chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Fever; chiils; vomiting; This is a spontaneous report from a contactable consumer (patient). A 14-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left arm on 03Jun2021 09:00 at the age of 14-years-old as dose 2, single for covid-19 immunisation at Pharmacy or Drug Store. The patient's medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for an unspecified indication, start and stop date were not reported received in two weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left leg on 13May2021 11:30 (at the age of 14-years-old) as single dose for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 04Jun2021 at 01:00, the patient experienced Fever, chills and vomiting. No treatment was received for adverse events. The outcome of events was recovering.  Lot/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Erythema, Fatigue, SARS-CoV-2 test
Clinical narrative: dry cough; Joints pain; red spots in the whole body; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: ER8737, expiration date was not reported), via an unspecified route of administration, administered in left arm on 06Apr2021 17:00 (at the age of 47-years-old) as dose 2, single for covid-19 immunization. The patient medical history was none. Concomitant medication included isotretinoin (ACCUTANE) taken for unknown indication from an unknown date. Other medications the patient received within 2 weeks of vaccination included Accutane. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6204, expiration date was not reported), via an unspecified route of administration, administered in left arm on 16Mar2021 12:00am (at the age of 47-years-old) as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient does not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. It was reported that, on 06May2021 the patient experienced joints pain, red spots in the whole body, fatigue, dry cough. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included RT-PCR (sars-cov-2 test): negative on 08May2021 Nasal Swab. No treatment was received for the adverse events. Device date: 03Jun2021. The reporter assessed the seriousness as non-serious. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Discomfort, Eye pain, Ocular hyperaemia
Clinical narrative: Redness around left eyeball; Feel heaviness when I blink; Little pain; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old (non-pregnant) female patient received BNT162b2 (pfizer-biontech covid-19 mRNA vaccine; Lot Number: EW0168) dose 1 single via an unspecified route of administration in the arm left on 14May2021 at 18:00 ( age at vaccination 25-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any concomitant medications. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Medical history included COVID-19 positive. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021, the patient experienced redness around left eyeball, feel heaviness when patient blink and little pain. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test included covid 19 was positive on an unknown date.Therapeutic measures were not taken as a result of these events. The clinical outcome of all the events was not recovered at the time of this report.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: Every day my son is getting the fever with 100 to 103.5 after vaccination these 3 weeks; This is a spontaneous report from a contactable consumer. This consumer reported for male consumer (reporter's son) that,  A 13-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0185) (at the age of 13 years old), via an unspecified route of administration, administered in arm left on 16May2021 18:00 as dose number unknown, single for covid-19 immunisation. Medical history included blood iron decreased from an unknown date and unknown if ongoing and no known allergies. Concomitant medication(s) included paracetamol (TYNELOL) taken for an unspecified indication, start and stop date were not reported; ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported. It was reported that on 17May2021 every day patient was getting the fever with 100 to 103.5 after vaccination these three weeks. They had been conducted blood work for viral and Covid everything which was negative. But fever was not controlling. No treatment was received for event. Patient did not have covid prior to vaccination. The patient was visited, doctor or other healthcare professional office/clinic visit. Patient was not tested for covid post vaccination. The outcome for the event was not recovered.  Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Nausea, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: left arm pain and tingling; left arm pain and tingling; fevers; nausea; heaviness of her head; This is a spontaneous from a contactable physician reported that.  A 64-years-old female patient received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 1 intramuscular, administered in Arm Left on 04Apr2021 (Batch/Lot Number: EW0169) as DOSE 1, SINGLE for covid-19 immunization (Age at vaccination 64 years). Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient past medical history included hypertension from an unknown date and unknown if ongoing, Allergies to Chamomile, codeine, latex, mango, Pineapple and shellfish. The patient's concomitant medications were not reported.  The patient previously took codeine and experienced drug hypersensitivity. 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 vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. On 13Apr2021 the patient developed left arm pain and tingling, fevers, nausea and what she describes as heaviness of her head. The adverse event results Doctor or other healthcare professional office/clinic visit. The patient received a treatment with Pepcid. The event outcome was Not recovered.  Device Date: 04Jun2021  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Pain
