chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Lymphocyte count, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: started to having arthralgias; myalgias; fever; fatigue; weakness; This is a spontaneous report from a contactable pharmacist. A 38-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EH9899), via intramuscular route of administration on 18Dec2020 17:45 (at the age of 38-years-old)  in left arm as single dose for COVID-19 immunisation. Vaccination facilitated in hospital. The patient's medical history included high serum parathyroid hormone and low back pain. Patient had Known allergies: Darvocet-N. Concomitant medication were bupropion 75mg, tizanidine 2mg, Eluryng (ethinylestradiol, etonogestrel), Azelastine 137 mcg/inh (0.1%) nasal spray, fexofenadine 180 mg, and Flonase (fluticasone propionate) 50 mcg/inh nasal spray. No other vaccine was received in four weeks. The patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EL0142), via intramuscular route of administration on 12Jan2021 17:00 in left arm as single dose for COVID-19 immunisation. It was reported patient experienced arthralgia, myalgia, fever, fatigue and weakness starting on 20Dec2021. The patient continuously had arthralgias, myalgias and weakness for the next few weeks. She follow up with physical therapist once a week to work on muscle weakness. She continuously had arthralgias and myalgias until 10Jan2021. Primary care provider on 07Jan2021 orders CBC, autoimmune and thyroid panel since she was having ongoing myalgias and arthralgias. Patient postpone 2nd dose because side effects from 1st vaccine were ongoing. Patient got 2nd dose vaccine on 12Jan at 4:30pm. On 13Jan at 11am the patient initially had nausea and arthralgias. Patient took Zofran 4mg ODT about 11:15am. 30mins later the patient tongue swelled. No lips swelling and no SOB. Patient immediately took liquid Benadryl 50mg to 75mg PO (Oral). Patient presented to ED, observed until 2pm. Patient received treatment. Patient received treatment included 60mg prednisone x 1 dose in ED, prescription for prednisone 40mg x 3 days, Benadryl 25mg to 50mg ev. Patient visited doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No covid prior vaccination and No covid tested post vaccination. Neither prior vaccination nor post vaccination covid was tested. The outcome of the events started to having arthralgias, myalgias, on 10Jan2021 was recovered and for other events recovered on unspecified date on 2021.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mean cell volume normal, Mean platelet volume increased, Monocyte count, Monocyte percentage, Myalgia
Clinical narrative: started to having arthralgias; myalgias; fever; fatigue; weakness; This is a spontaneous report from a contactable pharmacist. A 38-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EH9899), via intramuscular route of administration on 18Dec2020 17:45 (at the age of 38-years-old)  in left arm as single dose for COVID-19 immunisation. Vaccination facilitated in hospital. The patient's medical history included high serum parathyroid hormone and low back pain. Patient had Known allergies: Darvocet-N. Concomitant medication were bupropion 75mg, tizanidine 2mg, Eluryng (ethinylestradiol, etonogestrel), Azelastine 137 mcg/inh (0.1%) nasal spray, fexofenadine 180 mg, and Flonase (fluticasone propionate) 50 mcg/inh nasal spray. No other vaccine was received in four weeks. The patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EL0142), via intramuscular route of administration on 12Jan2021 17:00 in left arm as single dose for COVID-19 immunisation. It was reported patient experienced arthralgia, myalgia, fever, fatigue and weakness starting on 20Dec2021. The patient continuously had arthralgias, myalgias and weakness for the next few weeks. She follow up with physical therapist once a week to work on muscle weakness. She continuously had arthralgias and myalgias until 10Jan2021. Primary care provider on 07Jan2021 orders CBC, autoimmune and thyroid panel since she was having ongoing myalgias and arthralgias. Patient postpone 2nd dose because side effects from 1st vaccine were ongoing. Patient got 2nd dose vaccine on 12Jan at 4:30pm. On 13Jan at 11am the patient initially had nausea and arthralgias. Patient took Zofran 4mg ODT about 11:15am. 30mins later the patient tongue swelled. No lips swelling and no SOB. Patient immediately took liquid Benadryl 50mg to 75mg PO (Oral). Patient presented to ED, observed until 2pm. Patient received treatment. Patient received treatment included 60mg prednisone x 1 dose in ED, prescription for prednisone 40mg x 3 days, Benadryl 25mg to 50mg ev. Patient visited doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No covid prior vaccination and No covid tested post vaccination. Neither prior vaccination nor post vaccination covid was tested. The outcome of the events started to having arthralgias, myalgias, on 10Jan2021 was recovered and for other events recovered on unspecified date on 2021.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Neutrophil count, Neutrophil percentage increased, Platelet count normal, Protein total normal
