chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival discolouration, Implant site pain, Mastication disorder, Stomatitis
Clinical narrative: experiencing sores around those implants/quite painful; hard to chew; the regions are blackening.; "I" have implants and I am experiencing sores around those implants; This is a spontaneous report from a contactable consumer, the patient. A 52-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 on 22Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included dental implant. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an an unknown date as a single dose for COVID-19 immunisation. The patient had implants and on 26Apr2021 the patient experienced sores around those implants which makes it hard to chew and were quite painful, also those regions were blackening. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sores around those implants which makes it hard to chew and were quite painful and also those regions were blackening, were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Extreme fatigue; Extreme chills; Extreme muscle aches; Fever 102; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 03May2021 at 15:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included Penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 11Apr2021 at 16:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 03May2021 at 18:30, the patient experienced extreme fatigue, extreme chills, extreme muscle aches, fever 102 (unspecified units). on the same day(03May2021) the patient checked body temperature and the result was found to be 102 (unspecified units). Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue, extreme chills, extreme muscle aches and fever 102 was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Throat irritation
Clinical narrative: getting a tickle down at the bottom of our throat to our chest; coughing our heads off; This is a spontaneous report from a contactable consumer (reported for her husband) via medical information team. A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0172, Expiry date: unknown) via an unspecified route of administration in arm left on 27Apr2021 (at the age of 66-years-old) 14:00 as dose number 2, single for COVID-19 immunization. Patient was diabetic from an unknown date which was diagnosed 4 years ago and had blood pressure high from an unknown date and was diagnosed when he was 16 years old and patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0150, Expiry date: unknown) via an unspecified route of administration in left arm 06Apr2021 as dose number 1, single for COVID-19 immunization. The patient's concomitant medications were not reported. Patients wife stated that she and her husband (patient) both got vaccinated at the same time. They had no symptoms of anything and stayed there for 15 minutes. On their way home, 20 minutes into the drive, they started getting a tickle down at the bottom of their throat to their chest. Before they got home, they both started coughing their heads off. It has continued until yesterday (which was one week from receiving the vaccine) and now they still have a cough. The patient came down with a cough after receiving the shot which has lasted about a week. These events happened after the second dose, the first dose was fine, they did not have any side effects with the first one. Reporter and her husband experienced an adverse event with the second dose of the Pfizer Covid-19 vaccine. They received both doses. Outcome of event getting a tickle down at the bottom of our throat to our chest was recovering and coughing our heads off was recovered on unspecified date in May2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021503831 same reporter/drug/event, different patient
Age: 30.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Oropharyngeal discomfort, Throat irritation, Vaccination site erythema, Vaccination site rash
Clinical narrative: itching and "knot" in throat; superficial red bumps to upper right arm near vaccination site; itching and "knot" in throat; superficial red bumps to upper right arm near vaccination site; This is a spontaneous report from a contactable pharmacist. A 30-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8733), via intramuscular route of administration in the right arm on 29Apr2021 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization, rubella vaccine (RUBELLA), via an unspecified route of administration on 29Apr2021, (Batch/Lot number was not reported), for immunization. Medical history included known allergies, HPV vaccine, penicillin, walnuts, amoxicillin, avocado, azithromycin, banana, ciprofloxacin, grapes and asthma, crohns disease, ulcerative colitis, migraines, allergies from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8733), via intramuscular route of administration in the left arm on 08Apr2021 as dose 1, single for COVID-19 immunization. The patient did not receive any other medication in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that, patient developed mild itching and knot in throat, superficial red bumps to upper right arm near vaccination site. Patient was given 2 cups of water and symptoms resolved soon after. The patient did not receive any treatment for the events. The clinical outcome for the events was recovered on an unspecified date in 2021.  No follow-up attempts are required. No further information is expected
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: 'My' period cycle started 10 days early and it is heavier than usual; 'My' period cycle started 10 days early and it is heavier than usual; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient 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 10Apr2021 at the age of 33-years-old as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient did not take any concomitant medications. 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 COVID-19 vaccine. On 01May2021, the patient's period cycle started 10 days early and it was heavier than usual. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period cycle started 10 days early and it was heavier than usual was resolving at the time of the report.   No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: Severe constant upper abdominal pain; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), budesonide, formoterol fumarate (SYMBICORT), atorvastatin (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID) and metoclopramide hydrochloride (LIOTHYL): all from an unknown date for unspecified indication and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. On 05Mar2021 at 17:00, the patient experienced severe constant upper abdominal pain and nausea. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of severe constant upper abdominal pain and nausea and included treatment with unspecified anti-nausea medications (meds) and pain killers. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe constant upper abdominal pain and nausea was recovered on unknown date on 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Rash pruritic
