chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea haemorrhagic, Dizziness, Dyspepsia, Dyspnoea, Emotional distress
Clinical narrative: bloody bowel movement; Diarrhea; Headache; Fatigue at activity; nausea; This is a spontaneous report from a contactable pharmacist (patient herself). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL0142, expiration date: not reported), first dose via intramuscular route of administration, administered in Deltoid Left on 11Jan2021 13:00 (at the age of 44 years) as 0.3 ML single for covid-19 immunization. Medical history included abnormal uterine bleeding and iron deficiency anaemia from 27May2020 and ongoing, migraine from 28Aug2019 and ongoing. Concomitant medication(s) included ascorbic acid, glucose (500 mg) and ergocalciferol (4000 units) taken for an unspecified indication from an unspecified start date and ongoing; ferrous bisglycinate (IRON GLYCINATE) taken for anaemia oral from 27May2020 and ongoing; rizatriptan (10 mg) daily taken for migraine from 23Jul2019 to an unspecified stop date and oral multiavitamin. Patient had no Prior vaccinations (within 4 weeks). On 13Jan2021 07:00, the patient experienced bloody bowel movement, headache on 11Jan2021 13:00, diarrhea on 12Jan2021, fatigue at activity on 11Jan2021, nausea. Bloody bowel movement was reported as medically significant. Had a CBC, stool culture and imaging (x-ray of abdomen)-all were normal/unremarkable. Adverse events required visit to Physician office. Patient had no Prior vaccinations (within 4 weeks). The patient underwent lab tests and procedures which included full blood count had all values wnl on 14Jan2021 Hgb 13.8 g/dL and stool analysis had no infections findings on 14Jan2021. No treatment is required for headache, fatigue and diarrhea. Clinical outcome of the event was reported as recovered on 26Jan2021 for bloody bowel movement, recovered for headache, nausea on an unspecified date of 2021, recovered for diarrhea on 26Jan2021, recovered with sequel for fatigue on 15Jan2021.  Comments/Narrative: Patient states experiencing headache & abdominal discomfort post vaccine immediately. States GI effects lasted 3-4 days. Despite claim of bloody bowel movement, no indication of this in lab work.; Sender's Comments: Based on the information in the case report, a possible causal association between the event haematochezia and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Fatigue, Fear, Feeding disorder, Feeling abnormal
Clinical narrative: bloody bowel movement; Diarrhea; Headache; Fatigue at activity; nausea; This is a spontaneous report from a contactable pharmacist (patient herself). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL0142, expiration date: not reported), first dose via intramuscular route of administration, administered in Deltoid Left on 11Jan2021 13:00 (at the age of 44 years) as 0.3 ML single for covid-19 immunization. Medical history included abnormal uterine bleeding and iron deficiency anaemia from 27May2020 and ongoing, migraine from 28Aug2019 and ongoing. Concomitant medication(s) included ascorbic acid, glucose (500 mg) and ergocalciferol (4000 units) taken for an unspecified indication from an unspecified start date and ongoing; ferrous bisglycinate (IRON GLYCINATE) taken for anaemia oral from 27May2020 and ongoing; rizatriptan (10 mg) daily taken for migraine from 23Jul2019 to an unspecified stop date and oral multiavitamin. Patient had no Prior vaccinations (within 4 weeks). On 13Jan2021 07:00, the patient experienced bloody bowel movement, headache on 11Jan2021 13:00, diarrhea on 12Jan2021, fatigue at activity on 11Jan2021, nausea. Bloody bowel movement was reported as medically significant. Had a CBC, stool culture and imaging (x-ray of abdomen)-all were normal/unremarkable. Adverse events required visit to Physician office. Patient had no Prior vaccinations (within 4 weeks). The patient underwent lab tests and procedures which included full blood count had all values wnl on 14Jan2021 Hgb 13.8 g/dL and stool analysis had no infections findings on 14Jan2021. No treatment is required for headache, fatigue and diarrhea. Clinical outcome of the event was reported as recovered on 26Jan2021 for bloody bowel movement, recovered for headache, nausea on an unspecified date of 2021, recovered for diarrhea on 26Jan2021, recovered with sequel for fatigue on 15Jan2021.  Comments/Narrative: Patient states experiencing headache & abdominal discomfort post vaccine immediately. States GI effects lasted 3-4 days. Despite claim of bloody bowel movement, no indication of this in lab work.; Sender's Comments: Based on the information in the case report, a possible causal association between the event haematochezia and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Frustration tolerance decreased, Full blood count normal, Gait inability, Headache, Hypoaesthesia
