chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Within 4 hours I broke out in hives starting on scalp, then stomach. Next day both legs, then up stomach, include breasts. On arms. On day 3 my upper chest area, up neck and face; This is a spontaneous report received from a contactable Consumer (patient). A 71-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN5318, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 19Feb2021 13:00 (at the age of 71-year-old) as single dose for COVID-19 immunisation. The patient medical history included asthma and Guillain-Barre syndrome (in 1972). The patient had no allergies. Concomitant medication included omeprazole, cetirizine, fluticasone propionate, salmeterol (WIXELA INHUB) and montelukast sodium (SINGULAIR). The patient did not any other vaccine in four weeks. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient reported that she took first dose of COVID vaccine on 19Feb2021 at 13:00 and within 4 hours (at 17:00) she broke out in hives starting on her scalp and then her stomach. Next day both legs, then up her stomach to include her breasts. On her arms and on day 3 my upper chest area up her neck and face. The patient visited the physician office. The patient received Cetirizine 4x day and Pepic 20 mg 4x day as treatment. The outcome of the event was reported as recovering.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hot flush, Lymphadenopathy
Clinical narrative: lymph node swelling in armpit of injected arm; Arm soreness; headache; body exhaustion; chills; hot flashes; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 25-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in arm left on 23Feb2021 at 08:00 as 2nd dose, single for COVID-19 immunization. The patient did not had medical history and no known allergies. The patient's concomitant medications included IUD contraceptive received in two weeks. The patient did not receive other vaccine in four weeks. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in arm left on 04Feb2021 at 08:30 for COVID-19 immunization. On 23Feb2021, the patient experienced lymph node swelling in armpit of injected arm, arm soreness, headache, body exhaustion, chills, hot flashes and muscle aches. The patient did not receive treatment for the adverse events. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: lymph node swelling in armpit of injected arm; Arm soreness; headache; body exhaustion; chills; hot flashes; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 25-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in arm left on 23Feb2021 at 08:00 as 2nd dose, single for COVID-19 immunization. The patient did not had medical history and no known allergies. The patient's concomitant medications included IUD contraceptive received in two weeks. The patient did not receive other vaccine in four weeks. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in arm left on 04Feb2021 at 08:30 for COVID-19 immunization. On 23Feb2021, the patient experienced lymph node swelling in armpit of injected arm, arm soreness, headache, body exhaustion, chills, hot flashes and muscle aches. The patient did not receive treatment for the adverse events. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: bright fluorescent green urine; This is a spontaneous report from a contactable consumer (patient) reporting herself.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 23Feb2021 as a 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient received her first dose of the vaccine yesterday and woke up today (24Feb2021), had bright fluorescent green urine. The patient stated that, she reached out to her healthcare professional and just left providing a urine sample. The patient had asked whether this was a common side effect of the vaccine or not. Enquired that, the caller was asked if Pfizer was still working towards getting approval for the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Headache; injection site pain; This is a spontaneous report from a non-contactable consumer. A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 19Feb2021 12:30 as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose on 29Jan2021, 12:30 PM of BNT162B2 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was Unknown if there were any allergies reported. Patient was not covid prior vaccination. Patient did not tested covid post vaccination. It was unknown if there is any other medical history. The patient experienced headache, and injection site pain on 19Feb2021 14:30. The outcome if event was recovered.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: Neurological effects; This is a spontaneous report from a contactable consumer(patient). A 68-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: El9264) and first dose both via an unspecified route of administration in left arm on 02Feb2021 13:00 at single dose for Covid-19 immunization. Medical history included guillain-barre syndrome. The patient's concomitant medications were not reported. No prior vaccinations within 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient not tested with COVID-19 post vaccination. On 05Feb2021 06:00, the patient experienced neurological effects. Adverse event was resulted in [Doctor or other healthcare professional office/clinic visit]. No treatment was received for the adverse events. The outcome of events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Papule, Rash, Rash pruritic, Vaccination site rash
