chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain
Clinical narrative: Swollen lymph node-left armpit; Swollen lymph node-left armpit. Verysore and achy.; Very sore and achy; This is a spontaneous report from a contactable consumer, the patient. A 49-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Ep7534) via an unspecified route of administration in the left arm on 15Mar2021 at 10:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included Synthroid for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 17Mar2021 at 08:00, the patient had experienced swollen lymph node-left armpit, armpit pain and ache. The clinical outcome of the swollen lymph node, armpit pain and ache was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Dizziness, Muscle spasms, Pain
Clinical narrative: Fever 100 +; Extreme chills; Back ache / spasms and cramps; Overall body pain, inability to get out of bed; Lightheadedness, brain fog; Back ache / spasms and cramps; Back ache / spasms and cramps; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE BIONTECH; Lot number: EN6203) via an unspecified route administration in right arm on 26Feb2021 at 10:00 (at the age of 34-years-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH; Lot number: EN6206) via an unspecified route in left arm on 16Mar2021 at 8:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16March2021 at 14:00, the patient had experienced fever (more than 100), extreme chills, back ache, spasms and cramps, overall, his body was in pain, inability to get out of bed, lightheadedness, brain fog. He was not comfortable to drive for 24 hours after the vaccination with the first dose. It was reported that, the patient had similar experience after first shot, but lesser effects. The office recommended the patient to take the following day off from work because so many people had experienced intense adverse events after second dose. The patient did not receive any treatment for the events. The clinical outcome of the events fever (more than 100), extreme chills, back ache, spasms and cramps, overall body pain, inability to get out of bed, lightheadedness, brain fog was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 100 +; Extreme chills; Back ache / spasms and cramps; Overall body pain, inability to get out of bed; Lightheadedness, brain fog; Back ache / spasms and cramps; Back ache / spasms and cramps; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE BIONTECH; Lot number: EN6203) via an unspecified route administration in right arm on 26Feb2021 at 10:00 (at the age of 34-years-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH; Lot number: EN6206) via an unspecified route in left arm on 16Mar2021 at 8:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16March2021 at 14:00, the patient had experienced fever (more than 100), extreme chills, back ache, spasms and cramps, overall, his body was in pain, inability to get out of bed, lightheadedness, brain fog. He was not comfortable to drive for 24 hours after the vaccination with the first dose. It was reported that, the patient had similar experience after first shot, but lesser effects. The office recommended the patient to take the following day off from work because so many people had experienced intense adverse events after second dose. The patient did not receive any treatment for the events. The clinical outcome of the events fever (more than 100), extreme chills, back ache, spasms and cramps, overall body pain, inability to get out of bed, lightheadedness, brain fog was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Nausea, Vaccination site pain
Clinical narrative: light headed; Chills; Nausea; Pain/Soreness at injection site; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 63-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN6206,) via an unspecified route of administration in the left arm on 16Mar2021 at 11:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included heart disease. The patient did not have any allergies to medications, food, or other products. Concomitant medications included Atorvastatin (MANUFACTURER: UNKNOWN) for an unknown indication, Metoprolol (MANUFACTURER: UNKNOWN) for an unknown indication, Lisinopril (MANUFACTURER: UNKNOWN) for an unknown indication and Tamsulosin (FLOMAX) for an unknown indication. Since the vaccination, the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 16Mar2021, the patient experienced chills, nausea, pain/soreness at injection site, tiredness and light headed. The clinical outcome of the chills, nausea, pain/soreness at injection site, tiredness and light headed were recovering at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Feeling abnormal, Heart rate