Clinical narrative: day before getting the first vaccine, a medication she took and to which she had not reacted in the past was increased; rash persisted and worsened after the second dose; crazy itchy rash travelling on [her] body; feels like a "deep sort of pain"; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history included rash from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, via an unspecified route of administration from an unspecified date (Lot: unknown) to an unspecified date, as a single dose for covid-19 immunization. Reporter reported patient took Shingles at a younger age. The patient experienced day before getting the first vaccine, a medication the patient took and to which the patient had not reacted in the past was increased. On an unspecified date the patient experienced rash persisted and worsened after the second dose, crazy itchy rash travelling on her body, deep sort of pain and rash after each dose of the vaccine. The reporter reported that after each dose patient developed a rash, but it was worse after the second dose, stated patient had a deep pain like shingles, not readily going away, crazy itching traveling on her body, has been 4 weeks that she has had the rash. The doctors decided to stop the medication. The reporter reported regardless, the rash was worse after the second dose of the vaccine. Doctors determined the rash was due to the vaccine and may be starting medication for shingles as the rash was persisting. The outcome of the events of Rash aggravated, Itchy rash, pain and Potentiating drug interaction was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Muscular weakness
Clinical narrative: Dose 1: Legs became week. Could move them, but not stand up on them. Lasted approximately 2-3 hours. Reaction occurred within 15 minutes after the shot. Nurses made me go to the ER.; Dose 1: Legs became week. Could move them, but not stand up on them. Lasted approximately 2-3 hours. Reaction occurred within 15 minutes after the shot. Nurses made me go to the ER.; This is a spontaneous report from a contactable consumer (Patient himself). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8727 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 26Mar2021 12:15 as dose 1, single for COVID-19 immunization (Age at Vaccination was 57 years). The patient also received (other vaccine 4 weeks prior COVID vaccine) Diphtheria vaccine toxoid, Pertussis vaccine acellular 5-component, Tetanus vaccine toxoid (ADACEL, Lot Number: C5667AA), via an unspecified route of administration, administered in Arm Left on 11Mar2021 as dose 1, single for an unspecified indication and PMC (Sanofi). The patient medical history included Epilepsy, Migraine, Central Vestibular Disorder, and allergic to Sulpha Drugs and Shellfish from an unknown date and unknown if ongoing. Concomitant medications (Other medications in two weeks) included Clonazepam, Lacosamide, Lamotrigine and Omeprazole. It was reported that, he was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. On 26Mar2021 12:30, the patient experienced that his Legs became week, could move them, but not stand up on them, lasted approximately 2-3 hours, reaction occurred within 15 minutes after the shot. Nurses made him go to the ER. The patient has visited Emergency room as a result of events. The information regarding therapeutic measures taken as a result of events was unknown. The outcome of the events was recovered with sequelae on unspecified date of 2021.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling cold, Headache, Myalgia
Clinical narrative: Muscle pain; Joint pain; Feeling cold; Headache; Tired; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the right arm on 27Apr2021 at 12:30 (at the age of 42-years-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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 06Apr2021 at 14:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 01:45, the patient experienced muscle pain, joint pain, felt cold, headache and tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain, joint pain, felt cold, headache, tired was resolving 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: Rash, Urticaria
Clinical narrative: Hives on flank; heavier on opposite side from injection site; Rash on vaccine side of body under where purse strap rested/placed pressure; 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: UNKNOWN) via an unspecified route of administration in the arm left on 03May2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The medical history included nickel allergy. 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. The concomitant medications included escitalopram oxalate (LEXAPRO), desogestrel/ ethinylestradiol (MIRCETTE) and women's gummy multivitamin, all from unknown dates for unknown indications and unknown if ongoing. The patient previously took amoxicillin (MANUFACTURER UNKNOWN), linalool (MANUFACTURER UNKNOWN)  and experienced allergy. On 04May2021, the patient experienced hives on flank, heavier on opposite side from injection site and rash on vaccine side of body under where purse strap rested/placed pressure. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives on flank and rash on vaccine side of body under where purse strap rested/placed pressure were resolving at the time of this report.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Developed a rash; it looks like hives; Developed a rash; it looks like hives; This is a spontaneous report from a contactable consumer (patient's parent). A 16-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW0162, Expiry date: not reported) (age at the time of vaccination was 61 years), administered in Arm Left on 20Aper2021 as dose 2, single for COVID-19 immunization. The patient's medical history included pre-diabetic. The patient's concomitant medication was not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, on 01Apr2021 as dose 1, single for COVID-19 immunization. On 03May2021, the patient developed rash it looks like a hives. Treatment received included benadryl. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Pregnancy test, SARS-CoV-2 test