Clinical narrative: Fever; Chills; Body aches; Intense pain at injection site; Sever shaking; Rapid breathing; Radiating pain throughout whole body, decreased strength; Headache; Fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 15-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: ew0180; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 04Jun2021 17:00 (at the age of 15-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: ew0177; Expiration date: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. 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. On 05Jun2021 06:00 patient experienced fever, chills, body aches, intense pain at injection site, severe shaking, rapid breathing, radiating pain throughout whole body, decreased strength, headache and fatigue. Patient did not receive any treatment for adverse event. Since the vaccination, patient has not been tested for COVID-19. The outcome of all events was not recovered.  Follow-Up (27Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory rate increased, Tremor, Vaccination site pain
Clinical narrative: Fever; Chills; Body aches; Intense pain at injection site; Sever shaking; Rapid breathing; Radiating pain throughout whole body, decreased strength; Headache; Fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 15-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: ew0180; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 04Jun2021 17:00 (at the age of 15-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: ew0177; Expiration date: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. 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. On 05Jun2021 06:00 patient experienced fever, chills, body aches, intense pain at injection site, severe shaking, rapid breathing, radiating pain throughout whole body, decreased strength, headache and fatigue. Patient did not receive any treatment for adverse event. Since the vaccination, patient has not been tested for COVID-19. The outcome of all events was not recovered.  Follow-Up (27Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site lymphadenopathy
Clinical narrative: my injected arms' lymph is swollen; fatigue; fever; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for self that,  A 47-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0187) (at the age of 47 years old), dose 2 via an unspecified route of administration, administered in arm left on 03Jun2021 09:00 as dose 2, single for covid-19 immunisation in hospital. Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EW0170), dose 1 via an unspecified route of administration, administered in arm left on 13May2021 09:00 as dose 1, single for covid-19 immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that six hours after he took the second dose, on 05Jun2021 08:00 he started feeling fatigue and fever. In last 48 hours and then, after that he realized that his injected arm lymph was swollen. This was the first time he noticed the reaction after getting any kind of vaccines or injection. No treatment for events was received. Patient did not have covid prior to vaccination. He was not tested for covid post vaccination. The outcome for the events was not recovered.  Follow-Up (04Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cyanosis, Fatigue, Heart rate, Heart rate increased
Clinical narrative: On the morning after the 2nd dose had Fever 104.2 F; heart rate 126; vomiting; fatigue; mottled/bluish fingers and lips; mottled/bluish fingers and lips; This is a spontaneous report from a contactable consumer (patient). A 12-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0191), via an unspecified route of administration, administered in Right arm on 04Jun2021 13:15 at the age of 12-years-old as dose 2, single for covid-19 immunisation. Medical history included Von Willebrand Disease from an unknown date. The patient had no known allergies. Concomitant medication included ethinylestradiol, norgestrel (CRYSELLE) taken for an unspecified indication, start and stop date were not reported received in two weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0183), via an unspecified route of administration, administered in Right arm on 14May2021 13:00 at the age of 12-years-old as single dose for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has been tested for COVID-19 post vaccination. On 05Jun2021 at 06:00, in the morning the patient experienced after the 2nd dose had Fever 104.2 F, heart rate 126, vomiting, fatigue and mottled/bluish fingers and lips. Adverse events resulted in Emergency room/department or urgent care. The patient received treatment for adverse events with IV fluids. The patient underwent lab tests and procedures which included heart rate: 126 on 05Jun2021, fever (Body temperature): 104.2 fahrenheit fever on 05Jun2021, Applied biosystems 7500 real-time PCR (Nasal Swab) (sars-cov-2 test): negative on 03Jun2021. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Livedo reticularis, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: On the morning after the 2nd dose had Fever 104.2 F; heart rate 126; vomiting; fatigue; mottled/bluish fingers and lips; mottled/bluish fingers and lips; This is a spontaneous report from a contactable consumer (patient). A 12-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0191), via an unspecified route of administration, administered in Right arm on 04Jun2021 13:15 at the age of 12-years-old as dose 2, single for covid-19 immunisation. Medical history included Von Willebrand Disease from an unknown date. The patient had no known allergies. Concomitant medication included ethinylestradiol, norgestrel (CRYSELLE) taken for an unspecified indication, start and stop date were not reported received in two weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0183), via an unspecified route of administration, administered in Right arm on 14May2021 13:00 at the age of 12-years-old as single dose for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has been tested for COVID-19 post vaccination. On 05Jun2021 at 06:00, in the morning the patient experienced after the 2nd dose had Fever 104.2 F, heart rate 126, vomiting, fatigue and mottled/bluish fingers and lips. Adverse events resulted in Emergency room/department or urgent care. The patient received treatment for adverse events with IV fluids. The patient underwent lab tests and procedures which included heart rate: 126 on 05Jun2021, fever (Body temperature): 104.2 fahrenheit fever on 05Jun2021, Applied biosystems 7500 real-time PCR (Nasal Swab) (sars-cov-2 test): negative on 03Jun2021. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have a rash, that start 28May. It really only flare up in the morning when I wake up and at night before going to bed; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER8736), via an unspecified route of administration, administered in arm left on 21May2021 15:30 as dose 1, single (at the age of 37-year-old) for covid-19 immunization. The patient was non-pregnant at the time of vaccination. Medical history reported as none. There were no known allergies. Concomitant medication included mepyramine maleate, pamabrom, paracetamol (PAMPRIN). On 28May2021 06:00, the patient experienced rash. It really only flares up in the morning when she wakes up and at night before going to bed. It started on her hands, then ankles now it was on her arms, neck and face. The patient did not receive any treatment for the events. The patient did not received any other vaccine in four weeks. The patient had not covid prior to the vaccination and patient had not tested for covid post vaccination. The outcome of the event was not recovered.   Follow-up attempts were completed. No further information was expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pharyngeal swelling, Rash, Secretion discharge, Swelling
Clinical narrative: Swelled throat; rash; Feeling cold; mucus along with swollen neck and throat; mucus along with swollen neck and throat; This is a spontaneous report from a contactable consumer (patient). A 15-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8731, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 04Jun2021 at 08:30 (at the age of 15-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included vitiligo. There were no concomitant medications. No other vaccine received in four weeks, no other medications received in two weeks, no covid prior vaccination, no covid tested post vaccination, no Known allergies were reported. On 04Jun2021 at 12:00, the patient experienced swelled throat, rash, feeling cold, mucus along with swollen neck and throat, mucus along with swollen neck and throat. No treatment was received for events. Reported that event swelled throat still not gone to normal after 48 hours. The outcomes of events (swelled throat, feeling cold, mucus along with swollen neck and throat, mucus along with swollen neck and throat) were not recovered and the outcome of event (rash) was recovered on 05Jun2021 (after 24 hours).  Follow-Up (19Jul2021 and 05Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Fever 103.6; Chills; Nausea; Dizzy, couldn't drive because I was so dizzy; Exhausted; Headache; Aching all over; This is a spontaneous report from a contactable consumer (patient) reporting for herself.  A 54-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6199, Expiry date: unknown), via an unspecified route of administration, administered in left shoulder of left arm on 17May2021 at 10:30 AM as dose 1, single for COVID-19 immunization at public health clinic/administration facility. Medical history included Bells palsy and allergy to walnuts, mold and fungus. There were no concomitant medications. Patient was not pregnant at vaccination. Patient did not test for covid prior vaccination. Patient did not get covid tested post vaccination. Patient did not take other vaccine in four weeks. No other medications in two weeks. On 19May2021, she experienced fever 103.6, chills, nausea, dizzy, she couldn't drive because she was so dizzy, exhausted, headache, aching all over. Patient did not take any treatment. Patient underwent lab data and procedure which included Body temperature 103.6 on 19May2021. Outcome of all events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fever 103.6; Chills; Nausea; Dizzy, couldn't drive because I was so dizzy; Exhausted; Headache; Aching all over; This is a spontaneous report from a contactable consumer (patient) reporting for herself.  A 54-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6199, Expiry date: unknown), via an unspecified route of administration, administered in left shoulder of left arm on 17May2021 at 10:30 AM as dose 1, single for COVID-19 immunization at public health clinic/administration facility. Medical history included Bells palsy and allergy to walnuts, mold and fungus. There were no concomitant medications. Patient was not pregnant at vaccination. Patient did not test for covid prior vaccination. Patient did not get covid tested post vaccination. Patient did not take other vaccine in four weeks. No other medications in two weeks. On 19May2021, she experienced fever 103.6, chills, nausea, dizzy, she couldn't drive because she was so dizzy, exhausted, headache, aching all over. Patient did not take any treatment. Patient underwent lab data and procedure which included Body temperature 103.6 on 19May2021. Outcome of all events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Pain in extremity, Pyrexia