Clinical narrative: Tingling in face and feet; elevated blood pressure; elevated heart rate; Dizziness; Brain fog; This is spontaneous report from a contactable consumer, the patient. A 41-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 10:45 (at the age of 41-years-old) as a single dose for Covid-19 immunisation. The patient medical history included asthma, reflux and migraine from unknown date. Allergies to medications, food, or other products was reported to cats. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included meloxicam, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN), all for unknown indication from unknown date. The patient experienced tingling in face and feet, elevated blood pressure, elevated heart rate, dizziness and brain fog on 17Mar2021 at 10:45. The patient did not receive treatment for the reported events. The clinical outcome of the tingling sensation, elevated blood pressure, heart rate increased, dizziness and foggy feeling in head was recovering.   No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Paraesthesia
Clinical narrative: Tingling in face and feet; elevated blood pressure; elevated heart rate; Dizziness; Brain fog; This is spontaneous report from a contactable consumer, the patient. A 41-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 10:45 (at the age of 41-years-old) as a single dose for Covid-19 immunisation. The patient medical history included asthma, reflux and migraine from unknown date. Allergies to medications, food, or other products was reported to cats. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included meloxicam, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN), all for unknown indication from unknown date. The patient experienced tingling in face and feet, elevated blood pressure, elevated heart rate, dizziness and brain fog on 17Mar2021 at 10:45. The patient did not receive treatment for the reported events. The clinical outcome of the tingling sensation, elevated blood pressure, heart rate increased, dizziness and foggy feeling in head was recovering.   No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Nausea; Headache; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6203), via an unspecified route of administration in the left arm on 10Mar2021 at 11:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patients medical history included iron deficient anemia, anxiety, panic attacks, and vertical gastric sleeve surgery in 2015. The patients past drug history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL3247), via an unspecified route of administration in the left arm on 19Feb2021 at 11:00 hours, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within four weeks prior to the vaccination. The patient had not been tested for COVID-19, since the vaccination. The concomitant medications included multivitamin (MANUFACTURER UNKNOWN), iron supplement (MANUFACTURER UNKNOWN), from unknown dates and unknown if ongoing. On 12Mar2021, two days after the second vaccination, the patient experienced nausea, headache and vomiting after taking multivitamin and iron supplements. No therapeutic measures were taken for these events. The clinical outcome of nausea, headache and vomiting was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain in extremity
Clinical narrative: Dizziness; Sore arm; Nauseous; This is a spontaneous report received from a contactable consumer. A 56-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP- 7534) via an unspecified route of administration on the left arm on 16Mar2021 at 16:45 (at the age of 56-year-old), as single dose for COVID-19 immunisation. Medical history included inflammatory arthritis, bronchitis and high blood pressure. Concomitant medications included PLAQUENIL, benzonatate (MANUFACTURER UNKNOWN), lizinopril (MANUFACTURER UNKNOWN) and azathioprine (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on the left arm on 16Feb2021 at 16:45 (at the age of 56-year-old), as 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 4 weeks prior to the COVID-19 vaccine. The patient experienced sore arm, dizziness and nauseous on 17Mar2021 at 11:00. The patient did not receive treatment for the reported events. The clinical outcome of painful arm, dizziness and nauseous were recovering 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: Headache, Pain in extremity
Clinical narrative: Lightly sore arm; Slight headache; This is a spontaneous report received from a contactable consumer, the patient. A 41-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 16Mar2021 at 15:15 (at the age of 41-years-old) as a single dose for COVID-19 Immunisation. The medical history of the patient included rheumatoid arthritis (RA), fibromyalgia and Hashimoto's thyroiditis. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrocodone (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), methotrexate (MANUFACTURER UNKNOWN), REMICADE, all for an unspecified indication. The patient was allergic to MEDROL. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 17Mar2021 at 11:00, the patient experienced lightly sore arm and slight headache. The patient did not receive any treatment for the events. The clinical outcome for the events pain in arm and headache were not recovered.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular, Swelling face
