chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: The swollen part red; Swollen part little painful; Swollen lymph node having almost size of peas below the right chin; Fever 101 f; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er2613) via an unspecified route of administration in the left arm on 31Mar2021 at 17:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Apr2021 at 06:00, the patient experienced swollen lymph node having almost the size of peas below the right chin. The swollen part was red and it was a little painful when it was touched. On the same day, during the evening, the patient got a fever of 101 Fahrenheit (f). The patient did not get any other side effects of fever even after 10 days of taking the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department, or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event swollen lymph node having almost size of peas below the right chin, fever 101 f, the swollen part red, and swollen part little painful were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Frequent muscle twitching at the location of the vaccine in the left arm.; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 09Apr2021 at 11:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes type 2. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), metformin hydrochloride; sitagliptin phosphate monohydrate (JANUMET), metformin (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN and vitamin d nos (VITAMIN D); all for unknown indications from unknown dates. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 10Apr2021 at 07:00, the patient experienced frequent muscle twitching at the location of the vaccine in the left arm. 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 event. The clinical outcome of the event frequent muscle twitching at the location of the vaccine in the left arm was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Partial numbness/tingling sensation in left arm; Partial numbness left half of face; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 31Mar2021 at 18:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, narcolepsy, and sleep apnea. The patient did not have a history of allergies to medications, food, or other products. Concomitant medications included amlodipine besilate (AMLODIPINE BESYLATE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); both from unknown dates and for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 31Mar2021 at 19:00 the patient experienced partial numbness/tingling sensation in left arm and left half of face beginning within 20 minutes of injection, and subsiding after about 2 hours. The patient seemed to retain full muscle control throughout this time. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events partial numbness/tingling sensation in left arm and partial numbness left half of face were recovered on 31Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular, Skin discolouration, Vaccination site rash
Clinical narrative: Slightly sore, itchy splotches; Rash at injection site halfway down toelbow. Pink, slightly sore, itchysplotches.; Rash at injection site halfway down to elbow; Pink, slightly sore, itchy splotches.; itchy splotches.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 11:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history, concomitant medications were not reported. It was unknown if the patient had allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 08:00, the patient experienced rash at injection site halfway down to elbow. Pink, slightly sore, itchy splotches. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events rash at injection site halfway down to elbow. Pink, slightly sore, itchy splotches was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: 36 hours after injection, experienced severe, debilitating vertigo that last 3 days.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 31Mar2021 at 08:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included montelukast sodium (SINGULAIR) and salbutamol (ALBUTEROL) from an unknown date for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205,) via an unspecified route of administration in the right arm on 10 Mar2021 at 08:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 20:30, 36 hours after injection, the patient experienced severe, debilitating vertigo that lasted 3 days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the severe debilitating vertigo. The clinical outcome of the event severe, debilitating vertigo was recovered on 04Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Vision blurred
Clinical narrative: persistent blurred vision; Weakness in the chest area; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Mar2021 at 16:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. The patient did not have any allergies to medication, food or any other products. Concomitant medications included bupropion hydrochloride (WELLBUTRINE) and clonazepam (CLONOPINE) for unknown indications from unknown start dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient previously 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 09Mar2021 at 16:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01Apr2021 at 22:00 the patient experienced persistent blurred vision, from 12 days, appeared on 2nd day after vaccine and weakness in the chest area (how one feels after a long flu with severe cough). The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events persistent blurred vision and weakness in the chest area was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Enanthema, Herpes virus test, Rash, Streptococcus test
