chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Energy increased
Clinical narrative: all of a sudden she has energy and reports, "it feels like they shot me up with steroids or something."; This is a spontaneous report from a contactable consumer (patient). A female patient of age 81 (units not provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller stated she received the second dose of the Covid vaccine on Sunday (unspecified date) and reported not experiencing any side effects, absolutely no reactions whatsoever. She touched the area where the injection was given and nothing, no pain, no hurt. Caller stated all of a sudden, she had energy and reported: it feels like they shot me up with steroids or something. Caller also asked if Pfizer Covid vaccine was stored in the freezer. She stated, when it was out of the freezer, as she assumed it has a life of it was own and it was perfectly fine to give. Caller reported not seeing any freezers at her vaccination center in the mall. The outcome of event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Hypertension
Clinical narrative: This is a spontaneous report from a contactable consumer reported for mother and contactable consumer reported for herself. A 93-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9267; Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 12Feb2021 14:00 (at the age of 93-years-old) as DOSE 2, SINGLE for covid-19 immunisation at other facility. Patient was not pregnant at the time of vaccination. Medical history included high blood pressure, acid reflux disease from an unknown date and unknown if ongoing. Concomitant medication(s) included valsartan (VALSARTAN); omeprazole (OMEPRAZOLE); calcium (CALCIUM); colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient previously took CLEOCIN [CLINDAMYCIN HYDROCHLORIDE] and experienced allergy. The patient previously took first dose of BNT162B2 (Batch/Lot number: EL3247) in right arm on 22Jan2021 16:30 (at the age of 93-years-old) for covid-19 immunisation and experienced feeling washed out. The patient experienced high blood pressure, feeling very washed out as well on unspecified date in Feb2021. The patient underwent lab tests and procedures which included blood pressure measurement: 171/91. The event was stated as not serious. Three days after the second injection her blood pressure spiked on 16Feb2021 (reported as today) at 171/91 and feeling very washed out as well. No other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Clinical outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Nausea
Clinical narrative: Nausea; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201, Expiration date: 31Mar2021), via an unspecified route on 15Feb2021 (at the age of 64-years) as dose 1, single for covid-19 immunisation. The patient medical history included breast cancer, cholesterol from an unknown date and unknown if ongoing. The patient concomitant medications included Atorvastatin 40 mg for cholesterol, Tamoxifen, calcium carbonate (CALTRATE) from an unknown date and unknown if ongoing. On unspecified date, the patient experienced nausea. Patient stated, "I woke up with it, actually it woke me up, I am too nauseous to eat anything, I am just restricting my water. I had several Lab test, everything was normal." The outcome of the event was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Achy; headache; sore arm; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 16Feb2021 at 11:30 hours as dose 2, single (at the age of 62-years-old) for COVID-19 immunisation. Patient had no relevant medical history and had no known allergies. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 27Jan2021 as dose 1, single (at the age of 62-years-old) for COVID-19 immunisation. Concomitant medication(s) included levothyroxine sodium (Synthroid) taken for an unspecified indication, start and stop date were not reported. Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID -19 prior to vaccination and had not been tested for COVID-19, post vaccination. On 16Feb2021 at 20:00 hours, patient experienced achy, headache and sore arm. Patient received no treatment for the events. The outcome of all the events was recovering.   Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot number: not provided, expiration date not provided), via unknown route of administration, administered on an unknown date, as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medication was not provided. On an unknown date, following the 1st dose, the patient experienced arm soreness. Outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient's wife).  A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on 16Feb2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Feb2021, the patient experienced dizziness and has been lying in bed. The reporter stated that she was calling for her husband. He received the vaccine Tuesday 16Feb2021 and was experiencing dizziness and has been lying in bed. The reporter enquired, how long are these symptoms supposed to last. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Urine output decreased