Clinical narrative: Bright red rash starting to turn purple; raised, angry rash raised, angry rash all overback, chest, abdomen, neck and face.; raised, angry rash all over back, chest, abdomen, neck and face; Swollen right side face including cheek, eye and ear; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old adult non-pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 16Mar2021 at 10:45 AM (at the age 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Lyme disease, PCOS, asthma, rosacea, Hashimotos thyroiditis, diverticulosis, celiac and IBS. Multiple food and drug allergies reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 17Mar2021 at 05:00 AM, patient experienced raised, angry rash all over back, chest, abdomen, neck and face. Rash was bilateral and worse on right side. Patient also experienced Swollen right side face including cheek, eye and ear and bright red rash started to turn purple as the day passed. The patient did not receive any treatment for the events. The clinical outcome of rash all over back, chest, abdomen, neck and face, swollen face and red rash was recovering.   Information about lot/batch number cannot be obtained. No further information is expected
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Paraesthesia, Restlessness
Clinical narrative: Began to feel hot.; Upper extremities became to feel tingly or prickly internally/ tingling traveled to my legs; Antsy, fidgety and felt like bouncing off the walls.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP7534) via an unspecified route of administration in left arm on 16Mar2021 at 07:15 (at an age of 61-years-old) as a single dose for COVID-19 vaccination. Medical history included allergic to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 16Mar2021 at 07:30, approximately 10 minutes after the vaccination the patient had upper extremities felt tingly or prickly internally and began to feel hot. Then the tingling travelled to his legs, almost like the feeling when legs fall asleep. About an hour later felt like drank a pot of coffee, the patient was antsy, fidgety and felt like was bouncing off the walls. The clinical outcome of upper extremities felt tingly or prickly internally and began to feel hot, tingling travelled to the legs, almost like the feeling when legs fall asleep was recovered on an unknown date; while for the event antsy, fidgety and felt like was bouncing off the walls were recovered on 16Mar2021.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Cough; Severe sore throat; Bodyaches; Sneezing; Lightheaded; Fever; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old, patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via unspecified route of administration on left arm on 13Mar2021 at 12:00 as a single for COVID-19 immunisation. Medical history reported as none. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19 On 14Mar2021 at 00:00, the patient experienced cough, sneezing, lightheaded, severe sore throat, body aches, fever and fatigue. No therapeutic measures were taken for the events. The clinical outcome for the events of cough, sneezing, lightheaded, severe sore throat, body aches, fever and fatigue was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Sneezing
Clinical narrative: Cough; Severe sore throat; Bodyaches; Sneezing; Lightheaded; Fever; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old, patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via unspecified route of administration on left arm on 13Mar2021 at 12:00 as a single for COVID-19 immunisation. Medical history reported as none. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19 On 14Mar2021 at 00:00, the patient experienced cough, sneezing, lightheaded, severe sore throat, body aches, fever and fatigue. No therapeutic measures were taken for the events. The clinical outcome for the events of cough, sneezing, lightheaded, severe sore throat, body aches, fever and fatigue was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness around vaccination site; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955), via an unspecified route of administration in left arm on 16Mar2021 at 09:15 (at the age of 59-years-old) as a single dose for COVID-19 Immunisation. Medical history included allergy (unspecified allergies to medications, food, or other products). The patient was receiving unspecified concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 16Mar2021 at 16:00, the patient experienced soreness around vaccination site. The patient did not receive treatment for the event. The clinical outcome for the event soreness around vaccination site was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Dry mouth
