chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Confusional state, Palpitations, Spinal pain
Clinical narrative: severe pain in my spine all down my neck.; I had severe pain in my chest; confusion really bad; I also had heart palpitations for 2 days; This is a spontaneous report from a contactable consumer (patient).  A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0177 and expiry date was not reported), via an unspecified route of administration into right arm on 30May2021 at 16:45 (at the age of vaccination: 42-year-old) as Dose 1, single for COVID-19 immunization. Medical history included: Known allergies to chili peppers and chimoy, bells palsy and vasovogal condition of BP. The patient did not had any other vaccine in four weeks of first dose. Concomitant medications included: thyroid meds (within two weeks of BNT162B2). The patient was neither diagnosed with covid prior vaccination nor tested for Covid post vaccination. On an unspecified date at 09: 00 am, the patient stated that she had all the normal effects but severe pain in her spine all down neck. The patient also had severe pain in chest and confusion really bad and also had heart palpitations for 2 days. The patient did not receive any treatment for adverse events. Outcome of all events got recovered on an unspecified date with lasting effects (sequelae).  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: sore arm at injection site; Fever; fatigue; chills; body aches; dizziness; poor appetite; Sore arm; Headaches; This is a spontaneous report from a contactable consumer (Patient). A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 13Jun2021 11:00 (Batch/Lot Number: EW0185) (at the age of 13-Years-old) as dose 2, single for covid-19 immunisation. The medical history included Casein (milk protein) from an unknown date and unknown if ongoing. The concomitant medications included guanfacine (GUANFACINE); levocarnitine (LEVOCARNITINE) and guanfacine hydrochloride (TENEX). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 09:00 (Batch/Lot Number: EW0185) (at the age of 13-Years-old) as dose 1, single for covid-19 immunisation. The patient had not been tested for Covid-19 prior vaccination and post vaccination. No other vaccine was administered in four weeks of Covid-19 vaccination. On 13Jun2021 11:00, the patient experienced sore arm at injection site, fever, fatigue, chills, body aches, dizziness, poor appetite, sore arm and headaches. Therapeutic measures were taken for reported events with Tylenol. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: sore arm at injection site; Fever; fatigue; chills; body aches; dizziness; poor appetite; Sore arm; Headaches; This is a spontaneous report from a contactable consumer (Patient). A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 13Jun2021 11:00 (Batch/Lot Number: EW0185) (at the age of 13-Years-old) as dose 2, single for covid-19 immunisation. The medical history included Casein (milk protein) from an unknown date and unknown if ongoing. The concomitant medications included guanfacine (GUANFACINE); levocarnitine (LEVOCARNITINE) and guanfacine hydrochloride (TENEX). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 09:00 (Batch/Lot Number: EW0185) (at the age of 13-Years-old) as dose 1, single for covid-19 immunisation. The patient had not been tested for Covid-19 prior vaccination and post vaccination. No other vaccine was administered in four weeks of Covid-19 vaccination. On 13Jun2021 11:00, the patient experienced sore arm at injection site, fever, fatigue, chills, body aches, dizziness, poor appetite, sore arm and headaches. Therapeutic measures were taken for reported events with Tylenol. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Insomnia, Nasal congestion, Vomiting
Clinical narrative: i have been throwing up; heavy coughing; congestion; always exhausted; can't sleep; This is a spontaneous report from a contactable consumer (patient). A 20-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0217, Expiry date: not reported) via an unspecified route of administration, administered in Arm Right on 09Jun2021 11:45 (at the age of 20 years old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. The patient was non pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient had not received any other vaccine within 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. On 10Jun2021 10:30, the patient had been throwing up, heavy coughing, congestion, always exhausted but can't sleep. It was unknown if patient received treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.  Follow-up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Discomfort, Fatigue, Inflammation, Pain
