chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Insomnia, Myalgia, Pain assessment
Clinical narrative: muscle pain; unable to sleep; tendonitis; fever; shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 22Feb2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization received on 22Jan2021. It was reported that, Patient is male, aged 72, received first Pfizer vaccine on 22Jan2021 and his second Pfizer vaccine on 22Feb2021. He developed very bad muscle pain in the arm muscle where he was injected. He says at night it reaches a 9 out of 10 on the pain scale. He is unable to sleep. He went to the doctor and he said it may be tendonitis. He also experienced a mild 99 degree fever and a little shoulder pain. Patient was asking are these common side effects of the vaccine and Dr prescribed Medrol dose pack for patient, is this okay to take right after receiving second vaccine. The patient underwent lab tests and procedures which included FEVER (body temperature): mild 99 degree fever on an unspecified date, pain scale (pain assessment): 9 out of 10 on an unspecified date. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tendonitis
Clinical narrative: muscle pain; unable to sleep; tendonitis; fever; shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 22Feb2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization received on 22Jan2021. It was reported that, Patient is male, aged 72, received first Pfizer vaccine on 22Jan2021 and his second Pfizer vaccine on 22Feb2021. He developed very bad muscle pain in the arm muscle where he was injected. He says at night it reaches a 9 out of 10 on the pain scale. He is unable to sleep. He went to the doctor and he said it may be tendonitis. He also experienced a mild 99 degree fever and a little shoulder pain. Patient was asking are these common side effects of the vaccine and Dr prescribed Medrol dose pack for patient, is this okay to take right after receiving second vaccine. The patient underwent lab tests and procedures which included FEVER (body temperature): mild 99 degree fever on an unspecified date, pain scale (pain assessment): 9 out of 10 on an unspecified date. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: Swelling; Itching; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old non-pregnant female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: el9264) dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 08:45(age at vaccination:40 Years) as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination, Patient had received other medications Nifedipine, Xolair, Symbicort, Flonase, Vitamin D within 2weeks of vaccination. Medical history included asthma from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, food allergy (sea food) from an unknown date and unknown if ongoing, food allergy (shellfish) from an unknown date and unknown if ongoing, food allergy (peanuts, tree nuts) from an unknown date and unknown if ongoing, anaphylactic shock from an unknown date and unknown if ongoing. Concomitant medications included nifedipine (NIFEDIPINE) taken for an unspecified indication, start and stop date were not reported; omalizumab (XOLAIR) taken for an unspecified indication, start and stop date were not reported; budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE ALLERGY RELIEF) taken for an unspecified indication, start and stop date were not reported; cholecalciferol (VITAMINE D) taken for an unspecified indication, start and stop date were not reported. Patient didn't had covid prior to vaccination. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: el3248) via unspecified route of administration in Arm right on 28Jan2021 14:30(age at vaccination:40 years) as DOSE 1, SINGLE for covid-19 immunisation. No Therapeutic measures were taken for the events. Patient was not tested for covid to post vaccination. On 19Feb2021 the patient experienced swelling, itching. The outcome of the events swelling pruritus was recovering.  Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Tongue dry
Clinical narrative: my tongue was dry; tongue swelling slightly; This is a spontaneous report from a contactable consumer.   A 43-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200) dose 1 administered in Arm Right via an unspecified route, on 18Feb2021 14:00 (Age at vaccination: 43 years old) as DOSE 1,SINGLE for covid-19 immunisation.  Medical history included urticaria, fungal infection and scoliosis.The patient experienced drug hypersensitivity previously from aspirin/salicins, monistat varieties, tobramycin/dexamethasone.The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient did not receive any other medications in two weeks prior to the COVID vaccine.  The patient experienced tongue was dry and tongue swelling slightly on 18Feb2021 14:15. Patient was given two Benadryl thirty minutes after the vaccination.Within 2 hrs, patient felt her tongue was not swelling or dry.The outcome of the events are recovered on 18Feb2021.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Product administered at inappropriate site