Clinical narrative: started to having arthralgias; myalgias; fever; fatigue; weakness; This is a spontaneous report from a contactable pharmacist. A 38-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EH9899), via intramuscular route of administration on 18Dec2020 17:45 (at the age of 38-years-old)  in left arm as single dose for COVID-19 immunisation. Vaccination facilitated in hospital. The patient's medical history included high serum parathyroid hormone and low back pain. Patient had Known allergies: Darvocet-N. Concomitant medication were bupropion 75mg, tizanidine 2mg, Eluryng (ethinylestradiol, etonogestrel), Azelastine 137 mcg/inh (0.1%) nasal spray, fexofenadine 180 mg, and Flonase (fluticasone propionate) 50 mcg/inh nasal spray. No other vaccine was received in four weeks. The patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EL0142), via intramuscular route of administration on 12Jan2021 17:00 in left arm as single dose for COVID-19 immunisation. It was reported patient experienced arthralgia, myalgia, fever, fatigue and weakness starting on 20Dec2021. The patient continuously had arthralgias, myalgias and weakness for the next few weeks. She follow up with physical therapist once a week to work on muscle weakness. She continuously had arthralgias and myalgias until 10Jan2021. Primary care provider on 07Jan2021 orders CBC, autoimmune and thyroid panel since she was having ongoing myalgias and arthralgias. Patient postpone 2nd dose because side effects from 1st vaccine were ongoing. Patient got 2nd dose vaccine on 12Jan at 4:30pm. On 13Jan at 11am the patient initially had nausea and arthralgias. Patient took Zofran 4mg ODT about 11:15am. 30mins later the patient tongue swelled. No lips swelling and no SOB. Patient immediately took liquid Benadryl 50mg to 75mg PO (Oral). Patient presented to ED, observed until 2pm. Patient received treatment. Patient received treatment included 60mg prednisone x 1 dose in ED, prescription for prednisone 40mg x 3 days, Benadryl 25mg to 50mg ev. Patient visited doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No covid prior vaccination and No covid tested post vaccination. Neither prior vaccination nor post vaccination covid was tested. The outcome of the events started to having arthralgias, myalgias, on 10Jan2021 was recovered and for other events recovered on unspecified date on 2021.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Red blood cell count normal, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Streptococcus test negative
Clinical narrative: started to having arthralgias; myalgias; fever; fatigue; weakness; This is a spontaneous report from a contactable pharmacist. A 38-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EH9899), via intramuscular route of administration on 18Dec2020 17:45 (at the age of 38-years-old)  in left arm as single dose for COVID-19 immunisation. Vaccination facilitated in hospital. The patient's medical history included high serum parathyroid hormone and low back pain. Patient had Known allergies: Darvocet-N. Concomitant medication were bupropion 75mg, tizanidine 2mg, Eluryng (ethinylestradiol, etonogestrel), Azelastine 137 mcg/inh (0.1%) nasal spray, fexofenadine 180 mg, and Flonase (fluticasone propionate) 50 mcg/inh nasal spray. No other vaccine was received in four weeks. The patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EL0142), via intramuscular route of administration on 12Jan2021 17:00 in left arm as single dose for COVID-19 immunisation. It was reported patient experienced arthralgia, myalgia, fever, fatigue and weakness starting on 20Dec2021. The patient continuously had arthralgias, myalgias and weakness for the next few weeks. She follow up with physical therapist once a week to work on muscle weakness. She continuously had arthralgias and myalgias until 10Jan2021. Primary care provider on 07Jan2021 orders CBC, autoimmune and thyroid panel since she was having ongoing myalgias and arthralgias. Patient postpone 2nd dose because side effects from 1st vaccine were ongoing. Patient got 2nd dose vaccine on 12Jan at 4:30pm. On 13Jan at 11am the patient initially had nausea and arthralgias. Patient took Zofran 4mg ODT about 11:15am. 30mins later the patient tongue swelled. No lips swelling and no SOB. Patient immediately took liquid Benadryl 50mg to 75mg PO (Oral). Patient presented to ED, observed until 2pm. Patient received treatment. Patient received treatment included 60mg prednisone x 1 dose in ED, prescription for prednisone 40mg x 3 days, Benadryl 25mg to 50mg ev. Patient visited doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No covid prior vaccination and No covid tested post vaccination. Neither prior vaccination nor post vaccination covid was tested. The outcome of the events started to having arthralgias, myalgias, on 10Jan2021 was recovered and for other events recovered on unspecified date on 2021.