Clinical narrative: Chills; arm pain; fever 100.5; diarrhea; This is a spontaneous report from a contactable consumer or other non healthcare professional. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 15May2021 04:30 (Batch/Lot Number: EW0179) as DOSE 1,SINGLE, dose 2 via an unspecified route of administration, administered in Arm Right on 15May2021 (Batch/Lot Number: EW0172) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing Allergic to green beans and nuts. Concomitant medication(s) included beclometasone dipropionate (QVAR) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient experienced chills on 05Jun2021 17:45 with outcome of not recovered, arm pain causing pain in extremity on 05Jun2021 17:45 with outcome of not recovered, fever 100.5 causing pyrexia on 05Jun2021 17:45 with outcome of not recovered, diarrhoea on 05Jun2021 17:45 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature:at 100.5 on 05Jun2021. Therapeutic measures were taken as a result of these events.  Follow-up(27Jul2021):This is a Follow-up spontaneous report from a contactable consumer. This consumer reported in response to Non HCP letter sent that included: No information can be released on this person.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: strong pain/pangs in chest at middle of the night; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 64-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198, Expiry date: unknown), via an unspecified route of administration, administered in arm left on 16Mar2021 (at the age of 64 years old) as dose 1, single for covid-19 immunisation. Medical history included mitral valve prolapse, allergies, Known allergies: yes, Seasonal allergy, and low blood pressure. The concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient also received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6208, Expiry date: unknown), via an unspecified route of administration, administered in arm left on 06Apr2021 as dose 2, single for covid-19 immunisation and experienced similar events on 06Apr2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the event. The patient experienced strong pain/pangs in chest at middle of the night on Mar2021. Since then, she had chest pains/soreness/pangs, what she thought was myocarditis. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: I am bruising *very* easily, with just moderate pressure against my skin (arms, legs, hands, feet, torso).; This is a spontaneous report from a contactable consumer (patient) reported for herself that.  A 59-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 04Jun2021 11:00 (Batch/Lot Number: EW0171) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 59 years). Facility type vaccine: Pharmacy or Drug Store. The patient past medical history included osteoarthritis from an unknown date and unknown if ongoing and Acid reflux from an unknown date and unknown if ongoing. Concomitant medication(s) included naproxen (NAPROXEN, 5 days prior) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE, daily) taken for an unspecified indication, start and stop date were not reported.  The patient previously took tetanus toxoid and experienced drug hypersensitivity and bnt162b2 dose 1 via an unspecified route of administration, administered in Arm Right on 14May2021 10:30 am (Batch/Lot Number: EW0179) as DOSE 2, SINGLE for covid-19 immunization. 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 vaccine within 4 weeks prior to covid-19 vaccination. On 05Jun2021, The patient experienced bruising very easily, with just moderate pressure against my skin (arms, legs, hands, feet, torso). No treatment was received. The event outcome was not recovered.  Follow-up attempts are completed. No further information is expected
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Myalgia, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: hardness at injection sight.; May 12, 13, 14, 15 bone and muscle aches all over; May 12, 13, 14, 15 bone and muscle aches all over; intermittent fever; no energy; This is a spontaneous report received from a contactable Other HCP (Nurse). This 57-year-old non-pregnant female Nurse (patient herself) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EWD176; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 10May2021 17:00 (at the age of 57-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included fluoxetine (FLUOXETINE) taken for an unspecified indication. The patient previously took erythromycin and experienced drug hypersensitivity. On 12May2021 22:00 the patient experienced hardness at injection sight, may 12, 13, 14, 15 bone and muscle aches all over, intermittent fever and no energy. Patient did not receive any treatment for adverse event. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test (Nasal Swab) negative on 14May2021 post the vaccination. The outcome of event hardness at injection sight was resolved on an unspecified date in 2021 while all other events was resolved on 15May2021.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: hardness at injection sight.; May 12, 13, 14, 15 bone and muscle aches all over; May 12, 13, 14, 15 bone and muscle aches all over; intermittent fever; no energy; This is a spontaneous report received from a contactable Other HCP (Nurse). This 57-year-old non-pregnant female Nurse (patient herself) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EWD176; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 10May2021 17:00 (at the age of 57-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included fluoxetine (FLUOXETINE) taken for an unspecified indication. The patient previously took erythromycin and experienced drug hypersensitivity. On 12May2021 22:00 the patient experienced hardness at injection sight, may 12, 13, 14, 15 bone and muscle aches all over, intermittent fever and no energy. Patient did not receive any treatment for adverse event. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test (Nasal Swab) negative on 14May2021 post the vaccination. The outcome of event hardness at injection sight was resolved on an unspecified date in 2021 while all other events was resolved on 15May2021.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Miliaria, Urticaria
