chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaginal haemorrhage, Vertigo
Clinical narrative: high blood pressure; chest pains; cold sore; dizzy / lightheaded; vision is blurry; tingling in hands and feet; Memory loss; experienced early period with clotting which stopped in 2-3 days then started faint spotting; Throat closure sensations; This is a spontaneous report from a contactable consumer (patient).  A 40-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 03Apr2021 (Batch/Lot Number: Er8734) as single dose at the age of 40-year-old for covid-19 immunisation.  Medical history included allergy to amoxicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. No other medications the patient received within 2 weeks of vaccination. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date the patient experienced early period with clotting which stopped in 2-3 days then started faint spotting again a day later, high blood pressure, cold sore, dizzy / lightheaded, vision is blurry, chest pains, tingling in hands and feet, memory loss. On 03Apr2021 18:00 the patient experienced throat closure sensations. The course of events was as follows: Throat closure sensations, high blood pressure, chest pains, cold sore, dizzy / lightheaded, early period with clotting which stopped in 2-3 days then started faint spotting again a day later. After 25 days, I am still dizzy and have tingling in hands and feet. Memory loss, and vision is blurry. The adverse events resulted in Doctor visit, Emergency room/department or urgent care. The events early period with clotting and started faint spotting again a day later, throat closure sensations were considered medically significant. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Chest pain, Dizziness, Hypertension, Menstrual disorder
Clinical narrative: high blood pressure; chest pains; cold sore; dizzy / lightheaded; vision is blurry; tingling in hands and feet; Memory loss; experienced early period with clotting which stopped in 2-3 days then started faint spotting; Throat closure sensations; This is a spontaneous report from a contactable consumer (patient).  A 40-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 03Apr2021 (Batch/Lot Number: Er8734) as single dose at the age of 40-year-old for covid-19 immunisation.  Medical history included allergy to amoxicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. No other medications the patient received within 2 weeks of vaccination. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date the patient experienced early period with clotting which stopped in 2-3 days then started faint spotting again a day later, high blood pressure, cold sore, dizzy / lightheaded, vision is blurry, chest pains, tingling in hands and feet, memory loss. On 03Apr2021 18:00 the patient experienced throat closure sensations. The course of events was as follows: Throat closure sensations, high blood pressure, chest pains, cold sore, dizzy / lightheaded, early period with clotting which stopped in 2-3 days then started faint spotting again a day later. After 25 days, I am still dizzy and have tingling in hands and feet. Memory loss, and vision is blurry. The adverse events resulted in Doctor visit, Emergency room/department or urgent care. The events early period with clotting and started faint spotting again a day later, throat closure sensations were considered medically significant. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral herpes, Paraesthesia, Throat tightness, Vision blurred
Clinical narrative: high blood pressure; chest pains; cold sore; dizzy / lightheaded; vision is blurry; tingling in hands and feet; Memory loss; experienced early period with clotting which stopped in 2-3 days then started faint spotting; Throat closure sensations; This is a spontaneous report from a contactable consumer (patient).  A 40-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 03Apr2021 (Batch/Lot Number: Er8734) as single dose at the age of 40-year-old for covid-19 immunisation.  Medical history included allergy to amoxicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. No other medications the patient received within 2 weeks of vaccination. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date the patient experienced early period with clotting which stopped in 2-3 days then started faint spotting again a day later, high blood pressure, cold sore, dizzy / lightheaded, vision is blurry, chest pains, tingling in hands and feet, memory loss. On 03Apr2021 18:00 the patient experienced throat closure sensations. The course of events was as follows: Throat closure sensations, high blood pressure, chest pains, cold sore, dizzy / lightheaded, early period with clotting which stopped in 2-3 days then started faint spotting again a day later. After 25 days, I am still dizzy and have tingling in hands and feet. Memory loss, and vision is blurry. The adverse events resulted in Doctor visit, Emergency room/department or urgent care. The events early period with clotting and started faint spotting again a day later, throat closure sensations were considered medically significant. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Hyperhidrosis
