chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vestibular migraine
Clinical narrative: ocular migraine; ringing in her ear; pressure in the head; tachycardia; dizziness that turned to vertigo and she still has vertigo till this day; dizziness that turned to vertigo and she still has vertigo till this day; This is a spontaneous report from a contactable consumer (patient) via a 41-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date was not provided) dose 1 via an unspecified route of administration on 22Jan2021 at 10:20 dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. That night (on 22Jan2021), she had an ocular migraine for 7 days straight, ringing in her ear, pressure in the head, tachycardia that lasted 2 weeks, dizziness that turned to vertigo and she still has vertigo till this day, and she was now seeing a neurologist and taking medications. She was also seeing a vestibular specialist. She has not received her 2nd dose. The patient wanted to know whether ringing of the ear after the covid vaccine part of the severe allergic reactions was noted in the fact sheet. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Headache, Neck pain, Pyrexia
Clinical narrative: bronchitis; fatigue; low grade fever; This is a spontaneous report from a contactable nurse (patient).  A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 01Feb2021 at 16:00 (at the age of 71-years-old) as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks. Medical history included asthma. The patient did not have covid prior vaccination and she was not COVID tested post vaccination. Concomitant medications included amlodipine besilate (NORVASC), doxepin hydrochloride, montelukast sodium (SINGULAIR), omeprazole (PRILOSEC) and formoterol fumarate/mometasone furoate (DULERA), all taken for an unspecified indication, start and stop date were not reported.  The patient experienced bronchitis on 06Feb2021, fatigue on 02Feb2021 and low grade fever on 02Feb2021. It was reported that patient developed bronchitis about 4 days after her first dose and then was put on Levaquin and the prednisone taper but had not been around anyone that was sick. She did have a slight reaction after the first vaccine the second day like low grade fever and fatigue and thought that was sort of normal reaction. The events were resolved on an unsoecified date in Apr2021.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of bronchitis . The case will be reassessed once new information is 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: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: bronchitis; fatigue; low grade fever; This is a spontaneous report from a contactable nurse (patient).  A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 01Feb2021 at 16:00 (at the age of 71-years-old) as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks. Medical history included asthma. The patient did not have covid prior vaccination and she was not COVID tested post vaccination. Concomitant medications included amlodipine besilate (NORVASC), doxepin hydrochloride, montelukast sodium (SINGULAIR), omeprazole (PRILOSEC) and formoterol fumarate/mometasone furoate (DULERA), all taken for an unspecified indication, start and stop date were not reported.  The patient experienced bronchitis on 06Feb2021, fatigue on 02Feb2021 and low grade fever on 02Feb2021. It was reported that patient developed bronchitis about 4 days after her first dose and then was put on Levaquin and the prednisone taper but had not been around anyone that was sick. She did have a slight reaction after the first vaccine the second day like low grade fever and fatigue and thought that was sort of normal reaction. The events were resolved on an unsoecified date in Apr2021.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of bronchitis . The case will be reassessed once new information is 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: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bronchitis, Fatigue, Pyrexia
Clinical narrative: bronchitis; fatigue; low grade fever; This is a spontaneous report from a contactable nurse (patient).  A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 01Feb2021 at 16:00 (at the age of 71-years-old) as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks. Medical history included asthma. The patient did not have covid prior vaccination and she was not COVID tested post vaccination. Concomitant medications included amlodipine besilate (NORVASC), doxepin hydrochloride, montelukast sodium (SINGULAIR), omeprazole (PRILOSEC) and formoterol fumarate/mometasone furoate (DULERA), all taken for an unspecified indication, start and stop date were not reported.  The patient experienced bronchitis on 06Feb2021, fatigue on 02Feb2021 and low grade fever on 02Feb2021. It was reported that patient developed bronchitis about 4 days after her first dose and then was put on Levaquin and the prednisone taper but had not been around anyone that was sick. She did have a slight reaction after the first vaccine the second day like low grade fever and fatigue and thought that was sort of normal reaction. The events were resolved on an unsoecified date in Apr2021.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of bronchitis . The case will be reassessed once new information is 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: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Full blood count, Metabolic function test normal, Nausea, Swollen tongue
