chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain, Pyrexia
Clinical narrative: severe diarrhea; fever; Chills; Achy; This is a spontaneous report from a contactable other hcp. A 65-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EL3248), dose 2 via an unspecified route of administration, administered in Arm Right on 24Jan2021 08:20 as DOSE 2, SINGLE for covid-19 immunisation (at the age of 65 years). The patient medical history and concomitant medications were not provided. The patient previously received first dose of bnt162b2 on 02Jan2021 for covid-19 immunisation and experienced severe diarrhea. On 25Jan2021 patient experienced achy, 100.5 fever, chills. On 27Jan2021 at 08:00 experienced Severe diarrhea. Patient did not required visit to Emergency room/Physician office. Patient did not receive treatment medication. The patient underwent lab tests and procedures which included pyrexia: 100.5 on 25Jan2021. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Haematuria
Clinical narrative: had blood on the urine; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported that a 92-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 20Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Onan unspecified date, the patient experienced had blood on the urine. It was reported that reporter got the first dose yesterday together with elderly couple. She helped them to get the vaccine since they were of old age. The wife had blood on the urine, after the same dose. The outcome of event was unknown.   Information of lot and batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives; Itching; This is a spontaneous report received from a contactable consumer (Patient). A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9265), Solution for injection, via an unspecified route of administration on 26Jan2021 11:10 (at the age of 75-years-old) as single dose for covid-19 immunisation. Medical History (including any illness at time of vaccination) was reported as none. There were no concomitant medications. Patient previously received flu shot in Sep2020. No additional vaccines administered on same date of the Pfizer suspect. Patient did not receive any vaccine within four weeks of Pfizer vaccine. On 19Feb2021, the patient experienced hives and itching. Patient received the first dose of the Covid-19 vaccine 2 Jan2021. She was scheduled to get the second dose last Tuesday 16Feb2021. It was canceled due to bad weather. She was rescheduled for today. She was having a reaction to something. She cant imagine it would take that long. She had hives and itching. It started on her right arm and is not on her left arm. The itching was not as bad. It was controlled with Benadryl. No relevant test was performed. Patient did not visit emergency Room or physician office. Therapeutic measures were taken as a result of itching. The outcome of event hives was not recovered and itching was recovering.    Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Dizzy; diarrhea; headache; vomiting; fatigue; fever; chills; body aches; muscle aches; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 42-years-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3249), via an unspecified route of administration (at the age of 42-years), administered in arm left on 30Jan2021 at 08:30 as dose 1, single for COVID-19 immunization. Medical history included seizures, asthma, ptsd from an unknown date and unknown if ongoing. There were no concomitant medications. Patient did not have covid prior vaccination. The patient have known allergies. The patient did not received any other vaccine in four weeks. On 30Jan2021 at 10:00, the patient experienced dizzy, diarrhea, headache, vomiting, fatigue, fever, chills, body aches and muscle aches. The treatment was received for all the adverse events. The adverse events resulted in physician office visit. The patient underwent lab tests and procedures which included Covid-19 test: negative Nasal Swab on 03Feb2021. The clinical outcome for the events was reported as recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Dizzy; diarrhea; headache; vomiting; fatigue; fever; chills; body aches; muscle aches; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 42-years-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3249), via an unspecified route of administration (at the age of 42-years), administered in arm left on 30Jan2021 at 08:30 as dose 1, single for COVID-19 immunization. Medical history included seizures, asthma, ptsd from an unknown date and unknown if ongoing. There were no concomitant medications. Patient did not have covid prior vaccination. The patient have known allergies. The patient did not received any other vaccine in four weeks. On 30Jan2021 at 10:00, the patient experienced dizzy, diarrhea, headache, vomiting, fatigue, fever, chills, body aches and muscle aches. The treatment was received for all the adverse events. The adverse events resulted in physician office visit. The patient underwent lab tests and procedures which included Covid-19 test: negative Nasal Swab on 03Feb2021. The clinical outcome for the events was reported as recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swelling of lower eyelids, cheeks and nose; This is a spontaneous report from a contactable physician. A 55-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular route of administration, administered in Arm Left on 20Feb2021 at 15:45 pm (Batch/Lot Number: EL9266) as dose number unknown, single dose for covid-19 immunization (at the age of 55-years-old). Medical history included asthma from an unknown date and unknown if ongoing and had known allergies from an unknown date and unknown if ongoing. Patient had not taken any other vaccine in four weeks and not received other medications in two weeks. The patient's concomitant medications were not reported. Patient had no covid prior vaccination. Patient had not tested for covid post vaccination. It was reported that on 21Feb2021 the patient experienced swelling of lower eyelids, cheeks and nose. Therapeutic measures were taken as a result of swelling of lower eyelids, cheeks and nose with steroids, famotidine and Zyrtec. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient was not recovered from the events.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Delayed body rash on left shoulder, right neck, stomach,waistline; Delayed body rash on left and right arms; This is a spontaneous report from a Non-contactable consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, in left arm on 14Feb2021 15:00 as dose number unknown, single for Covid-19 immunisation. Facility type vaccine was pharmacy or drug store. Patients medical history included thyroid disease from an unspecified date and unknown if ongoing. Concomitant medication included Np Thyroid, taken for unspecified indication, start and stop date not reported (taken in two weeks). Patient was not pregnant at the time of vaccination. No other vaccine in four weeks was administered. On 17Feb2021, patient experienced delayed body rash on left shoulder, left and right arms, right neck, stomach, waistline onset 2 - 3 days after vaccination until present (lasting 5 days at present). No treatment was given as a result of the adverse events. Doctor or other healthcare professional office/clinic visit took pace due to the adverse events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of event was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash erythematous, Rash pruritic
Clinical narrative: "Covid Arm". Swollen, red itchy rash; "Covid Arm". Swollen, red itchy rash; "Covid Arm". Swollen, red itchy rash; This is a spontaneous report from a Non-contactable Consumer or other non-HCP. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 14Feb2021 at 17:45 (Lot Number: EL9269), as DOSE 2, SINGLE for covid-19 immunisation. The patient had no other medical history. The patient had no covid prior vaccination. The patient had no known allergies. Concomitant medication(s) included Simvastatin and Levothyroxine sodium (LEVOTHYROXINE), all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient had not been covid tested post vaccination. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 26Jan2021 at 08:30 AM (Lot Number: EL9262), as single for covid-19 immunisation. On 17Feb2021 at 07:00 AM, the patient experienced "covid arm", swollen, red itchy rash. No treatment was received to treat the events. The patient outcome of the events was resolving at the time of this report.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature fluctuation, Dizziness, Fatigue, Headache
Clinical narrative: joint ache; Vomiting; nausea; headache; fatigue; dizziness; fever; muscle ache; quick change in temperature; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 16Feb2021 at 13:00 hours as dose 2, single (at the age of 30-years-old) for COVID-19 immunisation. Medical history included asthma and depression (both from an unknown date and unknown if ongoing). Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9261 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 26Jan2021 at 13:00 hours as dose 1, single (at the age of 30-years-old) for COVID-19 immunisation and HPV vaccine for immunisation and had allergy to HPV vaccine. 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. The patient previously took codein and experienced allergy to codein. Concomitant medication(s) included ethinylestradiol, ferrous fumarate, norethisterone acetate (Microgestin FE) taken for an unspecified indication, start and stop date were not reported. On 17Feb2021, at 00:00 hours, patient experienced vomiting, nausea, headache, fatigue, dizziness, muscle ache, joint ache, fever and quick change in temperature. Patient had doctor or other healthcare professional office/clinic visit for all the events. Therapeutic measures were taken as a result of all the events treatment included unspecified medication (IV). The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: joint ache; Vomiting; nausea; headache; fatigue; dizziness; fever; muscle ache; quick change in temperature; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 16Feb2021 at 13:00 hours as dose 2, single (at the age of 30-years-old) for COVID-19 immunisation. Medical history included asthma and depression (both from an unknown date and unknown if ongoing). Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9261 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 26Jan2021 at 13:00 hours as dose 1, single (at the age of 30-years-old) for COVID-19 immunisation and HPV vaccine for immunisation and had allergy to HPV vaccine. 