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue, Thyroxine increased, Tri-iodothyronine free normal, Vitamin B12 normal, White blood cell count normal
Clinical narrative: started to having arthralgias; myalgias; fever; fatigue; weakness; This is a spontaneous report from a contactable pharmacist. A 38-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EH9899), via intramuscular route of administration on 18Dec2020 17:45 (at the age of 38-years-old)  in left arm as single dose for COVID-19 immunisation. Vaccination facilitated in hospital. The patient's medical history included high serum parathyroid hormone and low back pain. Patient had Known allergies: Darvocet-N. Concomitant medication were bupropion 75mg, tizanidine 2mg, Eluryng (ethinylestradiol, etonogestrel), Azelastine 137 mcg/inh (0.1%) nasal spray, fexofenadine 180 mg, and Flonase (fluticasone propionate) 50 mcg/inh nasal spray. No other vaccine was received in four weeks. The patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EL0142), via intramuscular route of administration on 12Jan2021 17:00 in left arm as single dose for COVID-19 immunisation. It was reported patient experienced arthralgia, myalgia, fever, fatigue and weakness starting on 20Dec2021. The patient continuously had arthralgias, myalgias and weakness for the next few weeks. She follow up with physical therapist once a week to work on muscle weakness. She continuously had arthralgias and myalgias until 10Jan2021. Primary care provider on 07Jan2021 orders CBC, autoimmune and thyroid panel since she was having ongoing myalgias and arthralgias. Patient postpone 2nd dose because side effects from 1st vaccine were ongoing. Patient got 2nd dose vaccine on 12Jan at 4:30pm. On 13Jan at 11am the patient initially had nausea and arthralgias. Patient took Zofran 4mg ODT about 11:15am. 30mins later the patient tongue swelled. No lips swelling and no SOB. Patient immediately took liquid Benadryl 50mg to 75mg PO (Oral). Patient presented to ED, observed until 2pm. Patient received treatment. Patient received treatment included 60mg prednisone x 1 dose in ED, prescription for prednisone 40mg x 3 days, Benadryl 25mg to 50mg ev. Patient visited doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No covid prior vaccination and No covid tested post vaccination. Neither prior vaccination nor post vaccination covid was tested. The outcome of the events started to having arthralgias, myalgias, on 10Jan2021 was recovered and for other events recovered on unspecified date on 2021.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Myalgia, Pyrexia
Clinical narrative: started to having arthralgias; myalgias; fever; fatigue; weakness; This is a spontaneous report from a contactable pharmacist. A 38-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EH9899), via intramuscular route of administration on 18Dec2020 17:45 (at the age of 38-years-old)  in left arm as single dose for COVID-19 immunisation. Vaccination facilitated in hospital. The patient's medical history included high serum parathyroid hormone and low back pain. Patient had Known allergies: Darvocet-N. Concomitant medication were bupropion 75mg, tizanidine 2mg, Eluryng (ethinylestradiol, etonogestrel), Azelastine 137 mcg/inh (0.1%) nasal spray, fexofenadine 180 mg, and Flonase (fluticasone propionate) 50 mcg/inh nasal spray. No other vaccine was received in four weeks. The patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EL0142), via intramuscular route of administration on 12Jan2021 17:00 in left arm as single dose for COVID-19 immunisation. It was reported patient experienced arthralgia, myalgia, fever, fatigue and weakness starting on 20Dec2021. The patient continuously had arthralgias, myalgias and weakness for the next few weeks. She follow up with physical therapist once a week to work on muscle weakness. She continuously had arthralgias and myalgias until 10Jan2021. Primary care provider on 07Jan2021 orders CBC, autoimmune and thyroid panel since she was having ongoing myalgias and arthralgias. Patient postpone 2nd dose because side effects from 1st vaccine were ongoing. Patient got 2nd