chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Diarrhoea, Dysstasia, Fatigue, Pain in extremity
Clinical narrative: appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; entire intestinal tract and stomach became hard; extended and felt like it was on fire and was extremely painful; vomiting along with diarrhea; vomiting along with diarrhea; pain and burning in my stomach and back; pain and burning in my stomach and back; This is a spontaneous report from a contactable consumer.   A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 12:15 (Batch/Lot Number: EP6955) as single dose (at the age of 60-year-old) for COVID-19 immunisation, administered at Pharmacy or Drug Store.  Medical history included known allergies: Sulfa drugs, aspirin cordisone. Patient had not COVID prior vaccination. Patient was not pregnant. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity. No other vaccine in fourweeks. On 29Mar2021 19:30 the patient experienced she felt tired, sore arm, entire intestinal tract and stomach became hard, extended and felt like it was on fire and was extremely painful, vomiting along with diarrhea, pain and burning in my stomach and back. On 31Mar2021 the patient experienced appendix had ruptured, diagnosed with appendicitis, could barely stand. The patient was hospitalized for appendix had ruptured and diagnosed with appendicitis for 2 days.  The events were considered serious as per hospitalization, disability, life threatening. Therapeutic measures were taken as a result of appendix had ruptured and diagnosed with appendicitis: appendectomy. COVID was not tested post vaccination.  Course of events was as follows: She had the shot on 29Mar2021 at 12:15, 4 hrs after she felt tired and had sore arm. 7 hours after, her entire intestinal tract and stomach became hard and extended and felt like it was on fire and was extremely painful. 4 hrs later she started vomiting along with diarrhea. The vomiting continued non stop along with the pain and burning in her stomach and back. On 31Mar2021 morning the pain settled into the right lower stomach and became so painful she could barely stand. She went to the ER and was diagnosed with appendicitis. She had surgery that night and found my appendix had ruptured. The OR nurse told he she was the 2nd lady that day who's appendix had ruptured after having their First COVID vaccine and there had been others. She believed this was absolutely the direct result of the vaccine. She queried why were we not warned of this violent side effect of the vaccine. The outcome of events was recovering.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; entire intestinal tract and stomach became hard; extended and felt like it was on fire and was extremely painful; vomiting along with diarrhea; vomiting along with diarrhea; pain and burning in my stomach and back; pain and burning in my stomach and back; This is a spontaneous report from a contactable consumer.   A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 12:15 (Batch/Lot Number: EP6955) as single dose (at the age of 60-year-old) for COVID-19 immunisation, administered at Pharmacy or Drug Store.  Medical history included known allergies: Sulfa drugs, aspirin cordisone. Patient had not COVID prior vaccination. Patient was not pregnant. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity. No other vaccine in fourweeks. On 29Mar2021 19:30 the patient experienced she felt tired, sore arm, entire intestinal tract and stomach became hard, extended and felt like it was on fire and was extremely painful, vomiting along with diarrhea, pain and burning in my stomach and back. On 31Mar2021 the patient experienced appendix had ruptured, diagnosed with appendicitis, could barely stand. The patient was hospitalized for appendix had ruptured and diagnosed with appendicitis for 2 days.  The events were considered serious as per hospitalization, disability, life threatening. Therapeutic measures were taken as a result of appendix had ruptured and diagnosed with appendicitis: appendectomy. COVID was not tested post vaccination.  Course of events was as follows: She had the shot on 29Mar2021 at 12:15, 4 hrs after she felt tired and had sore arm. 7 hours after, her entire intestinal tract and stomach became hard and extended and felt like it was on fire and was extremely painful. 4 hrs later she started vomiting along with diarrhea. The vomiting continued non stop along with the pain and burning in her stomach and back. On 31Mar2021 morning the pain settled into the right lower stomach and became so painful she could barely stand. She went to the ER and was diagnosed with appendicitis. She had surgery that night and found my appendix had ruptured. The OR nurse told he she was the 2nd lady that day who's appendix had ruptured after having their First COVID vaccine and there had been others. She believed this was absolutely the direct result of the vaccine. She queried why were we not warned of this violent side effect of the vaccine. The outcome of events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: got the shot for covid and died a few weeks later; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were reported as none. The patient got the shot for covid and died a few weeks later on an unspecified date. It was unknown if an autopsy was performed. The outcome of the event was fatal.  Information on the Lot/Batch number has been requested.; Reported Cause(s) of Death: got the shot for covid and died a few weeks later