Clinical narrative: bloody bowel movement; Diarrhea; Headache; Fatigue at activity; nausea; This is a spontaneous report from a contactable pharmacist (patient herself). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL0142, expiration date: not reported), first dose via intramuscular route of administration, administered in Deltoid Left on 11Jan2021 13:00 (at the age of 44 years) as 0.3 ML single for covid-19 immunization. Medical history included abnormal uterine bleeding and iron deficiency anaemia from 27May2020 and ongoing, migraine from 28Aug2019 and ongoing. Concomitant medication(s) included ascorbic acid, glucose (500 mg) and ergocalciferol (4000 units) taken for an unspecified indication from an unspecified start date and ongoing; ferrous bisglycinate (IRON GLYCINATE) taken for anaemia oral from 27May2020 and ongoing; rizatriptan (10 mg) daily taken for migraine from 23Jul2019 to an unspecified stop date and oral multiavitamin. Patient had no Prior vaccinations (within 4 weeks). On 13Jan2021 07:00, the patient experienced bloody bowel movement, headache on 11Jan2021 13:00, diarrhea on 12Jan2021, fatigue at activity on 11Jan2021, nausea. Bloody bowel movement was reported as medically significant. Had a CBC, stool culture and imaging (x-ray of abdomen)-all were normal/unremarkable. Adverse events required visit to Physician office. Patient had no Prior vaccinations (within 4 weeks). The patient underwent lab tests and procedures which included full blood count had all values wnl on 14Jan2021 Hgb 13.8 g/dL and stool analysis had no infections findings on 14Jan2021. No treatment is required for headache, fatigue and diarrhea. Clinical outcome of the event was reported as recovered on 26Jan2021 for bloody bowel movement, recovered for headache, nausea on an unspecified date of 2021, recovered for diarrhea on 26Jan2021, recovered with sequel for fatigue on 15Jan2021.  Comments/Narrative: Patient states experiencing headache & abdominal discomfort post vaccine immediately. States GI effects lasted 3-4 days. Despite claim of bloody bowel movement, no indication of this in lab work.; Sender's Comments: Based on the information in the case report, a possible causal association between the event haematochezia and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Limb discomfort, Loss of personal independence in daily activities, Migraine, Muscle spasms
Clinical narrative: bloody bowel movement; Diarrhea; Headache; Fatigue at activity; nausea; This is a spontaneous report from a contactable pharmacist (patient herself). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL0142, expiration date: not reported), first dose via intramuscular route of administration, administered in Deltoid Left on 11Jan2021 13:00 (at the age of 44 years) as 0.3 ML single for covid-19 immunization. Medical history included abnormal uterine bleeding and iron deficiency anaemia from 27May2020 and ongoing, migraine from 28Aug2019 and ongoing. Concomitant medication(s) included ascorbic acid, glucose (500 mg) and ergocalciferol (4000 units) taken for an unspecified indication from an unspecified start date and ongoing; ferrous bisglycinate (IRON GLYCINATE) taken for anaemia oral from 27May2020 and ongoing; rizatriptan (10 mg) daily taken for migraine from 23Jul2019 to an unspecified stop date and oral multiavitamin. Patient had no Prior vaccinations (within 4 weeks). On 13Jan2021 07:00, the patient experienced bloody bowel movement, headache on 11Jan2021 13:00, diarrhea on 12Jan2021, fatigue at activity on 11Jan2021, nausea. Bloody bowel movement was reported as medically significant. Had a CBC, stool culture and imaging (x-ray of abdomen)-all were normal/unremarkable. Adverse events required visit to Physician office. Patient had no Prior vaccinations (within 4 weeks). The patient underwent lab tests and procedures which included full blood count had all values wnl on 14Jan2021 Hgb 13.8 g/dL and stool analysis had no infections findings on 14Jan2021. No treatment is required for headache, fatigue and diarrhea. Clinical outcome of the event was reported as recovered on 26Jan2021 for bloody bowel movement, recovered for headache, nausea on an unspecified date of 2021, recovered for diarrhea on 26Jan2021, recovered with sequel for fatigue on 15Jan2021.  Comments/Narrative: Patient states experiencing headache & abdominal discomfort post vaccine immediately. States GI effects lasted 3-4 days. Despite claim of bloody bowel movement, no indication of this in lab work.; Sender's Comments: Based on the information in the case report, a possible causal association between the event haematochezia and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, SARS-CoV-2 test negative, Stool analysis normal