Clinical narrative: asthma; vaccine was not administered in the deltoid, it was given like in the tricep; This is a spontaneous report from a contactable physician. This physician reported for 2 patients. This is 2nd of 2 reports.  A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as DOSE NUMBER, UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccine was not administered in the deltoid, it was given like in the triceps leading to product administered at inappropriate site on 16Feb2021 and asthma on an unspecified date with outcome of unknown.  Follow-up (17Feb2021): This is a follow-up spontaneous report from a contactable physician. This physician reported for a patient that: Describes the administration site on himself as "from the shoulder 7 inches down and then from the elbow it's another 7 inches. Also would like to know what should be done if this is considered to be an incorrect injection site.   Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) :-PFIZER INC-2021170851 same reporter/drug/AE with different patient
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Heart rate increased
Clinical narrative: Chest felt odd; then rapid heartbeat began about 25 min after injection; Headache; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in left arm on 05Feb2021 13:45 (at the age of 72 years-old) as dose 1, single for COVID-19 immunization (Hospital). Patient medical history included ongoing hypothyroidism and insulin resistance, along with supraventricular tachycardia, and obesity unknown if both ongoing. Concomitant medications included levothyroxine sodium (UNITHROID), chlorthalidone (CHLORTHALIDONE), finasteride (FINASTERIDE), and colecalciferol (VIT D3) and zinc all taken for an unspecified indication. The patient previously took codeine, morphine, statins and experienced drug hypersensitivity. On 05Feb2021, after 15 minutes of drug administration, the patient's chest felt odd, followed by rapid heartbeat began about 25 minutes after injection and headache. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Patient took no other vaccine within four weeks of drug administration. Patient did not receive any treatment. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Severe Headache; significant arm pain again -decrease ROM to less 90'; significant arm pain again -decrease ROM to less 90'; Body aches; significant joint pains-especially in hands and wrists; This is a spontaneous report from a contactable other-HCP (Nurse, patient herself). A 55-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN 6201) intramuscularly in right arm on 16Feb2021 11:45 as dose 2, single (at the age of 55-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Vaccination facility type was reported as Hospital. Patient did not receive any other vaccine in four weeks. Patient medical history were reported as liver injury from 1986 to 1986, blood transfusion for lacerated liver repair, seasonal allergy, allergy to cats and dogs (animal), various Trees and various Nuts. Patient known allergies included allergies to Synalgos, Zyrtec. The concomitant medications were reported as estrogens conjugated, progesterone, mesterolone (RESTORE) taken for an unspecified indication, start and stop date for all medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3246) intramuscularly in left arm on 26Jan2021 as dose 1, single for COVID-19 immunization. Patient experienced significant arm pain, with decrease ROM to less 90, chills, brain fog, felt agitated and unsettled, headache as moderate with the first dose which lasted 3 days. Patient experienced significant arm pain again, decreased ROM to less than 90, severe headache, body aches and significant joint pains especially in hands and wrists on an unspecified date in Feb2021 which lasted for 3 days. The patient did not receive any treatment for the adverse events. The outcome of the events was resolved on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Severe arm pain; numbness and tingling in left arm; tingling in left arm; night chill/sweats; night chill/sweats; fever 100.1; headache; feeling unwell; This is a spontaneous report from a contactable other hcp (Nurse) (patient). A 35-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration, administered in arm left on 23Feb2021 16:30 (at the age of 35-year-old) at dose 1, single for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. Other medications in two weeks: Sprinters. Patient had no known allergies. Patient did not have other vaccine in four weeks. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. On 24Feb2021 16:00 the patient experienced severe arm pain, numbness and tingling in left arm, night chill/sweats, fever 100.1, headache, feeling unwell. The patient underwent lab tests and procedures which included fever: 100.1 on an unspecified date. Patient did not receive treatment for the adverse events. Outcome of the events was not resolved.   Follow-up (25May2021): Follow-up attempts completed. No further information expected
