chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood test, Computerised tomogram, Herpes zoster, Rash
Clinical narrative: abdominal pain and ended up getting shingles; Pain; abdominal pain and ended up getting shingles; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 09Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. A few days after the patient got that first dose of Pfizer COVID-19 Vaccine, he developed shingles and pain. Shingles is a painful and pretty debilitating condition because the pain is very bad. Further described shingles and pain, he had developed abdominal pains. The patient went to the regular doctor and the doctor could not figure out what it was so the doctor sent him for a CT (computerized tomogram) scan which proved there was nothing abnormal or positive in a bad way. Those CT result was negative or normal across the board. They also did blood tests and urine tests on him, all of the blood tests and urine tests results were negative and normal across the board. A few days after they went to that regular doctor, on Saturday, 16Jan2021 the pains got much more severe so she took her husband to the emergency room. They then ran another abdominal CT scan and they also agreed results of the abdominal CT scan were negative and normal across the board. They again ran blood tests and urine tests on him all with results of negative and normal across the board. They sent him home with a pain killer. About 2-3 hours after he got home from that emergency room visit he developed a rash around his abdomen, on his right side from his groin to the back of his hip on right side; that was Saturday night, 16Jan2021. Sunday they could not go to the doctor's office because they were closed. On Monday 18Jan2021, they went back to the regular doctor who checked him again. The doctor saw the rash and said no wonder they could not find anything on the CT scans, this is Shingles. The doctor gave him a couple of pain killers and an antiviral medication which he has been taking; but one of them he was developing a cough from so he stopped that medication and the cough stopped. Then he was having diarrhea here and there, so they looked up the side effects of the medications he was taking and stopped that medication because of the diarrhea. He was also taking an antiviral medication for the shingles. Clarification of which of those products stopped for cough and which for diarrhea not provided. The patient suspended the treatment with painkillers because he received the information that patients should not be taking painkillers prior to the administration of the vaccine. Patient had an appointment due tomorrow 30Jan2021 to receive the second dose of the vaccine and wanted to know if the patient should take the second dose of the vaccine. The outcome of the events was unknown.  Information on batch/lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: abdominal pain and ended up getting shingles; Pain; abdominal pain and ended up getting shingles; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 09Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. A few days after the patient got that first dose of Pfizer COVID-19 Vaccine, he developed shingles and pain. Shingles is a painful and pretty debilitating condition because the pain is very bad. Further described shingles and pain, he had developed abdominal pains. The patient went to the regular doctor and the doctor could not figure out what it was so the doctor sent him for a CT (computerized tomogram) scan which proved there was nothing abnormal or positive in a bad way. Those CT result was negative or normal across the board. They also did blood tests and urine tests on him, all of the blood tests and urine tests results were negative and normal across the board. A few days after they went to that regular doctor, on Saturday, 16Jan2021 the pains got much more severe so she took her husband to the emergency room. They then ran another abdominal CT scan and they also agreed results of the abdominal CT scan were negative and normal across the board. They again ran blood tests and urine tests on him all with results of negative and normal across the board. They sent him home with a pain killer. About 2-3 hours after he got home from that emergency room visit he developed a rash around his abdomen, on his right side from his groin to the back of his hip on right side; that was Saturday night, 16Jan2021. Sunday they could not go to the doctor's office because they were closed. On Monday 18Jan2021, they went back to the regular doctor who checked him again. The doctor saw the rash and said no wonder they could not find anything on the CT scans, this is Shingles. The doctor gave him a couple of pain killers and an antiviral medication which he has been taking; but one of them