chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling throughout entire body 15 minutes after vaccination; This is a spontaneous report from a non-contactable pharmacist. A female patient of an unknown age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151) via an intramuscular route of administration in the left arm on 10Apr2021 at 12:15 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that 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 10Apr2021, the patient experienced tingling throughout entire body 15 minutes after vaccination. It was reported that the event did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with BENADRYL. The clinical outcome of the event tingling throughout entire body 15 minutes after vaccination was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Muscular weakness, Musculoskeletal pain, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6202), at the age of 67, via an unspecified route of administration, right arm, on Mar 9, 2021, at 09:15, single dose, for COVID-19 immunisation. Medical history included allergy to penicillin and bee stings. Concomitant medications included tamsulosin hydrochloride 0.4mg for unknown indication from unknown date. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 10, 2021, patient experienced joint, neck, back, shoulders, hips, muscles, legs and buttocks pain; and weakness in arms and legs. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included prednisone. The clinical outcome of joint neck, back, shoulders, hips, muscles, legs and buttocks pain; and weakness in arms and legs: ongoing at the time of this report. No follow-up attempts needed. No further information expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6202), at the age of 67, via an unspecified route of administration, right arm, on Mar 9, 2021, at 09:15, single dose, for COVID-19 immunisation. Medical history included allergy to penicillin and bee stings. Concomitant medications included tamsulosin hydrochloride 0.4mg for unknown indication from unknown date. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 10, 2021, patient experienced joint, neck, back, shoulders, hips, muscles, legs and buttocks pain; and weakness in arms and legs. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included prednisone. The clinical outcome of joint neck, back, shoulders, hips, muscles, legs and buttocks pain; and weakness in arms and legs: ongoing at the time of this report. No follow-up attempts needed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test
Clinical narrative: Dizziness which started on 04/05/2021 over a week after the 2nd dose and still happening on 04/11/2021. Could be positional vertigo which I had once before about 8 year ago. But as dizziness is being reported as a COVID vaccine side effect .; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GP7533) via an unspecified route of administration in the right arm on 25Mar2021 at 18:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included positional vertigo which the patient had once before about 8 years ago. The patient had no known allergies to medications, food or other products. The patient did not receive 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 the right arm on 04Mar2021 at 18:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 05Apr2021, the patient experienced dizziness which started over a week after the 2nd dose and still happening on 11Apr2021. It was also reported that it could be positional vertigo which the patient had once before about 8 years ago but as dizziness was being reported as a COVID vaccine side effect, the patient thought to report this. On 27Mar2021, the patient underwent lab test and investigation which included PCR Oral Swab (Other) test and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of dizziness was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Headache, Lymph node pain, Myalgia
Clinical narrative: Muscle ache; Bones ache; Headache; Fatigue; Nausea; Pain in lymph node of my left arm pit; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 09Apr2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 25mcg for unknown indication. It was unknown whether the patient had any known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 at 13:00  (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 18:30, the patient experienced muscle ache, bones ache, headache, fatigue, nausea and pain in lymph node of left arm pit that has lasted after the other symptoms have gone. Therapeutic measures were not taken as a result of these 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 muscle ache, bone pain, headache, fatigue, nausea and lymph node pain was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Muscle ache; Bones ache; Headache; Fatigue; Nausea; Pain in lymph node of my left arm pit; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 09Apr2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 25mcg for unknown indication. It was unknown whether the patient had any known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 at 13:00  (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 18:30, the patient experienced muscle ache, bones ache, headache, fatigue, nausea and pain in lymph node of left arm pit that has lasted after the other symptoms have gone. Therapeutic measures were not taken as a result of these 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 muscle ache, bone pain, headache, fatigue, nausea and lymph node pain was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Dizziness, Flank pain, Full blood count, Haematuria
Clinical narrative: light headedness; panic attacks; flank pain; cloudy urine; hematuria; mild anemia; This is a spontaneous report from a contactable physician. A 34-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. 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 an unknown date in 2021 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 vaccination. On 08Apr2021, the patient developed light headedness, panic attacks, flank pain and cloudy urine. The event resulted in doctor or other healthcare professional office/clinic visit. On unknown date in Apr2021, the patient underwent Complete Blood Count (CBC) and the result was reported as a small amount of hematuria and mild anemia, which were new. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events light headedness, panic attacks, flank pain, cloudy urine, hematuria and mild anemia were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Urine abnormality
