chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Red bumps/hives on face. Not itchy or painful, but warm to the touch and hives/bumps are slightly raised and pink/red.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Mar2021 at 13:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to possibly penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metronidazole (MANUFACTURER UNKNOWN) and daily multivitamin (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications and unknown if ongoing. On 14Apr2021 at 23:00, the patient experienced red bumps/hives on face, not itchy or painful, but warm to the touch and hives/bumps were slightly raised and pink/red. The patient took OTC benadryl but bumps were still present 8 hours later. The patient continued to treat with benadryl. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included the treatment with diphenhydramine (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event red bumps/hives on face, not itchy or painful, but warm to the touch and hives/bumps were slightly raised and pink/red was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Insomnia, Nasopharyngitis, Restlessness
Clinical narrative: unable to sleep or rest comfortably; cold; feeling like he couldn't breathe; felt like his chest was being compressed and was very restless; felt like his chest was being compressed and was very restless; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 17-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0162), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 11:45 (age at the time of vaccination was 17 years) as DOSE 2, SINGLE for covid-19 immunisation at Hospital. Medical history included occassional vasovagal syncope from an unknown date and unknown if ongoing and known allergies were reported as no. Concomitant medication(s) and other medications in two weeks included ibuprofen (ADVIL [IBUPROFEN]) and vitamins nos (FLINTSTONES) both taken for an unspecified indication, start and stop date were not reported. Historically the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955) via an unspecified route of administration, administered in Arm Left on 25Mar2021 at 11:30 (age at the time of vaccination was 17 years) as DOSE 1, SINGLE for covid-19 immunisation. Other vaccine in four weeks was reported as no. The patient did not have covid prior to vaccination. On n 15Apr2021 at 05:30, the patient was unable to sleep or rest comfortably, cold, feeling like he couldn't breathe and felt like his chest was being compressed and was very restless. It was reported that, the patient woke up in the middle of the night, cold, and feeling like he couldn't breathe. He felt like his chest was being compressed and was very restless. The chest compression scared him and caused him to be unable to sleep or rest comfortably. He has since recovered and was feeling better. The patient was not tested for covid post vaccination. The treatment for ae was not received. The outcome of all the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, Pain in extremity
Clinical narrative: Arm ache; Severe backache; Difficulty walking; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient 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 an unknown date in Apr2021 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included Chronic Obstructive Pulmonary Disease (COPD) and COVID-19 from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 12:30 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Apr2021 at 20:00, the patient experienced arm ache, severe backache and difficulty walking. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm ache, severe backache and difficulty walking were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Pain in the arm I got the shot; Fever; Severe headache; Severe chills and shaking; Severe chills and shaking; Nausea; Vomiting; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0153) via an unspecified route of administration in the left arm on 13Apr2021 at 13:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 22:00, the patient experienced pain in the arm he got the shot, fever, severe headache, severe chills and shaking, nausea, vomiting and muscle pain. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in the arm he got the shot, fever, severe headache, severe chills and shaking, nausea, vomiting and muscle pain was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: Pain in the arm I got the shot; Fever; Severe headache; Severe chills and shaking; Severe chills and shaking; Nausea; Vomiting; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0153) via an unspecified route of administration in the left arm on 13Apr2021 at 13:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 22:00, the patient experienced pain in the arm he got the shot, fever, severe headache, severe chills and shaking, nausea, vomiting and muscle pain. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in the arm he got the shot, fever, severe headache, severe chills and shaking, nausea, vomiting and muscle pain 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: Asthenopia, Fatigue, Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: Heart started racing / felt and heard the pounding; Left arm tingled with pins and needles; Foggy head; Extremely tired (eyes heavy); Extremely tired (eyes heavy); Achy arm; HR ranged from 87 to 94 with more constant rate at 91-94 / Increased heart rate lasted until bed; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 14Apr2021 at 13:45 (at the age of 49-years-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. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), taken for an unknown indication from an unknown date and unknown if ongoing. On 14Apr2021 at 14:15, after 30 minutes of vaccination, the patient experienced achy arm; at 14:25, after 40 minutes of vaccination, got extremely tired (eyes heavy); at 14:30, after 45 minutes of vaccination, the patient experienced foggy head for 15 minutes duration; at 14:35, after 50 minutes of vaccination, left arm tingled with pins and needles (1 to 2 minutes duration); at 14:38, after 53 minutes of vaccination, the heart started racing and the patient decided to lie down and took the afternoon off; heart rate ranged from 87 to 94 with more constant rate at 91 to 94 (per fitbit charge 3), the patient felt and heard the pounding (no pain, no shortness of breath). The patient slept for about 1 hour. On 14Apr2021, increased heart rate lasted until bed at 22:10 and the patient had GREAT sleep for 8 hours 34 minutes, woke only for toilet and water. The patient awoke fully energized, heart rate was not obvious through her chest and seemed back to normal. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events foggy head was recovered on 14Apr2021 at 14:45; left arm tingled with pins and needles was recovered on 14Apr2021 and increased heart rate was recovered on 14Apr2021 at 22:10 while the events achy arm, extremely tired (eyes heavy), heart started racing, felt and heard the pounding were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: Heart started racing / felt and heard the pounding; Left arm tingled with pins and needles; Foggy head; Extremely tired (eyes heavy); Extremely tired (eyes heavy); Achy arm; HR ranged from 87 to 94 with more constant rate at 91-94 / Increased heart rate lasted until bed; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 14Apr2021 at 13:45 (at the age of 49-years-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. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), taken for an unknown indication from an unknown date and unknown if ongoing. On 14Apr2021 at 14:15, after 30 minutes of vaccination, the patient experienced achy arm; at 14:25, after 40 minutes of vaccination, got extremely tired (eyes heavy); at 14:30, after 45 minutes of vaccination, the patient experienced foggy head for 15 minutes duration; at 14:35, after 50 minutes of vaccination, left arm tingled with pins and needles (1 to 2 minutes duration); at 14:38, after 53 minutes of vaccination, the heart started racing and the patient decided to lie down and took the afternoon off; heart rate ranged from 87 to 94 with more constant rate at 91 to 94 (per fitbit charge 3), the patient felt and heard the pounding (no pain, no shortness of breath). The patient slept for about 1 hour. On 14Apr2021, increased heart rate lasted until bed at 22:10 and the patient had GREAT sleep for 8 hours 34 minutes, woke only for toilet and water. The patient awoke fully energized, heart rate was not obvious through her chest and seemed back to normal. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events foggy head was recovered on 14Apr2021 at 14:45; left arm tingled with pins and needles was recovered on 14Apr2021 and increased heart rate was recovered on 14Apr2021 at 22:10 while the events achy arm, extremely tired (eyes heavy), heart started racing, felt and heard the pounding were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Headache, Pain
Clinical narrative: Body ache (day after vaccine shot); Headache (day after vaccine shot); Chills (night of vaccine shot); Slight fever (night of vaccine shot); Soreness in chest (night of vaccineshot); Tiredness (night of vaccine shot and day after vaccine shot); This is a spontaneous report from a contactable other healthcare professional, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 3248) via an unspecified route of administration in the left arm on 14Apr2021 at 10:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19.The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications in two weeks reported as not applicable (N/A). On 14Apr2021, on the night of vaccination shot, the patient experienced chills, slight fever and soreness in chest. On 15Apr2021, day after vaccination shot, the patient experienced body ache, and headache. On 14Apr2021 and 15Apr2021, both the days on the night of vaccine shot and also day after vaccine shot, the patient experienced tiredness. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, slight fever, soreness in chest, tiredness, body aches and headache were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body ache (day after vaccine shot); Headache (day after vaccine shot); Chills (night of vaccine shot); Slight fever (night of vaccine shot); Soreness in chest (night of vaccineshot); Tiredness (night of vaccine shot and day after vaccine shot); This is a spontaneous report from a contactable other healthcare professional, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 3248) via an unspecified route of administration in the left arm on 14Apr2021 at 10:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19.The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications in two weeks reported as not applicable (N/A). On 14Apr2021, on the night of vaccination shot, the patient experienced chills, slight fever and soreness in chest. On 15Apr2021, day after vaccination shot, the patient experienced body ache, and headache. On 14Apr2021 and 15Apr2021, both the days on the night of vaccine shot and also day after vaccine shot, the patient experienced tiredness. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, slight fever, soreness in chest, tiredness, body aches and headache were not resolved 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, Feeling of body temperature change, Nausea, Polyuria, Thirst
Clinical narrative: Body ran hot and cold; shaking; Thirsty; Excessive urinating; Blurry eyes; Nausea; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 08Apr2021 at 14:30 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and sulfonamide allergy (sulfa). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN) all started from an unknown date taken for unknown indication and unknown if ongoing. On 10Apr2021, the patient reported that her body ran hot and cold, shaking, thirsty, excessive urinating, blurry eyes, nausea and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body ran hot and cold, shaking, thirsty, excessive urinating, blurry eyes, nausea and diarrhea was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vision blurred
