patient experienced a serious severe anaphylactic reaction. The event was considered as serious important medical event. It was further reported that patient experienced a serious severe anaphylactic reaction to the influenza vaccine (anaphylactic reaction) (unknown latency) following the administration of influenza vaccine and bnt162b2. It was unknown if the patient experienced any additional symptoms/event. It was unknown if there were lab data/ results available. The physician stated that he was an Infectious Disease physician and stated that his wife has an allergy to iodine and penicillin and has previously had a severe anaphylactic reaction to the influenza vaccine. He states that since she has had these allergies and reactions in the past he was looking into some research to see if he would recommend his wife to get the vaccine. He was asking for any information regarding the administration of the vaccine in 4 smaller doses rather than the current two dose series that was recommended. He reported that he understands the information may be limited and just wanted to check and see if there had been in studies done in this case. Advised that there was limited information on this topic but relayed that there are currently ongoing trials for pediatric patients that are being studies with a variety of different dosage amounts that may be helpful for him. It was not repotted if the patient received a corrective treatment for the event. At time of reporting, the outcome of event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of anaphylactic reaction due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram thorax, Dyspnoea
Clinical narrative: Chest pain; Shortness of breath; This is a spontaneous report from a contactable nurse. A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: ER8736), intramuscularly administered in the left deltoid on 12Jun2021 08:00 (at the age of 14-years-old) as dose 2, single for COVID-19 immunization. Medical history included dog bite. Concomitant medication included an unspecified antibiotic for dog bite. The patient previously received the first dose of BNT162B2 (lot number was not reported) on an unspecified date; and experienced increased inflammatory markers, pneumonia, and inflammation to the heart. On 13Jun2021, the patient experienced chest pain and shortness of breath. The events required physician office visit and were considered serious (important medical event). Treatment included antibiotics. Pneumonia was ruled out. Chest CT was performed with unknown results. The outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of chest pain and shortness of breath due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Bell's palsy
Clinical narrative: Bell's Palsy; Anaphylactic reaction; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sponsored program. (Patient reported for self). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that she had several medication allergies (possibly to thiosulfate) and trying to determine if those anaphylactic reaction to those medication; predispose her to have a reaction with the Pfizer COVID-19 vaccine. The patient experienced anaphylactic reaction and Bell's palsy on unspecified dates. The patient stated, her pharmacist told her to call Pfizer and give medications she was allergic to and to check on any cross reaction. The patient stated he had a side effect after the first dose of the vaccine. Should she get the second dose?, the patient queried stating, what if she had an anaphylactic reaction after the first does? Response given from (LAB-1457-10.0 Revised: 25Jun2021) under section 4 CONTRAINDICATIONS. Patient was referred to speak to her healthcare provider about the risks of the vaccine. Patient stated, the overlapping ingredient that was found in the mediations she was allergic to and Pfizer COVID-19 vaccine was polyethylene glycol; would that predispose the patient to having an anaphylactic reaction? the patient queried. For further queries, the patient was guided to PI on pfizer.com (FACT sheet for HCPs, Recipients and the PI). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100954802 same reporter/ drug, different AE/ patient;US-PFIZER INC-202100954801 same reporter/ drug, different AE/ patient
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: did not work; COVID-19; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer-sponsored program. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered on an unspecified date at the age of (59-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient got their first dose and 3 days later she came down with Covid. The patient came in like, couple of months later to get their second dose and then the doctor also said that the first dose does not count since they got covid. They were wondering if they should get the third dose as well, as they were saying first dose doesn't count.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Endocrine test, Thyroid function test, Thyroiditis subacute, Ultrasound scan
Clinical narrative: thyroiditis subacute; This is a spontaneous report from a non-contactable consumer. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced thyroiditis subacute. Time to onset was 0 days - occurring on the same evening. The reporter classified the seriousness criteria of life threatening, disabling/Incapacitating, intervention/medically important, congenital anomaly/birth defect, death, hospitalization required, hospitalization prolonged, other was reported as no. Treatment medication included corticosteroids for 2 months (tapered). On an unspecified date, the patient underwent lab tests and procedures which included endocrinological, thyroid function test, thyroid echography, all were resulted as unknown results. The outcome of the event was recovered.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: The patients was admitted with COVID after having the Pfizer COVID-19 vaccine; The patients was admitted with COVID after having the Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable other HCP (nurse) from a Pfizer sponsored program. A 79-years-old patient of an unspecified gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, NDC number and expiry date were not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history, investigation assessment and concomitant medications were not reported. The report was not related to a study or programme. The nurse reported that the patient was admitted with covid after having Pfizer covid-19 vaccine. Antibodies were not tested. The outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events of  DI , Covid 19 and suspect drug BNT162B2 cannot be excluded,Linked Report(s) : US-PFIZER INC-202100957229 same reporter, different patient, same drug, similar events