Clinical narrative: Menstrual period was supposed to start on April 17, it is now May 5 and still not started; This is a spontaneous report from a contactable nurse, the patient. A 32-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E19262) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in the left arm on 22Jan2021 at 13:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021, the patient's menstrual period was supposed to have started and until 05May2021, it had still not started. Her cycle was generally very normal and she had taken 3 home pregnancy tests and all were negative. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 20Apr2021, the patient underwent SARS-COV-2 test via nasal swab and the result was negative. The clinical outcome of the event menstrual period was supposed to have started and until 05May2021, it had still not started was unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Feeling abnormal, Headache, Myalgia
Clinical narrative: Fever; Muscle aches; Joint aches; Brain fog; Anxiety; Headache; Increased tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0173) via an unspecified route of administration in the left arm on 04Apr2021 at 11:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis and allergy to wheat. Concomitant medications included ferrous gluconate, vitamins nos, herbal nos (FLORADIX) taken for iron supplementation from an unknown date and unknown if ongoing. 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 COVID vaccine. On 05Apr2021 at 12:00, the patient experienced fever, muscle aches, joint aches, brain fog, anxiety, headache and increased tinnitus. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, muscle aches, joint aches, brain fog, anxiety, headache and increased tinnitus was resolved on an unknown date in 2021. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 02May2021 at 11:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Fever; Muscle aches; Joint aches; Brain fog; Anxiety; Headache; Increased tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0173) via an unspecified route of administration in the left arm on 04Apr2021 at 11:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis and allergy to wheat. Concomitant medications included ferrous gluconate, vitamins nos, herbal nos (FLORADIX) taken for iron supplementation from an unknown date and unknown if ongoing. 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 COVID vaccine. On 05Apr2021 at 12:00, the patient experienced fever, muscle aches, joint aches, brain fog, anxiety, headache and increased tinnitus. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, muscle aches, joint aches, brain fog, anxiety, headache and increased tinnitus was resolved on an unknown date in 2021. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 02May2021 at 11:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Insomnia
Clinical narrative: Insomnia; Dose 1: 17Apr2021 and Dose 2: 02May2021; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 02May2021 at 12:00 (at the age of 45-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 concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 02May2021 at 16:00, the patient experienced insomnia. The event insomnia did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event insomnia was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Heart rate, Heart rate increased, Poor peripheral circulation, Pyrexia
Clinical narrative: Fever; poor circulation in hands and feet; resting heart rate over 100; severe abdominal cramps; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant adult female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW150) via an unspecified route of administration in the arm left on 22Apr2021 at 18:00, as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. On an unknown date in 2021, the patient experienced fever, poor circulation in hands and feet, resting heart rate over 100 and severe abdominal cramps. On an unknown date in 2021, the patient's heart rate was measured and the result was found to be resting heart rate above 100. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, poor circulation in hands and feet, resting heart rate over 100 and severe abdominal cramps were resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Sore R armpit; swollen lymph nodes in armpit and throat; swollen lymph nodes in armpit and throat; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 04May2021 at 10:45 (at the age of 22-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. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. 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 right arm on 13Apr2021 at 10:45 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. On 05May2021 at 10:00, the patient experienced sore right armpit and swollen lymph nodes in armpit and throat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore right armpit and swollen lymph nodes in armpit and throat was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Breast tenderness, Erythema, Rash erythematous
Clinical narrative: On the 7th day a red rash also appeared on legs; Tenderness, redness and swelling on both breasts; Tenderness, redness and swelling on both breasts; Tenderness, redness and swelling on both breasts; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 26Apr2021 at 14:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included ductal carcinoma in situ (DCIS) in 2011 and recent urinary tract infection (UTI); both were unknown if ongoing and it was reported that she had implants due to breast reconstruction in 2011 following a bi-lateral mastectomy. The patient had no known allergies. 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 medication included unspecified antibiotics for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 04Apr2021 at 12:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 01May2021 at 15:00, 5 days after the second dose, the patient experienced tenderness, redness and swelling on both breasts. On 03May2021, 7 day after the vaccination, the patient had red rash appeared on her legs. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with unspecified antibiotics where her doctor feared for possible infection. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tenderness, redness and swelling on both breasts and red rash appeared on her legs was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Dysgeusia, Parosmia, Taste disorder