Clinical narrative: Body ran hot and cold; shaking; Thirsty; Excessive urinating; Blurry eyes; Nausea; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 08Apr2021 at 14:30 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and sulfonamide allergy (sulfa). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN) all started from an unknown date taken for unknown indication and unknown if ongoing. On 10Apr2021, the patient reported that her body ran hot and cold, shaking, thirsty, excessive urinating, blurry eyes, nausea and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body ran hot and cold, shaking, thirsty, excessive urinating, blurry eyes, nausea and diarrhea was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Headache; Pain injection site (right arm); Fever; Chills; This is a spontaneous report received from a contactable consumer (parent) for a patient. A 21-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, solution for injection, Lot number: Not available), via an unspecified route in the right arm on 14Apr2021 (age at vaccination: 21-year-old), as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included Oral Birth Control and Isotretinoin (ISOTRETINOIN AN). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 14Apr2021, patient experienced pain injection site (right arm), fever chills and headache. Patient did not receive any treatment for the events. The clinical outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Sneezing
Clinical narrative: Sneezing attacks; Congestion (could not breathe out of my nose); This is a spontaneous report from a contactable healthcare professional. A 22-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 right arm on 03Apr2021 at 16:15 (at the age of 22-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 medications included atomoxetine hydrochloride (STRATTERA) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 21:00, the patient experienced sneezing attacks and congestion (could not breathe out of her nose). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sneezing attacks and congestion (could not breathe out of her nose) was recovered on 04Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Diarrhoea, Headache
Clinical narrative: 3 days after 1st shot "I" suddenly became sick to "my" stomach, with chills and a fever; 3 days after 1st shot "I" suddenly became sick to "my" stomach, with chills and a fever; 3 days after 1st shot "I" suddenly became sick to "my" stomach/ Nausea; Muscles felt like lead; every joint hurt; Diarrhea; Bad headache; nausea and throwing up; was overall weak; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 6955) via an unspecified route of administration in the arm left on 06Apr2021 at 09:30(at the age of 60-years-old) as a single dose for COVID-19 immunisation. The medical history included diabetic, antiphospholipid syndrome, stage 4 kidney condition and degenerative disc disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. The patient previously took meloxicam (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 09Apr2021 at 21:00, 3 days after 1st shot the patient  suddenly became sick to stomach, with chills and a fever, nausea and throwing up, muscles felt like lead, every joint hurt, diarrhea, bad headache and this was lasted a couple of days and was overall weak. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sick to stomach, with chills and a fever, nausea and throwing up, muscles felt like lead, every joint hurt, diarrhea and bad headache and overall weak was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: 3 days after 1st shot "I" suddenly became sick to "my" stomach, with chills and a fever; 3 days after 1st shot "I" suddenly became sick to "my" stomach, with chills and a fever; 3 days after 1st shot "I" suddenly became sick to "my" stomach/ Nausea; Muscles felt like lead; every joint hurt; Diarrhea; Bad headache; nausea and throwing up; was overall weak; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 6955) via an unspecified route of administration in the arm left on 06Apr2021 at 09:30(at the age of 60-years-old) as a single dose for COVID-19 immunisation. The medical history included diabetic, antiphospholipid syndrome, stage 4 kidney condition and degenerative disc disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. The patient previously took meloxicam (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 09Apr2021 at 21:00, 3 days after 1st shot the patient  suddenly became sick to stomach, with chills and a fever, nausea and throwing up, muscles felt like lead, every joint hurt, diarrhea, bad headache and this was lasted a couple of days and was overall weak. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sick to stomach, with chills and a fever, nausea and throwing up, muscles felt like lead, every joint hurt, diarrhea and bad headache and overall weak was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Oral mucosal blistering, Pain in extremity, Peripheral swelling
Clinical narrative: 8 days after the vaccine developed pain, swelling, erythema/ happened on the arm that the injection was; 8 days after the vaccine developed pain, swelling, erythema/ happened on the arm that the injection was; 8 days after the vaccine developed pain, swelling, erythema/ happened on the arm that the injection was; 8 days after the vaccine developed/ mild blistering in the mouth; This is a spontaneous report from a contactable physician. An elderly female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe), via an unspecified route of administration on unspecified date in 2013 (reported as 8-years-ago) (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunisation. The patient's medical history and concomitant medications were not reported. The physician stated he had a patient who has a reaction to a previous non-covid vaccine. 8 years ago the patient had a Prevnar vaccine which shares components. She did not have an immediate reaction and did not have anaphylaxis. 8 days after the vaccine developed pain, swelling, erythema, and mild blistering in the mouth. He asked what does this mean in terms of getting the Pfizer-BioNTech Covid-19 vaccine. Would it be safe to get. He stated it should be considered that this happened on the arm that the injection was and happened at the same time as the blistering. He stated he knows there was no clear cut answer. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Fall, Feeling abnormal, Feeling hot, Oxygen saturation