he was developing a cough from so he stopped that medication and the cough stopped. Then he was having diarrhea here and there, so they looked up the side effects of the medications he was taking and stopped that medication because of the diarrhea. He was also taking an antiviral medication for the shingles. Clarification of which of those products stopped for cough and which for diarrhea not provided. The patient suspended the treatment with painkillers because he received the information that patients should not be taking painkillers prior to the administration of the vaccine. Patient had an appointment due tomorrow 30Jan2021 to receive the second dose of the vaccine and wanted to know if the patient should take the second dose of the vaccine. The outcome of the events was unknown.  Information on batch/lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Urine analysis
Clinical narrative: abdominal pain and ended up getting shingles; Pain; abdominal pain and ended up getting shingles; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 09Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. A few days after the patient got that first dose of Pfizer COVID-19 Vaccine, he developed shingles and pain. Shingles is a painful and pretty debilitating condition because the pain is very bad. Further described shingles and pain, he had developed abdominal pains. The patient went to the regular doctor and the doctor could not figure out what it was so the doctor sent him for a CT (computerized tomogram) scan which proved there was nothing abnormal or positive in a bad way. Those CT result was negative or normal across the board. They also did blood tests and urine tests on him, all of the blood tests and urine tests results were negative and normal across the board. A few days after they went to that regular doctor, on Saturday, 16Jan2021 the pains got much more severe so she took her husband to the emergency room. They then ran another abdominal CT scan and they also agreed results of the abdominal CT scan were negative and normal across the board. They again ran blood tests and urine tests on him all with results of negative and normal across the board. They sent him home with a pain killer. About 2-3 hours after he got home from that emergency room visit he developed a rash around his abdomen, on his right side from his groin to the back of his hip on right side; that was Saturday night, 16Jan2021. Sunday they could not go to the doctor's office because they were closed. On Monday 18Jan2021, they went back to the regular doctor who checked him again. The doctor saw the rash and said no wonder they could not find anything on the CT scans, this is Shingles. The doctor gave him a couple of pain killers and an antiviral medication which he has been taking; but one of them he was developing a cough from so he stopped that medication and the cough stopped. Then he was having diarrhea here and there, so they looked up the side effects of the medications he was taking and stopped that medication because of the diarrhea. He was also taking an antiviral medication for the shingles. Clarification of which of those products stopped for cough and which for diarrhea not provided. The patient suspended the treatment with painkillers because he received the information that patients should not be taking painkillers prior to the administration of the vaccine. Patient had an appointment due tomorrow 30Jan2021 to receive the second dose of the vaccine and wanted to know if the patient should take the second dose of the vaccine. The outcome of the events was unknown.  Information on batch/lot number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Lightheaded/feeling dizzy; BP 168/68, BP 158/73, BP 152/73; O2 SAT 97%, O2 SAT 96%, O2 SAT 97%; HR 62, HR 68, HR 69; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for a 79-year-old non-pregnant female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number: el3302, Expiration date: unknown), via an intramuscular route of administration in left arm on 04Feb2021 at 09:19 at a single dose for covid-19 immunization in clinic (at the age of 79-years). The patient had rash to PCN (penicillin). The  patient's medical history included HTN (hypertension) and concomitant medication included lisinopril for an unspecified indication on an unspecified date. The patient did not have any other illness at the time of vaccination and up to one month prior. Patient's vital signs were taken three times. On 04Feb2021 at 09:36, the patient experienced feeling lightheaded, BP (blood pressure) 168/68, BP 158/73, BP 152/73, oxygen saturation 97%, O2 SAT 96%, O2 SAT 97% and HR (heart rate) 62, HR 68, HR 69. Patient given water. After 20 minutes the patient stated feeling dizzy but wanted to leave. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Dizziness, Heart rate, Heart rate increased