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Severe arm pain; numbness and tingling in left arm; tingling in left arm; night chill/sweats; night chill/sweats; fever 100.1; headache; feeling unwell; This is a spontaneous report from a contactable other hcp (Nurse) (patient). A 35-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration, administered in arm left on 23Feb2021 16:30 (at the age of 35-year-old) at dose 1, single for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. Other medications in two weeks: Sprinters. Patient had no known allergies. Patient did not have other vaccine in four weeks. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. On 24Feb2021 16:00 the patient experienced severe arm pain, numbness and tingling in left arm, night chill/sweats, fever 100.1, headache, feeling unwell. The patient underwent lab tests and procedures which included fever: 100.1 on an unspecified date. Patient did not receive treatment for the adverse events. Outcome of the events was not resolved.   Follow-up (25May2021): Follow-up attempts completed. No further information expected
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspepsia, Fatigue, Hypertension
Clinical narrative: Nausea all the day; Tiredness; chills evening; severe heartburn; High Blood Pressure; vertigo when got out of Bed; Joint pain in shoulder; This is a spontaneous report from a contactable consumer or other non hcp. A 69-year-old female non pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 19Feb2021 17:00 (age at vaccination 69-year-old, Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hepatitis C (recovered), cholelithiasis from an unknown date and unknown if ongoing. Concomitant medications included colecalciferol, menaquinone-7 (VITAMIN D3 K2) and ubidecarenone (COQ 10) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. It was reported that facility type vaccine was hospital and no other vaccine in four weeks. No COVID prior vaccination and no COVID tested post vaccination. On 19Feb2021, the patient experienced joint pain in shoulder above the injection (adverse event Day1). Next morning she had vertigo when got out of bed on 20Feb2021. On 21Feb2021 (Day 3) she had high blood pressure. On 22Feb2021 (Day 4), she had vertigo in morning /high blood pressure and severe heartburn in evening. On 23Feb2021 (Day 5), she had nausea all day and tiredness and chills evening. It was reported that on day 6, she had tiredness and some chills. Patient not received treatment. The outcome of all events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: Nausea all the day; Tiredness; chills evening; severe heartburn; High Blood Pressure; vertigo when got out of Bed; Joint pain in shoulder; This is a spontaneous report from a contactable consumer or other non hcp. A 69-year-old female non pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 19Feb2021 17:00 (age at vaccination 69-year-old, Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hepatitis C (recovered), cholelithiasis from an unknown date and unknown if ongoing. Concomitant medications included colecalciferol, menaquinone-7 (VITAMIN D3 K2) and ubidecarenone (COQ 10) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. It was reported that facility type vaccine was hospital and no other vaccine in four weeks. No COVID prior vaccination and no COVID tested post vaccination. On 19Feb2021, the patient experienced joint pain in shoulder above the injection (adverse event Day1). Next morning she had vertigo when got out of bed on 20Feb2021. On 21Feb2021 (Day 3) she had high blood pressure. On 22Feb2021 (Day 4), she had vertigo in morning /high blood pressure and severe heartburn in evening. On 23Feb2021 (Day 5), she had nausea all day and tiredness and chills evening. It was reported that on day 6, she had tiredness and some chills. Patient not received treatment. The outcome of all events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Oral herpes, Vaccination site pain