Clinical narrative: Patient was sitting in a chair after given the Covid-19 vaccine and felt fuzzy; fell to the ground; and hit his face with some bruising; Witness notice he was shaking for a few seconds after the fall.; His skin felt fine warm when touch.; This is a spontaneous report received from a contactable Pharmacist. A 29-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0162) dose 1, intramuscularly administered in Arm Left on 15Apr2021 at 12:15 (at the age of 29-year-old) as dose 1, single for covid-19 immunization. Patient medical history was reported as none and patient's concomitant medications were not reported. other medications in 2 weeks was unknown.  Patient was not covid positive before vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and patient has not been tested for COVID-19 since the vaccination. On 15Apr2021 at 12:30 Patient was sitting in a chair after given the Covid-19 vaccine and felt fuzzy and fell to the ground and hit his face with some bruising. Witness notice he was shaking for a few seconds after the fall. He recovered conscious quickly and breath normal and said he was fine. His skin felt fine warm when touch. Paramedics came really quick and measure his oxygen levels and left shortly as his vitals are fine. Relevant laboratory tests included oxygen levels; result was unknown on 15April2021.They instructed him to seek emergency room if any symptoms arise. No treatment was received for the events. The outcome of event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Patient was sitting in a chair after given the Covid-19 vaccine and felt fuzzy; fell to the ground; and hit his face with some bruising; Witness notice he was shaking for a few seconds after the fall.; His skin felt fine warm when touch.; This is a spontaneous report received from a contactable Pharmacist. A 29-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0162) dose 1, intramuscularly administered in Arm Left on 15Apr2021 at 12:15 (at the age of 29-year-old) as dose 1, single for covid-19 immunization. Patient medical history was reported as none and patient's concomitant medications were not reported. other medications in 2 weeks was unknown.  Patient was not covid positive before vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and patient has not been tested for COVID-19 since the vaccination. On 15Apr2021 at 12:30 Patient was sitting in a chair after given the Covid-19 vaccine and felt fuzzy and fell to the ground and hit his face with some bruising. Witness notice he was shaking for a few seconds after the fall. He recovered conscious quickly and breath normal and said he was fine. His skin felt fine warm when touch. Paramedics came really quick and measure his oxygen levels and left shortly as his vitals are fine. Relevant laboratory tests included oxygen levels; result was unknown on 15April2021.They instructed him to seek emergency room if any symptoms arise. No treatment was received for the events. The outcome of event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Hypoaesthesia, Muscle spasms
Clinical narrative: severe leg cramping in my right leg; numbness from my butt to my heel; had diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0IS0) via an unspecified route of administration in the left arm on 02Apr2021 at 13:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive concomitant medications within two weeks of vaccination. On 06Apr2021, after 4 days of vaccination, the patient experienced had diarrhea. On 11Apr2021 at 07:00, after 9 days of vaccination, the patient experienced severe leg cramping in right leg, and numbness from butt to heel. The patient's mother (nurse) thought it was sciatica, and thought it might be a clot. The patient has never had leg cramping like this ever in his 55 years, so it seems somewhat coincidental and wanted to at least mention it, was very bad for a day or so, and still lingers 4 days later. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events diarrhea was resolved on 10Apr2021, after the duration of 4 days. The clinical outcome of the event severe leg cramping in right leg, and numbness from butt to heel was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Itching around her shoulder joints; Bumpy rash that has been the same for the last 10 days; She had a high fever for 24 hours; This is a spontaneous report received from contactable other health care professional (patient).A 69 (unspecified units) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration on 30Mar2021 as dose 2, single for covid-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration on 09Mar2021 as dose 1, single for covid-19 immunization. Medical history included: diabetes mellitus from 2004. The caller stated she has had diabetes since 2004 and ran out of testing strips so she is not sure if her blood sugar was wonky and whether that has something to do with it but she stated she has never had that happen and really thinks this was from the vaccine. The patient's concomitant medications were not reported. On 31Mar2021, the patient had a high fever for 24 hours but is not sure what the temperature was because she did not have a thermometer. She stated on 05Apr2021 she got some itching around her shoulder joints and that was accompanied by a bumpy rash that has been the same for the last 10 days. It was not over her whole body. It has not gotten any worse or better, just stayed the same. She asked how long this will last. Besides irritation, would it be better to ride it out. She stated her daughters are concerned about it. She does not have a primary care doctor. She stated she was just going to let it be and tell her daughters it was okay. The caller stated in the millions that have gotten both doses, she would think somebody would be keeping count of adverse reactions so that when the average consumer would like to have information on the vaccine there would be information. I have now been on the phone for 2 hours on hold then talking to a safety agent then on hold for you and now talking to you. This would be out of courtesy of people taking the time to call in to have this information. We should be able to pull up information, for example out of 20,000 people that reported a symptom how many reported it lasting longer than 5 days. She stated the patient would not be calling you guys back because it was too time consuming unless something crazy happens. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Bone pain, Burning sensation, Chills, Cough
Clinical narrative: Severe migraine; Nausea; Abdominal cramping; Burning skin rash on face & chest & hot to touch purple rash on both arms below injection site; Burning skin rash on face & chest & hot to touch purple rash on both arms below injection site; Skin sensitivity with itching burning sensation over most of body; Skin sensitivity with itching burning sensation over most of body; Skin sensitivity with itching burning sensation over most of body; Chest congestion; Cough; Esophageal spasm; Trouble swallowing; Diarrhea; Chills; Fever; Fatigue; Bone & muscle pain; Bone & muscle pain; Emotional upset; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and lyme disease. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 08Mar2021 at 13:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 08Apr2021 at 18:00, the patient experienced severe migraine, nausea and abdominal cramping, burning skin rash on face and chest and hot to touch purple rash on both arms below injection site, skin sensitivity with itching burning sensation over most of body, chest congestion and cough, esophageal spasm and trouble swallowing, diarrhea, chills, fever, fatigue, bone and muscle pain and emotional upset. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe migraine, nausea, abdominal cramping, burning skin rash on face and chest and hot to touch purple rash on both arms below injection site, skin sensitivity with itching burning sensation over most of body, chest congestion, cough, esophageal spasm, trouble swallowing, diarrhea, chills, fever, fatigue, bone and muscle pain and emotional upset was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysphagia, Emotional disorder, Fatigue, Feeling hot
Clinical narrative: Severe migraine; Nausea; Abdominal cramping; Burning skin rash on face & chest & hot to touch purple rash on both arms below injection site; Burning skin rash on face & chest & hot to touch purple rash on both arms below injection site; Skin sensitivity with itching burning sensation over most of body; Skin sensitivity with itching burning sensation over most of body; Skin sensitivity with itching burning sensation over most of body; Chest congestion; Cough; Esophageal spasm; Trouble swallowing; Diarrhea; Chills; Fever; Fatigue; Bone & muscle pain; Bone & muscle pain; Emotional upset; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and lyme disease. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 08Mar2021 at 13:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 08Apr2021 at 18:00, the patient experienced severe migraine, nausea and abdominal cramping, burning skin rash on face and chest and hot to touch purple rash on both arms below injection site, skin sensitivity with itching burning sensation over most of body, chest congestion and cough, esophageal spasm and trouble swallowing, diarrhea, chills, fever, fatigue, bone and muscle pain and emotional upset. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe migraine, nausea, abdominal cramping, burning skin rash on face and chest and hot to touch purple rash on both arms below injection site, skin sensitivity with itching burning sensation over most of body, chest congestion, cough, esophageal spasm, trouble swallowing, diarrhea, chills, fever, fatigue, bone and muscle pain and emotional upset was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Migraine, Myalgia, Nausea, Oesophageal spasm
Clinical narrative: Severe migraine; Nausea; Abdominal cramping; Burning skin rash on face & chest & hot to touch purple rash on both arms below injection site; Burning skin rash on face & chest & hot to touch purple rash on both arms below injection site; Skin sensitivity with itching burning sensation over most of body; Skin sensitivity with itching burning sensation over most of body; Skin sensitivity with itching burning sensation over most of body; Chest congestion; Cough; Esophageal spasm; Trouble swallowing; Diarrhea; Chills; Fever; Fatigue; Bone & muscle pain; Bone & muscle pain; Emotional upset; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and lyme disease. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 08Mar2021 at 13:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 08Apr2021 at 18:00, the patient experienced severe migraine, nausea and abdominal cramping, burning skin rash on face and chest and hot to touch purple rash on both arms below injection site, skin sensitivity with itching burning sensation over most of body, chest congestion and cough, esophageal spasm and trouble swallowing, diarrhea, chills, fever, fatigue, bone and muscle pain and emotional upset. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe migraine, nausea, abdominal cramping, burning skin rash on face and chest and hot to touch purple rash on both arms below injection site, skin sensitivity with itching burning sensation over most of body, chest congestion, cough, esophageal spasm, trouble swallowing, diarrhea, chills, fever, fatigue, bone and muscle pain and emotional upset was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.