Clinical narrative: light headedness; panic attacks; flank pain; cloudy urine; hematuria; mild anemia; This is a spontaneous report from a contactable physician. A 34-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. 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 an unknown date in 2021 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 vaccination. On 08Apr2021, the patient developed light headedness, panic attacks, flank pain and cloudy urine. The event resulted in doctor or other healthcare professional office/clinic visit. On unknown date in Apr2021, the patient underwent Complete Blood Count (CBC) and the result was reported as a small amount of hematuria and mild anemia, which were new. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events light headedness, panic attacks, flank pain, cloudy urine, hematuria and mild anemia were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Eye pain, Headache, Inflammation
Clinical narrative: Severe body aches; Sensitivity to light; Sore eyes; Inflammation; Ear pain; Flu like symptoms; Joint pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 10Apr2021 at 09:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 03:00, the patient experienced severe body aches, sensitivity to light, headache, sore eyes, joint pain, inflammation, ear pain, flu like symptoms. Therapeutic measures were not taken as a result of these 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 severe body aches, sensitivity to light, sore eyes, inflammation, ear pain, flu like symptoms, joint pain, headache was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Photophobia
Clinical narrative: Severe body aches; Sensitivity to light; Sore eyes; Inflammation; Ear pain; Flu like symptoms; Joint pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 10Apr2021 at 09:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 03:00, the patient experienced severe body aches, sensitivity to light, headache, sore eyes, joint pain, inflammation, ear pain, flu like symptoms. Therapeutic measures were not taken as a result of these 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 severe body aches, sensitivity to light, sore eyes, inflammation, ear pain, flu like symptoms, joint pain, headache was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Tinnitus
Clinical narrative: Ringing in ear; Feet are so swollen; Ankles are so swollen; This is a spontaneous report from a contactable consumer, the patient.  A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in left arm on 18Mar2021 at 11:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included ankle reconstruction from 2019/2020 and high blood pressure. The patient had no known allergies to medications, food, 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 medication included hydrochlorothiazide (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. On 21Mar2021, the patient experienced ringing in ear and reported that her feet and ankles were so swollen that she could not wear her shoes. The patient had ankle surgery on both ankles in 2020 and the swelling was down. The patient was able to wear her shoes and walk. Approximately 3 to 4 days after vaccine, her ankles and feet were so swollen that she could no longer get her shoes on. 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 the result of the events. The clinical outcome of the events ringing in ear and feet and ankles were so swollen was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on hands; This is a spontaneous report from a contactable consumer. An adult female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 03Apr2021 as a single dose for COVID-19 immunisation. Medical history included back pain. It was unknown whether the patient received any other medications within two weeks of vaccination. It was also unknown whether the patient had any allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown that the patient received any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced rash on hands. It was unknown whether any therapeutic measures were taken as a result of the reported event. The clinical outcome of the event rash on hands was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Extreme pain in Right arm, hurts to liftarm; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 10Apr2021 at 08:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sausages. The concomitant medications included rosuvastatin calcium (CRESTOR), vitamin d nos (MANUFACTURER UNKNOWN), topiramate (TOPAMAX) and montelukast sodium (SINGULAIR); all from an unknown start date for an unknown indication. 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 10Apr2021 at 08:30, the patient experienced extreme pain in right arm, hurts to lift arm. The patient did not receive any treatment for the event. 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 event extreme pain in right arm, hurts to lift arm was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Headache, Pain
Clinical narrative: body aches; tiredness; headache; brain fogginess; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 6955) via an unspecified route of administration in the right arm on 08Apr2021 at 15:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included cat allergy, oak tree allergy and latex sensitivity. Concomitant medications included cetirizine hydrochloride (manufacturer-ZYRTEC) taken from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 18Mar2021 at 15:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 08:00 the patient experienced body aches, tiredness, headache and brain fogginess. No therapeutic measures were taken as a result of 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 for the events general body pain, tiredness, headache and confused were resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Broke out in itchy, red splotches on left trunk, under both arms and left waist area; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 09Apr2021 at 10:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis/psoriasis and penicillin allergy. Concomitant medications included adalimumab (HUMIRA), pravastatin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and methotrexate (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously took flu shot and shingles shots on unknown dates and did not experience any reactions. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 10Apr2021 at 18:30 (32 hours after Pfizer vaccine), the patient broke out in itchy, red splotches on left trunk, under both arms and left waist area. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of event and included treatment with BENADRYL and application of a hydrocortisone cream. The clinical outcome of the event broke out in itchy, red splotches on left trunk, under both arms and left waist area was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Hypersensitivity, Rash