Clinical narrative: Dry mouth; Extremely dry eyes; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old non--pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot: en6208), via an unspecified route of administration in the right arm on 17Mar2021 at 1:45 PM (at the age of 47-years) as a single dose for COVID-19 immunisation. Medical history included migraines. Concomitant medications included loratadine (MANUFACTURER UNKNOWN) and BENADRYL. No other vaccine was received within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with covid-19 and was also not tested for COVID-19 since the vaccination. The patient experienced dry mouth and extremely dry eyes on 17Mar2021. No therapeutic measures were taken for the reported events. The clinical outcome of the events dry mouth and dry eyes were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Epistaxis, Fatigue, Headache, Pain in extremity
Clinical narrative: Arm soreness; Headache; Extreme fatigue; Dizziness; Bleeding from both nostrils; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6204), via an unspecified route of administration in left arm on 03Mar2021 at 14:15 (at the age of 64-years-old), as a single dose for COVID-19 Immunisation. The patient's medical history included 2 ischemic strokes on May2018. The patient did not had any allergies to medications, food, or other products. Prior to vaccination, the patient was not been diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patients concomitant medications were not reported. The patient experienced dizziness, 10 minutes after first shot, arm soreness for 3 days, headache from day 1 to 3 and 6 to 7, extreme fatigue from day 1 to 2 and 6 to 7 on 03Mar2021 at 14:30. The patient experienced bleeding from both nostrils (two weeks after first injection) on an unknown date in Mar2021 from day 3 until present. Bleeding started as dark bloody crust inside nose, then turned to red blood every time the nose was blown, from both nostrils. No therapeutic measures were taken for the events. At the time of report, the outcome of the events bleeding from both nostrils, arm soreness, headache, dizziness and extreme fatigue was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: Inflammation in hands, feet, legs, knees.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6202) via an unspecified route of administration in the left arm on 25Feb2021 at 14:30 hours (at the age of 56-years-old) for covid-19 immunisation. Medical history included Hashimotos disease. Concomitant medications included levothyroxine (MANUFACTUER UNKNOWN). The patient was not allergic to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Feb2021, the patient experienced inflammation in hands, feet, legs and knees. No therapeutic measures were taken as a result of adverse event. The clinical outcome of the event inflammation in hands, feet, legs and knees was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Malaise, Nausea
Clinical narrative: Soreness at injection site; Fever (low grade 100.6); Chills; Nausea; Diarrhea; Feeling unwell; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; lot number Unknown) via an unspecified route of administration in the left arm on 16Mar2021 at 10:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea, high blood pressure, obese and acid reflux from an unknown date. The patient was allergic to penicillin. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN) for an unknown indication, Esomeprazole (NEXIUM) for an unknown indication, famotidine (MANUFACTURER UNKNOWN) for an unknown indication and doxycycline(MANUFACTURER UNKNOWN) for an unknown indication. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On an unknown date, the patient experienced soreness at injection site, fever (low grade 100.6), chills, nausea, diarrhea and feeling unwell. The patient did not receive any treatment for the events The clinical outcome of the events soreness at injection site, fever (low grade 100.6), chills, nausea, diarrhea and feeling unwell were resolving at the time of report.   Information about lot number cannot be obtained. No further information is expected
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Soreness at injection site; Fever (low grade 100.6); Chills; Nausea; Diarrhea; Feeling unwell; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; lot number Unknown) via an unspecified route of administration in the left arm on 16Mar2021 at 10:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea, high blood pressure, obese and acid reflux from an unknown date. The patient was allergic to penicillin. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN) for an unknown indication, Esomeprazole (NEXIUM) for an unknown indication, famotidine (MANUFACTURER UNKNOWN) for an unknown indication and doxycycline(MANUFACTURER UNKNOWN) for an unknown indication. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On an unknown date, the patient experienced soreness at injection site, fever (low grade 100.6), chills, nausea, diarrhea and feeling unwell. The patient did not receive any treatment for the events The clinical outcome of the events soreness at injection site, fever (low grade 100.6), chills, nausea, diarrhea and feeling unwell were resolving at the time of report.   Information about lot number cannot be obtained. No further information is expected
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Body temperature, Chills, Headache