Clinical narrative: Five minutes after the injection my throat started to feel like it was closing, my lungs felt heavy and it was difficult to breathe, my face swelled and I started feeling dizzy and lightheaded. I was admitted to the ER following the allergic reaction.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Electrocardiogram, Hypersensitivity
Clinical narrative: Five minutes after the injection my throat started to feel like it was closing, my lungs felt heavy and it was difficult to breathe, my face swelled and I started feeling dizzy and lightheaded. I was admitted to the ER following the allergic reaction.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Throat tightness
Clinical narrative: Five minutes after the injection my throat started to feel like it was closing, my lungs felt heavy and it was difficult to breathe, my face swelled and I started feeling dizzy and lightheaded. I was admitted to the ER following the allergic reaction.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Dyspnoea, Pulmonary embolism, Ultrasound scan
Clinical narrative: Pulmonary embolisms; This is a spontaneous report received from a contactable consumer reported for herself (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm on 01Apr2021 11:00 (lot number: ER8733), at the age of 73-years-old, at single dose (unknown dose number) for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered. Patient medical history included high cholesterol, penicillin allergy, and high blood pressure. Concomitant medications included atorvastatin, valsartan, vitamin D3 and vitamin C (ascorbic acid). The patient previously took erythromycin for unspecified indication and experienced allergy. Patient was not pregnant at the time of vaccination. On 03Apr2021 at 15:00 (also reported as 36 hours after receiving the vaccine; pending clarification), patient experienced pulmonary embolism. The event was described as: patient developed shortness of breath and went to the hospital ER and was diagnosed with pulmonary embolism. The patient was then admitted to hospital on unspecified date (number of days of hospitalization was 5 days). The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), and Disability or permanent damage.  Treatment was received for the event which included apixaban (ELIQUIS). Outcome of the event was recovering.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolisms; This is a spontaneous report received from a contactable consumer reported for herself (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm on 01Apr2021 11:00 (lot number: ER8733), at the age of 73-years-old, at single dose (unknown dose number) for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered. Patient medical history included high cholesterol, penicillin allergy, and high blood pressure. Concomitant medications included atorvastatin, valsartan, vitamin D3 and vitamin C (ascorbic acid). The patient previously took erythromycin for unspecified indication and experienced allergy. Patient was not pregnant at the time of vaccination. On 03Apr2021 at 15:00 (also reported as 36 hours after receiving the vaccine; pending clarification), patient experienced pulmonary embolism. The event was described as: patient developed shortness of breath and went to the hospital ER and was diagnosed with pulmonary embolism. The patient was then admitted to hospital on unspecified date (number of days of hospitalization was 5 days). The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), and Disability or permanent damage.  Treatment was received for the event which included apixaban (ELIQUIS). Outcome of the event was recovering.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Swelling feet and hands; Tingling and numbness in my entire body, in the face, arms, leggs etc/pins and needles; Tingling and numbness in my entire body, in the face, arms, leggs etc; Migraine; Muscle pain; Tiredness; Chills; Nausea; Dizziness; Strong flue like symptoms; short breath; severe headache; tenderness/frozen arm; unable to move left arm where it was vaccinated; This is a spontaneous report from a contactable consumer (Patient).  