chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Echocardiogram, Heart rate, Heart rate increased, Positron emission tomogram
Clinical narrative: get in to the hospital due to my heart, AFib; Shortly after, his heart rate went up/Heart beat jumped so fast, sudden rapid heartbeat; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program.  A 48-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Apr2021 13:30 (Batch/Lot Number: EW0151) as single dose for covid-19 immunisation. Patient received the first dose on 14Mar2021 at the age of 47years old. The patient medical history was not reported. The patient's concomitant medications were not reported. Shortly (about an hour) after vaccination, his heart rate went up to 190 bpm and into atrial fibrillation. Heart beat jumped so fast, sudden rapid heartbeat. Caller sought medical care via emergency department, and went to doctor couple of times specially to heart doctor to make sure things are good. Patient was hospitalization for event Atrial fibrillation. Patient had Echocardiogram and PET scan on unknown date with result unknown.  Outcome of events was unknown.   Follow up needed, further information was requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chills, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: wasn't feeling good; he feels like he's going to fall out or pass out; he feels like he's going to fall out or pass out; walking like he is intoxicated with a wobble; sluggish all the time; heart rate has been elevated; nauseous; cold chills; severe headache; This is a spontaneous report from a contactable consumer (patient). The 33-years-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 14:00 (Lot Number: ER8727) as single dose for covid-19 immunization at the age of 33 years old. Medical history included asthma, scoliosis, his scoliosis has never caused him to walk like this before. The report was not related to a study or programme. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Concomitant medication(s) included marijuana. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient previously received bnt162b2, dose 1via an unspecified route of administration, on 13Mar2021 (Lot Number: EP7534) in right arm as single dose for covid-19 immunization at the age of 33 years old. The patient experienced he feels like he's going to fall out or pass out, walking like he is intoxicated with a wobble, sluggish all the time, heart rate has been elevated in May2021, nauseous, cold chills and severe headache on 04Apr2021, wasn't feeling good on an unspecified date. Reported as: The caller received both doses of the vaccine. He had the second dose of the vaccine on 03Apr2021 and about a month after the second dose (in the beginning of May2021) he noticed that he is walking like he is intoxicated with a wobble, he is sluggish all the time, and he cannot control pretty much how he feels sometimes. Sometimes feels like he is going to fall or pass out and his heart rate has been elevated. That all started about a month ago, which was a month after the vaccine and it is progressively getting worse. His boss is asking him if he has been drinking. He is not intoxicated. He reports the day after he received the second Covid 19 vaccine on 04Apr2021, he went to the emergency room because he wasn't feeling good. When asked to elaborate he says he felt nauseous, he had cold chills, and a severe headache. He was discharged from the emergency room. He had some blood work done and a Covid 19 virus test. His bloodwork was fine and his Covid 19 virus test was negative. The AEs Nauseous, cold chills, severe headache, Feeling unwell required a visit to Emergency Room. The outcome of the events Feeling abnormal, Feeling unwell, Headache, Chills, Nauseous was unknown and not recovered for the rest events.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Loss of consciousness, Malaise, Nausea
Clinical narrative: wasn't feeling good; he feels like he's going to fall out or pass out; he feels like he's going to fall out or pass out; walking like he is intoxicated with a wobble; sluggish all the time; heart rate has been elevated; nauseous; cold chills; severe headache; This is a spontaneous report from a contactable consumer (patient). The 33-years-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 14:00 (Lot Number: ER8727) as single dose for covid-19 immunization at the age of 33 years old. Medical history included asthma, scoliosis, his scoliosis has never caused him to walk like this before. The report was not related to a study or programme. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Concomitant medication(s) included marijuana. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient previously received bnt162b2, dose 1via an unspecified route of administration, on 13Mar2021 (Lot Number: EP7534) in right arm as single dose for covid-19 immunization at the age of 33 years old. The patient experienced he feels like he's going to fall out or pass out, walking like he is intoxicated with a wobble, sluggish all the time, heart rate has been elevated in May2021, nauseous, cold chills and severe headache on 04Apr2021, wasn't feeling good on an unspecified date. Reported as: The caller received both doses of the vaccine. He had the second dose of the vaccine on 03Apr2021 and about a month after the second dose (in the beginning of May2021) he noticed that he is walking like he is intoxicated with a wobble, he is sluggish all the time, and he cannot control pretty much how he feels sometimes. Sometimes feels like he is going to fall or pass out and his heart rate has been elevated. That all started about a month ago, which was a month after the vaccine and it is progressively getting worse. His boss is asking him if he has been drinking. He is not intoxicated. He reports the day after he received the second Covid 19 vaccine on 04Apr2021, he went to the emergency room because he wasn't feeling good. When asked to elaborate he says he felt nauseous, he had cold chills, and a severe headache. He was discharged from the emergency room. He had some blood work done and a Covid 19 virus test. His bloodwork was fine and his Covid 19 virus test was negative. The AEs Nauseous, cold chills, severe headache, Feeling unwell required a visit to Emergency Room. The outcome of the events Feeling abnormal, Feeling unwell, Headache, Chills, Nauseous was unknown and not recovered for the rest events.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sluggishness
Clinical narrative: wasn't feeling good; he feels like he's going to fall out or pass out; he feels like he's going to fall out or pass out; walking like he is intoxicated with a wobble; sluggish all the time; heart rate has been elevated; nauseous; cold chills; severe headache; This is a spontaneous report from a contactable consumer (patient). The 33-years-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 14:00 (Lot Number: ER8727) as single dose for covid-19 immunization at the age of 33 years old. Medical history included asthma, scoliosis, his scoliosis has never caused him to walk like this before. The report was not related to a study or programme. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Concomitant medication(s) included marijuana. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient previously received bnt162b2, dose 1via an unspecified route of administration, on 13Mar2021 (Lot Number: EP7534) in right arm as single dose for covid-19 immunization at the age of 33 years old. The patient experienced he feels like he's going to fall out or pass out, walking like he is intoxicated with a wobble, sluggish all the time, heart rate has been elevated in May2021, nauseous, cold chills and severe headache on 04Apr2021, wasn't feeling good on an unspecified date. Reported as: The caller received both doses of the vaccine. He had the second dose of the vaccine on 03Apr2021 and about a month after the second dose (in the beginning of May2021) he noticed that he is walking like he is intoxicated with a wobble, he is sluggish all the time, and he cannot control pretty much how he feels sometimes. Sometimes feels like he is going to fall or pass out and his heart rate has been elevated. That all started about a month ago, which was a month after the vaccine and it is progressively getting worse. His boss is asking him if he has been drinking. He is not intoxicated. He reports the day after he received the second Covid 19 vaccine on 04Apr2021, he went to the emergency room because he wasn't feeling good. When asked to elaborate he says he felt nauseous, he had cold chills, and a severe headache. He was discharged from the emergency room. He had some blood work done and a Covid 19 virus test. His bloodwork was fine and his Covid 19 virus test was negative. The AEs Nauseous, cold chills, severe headache, Feeling unwell required a visit to Emergency Room. The outcome of the events Feeling abnormal, Feeling unwell, Headache, Chills, Nauseous was unknown and not recovered for the rest events.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Limb discomfort, Neuropathy peripheral, Pain in extremity
Clinical narrative: couldn't lift arm or lay on it; red hematoma at injection site for weeks; burning from head to toe; Arm hurt; Neuropathy and Small Nerve Fiber Neuropathy; worst headache; This is a spontaneous report from a contactable consumer (patient).  A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 05May2021(at age of 60 years old) (Batch/Lot number was not reported) as 1st dose, single for Covid-19 immunisation.  Medical history included Hashimoto's, Fibromyalgia, Small Nerve Fiber Neuropathy, surgeries for defective veins and valves, poor circulation problems and kidney infection 10 years before shortly after undergoing cath lab procedure. The patient's concomitant medications were not reported.  Consumer call with questions regarding " I had side effects after the first dose of the vaccine.  