Clinical narrative: Rash around eyes and on forehead; Looks like pimples; Has history of allergies and has had similar beforebut seemed to have gotten worse after second shot.; This is a spontaneous report from a contactable consumer. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 09Apr2021 at 17:15 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. The patient had no known allergies to medications, food, or other products. Concomitant medications included cetirizine hydrochloride (ZYRTEC), ibuprofen (ADVIL) and alclometasone dipropionate cream 0.05% (MANUFACTURER UNKNOWN) all for unknown indications from an unknown date. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 at 17:15 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021 the patient experienced rash around eyes and on forehead which looked like pimples. Patient had history of allergies and  had similar before but seemed to have gotten worse after second shot. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The clinical outcome of the event rash around eyes and on forehead which looked like pimples and had history of allergies and had similar allergy before but seemed to have gotten worse after second shot was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering
Clinical narrative: Huge fever blisters on mouth; This is a spontaneous report from a contactable consumer, the patient. A 46-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 05Apr2021 at 18:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Concomitant medications included colecalciferol (VITAMIN D), iron (MANUFACTURER UNKNOWN), ESTRO-CORT, CORT-EAZE and THYRO-BOOST for an unknown indication from an unknown date within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 15:00, the patient experienced huge fever blisters on her mouth and never had a fever blister in her life. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event huge fever blisters on mouth was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EN6206) via an unspecified route of administration in the left arm on 07Mar2021 at 08:00, (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not take any concomitant medications. The patient had no known allergies to medications, food 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 14:00, the patient experienced headache. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event of headache was recovered on an unknown date in 2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8733) via an unspecified route of administration in the left arm on 28Mar2021, (at the age of 56-years-old), as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: fever; Body ache; Nausea; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer reported for her son (patient). A male patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 05Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the reporter called on behalf of her son who got vaccinated on 05Apr2021 as he was experiencing fever, body ache, and nausea after getting the first dose. And also the reporter asking if her son can take Tylenol. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cognitive disorder, Fatigue, Insomnia, Nightmare
Clinical narrative: Nightmares; Noted cognition impact; Difficulty staying asleep (2am, 4am wakeups with insomnia) then difficulty fully waking in the morning; New general tiredness; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 11:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included wolff-parkinson-white syndrome (oblated in 1999), sleep apnea (CPAP), obesity, blood pressure high (treated), bipolar disorder (treated) and gout from an unknown date. The patient was allergic to garlic (vegetable allergy). Concomitant medications included venlafaxine hydrochloride extended release (MANUFACTURER UNKNOWN) 37.5mg, losartan (MANUFACTURER UNKNOWN) 50mg and ULORIC from an unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient experienced nightmares (M.Night shamadome had nothing on her, the patient was dreaming complete "movies" including plot twists), new general tiredness, difficulty staying asleep (2am, 4am wakeups with insomnia) then difficulty fully waking in the morning, cognition impact, may be direct results of 2 above. Therapeutic measures were not taken as a result of these events. The clinical outcome of the events nightmares, new general tiredness, difficulty staying asleep (2am, 4am wakeups with insomnia) then difficulty fully waking in the morning and cognition impact was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy, Photophobia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8737), at the age of 38, via an unspecified route of administration, left arm, on Apr 8, 2021, at 14:45, single dose, for COVID-19 immunisation. Medical history reported as none. The patient did not have any allergies to food, medications or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EL9261), at the age of 38, via an unspecified route of administration, left arm, on Mar 11, 2021, at 16:45, single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On Apr 9, 2021, at 10:00 (20 hours after the second vaccination), patient had extreme lethargy, fatigue from small movements (like sitting up), sensitivity to light, sharp and splitting headaches. Adverse events still occurred at 60 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of extreme lethargy, fatigue from small movements (like sitting up), sensitivity to light, sharp and splitting headaches: not resolved (at the time of this report). No follow-up attempts needed. No further information expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6198), via an unspecified route of administration in the left arm on 10Apr2021 at 09:30 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history and 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 an unknown date, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 10:00, the patient experienced chills and fatigue. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills and fatigue were resolving at the 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: Fatigue, Pyrexia