Clinical narrative: bloody bowel movement; Diarrhea; Headache; Fatigue at activity; nausea; This is a spontaneous report from a contactable pharmacist (patient herself). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL0142, expiration date: not reported), first dose via intramuscular route of administration, administered in Deltoid Left on 11Jan2021 13:00 (at the age of 44 years) as 0.3 ML single for covid-19 immunization. Medical history included abnormal uterine bleeding and iron deficiency anaemia from 27May2020 and ongoing, migraine from 28Aug2019 and ongoing. Concomitant medication(s) included ascorbic acid, glucose (500 mg) and ergocalciferol (4000 units) taken for an unspecified indication from an unspecified start date and ongoing; ferrous bisglycinate (IRON GLYCINATE) taken for anaemia oral from 27May2020 and ongoing; rizatriptan (10 mg) daily taken for migraine from 23Jul2019 to an unspecified stop date and oral multiavitamin. Patient had no Prior vaccinations (within 4 weeks). On 13Jan2021 07:00, the patient experienced bloody bowel movement, headache on 11Jan2021 13:00, diarrhea on 12Jan2021, fatigue at activity on 11Jan2021, nausea. Bloody bowel movement was reported as medically significant. Had a CBC, stool culture and imaging (x-ray of abdomen)-all were normal/unremarkable. Adverse events required visit to Physician office. Patient had no Prior vaccinations (within 4 weeks). The patient underwent lab tests and procedures which included full blood count had all values wnl on 14Jan2021 Hgb 13.8 g/dL and stool analysis had no infections findings on 14Jan2021. No treatment is required for headache, fatigue and diarrhea. Clinical outcome of the event was reported as recovered on 26Jan2021 for bloody bowel movement, recovered for headache, nausea on an unspecified date of 2021, recovered for diarrhea on 26Jan2021, recovered with sequel for fatigue on 15Jan2021.  Comments/Narrative: Patient states experiencing headache & abdominal discomfort post vaccine immediately. States GI effects lasted 3-4 days. Despite claim of bloody bowel movement, no indication of this in lab work.; Sender's Comments: Based on the information in the case report, a possible causal association between the event haematochezia and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Full blood count, Haematochezia, Headache
Clinical narrative: bloody bowel movement; Diarrhea; Headache; Fatigue at activity; nausea; This is a spontaneous report from a contactable pharmacist (patient herself). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL0142, expiration date: not reported), first dose via intramuscular route of administration, administered in Deltoid Left on 11Jan2021 13:00 (at the age of 44 years) as 0.3 ML single for covid-19 immunization. Medical history included abnormal uterine bleeding and iron deficiency anaemia from 27May2020 and ongoing, migraine from 28Aug2019 and ongoing. Concomitant medication(s) included ascorbic acid, glucose (500 mg) and ergocalciferol (4000 units) taken for an unspecified indication from an unspecified start date and ongoing; ferrous bisglycinate (IRON GLYCINATE) taken for anaemia oral from 27May2020 and ongoing; rizatriptan (10 mg) daily taken for migraine from 23Jul2019 to an unspecified stop date and oral multiavitamin. Patient had no Prior vaccinations (within 4 weeks). On 13Jan2021 07:00, the patient experienced bloody bowel movement, headache on 11Jan2021 13:00, diarrhea on 12Jan2021, fatigue at activity on 11Jan2021, nausea. Bloody bowel movement was reported as medically significant. Had a CBC, stool culture and imaging (x-ray of abdomen)-all were normal/unremarkable. Adverse events required visit to Physician office. Patient had no Prior vaccinations (within 4 weeks). The patient underwent lab tests and procedures which included full blood count had all values wnl on 14Jan2021 Hgb 13.8 g/dL and stool analysis had no infections findings on 14Jan2021. No treatment is required for headache, fatigue and diarrhea. Clinical outcome of the event was reported as recovered on 26Jan2021 for bloody bowel movement, recovered for headache, nausea on an unspecified date of 2021, recovered for diarrhea on 26Jan2021, recovered with sequel for fatigue on 15Jan2021.  Comments/Narrative: Patient states experiencing headache & abdominal discomfort post vaccine immediately. States GI effects lasted 3-4 days. Despite claim of bloody bowel movement, no indication of this in lab work.; Sender's Comments: Based on the information in the case report, a possible causal association between the event haematochezia and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Stool analysis
