chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Viral test, Vomiting
Clinical narrative: Tiredness; vomiting; feeling unwell; This is a spontaneous report received from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route administration in left arm on 19Mar2021 at 10:00(at the age of 39- years-old) as a single dose for COVID-19 immunisation. Medical history included post-traumatic stress disorder, attention deficit hyperactive disorder, migraines, spinal issues, diabetic, arthritis, sleep apnea and asthma from unknown date. The patient was prescribed medication (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 19Mar2021 at 11:00, the patient experienced tiredness, feeling unwell and vomiting. The patient underwent a nasal swab test on 20Mar2021 which resulted negative. 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 events.  The clinical outcome of events tiredness, feeling unwell and vomiting was recovering.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye swelling, Lip swelling, Rash erythematous, Urticaria
Clinical narrative: Eyes swollen; Lips swollen; Red mottled rash over entire body; Hives on right wrist.; Teeth were chattering.; This is a spontaneous report from a contactable nurse, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EP6955), via an unspecified route of administration in the left arm on 19Mar2021 at 16:30 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included osteoporosis, asthma, hypothyroid, hypertension, hyperlipidaemia and allergy. 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 received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 19Mar2021 at 16:30, the patient experienced red mottled rash over entire body with hives on right wrist, eyes and lips were swollen and teeth were chattering. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was treated with oral BENADRYL 50 mg. The clinical outcome of events red rash, hives, lip swelling, eye swelling and teeth chattering was resolved on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever on and off; Slight nausea; Very unusual fatigue; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 42-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 left arm on 18Mar2021 at 17:15 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history included was not reported. The patient reported that her blood group was B negative and was healthy. The patient was allergic to metal, as stated that her skin could not tolerate anything that has nickel in it. 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 four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 19Mar2021 at 15:00, the patient experienced fever on and off, very unusual fatigue, some slight nausea and diarrhea. The patient did not receive any treatment for the events. 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. The clinical outcome of the events fever, fatigue, nausea and diarrhea was not recovered.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: This is a spontaneous report from contactable consumer, the patient. A 43year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via unspecified route of administration on 20Mar2021 at 12:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included acetaminophen; aspirin; caffeine (EXCEDRIN) for unspecified indication from unknown date. The patient previously received first dose of BNT162b2 via unspecified route of administration in the right arm on 27Feb2021 at 10:15 hours (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient previously received rizatriptan (MANUFACTURER UNKNOWN), tramadol (MANUFACTURER UNKNOWN), ketorolac (MANUFACTURER UNKNOWN), naproxen sodium (ALEVE) and naproxen sodium (MANUFACTURER UNKNOWN) for unspecified indication from unknown dates and experienced drug allergy . 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 experienced very bad back mid and lower back pain on 21Mar2021 at 16:00. The patient did not receive 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 back mid and lower back pain was unknown at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles on face near mouth, on the right side.; This is a spontaneous report received 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: ER2613) via an unspecified route of administration in the left arm on 18Mar2021, at 11:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar I disorder, type 2 diabetes mellitus, generalised anxiety disorder (GAD) and chronic bronchitis. The patient had history of allergy to penicillin. Concomitant medications included aripiprazole (ABILIFY), quetiapine (SEROQUEL), clonazepam (KLONOPIN) and lamotrigine (LAMICTAL), all for unknown indications from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021, at 09:00, the patient had shingles on her face near mouth in the right side. Therapeutic measures were taken as a result of shingles included valacyclovir (VALTREX). Adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event shingles was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Headache; fatigue; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 17Mar2021 at 15:00 (at the age of 37-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 diagnosed prior to vaccination. Patient had no allergy to medications, food, or other products. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ADDERALL and CLOMID for an unspecified indication on an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 17Mar2021 at 17:00, the patient experienced headache, fatigue and sore arm. The patient did not receive 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 headache, fatigue and sore arm was resolved on an unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Oropharyngeal pain, Pain