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Dyspnoea, Myocardial strain, Oxygen saturation, Pulmonary embolism
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 19-year-old female patient (not pregnant at event onset and time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 11Feb2021 at 00:00 (19-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included Ewing Sarcoma which was not ongoing (Diagnosed at 5 years old, treated with chemotherapy for 1 year, cancer free for 13 years). There were no known allergies. Concomitant medications included low dose ethinylestradiol, norgestimate (TRI-SPRINTEC) and montelukast sodium (SINGULAIR). No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 20Jan2021 at 00:00 (19-year-old at time of vaccination), at single dose, for COVID-19 immunization. Starting 15Feb2021 at 12:00, the patient began to have shortness of breath that got progressively worse throughout the week. On 22Feb2021, she woke up with severe shortness of breath and her O2 saturation was 82%. She went to the hospital emergency department and was given a chest CT, and diagnosed with large bilateral pulmonary embolisms. She also had severe right ventricular strain due to the PEs. She was rushed into an EKOS procedure and a IVC filter was also put in. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (4 days), and Life threatening illness (immediate risk of death from the event). COVID test (test type: Nasal Swab, test name: Novel Coronavirus PCR) post vaccination was Negative on 22Feb2021, and Negative on 29Mar2021. Therapeutic measures were taken as a result of the events and included Heparin drip, EKOS and IVC filter procedure. The outcome of the events was recovering. Information on the lot/batch number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 19-year-old female patient (not pregnant at event onset and time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 11Feb2021 at 00:00 (19-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included Ewing Sarcoma which was not ongoing (Diagnosed at 5 years old, treated with chemotherapy for 1 year, cancer free for 13 years). There were no known allergies. Concomitant medications included low dose ethinylestradiol, norgestimate (TRI-SPRINTEC) and montelukast sodium (SINGULAIR). No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 20Jan2021 at 00:00 (19-year-old at time of vaccination), at single dose, for COVID-19 immunization. Starting 15Feb2021 at 12:00, the patient began to have shortness of breath that got progressively worse throughout the week. On 22Feb2021, she woke up with severe shortness of breath and her O2 saturation was 82%. She went to the hospital emergency department and was given a chest CT, and diagnosed with large bilateral pulmonary embolisms. She also had severe right ventricular strain due to the PEs. She was rushed into an EKOS procedure and a IVC filter was also put in. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (4 days), and Life threatening illness (immediate risk of death from the event). COVID test (test type: Nasal Swab, test name: Novel Coronavirus PCR) post vaccination was Negative on 22Feb2021, and Negative on 29Mar2021. Therapeutic measures were taken as a result of the events and included Heparin drip, EKOS and IVC filter procedure. The outcome of the events was recovering. Information on the lot/batch number has been requested.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Brain stem stroke
Clinical narrative: Mom died of a Brain Stem stroke; This is a spontaneous report from a contactable consumer (who reported for the mother). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 03Mar2021 at 11:30 (at the age of 88-year-old) (Lot Number: EN6198) as single dose for COVID-19 immunisation. The patient was not tested for COVID-19 after vaccination. Relevant medical history included COVID-19 prior of vaccination. Concomitant medication included atorvastatin (LIPITOR) taken for an unspecified indication, start and stop date were not reported. On 09Mar2021 at 09:45, the patient experienced a brain stem stroke; the event required emergency room visit, the patient was hospitalized on 09Mar2021 and the event was considered serious also as life-threatening and causing disability. The patient received unspecified corrective treatments. The patient died due to brain stem stroke on 11Mar2021. An autopsy was not performed.; Reported Cause(s) of Death: Brain stem stroke
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Pharyngeal swelling, Throat irritation
Clinical narrative: Anaphylaxis; Lightheaded/Dizziness; Throat Swelling; Scratchy Throat; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via an unspecified route of administration, administered in left arm on 12Apr2021 at 09:30 (at 24-year-old, not pregnant at the time of vaccination) at single dose for COVID-19 immunisation. Medical history included known allergies: tree nuts. The patient had Covid-19 prior vaccination. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. No other medications were received in two weeks. On 12Apr2021 at 10:00 AM, the patient experienced anaphylaxis; lightheaded/dizziness; scratchy throat; throat swelling. The events resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the events included epinephrine and steroids to prevent swelling. The outcome of the events was recovered on an unspecified date in Apr2021. The patient did not have covid test post vaccination.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, SARS-CoV-2 test, Urinary tract infection, Urticaria