Clinical narrative: I broke out with a heat rash and hives on both sides of my neck and both wrists.; I broke out with a heat rash and hives on both sides of my neck and both wrists.; This is a spontaneous report from a contactable consumer (Patient). An adult non-pregnant female patient of an unspecified age (current age reported as 44-year-old) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0168, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date in May2021 at 10:00 AM as dose 2, single for COVID-19 immunization. The patient medical history included gout, factor five Leiden syndrome, and calcium deposits. The patient received unspecified concomitant medications. The patient previously took VIT E [tocopherol] and experienced drug hypersensitivity. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0153, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date in Apr2021at 07:00 AM as dose 1, single for COVID-19 immunization. The patient received other vaccine on an unspecified date in May2021. No other vaccine in four weeks. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that, on 07May2021 03:00 AM, two days after receiving second COVID shot, "I broke out with a heat rash and hives on both sides of my neck and both wrists". It continued today, a month after her 2nd shot was administered. The patient visited her naturopath, tried to schedule an appointment. The patient took unspecified treatment for the events. The outcome of the events was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: vomiting/threw up multiple times; nauseas for 12 plus hours; had a fever ranging from 100.7 to 101.5; This is a spontaneous report from a contactable consumer (Parent of patient). A 13-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0178, Expiry date: not reported), via intramuscular route of administration in left arm on 03Jun2021 16:00 (at age of 13-years-old) as dose 2, single for covid-19 immunization in Doctor's office/Urgent Care. Medical history included thin basement membrane disease (Ongoing monitoring, no surgery), vitamin d deficiency and penicillin allergy. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for vitamin d deficiency from 05May2021 and ongoing, colecalciferol (REPLESTA) taken for vitamin d deficiency from 05May2021 and ongoing. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0161, Expiration Date: Not reported), via intramuscular route of administration in left arm on 13May2021 16:00 (at age of 13-years-old) as dose 1, single for covid-19 immunization. The patient had not received any prior vaccinations. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. The caller reported that about 14 hours after the patient received the second covid shot (04Jun2021 at 04:00), the patient began vomiting. The patient threw up multiple times. The reporter estimated that the patient vomited about 4 times. The patient was nauseas for 12 plus hours and had a fever ranging from 100.7 to 101.5. The reporter assessed the events as non-serious. The patient underwent lab tests and procedures which included pyrexia: ranging from 100.7 to 101.5 on 04Jun2021. No relevant tests were performed. No therapeutic measures were taken in response to the events. The events recovered on an unspecified date in 2021 (patient had fully recovered).  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient developed rash on both arms 3 days after the vaccination.  It lasted for 2 weeks.; This is a spontaneous report from a contactable consumer (parent). A 14-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5318), via an unspecified route on unspecified date (at the age of 14-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included Known allergies: penicillin and some sunscreens. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced rash on both arms 3 days after the vaccination on 15May2021. It lasted for 2 weeks. Patient did not received treatment for events. The outcome of the events was recovered on May2021.  Information on Lot/Batch number was available. Additional information has been requested  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: she developed a rash on on her arm and chest within 2 hours of the shot; This is a spontaneous report from a contactable consumer (patient's mother). A 14-year-old female patient (reporter's daughter) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0185 and expiry date was not reported), via an unspecified route of administration, on 02Jun2021 (age vaccination: 14 years), as dose 2, single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included Penicillin allergy. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on an unspecified date, as dose 1, single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID Since the vaccination. The patient developed rash on both arms 3 days after the vaccination. It lasted for 2 weeks. Her 2nd vaccination was on 02Jun2021, and she developed a rash on on her arm and chest within 2 hours of the shot. The rash persists. The patient took Zyrtec and rash lessens with Zyrtec. Outcome of the event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Urticaria