A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm at the age of 58-years, on 14 Apr 2021 at 11:00 at a single dose at left arm for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported.no known allergies. she did not receive any other vaccines within 4 weeks prior to the COVID vaccine. it was unknown whether the patient was patient diagnosed with COVID-19 Prior to vaccination. Since the vaccination,the patient has not  been tested for COVID-19. on 14 Apr 2021 02:00 PM, the patient experienced Tingling and numbness in entire body, in the face, arms, legs, unable to move left arm where it was vaccinated, migraine, muscle pain, tiredness, chills, nausea, dizziness, swelling feet and hands. She also felt flue like symptoms, tenderness/frozen arm, tingling and numbness all over the body even face, mouth. Like pins and needles, swelling hands and feet, short breath, dizzy, nausea, severe headache. There was no treatment received for the events. The outcome of events migraine, muscle pain, tiredness, chills, nausea, dizziness, swelling feet and hands Was not recovered; whereas the outcome of other events was reported as Recovered/Resolved with Sequel.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Paraesthesia, Peripheral swelling, Tenderness
Clinical narrative: Swelling feet and hands; Tingling and numbness in my entire body, in the face, arms, leggs etc/pins and needles; Tingling and numbness in my entire body, in the face, arms, leggs etc; Migraine; Muscle pain; Tiredness; Chills; Nausea; Dizziness; Strong flue like symptoms; short breath; severe headache; tenderness/frozen arm; unable to move left arm where it was vaccinated; This is a spontaneous report from a contactable consumer (Patient).  A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm at the age of 58-years, on 14 Apr 2021 at 11:00 at a single dose at left arm for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported.no known allergies. she did not receive any other vaccines within 4 weeks prior to the COVID vaccine. it was unknown whether the patient was patient diagnosed with COVID-19 Prior to vaccination. Since the vaccination,the patient has not  been tested for COVID-19. on 14 Apr 2021 02:00 PM, the patient experienced Tingling and numbness in entire body, in the face, arms, legs, unable to move left arm where it was vaccinated, migraine, muscle pain, tiredness, chills, nausea, dizziness, swelling feet and hands. She also felt flue like symptoms, tenderness/frozen arm, tingling and numbness all over the body even face, mouth. Like pins and needles, swelling hands and feet, short breath, dizzy, nausea, severe headache. There was no treatment received for the events. The outcome of events migraine, muscle pain, tiredness, chills, nausea, dizziness, swelling feet and hands Was not recovered; whereas the outcome of other events was reported as Recovered/Resolved with Sequel.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Swelling feet and hands; Tingling and numbness in my entire body, in the face, arms, leggs etc/pins and needles; Tingling and numbness in my entire body, in the face, arms, leggs etc; Migraine; Muscle pain; Tiredness; Chills; Nausea; Dizziness; Strong flue like symptoms; short breath; severe headache; tenderness/frozen arm; unable to move left arm where it was vaccinated; This is a spontaneous report from a contactable consumer (Patient).  A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm at the age of 58-years, on 14 Apr 2021 at 11:00 at a single dose at left arm for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported.no known allergies. she did not receive any other vaccines within 4 weeks prior to the COVID vaccine. it was unknown whether the patient was patient diagnosed with COVID-19 Prior to vaccination. Since the vaccination,the patient has not  been tested for COVID-19. on 14 Apr 2021 02:00 PM, the patient experienced Tingling and numbness in entire body, in the face, arms, legs, unable to move left arm where it was vaccinated, migraine, muscle pain, tiredness, chills, nausea, dizziness, swelling feet and hands. She also felt flue like symptoms, tenderness/frozen arm, tingling and numbness all over the body even face, mouth. Like pins and needles, swelling hands and feet, short breath, dizzy, nausea, severe headache. There was no treatment received for the events. The outcome of events migraine, muscle pain, tiredness, chills, nausea, dizziness, swelling feet and hands Was not recovered; whereas the outcome of other events was reported as Recovered/Resolved with Sequel.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Influenza like illness, Migraine, Movement disorder, Myalgia