Clinical narrative: rash on the shoulder where she got vaccinated; rash was itchy, small, red, raised bumps like Eczema; rash was itchy, small, red, raised bumps like Eczema; rash was itchy, small, red, raised bumps like Eczema; rash was spreading like a small circular patch; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 21-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9264, expiration date not reported), dose 1 via an unspecified route of administration, administered in left arm on 19Feb2021, 14:45 (age at the time of vaccination 21-year-old) as 1st dose, single for covid-19 immunization. The patient medical history included, Wolff-Parkinson-white syndrome, Eczema (arms and back of legs), mental health conditions from an unknown date and unknown if ongoing. The patient concomitant medications in two weeks included Lisdexamfetamine mesilate (VYVANSE), Oxcarbazepine (TRILEPTAL), Escitalopram oxalate (LEXAPRO), Trazodone (TRAZODONE). The patient previously took Abilify and experienced Drug hypersensitivity, patient reported that when she first started taking Trileptal, she also had a rash reaction, but not as widespread as this. Patient usually only get eczema on the inside of my arms and back of my legs too. But patient had different reaction with BNT162B2. On 22Feb2021 at 09:00 after the vaccination the patient when she woke up she started to develop a rash on the shoulder where she got vaccinated. It was also on patient left collar a small patch. The rash was itchy, small, red, raised bumps like Eczema. On Wednesday the rash was spread to other parts of the body like chin, on thigh near groin, thigh near knee, further down left arm, and tonight stomach. The rash was spreading like a small circular patch. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not had COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. No treatment was received for the event. The events were not recovered at the time of report.   Follow-up attempts are completed. No further information is expected
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Decreased appetite, Dizziness, Fatigue
Clinical narrative: flu-like symptoms; joint and muscle pain in hips and back of thighs; joint and muscle pain in hips and back of thighs; headache; bodyaches; fever; lack of appetite; fatigue; weakness; light headedness; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EN5318), via an unspecified route of administration on 09Feb2021 (at the age of 65-years) as 1ST DOSE, SINGLE DOSE in Arm Left for covid-19 immunization. Medical history included: known allergies: Minor Adverse reaction to Yellow Fever Vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. Prior to the vaccination the patient was not diagnosed with COVID-19. On 09Feb2021, the patient experienced 5-7 days of flu-like symptoms: headache, bodyaches, fever, lack of appetite, fatigue, weakness, light headedness. Additionally, the patient had 5-7 days of joint and muscle pain in hips and back of thighs interfering with sleep at night. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. On 12Feb2021, post vaccination the patient had nasal swab test (SARS-CoV-2 test) and the result was negative. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia, Pain, Pyrexia
Clinical narrative: flu-like symptoms; joint and muscle pain in hips and back of thighs; joint and muscle pain in hips and back of thighs; headache; bodyaches; fever; lack of appetite; fatigue; weakness; light headedness; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EN5318), via an unspecified route of administration on 09Feb2021 (at the age of 65-years) as 1ST DOSE, SINGLE DOSE in Arm Left for covid-19 immunization. Medical history included: known allergies: Minor Adverse reaction to Yellow Fever Vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. Prior to the vaccination the patient was not diagnosed with COVID-19. On 09Feb2021, the patient experienced 5-7 days of flu-like symptoms: headache, bodyaches, fever, lack of appetite, fatigue, weakness, light headedness. Additionally, the patient had 5-7 days of joint and muscle pain in hips and back of thighs interfering with sleep at night. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. On 12Feb2021, post vaccination the patient had nasal swab test (SARS-CoV-2 test) and the result was negative. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: flu-like symptoms; joint and muscle pain in hips and back of thighs; joint and muscle pain in hips and back of thighs; headache; bodyaches; fever; lack of appetite; fatigue; weakness; light headedness; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EN5318), via an unspecified route of administration on 09Feb2021 (at the age of 65-years) as 1ST DOSE, SINGLE DOSE in Arm Left for covid-19 immunization. Medical history included: known allergies: Minor Adverse reaction to Yellow Fever Vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. Prior to the vaccination the patient was not diagnosed with COVID-19. On 09Feb2021, the patient experienced 5-7 days of flu-like symptoms: headache, bodyaches, fever, lack of appetite, fatigue, weakness, light headedness. Additionally, the patient had 5-7 days of joint and muscle pain in hips and back of thighs interfering with sleep at night. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. On 12Feb2021, post vaccination the patient had nasal swab test (SARS-CoV-2 test) and the result was negative. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Taste disorder, Urticaria