dose vaccine on 12Jan at 4:30pm. On 13Jan at 11am the patient initially had nausea and arthralgias. Patient took Zofran 4mg ODT about 11:15am. 30mins later the patient tongue swelled. No lips swelling and no SOB. Patient immediately took liquid Benadryl 50mg to 75mg PO (Oral). Patient presented to ED, observed until 2pm. Patient received treatment. Patient received treatment included 60mg prednisone x 1 dose in ED, prescription for prednisone 40mg x 3 days, Benadryl 25mg to 50mg ev. Patient visited doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No covid prior vaccination and No covid tested post vaccination. Neither prior vaccination nor post vaccination covid was tested. The outcome of the events started to having arthralgias, myalgias, on 10Jan2021 was recovered and for other events recovered on unspecified date on 2021.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Confusional state, Cough, Decreased appetite, Diarrhoea
Clinical narrative: experienced low blood pressure.; she couldn't breathe.; heart damage; bleeding stomach; kidney failure; was feverish; she experienced an achy body; This is a spontaneous report from a contactable registered nurse (patient) and a contactable consumer (patient's husband) from Pfizer sponsored program. This 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of adminsitration on 07Jan2021, at patient age of 69-year-old, as single dose (Lot number EK9231) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020, at patient age of 69-year-old, as single dose (Lot number EJ1685) for COVID-19 immunization. The patient received the second dose on 07Jan2021. In the late afternoon on 07Jan2021 (after taking second dose), the patient experienced an achy body and was feverish. The symptoms got worse the next few days. After that, she had kidney failure after taking the second dose and experienced low blood pressure. She also mentioned she couldn't breathe. She also had heart damage, and bleeding stomach. She was hospitalized because of this condition. The patient further stated that she was also intubated and on a ventilator. She didn't know how many days, so it kind of affected her all over. The patient's husband stated there were no underlying conditions found with his wife. The patient added she was healthy going into all of this. The patient was on dialysis for a while. The patient's husband clarified it was CRRT, and stated they ran the regular machine once for just under 30 minutes and she couldn't handle it. When they finally ran it again, she was able to go through it. She was on 6 pumps and a whole bunch of other stuff. The outcome of the events was unknown.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be excluded. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: experienced low blood pressure.; she couldn't breathe.; heart damage; bleeding stomach; kidney failure; was feverish; she experienced an achy body; This is a spontaneous report from a contactable registered nurse (patient) and a contactable consumer (patient's husband) from Pfizer sponsored program. This 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of adminsitration on 07Jan2021, at patient age of 69-year-old, as single dose (Lot number EK9231) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020, at patient age of 69-year-old, as single dose (Lot number EJ1685) for COVID-19 immunization. The patient received the second dose on 07Jan2021. In the late afternoon on 07Jan2021 (after taking second dose), the patient experienced an achy body and was feverish. The symptoms got worse the next few days. After that, she had kidney failure after taking the second dose and experienced low blood pressure. She also mentioned she couldn't breathe. She also had heart damage, and bleeding stomach. She was hospitalized because of this condition. The patient further stated that she was also intubated and on a ventilator. She didn't know how many days, so it kind of affected her all over. The patient's husband stated there were no underlying conditions found with his wife. The patient added she was healthy going into all of this. The patient was on dialysis for a while. The patient's husband clarified it was CRRT, and stated they ran the regular machine once for just under 30 minutes and she couldn't handle it. When they finally ran it again, she was able to go through it. She was on 6 pumps and a whole bunch of other stuff. The outcome of the events was unknown.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be excluded. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Dyspnoea, Gastric haemorrhage, Hypotension, Pain