Clinical narrative: Cold sore on my upper lip; Injection site soreness; Migraine; Headache; This is a spontaneous report from a contactable consumer (patient herself). A 52-years-old non-pregnant female patient received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:30 (at age of 52-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. No medical history and concomitant medications were reported. Patient had not known allergies. Other medical history was no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Feb2021 21:30 the patient experienced injection site soreness, migraine and headache while patient experienced cold sore on my upper lip on 23Feb2021. Patient did not receive any treatment for AEs. Since the vaccination, patient has not been tested for COVID-19. The outcome of all events was recovering.  Information about lot batch requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pruritus, Vaccination site swelling
Clinical narrative: Itching; Swelling of injection site; Sore throat; This is a spontaneous report from a contactable other hcp (patient). A 35-years-old female (non pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3248 and Expiration Date was not reported), via an unspecified route of administration administered in Arm Left on 18Jan2021 as dose 2, single for COVID-19 immunization. Medical history included , food allergy from an unknown date and unknown if ongoing Verbatim known allergies: Almonds , arthropod sting from an unknown date and unknown if ongoing Verbatim known allergies: bee stings , glucose tolerance impaired from an unknown date and unknown if ongoing other medical history : Pre-diabetes. The patient's concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL0140 and Expiration Date was not reported), via an unspecified route of administration administered in Arm Left on 26Dec2020 as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. Post vaccination the patient was not tested for COVID 19. On 18Jan2021, the patient experienced itching, swelling of injection site and sore throat. Patient received treatment of Ibuprofen for adverse events.The outcome of the events was recovered in 2021.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: Red itchy sore blotch on upper left arm (although not exactly at vaccination site); Red itchy sore blotch on upper left arm (although not exactly at vaccination site); Red itchy sore blotch on upper left arm (although not exactly at vaccination site); This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6203), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:45 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included venlafaxine, glucosamine and multivitamin taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). The patient was not pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (Lot number: EL8982), via an unspecified route of administration, administered in Right arm on 01Feb2021 11:45 AM for COVID-19 immunization. The patient did not receive any other vaccines in 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Patient did not know about known allergies. Facility where COVID-19 vaccine was administered at Doctor office/urgent care. On 23Feb2021 22:00, patient experienced red itchy sore blotch on upper left arm (although not exactly at vaccination site). There was no treatment for the events. The clinical outcome of events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dizziness, Hot flush, Nausea, Paraesthesia
Clinical narrative: tightness in face; saliva glands ached; prickly sensation; slight "asthma-like" breathing; hot flash lasting 20 min; dizziness; nausea upon standing; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 24Feb2021 at 09:30 am (Batch/Lot Number: EN6203) as dose 1, single for covid-19 immunization (at the age of 53-years-old). Medical history included diabetes, HBP (high blood pressure) and heart murmur from an unknown date and unknown if ongoing. Patient had known allergies to BHT/BHA preservatives. Concomitant medication(s) included metformin; amlodipine and furosemide all were taken for an unspecified indication, start and stop date were not reported. Patient had not received any other vaccine in four weeks. Patient had no if covid prior vaccination. Patient had not tested for covid post vaccination. Facility type vaccine was reported as other. It was reported that after receiving the dose of vaccine on 24Feb2021 at 10:00 pm the patient experienced tightness in face, saliva glands ached, prickly sensation, slight "asthma-like" breathing, hot flash lasting 20 min, dizziness and nausea upon standing. Patient had not received any treatment. Patient was recovering from the events at the time of report.   Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Salivary gland pain, Skin tightness