Clinical narrative: Swelling feet and hands; Tingling and numbness in my entire body, in the face, arms, leggs etc/pins and needles; Tingling and numbness in my entire body, in the face, arms, leggs etc; Migraine; Muscle pain; Tiredness; Chills; Nausea; Dizziness; Strong flue like symptoms; short breath; severe headache; tenderness/frozen arm; unable to move left arm where it was vaccinated; This is a spontaneous report from a contactable consumer (Patient).  A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm at the age of 58-years, on 14 Apr 2021 at 11:00 at a single dose at left arm for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported.no known allergies. she did not receive any other vaccines within 4 weeks prior to the COVID vaccine. it was unknown whether the patient was patient diagnosed with COVID-19 Prior to vaccination. Since the vaccination,the patient has not  been tested for COVID-19. on 14 Apr 2021 02:00 PM, the patient experienced Tingling and numbness in entire body, in the face, arms, legs, unable to move left arm where it was vaccinated, migraine, muscle pain, tiredness, chills, nausea, dizziness, swelling feet and hands. She also felt flue like symptoms, tenderness/frozen arm, tingling and numbness all over the body even face, mouth. Like pins and needles, swelling hands and feet, short breath, dizzy, nausea, severe headache. There was no treatment received for the events. The outcome of events migraine, muscle pain, tiredness, chills, nausea, dizziness, swelling feet and hands Was not recovered; whereas the outcome of other events was reported as Recovered/Resolved with Sequel.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Paraesthesia, Swelling, Tenderness
Clinical narrative: Swelling feet and hands; Tingling and numbness in my entire body, in the face, arms, leggs etc/pins and needles; Tingling and numbness in my entire body, in the face, arms, leggs etc; Migraine; Muscle pain; Tiredness; Chills; Nausea; Dizziness; Strong flue like symptoms; short breath; severe headache; tenderness/frozen arm; unable to move left arm where it was vaccinated; This is a spontaneous report from a contactable consumer (Patient).  A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm at the age of 58-years, on 14 Apr 2021 at 11:00 at a single dose at left arm for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported.no known allergies. she did not receive any other vaccines within 4 weeks prior to the COVID vaccine. it was unknown whether the patient was patient diagnosed with COVID-19 Prior to vaccination. Since the vaccination,the patient has not  been tested for COVID-19. on 14 Apr 2021 02:00 PM, the patient experienced Tingling and numbness in entire body, in the face, arms, legs, unable to move left arm where it was vaccinated, migraine, muscle pain, tiredness, chills, nausea, dizziness, swelling feet and hands. She also felt flue like symptoms, tenderness/frozen arm, tingling and numbness all over the body even face, mouth. Like pins and needles, swelling hands and feet, short breath, dizzy, nausea, severe headache. There was no treatment received for the events. The outcome of events migraine, muscle pain, tiredness, chills, nausea, dizziness, swelling feet and hands Was not recovered; whereas the outcome of other events was reported as Recovered/Resolved with Sequel.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19, UNK, UNK, UNK, COVID19, UNK, UNK, UNK
Symptoms: Arthralgia, Bone pain, Haemorrhage, Irritability, Swelling face
Clinical narrative: I am bleeding heavily because I am getting blood clots and stuff like that; I am bleeding heavily because I am getting blood clots and stuff like that; Lot of pain in my joints and in my bones; Lot of pain in my joints and in my bones; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; This is a spontaneous report from two contactable consumers (one was the patient). A patient of unspecified age and gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FN6200), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation; axitinib (INLYTA), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) at 2 pills once a day for clear cell renal cancer; pembrolizumab (KEYTRUDA), route of administration, start and stop date, batch/lot number and dose were not reported for clear cell renal cancer; zoledronic acid (ZOMETA), route of administration, start and stop date, batch/lot number and dose were not reported for the bones. The patient received the first dose of BNT162B2 on unknown date (Lot Number: CL9265) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient was getting terrible side effects from either the axitinib or the pembrolizumab. The patient was bleeding very heavily and the right side of face and tongue inside was very swollen and irritated. The patient was getting a lot of pain in the joints and bones. The patient was bleeding heavily because was getting blood clots and "stuff like that" (as reported). The actions taken with axitinib, pzoledronic acid, and embolizumab were unknown." The outcome of the events was unknown.  Follow up (23Apr2021): New information received from a contactable consumer includes reporter details.  No Follow-up attempts are needed. No further information is expected.  Follow-up (07May2021): This is a follow-up report to notify that the case 2021406450 and case 2021513212 are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 2021513212.