Clinical narrative: This is a spontaneous report received from a consumer, the patient. A 56-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 to left arm on 17Mar2021 at 18:15 (at the age of 56-year-old), as a single dose for COVID-19 immunisation. Medical history of the patient included diabetic. Concomitant medications were not reported. The patient had allergies to sulpha drug. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received EFFECTOR XR and XIGDUO medications within 2 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. On 18Mar2021 (day after the vaccine), the patient experienced injection site sore in arm hurt (vaccination site pain). On 19Mar2021, the patient had sore throat and cough, sneezing, chills, head and body aches. 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 events vaccination site pain, sore throat, cough, sneezing, chills, headache and body aches was not resolved at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a consumer, the patient. A 56-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 to left arm on 17Mar2021 at 18:15 (at the age of 56-year-old), as a single dose for COVID-19 immunisation. Medical history of the patient included diabetic. Concomitant medications were not reported. The patient had allergies to sulpha drug. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received EFFECTOR XR and XIGDUO medications within 2 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. On 18Mar2021 (day after the vaccine), the patient experienced injection site sore in arm hurt (vaccination site pain). On 19Mar2021, the patient had sore throat and cough, sneezing, chills, head and body aches. 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 events vaccination site pain, sore throat, cough, sneezing, chills, headache and body aches was not resolved at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Extreme fatigue; Sore muscles all over body; Mild headache; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) via an unspecified route of administration in the left arm on 11Mar2021 at 09:00, (at the age of 49 years old) as a single dose for COVID-19 immunisation. Medical history included Diabetes, hypo thyroiditis and overweight. Concomitant medication included metformin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURERUNKNOWN) for unknown indication from unknown date. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021 at 20:00, patient experienced extreme fatigue, sore muscles all over body and mild headache. The patient did not receive treatment for the reported events. It was reported that 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 fatigue. muscle soreness and headache were recovering.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Severe pain at jab site; shoulder (joints), neck and upper back, all localized to left side; This is a spontaneous report from a non-contactable consumer, the patient. A 52-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH, Lot number: EN6206) via an unknown route of administration at left arm on 18Mar2021 at 13:30 (at the age of 52-years) as a single dose for COVID-19 immunisation. The patient had allergy to soy, gluten intolerance, environmental allergies. Concomitant medications included Ibuprofen (MANUFACTURER UNKNOWN) and acetaminophen (MANUFACTURER UNKNOWN) within last two weeks for unknown indications. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested positive for COVID-19 since having the vaccine. Post vaccination, at 21:00, the patient experienced "severe pain at jab site, shoulder (joints), neck and upper back, all localized to left side". The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The treatment received included ice packs under and over arm, on upper back, neck (as reported) for the events vaccination site pain and pain in joint. The clinical outcome of the events vaccination site pain and pain in joint was resolved with sequelae (recovered with lasting effects as reported) on 21Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Mild diarrhea; nausea; This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route administration in left arm on 19Mar2021 at 16:15 (at the age of 51-years-old) as a single dose, for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within two weeks prior to the vaccination. On 20Mar2021 at 17:00, 24 hours after vaccine was administered, the patient experienced mild diarrhea and nausea for 6 hours. The patient did not receive any treatment for the events mild diarrhoea and nausea. 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 events nausea and diarrhoea was recovered on an unknown date.   Information about lot/batch number cannot be obtained. No further information expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Extreme muscle pain over entire body; Headache; Skin pain; Chills; Sweat; Hard to keep my balance; This is a spontaneous report from a contactable consumer, patient. A 79-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on unknown date (at the age of 79-year-old) as a single dose for COVID-19 immunization. Medical history included blood pressure high. The patient had known allergy with sulfa drugs. The patient taken other medications (unspecified) within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced extreme muscle pain over entire body, headache, skin pain, chills, sweat, hard to keep his balance on 15Mar2021 at 23:00. Therapeutic measures included treatment with high doses of Tylenol. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme muscle pain over entire body, headache, skin pain, chills, sweat, hard to keep his balance was recovered on an unknown date. Information about lot/ batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain of skin
Clinical narrative: Extreme muscle pain over entire body; Headache; Skin pain; Chills; Sweat; Hard to keep my balance; This is a spontaneous report from a contactable consumer, patient. A 79-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on unknown date (at the age of 79-year-old) as a single dose for COVID-19 immunization. Medical history included blood pressure high. The patient had known allergy with sulfa drugs. The patient taken other medications (unspecified) within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced extreme muscle pain over entire body, headache, skin pain, chills, sweat, hard to keep his balance on 15Mar2021 at 23:00. Therapeutic measures included treatment with high doses of Tylenol. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme muscle pain over entire body, headache, skin pain, chills, sweat, hard to keep his balance was recovered on an unknown date. Information about lot/ batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, SARS-CoV-2 test, Swelling