Clinical narrative: Pain on movement; Headache; Area of previous Shingles rash on left low back was irritated/burning; Pain across abdomen at waist; Low fever (100.2); Tight low back pain; Chills; Sniffles; This is a spontaneous report received from a contactable consumer, the patient. A 72-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E19267), via an unspecified route of administration in the left arm on 17Feb2021 at 13:00 (at the age of 72-years-old), and a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 10Mar2021 at 13:15 (at the age of 72-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included sleep apnea and shingles. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) 50mg and simvastatin (MANUFACTURER UNKNOWN) 40mg, from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any vaccines within four weeks prior to the COVID vaccine. On 18Feb2021 at 01:00, approximately 12 hours after the vaccination, the patient experienced sniffles/chills. On 19Feb2021 (Day 02), the patient had low fever (100.2), chills, pain across abdomen at waist and tight low back. The patient received paracetamol (TYLENOL). On 20Feb2021 (Day 03), the patient experienced significantly tight low back with pain on movement. Area of previous shingles rash on left low back was irritated/burning similar sensation to original rash. The patient had low fever/headache and received TYLENOL. On 21Feb2021 (Day 04), the patient low back pain and irritation continued with no fever. The patient received ibuprofen (MANUFACTURER UNKNOWN) then TYLENOL with no effect on pain, stiffness or irritation. On 22Feb2021 (Day 05), irritation lessened and stiffness also lightened. On 23Feb2021 (Day 06), the irritation was much reduced and low back movement was easier. On 24Feb2021 (day 07), irritation resolved and low back movement improved to negatable pain on movement. The clinical outcome of the events low grade fever was recovered on 21Feb2021, itchy rash was recovered on 24Feb2021 and chills, sniffles, headache, abdominal pain, pain upon movement and low back pain was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash pruritic, Rhinorrhoea
Clinical narrative: Pain on movement; Headache; Area of previous Shingles rash on left low back was irritated/burning; Pain across abdomen at waist; Low fever (100.2); Tight low back pain; Chills; Sniffles; This is a spontaneous report received from a contactable consumer, the patient. A 72-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E19267), via an unspecified route of administration in the left arm on 17Feb2021 at 13:00 (at the age of 72-years-old), and a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 10Mar2021 at 13:15 (at the age of 72-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included sleep apnea and shingles. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) 50mg and simvastatin (MANUFACTURER UNKNOWN) 40mg, from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any vaccines within four weeks prior to the COVID vaccine. On 18Feb2021 at 01:00, approximately 12 hours after the vaccination, the patient experienced sniffles/chills. On 19Feb2021 (Day 02), the patient had low fever (100.2), chills, pain across abdomen at waist and tight low back. The patient received paracetamol (TYLENOL). On 20Feb2021 (Day 03), the patient experienced significantly tight low back with pain on movement. Area of previous shingles rash on left low back was irritated/burning similar sensation to original rash. The patient had low fever/headache and received TYLENOL. On 21Feb2021 (Day 04), the patient low back pain and irritation continued with no fever. The patient received ibuprofen (MANUFACTURER UNKNOWN) then TYLENOL with no effect on pain, stiffness or irritation. On 22Feb2021 (Day 05), irritation lessened and stiffness also lightened. On 23Feb2021 (Day 06), the irritation was much reduced and low back movement was easier. On 24Feb2021 (day 07), irritation resolved and low back movement improved to negatable pain on movement. The clinical outcome of the events low grade fever was recovered on 21Feb2021, itchy rash was recovered on 24Feb2021 and chills, sniffles, headache, abdominal pain, pain upon movement and low back pain was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Biopsy, Chills, Pain, Rash