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. The patient previously took codein and experienced allergy to codein. Concomitant medication(s) included ethinylestradiol, ferrous fumarate, norethisterone acetate (Microgestin FE) taken for an unspecified indication, start and stop date were not reported. On 17Feb2021, at 00:00 hours, patient experienced vomiting, nausea, headache, fatigue, dizziness, muscle ache, joint ache, fever and quick change in temperature. Patient had doctor or other healthcare professional office/clinic visit for all the events. Therapeutic measures were taken as a result of all the events treatment included unspecified medication (IV). The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: arm is still swollen and red; arm is still swollen and red; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EL9267), dose 1 via an unspecified route of administration, administered in right arm on 10Feb2021 (at the age of 69-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included diabetes mellitus from 1999 to an unknown date. Concomitant medication, not had any other recent vaccinations or started any new medications. Patient said it has been years since patient had any other vaccinations. Patient got first dose on 10Feb and patient was supposed to go back 03Mar. Additional information for other conditions: patient diabetes was under control, it was under 7, it was diagnosed when she got sick because patient son went into the military and they couldn't find him and patient was emotional, patient diabetes was emotional. Investigation assessment: no. The patient experienced arm still swollen and red. Patient would like to know, should patient put ice on it. The outcome of the events were unknown.  Follow-up attempts completed. No further information expected
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen Left Armpit; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date: not reported), via an unspecified route of administration in arm left on 19Feb2021 at 17:30 (at the age of 30-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/ Lot number: unknown, Expiration date: not reported), via an unspecified route of administration in arm left on 29Jan2021 at 16:00 (at the age of 30-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient had no known allergies. Other vaccines in four weeks were reported as no. No covid prior vaccination and no covid tested post vaccination. On 22Feb2021 at 07:00 AM, the patient experienced swollen left armpit. Treatment was not received for the event. The outcome of the event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Dyspnoea, Nausea
Clinical narrative: pain medicine made her nauseous and dizzy; pain medicine made her nauseous and dizzy; back pain under ribs on left side; hard to breath; This is a spontaneous report from a contactable consumer.  A 60-year-old female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6200, Expiration date: unknown), via unspecified route, administered in left arm on 19Feb2021 (at the age of 60-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Foot surgery on 17Feb2021, and concomitant medications were not reported. On 20 feb2021, after the vaccination, the patient States her back has been hurting prior to vaccine because of her foot, but states that was usually her lower back, mid back. States she was not paying much attention to symptoms for aftereffects of the vaccine, states she experienced back pain under her ribs on the left side, same side she received the vaccine. Patient also stated that the pain made it hard to breathe, pain in the ribs is what takes her breath away. Caller states she did not take any pain medicine after her foot surgery on Wednesday, except for the first day. States the pain medicine made her sick, so she just took Ibuprofen.  She States she cannot handle pain medication. This medication was taken prior to the vaccine. States she took it Wednesday night, Thursday morning and Thursday night and then stopped taking it. States she was told not to take Ibuprofen the morning of the shot, she did not take any Friday morning prior to the vaccine. Patient also mentioned pain medicine made her nauseous and dizzy on an unspecified date. The events assessed as non-serious. The outcome of the events backpain and dyspnoea was not recovered and the outcome of nausea and dizziness was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (17May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Oropharyngeal pain, Throat irritation
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional (patient) reporting for herself. A 68-year-old female consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6201, expiration date: unknown), via intramuscularly administered in left upper arm on 19Feb2021 07:30 AM (at the age of 68-years-old) as DOSE 1, SINGLE for covid-19 immunization. Patient medical history included thyroid condition and blood pressure high. Patient declined to report concomitant medications saying she takes a bunch of medicine, is still taking her medications now and sees no change and that here are so many. The patient did not take prior Vaccinations within 4 weeks. No additional vaccines administered on same date of the Pfizer suspect. On 20Feb2021, patient experienced soreness in shoulder, very sore, Itchy throat, and Sore throat. Patient reported soreness in shoulder, very sore, not the first day but the second day, 20Feb2021, and on the second day she had some kind of itchy throat and sore throat. It went away by the evening of 20Feb2021. She woke up with it on the 20Feb2021, used cough drops to soothe her throat. Patient used Ricola herb cough drops with expiration date 16Mar2023 and applied heat to her arm which helped. The outcome of all the events was recovered on 20Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Periorbital swelling, Swelling face
