chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Headache, Hypoaesthesia oral, Musculoskeletal stiffness
Clinical narrative: Pepper spray feeling in mouth; Numbness around lips; Slight tightness of throat; Headache; Jaw pain; Ear pain; Chills; Neck stiffness; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Er8733), via an unspecified route of administration in the right arm on 30Mar2021 at 09:00 (at an age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient had an allergic reaction to ocrelizumab (OCREVUS). The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 30Mar2021, about 5 to 10 min after vaccine, the patient experienced pepper spray feeling in mouth, numbness around lips, slight tightness of throat, headache, jaw pain and ear pain. 12 hrs later, the patient still felt the same, but experienced chills, neck stiffness, arm pain. The events resulted in emergency room/department or urgent care visit. The patient did not receive any treatment for reported events. The clinical outcome of events pepper spray feeling in mouth, numbness around lips, slight tightness of throat, headache, jaw pain, ear pain, chills, neck stiffness, pain in arm were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain in jaw, Taste disorder, Throat tightness
Clinical narrative: Pepper spray feeling in mouth; Numbness around lips; Slight tightness of throat; Headache; Jaw pain; Ear pain; Chills; Neck stiffness; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Er8733), via an unspecified route of administration in the right arm on 30Mar2021 at 09:00 (at an age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient had an allergic reaction to ocrelizumab (OCREVUS). The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 30Mar2021, about 5 to 10 min after vaccine, the patient experienced pepper spray feeling in mouth, numbness around lips, slight tightness of throat, headache, jaw pain and ear pain. 12 hrs later, the patient still felt the same, but experienced chills, neck stiffness, arm pain. The events resulted in emergency room/department or urgent care visit. The patient did not receive any treatment for reported events. The clinical outcome of events pepper spray feeling in mouth, numbness around lips, slight tightness of throat, headache, jaw pain, ear pain, chills, neck stiffness, pain in arm were not resolved 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: Burning sensation, Hypoaesthesia
Clinical narrative: entire head was numb in addition to the top 1/2 of the face; head burning from the inside out and numb; 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: wep6955), via an unspecified route of administration in the left arm on 24Mar2021 at 08:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to food, medications, or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccines 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 24Mar2021 at 21:00, the patient felt her head burning from inside out and numb. It felt like she was boiling, however, no temperature. The entire head was numb in addition to the top 1/2 of her face. The patient did not receive any treatment for the events burning sensation and numbness facial. The clinical outcomes of the events burning sensation and numbness facial were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Pyrexia, Vomiting
Clinical narrative: chills; fever; fatigue; vomiting; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 58-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 right arm on 27Mar2021 at 11:00 (at the age of 58-years-old) as a single for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN). The patient did not have a history of allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021, 21:00, the patient experienced chills, fatigue, fever, vomiting and diarrhea. The patient did not receive any treatment for the reported events. Adverse 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 chills, fatigue, fever, vomiting and diarrhea was resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Mouth ulceration, Oral pain, Pain
Clinical narrative: mouth ulcer; Roof of mouth pain and tenderness; Low grade fever; body aches; no energy; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 27Mar2021 at 13:15 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included that the patient was a smoker. The patient had no known allergies to food, medications, or other products. The patient did not receive any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 06Mar2021 at 13:15 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. On 27Mar2021, first day of vaccination, the patient had low grade fever of 99.7 (unspecified units), body aches and no energy.  On 28Mar2021 at 12:00, second day of vaccination, the patient experienced ulcer in roof of the mouth, with pain and tenderness. On 29Mar2021, third day of vaccination, the mouth pain was worse. The patient reported that she was feeling better at the time of report except for mouth pain. The patient did not receive any treatment for the reported events. The event neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The clinical outcome of the events mouth ulcer with pain and tenderness was not resolved, while that of low grade fever, body aches and no energy was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: mouth ulcer; Roof of mouth pain and tenderness; Low grade fever; body aches; no energy; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 27Mar2021 at 13:15 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included that the patient was a smoker. The patient had no known allergies to food, medications, or other products. The patient did not receive any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 06Mar2021 at 13:15 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. On 27Mar2021, first day of vaccination, the patient had low grade fever of 99.7 (unspecified units), body aches and no energy.  On 28Mar2021 at 12:00, second day of vaccination, the patient experienced ulcer in roof of the mouth, with pain and tenderness. On 29Mar2021, third day of vaccination, the mouth pain was worse. The patient reported that she was feeling better at the time of report except for mouth pain. The patient did not receive any treatment for the reported events. The event neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The clinical outcome of the events mouth ulcer with pain and tenderness was not resolved, while that of low grade fever, body aches and no energy was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain
Clinical narrative: Swollen lymph under left arm; Headache; Body ache; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8727), via an unspecified route of administration in left arm on 25Mar2021 at 17:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included that the patient was diagnosed with COVID-19. Concomitant medications included vitamin b12 (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN). The patient was allergic to morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since having the vaccine, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced swollen lymph under her left arm where the vaccine was received and also experienced headache and body ache. The patient had not received any treatment measure for the reported events. The adverse event 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 swollen lymph, headache and body ache was unknown at the time of this report.  No follow-up attempts possible. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Mete swelled; This is a spontaneous report from a contactable health care professional. A 39-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: ER8730, Expiration date: not reported) via an unspecified route of administration, administered in Arm Left on 25Mar2021 18:00 (at the age of 39-year-old) as single dose for covid-19 immunisation. The patient medical history included allergy to mushroom. . Concomitant medication included lorazepam (ATIVAN) taken for an unspecified indication; zolpidem tartrate (AMBIEN) taken for an unspecified indication; gabapentin taken for an unspecified indication. The patient previously took diphenhydramine hydrochloride (BENADRYL), Morphine, Toradol and had allergies to these drugs. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested positive for covid-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 18:30 the patient experienced mete swelled. The patient received Steroid injection treatment for the event. The outcome of the event was recovering.   No follow-up attempts are possible; information about batch number cannot be obtained. ; Sender's Comments: Considering a plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported 'mete swelled' cannot be completed excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Decreased appetite, Hangover, Pain
Clinical narrative: I had 8 hangovers at once; complete loss of appetite; constant body aches and pain; intrusive brain fog; Any time I would sit down it would take at least 10 minutes to have the physical energy to stand up again.; This is a spontaneous report received from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on 26Mar2021 at 14:00 (at the age of 21-years-old), as a single dose for COVID-19 immunisation. Medical history included bipolar disorder. The patient had known allergies to artificial sweeteners, fish and tree nuts. The concomitant medication included lamotrigine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date. 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. On 27Mar2021 at 08:00, the patient experienced feeling like she had 8 hangovers at once after waking up and had experienced complete loss of appetite for full day, constant body aches and pain, and intrusive brain fog. It was also reported that at any time the patient would sit down, it would take at least 10 minutes to have the physical energy to stand up again. 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 events. The clinical outcome of the events hangover, appetite lost, general body pain, mental confusion and loss of energy was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever 100.1; fatigue; muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8732) via an unspecified route of administration in the left arm on 27Mar2021 at 14:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, obesity, high blood pressure and allergy to Sulphate drugs. . The patient received unspecified medications with in 2 weeks of the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021, the patient experienced fever, fatigue and muscle aches. The patient did not receive any treatment for the reported events. On 30Mar2021, the patient had a  body temperature of 100.1 (Unspecified units). 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 fever, fatigue and muscle aches was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Swelling face, Vaccination site pain
Clinical narrative: Puffiness on left side above waist (armpit, face); Headache; Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), via an unspecified route of administration on the left arm on 01Mar2021 at 08:15 (at the age of 62-year-old), as a first single dose for COVID-19 immunisation. Medical history included atrial fibrillation and other heart concerns. Concomitant medication included mtroplol (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), furosemide (MANUFACTURER UNKNOWN), Lsrtn (MANUFACTURER UNKNOWN), Xrlto (MANUFACTURER UNKNOWN), Actomnphn (MANUFACTURER UNKNOWN). The patient did not know whether had any known allergies. 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Mar2021 at 08:15, the patient experienced headache, very minor puffiness on left side above waist (armpit, face), extremely minors injection site soreness only if touched the next day. The patient also reported that headache and puffiness were gone next morning and soreness did not even last the entire day following injection. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, puffiness on left side above waist (armpit, face) was resolved on 02Mar2021 and injection site soreness was resolved on an 01Mar2021at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: Arm hurt where injected for 48 hours after shot; Swollen lymph node; Painful under right arm after shot; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non- pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number; Er2613), via an unspecified route of administration in the right arm on 25Mar2021 at 16:15 (at the age of 28-years-old), as single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number; En6199), via an unspecified route of administration in right arm on 04Mar2021 at 16:15 (at the age of 28-years-old), as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 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 tested for COVID-19. On 26Mar2021 at 04:00, the patient experienced hurtful arm where injected for 48 hours after shot, swollen lymph node and painful under right arm after shot. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events vaccination site pain, swollen lymph node and armpit pain was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Dysgeusia, Pruritus, Throat irritation
Clinical narrative: Itching all over; Itching increased to a burning; Minor chest burning; Tongue/throat itching; Tongue/throat itching; A metallic taste in the mouth; This is a spontaneous report from a non-contactable consumer (patient) reported for herself. A 32-year-old non pregnant female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot Number: ER8727) via an unspecified route of administration in arm Left on 22Mar2021 09:30 as dose 1, single at the age of 32 year for COVID-19 immunisation. Medical history included migraines, allergies to pineapples, nickel, from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, 09:45 AM 15 minutes after injection, patient experienced itching all over and a metallic taste in the mouth. Received a steroid shot that same day because itching increased to a burning and tongue/throat itching. As of today, five days after injection, I am still experiencing the same symptoms itching all over, occasional tongue, throat itching, minor chest burning. Treatment received was asteroid shot/steroid prescription/referral. Prescription of steroids and Benadryl stopped working. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue pruritus
Clinical narrative: Itching all over; Itching increased to a burning; Minor chest burning; Tongue/throat itching; Tongue/throat itching; A metallic taste in the mouth; This is a spontaneous report from a non-contactable consumer (patient) reported for herself. A 32-year-old non pregnant female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot Number: ER8727) via an unspecified route of administration in arm Left on 22Mar2021 09:30 as dose 1, single at the age of 32 year for COVID-19 immunisation. Medical history included migraines, allergies to pineapples, nickel, from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, 09:45 AM 15 minutes after injection, patient experienced itching all over and a metallic taste in the mouth. Received a steroid shot that same day because itching increased to a burning and tongue/throat itching. As of today, five days after injection, I am still experiencing the same symptoms itching all over, occasional tongue, throat itching, minor chest burning. Treatment received was asteroid shot/steroid prescription/referral. Prescription of steroids and Benadryl stopped working. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Body temperature, Decreased appetite, Fatigue
Clinical narrative: Swelling in the right armpit, close to side of breast.; About 24 hours later a little bit of swelling and aching transferred to left armpit as well.; Low grade fever -elevated just 1 above normal; Fatigue; Shooting pains in ankles and knees; Lessened appetite; slight nausea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the right arm on 27Mar2021 at 16:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included overweight, fatty liver and  latex allergy. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), one dose one week prior and lansoprazole (MANUFACTURER UNKNOWN) on an unknown date; both for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the right arm on 06Mar2021 at 15:45 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 17:45, the patient experienced swelling of the right armpit close to side of breast and the swelling was painful. It was significant enough to be obvious through clothing. About twenty-four hours later a little bit of swelling and aching transferred to left armpit as well. The patient also experienced low grade fever (elevated just 1 degree above normal), fatigue, shooting pains in ankles and knees, lessened appetite and slight nausea. The patient did not receive any treatment for the reported events. 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 axillary mass, axillary pain, low grade fever, fatigue, shooting pain, decreased appetite and nausea was recovering at this time of this report.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Swelling in the right armpit, close to side of breast.; About 24 hours later a little bit of swelling and aching transferred to left armpit as well.; Low grade fever -elevated just 1 above normal; Fatigue; Shooting pains in ankles and knees; Lessened appetite; slight nausea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the right arm on 27Mar2021 at 16:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included overweight, fatty liver and  latex allergy. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), one dose one week prior and lansoprazole (MANUFACTURER UNKNOWN) on an unknown date; both for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the right arm on 06Mar2021 at 15:45 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 17:45, the patient experienced swelling of the right armpit close to side of breast and the swelling was painful. It was significant enough to be obvious through clothing. About twenty-four hours later a little bit of swelling and aching transferred to left armpit as well. The patient also experienced low grade fever (elevated just 1 degree above normal), fatigue, shooting pains in ankles and knees, lessened appetite and slight nausea. The patient did not receive any treatment for the reported events. 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 axillary mass, axillary pain, low grade fever, fatigue, shooting pain, decreased appetite and nausea was recovering at this time of this report.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Nausea, Vaccination site pain