Sex: U
Vaccine: COVID19, UNK, UNK, UNK, COVID19, UNK, UNK, UNK
Symptoms: Swollen tongue, Thrombosis
Clinical narrative: I am bleeding heavily because I am getting blood clots and stuff like that; I am bleeding heavily because I am getting blood clots and stuff like that; Lot of pain in my joints and in my bones; Lot of pain in my joints and in my bones; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; This is a spontaneous report from two contactable consumers (one was the patient). A patient of unspecified age and gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FN6200), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation; axitinib (INLYTA), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) at 2 pills once a day for clear cell renal cancer; pembrolizumab (KEYTRUDA), route of administration, start and stop date, batch/lot number and dose were not reported for clear cell renal cancer; zoledronic acid (ZOMETA), route of administration, start and stop date, batch/lot number and dose were not reported for the bones. The patient received the first dose of BNT162B2 on unknown date (Lot Number: CL9265) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient was getting terrible side effects from either the axitinib or the pembrolizumab. The patient was bleeding very heavily and the right side of face and tongue inside was very swollen and irritated. The patient was getting a lot of pain in the joints and bones. The patient was bleeding heavily because was getting blood clots and "stuff like that" (as reported). The actions taken with axitinib, pzoledronic acid, and embolizumab were unknown." The outcome of the events was unknown.  Follow up (23Apr2021): New information received from a contactable consumer includes reporter details.  No Follow-up attempts are needed. No further information is expected.  Follow-up (07May2021): This is a follow-up report to notify that the case 2021406450 and case 2021513212 are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 2021513212.
Sex: U
Vaccine: COVID19, UNK, UNK, UNK, COVID19, UNK, UNK, UNK
Symptoms: Arthralgia, Bone pain, Glossitis, Haemorrhage, Skin irritation
Clinical narrative: I am bleeding heavily because I am getting blood clots and stuff like that; I am bleeding heavily because I am getting blood clots and stuff like that; Lot of pain in my joints and in my bones; Lot of pain in my joints and in my bones; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; This is a spontaneous report from two contactable consumers (one was the patient). A patient of unspecified age and gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FN6200), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation; axitinib (INLYTA), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) at 2 pills once a day for clear cell renal cancer; pembrolizumab (KEYTRUDA), route of administration, start and stop date, batch/lot number and dose were not reported for clear cell renal cancer; zoledronic acid (ZOMETA), route of administration, start and stop date, batch/lot number and dose were not reported for the bones. The patient received the first dose of BNT162B2 on unknown date (Lot Number: CL9265) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient was getting terrible side effects from either the axitinib or the pembrolizumab. The patient was bleeding very heavily and the right side of face and tongue inside was very swollen and irritated. The patient was getting a lot of pain in the joints and bones. The patient was bleeding heavily because was getting blood clots and "stuff like that" (as reported). The actions taken with axitinib, pzoledronic acid, and embolizumab were unknown." The outcome of the events was unknown.  Follow up (23Apr2021): New information received from a contactable consumer includes reporter details.  No Follow-up attempts are needed. No further information is expected.  Follow-up (07May2021): This is a follow-up report to notify that the case 2021406450 and case 2021513212 are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 2021513212.