Clinical narrative: left periorbital and eyeball swelling; left periorbital and eyeball swelling; left side facial swelling; This is a spontaneous report from a contactable nurse (patient herself). A 40-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: en9581), via intramuscular route, administered in left arm on 17Feb2021 13:00 (Age at vaccination: 40 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included asthma, Wilms tumor and anxiety. The patient was allergic to clindamycin and adhesive. Concomitant medication(s) included salbutamol (ALBUTEROL) inhaler. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: en5318) via intramuscular route in left arm on an unknown date as DOSE 1, SINGLE. The patient did not have any other vaccine in four weeks. On 18Feb2021 08:00, the patient experienced left side facial swelling. On 22Feb2021 08:00, the patient experienced left periorbital and eyeball swelling. The patient did not receive any treatment for the adverse event. The patient did not have covid before vaccination nor was tested since vaccination. The outcome of all the events was recovered on an unknown date in 2021.   Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: soreness in shoulder and upper arm, only on left side.; soreness in shoulder and upper arm, only on left side.; This is a spontaneous report from a non-contactable consumer or other non-Health Care Professional. A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 14:00 at the age of 31-years-old as DOSE 2, SINGLE for Covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Known allergies included Ciprofloxacin. Concomitant medication(s) included bupropion hydrochloride (WELLBUTRIN),amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); budesonide, formoterol fumarate (SYMBICORT); salbutamol (VENTOLIN [SALBUTAMOL]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. The patient previously took ciprofloxacin and experienced drug hypersensitivity. On 22Feb2021 04:30 the patient experienced soreness in shoulder and upper arm, only on left side. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pruritus, Laboratory test, Respiration abnormal, Swelling face
Clinical narrative: breathing is not as good since getting the vaccine; eyes itching; face turned red and was hot; Facial swelling; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received first dose of bnt162b2 (Pfizer Covid-19 vaccine, Solution for injection, Batch/lot number: EN9581, Expiration date: Unknown), via an unspecified route in the left arm on 06Feb2021 at 09:00 (age at vaccination: 80-year-old), as a single dose for covid-19 immunization. Medical history included hiatal hernia (ongoing), acid reflux (esophageal), blood pressure high, asthma and from 2016 Lyme's disease (ongoing). She went from Aug until Mar before it was discovered. She had to take repeated doses of Doxycycline. She had 5 bands. She still has 2 bands that are not positive. Her immune system shows that she has positive active Lyme's disease. She has 2 bands that are not active. She goes every 6 months and has the bands checked. She has an upcoming appointment scheduled. Patient was allergic to trees, grass, dirt and mold. Concomitant medications included losartan 25mg twice daily started taking in 2010 or 2011, ongoing for Blood pressure high, fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) 200mcg 1 puff daily started taking 3-4 years ago ongoing for asthma, fluticasone propionate (PROAIR) 1-2 puffs 4 times daily as needed ongoing from 2020 for asthma, allergy shots 3 injections monthly for allergy has been receiving for over 5 years, ongoing and omeprazole (PRILOSEC) 3 20mg daily for Acid reflux (esophageal) has been using for 10 years or more. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Feb2021 (day 804), patient experienced a lot of allergies. After receiving the vaccine her eyes were itching, face turned red and was hot. She also had swelling in her face. Her breathing was ok but she was told to go home and take Benadryl. She took it for 3 days. She has asthma. Her face was red, puffy and hot within 15 minutes after getting the vaccine. She had an appointment already scheduled to get an allergy shot the following week. On 07Feb2021 breathing is not as good since getting the vaccine. She uses nasal sprays and other medications for when her breathing is not good. She is scheduled to get the second dose on 01Mar2021. Her daughter doesn't want her to get it. The patient underwent lab test and procedure which included immune system shows that she has positive active Lyme's disease. The clinical outcome of eyes itching was recovered on 06Feb2021, face turned red and was hot was recovered on 07Feb2021, facial swelling was recovered on 08Feb2021, breathing is not as good since getting the vaccine was not recovered  Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: tenderness at the injection site; head to toe full body rash; This is a spontaneous report from a contactable consumer (reported for herself). A 60-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6200/Batch number was not reported), dose 1 via an unspecified route of administration on 16Feb2021 (at the age of 60-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines on the same day of vaccine vaccination. The patient experienced tenderness at the injection site on 17Feb2021 and head to toe full body rash on an unspecified date in 2021. The outcome of the event tenderness at the injection site was resolved on an unspecified date in 2021 and head to toe full body rash was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Condition aggravated, Eructation, Heart rate increased