Clinical narrative: Nausea; Arthralgias; Tongue swelled; This is a spontaneous report from a contactable Pharmacist. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL0142), via an intramuscular route, administered in Arm Left on 12Jan2021 at 05:00 PM (at the age of 38-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included high serum parathyroid hormone and low back pain; both from an unknown date and unknown if ongoing. No other vaccines received in four weeks. Concomitant medications included bupropion 75mg, tizanidine 2mg, ethinylestradiol, etonogestrel (ELURYNG), azelastine 137 mcg/inh (0.1%) nasal spray, fexofenadine 180 mg, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE] 50 mcg/inh nasal spray; all were taken in two weeks for an unspecified indication, start and stop date were not reported. The patient previously took Darvocet-n and experienced drug allergy and also received bnt162b2 (Batch/Lot Number: EH9899) via an intramuscular route, administered in Arm Left on 18Dec2020 at 05:40 PM as DOSE 1, SINGLE for COVID-19 immunisation and experienced arthralgias, myalgias, fever, fatigue and weakness starting on 20Dec2020. Vaccination facility type was hospital. The patient got second dose vaccine on 12Jan2021 at 4:30 pm. On 13Jan at 11 am the patient initially had nausea and arthralgias. Patient took Zofran 4mg ODT about 11:15 am. 30mins later the patient tongue swelled. No lips swelling and no SOB. Patient immediately took liquid Benadryl 50 mg to 75 mg per oral. Patient presented to ED, observed until 2 pm. The patient presented to emergency department (ED), observed until 2 PM. Therapeutic measures were taken as a result of the events with prednisone taken as 60 mg once dose in ED, prescription for prednisone 40 mg for 3 days, Benadryl 25 mg to 50 mg. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Outcome of the events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Nausea, Swollen tongue
Clinical narrative: Nausea; Arthralgias; Tongue swelled; This is a spontaneous report from a contactable Pharmacist. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL0142), via an intramuscular route, administered in Arm Left on 12Jan2021 at 05:00 PM (at the age of 38-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included high serum parathyroid hormone and low back pain; both from an unknown date and unknown if ongoing. No other vaccines received in four weeks. Concomitant medications included bupropion 75mg, tizanidine 2mg, ethinylestradiol, etonogestrel (ELURYNG), azelastine 137 mcg/inh (0.1%) nasal spray, fexofenadine 180 mg, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE] 50 mcg/inh nasal spray; all were taken in two weeks for an unspecified indication, start and stop date were not reported. The patient previously took Darvocet-n and experienced drug allergy and also received bnt162b2 (Batch/Lot Number: EH9899) via an intramuscular route, administered in Arm Left on 18Dec2020 at 05:40 PM as DOSE 1, SINGLE for COVID-19 immunisation and experienced arthralgias, myalgias, fever, fatigue and weakness starting on 20Dec2020. Vaccination facility type was hospital. The patient got second dose vaccine on 12Jan2021 at 4:30 pm. On 13Jan at 11 am the patient initially had nausea and arthralgias. Patient took Zofran 4mg ODT about 11:15 am. 30mins later the patient tongue swelled. No lips swelling and no SOB. Patient immediately took liquid Benadryl 50 mg to 75 mg per oral. Patient presented to ED, observed until 2 pm. The patient presented to emergency department (ED), observed until 2 PM. Therapeutic measures were taken as a result of the events with prednisone taken as 60 mg once dose in ED, prescription for prednisone 40 mg for 3 days, Benadryl 25 mg to 50 mg. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Outcome of the events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Dizziness, Headache, Pain in extremity
Clinical narrative: Within 15 minutes I felt really lightheaded; That night about 9pm my R arm was aching so bad; I got a horrible headache; lower backache; chills; Could not sleep.; Felt horrible till about noon the next day started to feel better slowly.; This is a spontaneous report from a contactable consumer(patient). A 42-years-old non-Pregnant female patient received second dose of bnt162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/lot number not provided), via an unspecified route of administration on an unknown date Feb2021 at 10:45 AM (at the age of 42-year-old) administered in Arm Right as a single dose for COVID-19 immunization at School or Student Health Clinic. The patient had received first dose of bnt162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/lot number not provided), via an unspecified route of administration on an unknown date Jan2021 at 10:30 am administered in Arm Right as a single dose for COVID-19 immunization at School or Student Health Clinic. Medical history included Chronic headaches from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient has not been tested for COVID-19. On an unknown date Feb2021, within 15 minutes the patient felt really lightheaded, which went away after about 1/2 hr. That night about 9pm my R arm was aching so bad, like she has never felt. Also got a horrible headache and lower backache, and chills. Could not sleep. Felt horrible till about noon the next day started to feel better slowly. No treatment was given for the events. The outcome of the event was recovering for Felt horrible till about noon the next day started to feel better slowly and recovered for other events on an unknown date Feb2021. Information on the Lot/Batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chills, Dizziness, Feeling abnormal, Headache