Should I get the second dose?" Side effects included "worst headache on 05May2021 for 2 days continued for weeks, couldnt lift arm or lay on it, red hematoma at injection site for weeks, burning from head to toe." Caller also reported that her arm hurt after the vaccine. Also reported she had to receive prednisone (her doctor put her on steroids) after first vaccine dose, also reported that her doctor gave her Methylprednisolone, which she took for 6 days, the medication did help somewhat with her symptoms, specifically, the burning from her neuropathy, headache and she couldnt lift her arm, the medication was not a miracle drug, but she did have some relief. She tapered the medication, she had less relief of her symptoms. The symptoms have subsided somewhat and it has taken several weeks. Caller just wanted to ask a medical professional if that ingredient (propyl ethlene glycol as provided and spelled by Caller) contributes to Small Nerve Fiber Neuropathy, Patient reported she went on vacation in January of 2020, after returning home she was very sick but was never diagnosed with Covid-19.  Caller reported that she had some type of neuropathy that had come back after she got the first vaccine, she had a splitting headache within 30 minutes of getting the vaccine, and it was really bad, for two days after the vaccine. Caller was concerned to take the second vaccine, because of her previous bad reaction, and her doctor told her to take her second dose and Second dose of vaccine scheduled for 10Jun2021, 36 days after the first dose of vaccine. Outcome for events was recovering.   Information regarding the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haematoma
Clinical narrative: couldn't lift arm or lay on it; red hematoma at injection site for weeks; burning from head to toe; Arm hurt; Neuropathy and Small Nerve Fiber Neuropathy; worst headache; This is a spontaneous report from a contactable consumer (patient).  A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 05May2021(at age of 60 years old) (Batch/Lot number was not reported) as 1st dose, single for Covid-19 immunisation.  Medical history included Hashimoto's, Fibromyalgia, Small Nerve Fiber Neuropathy, surgeries for defective veins and valves, poor circulation problems and kidney infection 10 years before shortly after undergoing cath lab procedure. The patient's concomitant medications were not reported.  Consumer call with questions regarding " I had side effects after the first dose of the vaccine.  Should I get the second dose?" Side effects included "worst headache on 05May2021 for 2 days continued for weeks, couldnt lift arm or lay on it, red hematoma at injection site for weeks, burning from head to toe." Caller also reported that her arm hurt after the vaccine. Also reported she had to receive prednisone (her doctor put her on steroids) after first vaccine dose, also reported that her doctor gave her Methylprednisolone, which she took for 6 days, the medication did help somewhat with her symptoms, specifically, the burning from her neuropathy, headache and she couldnt lift her arm, the medication was not a miracle drug, but she did have some relief. She tapered the medication, she had less relief of her symptoms. The symptoms have subsided somewhat and it has taken several weeks. Caller just wanted to ask a medical professional if that ingredient (propyl ethlene glycol as provided and spelled by Caller) contributes to Small Nerve Fiber Neuropathy, Patient reported she went on vacation in January of 2020, after returning home she was very sick but was never diagnosed with Covid-19.  Caller reported that she had some type of neuropathy that had come back after she got the first vaccine, she had a splitting headache within 30 minutes of getting the vaccine, and it was really bad, for two days after the vaccine. Caller was concerned to take the second vaccine, because of her previous bad reaction, and her doctor told her to take her second dose and Second dose of vaccine scheduled for 10Jun2021, 36 days after the first dose of vaccine. Outcome for events was recovering.   Information regarding the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: massive pulmonary embolism; This is a spontaneous report received from a contactable physician. A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (at age of 48 years old) (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation.  The patient was not pregnant at time of vaccination. Medical history included asthma and menorrhagia. No past drug.  Concomitant medication(s) the patient received within 2 weeks of vaccination included ethinylestradiol, norgestimate (SPRINTEC) taken for an unspecified indication, start and stop date were not reported.  The patient experienced massive pulmonary embolism on 10Apr2021 with outcome of recovering. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for massive pulmonary embolism for 30 days.  catheter-directed thrombolysis received for event. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of pulmonary embolism due to temporal relationship.  However, the concomitant medication of ethinylestradiol, norgestimate may have contributed to the development of the PE.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including VQ scan, pulmonary angiogram results and coagulation panel, and concomitant medications. This case will be reassessed once additional information is 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.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Cardiac function test, Heart rate, Heart rate increased