Clinical narrative: hives all over body; UTI; huge cold sore on nose; This is a spontaneous report from a contactable Other HCP (patient). A non-pregnant 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), via an unspecified route of administration at Left Arm on 26Jan2021 17:30 (at age of 31 years old) at single dose for COVID-19 immunisation. Medical history included allergies: Sulfa. Concomitant medications included fluoxetine hydrochloride (PROZAC); vitamin d nos; clarithromycin (MACROBID). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ek9231) on 07Jan2021 05:30 PM at left arm at 31 years old at single dose for COVID-19 immunisation. No COVID prior vaccination. Nasal Swab on 09Mar2021 was Negative. On 26Jan2021 09:00 PM, within 5 hours of getting my second vaccination, patient broke out in hives all over body. Patient called doctor and was prescribed steroids to help with the hives as antihistamines were not helping. A few days later patient woke up with a huge cold sore on nose which patient never had before. The same day patient was experiencing symptoms of a UTI and was prescribed Macrobid which had taken several times before. Within an hour of taking it patient's body was covered in hives and throat started to close. Patient immediately went to urgent care where received a shot of Benadryl. Patient was confident this reaction would not have happened if patient had not had this vaccine. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment (Prednisone and a shot of Benadryl) received. The outcome of the events was recovered in 2021.; 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 events Hives, UTI, Cold sores cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Computerised tomogram, Deep vein thrombosis, Hypoaesthesia
Clinical narrative: DVT in right leg; chest pain; PE in right lung was found on CT scan; numbness in both legs; Back pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 18Mar2021 13:30 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included breast cancer, hypothyroidism, diabetes. The patient did not have covid prior vaccination and no covid tested post vaccination. No known allergies. The patient was not pregnant. Concomitant medications in two weeks included metformin; atorvastatin (LIPITOR); levothyroxine sodium (SYNTHROID), vit d, multivitamin. No other vaccine in four weeks. Back pain started on 20Mar2021, chest and back pain on 24Mar2021 and chest pain continued until she went to the ER on 27Mar2021. When PE in right lung was found on CT scan on 23Mar2021 12:00 PM. The patient was hospitalized on 27Mar2021 and heparin was started and continued until 29Mar2021 when she was released. The DVT in right leg was found on 28Mar2021 with ultrasound after she mentioned numbness in both legs on 23Mar2021 12:00 PM. She started apixaban (ELIQUIS) on 29Mar2021 before leaving the hospital and still taking it now. She went to follow up appointment with hematologist that suggested that she remained on apixaban and return in 10 weeks for another checkup. The events 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). Number of days hospitalisation was 3. Treatment received for events included heparin and apixaban. The outcome of events was recovering. The patient received second dose of BNT162B2 in arm left on 09Apr2021 12:30 (Lot Number: EK8727).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Ultrasound scan
Clinical narrative: DVT in right leg; chest pain; PE in right lung was found on CT scan; numbness in both legs; Back pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 18Mar2021 13:30 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included breast cancer, hypothyroidism, diabetes. The patient did not have covid prior vaccination and no covid tested post vaccination. No known allergies. The patient was not pregnant. Concomitant medications in two weeks included metformin; atorvastatin (LIPITOR); levothyroxine sodium (SYNTHROID), vit d, multivitamin. No other vaccine in four weeks. Back pain started on 20Mar2021, chest and back pain on 24Mar2021 and chest pain continued until she went to the ER on 27Mar2021. When PE in right lung was found on CT scan on 23Mar2021 12:00 PM. The patient was hospitalized on 27Mar2021 and heparin was started and continued until 29Mar2021 when she was released. The DVT in right leg was found on 28Mar2021 with ultrasound after she mentioned numbness in both legs on 23Mar2021 12:00 PM. She started apixaban (ELIQUIS) on 29Mar2021 before leaving the hospital and still taking it now. She went to follow up appointment with hematologist that suggested that she remained on apixaban and return in 10 weeks for another checkup. The events 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). Number of days hospitalisation was 3. Treatment received for events included heparin and apixaban. The outcome of events was recovering. The patient received second dose of BNT162B2 in arm left on 09Apr2021 12:30 (Lot Number: EK8727).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Mesenteric artery aneurysm