Clinical narrative: bloody bowel movement; Diarrhea; Headache; Fatigue at activity; nausea; This is a spontaneous report from a contactable pharmacist (patient herself). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL0142, expiration date: not reported), first dose via intramuscular route of administration, administered in Deltoid Left on 11Jan2021 13:00 (at the age of 44 years) as 0.3 ML single for covid-19 immunization. Medical history included abnormal uterine bleeding and iron deficiency anaemia from 27May2020 and ongoing, migraine from 28Aug2019 and ongoing. Concomitant medication(s) included ascorbic acid, glucose (500 mg) and ergocalciferol (4000 units) taken for an unspecified indication from an unspecified start date and ongoing; ferrous bisglycinate (IRON GLYCINATE) taken for anaemia oral from 27May2020 and ongoing; rizatriptan (10 mg) daily taken for migraine from 23Jul2019 to an unspecified stop date and oral multiavitamin. Patient had no Prior vaccinations (within 4 weeks). On 13Jan2021 07:00, the patient experienced bloody bowel movement, headache on 11Jan2021 13:00, diarrhea on 12Jan2021, fatigue at activity on 11Jan2021, nausea. Bloody bowel movement was reported as medically significant. Had a CBC, stool culture and imaging (x-ray of abdomen)-all were normal/unremarkable. Adverse events required visit to Physician office. Patient had no Prior vaccinations (within 4 weeks). The patient underwent lab tests and procedures which included full blood count had all values wnl on 14Jan2021 Hgb 13.8 g/dL and stool analysis had no infections findings on 14Jan2021. No treatment is required for headache, fatigue and diarrhea. Clinical outcome of the event was reported as recovered on 26Jan2021 for bloody bowel movement, recovered for headache, nausea on an unspecified date of 2021, recovered for diarrhea on 26Jan2021, recovered with sequel for fatigue on 15Jan2021.  Comments/Narrative: Patient states experiencing headache & abdominal discomfort post vaccine immediately. States GI effects lasted 3-4 days. Despite claim of bloody bowel movement, no indication of this in lab work.; Sender's Comments: Based on the information in the case report, a possible causal association between the event haematochezia and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Laboratory test, Mobility decreased, Pain in extremity
Clinical narrative: pain in right arm; Difficulty walking; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Feb2021 at 11:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes and end-stage renal disease (ESRD). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications for dialysis and ESRD. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the right arm on 13Jan2021 at 16:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. On 22Feb2021, the patient experienced pain in the right arm. It was reported that one week later, the pain in the right arm had progressed and caused limited mobility. On an unknown date in Feb2021, few days following the second vaccination, the patient felt difficulty in walking on the sudden onset. The events resulted in emergency room/department visits or urgent care. The events also resulted in doctor or other healthcare professional office/clinic visits. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in the right arm and difficulty walking was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: pain in right arm; Difficulty walking; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Feb2021 at 11:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes and end-stage renal disease (ESRD). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications for dialysis and ESRD. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the right arm on 13Jan2021 at 16:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. On 22Feb2021, the patient experienced pain in the right arm. It was reported that one week later, the pain in the right arm had progressed and caused limited mobility. On an unknown date in Feb2021, few days following the second vaccination, the patient felt difficulty in walking on the sudden onset. The events resulted in emergency room/department visits or urgent care. The events also resulted in doctor or other healthcare professional office/clinic visits. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in the right arm and difficulty walking was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: Nausea; Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the right arm on 26Feb2021 at 09:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and allergy to isothiazolinones (methylisothiazolinone). Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient previously received paracetamol; oxycodone hydrochloride (PERCOCET) and methylchloroisothiazolinone (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Feb2021 at 11:30, the patient experienced nausea and vertigo. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea and vertigo were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: Intermittent nausea; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Feb2021 at 15:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included systemic lupus, lupus nephritis, cerebritis, and sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications included PREDNISONE, ATENOLOL, NIFEDIPINE, ESTRADIOL, and LEVOTHYROXINE, all for unknown indication from unknown date and unknown if ongoing. The patient previously took VASOTEC and TETRACYCLINE, and experienced drug allergy. On 27Feb2021 at 07:00, the patient experienced intermittent nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event intermittent nausea was not resolved at the time of this report.  No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lymphadenopathy, Oropharyngeal pain, Pyrexia