Clinical narrative: I feel inflammation all over my body, heaviness,Chest tightness, body pain, fatigue .; I feel inflammation all over my body, heaviness,Chest tightness, body pain, fatigue .; I feel inflammation all over my body, heaviness,Chest tightness, body pain, fatigue .; I feel inflammation all over my body, heaviness,Chest tightness, body pain, fatigue .; I feel inflammation all over my body, heaviness,Chest tightness, body pain, fatigue .; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: QW0182), via an unspecified route of administration, administered in Arm Left on 05May2021 12:00 as dose 2, single for COVID-19 immunisation (Age at Vaccination was 60 years). The patient medical history included none. The patient concomitant medications were not reported. The patient previously took Penicillin (Penicilline) and experienced allergy. It was reported that, she was not a pregnant at the time of vaccination. She did not receive any other vaccine in four weeks and any other medications in two weeks prior COVID vaccination. She was not diagnosed with COVID prior vaccination and not tested COVID post vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 04Apr2021 12:00 as dose 1, single for COVID-19 immunisation. On 06May2021 04:00, the patient experienced she feel inflammation all over her body, heaviness, chest tightness, body pain and fatigue. Patient has visited Physician office as a result of events. No therapeutic measures were taken as a result of events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: extremely stiff; pain in neck, shoulders, traveling to arms back and hips; pain in neck, shoulders, traveling to arms back and hips; pain in neck, shoulders, traveling to arms back and hips; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 65-year-old non pregnant female patient received bnt162b2 (BNT162B2 Formulation; solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 at 16:00 (Batch/Lot Number: ER8731) as DOSE 2, SINGLE (at the age of 65-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history reported as none and had no Known allergies. The patient did not have covid prior vaccination. Concomitant medications (other medications in two weeks) included bupropion hydrochloride (WELLBUTRIN) and calcium, colecalciferol (CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 on 26Mar2021 at 16.00 (Batch/lot number: ER8733, Left arm) (at the age of 65-year-old) for covid-19 immunisation and experienced thin line of numbness on the tip of tongue. The patient not received other vaccine in four weeks. The patient experienced started getting extremely stiff and pain in neck, shoulders, traveling to arms back and hips on 18Apr2021 at 07.00. The event caused Physician Office Visit. The patient not tested for covid post vaccination. The patient received unspecified anti-inflammatory and muscle relaxer. Therapeutic measures were taken as a result of events. The outcome of events reported as not recovered.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills; fever; achy; This is a spontaneous report from a non-contactable consumer (Patient) and contactable consumer (Pfizer employee) reported in response.   A 14-years-old female patient (non-pregnant) received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch No/Lot Number: Not reported) via an unspecified route of administration on 12Jun2021 (at the age of 14-years-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The historical vaccine included, patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch No/Lot Number: Not reported) via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunization. No Covid prior vaccination and it was unknown patient tested for Covid post vaccination. It was unknown if other vaccine taken within four weeks and not sure if other medications taken within two weeks. On 12Jun2021, patient experienced chills, fever, achy. Therapeutic measures taken as a result of events was unknown. The 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Rash
Clinical narrative: I was almost constantly lightheaded and dizzy; I broke out in a rash on both my arms/the rash had broke out on my left hip as well; This is a spontaneous report from a contactable consumer or other non hcp.   