Clinical narrative: feels like she is having a anxiety attack; belching after she eats; chest is heavy; Nausea; Rapid heart beat; chest is heavy was reported as worsened; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in arm left on 13Feb2021 at 13:13 (at the age of 69-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Concomitant Medications: Patient is on medication but has never had this before. Patient is used to getting vaccines and has never had a problem with a vaccine. The patient did not receive any other vaccines within 4 weeks prior vaccinations. The patient experienced chest is heavy was reported as worsened on an unspecified date in Feb2021; nausea, rapid heartbeat on 14Feb2021; chest is heavy on 17Feb2021; feels like she is having an anxiety attack, belching after she eats on 20Feb2021. The patient did not result in emergency room and physician office visit, but she did call the office. The patient is a consumer that was calling about the Covid-19 vaccine and she reported that she had the first shot on 13Feb2021. Patient said felt fine the whole day, but the next day she a lot of nausea and rapid heartbeat. Patient said that it is like 8 days in, and she still has rapid heartbeat. Patient said that her chest is heavy and she feels like she is having a anxiety attack. Patient called the doctor's office and thought she needed an EKG, she is afraid she is going to have a heart attack. They told her to call Pfizer and then to follow up with them on Wednesday 24Feb2021. Patient said that she wanted to know if she is safe to get the second shot or is it contraindicated. Patient thinks she had Covid in Dec2020, but 3 Covid tests all came back negative. Patient had 3 family members that tested positive when she was sick. Nausea: Patient said that her appetite is kind of screwed up, but has belching after she eats, but is not really nauseous now. Rapid Heartbeat: Patient noticed the rapid heartbeat when she laid down at night, but does not notice that as much now, but she has it all day long and said that it is like a heavy heart. Chest Heaviness: Patient said that she noticed the chest heaviness on Wednesday 17Feb2021. Patient thought at first it was just shallow breathing. Patient 2nd shot is scheduled for 06Mar2021. The patient underwent lab tests and procedures which included COVID tests was negative (3 Covid tests all came back negative). Outcome of the events rapid heartbeat, chest is heavy, feels like she is having a anxiety attack, belching after she eats was not recovered; chest is heavy was reported as worsened was unknown; nausea was recovered on 20Feb2021.  Follow-Up (PRD/SRD 03Apr2021): Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test
Clinical narrative: feels like she is having a anxiety attack; belching after she eats; chest is heavy; Nausea; Rapid heart beat; chest is heavy was reported as worsened; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in arm left on 13Feb2021 at 13:13 (at the age of 69-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Concomitant Medications: Patient is on medication but has never had this before. Patient is used to getting vaccines and has never had a problem with a vaccine. The patient did not receive any other vaccines within 4 weeks prior vaccinations. The patient experienced chest is heavy was reported as worsened on an unspecified date in Feb2021; nausea, rapid heartbeat on 14Feb2021; chest is heavy on 17Feb2021; feels like she is having an anxiety attack, belching after she eats on 20Feb2021. The patient did not result in emergency room and physician office visit, but she did call the office. The patient is a consumer that was calling about the Covid-19 vaccine and she reported that she had the first shot on 13Feb2021. Patient said felt fine the whole day, but the next day she a lot of nausea and rapid heartbeat. Patient said that it is like 8 days in, and she still has rapid heartbeat. Patient said that her chest is heavy and she feels like she is having a anxiety attack. Patient called the doctor's office and thought she needed an EKG, she is afraid she is going to have a heart attack. They told her to call Pfizer and then to follow up with them on Wednesday 24Feb2021. Patient said that she wanted to know if she is safe to get the second shot or is it contraindicated. Patient thinks she had Covid in Dec2020, but 3 Covid tests all came back negative. Patient had 3 family members that tested positive when she was sick. Nausea: Patient said that her appetite is kind of screwed up, but has belching after she eats, but is not really nauseous now. Rapid Heartbeat: Patient noticed the rapid heartbeat when she laid down at night, but does not notice that as much now, but she has it all day long and said that it is like a heavy heart. Chest Heaviness: Patient said that she noticed the chest heaviness on Wednesday 17Feb2021. Patient thought at first it was just shallow breathing. Patient 2nd shot is scheduled for 06Mar2021. The patient underwent lab tests and procedures which included COVID tests was negative (3 Covid tests all came back negative). Outcome of the events rapid heartbeat, chest is heavy, feels like she is having a anxiety attack, belching after she eats was not recovered; chest is heavy was reported as worsened was unknown; nausea was recovered on 20Feb2021.  Follow-Up (PRD/SRD 03Apr2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Myalgia
