chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Swelling face
Clinical narrative: right ankle and calf became swollen; right ankle and calf became swollen; puffiness in face; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm  on an unknown date in May2021 at 15.45 hours (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included deep vein thrombosis (DVT), pulmonary embolism (PE), and family history of diabetes. The patient have not reported any allergies to food, drugs or medication.  Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), ascorbic acid (VITAMIN C), elderberry (MANUFACTURER UNKNOWN) taken within two weeks of vaccination for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination it was unknown whether the patient had not been tested for COVID-19. On 21May2021 the patient experienced right ankle and calf became swollen once the patient returned home. That was three days ago and the patient still had the swelling, the left ankle was swollen but not as much, the patient also noticed puffiness in face. No therapeutic measures were taken as a result of the adverse events. The clinical outcome of the event right ankle became swollen (swollen ankles), calf became swollen ( calf swelling), puffiness in face (puffiness face)was not resolved at the time of the report.    No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: Breakout of hives; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ;Lot Number: EW0170) via an unspecified route of administration in the left arm on 30Apr2021 at 12:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included pollen allergy. Concomitant medications included triamcinolone acetonide (NASACORT) started on unknown date for pollen allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 12:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. On 17May2021, the patient underwent Rapid test and the result was found negative. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22May2021 at 13:00 the patient experienced breakout of hives It began around1:00 PM with hives appearing on buttocks and right hip. Hives spread to chest, back, arms, and thighs overnight. On 23May2021, At 7:00 AM patient took one 10 ml dose of children's Benadryl (liquid). The hives went away within 1-2 hours. Therapeutic measures were taken as a result of breakout of hives and included treatment with 10 ml dose of children's Benadryl (liquid) started on 23May2021. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event breakout of hives was recovered on 23May2021.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Poor peripheral circulation
Clinical narrative: Both legs feeling numb; like if they dont have oxygen going through them, I feel like the blood circulation in my legs is not the same .; heavy at times; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 15May2021 at 12:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was allergic to penicillin. The patient did not receive any medication within two weeks of 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 did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021, the patient experienced both legs felt numb, like if they did not have oxygen going through them, she felt like the blood circulation in her legs was not the same and heavy at times and she had to be constantly moving them. It was hard to explain and she did not want to get the second dose and scared as it could make it worse. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events both legs felt numb, like if they did not have oxygen going through them and blood circulation in legs was not the same and heavy at times were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Inflamed lymph nodes on  left side; Entire arm pit area swelled up; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8733), via an unspecified route of administration in the left arm on 28Mar2021 at 08:15 (at the age of 34-year-old), as a single dose for COVID-19 immunisation. Medical history included Hashimoto disease and the patient did not have a history of allergies to any food or medications or other products. Concomitant medications included levothyroxine sodium (SYNTHROID) and ethinylestradiol, norgestrel (CRYSELLE) for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), via an unspecified route of administration in the left arm on 07Mar2021 at 08:30 (at the age of 34-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 21:00, the patient experienced inflamed lymph nodes on left side and entire arm pit area swelled up. The patient reported as the events were lasted 3 days and then went away and once the inflammation went down patient felt fine. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the events. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of inflamed lymph nodes on left side and entire arm pit area swelled up were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity, Vaccination site irritation
Clinical narrative: Vaccination site irritation; Arm pain; Expired vaccine used; This is a spontaneous report from a contactable pharmacist. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an intramuscular route of administration in the left arm on 13May2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration on 20Apr2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. It was unknown if patient received any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if patient had tested for COVID-19. On 13May2021, patient was administered a short expiry lot (17 days from expiration) and patient experienced vaccination site irritation and arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event vaccination site irritation and arm pain were resolved on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Nauseous; Dizzy; Tired; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 14May2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date. On 21May2021 at 05:00, the patient experienced nauseous, dizzy and tired. Ten days after, and still felt tired, dizzy and nauseous at times, at the time of reporting. The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event nauseous, dizzy and tired was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Lymphadenopathy