A 40-years-old female patient received bnt162b2  (BNT162B2 Formulation: Solution for injection, Lot Number EW0180 and Expiration Date unknown), dose 2, single via an unspecified route of administration, administered in Arm Left on 12Jun2021 15:00 for covid-19 immunisation . Medical history included Epstein barr, asthma from an unknown date and unknown if ongoing, covid-19 from an unknown date and unknown if ongoing, The patient previously took Vicodin, imitrex and morphine  experienced drug hypersensitivity. The patient's concomitant medications were not reported. No other vaccine administer in 4 weeks. Patient was positive for Covid 19 prior to vaccination. No post vaccination covid tested.Patient historical vaccne was (BNT162B2 Formulation: Solution for injection, Lot Number EW0172 and Expiration Date unknown), dose 1, single via an unspecified route of administration, administered in Arm Left on 22May2021 15:00 for covid-19 immunisation. On 13Jun2021, 8:00 The patient experienced I was almost constantly lightheaded and dizzy, I broke out in a rash on both my arms/the rash had broke out on my left hip as well . Therapeutic measures Steroid shot and a steroid pack was prescribed. Patient underwent lab test included Covid 19 positive on an unknown date. The outcome of all events was unknown.  Follow-up attempts are completed. No further information is expected
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: I started developing a very itchy rash on my arms has since spread to my chest legs neck face and has gotten worse by the day; I started developing a very itchy rash on my arms has since spread to my chest legs neck face and has gotten worse by the day; I started developing a very itchy rash on my arms has since spread to my chest legs neck face and has gotten worse by the day; This is a spontaneous report from a contactable consumer (patient).   A 32-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0186), via an unspecified route of administration, administered in right arm on 03Jun2021 15:30 (at the age of 32 years) as dose number unknown, single for COVID-19 immunization. The patient's medical history included multiple sclerosis. The patient's concomitant medications included methadone (METHADONE). The patient previously took vancomycin, tramadol, Darvocet, Vicodin and had allergies. The patient did not take other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not test for COVID post vaccination. Patient was not pregnant at the time of vaccination. On 07Jun2021 02:00 (about 4 days after vaccine) the patient developed a very itchy rash on her arms, has spread to her chest, legs, neck, face and has gotten worse by the day. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Periorbital oedema, Urticaria
Clinical narrative: 2 weeks post perioribital edema for > 24 hours; swollen lips; Hives over entire chest , stomach and legs; This is a spontaneous report from a contactable other hcp (Patient). A 53-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0178,), via an unspecified route of administration, administered in Arm Left (Left deltoid) on 23May2021 16:00 (at the age of 53-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis from an unknown date and unknown if ongoing Verbatim: Hashimoto's thyroiditis. Concomitant medications included levothyroxine, liothyronine (NP THYROID), topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported. on 23May2021 after 3 hours later on 19:00 patient experienced swollen lips and hives over entire chest, stomach and legs. On an unspecified date 2 weeks post perioribital edema for greater then 24 hours . Therapeutic measures were taken patient received treatment with Topical steroids and antihistamines. The outcome of events was 2 weeks post perioribital edema for > 24 hours was recovered on unspecified date rest of all events recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Glossodynia, Influenza
Clinical narrative: I had low grade fever; body aches; fatigue for 5 days on first vaccine; Developed sores under my tongue; Chills; Flu; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that,  A 51-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW018B) (at the age of 51 years old), dose 1 intramuscular, administered in Arm Right on 17May2021 10:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included multiple sclerosis from 2015 and ongoing Other medical history: Multiple Sclerosis, cerebrovascular accident from 2020 to Sep2020, hypertension from 2017 and ongoing, sleep disorder from an unknown date and unknown if ongoing, nausea from an unknown date and unknown if ongoing, blood cholesterol abnormal from an unknown date and unknown if ongoing, muscle spasms from an unknown date and unknown if ongoing, tinnitus from an unknown date and unknown if ongoing. Concomitant medication(s) included cyclobenzaprine (CYCLOBENZAPRINE) taken for muscle spasms from 2018 and ongoing; vitamin d3 (VITAMIN D3) taken for multiple sclerosis from 2016 and ongoing; calcium carbonate, lycopodium clavatum, potassium carbonate, quinine sulfate, salicylic acid (TINNITUS RELIEF) taken for tinnitus from 2017 and ongoing; atorvastatin (ATORVASTATIN) taken for blood cholesterol abnormal from 2020 and