Clinical narrative: Swollen lips; Swollen neck; This is a spontaneous report from a contactable consumer, the patient. A 76-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 20Mar2021 at 14:00 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included type 1 diabetes. The patient did not have any allergies to medications, food, or other products. Concomitant medications included NORVASC, LANTUS, lisinopril (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21Mar2021 at 08:00, the patient experienced swollen neck and lips. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the swollen neck and lips was not recovered at the time of this report. Information about lot number cannot be obtained. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Lymphadenopathy, Rash
Clinical narrative: mouth dryness; lymph nodes swollen; rash on face, arms, torso, backand thighs; This is a spontaneous report received from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247) via an unspecified route of administration in left arm on 11Mar2021 at 11:15 (at the age of 47-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 includes unspecified vitamins (MANUFACTURER UNKNOWN) and biotin (MANUFACTURER UNKNOWN) taken for unspecified indication from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 17Mar2021, the patient experienced mouth dryness, lymph nodes swollen and rash on face, arms, torso, back and thighs. At the time of this report (since 5 days), the events were still persisting. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with ZYRTEC for rash and dry mouth. The clinical outcome of the events mouth dryness, lymph nodes swollen and rash on face, arms, torso, back and thighs were not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe soreness in left arm; This is a spontaneous report from a non-contactable consumer, the patient. A 52-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 the left arm on 19Mar2021 at 10:45 (at the age of 52-years old) as a single dose for COVID-19 immunisation. Medical history included soreness. The patient was not allergic to any food, medications, or other products. The patient received unspecified medications within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Past drug history included unspecified injection for which patient experienced soreness. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. On 19Mar2021 at 10:45, the patient experienced severe soreness in left arm to the point where it was hurting to use it and was painful. The patient stated that, it was not like the other unspecified injection soreness which she had experienced in the past. The patient did not receive treatment for the adverse event. The clinical outcome for the event severe soreness in left arm was resolving. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Headache; Fatigue; Dizziness; This is a spontaneous report received from a contactable consumer, the parent. A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EP6955), via an unspecified route of administration in the left arm on 20Mar2021 at 11:30 (at the age of 19-years-old), as a single dose for COVID-19 immunisation. Medical history included autism spectrum disorder (Asperger's Syndrome). The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 21Mar2021 at 00:00, the patient experienced fatigue, dizziness and headache. The patient did not receive any treatment for the adverse events. The adverse event 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 fatigue, dizziness and headache were recovered on 21Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Stabbing pain in joints especially leftand right shoulders and right knee, butalso big toes and thumbs; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration on 18Mar2021 at 10:00 (at the age of 67-years-old), as a single dose for COVID-19 immunisation. The patient previously, received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration to the left arm on 25Feb2021 at 1000, as a single dose for COVID-19 immunisation. Medical history included severe osteoarthritis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks of the COVID-19 vaccine. Concomitant medications included tramadol (MANUFACTURER UNKNOWN), vicodin (MANUFACTURER UNKNOWN), celebrex (MANUFACTURER UNKNOWN) and cyclobenzaprine (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not tested positive for COVID-19. On 18Mar2021 at 22:00, the patient experienced stabbing pain in joints involving the left and right shoulders, right knee, big toes and thumbs. The patient did not receive any treatment 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 the event of joint pain was recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Fatigue
Clinical narrative: Fatigue; Ear pain; This is a spontaneous report received from a contactable consumer, the parent. A 23-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: P6955) in the left arm via an unspecified route on 20Mar2021 at 11:30 as a single dose (at the age of 84-years-old) for COVID-19 immunisation. The patient had no known allergies. Medical history included ADHD. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within two weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021 at 12:00, the patient had fatigue and ear pain. The events not resulted 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 fatigue and ear pain was recovered on an unknown date. No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Muscular weakness, Nausea, Pain, Pyrexia