Clinical narrative: My arm muscle just started, like I tore something, and it hurt and it's sore; My right hip is so hurt so bad and is so sore; Don't feel good; This is a Spontaneous Report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 18Feb2021 as single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) for COVID-19 immunization. On an unspecified date in 2021 patient stated that "I had my second vaccine last Thursday on the 18Feb2021. 2 days ago Sunday, I had a reaction. I guess, I didn't think it was a reaction, I was doing something and suddenly my arm muscle just started, like I tore something, and it hurt and it's sore but I didn't take anything about it. Today I got up and my right hip is so hurt so bad and is so sore that I have to use support to walk. Then I also just don't feel good. Outcome of events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all on her trunk/rash going down her arms/ rash going into her groin area; This is a spontaneous report from a contactable consumer or other non hcp.  A 54-year-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot Number: was not provided) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot Number: was not provided) as single dose for COVID-19 immunisation. On an unspecified date, the patient experienced rash all on her trunk/rash going down her arms/her groin area. Caller stated that she had her second Pfizer dose yesterday and has a rash all on her trunk going down arms into her groin area. She wanted to know if she could take Benadryl or what was suggested. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Erythema, Fatigue
Clinical narrative: dizzy; felt warm; my arm became very sore and red; severe chills; muscle aches; headache; fatigued; my arm became very sore; 102 oral temperature; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN9581) via an unspecified route of administration on 19Feb2021 at 11:15 (at the age of 68-years-old) in right arm as a single dose for covid-19 immunization. Medical history included known allergies from penicillin, sulfa and azithromycin all from an unknown date and unknown if ongoing. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Concomitant medications included losartan (LOSARTAN); fish oil (FISH OIL) and vitamin d3 (VITAMIN D3) all taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number: EL3247) on 29Jan2021 at 11:30 in left arm for covid-19 immunization. On 19Feb2021 at 21:30, ten hours after receiving the vaccine her arm became very sore and red. She also developed severe chills, muscle aches and headache. She felt warm but did not check her temperature. She was also dizzy and fatigued. Over the next 24 hours the symptoms continued with lessening chills and headache. That evening she ran 102 oral temperature. The events were reported as non-serious. By the next morning all symptoms were mostly gone with lingering fatigue for 8 more hours. Her arm stayed sore to touch for 3 more days. The patient underwent lab tests and procedures which included body temperature: 102 on 19Feb2021. The patient did not receive any treatment. By day 3 after vaccine all symptoms were completely resolved in Feb2021.  Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: dizzy; felt warm; my arm became very sore and red; severe chills; muscle aches; headache; fatigued; my arm became very sore; 102 oral temperature; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN9581) via an unspecified route of administration on 19Feb2021 at 11:15 (at the age of 68-years-old) in right arm as a single dose for covid-19 immunization. Medical history included known allergies from penicillin, sulfa and azithromycin all from an unknown date and unknown if ongoing. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Concomitant medications included losartan (LOSARTAN); fish oil (FISH OIL) and vitamin d3 (VITAMIN D3) all taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number: EL3247) on 29Jan2021 at 11:30 in left arm for covid-19 immunization. On 19Feb2021 at 21:30, ten hours after receiving the vaccine her arm became very sore and red. She also developed severe chills, muscle aches and headache. She felt warm but did not check her temperature. She was also dizzy and fatigued. Over the next 24 hours the symptoms continued with lessening chills and headache. That evening she ran 102 oral temperature. The events were reported as non-serious. By the next morning all symptoms were mostly gone with lingering fatigue for 8 more hours. Her arm stayed sore to touch for 3 more days. The patient underwent lab tests and procedures which included body temperature: 102 on 19Feb2021. The patient did not receive any treatment. By day 3 after vaccine all symptoms were completely resolved in Feb2021.  Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blister, Diarrhoea, Erythema, Headache