Clinical narrative: Swollen lymph nodes on left side of neck and left armpit; Swollen lymph nodes on left side of neck and left armpit; General fatigue; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Feb2021 at 12:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression, penicillin allergy and wheat allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included sertraline hydrochloride (ZOLOFT) and ethinylestradiol/norgestimate (SPRINTEC); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Feb2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient previously received sulfamethoxazole/trimethoprim (BACTRIM) and cefalexin (KEFLEX); both for unknown indications on unknown dates and experienced drug allergy. On 27Feb2021 at 11:00, the patient experienced swollen lymph nodes on left side of her neck and left armpit, general fatigue and sore throat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph nodes on left side of neck and left armpit, general fatigue and sore throat was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Swollen lymph nodes on left side of neck and left armpit; Swollen lymph nodes on left side of neck and left armpit; General fatigue; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Feb2021 at 12:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression, penicillin allergy and wheat allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included sertraline hydrochloride (ZOLOFT) and ethinylestradiol/norgestimate (SPRINTEC); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Feb2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient previously received sulfamethoxazole/trimethoprim (BACTRIM) and cefalexin (KEFLEX); both for unknown indications on unknown dates and experienced drug allergy. On 27Feb2021 at 11:00, the patient experienced swollen lymph nodes on left side of her neck and left armpit, general fatigue and sore throat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph nodes on left side of neck and left armpit, general fatigue and sore throat was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Severe abdominal pain; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 26Feb2021 at 10:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included ascorbic acid (VITAMIN C) and colecalciferol (VITAMIN D3), both from unknown date for unknown indication and unknown if ongoing. The patient previously received erythromycin (MANUFACTURER UNKNOWN) on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021 at 13:15, the patient experienced severe abdominal pain and vomiting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe abdominal pain and vomiting was recovered on an unknown date in Feb2021.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: very strong metallic or medicinal taste; lips and tongue started to tingle; tongue started to go numb; mild itching in throat; pain in throat; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm right on 01Mar2021 at 13:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, started on an unknown date and unknown if ongoing. The patient had penicillin, bees and some food allergy. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); both were taken for an unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021, 45 minutes after vaccination, the patient experienced strong metallic or medicinal taste. A few minutes later patients' lips and tongue started to tingle. A few minutes after that her tongue started to go numb and then soon after that patient had a mild itching and pain in throat. The patient took benadryl, but it did not help. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event very strong metallic or medicinal taste was resolved on same day 01Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Paraesthesia oral, Throat irritation
Clinical narrative: very strong metallic or medicinal taste; lips and tongue started to tingle; tongue started to go numb; mild itching in throat; pain in throat; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm right on 01Mar2021 at 13:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, started on an unknown date and unknown if ongoing. The patient had penicillin, bees and some food allergy. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); both were taken for an unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021, 45 minutes after vaccination, the patient experienced strong metallic or medicinal taste. A few minutes later patients' lips and tongue started to tingle. A few minutes after that her tongue started to go numb and then soon after that patient had a mild itching and pain in throat. The patient took benadryl, but it did not help. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event very strong metallic or medicinal taste was resolved on same day 01Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Migraine, Nasopharyngitis, Oral discomfort