Clinical narrative: Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient) reported for herself. A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0191), second dose via an unspecified route of administration, administered in left arm on 04Jun2021 at 17:00 (at the age of 52-year-old) as dose 2, single for COVID-19 immunisation at pharmacy or drug store. Medical history included Lyme disease from an unknown date and unknown if ongoing. No known allergies were reported. Concomitant medications included valaciclovir hydrochloride (VALTREX) taken for an unspecified indication, start and stop date were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0183), first dose via an unspecified route of administration, administered in left arm on 15May2021 at 09:15 (at the age of 52-year-old) as dose 1, single for COVID-19 immunisation at pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other vaccines within 2 weeks of COVID vaccine included Valtrex. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there on 05Jun2021 at 03:00. No treatment was received for the events. The outcome of the events was reported as resolving.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Eye swelling
Clinical narrative: Eyes was slightly swollen,trouble opening his eyelash; Temperature was around 101 degree; This is a spontaneous report from a contactable consumer. A 12-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 04Jun2021 17:30 (at the age of 12 years old) as dose 2, single for COVID-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number EW0175), via an unspecified route of administration, administered in Arm Left on 14May2021 17:30 as dose 1, single for COVID-19 immunization. The consumer stated lot number for 2nd dose, It is EW0185 I don't know its 5 or S. I think it is muscular they did not find any veins I believe because it was in the top part of the left arm is where they gave here the shoulder so I think it is muscular. The patient medical history was not reported. There was no family medical history. There were no concomitant medications. My son who is 12 years old got the second dose of Pfizer vaccine on Friday evening which is 04Jun and he had a temperature on Saturday, 05Jun and his temperature was around 101 degree and we gave him Tylenol (treatment), 2 dose, one was on Friday evening other one was on Saturday morning and he took the third dose on Saturday night as well and the issue is when he woke up  morning on Sunday 06Jun his eyes was slightly swollen and we just wanted to report that would be a possible side effect of taking the vaccine but currently he doesn't have any body temperature, he is normal at 97 degree and he doesn't have any breathing related issue, we just wanted to report about his swollen eyes. And he has swollen eyes and that's the main concern for me and you know for him it's like he has trouble opening his eyelash, but he is feeling normal right now, no breathing related issue. He doesn't have any fever or temperature. For swollen eyes we gave him Claritin (treatment) and we are observing him. All doses of 10ml for both Tylenol and Claritin. The patient underwent lab tests and procedures which included body temperature: 101 on 05Jun2021, body temperature-97 on 06Jun2021.Therapeutic measures were taken as a result of temperature was around 101 degree and eyes was slightly swollen, trouble opening his eyelash. The outcome of event was unknown for eyes was slightly swollen, trouble opening his eyelash. The outcome of event was recovering for experienced temperature was around 101 degrees.  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 completed. No further information is expected
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash covering the torso, front and back. Not noticed until 6/5/21; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0191) via an unspecified route of administration, administered in left arm on 02Jun2021 at 09:45 AM, as DOSE 2, SINGLE (at the age of 12-year-old) for COVID-19 immunization. The patient medical history reported as none. The concomitant medications were not reported. Patient had no known allergies. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0172) via an unspecified route of administration in left arm on 12May2021 at 12:00 PM, as DOSE 1, SINGLE (at the age of 12 years-old) for COVID-19 immunization. No other vaccine in four weeks. No covid prior vaccination and not tested for covid post vaccination. The patient experienced rash covering the torso, front and back, not noticed until 6/5/21 on 05Jun2021. No treatment received for the events. The outcome of the event was resolving at the time of this report.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature abnormal, Fatigue, Headache, Limb discomfort, Pain
Clinical narrative: Low grade temp 99.2; Extreme arm discomfort.; Pounding headache.; Extreme tiredness; Body aches; This is a spontaneous report from a contactable consumer (patient).   A 35-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0185), via an unspecified route of administration, administered in right arm on 04Jun2021 at 19:15 PM (Age at Vaccination 35-years-old) as dose 2, single for Covid-19 immunization at Pharmacy or Drug Store. Medical history included allergies with latex, Benadryl, bee venom. Concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173) via an unspecified route of administration, administered in right arm on 14May2021 at 19:45 PM (Age at Vaccination 35-years-old) as dose 1, single for Covid-19 immunization. Patient did not take any prior Covid vaccination, and she did not get tested for Covid post vaccination. On 05Jun2021 patient experienced Extreme arm discomfort, pounding headache, extreme tiredness, body aches and low-grade temp 99.2, she did not take any treatment and no other medications in 2 weeks. The patient underwent lab data and procedure which include Body temperature abnormal Low-grade Temp 99.2 on 05Jun2021. Outcome of all events was recovering.  Follow-Up (26Jul2021): Follow-up attempts are completed. No further information is expected.