Clinical narrative: Clusters of tiny canker-like sores called enanthem.; develop a rash on the mucus membranes in the back of my mouth and soft palate.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8734) via an unspecified route of administration in the right arm on 07Apr2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included oral rash and suspected COVID-19 in Mar2020. The patient had no known allergies to medications, food, or other products. The patient did not receive any medications within two 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 had not been tested for COVID-19. On 08Apr2021 at 16:00, the patient experienced a rash on the mucus membranes in the back of mouth and soft palate. In the days that followed it had become worse and was now clusters of tiny canker-like sores called enanthem. The patient had this rash a few times since she had a strange cold in March 2020, which the patient now thought may have been COVID. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. On an unknown date in Oct2020, the patient underwent lab test which included all strep and herpes tests and the results were negative. The clinical outcome of the event a rash on the mucus membranes in the back of mouth and soft palate, clusters of tiny canker-like sores called enanthem was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hyperhidrosis, Urticaria
Clinical narrative: Headache; the next morning followedby dizziness; sweating; 3 days afterhives on my legs, arms and face.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0150), via an unspecified route of administration in the left arm on 08Apr2021 at 15:45(at the age of 36-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any medication within two weeks of vaccination. The patient had no allergies to food, medication and other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 07:30, the patient experienced headache the next morning followed by dizziness and sweating and felt like had a fever, but did not; three days after experienced hives on legs, arms and face. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event headache, dizziness, sweating and hives was resolving at this time of report.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: chills; fever 99.9; Symptoms began 8 hours after the shot including: intense fatigue, headache, body ache, and mild injection site pain. At 24 hours after injection, only fatigue; Symptoms began 8 hours after the shot including: chills, fever 99.9, intense fatigue, headache, body ache, and mild injection site pain. At 24 hours after injection, only fatigue and headache; Symptoms began 8 hours after the shot including: chills, fever 99.9, intense fatigue, headache, body ache, and mild injection site pain; mild injection site pain; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of 47-year-old received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 09Apr2021 at 09:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. No relevant medical history, she reported that she was healthy at the time of reporting. The patient did not receive any medication within two weeks of vaccination. The patient does not have any allergies to medications, food, or other products. The patient previously received first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the arm right on 19Mar2021 at 09:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 17:15, the patient had symptoms began 8 hours after the shot including chills, fever 99.9, intense fatigue, headache, body ache, and mild injection site pain.  At 24 hours after injection, only fatigue and headache. At 34 hours after, the patient was feeling well again. On 09Apr2021, the patient checked Body temperature and the result was 99.9(unspecified units). No therapeutic measures were taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, fever 99.9, body ache, and mild injection site pain were recovered on 10Apr2021. The clinical outcome of the events fatigue and headache were recovered on 10Apr2021 at 21:15.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: chills; fever 99.9; Symptoms began 8 hours after the shot including: intense fatigue, headache, body ache, and mild injection site pain. At 24 hours after injection, only fatigue; Symptoms began 8 hours after the shot including: chills, fever 99.9, intense fatigue, headache, body ache, and mild injection site pain. At 24 hours after injection, only fatigue and headache; Symptoms began 8 hours after the shot including: chills, fever 99.9, intense fatigue, headache, body ache, and mild injection site pain; mild injection site pain; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of 47-year-old received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 09Apr2021 at 09:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. No relevant medical history, she reported that she was healthy at the time of reporting. The patient did not receive any medication within two weeks of vaccination. The patient does not have any allergies to medications, food, or other products. The patient previously received first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the arm right on 19Mar2021 at 09:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 17:15, the patient had symptoms began 8 hours after the shot including chills, fever 99.9, intense fatigue, headache, body ache, and mild injection site pain.  At 24 hours after injection, only fatigue and headache. At 34 hours after, the patient was feeling well again. On 09Apr2021, the patient checked Body temperature and the result was 99.9(unspecified units). No therapeutic measures were taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, fever 99.9, body ache, and mild injection site pain were recovered on 10Apr2021. The clinical outcome of the events fatigue and headache were recovered on 10Apr2021 at 21:15.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Joint swelling, Pain, Pain in extremity