Clinical narrative: Fatigue; Fever; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 05Apr2021 at 14:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic pain, spine fracture with multiple disc herniations. The patient was allergic to sulfa drugs, penicillin and bee stings. 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. The patient previously took bupropion, venlafaxine and acetaminophen and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 14Mar2021 at 14:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 06Apr2021 at 02:00, the patient experienced fatigue and fever. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the fatigue and fever which included treatment with MOTRIN 800mg, thrice daily. The clinical outcome of the events fatigue and fever were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Nuchal rigidity, Tinnitus
Clinical narrative: Non-Stop ringing in ears. Sometimes very loud; Neck pain; Feeling of heaviness on back of neck; This is a spontaneous report from a contactable consumer, the patient. A 41-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 right arm on 31Mar2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. Concomitant medications included losartan (MANUFACTURER UNKNOWN) of 50mg; from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PA156051) via an unspecified route of administration in the right arm on an unspecified date in 2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced non-stop ringing in ears. Sometimes very loud, neck pain and feeling of heaviness on back of neck. No therapeutic measures were taken for the reported events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of non-stop ringing in ears, neck pain and feeling of heaviness on back of neck was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8727), via an unspecified route of administration in the right arm on 19Mar2021 at 16:00 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), ramipril (MANUFACTURER UNKNOWN), diltiazem (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 12:00, the patient experienced tinnitus. The adverse event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether the therapeutic measures were taken as a result of the adverse event. The clinical outcome of the event tinnitus was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Hypoaesthesia, Myalgia
Clinical narrative: Tender/numbness on left side of body; Chest pains; Nausea; Fever; Chills; Muscle pains; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 22-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 the left arm on 19Mar2021 at 08:15 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient has no known allergies to food, medications or other products. Concomitant medications included birth control pills. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 00:00 the patient experienced tender/numbness on left side of body, chest pains, nausea, fever, chills, muscle pains and headaches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tender/numbness on left side of body, chest pains, nausea, fever, chills, muscle pains and headaches were recovered with lasting effects. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8729) via an unspecified route of administration in the left arm on 09Apr2021 at 13:00 (at the age of 22-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Tender/numbness on left side of body; Chest pains; Nausea; Fever; Chills; Muscle pains; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 22-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 the left arm on 19Mar2021 at 08:15 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient has no known allergies to food, medications or other products. Concomitant medications included birth control pills. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 00:00 the patient experienced tender/numbness on left side of body, chest pains, nausea, fever, chills, muscle pains and headaches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tender/numbness on left side of body, chest pains, nausea, fever, chills, muscle pains and headaches were recovered with lasting effects. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8729) via an unspecified route of administration in the left arm on 09Apr2021 at 13:00 (at the age of 22-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 62-year-old (non-pregnant) female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 62, via an unspecified route of administration, left arm, on Apr 6, 2021, at 15:00, single dose, for COVID-19 immunisation. Medical history included breast cancer in 2012 and penicillin allergy. The patient received other medications within two weeks of vaccination; names were unspecified. The patient previously took Codeine, Tylenol (acetaminophen); all from an unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr 2021, patient vomited the entire evening. On Apr 6, 2021, patient experienced a headache, aches and severe 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, emergency room/department or urgent care. The clinical outcome of headache, aches, severe nausea and vomited the entire evening: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Redness and swelling in a 1 1/2 in diameter around the injection; Redness and swelling in a 1 1/2 in diameter around the injection; Soreness lasting til 48 hours afterinjection; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 09Apr2021 at 09:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC), paracetamol (TYLENOL), naproxen sodium (ALEVE) all for unspecified indications from on unknown date. The patient had known allergies to tetracycline, amoxicillin and zithromax. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 12:00 the patient experienced redness and swelling in a 1 1/2 in diameter around the injection with soreness which lasted till 48 hours after injection. Therapeutic measures were not taken as a result of 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 the events redness and swelling in a 1 1/2 in diameter around the injection and soreness were recovered on 11April2021.   No follow-up attempts are needed. No further information is expected.