Clinical narrative: abdominal mesenteric aneurysm; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 05Feb2021 15:00 (Lot Number: EL9269) as single dose for covid-19 immunisation. Medical history was reported as none. The patient did not have covid prior vaccination and no covid tested post vaccination. No known allergies. Concomitant medications in two weeks included ibuprofen (ADVIL); cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC DUO). No other vaccine in four weeks. The patient had an abdominal mesenteric aneurysm 19 days after the first vaccine on 24Feb2021. He had no way of knowing if it was linked to the vaccine but did not know if there had been any other reports of this type of event. He spent 5 days in the hospital and then recovered. The event resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). It was unknown if treatment received. The outcome of event was recovered. He received the second vaccine without issues.; Sender's Comments: The causal relationship between BNT162B2 and the event abdominal mesenteric aneurysm cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Appendicitis perforated, Complicated appendicitis, Diarrhoea, Nausea
Clinical narrative: perforated appendicitis with appendectomy; Abdomen pain; diarrhea; acute gangrenous, perforated appendicitis; minimal nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Mar2021 16:00 (Lot Number: EN6204) (at the age of 54-year-old) as single dose for covid-19 immunisation. Medical history included hypertension. The patient did not have covid prior vaccination. Concomitant medications included ascorbic acid (VIT C); zinc; ergocalciferol (VIT D); vitamin K2 (menaquinone); vitamin b complex (B COMPLEX) and multivitamin, all taken for an unspecified indication, start and stop date were not reported. The patient had known allergies: sulfamethoxazole, trimethoprim (SEPTRA), clindamycin, rabeprazole sodium (ACIPHEX), esomeprazole sodium (NEXIUM). The patient previously took the historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 26Feb2021 14:30 (lot number: EN6200) (at the age of 54-year-old) as single dose for COVID-19 immunisation. The patient experienced abdomen pain, minimal nausea, diarrhea, acute gangrenous, perforated appendicitis with appendectomy on 20Mar2021 14:00. The events 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). The patient hospitalized from an unspecified date in 2021 to an unspecified date in 2021 for 3 days. The patient received treatment included appendectomy. The patient underwent lab tests and procedures which included covid test (blood test) date on 22Mar2021 with result of negative. The outcome of the events was recovering.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: perforated appendicitis with appendectomy; Abdomen pain; diarrhea; acute gangrenous, perforated appendicitis; minimal nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Mar2021 16:00 (Lot Number: EN6204) (at the age of 54-year-old) as single dose for covid-19 immunisation. Medical history included hypertension. The patient did not have covid prior vaccination. Concomitant medications included ascorbic acid (VIT C); zinc; ergocalciferol (VIT D); vitamin K2 (menaquinone); vitamin b complex (B COMPLEX) and multivitamin, all taken for an unspecified indication, start and stop date were not reported. The patient had known allergies: sulfamethoxazole, trimethoprim (SEPTRA), clindamycin, rabeprazole sodium (ACIPHEX), esomeprazole sodium (NEXIUM). The patient previously took the historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 26Feb2021 14:30 (lot number: EN6200) (at the age of 54-year-old) as single dose for COVID-19 immunisation. The patient experienced abdomen pain, minimal nausea, diarrhea, acute gangrenous, perforated appendicitis with appendectomy on 20Mar2021 14:00. The events 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). The patient hospitalized from an unspecified date in 2021 to an unspecified date in 2021 for 3 days. The patient received treatment included appendectomy. The patient underwent lab tests and procedures which included covid test (blood test) date on 22Mar2021 with result of negative. The outcome of the events was recovering.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Nodule, Peripheral venous disease, Thrombophlebitis superficial, Vascular pain
Clinical narrative: Nodule on both forearm; swelling along veins and they became painful; swelling along veins and they became painful; 2 superficial venous thromboses, one in my arm and another in my leg; 2 superficial venous thromboses, one in my arm and another in my leg; Deep vein thrombosis leg; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left on 25Jan2021 (Lot Number: EL3247), as single dose, for COVID-19 immunisation. Patient was vaccinated in the hospital. Medical history and concomitant medications were none. Patient did not have known allergies. Patient did not have COVID-19 prior to vaccination. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL0142) on 04Jan2021 at 11:30 AM in left arm and experienced nodule on extremity and vaccination site nodule. The patient experienced deep vein thrombosis leg (medically significant, life threatening) in 2021 with outcome of not recovered, nodule on both forearm (life threatening) on 25Jan2021 with outcome of not recovered, swelling along veins and they became painful (life threatening) in 2021 with outcome of not recovered, swelling along veins and they became painful (life threatening) in 2021 with outcome of not recovered, 2 superficial venous thromboses, one in arm and another in leg (life threatening) in 2021 with outcome of not recovered. It was reported that within hours from second dose the nodules reappeared. At this time, patient was told to take Allegra and did so for 4 weeks. A month later, patient began to see some swelling along his veins and they became painful. This developed into a DVT, deep venous thrombosis, in leg and 2 superficial venous thromboses, one in arm and another in leg. all the events required physician office visit. None of the events occurred at vaccination site, but physician believed they were triggered by receiving the vaccine. Treatment of Eliquis was initiated the day before report. Patient was not tested for COVID-19 post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: got clots all over the body; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced got clots all over the body in Mar2021 and he passed away. Pfizer has not been reporting any effects of blood clot. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: got clots all over the body