Clinical narrative: Lightheaded/feeling dizzy; BP 168/68, BP 158/73, BP 152/73; O2 SAT 97%, O2 SAT 96%, O2 SAT 97%; HR 62, HR 68, HR 69; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for a 79-year-old non-pregnant female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number: el3302, Expiration date: unknown), via an intramuscular route of administration in left arm on 04Feb2021 at 09:19 at a single dose for covid-19 immunization in clinic (at the age of 79-years). The patient had rash to PCN (penicillin). The  patient's medical history included HTN (hypertension) and concomitant medication included lisinopril for an unspecified indication on an unspecified date. The patient did not have any other illness at the time of vaccination and up to one month prior. Patient's vital signs were taken three times. On 04Feb2021 at 09:36, the patient experienced feeling lightheaded, BP (blood pressure) 168/68, BP 158/73, BP 152/73, oxygen saturation 97%, O2 SAT 96%, O2 SAT 97% and HR (heart rate) 62, HR 68, HR 69. Patient given water. After 20 minutes the patient stated feeling dizzy but wanted to leave. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased, Reticuloendothelial system stimulated
Clinical narrative: Lightheaded/feeling dizzy; BP 168/68, BP 158/73, BP 152/73; O2 SAT 97%, O2 SAT 96%, O2 SAT 97%; HR 62, HR 68, HR 69; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for a 79-year-old non-pregnant female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number: el3302, Expiration date: unknown), via an intramuscular route of administration in left arm on 04Feb2021 at 09:19 at a single dose for covid-19 immunization in clinic (at the age of 79-years). The patient had rash to PCN (penicillin). The  patient's medical history included HTN (hypertension) and concomitant medication included lisinopril for an unspecified indication on an unspecified date. The patient did not have any other illness at the time of vaccination and up to one month prior. Patient's vital signs were taken three times. On 04Feb2021 at 09:36, the patient experienced feeling lightheaded, BP (blood pressure) 168/68, BP 158/73, BP 152/73, oxygen saturation 97%, O2 SAT 96%, O2 SAT 97% and HR (heart rate) 62, HR 68, HR 69. Patient given water. After 20 minutes the patient stated feeling dizzy but wanted to leave. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Chills, Fatigue, Feeling abnormal
Clinical narrative: bled a bit; pain in left finger joints/ joint aches; sudden heaviness in arm; chills; severe fatigue; over all unwell/uneasy feeling; Nausea started about the 5th hour; feeling feverish, but never had a real fever; odd little pains in the left side of her neck; tension type headache; foggy; blood vein and possibly a nerve was hit; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Feb2021 (lot number: EL9265) at 10:00 at single dose for COVID-19 immunisation. The relevant medical history included arthritis, breathing issues - asthma/copd still being tested, hypertension, liver issues and known allergies: Ct contrast, Dilaudid, Flagyl combined with doxycyline or cephlexinc. Concomitant medications were reported as none. At injection, a blood vein and possibly a nerve was hit. She felt the nurse followed all proper protocol for finishing the injection and notifying RN in charge. On 03Feb2021 at 2:00 PM, the patient had immediate pain in left finger joints and sudden heaviness in arm within a couple of minutes. It bled a bit. She was still having some issues with the hand, but the injection site was fine. She was concerned about the number of symptoms, the severeness and the length of time they had lasted. This was very worrisome and unexpected from all other accounts by others and everything she had read on the first vaccine. She was feeling 'off' within 2 hours, by the 4th hour She had developed chills, severe fatigue and over all unwell/uneasy feeling. Nausea started about the 5th hour and she started feeling feverish, but never had a real fever, odd little pains in the left side of her neck, but that subsided. Developed tension type headache, joint aches, foggy. This continued for about 4 1/2 days. Unable to function without Tylenol every 5hr. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling jittery, Injection site pain, Limb discomfort, Malaise, Nausea