Clinical narrative: This is a spontaneous report received from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 10May2021 at 14:30 (at the age of 49-years-old) as a single dose for COVID-19 immunization. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. On 17May2021, first dose after one week, patient experienced one swollen lymph nodes on right side of the armpit. It got better after 5-6days. she also had minor dizziness and weakness after one week of the shot. No therapeutic measures were taken as a result of reported events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events minor dizziness after one week of the shot, weakness after one week of the shot and first dose after one week, there is one swollen lymph nodes on right side of the armpit were resolving at the time of this report. No follow-up attempts are possible; No further information expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Chest discomfort, Dyspnoea, Heart rate decreased
Clinical narrative: Filing pression on my chest; My hearth I was filing like was bigger; He hearth rate I was feeling slow; I started filing short of breath; This is a spontaneous report from a contactable consumer. This 55-year-old female (Non-pregnant) consumer (patient) reported that himself received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date not reported), via an unspecified route of administration in Left arm on 06Apr2021 at 09:00 AM (Age at Vaccination 55-year-old) as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date not reported), via an unspecified route of administration in Left arm on 27Apr2021 at 09:15 AM, (Age at Vaccination 55-year-old) as a dose 2, single for covid-19 immunisation. Patient had no Known allergies. On 13Apr2021 8 days after patient had her first vaccine doses, patient started filing pression on my chest, and my heart she was filing like was bigger and the hearth rate she was feeling slow. The feeling was bothering all day, until she started filing short of breath. when to the hospital that day, but I wait too long and I decided to leave, two days later I went to my primary doctor, they did an EKG and told me was normal, the I went to a Cardiologist and he told me that was probably my muscle, but that I was fine. The outcome of the events recovered.  Follow up (12Jul2021): This is a follow up-spontaneous report from a contactable nurse. This nurse reported for the patient in response to HCP letter [sent to other HCP] via follow-up letter which included   Information on lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Maternal exposure during pregnancy
Clinical narrative: Swollen lymph node above collarbone,same side as injection.; is_pregnant:Yes/last_menstrual_date:16Oct2020; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in the right arm on 19May2021 at 08:45 at the age of 29-years-old as dose 2, single for COVID-19 immunisation. The patient's gestation period was 32 weeks. Medical history was reported as none and the patient did not have a history of allergies to any food or medications or other products. The patient had last menstrual cycle on 16Oct2020 and expected delivery date was 16Jul2021. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in the left arm on 28Apr2021 at 08:45 at the age of 29-years-old as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19May2021, the patient experienced is_pregnant:yes/last_menstrual_date:16oct2020 (maternal exposure during pregnancy) on 19May2021 and on 20May2021, the patient experienced swollen lymph node above collarbone, same side as injection only after the second shot. The patient did not receive any treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The mother reported she became pregnant while taking bnt162b2. The mother was 32 Weeks pregnant at the onset of the event. The mother was due to deliver on 23Jul2021. The clinical outcome of the event, Maternal exposure during pregnancy, third trimester was unknown while swollen lymph node above collarbone, same side as injection was not recovered at the time of this report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101057903 Mother/fetus
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Dry mouth, Fatigue, Lip erythema
Clinical narrative: Extreme dry mouth morning after vaccine; Red sores on inner, upper lip; Red sores on inner, upper lip; Continuing fatigue; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170), via an unspecified route of administration in the right arm on 15May2021 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history included sjogren's syndrome, depression, anxiety, asthma and fruit allergy from pineapple. Concomitant medications included levothyroxine sodium (SYNTHROID), mometasone furoate (ASMANEX), duloxetine hydrochloride (CYMBALTA) and birth control (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM), cefixime (BIOXIN), benzocaine (MANUFACTURER UNKNOWN) and resorcinol,chlorothymol, benzocaine (LANACANE); all on unknown dates for unspecified indications and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16May2021, the patient experienced extreme dry mouth morning after vaccine followed by red sores on inner, upper lip. Last for a few days then go away but return in another part of the mouth/lip and continuing fatigue. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events extreme dry mouth, red sores on inner, upper lip and continuing fatigue were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: "My mensural cycle moved forward two weeks. My period started 5 days after my second shot which was mid cycle. It is continuing regularly and the moved forward timing"; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 03Apr2021 at 14:15(at-the-age-46-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 13Mar2021 at 14:15(at-the-age-46-years-old) as a single dose for COVID-19 immunisation. On 08Apr2021 at 14:30, the patient reported that her mensural cycle moved forward two weeks as the period started 5 days after her second shot which was mid cycle continuing regularly and moved forward timing. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event her mensural cycle moved forward two weeks period started 5 days after her second shot which was mid cycle continuing regularly and moved forward timing was resolved with sequelae at the time of this report.  No follow-up attempts are possible; no further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Crook of opposite arm developed a rash; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP-6955) via an unspecified route of administration in the left arm on 15Mar2021 at 15:00 (at the age of 58-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP-7533) via an unspecified route of administration in the left arm on 06Apr2021 at 15:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as not really. The patient previously took Erythromycin (MANUFACTURER UNKNOWN) and Levaquin (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) and esomeprazole magnesium (NEXIUM) both for unknown indications from unknown start dates and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 the patient developed a rash on the crook of opposite arm. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event developed a rash on the crook of opposite arm was not resolved, at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Headache, Insomnia, Lymphadenopathy
Clinical narrative: Enlarged lymph node on left side back of neck; Hives all over body; Hives all over body, extreme itching/burning; Hives all over body, extreme itching/burning; Trouble sleeping; Some additional wheezing; Itchy throat; Headaches; Extreme back pain; Arm rash; Arm rash/soreness; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 05May2021 at 14:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included Post-Traumatic Stress Disorder (PTSD), asthma, seasonal allergies, sciatica, Adrenocorticotropic Hormone (ACTH) deficiency, trichotillomania, agoraphobia, neurological disorders otherwise unspecified, Polycystic Ovarian Syndrome (PCOS), chronic kidney stones, early stage fatty liver changes, obesity, chronic insomnia, Irritable Bowel Syndrome with Diarrhea (IBS-D), Gastroesophageal Reflux Disease (GERD) and Deep Vein Thrombosis (DVT). The patient had no allergies to medications, food, or other products. Concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX), budesonide, formoterol fumarate (SYMBICORT), levocabastine hydrochloride (ZYRTEC), salbutamol (VENTOLIN), zolpidem tartrate (AMBIEN) and ferrous sulfate (SLOW-FE), all taken for unspecified indications from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 16:00, the patient experienced enlarged lymph node on left side back of neck, hives all over body, extreme itching/burning, trouble sleeping, some additional wheezing, itchy throat, headaches, extreme back pain and arm rash and soreness. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with hydroxyzine, prednisone, recommendation Over The Counter (OTC) medications. The clinical outcome of the events enlarged lymph node on left side back of neck, hives all over body, extreme itching/burning, trouble sleeping, wheezing, itchy throat, headaches, extreme back pain and arm rash and soreness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Throat irritation, Urticaria
Clinical narrative: Enlarged lymph node on left side back of neck; Hives all over body; Hives all over body, extreme itching/burning; Hives all over body, extreme itching/burning; Trouble sleeping; Some additional wheezing; Itchy throat; Headaches; Extreme back pain; Arm rash; Arm rash/soreness; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 05May2021 at 14:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included Post-Traumatic Stress Disorder (PTSD), asthma, seasonal allergies, sciatica, Adrenocorticotropic Hormone (ACTH) deficiency, trichotillomania, agoraphobia, neurological disorders otherwise unspecified, Polycystic Ovarian Syndrome (PCOS), chronic kidney stones, early stage fatty liver changes, obesity, chronic insomnia, Irritable Bowel Syndrome with Diarrhea (IBS-D), Gastroesophageal Reflux Disease (GERD) and Deep Vein Thrombosis (DVT). The patient had no allergies to medications, food, or other products. Concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX), budesonide, formoterol fumarate (SYMBICORT), levocabastine hydrochloride (ZYRTEC), salbutamol (VENTOLIN), zolpidem tartrate (AMBIEN) and ferrous sulfate (SLOW-FE), all taken for unspecified indications from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 16:00, the patient experienced enlarged lymph node on left side back of neck, hives all over body, extreme itching/burning, trouble sleeping, some additional wheezing, itchy throat, headaches, extreme back pain and arm rash and soreness. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with hydroxyzine, prednisone, recommendation Over The Counter (OTC) medications. The clinical outcome of the events enlarged lymph node on left side back of neck, hives all over body, extreme itching/burning, trouble sleeping, wheezing, itchy throat, headaches, extreme back pain and arm rash and soreness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Enlarged lymph node on left side back of neck; Hives all over body; Hives all over body, extreme itching/burning; Hives all over body, extreme itching/burning; Trouble sleeping; Some additional wheezing; Itchy throat; Headaches; Extreme back pain; Arm rash; Arm rash/soreness; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 05May2021 at 14:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included Post-Traumatic Stress Disorder (PTSD), asthma, seasonal allergies, sciatica, Adrenocorticotropic Hormone (ACTH) deficiency, trichotillomania, agoraphobia, neurological disorders otherwise unspecified, Polycystic Ovarian Syndrome (PCOS), chronic kidney stones, early stage fatty liver changes, obesity, chronic insomnia, Irritable Bowel Syndrome with Diarrhea (IBS-D), Gastroesophageal Reflux Disease (GERD) and Deep Vein Thrombosis (DVT). The patient had no allergies to medications, food, or other products. Concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX), budesonide, formoterol fumarate (SYMBICORT), levocabastine hydrochloride (ZYRTEC), salbutamol (VENTOLIN), zolpidem tartrate (AMBIEN) and ferrous sulfate (SLOW-FE), all taken for unspecified indications from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 16:00, the patient experienced enlarged lymph node on left side back of neck, hives all over body, extreme itching/burning, trouble sleeping, some additional wheezing, itchy throat, headaches, extreme back pain and arm rash and soreness. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with hydroxyzine, prednisone, recommendation Over The Counter (OTC) medications. The clinical outcome of the events enlarged lymph node on left side back of neck, hives all over body, extreme itching/burning, trouble sleeping, wheezing, itchy throat, headaches, extreme back pain and arm rash and soreness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear disorder, Fatigue, Feeling abnormal, Head discomfort
Clinical narrative: Suspected vestibular neuritis unconfirmed; Brain fog; Head pressure; Ear fullness; Vertigo; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0167) via an unspecified route of administration in the left arm on 18May2021 at 14:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. Patient had no allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021 the patient experienced brain fog, fatigue, head pressure, ear fullness, vertigo, dizziness and suspected vestibular neuritis unconfirmed. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the adverse events and included treatment with NSAID (MANUFACTURER UNKNOWN) from unknown date and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event brain fog, fatigue, head pressure, ear fullness, vertigo, dizziness and suspected vestibular neuritis unconfirmed was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vestibular neuronitis
Clinical narrative: Suspected vestibular neuritis unconfirmed; Brain fog; Head pressure; Ear fullness; Vertigo; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0167) via an unspecified route of administration in the left arm on 18May2021 at 14:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. Patient had no allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021 the patient experienced brain fog, fatigue, head pressure, ear fullness, vertigo, dizziness and suspected vestibular neuritis unconfirmed. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the adverse events and included treatment with NSAID (MANUFACTURER UNKNOWN) from unknown date and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event brain fog, fatigue, head pressure, ear fullness, vertigo, dizziness and suspected vestibular neuritis unconfirmed was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pruritus
Clinical narrative: Itchiness which led to rash; Excruciating headache; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19May2021 at 09:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, meniere's disease. The patient had known allergies to strawberries, watermelon, drugs penicillin and valsartan. Concomitant medications included hydralazine (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 09:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19May2021 at 10:30 the patient experienced itchiness which led to rash, excruciating headache and diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events itchiness which led to rash, excruciating headache and diarrhea were not recovered at the time of this report.  No follow-up attempts are needed; information about lot\batch number cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea at rest
Clinical narrative: Shortness of breath without exerting myself; Minor chest pain in the center; This is a spontaneous report from a contactable consumer (patient himself). A 39-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, at age 39 years (as reported), administered in left arm on 02May2021 15:00 (Batch/Lot Number: ER8735) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history was none. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. On 03May2021 at 11:00, patient experienced shortness of breath without exerting himself and minor chest pain in the center. No treatment for the adverse events. Facility where the most recent COVID-19 vaccine was administered at a pharmacy/drugstore. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The patient was vaccinated with BNT162B2 (lot number: ER8736) on the left arm on 23May2021 at 03:00 PM as DOSE 2, SINGLE, for COVID-19 immunisation.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe ringing in my ears; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 27Mar2021 at 03:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. Concomitant medications included atorvastatin calcium (LIPITOR), cetirizine hydrochloride (ZYRTEK), acetylsalicylic acid (BABY ASPIRIN) and allopurinol sodium (ALLOPURINOL); all from an unknown date for unknown indications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 14:00, the patient experienced severe ringing in ears. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events an included treatment with sleep aid because ringing was so loud and could not sleep. The clinical outcome of the event severe ringing in ears was not recovered at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 17Apr2021 at 13:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling in arm / tingling got worse.; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EE0164) via an unspecified route of administration in the left arm on 16Apr2021 at 12:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 07May2021 at 14:15 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have allergies to medications, food, or other products. The patient did not receive any medication within two weeks of 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 did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021, after the first shot, the patient experienced tingling in the left arm where the shot was given and she did not have this before. After the second shot, the tingling got worse. She was almost 3 weeks after the shot, but it did not go away. It got worse when she slept and when she lifted her arm. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tingling in arm was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Heart rate, Heart rate increased, Pain
Clinical narrative: Severe chest pain; Elevated heart rate.; Dizziness; Fever; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 53-years-old male patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8729) via an unspecified route of administration in left arm on 30Apr2021 at 13:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included blood clots and penicillin allergy. Concomitant medications included doxycycline (ORACEA) for an unknown indication from an unknown duration. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8729) via an unspecified route of administration in left arm on 08Apr2021 at 15:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Apr2021 (at 02:00 as reported), the patient had experienced severe chest pain, elevated heart rate, dizziness, fever and body aches. On 30Apr2021, the patient underwent Heart rate and the result was Elevated. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the events severe chest pain, elevated heart rate, dizziness, fever and body aches was recovered on unknown date.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe chest pain; Elevated heart rate.; Dizziness; Fever; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 53-years-old male patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8729) via an unspecified route of administration in left arm on 30Apr2021 at 13:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included blood clots and penicillin allergy. Concomitant medications included doxycycline (ORACEA) for an unknown indication from an unknown duration. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8729) via an unspecified route of administration in left arm on 08Apr2021 at 15:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Apr2021 (at 02:00 as reported), the patient had experienced severe chest pain, elevated heart rate, dizziness, fever and body aches. On 30Apr2021, the patient underwent Heart rate and the result was Elevated. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the events severe chest pain, elevated heart rate, dizziness, fever and body aches was recovered on unknown date.  No follow-up attempts are needed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Bad rash on his chest, stomach, privates, back; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the right arm on 18May2021 at 13:15 as a single dose for COVID-19 immunisation. Medical history included central processing auditory disorder and COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20May2021 at 16:00, 2 days after the vaccination, the patient experienced bad rash on his chest, stomach, privates, back. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. The clinical outcome of bad rash on his chest, stomach, privates, back was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acne
Clinical narrative: Pimples or like pimples on neck back and left side near ear and surrounding area; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the right arm on 17May2021 at 11:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis C and other related pain issues. The patient had known allergies to unspecified medications, food, or other products. Concomitant medications included tamsulosin (MANUFACTURER UNKNOWN), oxycodone (MANUFACTURER UNKNOWN), tapentadol hydrochloride (NUCYNTA ER), diazepam (MANUFACTURER UNKNOWN) and vitamins; all taken from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 23Apr2021 at 09:45 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021 at 17:00, the patient experienced pimples or like pimples on neck back and left side near ear and surrounding area. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event pimples or like pimples on neck back and left side near ear and surrounding area was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Odynophagia, Pyrexia, SARS-CoV-2 test
Clinical narrative: 101.7 degree fever,; pain when swallowing; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO183) via an unspecified route of administration in the left arm on 10May2021 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24May2021, the patient reported that after 2 weeks of receiving first dose, the patient noticed white glands in back of throat and experienced 101.7 degree fever, pain when swallowing. On an unknown date, the patient underwent nasal swab test and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. On 24May2021, the patient underwent test for body temperature and the result was 101.7 degree fever. The clinical outcome for the events fever and swallowing painful were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.