Clinical narrative: chills; Body Rash; No energy; Aches; This is a spontaneous report from a contactable consumer other non HCP/ patient. A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via unspecified route of administration on 02Mar2021 at 13:00 (at the age of 59-year-old non-pregnant) as UNKNOWN, SINGLE DOSE for COVID-19 Immunisation. Medical history was reported as none and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient experienced Body rash, chills, aches, no energy on 04Mar2021 at 00:00 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse event included urgent care from dermatologist which included treatment with cream for rash and punch biopsy for back. Lab data included biopsy with unknown result on an unknown date. Clinical outcome of the events body rash, chills, aches, no energy was recovered.   Information about lot/batch number cannot be obtained. No further information is expected.  Amendment was made by DSU: This follow-up information is being submitted to amend previously reported information on Patient's first Name added, Age/Units captured as 59 years per event's onset "4Mar2021", Country added, Age at Vaccination updated from 60 to 59, For the reported event rash Treatment Received was captured as "yes' as per source dermatologist who did a punch biopsy and gave patient a cream for rash. Relevant Med History changed to None added since provided other medical history as none, removed Unknown from Lot# field, punch biopsy on back captured as lab data. Also, it was mentioned as Information about lot/batch number cannot be obtained. No further information is expected. updated as "No follow-up attempts are needed; information about lot/batch number cannot be obtained." Per SER055
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Erythema, Fatigue
Clinical narrative: Muscle pain; Chills; Tired; Arm swollen; could not move; had no strength in arms or legs, could not call for help and was lying on floor; Teeth hurt; arm swollen - hot and red; Severe headache; Next day at night-couldn't catch breath-gasping for air &breath; arm swollen - hot and red; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9266), dose 2, single via an unspecified route of administration on the left arm on 15Mar2021 at 08:45 at age of 74 years old for COVID-19 immunization. The past drug included BNT162B2 dose 1, single, (lot/Batch no: unknown) via an unspecified route of administration on 22Feb2021 08:45 at age of 74 years old for COVID-19 immunization. The patient did not have symptoms associated with COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Medical history included diabetes, obesity and receiving Electroconvulsive therapy (ECT) treatments. Concomitant medications included bupropion (WELLBUTRIN), desvenlafaxine (PRISTIQ), trazodone (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and carvedilol (MANUFACTURER UNKNOWN) for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on the next day at night (16Mar2021), she could not catch breath- gasping for air & breath, she could move but had no strength in arms or legs, could not call for help and was lying on floor, could not move, had severe headache, arm swollen - hot and red, tired, had chills, muscle pain and even teeth hurt. No therapeutics measures were taken for the events. The clinical outcome of all the events were reported as resolved with sequelae on an unspecified date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Gait inability, Headache, Myalgia, Peripheral swelling
Clinical narrative: Muscle pain; Chills; Tired; Arm swollen; could not move; had no strength in arms or legs, could not call for help and was lying on floor; Teeth hurt; arm swollen - hot and red; Severe headache; Next day at night-couldn't catch breath-gasping for air &breath; arm swollen - hot and red; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9266), dose 2, single via an unspecified route of administration on the left arm on 15Mar2021 at 08:45 at age of 74 years old for COVID-19 immunization. The past drug included BNT162B2 dose 1, single, (lot/Batch no: unknown) via an unspecified route of administration on 22Feb2021 08:45 at age of 74 years old for COVID-19 immunization. The patient did not have symptoms associated with COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Medical history included diabetes, obesity and receiving Electroconvulsive therapy (ECT) treatments. Concomitant medications included bupropion (WELLBUTRIN), desvenlafaxine (PRISTIQ), trazodone (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and carvedilol (MANUFACTURER UNKNOWN) for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on the next day at night (16Mar2021), she could not catch breath- gasping for air & breath, she could move but had no strength in arms or legs, could not call for help and was lying on floor, could not move, had severe headache, arm swollen - hot and red, tired, had chills, muscle pain and even teeth hurt. No therapeutics measures were taken for the events. The clinical outcome of all the events were reported as resolved with sequelae on an unspecified date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Muscle pain; Chills; Tired; Arm swollen; could not move; had no strength in arms or legs, could not call for help and was lying on floor; Teeth hurt; arm swollen - hot and red; Severe headache; Next day at night-couldn't catch breath-gasping for air &breath; arm swollen - hot and red; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9266), dose 2, single via an unspecified route of administration on the left arm on 15Mar2021 at 08:45 at age of 74 years old for COVID-19 immunization. The past drug included BNT162B2 dose 1, single, (lot/Batch no: unknown) via an unspecified route of administration on 22Feb2021 08:45 at