Clinical narrative: bled a bit; pain in left finger joints/ joint aches; sudden heaviness in arm; chills; severe fatigue; over all unwell/uneasy feeling; Nausea started about the 5th hour; feeling feverish, but never had a real fever; odd little pains in the left side of her neck; tension type headache; foggy; blood vein and possibly a nerve was hit; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Feb2021 (lot number: EL9265) at 10:00 at single dose for COVID-19 immunisation. The relevant medical history included arthritis, breathing issues - asthma/copd still being tested, hypertension, liver issues and known allergies: Ct contrast, Dilaudid, Flagyl combined with doxycyline or cephlexinc. Concomitant medications were reported as none. At injection, a blood vein and possibly a nerve was hit. She felt the nurse followed all proper protocol for finishing the injection and notifying RN in charge. On 03Feb2021 at 2:00 PM, the patient had immediate pain in left finger joints and sudden heaviness in arm within a couple of minutes. It bled a bit. She was still having some issues with the hand, but the injection site was fine. She was concerned about the number of symptoms, the severeness and the length of time they had lasted. This was very worrisome and unexpected from all other accounts by others and everything she had read on the first vaccine. She was feeling 'off' within 2 hours, by the 4th hour She had developed chills, severe fatigue and over all unwell/uneasy feeling. Nausea started about the 5th hour and she started feeling feverish, but never had a real fever, odd little pains in the left side of her neck, but that subsided. Developed tension type headache, joint aches, foggy. This continued for about 4 1/2 days. Unable to function without Tylenol every 5hr. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain in extremity, Tension headache
Clinical narrative: bled a bit; pain in left finger joints/ joint aches; sudden heaviness in arm; chills; severe fatigue; over all unwell/uneasy feeling; Nausea started about the 5th hour; feeling feverish, but never had a real fever; odd little pains in the left side of her neck; tension type headache; foggy; blood vein and possibly a nerve was hit; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Feb2021 (lot number: EL9265) at 10:00 at single dose for COVID-19 immunisation. The relevant medical history included arthritis, breathing issues - asthma/copd still being tested, hypertension, liver issues and known allergies: Ct contrast, Dilaudid, Flagyl combined with doxycyline or cephlexinc. Concomitant medications were reported as none. At injection, a blood vein and possibly a nerve was hit. She felt the nurse followed all proper protocol for finishing the injection and notifying RN in charge. On 03Feb2021 at 2:00 PM, the patient had immediate pain in left finger joints and sudden heaviness in arm within a couple of minutes. It bled a bit. She was still having some issues with the hand, but the injection site was fine. She was concerned about the number of symptoms, the severeness and the length of time they had lasted. This was very worrisome and unexpected from all other accounts by others and everything she had read on the first vaccine. She was feeling 'off' within 2 hours, by the 4th hour She had developed chills, severe fatigue and over all unwell/uneasy feeling. Nausea started about the 5th hour and she started feeling feverish, but never had a real fever, odd little pains in the left side of her neck, but that subsided. Developed tension type headache, joint aches, foggy. This continued for about 4 1/2 days. Unable to function without Tylenol every 5hr. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Limb discomfort
Clinical narrative: bled a bit; pain in left finger joints/ joint aches; sudden heaviness in arm; chills; severe fatigue; over all unwell/uneasy feeling; Nausea started about the 5th hour; feeling feverish, but never had a real fever; odd little pains in the left side of her neck; tension type headache; foggy; blood vein and possibly a nerve was hit; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Feb2021 (lot number: EL9265) at 10:00 at single dose for COVID-19 immunisation. The relevant medical history included arthritis, breathing issues - asthma/copd still being tested, hypertension, liver issues and known allergies: Ct contrast, Dilaudid, Flagyl combined with doxycyline or cephlexinc. Concomitant medications were reported as none. At injection, a blood vein and possibly a nerve was hit. She felt the nurse followed all proper protocol for finishing the injection and notifying RN in charge. On 03Feb2021 at 2:00 PM, the patient had immediate pain in left finger joints and sudden heaviness in arm within a couple of minutes. It bled a bit. She was still having some issues with the hand, but the injection site was fine. She was concerned about the number of symptoms, the severeness and the length of time they had lasted. This was very worrisome and unexpected from all other accounts by others and everything she had read on the first vaccine. She was feeling 'off' within 2 hours, by the 4th hour She had developed chills, severe fatigue and over all unwell/uneasy feeling. Nausea started about the 5th hour and she started feeling feverish, but never had a real fever, odd little pains in the left side of her neck, but that subsided. Developed tension type headache, joint aches, foggy. This continued for about 4 1/2 days. Unable to function without Tylenol every 5hr. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nausea, Neck pain, Neurological procedural complication, Pyrexia