Clinical narrative: tightness in face; saliva glands ached; prickly sensation; slight "asthma-like" breathing; hot flash lasting 20 min; dizziness; nausea upon standing; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 24Feb2021 at 09:30 am (Batch/Lot Number: EN6203) as dose 1, single for covid-19 immunization (at the age of 53-years-old). Medical history included diabetes, HBP (high blood pressure) and heart murmur from an unknown date and unknown if ongoing. Patient had known allergies to BHT/BHA preservatives. Concomitant medication(s) included metformin; amlodipine and furosemide all were taken for an unspecified indication, start and stop date were not reported. Patient had not received any other vaccine in four weeks. Patient had no if covid prior vaccination. Patient had not tested for covid post vaccination. Facility type vaccine was reported as other. It was reported that after receiving the dose of vaccine on 24Feb2021 at 10:00 pm the patient experienced tightness in face, saliva glands ached, prickly sensation, slight "asthma-like" breathing, hot flash lasting 20 min, dizziness and nausea upon standing. Patient had not received any treatment. Patient was recovering from the events at the time of report.   Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Flushing, Headache, Vaccination site pain
Clinical narrative: Headache; severe joint pain; flush face; snow chills; injection site pain; This is a spontaneous report from a contactable consumer. This 49-Year-old female consumer (Patient) reported that:  A 49-years-female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not provided), via an unspecified route of administration, administered on left arm (age at the vaccination was 49 years) on 22Feb2021 02:45 PM at single dose for COVID-19 immunisation. Patient previously had first dose of bnt162b2. Patient medical history included Hypothyroidism, migraines and  knee/foot surgeries. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. Patient concomitant medications included Tylenol, Excedrine and ibuprofen, prescriptions. On 23Feb2021 10:00Am, patient had experienced headache, severe joint pain, flush face, snow chills and injection site pain (Vaccination site pain).. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On an unspecified date in 2021, the outcome of the events were recovered.  Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Headache; Injection site pain; tiredness; chills; joint pain; Nausea; feeling unwell; This is a spontaneous report from a contactable consumer(patient) reported that. A 66-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Feb2021 09:00 (Batch/Lot Number: Pfizer Eng201) as DOSE 1 SINGLE for covid-19 immunization(Age at vaccination 66 years). The patient Medical history included compression fracture L1 vertebrae 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. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 22Feb2021, the patient experienced headache, injection site pain, tiredness, chills, joint pain, Nausea and feeling unwell. No treatment was reported. The event outcome was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Headache; Injection site pain; tiredness; chills; joint pain; Nausea; feeling unwell; This is a spontaneous report from a contactable consumer(patient) reported that. A 66-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Feb2021 09:00 (Batch/Lot Number: Pfizer Eng201) as DOSE 1 SINGLE for covid-19 immunization(Age at vaccination 66 years). The patient Medical history included compression fracture L1 vertebrae 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. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 22Feb2021, the patient experienced headache, injection site pain, tiredness, chills, joint pain, Nausea and feeling unwell. No treatment was reported. The event outcome was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Rash, Red ear syndrome
Clinical narrative: ear flap was red and inflamed; ear rash; ear is red and tender. It was on the right at first, but she is seeing it on the left today; This is a spontaneous report from a contactable pharmacist. This female pharmacist reported that:  Patient characteristics: Patient sex: Female  Reaction(s)/Event(s): Reaction/event as reported by primary source: ear rash Reaction/event as reported by primary source: ear flap was red and inflamed Reaction/event as reported by primary source: ear is red and tender Reaction/event as reported by primary source: was on the right at first, but she is seeing it on the left today Reaction/event as reported by primary source: I end up going to ER and they think it could be Vertigo  Drug(s) Information: Characterization of drug role: SUSPECT Proprietary medicinal product name: COVID 19 VACCINE Action taken: Unknown Btch/lot number: Not Provided  Narrative case summary and further information:  Case narrative: Submitted by Call Centre 1 Ref: #; ININ: # Selected Report Type: Initial Is the patient also the reporter? Yes Reporter type: Pharmacist   Dates for ear rash: (From: Unspecified To: Unspecified) Dates for ear flap was red and inflamed: (From: Unspecified To: Unspecified) Dates for ear is red and tender: (From: Unspecified To: Unspecified) Dates for was on the right at first, but she is