Sex: U
Vaccine: COVID19, UNK, UNK, UNK, COVID19, UNK, UNK, UNK
Symptoms: Swelling face, Swollen tongue, Thrombosis
Clinical narrative: I am bleeding heavily because I am getting blood clots and stuff like that; I am bleeding heavily because I am getting blood clots and stuff like that; Lot of pain in my joints and in my bones; Lot of pain in my joints and in my bones; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; This is a spontaneous report from two contactable consumers (one was the patient). A patient of unspecified age and gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FN6200), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation; axitinib (INLYTA), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) at 2 pills once a day for clear cell renal cancer; pembrolizumab (KEYTRUDA), route of administration, start and stop date, batch/lot number and dose were not reported for clear cell renal cancer; zoledronic acid (ZOMETA), route of administration, start and stop date, batch/lot number and dose were not reported for the bones. The patient received the first dose of BNT162B2 on unknown date (Lot Number: CL9265) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient was getting terrible side effects from either the axitinib or the pembrolizumab. The patient was bleeding very heavily and the right side of face and tongue inside was very swollen and irritated. The patient was getting a lot of pain in the joints and bones. The patient was bleeding heavily because was getting blood clots and "stuff like that" (as reported). The actions taken with axitinib, pzoledronic acid, and embolizumab were unknown." The outcome of the events was unknown.  Follow up (23Apr2021): New information received from a contactable consumer includes reporter details.  No Follow-up attempts are needed. No further information is expected.  Follow-up (07May2021): This is a follow-up report to notify that the case 2021406450 and case 2021513212 are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 2021513212.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rectal haemorrhage, Thrombosis
Clinical narrative: deathly ill after the vaccine; blood clots in stool; This is a spontaneous report from a contactable pharmacist. An adult female patient received COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: Unknown) 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: Pharmacy or Drug Store. The patient experienced deathly ill after the vaccine and blood clots in stool on 16Apr2021 with outcome of recovering. Patient stated they had blood clots in stool 2 weeks after the vaccination but was deathly ill after the vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the events "deathly ill" and "blood clots in stool" with COVID-19 vaccine 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Near death experience, Thrombosis
Clinical narrative: deathly ill after the vaccine; blood clots in stool; This is a spontaneous report from a contactable pharmacist. An adult female patient received COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: Unknown) 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: Pharmacy or Drug Store. The patient experienced deathly ill after the vaccine and blood clots in stool on 16Apr2021 with outcome of recovering. Patient stated they had blood clots in stool 2 weeks after the vaccination but was deathly ill after the vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the events "deathly ill" and "blood clots in stool" with COVID-19 vaccine 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling
Clinical narrative: she is still kind of sore and irritated; she is still kind of sore and irritated; This is a spontaneous report from a contactable consumer reporting for herself.     A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 28Apr2021 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced she is still kind of sore and irritated on 28Apr2021 with outcome of not recovered.  Course of the event: Caller said that the reaction happened within a half hour of her getting the second dose of the vaccine and got worse as the afternoon went on. She is still paying for it today. She said that they monitored her for almost 5 hours in the ER and did everything that they could do.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Irritability, Pain
Clinical narrative: she is still kind of sore and irritated; she is still kind of sore and irritated; This is a spontaneous report from a contactable consumer reporting for herself.     A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 28Apr2021 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced she is still kind of sore and irritated on 28Apr2021 with outcome of not recovered.  Course of the event: Caller said that the reaction happened within a half hour of her getting the second dose of the vaccine and got worse as the afternoon went on. She is still paying for it today. She said that they monitored her for almost 5 hours in the ER and did everything that they could do.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Headache, Hyperhidrosis