Clinical narrative: bled a bit; pain in left finger joints/ joint aches; sudden heaviness in arm; chills; severe fatigue; over all unwell/uneasy feeling; Nausea started about the 5th hour; feeling feverish, but never had a real fever; odd little pains in the left side of her neck; tension type headache; foggy; blood vein and possibly a nerve was hit; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Feb2021 (lot number: EL9265) at 10:00 at single dose for COVID-19 immunisation. The relevant medical history included arthritis, breathing issues - asthma/copd still being tested, hypertension, liver issues and known allergies: Ct contrast, Dilaudid, Flagyl combined with doxycyline or cephlexinc. Concomitant medications were reported as none. At injection, a blood vein and possibly a nerve was hit. She felt the nurse followed all proper protocol for finishing the injection and notifying RN in charge. On 03Feb2021 at 2:00 PM, the patient had immediate pain in left finger joints and sudden heaviness in arm within a couple of minutes. It bled a bit. She was still having some issues with the hand, but the injection site was fine. She was concerned about the number of symptoms, the severeness and the length of time they had lasted. This was very worrisome and unexpected from all other accounts by others and everything she had read on the first vaccine. She was feeling 'off' within 2 hours, by the 4th hour She had developed chills, severe fatigue and over all unwell/uneasy feeling. Nausea started about the 5th hour and she started feeling feverish, but never had a real fever, odd little pains in the left side of her neck, but that subsided. Developed tension type headache, joint aches, foggy. This continued for about 4 1/2 days. Unable to function without Tylenol every 5hr. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tension headache, Vaccination site haemorrhage
Clinical narrative: bled a bit; pain in left finger joints/ joint aches; sudden heaviness in arm; chills; severe fatigue; over all unwell/uneasy feeling; Nausea started about the 5th hour; feeling feverish, but never had a real fever; odd little pains in the left side of her neck; tension type headache; foggy; blood vein and possibly a nerve was hit; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Feb2021 (lot number: EL9265) at 10:00 at single dose for COVID-19 immunisation. The relevant medical history included arthritis, breathing issues - asthma/copd still being tested, hypertension, liver issues and known allergies: Ct contrast, Dilaudid, Flagyl combined with doxycyline or cephlexinc. Concomitant medications were reported as none. At injection, a blood vein and possibly a nerve was hit. She felt the nurse followed all proper protocol for finishing the injection and notifying RN in charge. On 03Feb2021 at 2:00 PM, the patient had immediate pain in left finger joints and sudden heaviness in arm within a couple of minutes. It bled a bit. She was still having some issues with the hand, but the injection site was fine. She was concerned about the number of symptoms, the severeness and the length of time they had lasted. This was very worrisome and unexpected from all other accounts by others and everything she had read on the first vaccine. She was feeling 'off' within 2 hours, by the 4th hour She had developed chills, severe fatigue and over all unwell/uneasy feeling. Nausea started about the 5th hour and she started feeling feverish, but never had a real fever, odd little pains in the left side of her neck, but that subsided. Developed tension type headache, joint aches, foggy. This continued for about 4 1/2 days. Unable to function without Tylenol every 5hr. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Headache, Hypertension, Myalgia, Pericarditis