Clinical narrative: I now have a 2" by 4" welt on my arm that is warm to the touch; This was in addition to a small welt I got on my arm a few hours after injection, which lasted 2-3 days; I got a weird taste in my mouth that lasted about 3 days; This is a spontaneous report from a non-contactable consumer (patient). A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown and expiration date was not reported) via an unspecified route of administration in left arm on 10Feb2021 at 14:00 (at age of 42-years-old) as unknown dose, single for covid-19 immunization. Medical history included thalassemia, high blood pressure, allergies to pet dander and pollen. Concomitant medication included lisinopril and ciprofloxacin (CIPRO). Patient did not receive other vaccine in four weeks of vaccination. Patient has not COVID, prior vaccination. Patient has not been tested for COVID, post vaccination.   On 10Feb2021, (almost immediately after injection), got a weird taste in mouth that lasted about 3 days and small welt got on her arm a few hours after injection, which lasted 2-3 days. On 17Feb2021, (day 7 after injection) have a 2" by 4" welt on her arm that was warm to the touch, which she believed called COVID arm. No treatment was received. The outcome of events was resolving.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Urticaria
Clinical narrative: Hives; Chills; sweats; This is a spontaneous report from a contactable consumer.   A 85-years-old elderly male 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 left arm on 01Feb2021 at 12:00 as, single for COVID-19 immunization. Patient's medical history included hay fever and penicillin allergy. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: unknown) on 11Jan2021. Concomitant medications included diltiazem, warfarin and simvastatin for an unspecified indication, start and stop date were not reported. Patient had no COVID-19 infection prior to vaccination and patient was not tested for COVID-19 post vaccination. on 03Feb2021 at 16:00, The patient experienced hives, chills and sweats. He was treated with Ointment and compression hose. Patient was not tested positive for covid post vaccination. The outcome events was reported as recovered.  Information about lot/ batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Feeling abnormal, Musculoskeletal chest pain
Clinical narrative: she doesn't feel good; can't catch her breath; rib cage is kind of sore; Chills; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 23Feb2021 as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 23Feb2021 (last night), patient experienced chills. At 21:30, rib cage was kind of sore. On 24Feb2021 at 21:00, patient can't catch her breath. It was reported that chills stopped last night. Outcome: attempted to capture outcome of chills, unable to confirm if recovered completely or with last effects. The patient stated that they stopped last night, she does not have chills now but she does not feel good. Patient was calling to see what should she do. Should the patient go to a walk in. It was reported that patient handed phone to (name), because she said she had to catch her breath, to provide mailing address who also provided details intermittently during report. However, patient provided most of details during interaction. The patient was calling because she wanted us to advise her on what to do to get relief. She went online for urgent care and could not be seen until 11:00. She was hoping we would be able to get her in at Banner. She mentioned she waited almost an hour to wait to talk. The outcome of the event can't catch her breath was not recovered and outcome of the event chills was recovered and outcome of the others events was unknown.   Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Musculoskeletal stiffness, Neuralgia, Vaccination site pain
Clinical narrative: nerve pain from his ulnar nerve to his elbow and his hand and it came around to his chest, and his chest was on fire and his abdomen and his hip and foot; arm at the injection site was sore; Neck stiff; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262; Expiration Date: 31May2021), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 (at the age of 41-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications was not reported. The reporter said the first day he didn't feel anything. The caller states that on the second day after getting the vaccine, arm at the injection site was sore and neck stiff on 08Feb2021. Caller states that the Tuesday after his vaccine, he was fine most of the day but in the afternoon the patient experienced nerve pain from his ulnar nerve to his elbow and his hand and it came around to his chest, and his chest was on fire and his abdomen and his hip and foot on 09Feb2021. Caller woke up the next day with no pain, but his left arm was weak. Caller states that the day after that, everything seemed fine except whenever he uses his left arm, the triceps and armpit still hurt. Caller was scheduled for his second dose this coming Sunday, and he was wondering what the recommendations are for getting the second dose with having had symptoms like this following the first dose. Caller reported that the pain to the injection site on his left arm has resolved but he is still having nerve pain in his left arm.  