ongoing; propranolol (PROPRANOLOL) taken for high blood pressure from 2020 and ongoing; melatonin (MELATONIN) taken for sleep disorder from 2014 and ongoing; promethazine (PROMETHAZINE) taken for nausea from 2016 and ongoing; zolpidem (ZOLPIDEM) taken for sleep disorder from 2016 and ongoing; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for cerebrovascular accident from 2020 and ongoing. On 17May2021 17:00, patient experienced low grade fever, body aches, fatigue for 5 days on first vaccine. She Developed sores under her tongue that have gotten worse over a month. She also started feeling feverish, chills, Body aches. This got worse over 24 hours and lasted five days. Fever was not more than 102. No treatment was received for events. She did not have covid prior to vaccination. She was not tested for covid post vaccination. She did not have known allergies. The patient was visited physician office. Lab data included, low grade fever, Fever was not more than 102 on 17-MAY-2021. The outcome for the event of Developed sores under my tongue was not recovered. The outcome for the event of chills was unknown. The outcome for the events of I had low grade fever, body aches, fatigue for 5 days on first vaccine and flu was recovered on 22May2021.  Follow-Up (04Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: I had low grade fever; body aches; fatigue for 5 days on first vaccine; Developed sores under my tongue; Chills; Flu; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that,  A 51-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW018B) (at the age of 51 years old), dose 1 intramuscular, administered in Arm Right on 17May2021 10:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included multiple sclerosis from 2015 and ongoing Other medical history: Multiple Sclerosis, cerebrovascular accident from 2020 to Sep2020, hypertension from 2017 and ongoing, sleep disorder from an unknown date and unknown if ongoing, nausea from an unknown date and unknown if ongoing, blood cholesterol abnormal from an unknown date and unknown if ongoing, muscle spasms from an unknown date and unknown if ongoing, tinnitus from an unknown date and unknown if ongoing. Concomitant medication(s) included cyclobenzaprine (CYCLOBENZAPRINE) taken for muscle spasms from 2018 and ongoing; vitamin d3 (VITAMIN D3) taken for multiple sclerosis from 2016 and ongoing; calcium carbonate, lycopodium clavatum, potassium carbonate, quinine sulfate, salicylic acid (TINNITUS RELIEF) taken for tinnitus from 2017 and ongoing; atorvastatin (ATORVASTATIN) taken for blood cholesterol abnormal from 2020 and ongoing; propranolol (PROPRANOLOL) taken for high blood pressure from 2020 and ongoing; melatonin (MELATONIN) taken for sleep disorder from 2014 and ongoing; promethazine (PROMETHAZINE) taken for nausea from 2016 and ongoing; zolpidem (ZOLPIDEM) taken for sleep disorder from 2016 and ongoing; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for cerebrovascular accident from 2020 and ongoing. On 17May2021 17:00, patient experienced low grade fever, body aches, fatigue for 5 days on first vaccine. She Developed sores under her tongue that have gotten worse over a month. She also started feeling feverish, chills, Body aches. This got worse over 24 hours and lasted five days. Fever was not more than 102. No treatment was received for events. She did not have covid prior to vaccination. She was not tested for covid post vaccination. She did not have known allergies. The patient was visited physician office. Lab data included, low grade fever, Fever was not more than 102 on 17-MAY-2021. The outcome for the event of Developed sores under my tongue was not recovered. The outcome for the event of chills was unknown. The outcome for the events of I had low grade fever, body aches, fatigue for 5 days on first vaccine and flu was recovered on 22May2021.  Follow-Up (04Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Small rash on upper left thigh; This is a spontaneous report from a contactable consumer (patient)  A 41-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0185), via an unspecified route of administration, administered in left arm on 02Jun2021 at 19:30 AM (Age at vaccination: 41 years old) as dose 1, single for covid-19 immunization at a hospital. Patient's medical history included: known allergies: Ibuprofen and the mental nickel from an unspecified date. Concomitant medication(s) included Telmisartan and ethinylestradiol/norgestimate (SPRINTEC), both taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of vaccination. There were no other vaccines in 4 weeks, no Covid prior vaccination, she did not get tested for Covid post vaccination. Patient experienced small rash on upper left thigh 04Jun2021. Patient took unknown treatment which was advised by primary doctor regarding the issue. Outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Swelling face