Clinical narrative: Within 15 minutes I felt really lightheaded; That night about 9pm my R arm was aching so bad; I got a horrible headache; lower backache; chills; Could not sleep.; Felt horrible till about noon the next day started to feel better slowly.; This is a spontaneous report from a contactable consumer(patient). A 42-years-old non-Pregnant female patient received second dose of bnt162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/lot number not provided), via an unspecified route of administration on an unknown date Feb2021 at 10:45 AM (at the age of 42-year-old) administered in Arm Right as a single dose for COVID-19 immunization at School or Student Health Clinic. The patient had received first dose of bnt162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/lot number not provided), via an unspecified route of administration on an unknown date Jan2021 at 10:30 am administered in Arm Right as a single dose for COVID-19 immunization at School or Student Health Clinic. Medical history included Chronic headaches from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient has not been tested for COVID-19. On an unknown date Feb2021, within 15 minutes the patient felt really lightheaded, which went away after about 1/2 hr. That night about 9pm my R arm was aching so bad, like she has never felt. Also got a horrible headache and lower backache, and chills. Could not sleep. Felt horrible till about noon the next day started to feel better slowly. No treatment was given for the events. The outcome of the event was recovering for Felt horrible till about noon the next day started to feel better slowly and recovered for other events on an unknown date Feb2021. Information on the Lot/Batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Within 15 minutes I felt really lightheaded; That night about 9pm my R arm was aching so bad; I got a horrible headache; lower backache; chills; Could not sleep.; Felt horrible till about noon the next day started to feel better slowly.; This is a spontaneous report from a contactable consumer(patient). A 42-years-old non-Pregnant female patient received second dose of bnt162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/lot number not provided), via an unspecified route of administration on an unknown date Feb2021 at 10:45 AM (at the age of 42-year-old) administered in Arm Right as a single dose for COVID-19 immunization at School or Student Health Clinic. The patient had received first dose of bnt162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/lot number not provided), via an unspecified route of administration on an unknown date Jan2021 at 10:30 am administered in Arm Right as a single dose for COVID-19 immunization at School or Student Health Clinic. Medical history included Chronic headaches from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient has not been tested for COVID-19. On an unknown date Feb2021, within 15 minutes the patient felt really lightheaded, which went away after about 1/2 hr. That night about 9pm my R arm was aching so bad, like she has never felt. Also got a horrible headache and lower backache, and chills. Could not sleep. Felt horrible till about noon the next day started to feel better slowly. No treatment was given for the events. The outcome of the event was recovering for Felt horrible till about noon the next day started to feel better slowly and recovered for other events on an unknown date Feb2021. Information on the Lot/Batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Severe body aches; Severe joint pain; This is a spontaneous report received from a contactable other hcp (Patient). A 32-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported) and dose 2 via an unspecified route of administration on 09Feb2021 10:15 (Batch/Lot Number: EL1283) both as single dose for COVID-19 immunisation. Medical history included Pregnancy/birth from Oct2019 and attention deficit hyperactivity disorder (ADHD). Patient had no known allergies. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID-19 prior to vaccination and she was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced severe body aches and severe joint pain. It was reported that severe body aches and severe joint pain started mild and both progressively worsened. Patient did not receive any treatment due to adverse events. The outcome of event was not recovered.   Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report from a contactable physician. A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL1284, Expiry date was not reported), age 37 year at the vaccination), via an unspecified route of administration, administered in Arm Left on 08Jan2021 08:00 as dose 2, single for COVID-19 immunization at hospital. The patient medical history was not reported. Concomitant medication(s) included sertraline was taken for an unspecified indication, start and stop date were not reported; bupropion.No other vaccine received in four weeks. No prior covid vaccination. Known allergies was reported as no. Other medical history were none. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EH989, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 18Dec2020 08:00 AM as dose 1, single for COVID-19 immunization. The patient experienced tinnitus on Jan2021.  The outcome of the event was not recovered.   Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration, Injection site bruising, Injection site discomfort, Injection site pain