It was stated that nerve pain that right now it did not hurt, but if he were to use his arm, and do labor, that was when the nerve pain flare ups. Caller states that when he was resting it was good, but when he uses his arm, it flares up. Caller states the nerve pain was persisting, because it was not worse, but it was not going away. The patient underwent lab tests and procedures which included blood test: everything was good on Nov2020 everything was good. Outcome of the event (nerve pain from his ulnar nerve to his elbow and his hand and it came around to his chest, and his chest was on fire and his abdomen and his hip and foot) was not recovered, arm at the injection site was sore was recovered on an unspecified date and neck stiff was recovered on 10Feb2021.   Follow-up attempts completed. No further information expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Idiopathic urticaria
Clinical narrative: 1st dose facial numbness for 13 hours after vaccination; pain when breathing 8 hours after vaccine; Now have recurrent idiopathic hives since being vaccinated; This is a spontaneous report received from a non-contactable female consumer (patient). A 27-year-old non-pregnant female patient received first dose of 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 21Jan2021 (at the age of 27-year-old) at a 1st dose, single for COVID-19 immunization. The patient's medical history included psoriatic arthritis, idiopathic autoimmune hives, allergies to bactrim, penicillin, peanuts, shellfish, watermelon. Concomitant medications included Humira, prednisone, Zyrtec. On an unspecified date, the patient experienced 1st dose facial numbness for 13 hours after vaccination, pain when breathing 8 hours after vaccine and now have recurrent idiopathic hives since being vaccinated. AE resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of 1st dose facial numbness for 13 hours after vaccination, pain when breathing 8 hours after vaccine and now have recurrent idiopathic hives since being vaccinated. AE treatment allergy medication included epi pen, allergy testing. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had no covid prior vaccination. Patient has not been tested for COVID-19 post the vaccination. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Major dizziness and nausea; Major dizziness and nausea; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 14:30 (Batch/Lot number was not reported) (at the age of 70) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. No COVID prior vaccination. No COVID tested post vaccination. The patient experienced major dizziness and nausea on 25Feb2021, major dizziness and nausea on 25Feb2021. The events outcome was recovering.    No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: I have had back pain ever since the day I got the vaccine.; This is a spontaneous report from a contactable other HCP (patient).   A 38-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 13Feb2021 11:30 (Lot Number: EL9262) as single dose for covid-19 immunisation. The patient received the first dose lot # EL3249 on 21Jan2021 12:30 right arm. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. No known allergies.  The patient medical history was not reported. No other medications in two weeks. The patient experienced 'back pain ever since the day i got the vaccine' on 13Feb2021 13:30. Unknown if treatment received. The outcome was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: headache; chills; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration as 1st dose, single dose on 18Feb2021 for COVID-19 immunisation and varicella zoster vaccine rge (cho) (SHINGRIX) (Batch/Lot number was not reported) via an unspecified route as 2nd dose single dose on 22Feb2021 for immunisation. The patient medical history and concomitant medications were not reported.  The patient wanted to know should he get his second dose of the covid vaccine in 2 weeks when it was due or start over. On 23Feb2021 experienced headache and chills. The outcome of events was unknown.   Follow-up (24Feb2021): This is a follow-up spontaneous report from a Pfizer sponsored Program. A contactable consumer (patient) reported event information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: This is a spontaneous report from a contactable consumer. A 71-years-old female patient received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 12:15 (Batch/Lot Number: EL9262) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included hypertension, gastroesophageal reflux disease, multiple allergies, arthritis. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE); omeprazole (OMEPRAZOLE). The patient experienced weakness in my right arm on 31Jan2021 with outcome of not recovered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Urticaria