Clinical narrative: Diminished urine output even after regular water in take; diarrhea; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm left on 16Feb2021 at 18:00 (lot number: EN6200) (age at vaccination 70-year-old) as dose 2, single dose for COVID-19 immunization. The patient medical history included hypertension, chronic venous insufficiency from an unknown date and unknown if ongoing and 2 replaced hips hysterectomy on an unknown date. The patient concomitant medications included Norvasc, Famotidine 81mg and aspirin.The patient had known allergies with oxycontin from an unknown date and unknown if ongoing. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route at left arm on 26Jan2021 at 06:00 pm (lot number: EL9264) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had diminished urine output even after regular water in take and diarrhea 17Feb2021 at 11:00 am. The patient did not receive any treatment to the events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Sore arm - could not lift/moved stiffly rest of day after shot; Headaches - more than normal to occur for me; Exhaustion - plain and simple; Sore arm - could not lift/moved stiffly rest of day after shot; This is a spontaneous report from a contactable consumer (patient). A 28-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN 5318 and expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 26Jan2021 08:15 (Age at vaccination was 28 years) as dose 1 single for COVID-19 immunization. Medical history included irritable bowel syndrome (IBS), drug hypersensitivity (Allergies to medications), food allergy from (Allergies to food) all an unknown date and unknown if ongoing. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT); trazodone (TRAZODONE); ethinylestradiol, norgestimate (TRI FEMYNOR); loratadine (CLARITINE); cyanocobalamin (B12-VITAMIIN); colecalciferol (D3) all taken for an unspecified indication, start and stop date were not reported. The patient previously took zithromax and experienced hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 26Jan2021 09:00, the patient experienced sore arm - could not lift/moved stiffly rest of day after shot, headaches - more than normal to occur for me, exhaustion - plain and simple. Patient did not received any treatment for the adverse event. Since the vaccination, patient not tested for COVID-19. The Outcome for the events Sore arm - could not lift/moved stiffly rest of day after shot and Headaches - more than normal to occur for me was recovering and the event Exhaustion - plain and simple was recovered in 2021.     Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: large swollen area that turned red and hot below the injection site.; Right arm got sore and stiff; Right arm got sore and stiff; large swollen area that turned red and hot below the injection site.; large swollen area that turned red and hot below the injection site.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9809) via an unspecified route of administration, administered in Arm Right on 11Feb2021 10:30 (at the age of 69-year-old) as single dose for COVID-19 immunization. The Patient had no relevant medical history and had no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), omeprazole, azelastine taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL8982) via an unspecified route of administration, administered in Arm Left on 21Jan2021 11:30 AM (at the age of 69-year-old) as single dose for COVID-19 immunization. On 12Feb2021, the patient experienced right arm got sore and stiff and a large swollen area that turned red and hot below the injection site. The patient did not receive any treatment for the events. The patient had not been tested for covid-19 post vaccination. Outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Pain in extremity, SARS-CoV-2 test
Clinical narrative: soreness after the first day with my arm; This is a spontaneous report from Pfizer sponsored program Sup-port via contactable consumer (patient, self-reported). A 76-year-old female received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VAC-CINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date (age at vaccination: 76 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient reported that she received the second dose of the Pfizer BioNTech COVID-19 vaccine 9 days ago and would like to know if she was okay to take Prolia. The patient stated she has not started taking this medication yet as she was supposed to meet with her endocrinologist tomorrow about starting the injections every 6 months and would just like to know if there is any information available before she sees him/her. The patient also mentioned that after her first dose of the vaccine she "had no reaction whatsoever" but then goes on to state that she had "just a little soreness after the first day with her arm" on an unspecified date. The patient stated that she placed ice on the injection site and "after 2 days it didn't bother her." The patient also stated that "with the second shot it only bothered her one day." The patient underwent lab tests and procedure included antibody test and nasal swab test with negative results on an unspecified date. The patient would like to know if she has bloodwork taken after receiving the Pfizer BioNTech COVID-19 vaccine and asked what she should expect. Outcome of the event was un-known.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Influenza like illness
Clinical narrative: Day after 2nd dose vaccination (14Feb2021): slight dizziness, chills, flu-like symptoms.Very tired and required rest. Symptoms lasted approximately 1 day.; Day after 2nd dose vaccination (14Feb2021): slight dizziness, chills, flu-like symptoms.Very tired and required rest. Symptoms lasted approximately 1 day.; Day after 2nd dose vaccination (14Feb2021): slight dizziness, chills, flu-like symptoms.Very tired and required rest. Symptoms lasted approximately 1 day.; Day after 2nd dose vaccination (14Feb2021): slight dizziness, chills, flu-like symptoms.Very tired and required rest. Symptoms lasted approximately 1 day.; This is a spontaneous report from a contactable consumer. A 72-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in right arm on 13Feb2021 (age at vaccination was 72 years) as dose 2, single for COVID-19 immunisation. It was unknown wheatear patient was received other vaccine in four weeks. The patient was currently a non-smoker, but history as a smoker. Other details were reported as unknown. Known allergies were unknown. Concomitant medication were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in right arm on 22Jan2021 (age at vaccination was 72 years) dose 1, single for COVID-19 immunisation. The day after second dose vaccination, on 14Feb2021, the patient experienced slight dizziness, chills, flu like symptoms, very tired and required rest. Symptoms lasted approximately 1 day. No treatment received for adverse event. No COVID prior vaccination and patient was not COVID tested post vaccination. Outcome of the events was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Pain