age of 74 years old for COVID-19 immunization. The patient did not have symptoms associated with COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Medical history included diabetes, obesity and receiving Electroconvulsive therapy (ECT) treatments. Concomitant medications included bupropion (WELLBUTRIN), desvenlafaxine (PRISTIQ), trazodone (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and carvedilol (MANUFACTURER UNKNOWN) for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on the next day at night (16Mar2021), she could not catch breath- gasping for air & breath, she could move but had no strength in arms or legs, could not call for help and was lying on floor, could not move, had severe headache, arm swollen - hot and red, tired, had chills, muscle pain and even teeth hurt. No therapeutics measures were taken for the events. The clinical outcome of all the events were reported as resolved with sequelae on an unspecified date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Limb immobilisation, Pain in extremity
Clinical narrative: 4 distinct episodes of vomiting, with 3 or 4 separate vomits in each episode. Vomiting lasted over a 6 hour period; Chills; Severe tired; Left arm immobilized by significant pain; Left arm immobilized by significant pain; Weakness; This is spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 10Mar2021 at 09:30 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 10Mar2021 at 10:15, the patient experienced 4 distinct episodes of vomiting, with 3 or 4 separate vomits in each episode, vomiting lasted over a 6 hours period. The episode of vomiting was stopped about 2 hours after taking a dose of ZOFRAN. The patient had chills for about an hour after initial episode of vomiting and left arm immobilized by significant pain for 2 days. The patient experienced severe tiredness or weakness on the day of the vaccine and could not get out of bed except to vomit.  It was reported that the patient had vaccination on Wednesday, however the patient did not feel back to full strength until 14Mar2021 (Sunday). The patient was very surprised by how sick she felt after the first dose of COVID-19 vaccine. Therapeutic measures were taken for the event treatment included ZOFRAN for severe vomiting. The clinical outcome of events 4 distinct episodes of vomiting and chills was recovered on 10Mar2021, left arm immobilized and significant pain was recovered on 12Mar2021, severe tired and weakness was recovered on 14Mar2021 on an unknown date.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 4 distinct episodes of vomiting, with 3 or 4 separate vomits in each episode. Vomiting lasted over a 6 hour period; Chills; Severe tired; Left arm immobilized by significant pain; Left arm immobilized by significant pain; Weakness; This is spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 10Mar2021 at 09:30 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 10Mar2021 at 10:15, the patient experienced 4 distinct episodes of vomiting, with 3 or 4 separate vomits in each episode, vomiting lasted over a 6 hours period. The episode of vomiting was stopped about 2 hours after taking a dose of ZOFRAN. The patient had chills for about an hour after initial episode of vomiting and left arm immobilized by significant pain for 2 days. The patient experienced severe tiredness or weakness on the day of the vaccine and could not get out of bed except to vomit.  It was reported that the patient had vaccination on Wednesday, however the patient did not feel back to full strength until 14Mar2021 (Sunday). The patient was very surprised by how sick she felt after the first dose of COVID-19 vaccine. Therapeutic measures were taken for the event treatment included ZOFRAN for severe vomiting. The clinical outcome of events 4 distinct episodes of vomiting and chills was recovered on 10Mar2021, left arm immobilized and significant pain was recovered on 12Mar2021, severe tired and weakness was recovered on 14Mar2021 on an unknown date.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Insomnia
Clinical narrative: could not sleep (toss and turn all night); Headache; Flu like symptoms; Chills; This is a spontaneous report received from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: lot number: EL3247) via an unspecified route of administration in the left arm on 23Feb2021 at 11:15 (at the age of 50-year-old) and her second dose of BNT162B2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot number: EL3247,) via an unspecified route of administration in the left arm on 16Mar2021 at 10:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications of the patient were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 10:30 PM, the patient could not sleep (toss and turn all night), experienced headache, flu like symptoms and chills. The patient did not receive any treatment for the events. The clinical outcome of the events could not sleep, headache, flu like symptoms and chills were recovering.   No follow-up attempts are needed. No further information is expected.