Clinical narrative: About 4.5 hours after vaccination I started to see small hives popping up on my arms.  Over the next hour it spread to my shoulders, neck, chest, upper and middle back, blotches on my thighs and tops/small bumps turned into welts; blotches on my thighs and tops of my feet, behind,my ears and on my left temple.; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 20Feb2021 08:30 (Batch/Lot Number: EM9810) as a single dose for covid-19 immunization. Medical history included depression, anxiety and high blood pressure. Concomitant medications included sertraline and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR); both taken with-in 2 weeks of vaccination on an unknown date. No other vaccine in four weeks, no covid prior vaccination, no covid test done post vaccination and No known allergies. On 20Feb2021 at 12:45, about 4.5 hours after vaccination the patient started to see small hives popping up on her arms. Over the next hour it spread to her shoulders, neck, chest, upper and middle back, blotches on her thighs and tops of her feet, behind her ears and on her left temple. The small bumps turned into welts. Cold shower and benadryl helped as treatment and no other issues aroused. The outcome of the events was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable Nurse. A 75-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), dose 1 via an unspecified route of administration on 13Feb2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced breaking out hives. Treatment for event included: applying ice to hives, not taken any medicine. Patient was scheduled for second dose on 06Mar2021. stated, "I got it from hospital.". "I am applying ice to it, I have not taken any medicine." The action taken in response to the event(s), for bnt162b2 was not applicable. The causality assessment from reporting person was Yes. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Body temperature, Hypotension, Inappropriate schedule of product administration, Obstructive airways disorder
Clinical narrative: patient received 1st dose on 26 jan2021,second dose on 11 feb2021; patient received 1st dose on 26 jan2021,second dose on 11 feb2021; Hives; Facial swelling; Sore Arm; Lost voice indicative of airway swelling; Lost voice indicative of airway swelling; Extreme sleepiness indicative of low blood pressure; Extreme sleepiness indicative of low blood pressure; Fever - 102; This is a spontaneous report from a contactable consumer (patient). A 39 years old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 11Feb2021 at 14:00 as a 2nd dose, single dose for COVID-19 immunization. The patient's medical history included chronic urticaria, allergic to fire, ant bites, dog dander, dust mites. The patient's concomitant medications included lisdexamfetamine mesylate (VYVANSE), cetirizine (CETIRIZINE) and fexofenadine (FEXOFENADINE). Facility type vaccine was reported as Hospital. No other vaccine was administered four weeks prior to COVID-19 vaccine. On an unknown date in Dec2020, the patient underwent lab test and procedure which included covid test type Nasal Swab: Inconclusive. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 26Jan2021 at 14:00 as a 1st dose, single dose for COVID-19 immunization. On 12Feb2021 at 12:00 PM, the patient experienced sore arm, hives, lost voice indicative of airway swelling, extreme sleepiness indicative of low blood pressure, facial swelling and fever 102. The patient received 1st dose on 26 jan2021, second dose on 11 feb2021 (Inappropriate schedule of product administration)(Off label use) on an unspecified date. The patient underwent lab test and procedure post vaccination with COVID vaccine which include COVID test nasal swab: Inconclusive. The patient visited doctor or other healthcare professional office/clinic visit as result of the events. The patient took Epipen, prednisolone, antihistamines as treatment medication for the resulted events. The clinical outcome of the events were resolved on an unspecified date in 2021 and outcome of the patient received 1st dose on 26 jan2021,second dose on 11 feb2021 was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Pyrexia, SARS-CoV-2 test, Somnolence