Clinical narrative: One hour after shot, red swelling on cheeks of face; One hour after shot, red swelling on cheeks of face; This is a spontaneous report from a contactable consumer (patient). A 14-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: CWD178, Expiry date: unknown) (age at the time of vaccination was 14 years), administered in Arm Left on 15Jun2021 at 13:15 as dose 1, single for COVID-19 immunization. The patient's medical history included seizure disorder. The patient's concomitant medication included valproic acid. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. The patient was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. The patient had known allergies. On 15Jun2021 at 14:30, the patient has red swelling on cheeks of face. No treatment received. The outcome of the events was not resolved.  Follow-up attempts were completed. No further information was expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Significant nose bleed; This is a spontaneous report from a contactable consumer (patient). A 12-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0196), via an unspecified route of administration in left arm on 14Jun2021 at 17:00 (at the age of 12 years old, not pregnant at the time of vcciantion) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0185), via an unspecified route of administration in left arm on 17May2021 at 04:00 PM (at the age of 12 years old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 15Jun2021 at 14:00 patient experienced significant nose bleed. It was unknown if patient received any treatment for event. The outcome of event was not recovered.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, SARS-CoV-2 test
Clinical narrative: Loss if taste about 6 hours after second vaccine; This is a spontaneous report from a contactable consumer (patient). This 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ew0181) via an unspecified route of administration, administered in right arm on 15Jun2021 13:30 (at the age of 55 years old) as dose 2, single for COVID-19 immunization. The patient medical history included HLRCC, salivary gland cancer, carcinoid tumor and adhesions from an unknown date and unknown if ongoing. The patient had antibiotics, sulpha, walnuts and hazelnuts allergies. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccine in four weeks. The patient concomitant medications included naltrexone, famotidine (PEPCID [FAMOTIDINE]), Allegra (FEXOFENADINE HYDROCHLORIDE), Benadryl (DIPHENHYDRAMINE HYDROCHLORIDE), ibuprofen and vitamin start dates and stop dates were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Ew0178) on 25May2021 13:30 on right arm (at the age of 55 years old) as dose 1, single for COVID-19 immunization. On 15Jun2021 at 19:30, the patient experienced loss if taste about 6 hours after second vaccine. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab) which result was negative on 09Mar2021. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Erythema, Glossodynia, Lip blister, Lip haemorrhage
Clinical narrative: Back part of tongue is sore; lips swollen; Nose and lips swollen; Rash on both arms; itchy rash on both arms; Itchy fingers; Red faced and red hands; Blisters on lips; Blisters on outer nose; Blisters on lips and bleeding also; Red faced and red hands; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient). A 60-year-old male patient received bnt162b2 (BNT162B2 Formulation; solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10Jun2021 at 13:00 (Batch/Lot Number: ER8727) as DOSE 2, SINGLE (at the age of 60-year-old) for COVID-19 immunisation. Medical history included High blood pressure, borderline cholesterol being high and COVID (covid prior vaccination) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on 20May2021 at 13.00 (Batch/lot number: ER8727, in left arm) for covid-19 immunisation. The patient previously took Lipitor (Some statins. etc. Lipitor) and experienced Known allergies. No other vaccine received in in four weeks. The patient received unspecified other medications in two weeks. On 10Jun2021 at 18.00, the patient experienced nose and lips swollen, rash on both arms, itchy fingers and itchy rash on both arms, red faced and red hands, blisters on outer nose, blisters on lips and bleeding also and back part of tongue was sore. The event caused Physician Office Visit. The patient not tested for covid post vaccination. The patient received unspecified treatment for events (Meds from nurse practitioner). Therapeutic measures were taken as a result of events. The outcome of events reported as not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Rash, Rash pruritic, Swelling