seeing it on the left today: (From: Unspecified To: Unspecified)  Is Covid-19 vaccine a Pfizer product? Unspecified Covid-19 vaccine manufacturer: Unspecified Dates for Covid-19 vaccine: (Start: Unspecified Stop: Unspecified) NDC number of Covid-19 vaccine: Not Provided  Reason for no lot number: of Covid-19 vaccine: Caller unwilling to complete the report Expiry Date of Covid-19 vaccine: Not Provided Other Products: Not Provided Patient History: Not Provided Investigation Assessment: Not Provided  Additional Context: Caller is a pharmacist that was calling about the Covid-19 vaccine and reported that she took the second dose of the vaccine on Saturday 13Feb2021 and after 2 days she noticed a ear rash and her ear flap was red and inflamed. She stated that her ear is red and tender. It was on the right at first, but she is seeing it on the left today.  Caller asked, has this been a side effect that was reported with the vaccine? Caller declined a safety report at this time as she had a meeting in about 5 minutes from the time of the report.   Information for Lot/Batch number is requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood urine, SARS-CoV-2 test
Clinical narrative: blood in my urine; back pain; This is a spontaneous report from a contactable consumer. A 20-Year-old male patient received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: EN6203, Expiration date: Unknown, Solution for injection), on 22Feb2021 around 10:00Am on left Arm as Dose 2 single for covid 19 immunization (age at vaccination: 20-Year-old). Medical history included IgA Nephropathy. Concomitant medications were reported as unknown. Patient previously received first dose of BNT162B2 (Batch/Lot number: EL9262) around 02:15 PM on left Arm as Dose 1 single for covid 19 immunization on 26Jan2021. The patient had not received any other vaccine in four weeks. The patient had received unspecified other medication in two weeks. The patient had not affected with covid19 before vaccination. On 23Feb2021 (night after patient received second vaccination) around 10:00PM he started to feel some back pain and observed blood in his urine and somewhat unsurprising to him as he had IgA Nephropathy, and such a reaction to a vaccine would make sense within the mechanisms of his condition. However, this was still the first time in about a year that he had experienced these symptoms, and there was not very much information about the potential relationship between the vaccine and this disease on the internet, so it was still a bit shocking, and if he had receive a response from this report he would appreciate any information we have on whether or not similar incidents have occurred in IgA patients. None of the Allergies were reported. No therapeutic treatments were received. It was reported that patient had tested covid after vaccination. On 22Feb2021 the patient laboratorial test included Covid test (Nasal Swab) which had shown negative result. The outcome of the events were reported as unknown.  Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Pain at the injection site-mild; Mild fever; chills; body ache; generalized exhaustion; This is a spontaneous report from a contactable Physician. This 47-year old male Physician(patient) reported.  A 47-years-old male patient received bnt162b2 (BNT162B2, Batch/Lot number was unknown) (Misplaced/discarded) via intramuscular route of administration, administered in Arm Left on 21Jan2021 14:00 as dose 2, single for covid-19 immunisation (age at the vaccination 47 years old). The historical drug bnt162b2 (BNT162B2, Batch/Lot number was unknown) via intramuscular route of administration, administered in Arm Left on 31Dec2020, 09:00 as dose 1, single for covid-19 immunisation. The medical history was no known allergies. and concomitant medication was not reported. The patient experienced pain at the injection site-mild Mild fever, chills, body ache and generalized exhaustion on 22Jan2021 02:00. The patient received the acetaminophen 1 gm oral tablet 24 hours after the vaccination as a treatment. The patient was not covid prior vaccination: and not covid tested post vaccination. Lab data included mild fever on 22Jan2021. The outcome of the events was recovered on an unspecified date in 2021.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Influenza like illness, Musculoskeletal stiffness