Clinical narrative: Injected the vaccine "pretty low about 4.5-5 inches from the top of my shoulder." vaccine was not administered in the deltoid muscle/ vaccine injected low in arm and not in the muscle; arm is pretty sore to lay on and the fatty tissue is sore; pain at the injection site; This is a spontaneous report from a Pfizer sponsored program from a contactable pharmacist, the patient.  A 34-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, administered in the left arm on Friday 05Feb2021(at the age of 34 years) as dose 1, single, for COVID-19 immunization, by a technician. Reason for not providing lot number was mentioned as patient was unwilling to complete the report. The patient's medical history and concomitant medications were not reported. On 05Feb2021, they injected the vaccine pretty low about 4.5-5 inches from the top of her shoulder (injected low in the arm and not in the muscle) and she believed that the vaccine was administered incorrectly, because it was not administered in the deltoid muscle (Vaccine administered at inappropriate site). She stated that, on unspecified date in 2021, her arm was pretty sore to lay on and the fatty tissue was sore, and she experienced pain at the injection site but did not experience any muscle soreness in her triceps or deltoid muscle. The outcome for the events was unknown at the time of report.  Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Product administered at inappropriate site, Vaccination site pain
Clinical narrative: Injected the vaccine "pretty low about 4.5-5 inches from the top of my shoulder." vaccine was not administered in the deltoid muscle/ vaccine injected low in arm and not in the muscle; arm is pretty sore to lay on and the fatty tissue is sore; pain at the injection site; This is a spontaneous report from a Pfizer sponsored program from a contactable pharmacist, the patient.  A 34-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, administered in the left arm on Friday 05Feb2021(at the age of 34 years) as dose 1, single, for COVID-19 immunization, by a technician. Reason for not providing lot number was mentioned as patient was unwilling to complete the report. The patient's medical history and concomitant medications were not reported. On 05Feb2021, they injected the vaccine pretty low about 4.5-5 inches from the top of her shoulder (injected low in the arm and not in the muscle) and she believed that the vaccine was administered incorrectly, because it was not administered in the deltoid muscle (Vaccine administered at inappropriate site). She stated that, on unspecified date in 2021, her arm was pretty sore to lay on and the fatty tissue was sore, and she experienced pain at the injection site but did not experience any muscle soreness in her triceps or deltoid muscle. The outcome for the events was unknown at the time of report.  Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Injection Site Pain; Fever; Headache; Body Ache; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL 9264, Expiration Date: not reported), via an unspecified route of administration in left arm on 10Feb2021 12:30 as dose 2, single for COVID-19 immunization (at the age of 30-year-old). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3249, Expiration Date: not reported), via an unspecified route of administration in left arm on 19Jan2021 10:45 as dose 1, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Vaccine was administered at hospital. Medical history included anxiety and allergies to amoxicillin. Concomitant medication(s) (within 2 weeks of vaccination) included sertraline and bifidobacterium lactis (PROBIOTIC) taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced injection site pain, fever, headache, body ache and tiredness on 11Feb2021 01:00. Reported seriousness for the events was non-serious. The patient did not receive treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Injection Site Pain; Fever; Headache; Body Ache; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL 9264, Expiration Date: not reported), via an unspecified route of administration in left arm on 10Feb2021 12:30 as dose 2, single for COVID-19 immunization (at the age of 30-year-old). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3249, Expiration Date: not reported), via an unspecified route of administration in left arm on 19Jan2021 10:45 as dose 1, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Vaccine was administered at hospital. Medical history included anxiety and allergies to amoxicillin. Concomitant medication(s) (within 2 weeks of vaccination) included sertraline and bifidobacterium lactis (PROBIOTIC) taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced injection site pain, fever, headache, body ache and tiredness on 11Feb2021 01:00. Reported seriousness for the events was non-serious. The patient did not receive treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Lymphadenopathy, Nausea
Clinical narrative: left armpit lymph node swelling; injection site pain; headache; nausea; joint pain; This is a spontaneous report from a contactable consumer (Patient). A 63-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration, in the left arm on 10Feb2021 at 13:00 (at the age of 63-years-old) as dose 1, single for covid-19 immunisation. Facility type vaccine was hospital. Medical history included asthma and obesity both from an unknown date and unknown if ongoing. Known allergies included penicillin. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), fluticasone propionate (FLONASE), Multi-Vit, cyanocobalamin (B-12), biotin and colecalciferol (VITAMIN D) all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination 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 vaccines within four weeks prior to the vaccination. On 10Feb2021 at 13:30, the patient experienced left armpit lymph node swelling, injection site pain, headache, nausea and joint pain. The patient did not receive any treatment for the event. Outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Lymphadenopathy, Nausea, Vaccination site pain