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Pain in extremity, Pulmonary thrombosis, Thrombosis
Clinical narrative: Blood Clot/The Blood clot was in the legs and went to his lungs; Blood Clot/The Blood clot was in the legs and went to his lungs; fell; Leg pain; This is a spontaneous report from a contactable consumer.   A 51-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 27Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation.  Medical history included thrombosis from 2020 to an unknown date, it was Months ago in 2020, He was prescribed a medicine for blood clots, but since then he has had no issues, anxiety from an unknown date and unknown if ongoing. Her brother in law had anxiety about even getting the vaccine. The patient experienced leg pain on Mar2021 , pulmonary thrombosis, leg thrombosis and fall on an unspecified date.  The patient died on 02Apr2021.  An autopsy was not performed. The clinical course was the following: The Blood clot was in the legs and went to his lungs, his leg never got red or anything and it was a blood clot. He was having such bad leg pain, it's too bad, had there been some sort of warning, he would have thought to wait till next year. There was nothing the day he got vaccine, but that night his leg started hurting, his girlfriend said let me go get a cold wrap and she wrapped it, he's a farmer. He wakes up the next day and his leg is still hurting, the 3rd day it goes on, his leg still hurting and no one is thinking it a blood clot, he calls the doctor and tells the doctor his leg is hurting, they suggest ibuprofen for inflammation, the next day thought maybe it's better, by Friday he was making breakfast, fell and died. With his girlfriend she said what's going on, and he went straight to hospital, they said the clot in his leg went to the lung. The Blood clot when it was in the leg it never got hot, red, or anything like that. He had the vaccine in the morning and on that same day the leg pain started later that night. It Started out with Leg Pain, she does not know if it was right or left but it was just one leg.; Reported Cause(s) of Death: Thrombosis pulmonary; Thrombosis leg; Fall; Leg pain
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Eyelid function disorder, Flushing, Heart rate, Hypertension
Clinical narrative: I could not open my eyes; associated with Mild flushed; EPISODIC Parosymal Hypertension/hypertensive episode lasted for 5 hours to 7hours per day/ highest BP at home was 216/95 mmhg/ episode of Paroxysmal hypertensive episode associated with tachycardia.; I developed a continuous tearing & watery nasal dripping that lasted for 7 hours; episode associated with tachycardia; I developed a continuous tearing & watery nasal dripping that lasted for 7 hours; I was not feeling well; This is a spontaneous report from a contactable physician (patient). A 71-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in left arm on 25Feb2021 10:00 (Lot Number: EN6200) as single dose for COVID-19 immunisation. Medical history included thyroid cancer, hypertension, Sjogren's syndrome, hyperlipidaemia. Concomitant medication included amlodipine, aspirin, atorvastatin calcium (ATORVAS). No other vaccine was received in four weeks. No covid prior vaccination. The patient previously took lisinopril and experienced allergy (caused cough). The patient underwent COVID test  via nasal swab post vaccination on 08Mar2021 and result was negative. 2 days after receiving vaccine on 27Feb2021, the patient developed a continuous tearing and watery nasal dripping that lasted for 7 hours. At that time, the patient could not open eyes and the patient was not feeling well. and then one and off episode of paroxysmal hypertensive episode associated with tachycardia. Highest BP at home was 216/95 mmHg and worsening PR was 126/4min. Associated with mild flushed but not associated with clammy, no dyspnea, no nausea or vomiting, no diarrhea, no right side abdominal pain. This hypertensive episode lasted for 5 hours to 7 hours per day. The patient contacted to primary care doctor twice in different days. The patient was brought to ER where the patient got first Pfizer shot. Stayed one night 5 as observation patient on 08Mar2021 and next day 09Mar2021, the patient was admitted to Medicine floor. During hopitalization, this episodic parosymal hypertension was continued SBP was up to 211 and finally discharged from hospital on 21Mar2021. The events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event. Extensive work up was done. No treatment was received for events. The outcome of events was recovering.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available.