Clinical narrative: Diagnosed with pericarditis and admitted to the hospital; This is a spontaneous report from a contactable other HCP (patient). A 42-years-old female patient received the second dose of BNT162B2 (COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 11Jan2021 (Lot Number: EL1284) at age of 42 years as single dose for covid-19 immunisation. Medical history included seasonal allergies coconut allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY). Historical vaccine included the first dose of BNT162B2 for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient developed severe sudden chest pain. Taken to the ER via ambulance. Diagnosed with pericarditis and admitted to the hospital (3 days hopitalization). Given colchicine and high dose NSAIDs. Had to go on short term disability due to the pain. Then given steroids at home. No prior health history and healthy. Received the second dose of the vaccine 3 weeks prior to pericarditis. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovered.  Follow up attempts needed. Further information is expected.; Sender's Comments:  Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event pericarditis cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: Diagnosed with pericarditis and admitted to the hospital; This is a spontaneous report from a contactable other HCP (patient). A 42-years-old female patient received the second dose of BNT162B2 (COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 11Jan2021 (Lot Number: EL1284) at age of 42 years as single dose for covid-19 immunisation. Medical history included seasonal allergies coconut allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY). Historical vaccine included the first dose of BNT162B2 for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient developed severe sudden chest pain. Taken to the ER via ambulance. Diagnosed with pericarditis and admitted to the hospital (3 days hopitalization). Given colchicine and high dose NSAIDs. Had to go on short term disability due to the pain. Then given steroids at home. No prior health history and healthy. Received the second dose of the vaccine 3 weeks prior to pericarditis. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovered.  Follow up attempts needed. Further information is expected.; Sender's Comments:  Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event pericarditis cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Paraesthesia oral, Urticaria
Clinical narrative: tingling to left side of face/corner of lips, followed up with neurology with benign findings. had benign MRI done.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Paraesthesia, Paraesthesia oral
Clinical narrative: tingling to left side of face/corner of lips, followed up with neurology with benign findings. had benign MRI done.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Herpes zoster, Lymphadenopathy, Musculoskeletal stiffness, Neck pain
Clinical narrative: lesions appeared on the patient's scalp and neck which later on diagnosed as shingles; Fatigue; Pain and swelling in neck and back of head; Pain and swelling in neck and back of head; Pain and swelling in neck and back of head; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Feb2021 18:00 (lot number: EL9267) as SINGLE DOSE for COVID-19 immunization. Patient had no medical history. Concomitant medications included hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ); sertraline hydrochloride (ZOLOFT). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 26Feb2021 07:00, the patient began to experience fatigue, pain and swelling in neck and back of head. On 01Mar2021, lesions appeared on the patient's scalp and neck which later on diagnosed as shingles. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with acylclovir, prednisone and gabapentin. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain of skin, Physical examination, Swelling
Clinical narrative: lesions appeared on the patient's scalp and neck which later on diagnosed as shingles; Fatigue; Pain and swelling in neck and back of head; Pain and swelling in neck and back of head; Pain and swelling in neck and back of head; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Feb2021 18:00 (lot number: EL9267) as SINGLE DOSE for COVID-19 immunization. Patient had no medical history. Concomitant medications included hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ); sertraline hydrochloride (ZOLOFT). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 26Feb2021 07:00, the patient began to experience fatigue, pain and swelling in neck and back of head. On 01Mar2021, lesions appeared on the patient's scalp and neck which later on diagnosed as shingles. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with acylclovir, prednisone and gabapentin. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Herpes zoster, Neck pain, Swelling