Clinical narrative: Inflammation in the knuckle/inflammation in the knuckle especially little finger; Redness throughout fingers; Diarrhea; Quesy stomach; Headache; Sore arm; Face had blisters between nose and lips; Blisters on right two fingers; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266, Expiration date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left (upper arm) on 08Feb2021 14:35 (at the age of 70-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient history of all previous immunization with the Pfizer vaccine and any additional vaccines administered on same date of the Pfizer suspect was none reported. Facility where COVID-19 vaccine was administered at clinic. Vaccine was not administered at military facility. Patient prior vaccinations within 4 weeks and adverse events prior vaccinations were none reported. Patient mentioned that she had diarrhea, queasy stomach, headache, sore arm. She also had face blisters between her nose and lips (09Feb2021). She had blisters on her right two fingers (Feb2021). Her pink and ring finger. Her knuckles were inflamed. She had redness throughout her fingers. She was still dealing with the redness throughout fingers. Some of the blisters had popped and she was dealing with the after effect with the open blisters. Face had blisters between nose and lips took ten days for these to heal. They had totally gone away, and she had no effects from these anymore. The blisters on the right two fingers were still there. She started to notice these two days after the shot. At first the area turned red and then it took about three days or so before she started to see a blister on it. It took another couple of days for it to pop. The inflammation in the knuckle especially little finger she was still dealing with. Stated had been staying home the whole year and was thinking would have to get it so everyone could start getting back to a normal life. Did not think it would end without taking the shot. She also mentioned she knows people who had passed away from COVID and thought it was necessary to get the vaccine. Patient did not visit emergency room and physician's office for adverse events. There was no investigation assessment. The clinical outcome of events diarrhea, blisters on right two fingers and inflammation in the knuckle/inflammation in the knuckle especially little finger was not recovered, event quesy stomach, headache was recovered on 12Feb2021, event sore arm recovered on 11Feb2021, event face had blisters between nose and lips was recovered on an unspecified date in Feb2021 and another event outcome was unknown.  Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Inflammation in the knuckle/inflammation in the knuckle especially little finger; Redness throughout fingers; Diarrhea; Quesy stomach; Headache; Sore arm; Face had blisters between nose and lips; Blisters on right two fingers; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266, Expiration date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left (upper arm) on 08Feb2021 14:35 (at the age of 70-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient history of all previous immunization with the Pfizer vaccine and any additional vaccines administered on same date of the Pfizer suspect was none reported. Facility where COVID-19 vaccine was administered at clinic. Vaccine was not administered at military facility. Patient prior vaccinations within 4 weeks and adverse events prior vaccinations were none reported. Patient mentioned that she had diarrhea, queasy stomach, headache, sore arm. She also had face blisters between her nose and lips (09Feb2021). She had blisters on her right two fingers (Feb2021). Her pink and ring finger. Her knuckles were inflamed. She had redness throughout her fingers. She was still dealing with the redness throughout fingers. Some of the blisters had popped and she was dealing with the after effect with the open blisters. Face had blisters between nose and lips took ten days for these to heal. They had totally gone away, and she had no effects from these anymore. The blisters on the right two fingers were still there. She started to notice these two days after the shot. At first the area turned red and then it took about three days or so before she started to see a blister on it. It took another couple of days for it to pop. The inflammation in the knuckle especially little finger she was still dealing with. Stated had been staying home the whole year and was thinking would have to get it so everyone could start getting back to a normal life. Did not think it would end without taking the shot. She also mentioned she knows people who had passed away from COVID and thought it was necessary to get the vaccine. Patient did not visit emergency room and physician's office for adverse events. There was no investigation assessment. The clinical outcome of events diarrhea, blisters on right two fingers and inflammation in the knuckle/inflammation in the knuckle especially little finger was not recovered, event quesy stomach, headache was recovered on 12Feb2021, event sore arm recovered on 11Feb2021, event face had blisters between nose and lips was recovered on an unspecified date in Feb2021 and another event outcome was unknown.  Follow-up attempts completed. No further information expected.