Clinical narrative: My sense of smell and taste have been altered.; My sense of smell and taste have been altered.; I cannot eat without having a burnt taste in my mouth.; Many things I cannot smell; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Apr2021 at 12:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Apr2021, the patient experienced sense of smell and taste had been altered and the patient could no longer enjoy any fried food, most meat, and a lot of grilled style foods, she couldn't eat without having a burnt taste in her mouth and many things she couldn't smell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sense of smell and taste had been altered, burnt taste in mouth and many things she couldn't smell was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever; Chills; Body aches; Headache; Upset stomach; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04May2021 at 09:00 (at the age of 29-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 take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 16Apr2021 at 09:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 04May2021 at 18:30, the patient experienced fever, chills, body aches, headache and upset stomach. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, body aches, headache and upset stomach were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Restlessness
Clinical narrative: Restlessness; Insomnia; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 27-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. Concomitant medication was not reported. It was not reported if the patient had received other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced restlessness and insomnia. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events restlessness and insomnia were unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Night sweats, Pruritus
Clinical narrative: Itching of entire body; Profuse sweating at night; Insomnia; This is a spontaneous report from a contactable other healthcare professional, the patient. A 46-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 01:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included hypersensitivity reactions and penicillin allergy. 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. The patient did not receive any concomitant medications within 2 weeks prior to the vaccination. On 15Apr2021, the patient experienced itching of entire body, profuse sweating at night and insomnia for 2 weeks. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not 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 insomnia was resolved with sequelae on 29Apr2021, after the duration of two weeks while that of the events itching of entire body and profuse sweating at night were resolved with sequelae on an unknown date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Headache; Pain at the injection location; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04May2021 at 19:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient has no known allergies. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and empagliflozin (JARDIANCE) all taken for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 20:00, the patient experienced headache for about 5 hours and slight headache 15 hours later, improving and pain at the injection location. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache and pain at injection location was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Infertility, Infertility tests
Clinical narrative: Extended menstrual period (more than 10days); Low fertility hormones; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration on an unknown date (at the age of 37-years-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. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date, the patient experienced extended menstrual period (more than 10 days) and low fertility hormones. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient underwent lab tests and procedures included fertility hormonal test and the result was found to be low fertility hormones. The clinical outcome of the events extended menstrual period (more than 10 days) and low fertility hormones was not resolved at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Menstruation irregular, Pain, Pyrexia
Clinical narrative: Fever; Chills; Headache; Sever Body aches; Change in menstrual  cycle up to and possible beyond 2 month of last dose; This is a spontaneous report from a contactable healthcare professional, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 13Mar2021 at the age of 39-years-old as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, atopic dermatitis, asthma, calculus of the kidney, migraines, cystic-bullous disease of lung, and multiple idiopathic pulmonary cysts. 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. The patient received unspecified concomitant medication within two weeks of vaccination. The patient previously received ESTROGEN from an unknown date for an unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 20Feb2021 at the age of 39-years-old as a single dose for COVID-19 immunisation. On 12Apr2021, the patient experienced fever, chills, headache, sever body aches, changes in menstrual cycle up to, and possible beyond 2 months of last dose. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, headache, sever body aches, change in menstrual cycle up, and possible beyond 2 months of last dose was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site scab
Clinical narrative: About three days after injection, it felt like a cut had opened at the injection site and then a thin vertical scab about 0.5 inches long formed at the injection site. The scab is still there 2 weeks; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 27Apr2021 at 10:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Apr2021, about three days after injection, the patient felt like a cut had opened at the injection site and then a thin vertical scab about 0.5 inches long formed at the injection site. The scab was still there 2 weeks later. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt like a cut had opened at the injection site and then a thin vertical scab about 0.5 inches long formed at the injection site was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Severe pain in right arm; Severe pain in shoulder; This is a spontaneous report from a non-contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the arm left on 27Apr2021 at 17:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. 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 arm left on 06Apr2021 20:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 02May2021, after moderate yard work during afternoon, at 23:00 the patient experienced severe pain in right arm and severe pain in shoulder. The patient reported that, the pain was worsening. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with unspecified pain killer and ice pad. The clinical outcome of the events severe pain in right arm and severe pain in shoulder was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.