Clinical narrative: rapid heart rate; anxiety; This is a spontaneous report from a contactable nurse reported for nephew from a Pfizer-sponsored program.  A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received by the Pfizer Covid vaccine and was now complaining of rapid heart rate. He had never had anything like this happen before. The patient had been transported to the hospital 5 times as a result of his symptoms and all cardiac workup tests had resulted negative for cardia issues. The doctor said its anxiety but it is not anxiety. They put the patient on a blood pressure medicine for his high heart rate. Reporter was concerned that the patient was being treated for anxiety rather than treating this a symptom due to lack of knowledge about the side effects of the Pfizer covid vaccine. The patient was in the hospital right now. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the  reported events cannot be excluded  based on temporal relationship. The information available in this report is limited. Of note, medical history and concomitant medications were not provided. Case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Hypoaesthesia, Inner ear disorder, Muscle twitching, Paraesthesia
Clinical narrative: inner ear not able to find my balance feeling; off balance; numbness turned into pins and needles; my numb legs began twitching uncontrollable; I was not able to walk or lift my legs; my feet began going numb. The numbness climbed up my legs to where my legs attach to my torso. I also experienced numbness in my hands and arm, cheeks; my tongue became heavy; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jun2021 14:15 (Batch/Lot Number: EW0177) as single dose for covid-19 immunisation at the age of 35-year-old.  Medical history included Congenital deafness/hard of hearing. Sensory processing disorder and allergic to Septra (co-timoxazole). There were no concomitant medications.  The consumer reported about 10 minutes after the shot, my feet began going numb. The numbness climbed up my legs to where my legs attach to my torso. I also experienced numbness in my hands and arm, cheeks, and my tongue became heavy. About 25 minutes after the shot, I was not able to walk or lift my legs. This was extremely scary. About 40 minutes after the shot, my numb legs began twitching uncontrollable. The twitching lasted about 10 minutes. About 2 hours after my shot I was able to walk again and the numbness turned into pins and needles. At about 7 hours after the shot the pins and needles subsided. The next morning I felt like I was on a ship. It was not a dizzy feeling, but more of an inner ear not able to find my balance feeling. I am still off balance. The pins and needles comes and goes. The events resulted in doctor or other healthcare professional office/clinic visit and prolonged hospitalization. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination and hasn't been tested for COVID-19 since the vaccination.  Follow-up attempts are needed. Further information is requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue disorder, Walking disability
Clinical narrative: inner ear not able to find my balance feeling; off balance; numbness turned into pins and needles; my numb legs began twitching uncontrollable; I was not able to walk or lift my legs; my feet began going numb. The numbness climbed up my legs to where my legs attach to my torso. I also experienced numbness in my hands and arm, cheeks; my tongue became heavy; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jun2021 14:15 (Batch/Lot Number: EW0177) as single dose for covid-19 immunisation at the age of 35-year-old.  Medical history included Congenital deafness/hard of hearing. Sensory processing disorder and allergic to Septra (co-timoxazole). There were no concomitant medications.  The consumer reported about 10 minutes after the shot, my feet began going numb. The numbness climbed up my legs to where my legs attach to my torso. I also experienced numbness in my hands and arm, cheeks, and my tongue became heavy. About 25 minutes after the shot, I was not able to walk or lift my legs. This was extremely scary. About 40 minutes after the shot, my numb legs began twitching uncontrollable. The twitching lasted about 10 minutes. About 2 hours after my shot I was able to walk again and the numbness turned into pins and needles. At about 7 hours after the shot the pins and needles subsided. The next morning I felt like I was on a ship. It was not a dizzy feeling, but more of an inner ear not able to find my balance feeling. I am still off balance. The pins and needles comes and goes. The events resulted in doctor or other healthcare professional office/clinic visit and prolonged hospitalization. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination and hasn't been tested for COVID-19 since the vaccination.  Follow-up attempts are needed. Further information is requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots in greater saphenous vein; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Apr2021 08:00 at single dose in left arm (at the age of 55-year-old) for COVID-19 immunization. Medical history included covid-19. Concomitant medication included iodine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 15Apr2021, the patient experienced blood clots in greater saphenous vein. The event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included Eliquis. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Bottom  lip is numb. Feels like when you get that anesthetic on your gum at the dentist; This is a spontaneous report from a contactable other hcp (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0186), dose 1 via an unspecified route of administration, administered in arm left on 08Jun2021 as dose 1, singe for covid-19 immunisation. Medical history included blood pressure measurement (BP). Concomitant medication included metoprolol. The patient previously received flu shots and experienced allergies. The patient stated, "Bottom lip is numb. Feels like when you get that anesthetic on your gum at the dentist (on 08Jun2021 11:45)." The patient received treatment for AE included Benadryl. The patient did not receive any other vaccines 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 not been tested for COVID-19. The outcome of the event was resolving.; Sender's Comments: Based on the close temporal relationship, the association between the event "bottom lip is numb" with BNT162b2 can not be completely 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.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Drug ineffective, Dry skin, Pruritus, Suspected COVID-19
Clinical narrative: Also she got COVID and she was pretty sick; Also she got COVID and she was pretty sick; Losing hair; Having an itchy and dry scalp; Having an itchy and dry scalp; This is a spontaneous report from a contactable consumer. 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 DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the COVID vaccine and was losing a lot of hair and also, she got COVID and she was pretty sick. The patient also had itchy and dry scalp. Outcome of the events was unknown.   Information on the batch/lot number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Encephalopathy, Psychotic disorder, SARS-CoV-2 test, Syncope
Clinical narrative: Syncope; Psychosis; Encephalopathy; This is a spontaneous report from a contactable physician. A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 18May2021 12:00 at the age of 59-years-old (Batch/Lot Number: EW0176) as single dose for COVID-19 immunization. Relevant medical history and concurrent conditions included hypertension (HTN), overactive bladder, benign prostatic hyperplasia (BPH). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered on 22Apr2021 at the age of 59-years-old (Batch/Lot Number: ew0164) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included amlodipine, lisinopril, oxybutynin, tamsulosin, hydroxyzine. The patient experienced syncope, psychosis/encephalopathy within 2 hours at 18May2021 14:00. Duration of hospitalization was 2. AE treatment included antipsychotics. The patient underwent lab tests and procedures which included Nasal Swab: negative on 20May2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Paraesthesia, Pyrexia, Thrombosis
Clinical narrative: blood clot; he woke up with a numb hip up to his calf and his foot has been tingling; he woke up with a numb hip up to his calf and his foot has been tingling; chills and fever; chills and fever; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 04Jun2021 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history not reported. Concomitant medications included ongoing apixaban (ELIQUIS) as blood thinner. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14May2021 for COVID-19 immunisation. The caller (name withheld) said that she and her husband received the Pfizer Covid-19 Vaccine 1st dose on 14May2021 and 2nd dose on 04Jun2021. Last Saturday (on 05Jun2021), her husband (name withheld) started to experience side effects like chills and fever. Yesterday (on 07Jun2021), he woke up with a numb hip up to his calf and his foot had been tingling. She also mentioned that her husband was taking a blood thinner called apixaban and they thought he had a blood clot. They were asking if they should go to the hospital. The outcome of all events was unknown.   Information about batch/lot number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Ear discomfort, Endolymphatic hydrops, Headache
Clinical narrative: fluid in my inner ear; extreme aches, chills, and severe headaches; extreme aches, chills, and severe headaches; extreme aches, chills, and severe headaches; My ear still was feeling pressure; vertigo; vomitting; dizziness; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 15Apr2021 11:30 at the age of 56-years-old (Lot Number: EP6955) as single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 19Mar2021 09:15 AM (Lot Number: EN6205) as single dose for COVID-19 immunization. The patient previously took pencillin and experienced known_allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included estradiol, estriol (BI EST). It was reported: After first dose of the vaccine I felt fine but had the feeling that my right ear had a bit of pressure in