Clinical narrative: stabbing pain in temples; I have had a headache since the vaccine; Joint Swelling in my hands and back of my neck; Stomach upset; Stabbing pain in upper thighs and legs; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 03Apr2021 at 14:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to egg, wheat and dairy products. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 14:30 since the vaccine, the patient experienced headache a pressure painful headache, which was going on for 9 days, otherwise the patient reported that she never gets headache she only get one headache may be once a year so this was very concerning for her. The patient also experienced joint swelling in her hands and back of her neck, stabbing pain in her temples, upper thighs, legs, etc. The constant headache made her stomach queasy. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events. The clinical outcome of the events headache, pain in temples upper thighs, legs, joint swelling in her hands and back of her neck and stomach queasy was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 22Mar2021 at 13:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. The patient had no known allergies. Concomitant medications included norethisterone (MANUFACTURER UNKNOWN) and escitalopram oxalate (ESCITALOPRAM). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 15:00, the patient experienced sore arm and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events sore arm and tiredness were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus, Vertigo
Clinical narrative: tinnitus got considerably louder; developed vertigo like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 at 11:00 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included known allergies to Fire Ants, Wasps, etc. Concomitant medications included montelukast sodium (SINGULAIR), fluticasone propionate (FLONASE) and azelastine (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 21:00, the patient experienced the two major adverse events which were tinnitus that got considerably louder and developed vertigo like symptoms. The problems had been present till the time of reporting for almost three weeks. The event resulted 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. The patient underwent lab tests and procedures which included nasal swab for COVID-19 on 01Apr2021 and tested negative. The clinical outcome of the events tinnitus got considerably louder and vertigo like symptoms were not recovered at this time of report.  No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Really bad upper abdominal pain; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 08Apr2021 at 12:00(at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis rheumatoid and penicillin allergy. The patient received medication(unspecified) within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 00:00, the patient experienced really bad upper abdominal pain .The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event really bad upper abdominal pain was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0150), at the age of 84, via an unspecified route of administration, right arm, on Apr 5, 2021, at 08:45, single dose, for COVID-19 immunisation. Medical history reported as none. The patient did not have a history of allergies to any food, medications or other products. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On an unknown date in Apr 2021, patient was vomiting and had heart rate up to 125 beats for 8 hours. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures taken for the events. The clinical outcome of vomiting and heart rate up to 125 beats  for 8 hours recovered on an unknown date in Apr 2021. No follow-up attempts needed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Skin tightness, Swelling face
Clinical narrative: Numbness from the bottom of neck to the top of head on the left side and the top 1/4 of head on the right side.; Numbness extended to top of tongue; Numbness extended to mouth; Tingling from the bottom of neck to the top of  head on the left side and the top 1/4 of  head on the right side.; Cheek was tight; Cheek was swollen; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 13:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included back pain, surgery (spinal fusion L4-S1) in 2014, current herniated disk, bulging disk/degenerative disk disease and bursitis. Patient previously received penicillin, sulfa and biaxin and experienced allergy. Concomitant medications included pregabalin (LYRICA), etodolac (LODINE), tramadol (MANUFACTURER UNKNOWN), tizanidine (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN) all for unknown indications from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 13:30, the patient experienced numbness and tingling from the bottom of neck to the top of head on the left side and the top 1/4 of head on the right side. The numbness extended in mouth and the top of tongue, but it did not affect the ability to breathe or speak, cheek was tight and swollen for almost three days. The tingling in face, head lasted for probably one full day but the numbness of tongue went away after about two-three hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of numbness in top of tongue was recovered on 17Mar2021 and the clinical outcome of tingling from the bottom of neck to the top of head on the left side and the top 1/4 of head on the right side was recovered on 18Mar2021. The clinical outcome of the event cheek tightness and cheek swollen was recovered on 20Mar2021. The clinical outcome of the event numbness from the bottom of  neck to the top of head on the left side and the top 1/4 of my head on the right side and numbness extended in mouth was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Pain in extremity