Clinical narrative: left armpit lymph node swelling; injection site pain; headache; nausea; joint pain; This is a spontaneous report from a contactable consumer (Patient). A 63-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration, in the left arm on 10Feb2021 at 13:00 (at the age of 63-years-old) as dose 1, single for covid-19 immunisation. Facility type vaccine was hospital. Medical history included asthma and obesity both from an unknown date and unknown if ongoing. Known allergies included penicillin. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), fluticasone propionate (FLONASE), Multi-Vit, cyanocobalamin (B-12), biotin and colecalciferol (VITAMIN D) all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination 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 vaccines within four weeks prior to the vaccination. On 10Feb2021 at 13:30, the patient experienced left armpit lymph node swelling, injection site pain, headache, nausea and joint pain. The patient did not receive any treatment for the event. Outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral pruritus, Pruritus, Swelling of eyelid
Clinical narrative: Mild swelling of upper lids; itching sensation around mouth/mild itching sensation to whole face going into outer ears; itching sensation around mouth/mild itching sensation to whole face going into outer ears; itching sensation around mouth/mild itching sensation to whole face going into outer ears; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 66-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9264) via an unspecified route of administration in left arm on 01Feb2021 13:30 as dose 1, single (at the age of 66-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history included known allergies and had been having mild asthma attributing it to post-nasal drip/nasal congestion. History of food allergies, celiac disease, MS, Hypertension. The concomitant medications were not specified. Vaccination facility type was reported as Other (Covid Immunization Clinic, Health Center). Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19, prior to vaccination and was not tested for COVID-19, post vaccination. Patient experienced mild swelling of upper lids about 15-20 mins after vaccine injection, with further development of itching sensation around mouth on 01Feb2021. Persistent mild upper lid swelling with spread of mild itching sensation to whole face going into outer ears on 01Feb2021. Took Benadryl 25mg, with no change in half hour. Took another Benadryl 25 mg with improvement of symptoms. Patient received treatment for the adverse events which included Benadryl total 50 mg. The outcome of the events was recovering.    Follow-up (20May2021): Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pruritus, Eyelids pruritus, Pruritus, Swelling of eyelid
Clinical narrative: Mild swelling of upper lids; itching sensation around mouth/mild itching sensation to whole face going into outer ears; itching sensation around mouth/mild itching sensation to whole face going into outer ears; itching sensation around mouth/mild itching sensation to whole face going into outer ears; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 66-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9264) via an unspecified route of administration in left arm on 01Feb2021 13:30 as dose 1, single (at the age of 66-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history included known allergies and had been having mild asthma attributing it to post-nasal drip/nasal congestion. History of food allergies, celiac disease, MS, Hypertension. The concomitant medications were not specified. Vaccination facility type was reported as Other (Covid Immunization Clinic, Health Center). Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19, prior to vaccination and was not tested for COVID-19, post vaccination. Patient experienced mild swelling of upper lids about 15-20 mins after vaccine injection, with further development of itching sensation around mouth on 01Feb2021. Persistent mild upper lid swelling with spread of mild itching sensation to whole face going into outer ears on 01Feb2021. Took Benadryl 25mg, with no change in half hour. Took another Benadryl 25 mg with improvement of symptoms. Patient received treatment for the adverse events which included Benadryl total 50 mg. The outcome of the events was recovering.    Follow-up (20May2021): Follow-up attempts completed. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; Joint pain; Fever; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 59-years-old, non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 13Feb2021 (at the age of 59-years-old) as dose 2, single for covid-19 immunisation in other facility. The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination. Medical history included known allergies shellfish. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1283, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 23Jan2021 (at the age of 59-years-old) as dose 1, single for covid-19 immunisation in other facility. On 13Feb2021 at 22:30, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea and feeling unwell. No treatment was given for the events. The outcome of the events recovered on an unspecified date of 2021.  Follow-up attempts completed. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; Joint pain; Fever; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 59-years-old, non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 13Feb2021 (at the age of 59-years-old) as dose 2, single for covid-19 immunisation in other facility. The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination. Medical history included known allergies shellfish. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1283, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 23Jan2021 (at the age of 59-years-old) as dose 1, single for covid-19 immunisation in other facility. On 13Feb2021 at 22:30, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea and feeling unwell. No treatment was given for the events. The outcome of the events recovered on an unspecified date of 2021.  Follow-up attempts completed. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; Joint pain; Fever; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 59-years-old, non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 13Feb2021 (at the age of 59-years-old) as dose 2, single for covid-19 immunisation in other facility. The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination. Medical history included known allergies shellfish. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1283, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 23Jan2021 (at the age of 59-years-old) as dose 1, single for covid-19 immunisation in other facility. On 13Feb2021 at 22:30, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea and feeling unwell. No treatment was given for the events. The outcome of the events recovered on an unspecified date of 2021.  Follow-up attempts completed. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; Joint pain; Fever; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 59-years-old, non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 13Feb2021 (at the age of 59-years-old) as dose 2, single for covid-19 immunisation in other facility. The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination. Medical history included known allergies shellfish. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1283, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 23Jan2021 (at the age of 59-years-old) as dose 1, single for covid-19 immunisation in other facility. On 13Feb2021 at 22:30, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea and feeling unwell. No treatment was given for the events. The outcome of the events recovered on an unspecified date of 2021.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itchy arms especially left arm which was vaccinated; Rash and itchy arms especially left arm which was vaccinated; This is a spontaneous report from a contactable consumer. A 71-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 16:30 (at the age of 71-years-old) as a single dose for covid-19 immunization. Medical history included diabetes mellitus, blood cholesterol increased. Concomitant medication(s) in two weeks included metformin; atorvastatin (LIPITOR [ATORVASTATIN]). The patient was not pregnant at the time of vaccination. The patient did not have any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Feb2021 16:00, the patient experienced rash and itchy arms especially left arm which was vaccinated (5th day after vaccination). Need to know if 2nd dose can be taken or not. Claritin taken on 12th and Benadryl taken on 14th as itching and rash are persistent. Applied hydrocortisone cream as well for itching on 14Feb2021. The patient recevied treatment for adverse events. Outcome of the event was not recovered, at the time of this report.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain, Pain in extremity, Toothache
Clinical narrative: toothache left side; left elbow achy; all left joints very achy, right side less achy; all joints very achy, slight swelling left wrist; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 31Jan2021 12:00 (Batch/Lot Number: EL9264) as DOSE 1 SINGLE for covid-19 immunization(Age at vaccination 68 years). The patient past Medical history included Sjogren's syndrome from an unknown date and unknown if ongoing. Concomitant medication(s) included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, alpha lipoic acid (ALPHA LIPOIC ACID) taken for an unspecified indication, Vit d3 (VIT D3) taken for an unspecified indication and Vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 05Feb2021, the day after the vaccination, the patient experienced toothache left side, left elbow achy, all left joints very achy, right side less achy, all joints very achy and slight swelling left wrist. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received.The event outcome was Not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint swelling, Toothache
Clinical narrative: toothache left side; left elbow achy; all left joints very achy, right side less achy; all joints very achy, slight swelling left wrist; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 31Jan2021 12:00 (Batch/Lot Number: EL9264) as DOSE 1 SINGLE for covid-19 immunization(Age at vaccination 68 years). The patient past Medical history included Sjogren's syndrome from an unknown date and unknown if ongoing. Concomitant medication(s) included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, alpha lipoic acid (ALPHA LIPOIC ACID) taken for an unspecified indication, Vit d3 (VIT D3) taken for an unspecified indication and Vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 05Feb2021, the day after the vaccination, the patient experienced toothache left side, left elbow achy, all left joints very achy, right side less achy, all joints very achy and slight swelling left wrist. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received.The event outcome was Not recovered.