it. After my 2nd shot on a Thurs. I experienced similar side effects as some do. I had extreme aches, chills, and severe headaches. I am a teacher and called in sick the next day. I still passed it on as no big deal until my headache didn't go away. By Monday my headache was severe but I tried going back to work. My ear still was feeling pressure. My Tues. morning I woke up with a headache and vertigo to the point I was vomitting. Went to doctor It was probably fluid in my inner ear. Woke up 2nd day with Vertigo again, went doctor and was given a migrain shot to control my headache. Vertigo subsided. Missed 2 more of work. One month later Vertigo returned with a severe headache. Went to the doctor and she prescribed vestibular therapy. They tested for crystals but ruled it out. They are now trying to treat nerve/tissue damage in my inner ear. Battling dizziness." All adverse events start date was 15Apr2021 07:30 PM. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included Vestibular Therapy and Migraine Shot. The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021671886 Same patient and vaccine, different dose and events
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vertigo, Vomiting
Clinical narrative: fluid in my inner ear; extreme aches, chills, and severe headaches; extreme aches, chills, and severe headaches; extreme aches, chills, and severe headaches; My ear still was feeling pressure; vertigo; vomitting; dizziness; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 15Apr2021 11:30 at the age of 56-years-old (Lot Number: EP6955) as single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 19Mar2021 09:15 AM (Lot Number: EN6205) as single dose for COVID-19 immunization. The patient previously took pencillin and experienced known_allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included estradiol, estriol (BI EST). It was reported: After first dose of the vaccine I felt fine but had the feeling that my right ear had a bit of pressure in it. After my 2nd shot on a Thurs. I experienced similar side effects as some do. I had extreme aches, chills, and severe headaches. I am a teacher and called in sick the next day. I still passed it on as no big deal until my headache didn't go away. By Monday my headache was severe but I tried going back to work. My ear still was feeling pressure. My Tues. morning I woke up with a headache and vertigo to the point I was vomitting. Went to doctor It was probably fluid in my inner ear. Woke up 2nd day with Vertigo again, went doctor and was given a migrain shot to control my headache. Vertigo subsided. Missed 2 more of work. One month later Vertigo returned with a severe headache. Went to the doctor and she prescribed vestibular therapy. They tested for crystals but ruled it out. They are now trying to treat nerve/tissue damage in my inner ear. Battling dizziness." All adverse events start date was 15Apr2021 07:30 PM. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included Vestibular Therapy and Migraine Shot. The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021671886 Same patient and vaccine, different dose and events
Sex: F
Vaccine: COVID19
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Stevens-Johnson syndrome; This is a spontaneous report from a contactable Pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as first single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Pharmacist stated that she had a patient who received the 1st dose of Pfizer vaccine and developed Stevens-Johnson syndrome. The patient wanted to receive moderna vaccine. Pharmacist wanted to know can the patient receive the moderna vaccine and does the moderna also can cause the same side effect, if causes what is the percentage. Pharmacist did not have the patient details. Outcome of the event was unknown.  Information about lot/batch number is requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Stevens-Johnson syndrome 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: Hypersensitivity, Rash
Clinical narrative: a severe allergic reaction; broke out in a rash; This is a spontaneous report from a contactable other HCP (nurse) reporting for herself.  A female patient of an unspecified age received first dose of BNT162B2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a severe allergic reaction and broke out in a rash on an unspecified date. Reporter stated that she got her first shot and the whole top of body broke out in a rash, should she get the second shot. It was all over the trunk of body. Reporter stated she got a paper here. It says Pfizer biontech covid 19 vaccine. She does know she has a paper and it said that if you have difficulty breathing, swelling of the face and throat or a bad rash all over body that its supposed to be a severe allergic reaction. Outcome of the events was unknown.  Information about lot/batch number requested.; Sender's Comments: Considering temporal relationship, the reported severe allergic reaction with rash were likely related to vaccination with BNT162B2.  The case will be reassessed should additional 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 agencies, as appropriate.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Head injury, Pallor, Syncope, Vital signs measurement