Clinical narrative: Body aching; Chills; slight headache; Upset stomach; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262), dose 2 via an unspecified route of administration, administered in left arm on 12Feb2021 at 02:30pm (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included A-fib/atrial fibrillation, hypothyroid and known allergies to some cillins use other antibiotics. Concomitant medications included unspecified medications, received in the last two weeks. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3246), dose 1 via an unspecified route of administration, administered in left arm on 22Jan2021, at 02:30 pm (at the age of 73-year-old) as a single dose for COVID-19 immunisation. It has been six days since her second vaccine. She was still having body aching, chills, slight headache, upset stomach on 13Feb2021 at 12:00am. Treatment was not received for the adverse events. Outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my arm is a little sore; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 16Feb2021 as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced arm is a little sore. The patient received 2nd dose and she was experiencing no side effects. The patient stated that she is at the 23rd hour. In fact, the patient felt better than she usually does, her arm is a little sore. The patient said it is about the same as the first time. The patient asked if the shot was good or that he gave me enough. The patient asked if the vaccine was working because she was not experiencing side effects like other people. The reporter asked about a test for antibodies to see if the vaccine is working, referred further about antibody testing. The outcome of the event is unknown.   Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia, Pain
Clinical narrative: Sharp shooting pain; head seems like on nerve; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown, Expiry date: unknown), dose 1 via an unspecified route of administration, administered in left arm on 12Feb2021 13:15 (at the age of 71-year-old) dose 1, single for COVID-19 immunisation at hospital. Medical history included atrial fibrillation, drug hypersensitivity to Sulfa, tetanus, aspartame artificial sweetener. Concomitant medications included verapamil, alprazolam, zinc received within 2 weeks of vaccination. 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 vaccination, the patient had not been tested for COVID-19. On 15Feb2021 12:00, patient experienced sharp shooting pain on certain spot the head seems like on nerve. Had the same pain once when given sulfa drugs. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. The outcome of events was not recovered.    Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous case received from a contactable consumer. A 70-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot/batch number and expiration date were not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient had also administered acetylsalicylic acid (ANACIN 81, formulation: unknown; Lot/batch number were not reported) via an unspecified route of administration on an unspecified date for an unspecified indication. Medical history and concomitant medications were not reported. It was reported that the patient has been non-stop on Anacin. He lives off of Anacin. The caller states maybe 2 or 3 hours after the first shot he had a sore arm but he has had no reactions because he was taking Anacin and had Anacin in his system. She read to not take anything prior to receiving the vaccine and she believes Anacin has aspirin in it. She believes it has aspirin on the bottle. She was just telling him he should not have been taking the Anacin prior to the vaccine. She mentions he was 70 years old. She had no idea if he was on his first bottle or maybe on his bottle when he received the vaccine. The outcome of the event was unknown.  Follow-up attempts are completed. No further information was expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Slight body aches; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 37-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 15Feb2021 at 11:45 am (age at vaccination was 37 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. The patient had known allergy to gluten. Concomitant medications the patient received within two weeks of vaccination included probiotics and vitamins taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 27Jan2021 at 10:30 am (age at vaccination was 37 years) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Feb2021 at 19:00 pm, the patient experienced slight body aches. No treatment was received for the adverse event. The outcome of the event was resolved on an unspecified date in 2021.   Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision starting at 6:30 am 17Feb2021; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 44-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EM9810) via an unspecified route of administration in left arm on 15Feb2021 10:15 (at the age of 44-years-old) as dose 2, single for COVID-19 immunization. Vaccination facility type was reported as Hospital. Patient was not pregnant at the time of vaccination. Patient medical history included known allergies (hypersensitivity). The concomitant medications included levocetirizine dihydrochloride (XYZAL), melatonin, ergocalciferol (VITAMIN D). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 25Jan2021 08:30 as dose 1, single for COVID-19 immunization. The patient experienced blurred vision starting on 17Feb2021 06:30. Therapeutic measures were taken as a result of blurred vision. The adverse events resulted in emergency room/department or urgent care.  The outcome of the event was unknown.     Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy
Clinical narrative: swollen gland under jaw on same side as shot; extremely tired/Less tired; dull headache; lymph nodes in armpit swollen on same side as shot; This is a spontaneous report from a contactable patient (reported herself).  A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: En6201), via unspecified route of administration, in left arm on 13Feb2021 08:45 AM (at the age of 44-year-old) as a dose 1, single for COVID-19 immunization. The patient had a medical history of treatment with high blood pressure and allergy to penicillin. The concomitant medication of the patient in two weeks included atenolol (ATENOLOL), hctz (HCTZ), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and birth control pills. Patient does not receive any other vaccines within 4 weeks, and it was unknown if patient had COVID prior to vaccination. The patient was not tested post COVID vaccination. On 13Feb2021 10:00 AM patient experienced day one and two extremely tired and day 3 less tired and on day one and two dull headache, on day two patient experienced swollen gland under jaw on same side as shot and on day 4 lymph nodes in armpit swollen on same side as shot. The patient does not receive any treatment for the reported events. Outcome for all the events were not recovered. Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Fatigue; chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiry date: unknown, Age at vaccination was 48 years) via an unspecified route of administration, administered in Right arm on 16Feb2021 12:45 PM as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical Vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiry date: unknown, Age at vaccination was 48 years) via an unspecified route of administration, administered in Left arm on 28Jan2021 8.00 AM as dose 1, single for covid-19 immunization. Past drug event includes naproxen sodium due to which patient experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. On 17Feb2021 10:00 am the patient experienced, Fatigue, chills and body aches. The patient did not receive any treatment for the events. Outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 23-year-old (non-pregnant) female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), at the age of 23, via an unspecified route of administration, on Feb 17, 2021, at 06:30 pm, left arm, single dose, for COVID-19 immunisation. The patient medical history not reported. The patient has no known allergies. Concomitant medication included Effexor and Abilify (other medications were received in two weeks). No other vaccine in four weeks. Patient did not have COVID prior to the vaccination, and has not tested for COVID post vaccination. On Feb 17, 2021, at 08:15 pm, patient experienced intense headache. No treatment received for the event. The outcome of the event: recovering. No follow-up attempts possible. Information on lot/batch number cannot be obtained. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Grip strength decreased, Migraine, Muscle tightness, Nausea, Pain
Clinical narrative: severe muscle tension; Extreme pain; numbness in site arm; inability to grip; migraine; moderate nausea; This is a spontaneous report from a contactable other HCP (patient). A 37-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 16Feb2021 at 12:30 (at the age of 37-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccine in 4 weeks. The patient had an allergy of gantricin and milk/soy intolerant. The patient's medical history included chronic bronchitis/pneumonia, asthma, sprained or torn left rotator cuff. Concomitant medication was not reported. On 17Feb2021 at 12:15 the patient experienced severe muscle tension through neck and down to elbow and numbness in site arm, inability to grip objects, migraine, moderate nausea, extreme pain. On an unspecified date, the patient underwent lab tests and procedures which included Extreme pain: 8-9/10. No covid not had prior vaccination, covid test not done post vaccination. The patient was received treatment as Tylenol, ultram, and tizanidine do not help at all and had an Rx for prednisone for a sprained rotator cuff, but have not started and not sure when I can start due to no one knowing an answer with vaccine when I can have it. The outcome of events was not recovered.    Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, Vaccination site hypoaesthesia
Clinical narrative: severe muscle tension; Extreme pain; numbness in site arm; inability to grip; migraine; moderate nausea; This is a spontaneous report from a contactable other HCP (patient). A 37-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 16Feb2021 at 12:30 (at the age of 37-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccine in 4 weeks. The patient had an allergy of gantricin and milk/soy intolerant. The patient's medical history included chronic bronchitis/pneumonia, asthma, sprained or torn left rotator cuff. Concomitant medication was not reported. On 17Feb2021 at 12:15 the patient experienced severe muscle tension through neck and down to elbow and numbness in site arm, inability to grip objects, migraine, moderate nausea, extreme pain. On an unspecified date, the patient underwent lab tests and procedures which included Extreme pain: 8-9/10. No covid not had prior vaccination, covid test not done post vaccination. The patient was received treatment as Tylenol, ultram, and tizanidine do not help at all and had an Rx for prednisone for a sprained rotator cuff, but have not started and not sure when I can start due to no one knowing an answer with vaccine when I can have it. The outcome of events was not recovered.    Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Tinging sensation of lips; This is a spontaneous report from a contactable other hcp (patient's parent). A 39-years-old female patient received bnt162b2 (BNT162B2, Formulation: solution for injection; Lot Number: EL3246; expiry date: unknown) via intramuscular route, administered in Left deltoid muscle of arm on 04Jan2021 10:00 as dose1, single (at the age of 39 years) for COVID-19 immunization. Medical history included seasonal allergies, burning and itchiness when using latex condoms or latex gloves from an unknown date and unknown if ongoing, got welts on skin when getting henna tattoo from an unknown date and unknown if ongoing, chemical allergy from an unknown date and unknown if ongoing, environmental allergy from an unknown date and unknown if ongoing, corticosteroid allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Zyrtec10mg every night, for the last past year. The patient did not receive any vaccines for any other condition prior to the event. The patient did not receive any recent vaccines for SARS-COV2 other than PFIZER COVID19 vaccine prior to event. The patient did not receive any other vaccines around the time of PFIZER COVID-19 vaccination. On 04Jan2021, experienced lip tingling 20 minutes after getting the first dose this lasted 40 minutes. The outcome of the events was recovered on 04Jan2021.   Follow-up attempts completed. No further information expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysphagia, Investigation, Pain, Tonsillar hypertrophy
Clinical narrative: having some trouble swallowing; aches; something to do with my tonsils. I hesitate to say they are enlarged as I went to urgent care; chills; This is a spontaneous case received from a contactable consumer (patient). A 22-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot/batch number was not reported) via an unspecified route of administration in left arm on 12Feb2021 14:00 (age at vaccination 22-year-old and patient was not pregnant at the time of vaccination) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient past drug event included known allergies to ceftriaxone. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. Other vaccine in four weeks was reported as none. On 12Feb2021 20:00, the patient stated that she noticed she was having some trouble swallowing. This was also about the time other side effects (aches, chills) began setting in but those all subsided within 24 hours. The swallowing problem had persisted. It was hard to explain the exact feeling but she cannot always swallow on command. She does not had a sore throat, but she does think it could have something to do with her tonsils. She hesitates to say they are enlarged as she went to urgent care on 16Feb. The patient underwent procedure which included throat and lymph nodes were checked and results was normal. The patient did not have COVID prior vaccination. COVID tested post vaccination was reported as none. AE resulted in emergency room/department or urgent care. No treatment was received for the adverse events. Outcome of the event was recovered for aches and chills 2021 and not recovered for other events.  Follow-up attempts are completed. No further information was expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: headache; fatigue; body aches; This is a spontaneous report from a contactable consumer (patient himself) via COVAES. A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in arm left on 17Feb2021 13:00 as dose 2, single for COVID-19 immunisation (at the age of 60-year-old). Medical history included stage 0 CLL. Concomitant medications included vitamin d [vitamin d nos], ubidecarenone (COQ10 [UBIDECARENONE]), cyanocobalamin (VIT B12), atorvastatin (LIPITOR [ATORVASTATIN]), diclofenac, minerals nos and vitamins nos (CENTRUM [MINERALS NOS; VITAMINS NOS]). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in arm left on 27Jan2021 13:015 as dose 1, single for COVID-19 immunisation. The patient previously also took doxycycline, tetracycline and experienced known allergies. The patient did not take any other vaccine in four weeks. The patient did not have COVID prior vaccination and not tested for COVID post vaccination. On 18Feb2021 04:30, the patient experienced headache, fatigue and body aches. Timeframe between vaccination and starting of symptoms was 15 hrs 30 min. The patient did not receive any treatment for adverse events. The outcome of the events was not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Muscle spasms, Muscle twitching
Clinical narrative: Intermittent: facial twitching, eyes twitching, 2 fingers of right hand involuntarily moving and twitching, nerves jumping in legs; Intermittent: 2 fingers of right hand involuntarily moving and twitching; Intermittent: toes twitching and spasms; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 74-year-old non pregnant female patient received bnt162b2 (BNT162B2 formulation; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 (Batch/Lot Number: EM9809) as DOSE 1, SINGLE (at the age of 74-year-old) for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included SVT (supraventricular tachycardia), A-Fib (atrial fibrillation), Hashimotos disease, Fuchs corneal dystrophy, asthma and Known allergies to shellfish from an unknown date and unknown if ongoing. The patient not diagnosed with COVID prior to vaccination. Concomitant medications included montelukast sodium (SINGULAIR), apixaban (ELIQUIS), d-mannose (D-MANNOSE) and fish oil (FISH OIL) all concomitant's taken for an unspecified indication, start and stop date were not reported. The patient previously took bactrim and experienced Known allergies. The patient did not receive any other vaccine in four weeks. The patient had Intermittent: facial twitching, eyes twitching ,2 fingers of right hand involuntarily moving and twitching, toes twitching and spasms, nerves jumping in legs on 08Feb2021. The patient not tested for COVID post vaccination. No treatment received for events. The outcome of events reported as not recovered.   Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm; headache; chills; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 24-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247) (at the age of 24-years-old), via an unspecified route of administration, administration on left arm on 16Feb2021 16.00 as dose 2, single for covid-19 immunization. Patient had no known allergies and no relevant medical history. The patient concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), dose 1, on 26Jan2021 for covid-19 immunization. The patient was not pregnant. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experiencing sore arm, headache, chills and fatigue on 17Feb2021. The outcome of the events was recovered on an unspecified date 2021.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Exactly 8 hours after the injection I had an acute attack of gout.  This is day 8.  I did nothing to provoke it.  None in months.; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269, Expiry date was not reported), via an unspecified route of administration on 10Feb2021 11:15 (at the age of 69-years-old) in Arm Left as dose 1, single for COVID-19 immunization. The Patient Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medications included amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported. The Patient had no known allergies. The patient had not received other vaccine in 4 weeks. The Patient had not diagnosed with COVID-19 prior to vaccination and the patient had not tested for COVID-19 post vaccination. On 10Feb2021 18:00, the patient experienced exactly 8 hours after the injection she had an acute attack of gout and this is day 8. She did nothing to provoke it and none in months. The Patient received treatment for the adverse event was unknown. The outcome for the event was recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Dizziness
Clinical narrative: She has had trouble with her bowels, she's "pretty constipated"; She felt "lightheaded" the day after the second dose; This is a spontaneous report from a non-contactable consumer (patient herself). A female patient of unspecified age received BNT162b2 (COMIRNATY, Formulation: solution for injection, Batch/lot number: not reported, Expiry date: Not reported), via an unspecified route of administration on 15Feb2021 as dose 2, single for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. Patient had no known allergies. The patient previously received first dose of BNT162b2 (COMIRNATY, Formulation: solution for injection, Batch/lot number: not reported, Expiry date: Not reported), via an unspecified route of administration on 25Jan2021 as dose 1, single for COVID-19 immunisation. Patient felt "lightheaded" the day after the second dose. She has had trouble with her bowels, she's "pretty constipated", so her doctor relayed to her that she could use the laxative Miralax, she already took it. She also mentioned she is taking all her other medicines, did not specify which. She stated that her symptoms were not related to the vaccine, she has always had them, and she just wanted to know if she could take a laxative. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder
Clinical narrative: During her 15 minute waiting period after the injection, the patient began to experience right eye drooping; This is a spontaneous report from a non-contactable other healthcare professional. A 80-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6201, expiration date: not reported), via intramuscular route, administered in left arm on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: not reported) as dose 1 on unknown date for covid-19 immunization. On an unknown date, during her 15-minute waiting period after the injection, the patient began to experience right eye drooping. The patient denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient to follow up with PCP/new PCP if her blood pressure at home continues to be elevated greater than 140/90. Patient was stable on the day of reporting and was feeling good. Patient did well on her ambulation without stopping. The outcome of event was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Chills; achiness; Fever; tiredness; Sore throat; This is a follow up spontaneous report from a Pfizer-sponsored program. A contactable 91-Year-old female consumer reported.  A 91-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9264), dose 1 via an unspecified route of administration, administered in Arm Right on 31Jan2021 10:38 as dose 1, single for COVID-19 immunization. Medical history was not reported. Concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. No additional vaccines administered on same date of the Pfizer suspect. No adverse event following prior vaccinations. It was reported that the patient reported some side effects after receiving the first dose of the vaccine. The side effects included Chills, achiness, Fever, tiredness and Sore throat on 01Feb2021. The patient reported that the fever was sporadic and low grade. The patient asked if the patient could take Benadryl or Tylenol before the second shot, because she had reaction to most medication and usually took Benadryl, mostly before antibiotics. The second shot is due on 22Feb2021 at 1:45pm. The events did not result in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date. Therapeutic measures included Tylenol after a week for the reported events. Outcome of the events Chills, achiness, Fever, tiredness and Sore throat was reported as recovered on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.