Clinical narrative: very strong metallic or medicinal taste; lips and tongue started to tingle; tongue started to go numb; mild itching in throat; pain in throat; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm right on 01Mar2021 at 13:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, started on an unknown date and unknown if ongoing. The patient had penicillin, bees and some food allergy. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); both were taken for an unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021, 45 minutes after vaccination, the patient experienced strong metallic or medicinal taste. A few minutes later patients' lips and tongue started to tingle. A few minutes after that her tongue started to go numb and then soon after that patient had a mild itching and pain in throat. The patient took benadryl, but it did not help. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event very strong metallic or medicinal taste was resolved on same day 01Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Oropharyngeal pain, Paraesthesia oral
Clinical narrative: very strong metallic or medicinal taste; lips and tongue started to tingle; tongue started to go numb; mild itching in throat; pain in throat; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm right on 01Mar2021 at 13:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, started on an unknown date and unknown if ongoing. The patient had penicillin, bees and some food allergy. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); both were taken for an unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021, 45 minutes after vaccination, the patient experienced strong metallic or medicinal taste. A few minutes later patients' lips and tongue started to tingle. A few minutes after that her tongue started to go numb and then soon after that patient had a mild itching and pain in throat. The patient took benadryl, but it did not help. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event very strong metallic or medicinal taste was resolved on same day 01Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Oropharyngeal pain, Paraesthesia oral, Throat irritation
Clinical narrative: very strong metallic or medicinal taste; lips and tongue started to tingle; tongue started to go numb; mild itching in throat; pain in throat; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm right on 01Mar2021 at 13:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, started on an unknown date and unknown if ongoing. The patient had penicillin, bees and some food allergy. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); both were taken for an unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021, 45 minutes after vaccination, the patient experienced strong metallic or medicinal taste. A few minutes later patients' lips and tongue started to tingle. A few minutes after that her tongue started to go numb and then soon after that patient had a mild itching and pain in throat. The patient took benadryl, but it did not help. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event very strong metallic or medicinal taste was resolved on same day 01Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in right fingers/ pain in right foot; Pain in knuckles; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Feb2021 at 13:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On 18Feb2021 at 10:00, the patient experienced pain in right fingers, knuckles, and right foot. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in right fingers/ pain in right foot and pain in knuckles was not resolved at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Pain in right fingers/ pain in right foot; Pain in knuckles; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Feb2021 at 13:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On 18Feb2021 at 10:00, the patient experienced pain in right fingers, knuckles, and right foot. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in right fingers/ pain in right foot and pain in knuckles was not resolved at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Strong dizziness/ dizzy, sometime more, sometimes less; do not feel well; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Feb2021 at 15:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension benign. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN) and calcium citrate (CITRACAL); all for unknown indication from an unknown date and unknown if ongoing. On 02Feb2021 at 07:00, next day after vaccination when the patient woke up, experienced strong dizziness. Since then, the patient did not feel well and was dizzy, sometime more, sometimes less. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events strong dizziness, did not feel well and was dizzy was not recovered at the time of this report. The patient also received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Feb2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.