Clinical narrative: patient received 1st dose on 26 jan2021,second dose on 11 feb2021; patient received 1st dose on 26 jan2021,second dose on 11 feb2021; Hives; Facial swelling; Sore Arm; Lost voice indicative of airway swelling; Lost voice indicative of airway swelling; Extreme sleepiness indicative of low blood pressure; Extreme sleepiness indicative of low blood pressure; Fever - 102; This is a spontaneous report from a contactable consumer (patient). A 39 years old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 11Feb2021 at 14:00 as a 2nd dose, single dose for COVID-19 immunization. The patient's medical history included chronic urticaria, allergic to fire, ant bites, dog dander, dust mites. The patient's concomitant medications included lisdexamfetamine mesylate (VYVANSE), cetirizine (CETIRIZINE) and fexofenadine (FEXOFENADINE). Facility type vaccine was reported as Hospital. No other vaccine was administered four weeks prior to COVID-19 vaccine. On an unknown date in Dec2020, the patient underwent lab test and procedure which included covid test type Nasal Swab: Inconclusive. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 26Jan2021 at 14:00 as a 1st dose, single dose for COVID-19 immunization. On 12Feb2021 at 12:00 PM, the patient experienced sore arm, hives, lost voice indicative of airway swelling, extreme sleepiness indicative of low blood pressure, facial swelling and fever 102. The patient received 1st dose on 26 jan2021, second dose on 11 feb2021 (Inappropriate schedule of product administration)(Off label use) on an unspecified date. The patient underwent lab test and procedure post vaccination with COVID vaccine which include COVID test nasal swab: Inconclusive. The patient visited doctor or other healthcare professional office/clinic visit as result of the events. The patient took Epipen, prednisolone, antihistamines as treatment medication for the resulted events. The clinical outcome of the events were resolved on an unspecified date in 2021 and outcome of the patient received 1st dose on 26 jan2021,second dose on 11 feb2021 was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: patient received 1st dose on 26 jan2021,second dose on 11 feb2021; patient received 1st dose on 26 jan2021,second dose on 11 feb2021; Hives; Facial swelling; Sore Arm; Lost voice indicative of airway swelling; Lost voice indicative of airway swelling; Extreme sleepiness indicative of low blood pressure; Extreme sleepiness indicative of low blood pressure; Fever - 102; This is a spontaneous report from a contactable consumer (patient). A 39 years old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 11Feb2021 at 14:00 as a 2nd dose, single dose for COVID-19 immunization. The patient's medical history included chronic urticaria, allergic to fire, ant bites, dog dander, dust mites. The patient's concomitant medications included lisdexamfetamine mesylate (VYVANSE), cetirizine (CETIRIZINE) and fexofenadine (FEXOFENADINE). Facility type vaccine was reported as Hospital. No other vaccine was administered four weeks prior to COVID-19 vaccine. On an unknown date in Dec2020, the patient underwent lab test and procedure which included covid test type Nasal Swab: Inconclusive. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 26Jan2021 at 14:00 as a 1st dose, single dose for COVID-19 immunization. On 12Feb2021 at 12:00 PM, the patient experienced sore arm, hives, lost voice indicative of airway swelling, extreme sleepiness indicative of low blood pressure, facial swelling and fever 102. The patient received 1st dose on 26 jan2021, second dose on 11 feb2021 (Inappropriate schedule of product administration)(Off label use) on an unspecified date. The patient underwent lab test and procedure post vaccination with COVID vaccine which include COVID test nasal swab: Inconclusive. The patient visited doctor or other healthcare professional office/clinic visit as result of the events. The patient took Epipen, prednisolone, antihistamines as treatment medication for the resulted events. The clinical outcome of the events were resolved on an unspecified date in 2021 and outcome of the patient received 1st dose on 26 jan2021,second dose on 11 feb2021 was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: Fever of 100.9 F; arm site soreness (moderate); moderate body aches; moderate headache; moderate chills; tiredness; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 24-year-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200, Expiration Date: unknown) via an unspecified route of administration, administered in right arm on 25Feb2021 at 13:45 pm (age at vaccination was 24 years) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included migraines. The patient did not have allergies to medications, food, or other products. Concomitant medications patient received within 2 weeks of vaccination included escitalopram oxalate (LEXAPRO), cetirizine hydrochloride (ZYRTEC), birth control and multivitamin. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9263, Expiration Date: unknown) via an unspecified route of administration, administered in right arm on 04Feb2021 at 13:45 pm (age at vaccination was 24 years) as 1ST DOSE, SINGLE for COVID-19 immunization. On 26Feb2021 at 01:00 am, the patient experienced fever of 100.9 F, arm site soreness (moderate), moderate body aches, moderate headache, moderate chills and tiredness. The patient underwent lab tests and procedures which included body temperature: 100.9 Fahrenheit on 26Feb2021. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The events were reported as non-serious. The outcome of events was recovering.