Clinical narrative: stiffness in her muscles and chills and aches; stiffness in her muscles and chills and aches; stiffness in her muscles and chills and aches; she felt worse-shaky, icy cold to her bones and tired; temperature - it was 100.8; flu-like symptoms; nausea; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EN6200) via an unspecified route of administration in left arm on 23Feb2021 at 11:45 (at the age of 63-year-old) as single dose for COVID-19 immunization. Medical history of the patient included high blood pressure, obesity, and COVID-19. Patient had no known allergies. Concomitant/other medications in two weeks included acetylsalicylic acid [ASPIRIN], lisinopril dihydrate [Lisinopril 10mg], Fluoxetine 40mg all taken for unspecified indications. Patient did not receive any other vaccine in four weeks of COVID-19 vaccine. Patient had COVID prior vaccination on an unspecified date and was not tested for COVID post vaccination. On 24Feb2021, patient woke up in the morning with stiffness in her muscles and chills and aches, as the day progressed, she felt worse-shaky, icy cold to her bones and tired. Patient came home and slept for a couple of hours and when patient woke up, she took her temperature it was 100.8. She had nausea and flu-like symptoms. Treatment received included Ibuprofen and fluids (self-prescribed). Outcome of the events were not recovered.  Follow-up attempts completed. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: stiffness in her muscles and chills and aches; stiffness in her muscles and chills and aches; stiffness in her muscles and chills and aches; she felt worse-shaky, icy cold to her bones and tired; temperature - it was 100.8; flu-like symptoms; nausea; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EN6200) via an unspecified route of administration in left arm on 23Feb2021 at 11:45 (at the age of 63-year-old) as single dose for COVID-19 immunization. Medical history of the patient included high blood pressure, obesity, and COVID-19. Patient had no known allergies. Concomitant/other medications in two weeks included acetylsalicylic acid [ASPIRIN], lisinopril dihydrate [Lisinopril 10mg], Fluoxetine 40mg all taken for unspecified indications. Patient did not receive any other vaccine in four weeks of COVID-19 vaccine. Patient had COVID prior vaccination on an unspecified date and was not tested for COVID post vaccination. On 24Feb2021, patient woke up in the morning with stiffness in her muscles and chills and aches, as the day progressed, she felt worse-shaky, icy cold to her bones and tired. Patient came home and slept for a couple of hours and when patient woke up, she took her temperature it was 100.8. She had nausea and flu-like symptoms. Treatment received included Ibuprofen and fluids (self-prescribed). Outcome of the events were not recovered.  Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: Rash on neck and shoulders; This is a spontaneous report from a contactable other health professional (patient). A 24-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via intramuscular route of administration, administered in Arm Right on 05Jan2021 14:00 (at the age of 24 years old) as dose number unknown, single for COVID-19 immunisation at nursing home. Medical history included COVID-19 from an unknown date and unknown if ongoing (COVID prior vaccination: Yes). Concomitant medications within two weeks included birth control. Patient did not received other vaccine within four weeks of COVID vaccine. Patient have COVID prior to vaccination. The patient experienced rash on neck and shoulders on 2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient tested for COVID post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown on 2021. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: Facial swelling; swelling in sinus area; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6198), via an unspecified route of administration in arm left on 18Feb2021 at 09:00 (at the age of 68-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included hypertension, lumpectomy in right breast and breathing difficulty. The patient had allergies. The concomitant medications of the patient included fluticasone propionate (FLONASE) taken for hypersensitivity, dyspnoea 2 sprays each nostril daily, from Apr2019 and ongoing, furosemide (FUROSEMIDE) 40mg daily taken for an unspecified indication from 2010 and ongoing, letrozole (LETROZOLE) 2.5 mg daily taken for breast conserving surgery from Jul2019 and ongoing, losartan potassium (LOSARTAN POTASSIUM) 50mg daily taken for hypertension from Oct2020 and ongoing and metoprolol (METOPROLOL) 100mg daily taken for hypertension from 2010 and ongoing. The patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9262), via an unspecified route of administration in arm left on 28Jan2021 (at the age of 68-years-old) as single dose for COVID-19 immunisation. The prior vaccinations and relevant tests were reported as none. On 18Feb2021, the patient experienced facial swelling and swelling in sinus area. The patient reported she received the vaccine around 9:00am that morning. She came home around 1:30-2:00pm. She felt like her face was reacting like it was swelling. She typically uses Flonase daily. She called the doctor to ask if it is ok for her