Clinical narrative: experienced low blood pressure.; she couldn't breathe.; heart damage; bleeding stomach; kidney failure; was feverish; she experienced an achy body; This is a spontaneous report from a contactable registered nurse (patient) and a contactable consumer (patient's husband) from Pfizer sponsored program. This 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of adminsitration on 07Jan2021, at patient age of 69-year-old, as single dose (Lot number EK9231) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020, at patient age of 69-year-old, as single dose (Lot number EJ1685) for COVID-19 immunization. The patient received the second dose on 07Jan2021. In the late afternoon on 07Jan2021 (after taking second dose), the patient experienced an achy body and was feverish. The symptoms got worse the next few days. After that, she had kidney failure after taking the second dose and experienced low blood pressure. She also mentioned she couldn't breathe. She also had heart damage, and bleeding stomach. She was hospitalized because of this condition. The patient further stated that she was also intubated and on a ventilator. She didn't know how many days, so it kind of affected her all over. The patient's husband stated there were no underlying conditions found with his wife. The patient added she was healthy going into all of this. The patient was on dialysis for a while. The patient's husband clarified it was CRRT, and stated they ran the regular machine once for just under 30 minutes and she couldn't handle it. When they finally ran it again, she was able to go through it. She was on 6 pumps and a whole bunch of other stuff. The outcome of the events was unknown.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be excluded. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Renal failure
Clinical narrative: experienced low blood pressure.; she couldn't breathe.; heart damage; bleeding stomach; kidney failure; was feverish; she experienced an achy body; This is a spontaneous report from a contactable registered nurse (patient) and a contactable consumer (patient's husband) from Pfizer sponsored program. This 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of adminsitration on 07Jan2021, at patient age of 69-year-old, as single dose (Lot number EK9231) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020, at patient age of 69-year-old, as single dose (Lot number EJ1685) for COVID-19 immunization. The patient received the second dose on 07Jan2021. In the late afternoon on 07Jan2021 (after taking second dose), the patient experienced an achy body and was feverish. The symptoms got worse the next few days. After that, she had kidney failure after taking the second dose and experienced low blood pressure. She also mentioned she couldn't breathe. She also had heart damage, and bleeding stomach. She was hospitalized because of this condition. The patient further stated that she was also intubated and on a ventilator. She didn't know how many days, so it kind of affected her all over. The patient's husband stated there were no underlying conditions found with his wife. The patient added she was healthy going into all of this. The patient was on dialysis for a while. The patient's husband clarified it was CRRT, and stated they ran the regular machine once for just under 30 minutes and she couldn't handle it. When they finally ran it again, she was able to go through it. She was on 6 pumps and a whole bunch of other stuff. The outcome of the events was unknown.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be excluded. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Headache, Influenza, Injection site pain
Clinical narrative: fever 101-100 (which resolved now) but having headache; Chills; fever 101-100 (which resolved now) but having headache; joint pain; fatigue; Shortness of breath; bruising at the injection site on right upper arm; swelling at injection site right upper arm; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EL3249, expiration date unknown) 2nd dose, via an unspecified route of administration administered in right upper arm on 02Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021, as single dose for COVID-19 immunization. Caller stated that he had his second shot of vaccine on 02Feb2021 in last week and after that he had having side effects from 03Feb2021 as he was having fever 101-100, chills, joint pain, bruising and swelling at injection site and shortness of breath. He stated that that his fever was 101 for the first two days and the third fourth days that it was 100.5. Caller wanted to know if this was normal, and should he go to ER and also mentioned that the fever was resolved now but he still has some joint pain and headache. He also mentioned that due to side effects he has missed four days of work. Therapeutic measures were taken with Tylenol and aspirin to treat the events. On feb2021, the patient underwent lab tests and procedures which included body temperature which result showed fever was 101 for the first two days and the third fourth days that it was 100.5. The outcome of the event Pyrexia was recovered on 05Feb2021 and patient was recovering from the events of chills, dyspnoea and vaccination site swelling and was not recovered from the events of headache joint pain, fatigue, arthralgia and vaccination site bruising.  Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: fever 101-100 (which resolved now) but having headache; Chills; fever 101-100 (which resolved now) but having headache; joint pain; fatigue; Shortness of breath; bruising at the injection site on right upper arm; swelling at injection site right upper arm; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EL3249, expiration date unknown) 2nd dose, via an unspecified route of administration administered in right upper arm on 02Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021, as single dose for COVID-19 immunization. Caller stated that he had his second shot of vaccine on 02Feb2021 in last week and after that he had having side effects from 03Feb2021 as he was having fever 101-100, chills, joint pain, bruising and swelling at injection site and shortness of breath. He stated that that his fever was 101 for the first two days and the third fourth days that it was 100.5. Caller wanted to know if this was normal, and should he go to ER and also mentioned that the fever was resolved now but he still has some joint pain and headache. He also mentioned that due to side effects he has missed four days of work. Therapeutic measures were taken with Tylenol and aspirin to treat the events. On feb2021, the patient underwent lab tests and procedures which included body temperature which result showed fever was 101 for the first two days and the third fourth days that it was 100.5. The outcome of the event Pyrexia was recovered on 05Feb2021 and patient was recovering from the events of chills, dyspnoea and vaccination site swelling and was not recovered from the events of headache joint pain, fatigue, arthralgia and vaccination site bruising.  Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dyspnoea, Fatigue
Clinical narrative: fever 101-100 (which resolved now) but having headache; Chills; fever 101-100 (which resolved now) but having headache; joint pain; fatigue; Shortness of breath; bruising at the injection site on right upper arm; swelling at injection site right upper arm; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EL3249, expiration date unknown) 2nd dose, via an unspecified route of administration administered in right upper arm on 02Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021, as single dose for COVID-19 immunization. Caller stated that he had his second shot of vaccine on 02Feb2021 in last week and after that he had having side effects from 03Feb2021 as he was having fever 101-100, chills, joint pain, bruising and swelling at injection site and shortness of breath. He stated that that his fever was 101 for the first two days and the third fourth days that it was 100.5. Caller wanted to know if this was normal, and should he go to ER and also mentioned that the fever was resolved now but he still has some joint pain and headache. He also mentioned that due to side effects he has missed four days of work. Therapeutic measures were taken with Tylenol and aspirin to treat the events. On feb2021, the patient underwent lab tests and procedures which included body temperature which result showed fever was 101 for the first two days and the third fourth days that it was 100.5. The outcome of the event Pyrexia was recovered on 05Feb2021 and patient was recovering from the events of chills, dyspnoea and vaccination site swelling and was not recovered from the events of headache joint pain, fatigue, arthralgia and vaccination site bruising.  Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Pyrexia, Vaccination site bruising, Vaccination site swelling