Clinical narrative: Myocarditis, it's a heart inflammation; Pain; unknown if might have pain; This is a spontaneous report from a contactable consumer for reporter's son. A 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: ER8731; expiration date: 31Jul2021) via an unspecified route of administration in right arm on 14Apr2021 (22-year-old at vaccination) at a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as no. The patient experienced myocarditis, it's a heart inflammation on 17Apr2021 with outcome of recovered 21Apr2021, pain; unknown if might have pain on an unspecified date with outcome of unknown. The patient was hospitalized for myocarditis from 17Apr2021 to 21Apr2021. The patient was getting the vaccine two weeks ago and had an adverse reaction and ended up in hospital. He ended up getting myocarditis/it's a heart inflammation, so the reporter just wanted to report to "CBC" (not clarified) he was in the hospital for like 4 days. He had done lot of blood work and test. He was in hospital in intensive care Unit, blood test and everything. He had electrocardiogram, MRI, he had it all." Treatment for the event was reported as they had given him some painkillers (unknown if might have pain), it could be warfarin and "formoterol" (further not clarified the name) something like that and warfarin, on acetylsalicylic acid (ASPIRIN) and colchicine. He was on colchicine right now and doctor ended giving him steroid, now he started taking that.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Pain
Clinical narrative: Myocarditis, it's a heart inflammation; Pain; unknown if might have pain; This is a spontaneous report from a contactable consumer for reporter's son. A 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: ER8731; expiration date: 31Jul2021) via an unspecified route of administration in right arm on 14Apr2021 (22-year-old at vaccination) at a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as no. The patient experienced myocarditis, it's a heart inflammation on 17Apr2021 with outcome of recovered 21Apr2021, pain; unknown if might have pain on an unspecified date with outcome of unknown. The patient was hospitalized for myocarditis from 17Apr2021 to 21Apr2021. The patient was getting the vaccine two weeks ago and had an adverse reaction and ended up in hospital. He ended up getting myocarditis/it's a heart inflammation, so the reporter just wanted to report to "CBC" (not clarified) he was in the hospital for like 4 days. He had done lot of blood work and test. He was in hospital in intensive care Unit, blood test and everything. He had electrocardiogram, MRI, he had it all." Treatment for the event was reported as they had given him some painkillers (unknown if might have pain), it could be warfarin and "formoterol" (further not clarified the name) something like that and warfarin, on acetylsalicylic acid (ASPIRIN) and colchicine. He was on colchicine right now and doctor ended giving him steroid, now he started taking that.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Electrocardiogram, Magnetic resonance imaging, Myocarditis, Pain
Clinical narrative: Myocarditis, it's a heart inflammation; Pain; unknown if might have pain; This is a spontaneous report from a contactable consumer for reporter's son. A 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: ER8731; expiration date: 31Jul2021) via an unspecified route of administration in right arm on 14Apr2021 (22-year-old at vaccination) at a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as no. The patient experienced myocarditis, it's a heart inflammation on 17Apr2021 with outcome of recovered 21Apr2021, pain; unknown if might have pain on an unspecified date with outcome of unknown. The patient was hospitalized for myocarditis from 17Apr2021 to 21Apr2021. The patient was getting the vaccine two weeks ago and had an adverse reaction and ended up in hospital. He ended up getting myocarditis/it's a heart inflammation, so the reporter just wanted to report to "CBC" (not clarified) he was in the hospital for like 4 days. He had done lot of blood work and test. He was in hospital in intensive care Unit, blood test and everything. He had electrocardiogram, MRI, he had it all." Treatment for the event was reported as they had given him some painkillers (unknown if might have pain), it could be warfarin and "formoterol" (further not clarified the name) something like that and warfarin, on acetylsalicylic acid (ASPIRIN) and colchicine. He was on colchicine right now and doctor ended giving him steroid, now he started taking that.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Bone pain, Chills
Clinical narrative: hallucinations; Severe pain unable to lift left arm; severe body/joint aches; severe body/joint aches; severe headache; black spots in vision; weakness; fatigue; insomnia; confusion; nausea; stomach pain; chills; fever; Pregnancy at time of Vaccination: Yes; This is a spontaneous report from a contactable consumer reported for herself. This 34-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) via an unspecified route of administration in the left arm on 28Apr2021 01:00 PM at the same age as single dose for COVID-19 immunisation. Medical history included Leiden factor V and pregnancy. Concomitant medications included minerals nos/vitamins nos (PRENATAL VITAMINS), folic acid, labetalol, acetylsalicylic acid (ASPIRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) on 01Apr2021 at 03:00 PM for COVID-19 immunisation, experiencing exposure during pregnancy; received amoxicillin;clavulanic acid (AUGMENTIN) experiencing severe vomiting but not an anaphylactic reaction. The patient experienced severe pain unable to lift left arm, severe body/joint aches, severe headache, black spots in vision, weakness, fatigue, insomnia, confusion, nausea, stomach pain, chills, fever, hallucinations; on 29Apr2021 at 04:00 am. The patient was pregnancy at time of vaccination. Pregnancy due date was 23Aug2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event exposure during pregnancy was unknown, of the other events was recovering.   Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Exposure during pregnancy, Fatigue, Headache, Injection site pain