Clinical narrative: Pain around injection site; Severe fatigue; mild muscle/ joint pain; mild muscle/ joint pain; Mild nausea; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6995), via an unspecified route of administration in the right arm on 25Mar2021 at 08:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications received within two weeks of vaccination included methylphenidate hydrochloride (RITALIN), Sertraline hydrochloride (ZOLOFT) and testosterone (MANUFACTURER UNKNOWN) for unknown indications from unknown date. On 25Mar2021 at 12:00, the patient experienced pain around injection site, severe fatigue, mild muscle/ joint pain and mild nausea. The patient did not receive any treatment for the events. 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 vaccination site pain, severe fatigue, muscle pain, joint pain and mild nausea was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable consumer, the patient. A 63-Year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP 7534) via an unspecified route of administration in left arm on 24Mar2021 at 16:00 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patient medical history included atrial fibrillation, chronic obstructive pulmonary disease (COPD), benign prostatic hyperplasia (BPH) and tinnitus. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), WELLBUTRIN, atenolol (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN), SYMBICOR received within 2 weeks of vaccination. The patient had known allergies to penicillin, terramycin and lomotil. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. On 25Mar2021 at 01:00, the patient experienced ongoing tinnitus in left ear that had intensified dramatically since vaccine dose. On 13Mar2021, the patient underwent nasal swab (rapid test) and the test result was negative. 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. No therapeutic measures were taken as a result of the event. The clinical outcome for the event tinnitus was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: four straight days of moderate flu-like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 52-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 on 21Mar2021 at 16:30 (age at vaccination 52-years-old) in the left arm as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN) at a dose of 25mg per day taken for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 06:00 since the vaccination, the patient experienced moderate flu-like symptoms for four straight days of moderate flu-like symptoms, minus fever. On the fifth day (26Mar2021) of reporting also he does not know how much these symptoms will be longer and persists. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events of flu-like symptoms was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain in extremity
Clinical narrative: Chills; Diarrhea; Left arm pain about 2 hours after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in right arm on 24Mar2021 at 00:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma and had known allergy to sulfa drugs. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 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. The patient experienced left arm pain about 2 hours after vaccine, and chills and diarrhea 2 days after vaccine on 26Mar2021. The adverse 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 events. The clinical outcome of events painful Left arm, chills and diarrhea was recovered on Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Miliaria, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 06Mar2021 at 17:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. Medical history included thyroid, pollen allergy and fruit allergy (melon a doctor thinks it pollen but patient had to get tested for pollen allergy). The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since vaccination, the patient had not tested for COVID-19. Concomitant medication included levothyroxine; 50 Milligram (mg) (MANUFACTURER UNKNOWN) form an unknown date for an unknown indication. On 10Mar2021 at 09:00, the patient experienced her period was about a week late, four days after had a mild heat like rash on face and chest but did not last long and get like that when she has melon. The patient had not received any treatment for the reported events. 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 late period, heat rash on face and chest was recovered on an unknown data in Jun2021. No follow-up attempts possible. No further information expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Flatulence, Vomiting