Clinical narrative: Back part of tongue is sore; lips swollen; Nose and lips swollen; Rash on both arms; itchy rash on both arms; Itchy fingers; Red faced and red hands; Blisters on lips; Blisters on outer nose; Blisters on lips and bleeding also; Red faced and red hands; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient). A 60-year-old male patient received bnt162b2 (BNT162B2 Formulation; solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10Jun2021 at 13:00 (Batch/Lot Number: ER8727) as DOSE 2, SINGLE (at the age of 60-year-old) for COVID-19 immunisation. Medical history included High blood pressure, borderline cholesterol being high and COVID (covid prior vaccination) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on 20May2021 at 13.00 (Batch/lot number: ER8727, in left arm) for covid-19 immunisation. The patient previously took Lipitor (Some statins. etc. Lipitor) and experienced Known allergies. No other vaccine received in in four weeks. The patient received unspecified other medications in two weeks. On 10Jun2021 at 18.00, the patient experienced nose and lips swollen, rash on both arms, itchy fingers and itchy rash on both arms, red faced and red hands, blisters on outer nose, blisters on lips and bleeding also and back part of tongue was sore. The event caused Physician Office Visit. The patient not tested for covid post vaccination. The patient received unspecified treatment for events (Meds from nurse practitioner). Therapeutic measures were taken as a result of events. The outcome of events reported as not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Joint swelling, Pain, Peripheral swelling
Clinical narrative: Wrist & hand swelled; Wrist & hand swelled; Extremely painful; Red; Warm; This is a spontaneous report from a contactable consumer. A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration, administered in Arm Right on 08Apr2021 11:15 (Lot Number: EW0253) as DOSE 2, SINGLE (at the age of 70-year-old) for covid-19 immunisation. Medical history included High Blood Pressure, gout in toe, Cholesterol. Concomitant medication(s) included allopurinol (ALLOPURINOL); omeprazole (OMEPRAZOLE); atenolol (ATENOLOL); rosuvastatin calcium (CRESTOR); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6208) via an unspecified route of administration at right arm as dose 1, single on 18Mar2021 10:15 (at the age of 70-year-old) for covid-19 immunisation. No other vaccine in four weeks. No known allergies reported. On 10Apr2021, at 08:00, the patient experienced Wrist & hand swelled, extremely painful, red, warm. No treatment received. No covid prior vaccination. No covid tested post vaccination. The outcome of the event was recovered on 2021.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever 99-100 via forehead /low fever 99-100 now 7 days post vaccination; fever of 102-103 taken via forehead; This is a spontaneous report from a contactable Other Healthcare Professional reporting for a patient.  A 15-years-old male patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch No: Not reported/Lot Number: EW0180) via intramuscular route on 08Jun2021 (at the age of 15-years-old) as dose 2, single for covid-19 immunization. The patient medical history included known allergy to peanut and concomitant medications were not reported. The historical vaccine included patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch No: Not reported/Lot Number: EW0185) via an intramuscular route on 18May2021 (at the age of 15-years-old) as dose 1, single for covid-19 immunization. Patient had no covid prior vaccination and was not tested post vaccination. It was unknown if other vaccine taken within four weeks. Patient did not receive his vaccination at reporter clinic. On 09Jun2021, Mom of patient called to report a fever of 102-103 taken via forehead and asked if ok to give Tylenol and the PCP said it was ok to give. On 14Jun2021, Mom of patient called again and said that the patient was still having fever 99-100 via forehead and had no other symptoms otherwise he was feeling fine. Patient had virtual appointment with provider on 15Jun2021 and reported that, the patient was still having low fever 99- 100 now 7 days post vaccination and no other symptoms at this time. The patient underwent lab tests and procedures which included body temperature taken via forehead on 09Jun2021 which results as 102-103, on 14Jun2021 body temperature via forehead was measured as 99-100, and on 15Jun2021 body temperature was measured still having low fever 99-100 now 7 days post vaccination. The therapeutic measure taken as a result of event was Unknown. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pyrexia