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Fever of 100.9 F; arm site soreness (moderate); moderate body aches; moderate headache; moderate chills; tiredness; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 24-year-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200, Expiration Date: unknown) via an unspecified route of administration, administered in right arm on 25Feb2021 at 13:45 pm (age at vaccination was 24 years) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included migraines. The patient did not have allergies to medications, food, or other products. Concomitant medications patient received within 2 weeks of vaccination included escitalopram oxalate (LEXAPRO), cetirizine hydrochloride (ZYRTEC), birth control and multivitamin. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9263, Expiration Date: unknown) via an unspecified route of administration, administered in right arm on 04Feb2021 at 13:45 pm (age at vaccination was 24 years) as 1ST DOSE, SINGLE for COVID-19 immunization. On 26Feb2021 at 01:00 am, the patient experienced fever of 100.9 F, arm site soreness (moderate), moderate body aches, moderate headache, moderate chills and tiredness. The patient underwent lab tests and procedures which included body temperature: 100.9 Fahrenheit on 26Feb2021. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The events were reported as non-serious. The outcome of events was recovering.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Extreme hives all over/full blown hives that itch and hurt; This is a spontaneous report from a contactable consumer (patient, self-reported).  A 72-year-old male patient (age at vaccination: 72 Year) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL1283 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 21Feb2021 at 11:15 AM, as a single dose for COVID-19 immunization at public health clinic/veterans administration facility. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9264 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 31Jan2021 at 11:15 AM, as a single dose for COVID-19 immunization at public health clinic/veterans administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included atrial fibrillation. Concomitant medications included Warfarin 5mg, Metoprolol Tartrate, and Terazosin HCL. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on an unknown date in Feb2021, he had extreme hives all over, concentrated in his midsection. He had started feeling itchy about 3 days before his second shot and once he got that it turned into full blown hives that itch and hurt. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment received for the adverse event. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Sinus disorder
Clinical narrative: Sinus; Shoulder pain; This is a spontaneous report from a contactable consumer (Patient). A 36-year-old male patient received BNT162B2, dose 1 via unknown route in left arm on 24Feb2021 at 10:00 AM (at the age of 36 years old) at single dose for covid-19 immunization. The patient medical history included seizure disorder and had known allergies: penicillin. Concomitant medications were not reported. Patient had other unspecified medications in two weeks. There was no other vaccine in four weeks. The patient experienced sinus and shoulder pain on 24Feb2021 at 03:00 PM. AEs was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No Covid prior vaccination and no Covid tested post vaccination. No treatment for the AEs. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected. The information about lot number and expiration date cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitis left ear; This is a spontaneous report from a contactable consumer (Patient). A 75-year-old female patient received BNT162B2 (Lot Number: EN6200), dose 2 via unknown route in right arm on 25Feb2021 at 10:00 AM (at the age of 75 years old) at single dose for covid-19 immunization. The patient medical history included breast cancer, atrial fibrillation and had known allergies: penicillin, sulfa, intravenous (IV) contrast. Patient was not pregnant. Concomitant medications included apixaban (ELIQUIS), diltiazem, propafenone, letrozole. No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (Lot Number: EN5318) via unknown route in left arm on 03Feb2021 at 03:45 PM at single dose for covid-19 immunization. The patient experienced Tinnitis left ear on 26Feb2021 at 05:00 AM. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No Covid prior vaccination and no Covid tested post vaccination. No treatment for the AE Tinnitis left ear. The outcome of event was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: large red hives with intense itching on arms, back, torso, legs; This is a spontaneous report received from a contactable consumer (patient). A 84-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6198), via an unspecified route of administration on 26Feb2021 at 15:15 (at the age of 84-years-old) as first dose, single in the left arm for covid-19 immunisation. The patient medical history included diabetes, atrial fibrillation and high blood pressure. The patient's concomitant medications included lisinopril, metformin, metoprolol, apixaban (ELIQUIS), "multi vit". Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021 at 20:00, the patient experienced large red hives with intense itching on arms, back, torso, legs. The patient did not receive any treatment for the event. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.