Clinical narrative: fever 101-100 (which resolved now) but having headache; Chills; fever 101-100 (which resolved now) but having headache; joint pain; fatigue; Shortness of breath; bruising at the injection site on right upper arm; swelling at injection site right upper arm; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EL3249, expiration date unknown) 2nd dose, via an unspecified route of administration administered in right upper arm on 02Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021, as single dose for COVID-19 immunization. Caller stated that he had his second shot of vaccine on 02Feb2021 in last week and after that he had having side effects from 03Feb2021 as he was having fever 101-100, chills, joint pain, bruising and swelling at injection site and shortness of breath. He stated that that his fever was 101 for the first two days and the third fourth days that it was 100.5. Caller wanted to know if this was normal, and should he go to ER and also mentioned that the fever was resolved now but he still has some joint pain and headache. He also mentioned that due to side effects he has missed four days of work. Therapeutic measures were taken with Tylenol and aspirin to treat the events. On feb2021, the patient underwent lab tests and procedures which included body temperature which result showed fever was 101 for the first two days and the third fourth days that it was 100.5. The outcome of the event Pyrexia was recovered on 05Feb2021 and patient was recovering from the events of chills, dyspnoea and vaccination site swelling and was not recovered from the events of headache joint pain, fatigue, arthralgia and vaccination site bruising.  Follow-up attempts completed. No further information expected.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Mobility decreased, Nausea, Pain
Clinical narrative: Whole body was in pain including my neck it felt like someone beat me up with a baseball bat; Whole body was in pain including my neck it felt like someone beat me up with a baseball bat; very nauseous; This is a spontaneous report from a contactable consumer (patient). A 82-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1284, Expiration date: Not reported), via an unspecified route of administration, administered in arm left on 04Feb2021 09:15 as 2ND DOSE, SINGLE (age at vaccination 82-years) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265, Expiration date: Not reported), via an unspecified route of administration, administered in arm left on 14Jan2021 15:30 as 1ST dose, single for COVID-19 immunization. The patient was not had COVID prior vaccination, and the test was not performed post vaccination. The patient did not receive any other vaccine within four weeks. The patient did not receive any other medication within two weeks. On 05Feb2021 12:30, the patient experienced that whole body was in pain including my neck it felt like someone beat me up with a baseball bat. I could not even get out of bed in the morning I also became very nauseous and thought I was going to throw up what can I do to get over these side effects. The treatment was not received for the event. The outcome of the events was reported as recovering.  Follow-up attempts completed. No further information expected.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Whole body was in pain including my neck it felt like someone beat me up with a baseball bat; Whole body was in pain including my neck it felt like someone beat me up with a baseball bat; very nauseous; This is a spontaneous report from a contactable consumer (patient). A 82-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1284, Expiration date: Not reported), via an unspecified route of administration, administered in arm left on 04Feb2021 09:15 as 2ND DOSE, SINGLE (age at vaccination 82-years) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265, Expiration date: Not reported), via an unspecified route of administration, administered in arm left on 14Jan2021 15:30 as 1ST dose, single for COVID-19 immunization. The patient was not had COVID prior vaccination, and the test was not performed post vaccination. The patient did not receive any other vaccine within four weeks. The patient did not receive any other medication within two weeks. On 05Feb2021 12:30, the patient experienced that whole body was in pain including my neck it felt like someone beat me up with a baseball bat. I could not even get out of bed in the morning I also became very nauseous and thought I was going to throw up what can I do to get over these side effects. The treatment was not received for the event. The outcome of the events was reported as recovering.  Follow-up attempts completed. No further information expected.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Neck pain, Pain