Clinical narrative: Extreme/Unbearable Joint pain; Extreme/Unbearable Muscle pain; Extreme Fatigue; high fever; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 17May2021 at 10:00 AM (at the age of 31 years old, not pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included arthritis, neuropathy peripheral, behcet's syndrome. The patient had known allergies to penicillin. Concomitant medications in two weeks included gabapentin; baclofen, ibuprofen; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 07Jun2021 patient experienced extreme/unbearable joint and muscle pain, extreme fatigue, high fever. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 12Jun2021 at 10:00 AM for covid-19 immunisation. The patient did not received treatment due to the events. The outcome of events was recovering.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: my symptoms of dermatographia have fully returned; itchy; welts; hives; This is a spontaneous report from a contactable consumer (patient reported for himself).   A 28-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0167) via an unspecified route of administration, in left arm on 06May2021 14:00 (at the age of 28-years-old) as dose 2, single for covid-19 immunization. The patient medical history included dermatographia. Patient previously took amoxicillin and had experienced allergy. Patient was known allergic to penicillin. The patient concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0164) via an unspecified route of administration, in left arm on 15Apr2021 14:00 (at the age of 28-years-old) as dose 1, single for covid-19 immunization. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other vaccine in four weeks. Patient reported that he previously had dermatographia growing up, all symptoms and issues have been resolved for the past 5 years (ending when he was 23 years of age). Patient reported upon receiving his 2nd Pfizer vaccination, his symptoms of dermatographia have fully returned on 06May2021 at 20:00, that included itchy welts and hives that occurred from physical contact (scratching his skin, colliding with an object, abrasion from his pillow when he slept, etc). These symptoms have been going for a little over a month now without easing up. Patient did not receive any treatment for the events. Outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: fever (max. 102.8F) lasted two days; Headache/ Headaches continued for four days; nausea; dizziness; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself (patient).  A 24-years-old female non pregnant patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation:  solution for injection, lot number: EN6204, expiry date: unknown) via an unspecified route of administration in Left arm on 02Apr2021 as dose 2, single and bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP6955, expiry date: unknown) via an unspecified route of administration in left arm no known allergies. Concomitant medications included lamotrigine, quetiapine, bupropion, escitalopram taken for unspecified indication, start and stop date not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient did not have Covid prior to vaccination and was not tested for it post vaccination. On 14Mar2021, the patient experienced fever (max. 102.8f) lasted two days, headache/ headaches continued for four days, nausea and dizziness. The patient underwent lab tests and procedures which included body temperature:102.8 fahrenheit on an unknown date in 2021. No treatment was received by the patient for AEs. The outcome of event was recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood magnesium, Blood thyroid stimulating hormone, Erythema, Full blood count
Clinical narrative: 1st dose 13May2021 2nd doce 25May2021; T cell reaction; RUE Sever Redness; pain; This is a spontaneous report from a contactable Nurse (Patient). This nurse reported for herself in response to HCP letter sent in cross reference case which included that a 43-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Right Upper Arm on 25May2021 at 07:30 (at the age of 43-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing GERD, ongoing thyroid, Hypo, ongoing Mild HTN, ongoing seasonal allergies, EGD from Jan2021 to an unknown date. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0162), via Intramuscular route of administration, administered in Upper Right Arm on 13May2021 at 09:30 (at the age of 43-year-old) as DOSE 1, SINGLE for covid-19 immunisation and experienced lip and right cheek got very tingly/tingling in cheeks and lips, numbness that goes under her chin and down throat then from her tongue to the back of her throat/cheeks and lips went numb/numbness was all over her face bilaterally/numbness tongue down her throat, concerned about signs of Bell's palsy, pounding headache, lightheadedness and dizziness, severe left ear pain which was Important medical event as seriousness criteria which required to visit physician office and emergency room and received treatment with prednisone taper dose x days with outcome recovered on 25May2021. On 25May2021 at 07:30, the patient experienced 1st dose 13may2021 2nd dose 25may2021, t cell reaction, rue sever redness, pain. Events required to visit physician office. On 13May2021 the patient underwent lab tests and procedures which included non-fasting glucose resulted as 117, magnesium, TSH, BMP all resulted as normal, CBC: Lymphocytes absolute 3.30 H. Therapeutic measures were taken for events with Clobetasol. The outcomes of events were recovering.  Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Inappropriate schedule of product administration, Metabolic function test, Pain
Clinical narrative: 1st dose 13May2021 2nd doce 25May2021; T cell reaction; RUE Sever Redness; pain; This is a spontaneous report from a contactable Nurse (Patient). This nurse reported for herself in response to HCP letter sent in cross reference case which included that a 43-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Right Upper Arm on 25May2021 at 07:30 (at the age of 43-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing GERD, ongoing thyroid, Hypo, ongoing Mild HTN, ongoing seasonal allergies, EGD from Jan2021 to an unknown date. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0162), via Intramuscular route of administration, administered in Upper Right Arm on 13May2021 at 09:30 (at the age of 43-year-old) as DOSE 1, SINGLE for covid-19 immunisation and experienced lip and right cheek got very tingly/tingling in cheeks and lips, numbness that goes under her chin and down throat then from her tongue to the back of her throat/cheeks and lips went numb/numbness was all over her face bilaterally/numbness tongue down her throat, concerned about signs of Bell's palsy, pounding headache, lightheadedness and dizziness, severe left ear pain which was Important medical event as seriousness criteria which required to visit physician office and emergency room and received treatment with prednisone taper dose x days with outcome recovered on 25May2021. On 25May2021 at 07:30, the patient experienced 1st dose 13may2021 2nd dose 25may2021, t cell reaction, rue sever redness, pain. Events required to visit physician office. On 13May2021 the patient underwent lab tests and procedures which included non-fasting glucose resulted as 117, magnesium, TSH, BMP all resulted as normal, CBC: Lymphocytes absolute 3.30 H. Therapeutic measures were taken for events with Clobetasol. The outcomes of events were recovering.  Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Frontal sinus operation
Clinical narrative: fatigue; swollen lymph node left armpit; swollen lymph node left armpit beginning day after vaccine, currently still somewhat swollen and tender; sinus pain; congestion; full body aches; shivering/chills; hot flashes; cough; cough (from sinus drainage); headache; decreased appetite; insomnia; This is a spontaneous report from a contactable Other Health Care Professional (patient) reported for herself.   A 26-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0202) via an unspecified route of administration, administered in Arm Left on 12Jun2021 (Age at Vaccination: 26-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history includes SVT, GERD, IBS. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), cyproheptadine hydrochloride (PERIACTIN), omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), prolactin and medical marijuana taken two weeks of medication. Patient had known allergies of Sulfa drugs and Flagyl. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. 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 21May2021 (Age at Vaccination: 26-years-old) as DOSE 1, SINGLE for COVID-19 immunization. On 13Jun2021, the patient experienced swollen lymph node left armpit beginning day after vaccine, currently still somewhat had swollen and tender 6 days later, sinus pain, congestion, full body aches, shivering/chills, hot flashes, cough (from sinus drainage), headache, decreased appetite, insomnia, fatigue, all began 1-2 days after vaccine and continuing presently 6 days after vaccine. No treatment was taken for adverse events. Outcome of all adverse events was not recovered.   No follow-up attempts are possible. No further information is expected.  Other medications in two weeks: Vyvanse, prolactin, Prilosec, medical marijuana