Clinical narrative: diarrhea; gassy; vomit's; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 26Mar2021 at 14:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication was not reported. Allergies to medications, food or other products were reported as no. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient had experienced diarrhoea, gassy and vomits. 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 received any treatment for the events. The clinical outcome of the events diarrhoea, gassy and vomits was recovered at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Started menstrual period the next morning when not due for two weeks and periods have never been irregular; This is a spontaneous report from a non-contactable nurse, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 23Mar2021 at 10:45 (age at vaccination was 35-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Patient had no known drug allergy. Concomitant medications included montelukast (MANUFACTURER UNKNOWN), erenumab (AIMOVIG), spironolactone (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC) for unspecified indications from unspecified dates received within 2 weeks of vaccination. The patient did not have any known allergies to food, medications, or other products. The patient did not receive 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, the patient had not been tested for COVID-19. On 24Mar2021, the next morning after receiving vaccine, patient started with her menstrual period when not due for two weeks and reported that periods had never been irregular. No therapeutic measures were taken for the adverse events. 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 menstruation irregular was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever 104 less than 24 hr post second dose; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The medical history was not reported. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration on 25Mar2021, as a single dose for COVID-19 immunisation. Prior to the vaccination, it was unknown if patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced fever 104(unit unspecified) in less than 24 hours after the second dose. It was unknown whether the patient received any treatment for the event. The clinical outcome of the event fever was unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: wrist started feelingtired and numb; stiffness; Wrist Hurting; Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH mRNA COVID-19 vaccine; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 21Mar2021 at 18:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021, the patient's wrist was hurting. Th arm soreness/stiffness had subsided, but wrist started feeling tried and numb, then started to hurt. The patient never had this issue before the vaccine. The patient had not gone to doctor yet, but it had been a problem. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events wrist hurting, arm soreness, stiffness and wrist started feeling tried and numb. The clinical outcomes of the events arm soreness and stiffness were recovered on an unknown date in Mar2021 while that of wrist hurting and wrist started feeling tried and numb were not recovered at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Heart rate increased, Hyperhidrosis, Musculoskeletal stiffness
Clinical narrative: Neck stiff; Left armpit area swollen; Armpit area tender; Heart beat a couple of times felt veryrapid; Neck sore; Itchy throat; Wheezing; Aches, hit by a truck feeling; Sweats; Sore left arm; Headache; Nausea; This is a spontaneous report from contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E86955 or EP6955) via an unspecified route of administration in the left arm on 28Mar2021 at 12:45 (at the age of 43-years-old) as a single dose, for COVID-19 immunisation. Medical history included asthma and body mass index (BMI). The patient did not have any allergies to medications, food, or other products. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) on occasion for an unknown indication from an unknown date. The patient did not receive any other vaccine within four weeks of vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in the left arm on 07Mar2021 at 15:30 (at the age of 43-years-old) as single dose, for COVID-19 immunisation. On 28Mar2021 at 17:30 (also reported as night of second dose), the patient experienced sore left arm, itchy throat, wheezing (needed to use inhaler), headache, sweats, nausea, aches, hit by a truck feeling which lasted until end of day on 29Mar2021. On 30Mar2021, the patient felt better but her neck was stiff and sore and left armpit area swollen and tender and heart beat a couple of times felt very rapid. The adverse 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 events. The clinical outcome of the events of pain in arm, itchy throat, wheezing, headache, sweaty, nausea, pain, neck stiff, neck pain, local swelling, armpit pain and heart rate high was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Swelling
Clinical narrative: Neck stiff; Left armpit area swollen; Armpit area tender; Heart beat a couple of times felt veryrapid; Neck sore; Itchy throat; Wheezing; Aches, hit by a truck feeling; Sweats; Sore left arm; Headache; Nausea; This is a spontaneous report from contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E86955 or EP6955) via an unspecified route of administration in the left arm on 28Mar2021 at 12:45 (at the age of 43-years-old) as a single dose, for COVID-19 immunisation. Medical history included asthma and body mass index (BMI). The patient did not have any allergies to medications, food, or other products. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) on occasion for an unknown indication from an unknown date. The patient did not receive any other vaccine within four weeks of vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in the left arm on 07Mar2021 at 15:30 (at the age of 43-years-old) as single dose, for COVID-19 immunisation. On 28Mar2021 at 17:30 (also reported as night of second dose), the patient experienced sore left arm, itchy throat, wheezing (needed to use inhaler), headache, sweats, nausea, aches, hit by a truck feeling which lasted until end of day on 29Mar2021. On 30Mar2021, the patient felt better but her neck was stiff and sore and left armpit area swollen and tender and heart beat a couple of times felt very rapid. The adverse 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 events. The clinical outcome of the events of pain in arm, itchy throat, wheezing, headache, sweaty, nausea, pain, neck stiff, neck pain, local swelling, armpit pain and heart rate high was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.