Clinical narrative: Whole body was in pain including my neck it felt like someone beat me up with a baseball bat; Whole body was in pain including my neck it felt like someone beat me up with a baseball bat; very nauseous; This is a spontaneous report from a contactable consumer (patient). A 82-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1284, Expiration date: Not reported), via an unspecified route of administration, administered in arm left on 04Feb2021 09:15 as 2ND DOSE, SINGLE (age at vaccination 82-years) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265, Expiration date: Not reported), via an unspecified route of administration, administered in arm left on 14Jan2021 15:30 as 1ST dose, single for COVID-19 immunization. The patient was not had COVID prior vaccination, and the test was not performed post vaccination. The patient did not receive any other vaccine within four weeks. The patient did not receive any other medication within two weeks. On 05Feb2021 12:30, the patient experienced that whole body was in pain including my neck it felt like someone beat me up with a baseball bat. I could not even get out of bed in the morning I also became very nauseous and thought I was going to throw up what can I do to get over these side effects. The treatment was not received for the event. The outcome of the events was reported as recovering.  Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Pyrexia
Clinical narrative: chills; low grade fever; This is a spontaneous report received from a contactable consumer or other non-health care professional. A 72-years-old male patient received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration and administered in right arm on 06Feb2021 16:15 as unknown, single for COVID-19 immunization. The patient didnot receive any other vaccines within 4 weeks prior to the COVID vaccine and didnt receive any other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with covid-19 and no allergies to medications, food, or other products. The patient didnot tested for covid-19 since vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced chills and low-grade fever on 07Feb2021 at 10:00 pm. No therapeutic measures were taken as a result of events. The outcome of events was recovered on unspecified date.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; low grade fever; This is a spontaneous report received from a contactable consumer or other non-health care professional. A 72-years-old male patient received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration and administered in right arm on 06Feb2021 16:15 as unknown, single for COVID-19 immunization. The patient didnot receive any other vaccines within 4 weeks prior to the COVID vaccine and didnt receive any other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with covid-19 and no allergies to medications, food, or other products. The patient didnot tested for covid-19 since vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced chills and low-grade fever on 07Feb2021 at 10:00 pm. No therapeutic measures were taken as a result of events. The outcome of events was recovered on unspecified date.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Hypoaesthesia, Injection site hypoaesthesia, Injection site reaction, Muscle tightness
Clinical narrative: Lt arm became numb & weak w/muscle tightness, legs & feet become numb and face/throat became numb; tingling and muscle tightness along with bilateral knee pain; muscle tightness/forearm muscle tightness; face/throat became numb along with a puffy eyelid; Lt arm became numb & weak w/muscle tightness; face/throat became numb along with a puffy eyelid; tingling and muscle tightness along with bilateral knee pain; This is a spontaneous report from a contactable nurse (patient). A 56-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL0142), via an unspecified route of administration, administered in left arm on 06Jan2021 (at the age of 56-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension and high Cholesterol. The patient had no known allergies. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccine in four weeks. Within 5 minutes of received the first vaccine on 06Jan2021, the patient had left arm became numb and weak with muscle tightness; then 1-2 hrs later legs and feet became numb with tingling and muscle tightness along with bilateral knee pain; then 2 hrs later the left side of face/throat became numb along with a puffy eyelid; this lasted 8 days then started resolving; then by the 12th day all symptoms stopped resolving and returned along with right arm numbness/paresthesia and forearm muscle tightness; the numbness and muscle tightening in arms and legs lasted another 2 days; patient still (at the time of report) had some left facial numbness along with paresthesia in both arms elbow to fingers and both legs knees to feet along with occasional knee pain. The patient went to the urgent care on day 2 post vaccine symptoms and day and day 12 post vaccine and was prescribed a muscle relaxant. The patient underwent lab tests and procedures which included nasal swab: negative on 01Feb2021. Therapeutic measures were taken as a result of events and treatment with muscle relaxant. The outcome of the events was resolving.  Follow-up attempts are completed. No further information is expected.