Clinical narrative: lesions appeared on the patient's scalp and neck which later on diagnosed as shingles; Fatigue; Pain and swelling in neck and back of head; Pain and swelling in neck and back of head; Pain and swelling in neck and back of head; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Feb2021 18:00 (lot number: EL9267) as SINGLE DOSE for COVID-19 immunization. Patient had no medical history. Concomitant medications included hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ); sertraline hydrochloride (ZOLOFT). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 26Feb2021 07:00, the patient began to experience fatigue, pain and swelling in neck and back of head. On 01Mar2021, lesions appeared on the patient's scalp and neck which later on diagnosed as shingles. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with acylclovir, prednisone and gabapentin. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot in lower left leg; pain in leg was still killing her; low grade headache; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 12Feb2021 (Batch/Lot number was not reported) at age of 58 years as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical Vaccine included the first dose of BNT162B2 injection at left arm on 23Jan2021 at age of 58 years as single dose for COVID-19 immunisation and experienced pain in her leg and difficult to walk. Patient did not have family medical history relevant to AE. On 12Feb2021, patient received her 2nd dose of vaccine. On 13Feb2021, pain in leg was still killing her, plus she had low grade headache. A friend whos nurse, indicated that she thought patient had a blood clot and urged her to go to ER. Patient went to the ER on 13Feb2021 and ultrasound identified a blood clot in the lower left leg. Patient saw hematologist on 12Mar2021 who took several vials of blood for testing (20-25 vials); results did not show any issues. He ruled out any reaction for clot due to the following: Surgery hospitalization, pregnancy, cancer, any family history of blood clots prolonged sitting, smocking, obesity, BC pills, trauma, age, disease, infection or autoimmune disorder. Ultrasound on 13Feb2021 result was positive for clot, clot in the lower left leg. Treatment was received. Outcome of events was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021156092 same patient, different vaccine dose/AE
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity, Thrombosis, Ultrasound scan
Clinical narrative: blood clot in lower left leg; pain in leg was still killing her; low grade headache; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 12Feb2021 (Batch/Lot number was not reported) at age of 58 years as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical Vaccine included the first dose of BNT162B2 injection at left arm on 23Jan2021 at age of 58 years as single dose for COVID-19 immunisation and experienced pain in her leg and difficult to walk. Patient did not have family medical history relevant to AE. On 12Feb2021, patient received her 2nd dose of vaccine. On 13Feb2021, pain in leg was still killing her, plus she had low grade headache. A friend whos nurse, indicated that she thought patient had a blood clot and urged her to go to ER. Patient went to the ER on 13Feb2021 and ultrasound identified a blood clot in the lower left leg. Patient saw hematologist on 12Mar2021 who took several vials of blood for testing (20-25 vials); results did not show any issues. He ruled out any reaction for clot due to the following: Surgery hospitalization, pregnancy, cancer, any family history of blood clots prolonged sitting, smocking, obesity, BC pills, trauma, age, disease, infection or autoimmune disorder. Ultrasound on 13Feb2021 result was positive for clot, clot in the lower left leg. Treatment was received. Outcome of events was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021156092 same patient, different vaccine dose/AE
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seasonal allergy
Clinical narrative: 5 days after vaccination experiencing seasonal allergies; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient took 2nd dose and 5 days after vaccination was experiencing seasonal allergies. The outcome of the event was unknown.   Information about lot/batch has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Fatigue, Pruritus
Clinical narrative: extreme itching in hands, feet, scalp; no appetite for 2 weeks; This is a spontaneous report from a contactable Other Health Professional. A 52-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: Unknown; Expiry Date: Unknown), via an unspecified route of administration in left arm on 18Jan2021 as single dose for COVID-19 Immunization. The patient's medical history included known allergies. Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: Unknown; Expiry Date: Unknown), via intramuscular rote of administration in left arm on 28Dec2020 at 05:15 PM as single dose for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and post vaccination not tested COVID. The patient experienced Severe fatigue, and no appetite for 2 weeks, now those symptoms are better but now have extreme itching in hands, feet, scalp on 25Jan2021. It is unbearable, and have been on Medrol dose pack, now Atarax, and prednisone (higher dose) and still have uncontrollable itching with only relief at night. Also have welps that come up. So we are now on 3 weeks with no relief from the 2nd part of the vaccine. The patient received any treatment for adverse event (Prednisone, steroid shot and Medrol dose pack). The clinical outcome of the event no appetite for 2 weeks was recovering and the outcome of the event extreme itching in hands, feet, scalp was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Pruritus