Clinical narrative: hallucinations; Severe pain unable to lift left arm; severe body/joint aches; severe body/joint aches; severe headache; black spots in vision; weakness; fatigue; insomnia; confusion; nausea; stomach pain; chills; fever; Pregnancy at time of Vaccination: Yes; This is a spontaneous report from a contactable consumer reported for herself. This 34-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) via an unspecified route of administration in the left arm on 28Apr2021 01:00 PM at the same age as single dose for COVID-19 immunisation. Medical history included Leiden factor V and pregnancy. Concomitant medications included minerals nos/vitamins nos (PRENATAL VITAMINS), folic acid, labetalol, acetylsalicylic acid (ASPIRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) on 01Apr2021 at 03:00 PM for COVID-19 immunisation, experiencing exposure during pregnancy; received amoxicillin;clavulanic acid (AUGMENTIN) experiencing severe vomiting but not an anaphylactic reaction. The patient experienced severe pain unable to lift left arm, severe body/joint aches, severe headache, black spots in vision, weakness, fatigue, insomnia, confusion, nausea, stomach pain, chills, fever, hallucinations; on 29Apr2021 at 04:00 am. The patient was pregnancy at time of vaccination. Pregnancy due date was 23Aug2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event exposure during pregnancy was unknown, of the other events was recovering.   Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Neck pain, Pain, Respiratory tract congestion
Clinical narrative: hallucinations; Severe pain unable to lift left arm; severe body/joint aches; severe body/joint aches; severe headache; black spots in vision; weakness; fatigue; insomnia; confusion; nausea; stomach pain; chills; fever; Pregnancy at time of Vaccination: Yes; This is a spontaneous report from a contactable consumer reported for herself. This 34-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) via an unspecified route of administration in the left arm on 28Apr2021 01:00 PM at the same age as single dose for COVID-19 immunisation. Medical history included Leiden factor V and pregnancy. Concomitant medications included minerals nos/vitamins nos (PRENATAL VITAMINS), folic acid, labetalol, acetylsalicylic acid (ASPIRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) on 01Apr2021 at 03:00 PM for COVID-19 immunisation, experiencing exposure during pregnancy; received amoxicillin;clavulanic acid (AUGMENTIN) experiencing severe vomiting but not an anaphylactic reaction. The patient experienced severe pain unable to lift left arm, severe body/joint aches, severe headache, black spots in vision, weakness, fatigue, insomnia, confusion, nausea, stomach pain, chills, fever, hallucinations; on 29Apr2021 at 04:00 am. The patient was pregnancy at time of vaccination. Pregnancy due date was 23Aug2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event exposure during pregnancy was unknown, of the other events was recovering.   Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: hallucinations; Severe pain unable to lift left arm; severe body/joint aches; severe body/joint aches; severe headache; black spots in vision; weakness; fatigue; insomnia; confusion; nausea; stomach pain; chills; fever; Pregnancy at time of Vaccination: Yes; This is a spontaneous report from a contactable consumer reported for herself. This 34-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) via an unspecified route of administration in the left arm on 28Apr2021 01:00 PM at the same age as single dose for COVID-19 immunisation. Medical history included Leiden factor V and pregnancy. Concomitant medications included minerals nos/vitamins nos (PRENATAL VITAMINS), folic acid, labetalol, acetylsalicylic acid (ASPIRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) on 01Apr2021 at 03:00 PM for COVID-19 immunisation, experiencing exposure during pregnancy; received amoxicillin;clavulanic acid (AUGMENTIN) experiencing severe vomiting but not an anaphylactic reaction. The patient experienced severe pain unable to lift left arm, severe body/joint aches, severe headache, black spots in vision, weakness, fatigue, insomnia, confusion, nausea, stomach pain, chills, fever, hallucinations; on 29Apr2021 at 04:00 am. The patient was pregnancy at time of vaccination. Pregnancy due date was 23Aug2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event exposure during pregnancy was unknown, of the other events was recovering.   Information on the lot/batch number has been requested.