Clinical narrative: Prolonged fever; body aches and pain; muscle weakness; extreme migraines; nausea; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN6204) via unspecified route of administration in left arm on date 20Mar2021 (at an age of 24-year-old) at 16:00 for COVID-19 immunisation. Medical history included diabetes since an unknown date also allergic to Red40 and aripiprazole (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202) via unspecified route of administration on left arm on 27Feb2021 as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. The patient experienced body aches and pain, extreme migraines, muscle weakness, nausea, prolonged fever on 21Mar2021 at 08:00. It was unknown if the patient received any treatments for the events. The clinical outcome of the events body aches and pain, extreme migraines, muscle weakness, nausea, prolonged fever was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable consumer, the patient. A 65 years old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL9265) via an unspecified route in left arm on 22Feb2021, at 09:15 AM as a second single dose for COVID-19 immunisation. The patients medical history included dupuytren's Contracture. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN), received in two weeks of vaccination. It was reported that, prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine and no known allergies to medications, food or other products. On 01Mar2021, the patient experienced developed moderate-severe tinnitus in left ear (patient stated that he had minor tinnitus for many years, but barely noticeable. About 1 week after second dose of vaccine). The patient did not receive any treatment for events. The clinical outcome of tinnitus was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle tightness, Nuchal rigidity
Clinical narrative: Intense tightness in neck, shoulders, and both arms.; turn neck right or left, can hear creaking; Muscle spasms in biceps both arms; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the right arm on 14Mar2021 at 17:30 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included lisinopril 5mg (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. It was unknown that the patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested positive for COVID-19 since having the vaccine. On 15Mar2021 at 08:00, the patient had intense tightness in neck, shoulders and both arms. When patient turn her neck right or left, she can hear creaking and the patient experienced muscle spasms in biceps both arms for a week, range of motion in both arms limited. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of intense tightness in neck, shoulders, and both arms, turn neck right or left, can hear creaking and muscle spasms in biceps both arms was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Asthenia, Vaccination site reaction
Clinical narrative: Raised, hot, hard, itchy bump at injection site one week post vaccine.; Weakness; Arthritis in left hand; This is a spontaneous report from a contactable consumer, the patient. A 49-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 13Mar2021 at 09:00 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included psoriasis. The patient did not have any allergies to medications, food, or other products. 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 concomitant medications. The patient did not receive any other vaccines within four weeks prior to COVID vaccination. On 20Mar2021 at 23:00, the patient experienced raised, hot, hard, itchy bump at injection site one week post vaccine (vaccination site reactions) and weakness (asthenia) or arthritis in the left hand. The treatment received for the adverse event was unknown. The event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vaccination site reactions, asthenia and arthritis were not resolved at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Headache, Nausea, Pain
Clinical narrative: metallic taste in mouth; fever; exhaustion; headache; nausea; body ache; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 20Mar2021 at 10:30(at the age of 31 years old) as a single dose for COVID-19 immunisation. Medical history included Multiple chronic illnesses - do not fit in the space allotted. Concomitant medications were reported as Yes, they do not fit in the space provided. Any allergies to medications, food, or other products was reported as Many allergies - I cannot fit them in the space allotted. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the left arm on 26Feb2021 at 16:45 as a single dose for COVID-19 immunisation. The patient not received 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 was tested for COVID-19. On 20Mar2021 at 23:30, the patient experienced metallic taste in mouth and otherwise, textbook reaction - fever, exhaustion, headache, nausea, head and body aches. The patient did not receive treatment for the reported event. 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 metallic taste, fever, exhaustion, headache, nausea, head and body aches was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: metallic taste in mouth; fever; exhaustion; headache; nausea; body ache; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 20Mar2021 at 10:30(at the age of 31 years old) as a single dose for COVID-19 immunisation. Medical history included Multiple chronic illnesses - do not fit in the space allotted. Concomitant medications were reported as Yes, they do not fit in the space provided. Any allergies to medications, food, or other products was reported as Many allergies - I cannot fit them in the space allotted. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the left arm on 26Feb2021 at 16:45 as a single dose for COVID-19 immunisation. The patient not received 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 was tested for COVID-19. On 20Mar2021 at 23:30, the patient experienced metallic taste in mouth and otherwise, textbook reaction - fever, exhaustion, headache, nausea, head and body aches. The patient did not receive treatment for the reported event. 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 metallic taste, fever, exhaustion, headache, nausea, head and body aches was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Chills, Headache
Clinical narrative: Numbness in the left side of my face as well as both of my lips; Muscle pain all over body; Joint pain all over body; Headache; Elevated temperature of around 99 degrees; Chills; This is a spontaneous report from a contactable consumer. A 39-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) in left arm on 19Mar2021 at 10.45 am as a single dose (at the age of 39 years) for COVID-19 immunisation. Medical history included hypertension and obesity. Concomitant medication included blood pressure medication (not mentioned name of the medication). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 19Mar2021 at 19:45,the patient experienced numbness in the left side of my face as well as both of my lips, muscle pain all over body, joint pain all over body, headache, elevated temperature of around 99 degrees and chills. 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 event. The clinical outcome of the events numbness, muscle pain, joint pain, headache, elevated temperature and chills was still recovering at the time of the reporting. No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia
Clinical narrative: Numbness in the left side of my face as well as both of my lips; Muscle pain all over body; Joint pain all over body; Headache; Elevated temperature of around 99 degrees; Chills; This is a spontaneous report from a contactable consumer. A 39-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) in left arm on 19Mar2021 at 10.45 am as a single dose (at the age of 39 years) for COVID-19 immunisation. Medical history included hypertension and obesity. Concomitant medication included blood pressure medication (not mentioned name of the medication). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 19Mar2021 at 19:45,the patient experienced numbness in the left side of my face as well as both of my lips, muscle pain all over body, joint pain all over body, headache, elevated temperature of around 99 degrees and chills. 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 event. The clinical outcome of the events numbness, muscle pain, joint pain, headache, elevated temperature and chills was still recovering at the time of the reporting. No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Malaise, Nausea
Clinical narrative: Arm pain; Soreness at injection site; Swollen gland in arm pit; Nausea; Headache; Fatigue; General feeling unwell; This is a spontaneous report received from a contactable consumer, the patient. A 34-Years-Old non-pregnant female patient received second of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER2613) via an unspecified route and on right arm on 19Mar2021 ( at 34 years of age )at 09:30 AM as a single dose for COVID-19 immunisation. The patients medical history included allergies to sulfa drugs. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6201) via an unspecified route and on right arm on 26Feb2021, at 09:00 AM as a single dose for COVID-19 immunisation. The patients did not receive any other vaccines within four weeks prior to the COVID vaccine. It was reported that, prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 20Mar2021, at 08:00 AM, the patient experienced soreness at injection site (vaccination site pain), swollen gland in arm pit, incredibly uncomfortable (swollen lymph nodes) nausea, pain in the arm, headache, fatigue and general feeling unwell (feeling unwell). The patient did not receive any treatment for events. The clinical outcome of vaccination site pain, swollen lymph nodes, pain in the arm, nausea, headache, fatigue and feeling unwell was recovering at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Arm pain; Soreness at injection site; Swollen gland in arm pit; Nausea; Headache; Fatigue; General feeling unwell; This is a spontaneous report received from a contactable consumer, the patient. A 34-Years-Old non-pregnant female patient received second of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER2613) via an unspecified route and on right arm on 19Mar2021 ( at 34 years of age )at 09:30 AM as a single dose for COVID-19 immunisation. The patients medical history included allergies to sulfa drugs. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6201) via an unspecified route and on right arm on 26Feb2021, at 09:00 AM as a single dose for COVID-19 immunisation. The patients did not receive any other vaccines within four weeks prior to the COVID vaccine. It was reported that, prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 20Mar2021, at 08:00 AM, the patient experienced soreness at injection site (vaccination site pain), swollen gland in arm pit, incredibly uncomfortable (swollen lymph nodes) nausea, pain in the arm, headache, fatigue and general feeling unwell (feeling unwell). The patient did not receive any treatment for events. The clinical outcome of vaccination site pain, swollen lymph nodes, pain in the arm, nausea, headache, fatigue and feeling unwell was recovering at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site was warm; Injection site red; Injection site raised swollen; Injection site itching; This is a spontaneous report from a contactable nurse, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6207), via an intramuscular route in the left arm on 18Mar2021 at 15:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included losartan (MANUFACTURER UNKNOWN), LO LOESTRIN, propranolol (MANUFACTURER UNKNOWN) and EFFEXOR. The patient previously received ALEVE and codeine and experienced an allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 19Mar2021 at 09:00, the patient reported that the injection site was warm (vaccination site was warmth), red (vaccination site erythema), raised, swollen (vaccination site swelling) and itching (vaccination site pruritis). The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event injection site was warm, injection site red, injection site raised swollen and injection site itching were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Diarrhea; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via unspecified route of administration in the left arm on 17Mar2021 at 14:45 (at the age of 73-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, hypertension and known allergies to penicillin (PCN), sulfa, cefadroxil (DURICEF), cephalexin (KEFLEX), soy, dairy and peanuts. The patient received unspecified medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via unspecified route administration in the left arm on 24Feb2021 at 12:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. 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 four weeks prior to the COVID vaccine. On 18Mar2021 at 13:30, the patient experienced diarrhea and nausea. The adverse event 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 events diarrhea and nausea. The clinical outcomes of the events diarrhea and nausea was not recovered at the report.   No follow-up attempts are needed. No further information is expected.