Clinical narrative: Severe back pain; Hip pain; Leg pain; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533) via an unspecified route of administration in the right arm on 01Apr2021 at 10:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included liver transplant, kidney transplants "(3)", spinal fusion, bilateral mastectomy, hypothyroidism, steroid-induced diabetes, glaucoma, osteoporosis and pancreatic cysts (IPMN). Concomitant medications included prednisone (MANUFACTURER UNKNOWN), tacrolimus (PROGRAF), lisinopril (MANUFACTURER UNKNOWN), carvedilol (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN). The patient previously received tetracycline (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the right arm on 04Mar2021 at 14:30 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 22:00, the patient experienced severe back, hip and leg pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events severe back, hip and leg pain were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy bone marrow, Condition aggravated, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: Severe back pain; Hip pain; Leg pain; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533) via an unspecified route of administration in the right arm on 01Apr2021 at 10:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included liver transplant, kidney transplants "(3)", spinal fusion, bilateral mastectomy, hypothyroidism, steroid-induced diabetes, glaucoma, osteoporosis and pancreatic cysts (IPMN). Concomitant medications included prednisone (MANUFACTURER UNKNOWN), tacrolimus (PROGRAF), lisinopril (MANUFACTURER UNKNOWN), carvedilol (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN). The patient previously received tetracycline (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the right arm on 04Mar2021 at 14:30 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 22:00, the patient experienced severe back, hip and leg pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events severe back, hip and leg pain were not recovered 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: Oligomenorrhoea
Clinical narrative: Menstruating since 3/30/21. Today is 4/11/21. My period has never lasted more than 5 days.; This is a spontaneous report from a contactable healthcare professional. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Mar2021 at 16:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 60 mg, colecalciferol (VITAMIN D3), mecobalamin (VITAMIN B12) and ascorbic acid (VITAMIN C), all taken from unknown dates for unspecified indications. The patient previously 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 07Mar2021 at 16:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient experienced menstrual period and it had been continuing till 11Apr2021. It was reported that the patient's period never lasted more than 5 days. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event menstrual cycle started on 30Mar2021 and continuing till 11Apr2021 was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever (from Thursday night toSaturday morning); Chills; Cough; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 26Mar2021(at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included  asthma. The patient did not have any allergies to medications, food, or other products. The patient did not receive any medication within two 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 had been tested for COVID-19. On 01Apr2021 at 08:00, the patient had fever (from Thursday night to Saturday morning), chills (Thursday and Friday) and cough (dry cough stared on Thursday still on).On 14Feb2021, the patient underwent nasal swab SARS CoV-2 test and the result was negative. Therapeutic measures were taken as a result of events and included treatment with ROBITUSSIN. The clinical outcome of the event fever was recovered with sequelae on 03Apr2021.The clinical outcome of the event chills was recovered with sequelae on 02Apr2021. The clinical outcome of the event cough was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eye disorder, Fatigue, Hyperhidrosis
Clinical narrative: fevers; chills; sweating buckets; joints were aching; felt like he had dirt in his eyes; flu like symptoms; sweating profusely; felt drained; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8729, patient was 59-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 04:10 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included seasonal allergies, seasonal asthma, covid-19 virus from Dec2020 to unknown and had to quarantine for 2 weeks at Christmas time last year. There were no concomitant medications. Historical vaccine included received tetanus vaccine last year for immunization. Reported that patient received the Covid 19 vaccine, waited and left the facility. He had no problems. Patient went to bed last night, and he started getting fevers and chills throughout the night with others events. His wife told him to call and report it. Probably around midnight last night patient got up to go to the bathroom and he noticed he had been sweating profusely and had the chills. A day after vaccination in morning he felt drained. Once he got up this morning and took a shower that seemed to help. This reminds him of having a 24 hour bug or flu. He was totally not expecting it. He does feel improved. He feels better than he did. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional Administered Vaccines on same date with the Pfizer vaccine considered as suspect. The patient had not received any vaccine prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations. On 07Apr2021, the patient experienced fevers, chills, sweating buckets, joints were aching, felt like he had dirt in his eyes, flu like symptoms, sweating profusely, on an unspecified date in Apr2021, the patient experienced felt drained. No AE(s) require a visit to emergency room and physician office. The outcome of event (felt drained) was unknown, and the outcomes of events (fevers, chills, sweating buckets, joints were aching, felt like he had dirt in his eyes, flu like symptoms, sweating profusely) were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: fevers; chills; sweating buckets; joints were aching; felt like he had dirt in his eyes; flu like symptoms; sweating profusely; felt drained; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8729, patient was 59-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 04:10 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included seasonal allergies, seasonal asthma, covid-19 virus from Dec2020 to unknown and had to quarantine for 2 weeks at Christmas time last year. There were no concomitant medications. Historical vaccine included received tetanus vaccine last year for immunization. Reported that patient received the Covid 19 vaccine, waited and left the facility. He had no problems. Patient went to bed last night, and he started getting fevers and chills throughout the night with others events. His wife told him to call and report it. Probably around midnight last night patient got up to go to the bathroom and he noticed he had been sweating profusely and had the chills. A day after vaccination in morning he felt drained. Once he got up this morning and took a shower that seemed to help. This reminds him of having a 24 hour bug or flu. He was totally not expecting it. He does feel improved. He feels better than he did. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional Administered Vaccines on same date with the Pfizer vaccine considered as suspect. The patient had not received any vaccine prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations. On 07Apr2021, the patient experienced fevers, chills, sweating buckets, joints were aching, felt like he had dirt in his eyes, flu like symptoms, sweating profusely, on an unspecified date in Apr2021, the patient experienced felt drained. No AE(s) require a visit to emergency room and physician office. The outcome of event (felt drained) was unknown, and the outcomes of events (fevers, chills, sweating buckets, joints were aching, felt like he had dirt in his eyes, flu like symptoms, sweating profusely) were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Apr2021 at 15:30(at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient did not have any allergies to food, medications or other products. Concomitant medications included escitalopram oxalate (LEXAPRO), venlafaxine hydrochloride (EFFEXOR), paracetamol (TYLENOL), alprazolam (XANAX) and levonorgestrel (MIRENA); all for unknown indication and start date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 11Apr2021 at 23:00, the patient experienced diarrhea. The patient did not receive any treatment for the event. The clinical outcome of the event diarrhea was recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: I am still not feeling normal; low grade fever; Chills; Muscle ache; Fatigue; This is a spontaneous report from a contactable consumer (Patient). A 47-year-old (age at vaccination 45 years) male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot Number: ER8727) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included calcium carbonate, colecalciferol (VITAMIN D). The patient experienced low grade fever, chills, muscle ache, fatigue (non-serious) on 29Mar2021. On an unspecified date, patient reported that i am still not feeling normal. The outcome of the events low grade fever and chills was recovered on unknown date. The outcome of the events muscle ache, fatigue and i am still not feeling normal was not recovered. The patient underwent lab tests and procedures which included two sars-cov-2 test: negative on unknown date. Therapeutic measures were taken as a result of low grade fever, chills, muscle ache, fatigue and i am still not feeling normal. It was reported that patient received 400mg of Ibuprofen and 1000mg of Tylenol as a treatment drugs.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: I am still not feeling normal; low grade fever; Chills; Muscle ache; Fatigue; This is a spontaneous report from a contactable consumer (Patient). A 47-year-old (age at vaccination 45 years) male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot Number: ER8727) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included calcium carbonate, colecalciferol (VITAMIN D). The patient experienced low grade fever, chills, muscle ache, fatigue (non-serious) on 29Mar2021. On an unspecified date, patient reported that i am still not feeling normal. The outcome of the events low grade fever and chills was recovered on unknown date. The outcome of the events muscle ache, fatigue and i am still not feeling normal was not recovered. The patient underwent lab tests and procedures which included two sars-cov-2 test: negative on unknown date. Therapeutic measures were taken as a result of low grade fever, chills, muscle ache, fatigue and i am still not feeling normal. It was reported that patient received 400mg of Ibuprofen and 1000mg of Tylenol as a treatment drugs.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Pain, Pain in extremity
Clinical narrative: Fatigue; Chills; Arm pain; Unwell feeling; Body aches; This is a spontaneous report from a contactable consumer. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 07Apr2021 at 14:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included lisinopril (MANUFACTUER UNKNOWN) 20 mg per day. The patient previously took Atarax and experienced allergy to it. It was reported that, prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 06:00 the patient experienced fatigue, chills, arm pain, unwell feeling and body aches. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fatigue, chills, arm pain, unwell feeling and body aches was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.