Clinical narrative: fainted; Hit his head on the floor; pale looking; This is a spontaneous report from a contactable pharmacist. A 12-year-old male patient received first dose of bnt162b2 intramuscularly administered in right arm on 08Jun2021 at 15:00 (Batch/Lot Number: EW0187) at age of 12-year-old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. On 08Jun2021 at 15: 10, 10 minutes after the shot (also reported on 08Jun2021 at 15: 00), the patient fainted, hit his head on the floor, conscious but pale looking. Patient's weight 160 lbs, vitals normal per grand ma and emt left after having him seat on the chair. The adverse event result in Emergency room/department or urgent care. The outcome of events was recovered on Jun2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported event syncope and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac failure congestive
Clinical narrative: congestive heart failure; Heart problem/heart down; This is a spontaneous report from a Pfizer-sponsored program.  A contactable consumer reported that a 90-year-old female patient 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 1, single and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced congestive heart failure and heart problem/heart down. The patient had a heart problem after the Pfizer Covid vaccine. The patient had congestive heart failure and was 90 years old. The hospital said for the patient to get the second shot and it shut her heart down and the patient passed away. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information on Lot/Batch number has been requested.; Reported Cause(s) of Death: congestive heart failure; Heart problem/heart down
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Fatigue, Hemiplegia, Pain in extremity
Clinical narrative: Stroke; hemiparalysis on the left side and a long road back/left arm and left foot are paralyzed and he can't walk; tired; sore arm; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's wife) reported that a 65-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the right arm on 12Mar2021, dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took aspirin, fish oil and vitamins (unspecified). The patient did not have prior vaccinations within 4 weeks from the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 on 19Feb2021 AT 16:00 in the right arm. The patient experienced a stroke on 17May2021. It was after his second dose of the Covid vaccine. The reporter said that the most worrying thing is through all of the tests they can't find anything that attributed to the stroke. The patient plays tennis one level below pro and played 4 times that week, he played golf that Saturday, cut the grass on Sunday and there is nothing to attribute to the stroke. The patient has hemiparalysis on the left side and a long road back. The patient can talk but his left arm and left foot are paralyzed and he can't walk, he is in a wheel chair and undergoing intense Physical Therapy. The patient was also tired and he had a sore arm. The patient was hospitalized from 17May2021 to 04Jun2021 due to the events stroke and hemiparalysis on the left side and a long road back/left arm and left foot are paralyzed and he can't walk. The patient visited the physician's office on 08Jun2021. The events stroke and hemiparalysis on the left side and a long road back/left arm and left foot are paralyzed and he can't walk were recovering while the events tired and sore arm have recovered on an unknown date.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died because of the vaccine; This is a spontaneous report from a Non-contactable consumer (patient's grandson). A male 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 single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died because of the vaccine on an unspecified date. The cause of death was not reported. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: died because of the vaccine
Sex: M
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: diagnosed with ITP; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN1185), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient relays he had COVID vaccine in March, then subsequently was diagnosed with ITP on Mar2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy left side of face; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0151) via an unspecified route of administration, administered in Arm Left on an unspecified date as, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies and did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior and since the vaccination the patient was not diagnosed with COVID-19. The patient previously took BNT162B2(Batch/Lot Number: EN6207) via an unspecified route of administration, administered in Arm Left on 17Mar2021. On 01May2021 the patient experienced bells palsy left side of face. The adverse event was resulted in a visit to doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included treatment with Steroid and antibiotic. The outcome of the event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.