Clinical narrative: extreme itching in hands, feet, scalp; no appetite for 2 weeks; This is a spontaneous report from a contactable Other Health Professional. A 52-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: Unknown; Expiry Date: Unknown), via an unspecified route of administration in left arm on 18Jan2021 as single dose for COVID-19 Immunization. The patient's medical history included known allergies. Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: Unknown; Expiry Date: Unknown), via intramuscular rote of administration in left arm on 28Dec2020 at 05:15 PM as single dose for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and post vaccination not tested COVID. The patient experienced Severe fatigue, and no appetite for 2 weeks, now those symptoms are better but now have extreme itching in hands, feet, scalp on 25Jan2021. It is unbearable, and have been on Medrol dose pack, now Atarax, and prednisone (higher dose) and still have uncontrollable itching with only relief at night. Also have welps that come up. So we are now on 3 weeks with no relief from the 2nd part of the vaccine. The patient received any treatment for adverse event (Prednisone, steroid shot and Medrol dose pack). The clinical outcome of the event no appetite for 2 weeks was recovering and the outcome of the event extreme itching in hands, feet, scalp was not recovered.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood glucose increased, Immune thrombocytopenia, Immunoglobulin therapy, Oral mucosa haematoma, Platelet count decreased
Clinical narrative: PMHx of gestational DM presented to the ED on 3/6/21 with black spots on tongue and sides of mouth in addition to gum bleeding all that started suddenly on Friday night, 03/05/21.  She also noted a petechial rash on her chest, face, and abdomen.  She has no history of this in the past, nor prior bleeding events.  She has had 2 deliveries without abnormal bleeding.  She did receive the first dose of her Moderna vaccine on 2/24/21.  She also started having menstrual period on 02/26 which were heavier than usual for past 2 days then became more regular. Her periods usually last 7-8 days.   Platelets were 3K on admission.  She denies any recent infection or new medications.  She felt very well preceding this event.  She did not have any other reactions from the Moderna vaccine.  A recent cbc on 1/11/21 was completely normal with a platelet count of 238K.   3/6/21 CBC on admission:  10.2>13.6<3k No other CBC with diff abnormalities DIC labs are negative; Hemolysis labs are negative. She is noted to have iron deficiency In the ED she was given 4 units of platelets. She was started on 40mg po daily Decadron on 3/6/21.  3/7/21 plts rose to 8K;  Black spots and petechiae significantly decreased, 3/8/21 plts rose to 54K; Patient clinically stable. 3/9/21 plts rose to 84K 3/23/21 plts 201K patient was treated with dexamethasone and IVIG
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet transfusion, Tongue haematoma
Clinical narrative: PMHx of gestational DM presented to the ED on 3/6/21 with black spots on tongue and sides of mouth in addition to gum bleeding all that started suddenly on Friday night, 03/05/21.  She also noted a petechial rash on her chest, face, and abdomen.  She has no history of this in the past, nor prior bleeding events.  She has had 2 deliveries without abnormal bleeding.  She did receive the first dose of her Moderna vaccine on 2/24/21.  She also started having menstrual period on 02/26 which were heavier than usual for past 2 days then became more regular. Her periods usually last 7-8 days.   Platelets were 3K on admission.  She denies any recent infection or new medications.  She felt very well preceding this event.  She did not have any other reactions from the Moderna vaccine.  A recent cbc on 1/11/21 was completely normal with a platelet count of 238K.   3/6/21 CBC on admission:  10.2>13.6<3k No other CBC with diff abnormalities DIC labs are negative; Hemolysis labs are negative. She is noted to have iron deficiency In the ED she was given 4 units of platelets. She was started on 40mg po daily Decadron on 3/6/21.  3/7/21 plts rose to 8K;  Black spots and petechiae significantly decreased, 3/8/21 plts rose to 54K; Patient clinically stable. 3/9/21 plts rose to 84K 3/23/21 plts 201K patient was treated with dexamethasone and IVIG