Sex: U
Vaccine: COVID19
Symptoms: Lacrimation increased, Malaise, Peritonitis bacterial, Rhinorrhoea, SARS-CoV-1 test
Clinical narrative: I could not open my eyes; associated with Mild flushed; EPISODIC Parosymal Hypertension/hypertensive episode lasted for 5 hours to 7hours per day/ highest BP at home was 216/95 mmhg/ episode of Paroxysmal hypertensive episode associated with tachycardia.; I developed a continuous tearing & watery nasal dripping that lasted for 7 hours; episode associated with tachycardia; I developed a continuous tearing & watery nasal dripping that lasted for 7 hours; I was not feeling well; This is a spontaneous report from a contactable physician (patient). A 71-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in left arm on 25Feb2021 10:00 (Lot Number: EN6200) as single dose for COVID-19 immunisation. Medical history included thyroid cancer, hypertension, Sjogren's syndrome, hyperlipidaemia. Concomitant medication included amlodipine, aspirin, atorvastatin calcium (ATORVAS). No other vaccine was received in four weeks. No covid prior vaccination. The patient previously took lisinopril and experienced allergy (caused cough). The patient underwent COVID test  via nasal swab post vaccination on 08Mar2021 and result was negative. 2 days after receiving vaccine on 27Feb2021, the patient developed a continuous tearing and watery nasal dripping that lasted for 7 hours. At that time, the patient could not open eyes and the patient was not feeling well. and then one and off episode of paroxysmal hypertensive episode associated with tachycardia. Highest BP at home was 216/95 mmHg and worsening PR was 126/4min. Associated with mild flushed but not associated with clammy, no dyspnea, no nausea or vomiting, no diarrhea, no right side abdominal pain. This hypertensive episode lasted for 5 hours to 7 hours per day. The patient contacted to primary care doctor twice in different days. The patient was brought to ER where the patient got first Pfizer shot. Stayed one night 5 as observation patient on 08Mar2021 and next day 09Mar2021, the patient was admitted to Medicine floor. During hopitalization, this episodic parosymal hypertension was continued SBP was up to 211 and finally discharged from hospital on 21Mar2021. The events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event. Extensive work up was done. No treatment was received for events. The outcome of events was recovering.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available.
Sex: U
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: I could not open my eyes; associated with Mild flushed; EPISODIC Parosymal Hypertension/hypertensive episode lasted for 5 hours to 7hours per day/ highest BP at home was 216/95 mmhg/ episode of Paroxysmal hypertensive episode associated with tachycardia.; I developed a continuous tearing & watery nasal dripping that lasted for 7 hours; episode associated with tachycardia; I developed a continuous tearing & watery nasal dripping that lasted for 7 hours; I was not feeling well; This is a spontaneous report from a contactable physician (patient). A 71-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in left arm on 25Feb2021 10:00 (Lot Number: EN6200) as single dose for COVID-19 immunisation. Medical history included thyroid cancer, hypertension, Sjogren's syndrome, hyperlipidaemia. Concomitant medication included amlodipine, aspirin, atorvastatin calcium (ATORVAS). No other vaccine was received in four weeks. No covid prior vaccination. The patient previously took lisinopril and experienced allergy (caused cough). The patient underwent COVID test  via nasal swab post vaccination on 08Mar2021 and result was negative. 2 days after receiving vaccine on 27Feb2021, the patient developed a continuous tearing and watery nasal dripping that lasted for 7 hours. At that time, the patient could not open eyes and the patient was not feeling well. and then one and off episode of paroxysmal hypertensive episode associated with tachycardia. Highest BP at home was 216/95 mmHg and worsening PR was 126/4min. Associated with mild flushed but not associated with clammy, no dyspnea, no nausea or vomiting, no diarrhea, no right side abdominal pain. This hypertensive episode lasted for 5 hours to 7 hours per day. The patient contacted to primary care doctor twice in different days. The patient was brought to ER where the patient got first Pfizer shot. Stayed one night 5 as observation patient on 08Mar2021 and next day 09Mar2021, the patient was admitted to Medicine floor. During hopitalization, this episodic parosymal hypertension was continued SBP was up to 211 and finally discharged from hospital on 21Mar2021. The events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event. Extensive work up was done. No treatment was received for events. The outcome of events was recovering.