to take it. She is unsure if she should use the spray. She asked can she take Benadryl or Flonase to get relief in that area. The outcome of the events was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: my arm started turning red, swollen; very painful; itchy; feverish; allergic reaction; my arm started turning red, swollen; This is a spontaneous report from a contactable consumer. A 78-years-old non-pregnant Female patient received second dose of BNT162B2, (formulation: Solution for injection, Lot Number: Phizer, EN5378), via an unspecified route of administration, administered in Arm Left on 20Feb2021 at 11:00 as dose 2, single for covid-19 immunization. Medical history included drug hypersensitivity (sulfa drugs). The patient previously took zofran [ondansetron] and experienced drug hypersensitivity, monosodium glutamate and experienced drug hypersensitivity. The patient previously had tetanus vaccine and experienced hypersensitivity. Concomitant medications received in two weeks included naproxen sodium (ALEVE). There were no other vaccine in four weeks. The patient did not had Covid prior vaccination and did not tested for Covid post vaccination. The patient previously received first dose of BNT162B2, (formulation: Solution for injection, Lot Number: EL3245), via an unspecified route of administration, administered in Arm Right on 28Jan2021at 14:00 as dose 1, single for covid-19 immunization. On 21Feb2021 at 13:00, the patient experienced her arm started turning red, swollen, very painful, itchy, feverish and allergic reaction. It was reported that the day after the shot on Feb20, her arm started turning red, swollen, very painful, itchy, and feverish in a circle around the injection site in a 4 and 3/ 4inch diameter circle. The only relief night or day was when she had an ice pack on it. She could just sleep in short naps for the next 3 nights. The patient feared it to be infected, but as the edges of the area are lightening, it could be an allergic reaction. Cortisone cream did not help. She made numerous calls but was not able to get an appointment to be seen right away even virtually; and since it was improving, she will probably quit trying, Just wanted Pfizer to be aware this can happen and to alert those health professionals involved as to the possibility of this and how to advise patients. The events very painful, feverish and allergic reaction were not treated. The patient was recovering from all events.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: my arm started turning red, swollen; very painful; itchy; feverish; allergic reaction; my arm started turning red, swollen; This is a spontaneous report from a contactable consumer. A 78-years-old non-pregnant Female patient received second dose of BNT162B2, (formulation: Solution for injection, Lot Number: Phizer, EN5378), via an unspecified route of administration, administered in Arm Left on 20Feb2021 at 11:00 as dose 2, single for covid-19 immunization. Medical history included drug hypersensitivity (sulfa drugs). The patient previously took zofran [ondansetron] and experienced drug hypersensitivity, monosodium glutamate and experienced drug hypersensitivity. The patient previously had tetanus vaccine and experienced hypersensitivity. Concomitant medications received in two weeks included naproxen sodium (ALEVE). There were no other vaccine in four weeks. The patient did not had Covid prior vaccination and did not tested for Covid post vaccination. The patient previously received first dose of BNT162B2, (formulation: Solution for injection, Lot Number: EL3245), via an unspecified route of administration, administered in Arm Right on 28Jan2021at 14:00 as dose 1, single for covid-19 immunization. On 21Feb2021 at 13:00, the patient experienced her arm started turning red, swollen, very painful, itchy, feverish and allergic reaction. It was reported that the day after the shot on Feb20, her arm started turning red, swollen, very painful, itchy, and feverish in a circle around the injection site in a 4 and 3/ 4inch diameter circle. The only relief night or day was when she had an ice pack on it. She could just sleep in short naps for the next 3 nights. The patient feared it to be infected, but as the edges of the area are lightening, it could be an allergic reaction. Cortisone cream did not help. She made numerous calls but was not able to get an appointment to be seen right away even virtually; and since it was improving, she will probably quit trying, Just wanted Pfizer to be aware this can happen and to alert those health professionals involved as to the possibility of this and how to advise patients. The events very painful, feverish and allergic reaction were not treated. The patient was recovering from all events.  Follow-up attempts completed. No further information expected.