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired Menactra was given to a patient/an expired 0.5ml dose of Adacel was administered in MT's right deltoid with no ae; Initial information received on 30-Mar-2021 regarding an unsolicited valid  non-serious case from a other health professional (reference number :00540911).  This case involves a 16 years old female patient who received expired 0.5 ml doses of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and expiration date not reported via unknown route in the right deltoid) and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6565AA and expiration date:28-Mar-2021 via unknown route in an unknown administration site) for prophylactic vaccination on 29-Mar-2021 (expired product administered). And reporter wanted to know what to do.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEDROXYPROGESTERONE ACETATE (DEPO PROVERA, injection) on that same visit (that is on 29-Mar-2021).  It was an actual medication error due to expired vaccine used (same day latency).  It was not reported that the patient experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number of Adacel for this case.
Age: 72.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of TENIVAC was administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Agency (Reference number- 00541423) and transmitted to Sanofi on 30-Mar-2021.  This case involves a 72 years old male patient who experienced expired 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6187AA and expiration date 06-Feb-2021) via intramuscular route in an unknown administration site for prophylactic vaccination(Expired product administered) on 29-Mar-2021.  The patient's medical history, past medical treatment(s), vaccination(s), family history, risk factor and concomitant medication were not provided.   It was an actual medication error due to expired vaccine used (same day latency).  It was not reported that the patient experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Medication error, Wrong product administered
Clinical narrative: A patient received ADACEL instead of Daptacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Medical Information (Reference number- 00551959).  This case involves a five-year-old male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot u6621ba and expiry date: 21-Mar-2022) via an intramuscular route in the right thigh for prophylactic vaccination on 25-Feb-2021 instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination.  This was a case of actual medication error due to wrong vaccine administered (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Woke up following day with high pitch tinnitus in both ears. The condition is constant. Planning to make appointment with my primary care physician.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Injection site swelling, Nausea, Pain
Clinical narrative: Fever & chills Nausea & Vomiting Uncontrollable yawning/stretching Trouble breathing Swelling and pain on injection site on right arm Pain on entire right side of body (injection side) Trouble sleeping
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder, Vomiting, Yawning
Clinical narrative: Fever & chills Nausea & Vomiting Uncontrollable yawning/stretching Trouble breathing Swelling and pain on injection site on right arm Pain on entire right side of body (injection side) Trouble sleeping
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rash pruritic, Urticaria
Clinical narrative: Friday evening I started with chills and a fever about 7:30pm, both were relieved by Tylenol. Saturday evening about 33 hours after my second (about 6:30pm on 4/17) vaccine dose I noticed small itchy bumps on my left foot, by 9pm that evening the ?hives? were all over my hands and feet. I put some lotion on them and took some Benedryl, but as of 4/19 I still have the hives- small itchy red bumps  on my hands and feet.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Oral herpes, Urticaria
Clinical narrative: Hives on face for and  occasional hot flashes for 2 days, fever blister on  lip.   Benadryl stopped the hives.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: Localized swelling, hot to the touch , soreness - all one week out.  Was initially sore the two days then disappeared. Returned this weekend.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: 4 days after vaccine began getting all over body hives/itchy rash that spread rapidly. Was able to mitigate for 18 hours with over the counter allergy antihistamine medication. Hives came back after allergy medication wore off.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Dysphagia, Dyspnoea
Clinical narrative: Night after vaccine started to have chills, headache, coughing, muscle aches, some difficulty breathing and swallowing, lack of appetite. Still having symptoms. Calling clinic today
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Night after vaccine started to have chills, headache, coughing, muscle aches, some difficulty breathing and swallowing, lack of appetite. Still having symptoms. Calling clinic today