chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Muscle spasms
Clinical narrative: Abdominal pain; Cramp; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP6955), via an unspecified route of administration in the left arm on 31Mar2021 at 10:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included pollen allergy. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247), via an unspecified route of administration in the left arm on 10Mar2021 at 10:30 (at the age of 34-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 10:00, after 24 hours of vaccination, the patient experienced abdominal pain and cramp for 3 hours. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the abdominal pain and cramp was resolved on 01Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation irregular
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 19-years-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 28Mar2021 at 11:30 (at the age of 19-years-old) as a single dose for COVID-19 immunization. Medical history included hormonal implant inserted in Feb2019 and birth control. The patient did not have any allergies to medications, food, or other products. Concomitant medications included etonogestrel (NEXPLANON) for birth control from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021, within 12 hours of receiving the vaccine, the patient started to have period and it had not varied greatly in flow and cramps.  No therapeutic measures were taken as a result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events irregular periods and menstrual cramps was unknown at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: Swollen lymph nodes under armpit of injection; dull headache; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: ek873c), via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and high cholesterol. The patient did not have any allergies to medications, food, or other products. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: ENGZ06), via an unspecified route of administration in the left arm on 09Mar2021 at 10:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 15:00, +30hrs after second shot, the patient experienced swollen lymph nodes under armpit of injection site and dull headache. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events swollen lymph nodes under armpit of injection site and dull headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Ear discomfort, Ear pain, Eye pain, Feeling abnormal
Clinical narrative: Awful; Growing pain in left ear; Excessive pressure in ear; Excessive pressure behind eye (particularly left eye); Little eye pain; Dry eyes; 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 31Mar2021 at 15:15 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, nerve damage from child birth, C-section, reactive hypoglycemia, gluten intolerance and migraine with aura. The patient had allergy to pineapple, some adhesives and some more (unspecified). The patient received other unspecified medication within two weeks of vaccination. The patient previously took rofecoxib (VIOXX), phenazopyridine hydrochloride (PYRIDIUM), diphenhydramine hydrochloride (BENADRYL) all on an unknown date for unknown indication and experienced drug allergy. The patient previously took influenza vaccine (flu shot) (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced allergy to vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 20:00, the patient experienced growing pain in left ear, excessive pressure in ear and also behind the eye particularly the left eye. The patient felt like there was expanding cotton or something in left ear which was trying to burst forth from head. At the same time, the patient also experienced dry eyes and little eye pain. It got steadily worsened all day until around 13:30 on 01Apr2021, the pain and other symptoms were just blossomed (as reported). The patient felt like the ear drum would explode or something and felt awful. The events resulted in doctor or other healthcare professional office/clinic visit. The doctor had advised the patient to report the events. The patient was advised to take ibuprofen (ADVIL) and loratadine; pseudoephedrine sulfate (CLARITIN D) for the events and to wait. The clinical outcome of the events little eye pain, dry eyes, awful, growing pain in left ear, excessive pressure in ear and excessive pressure behind eye (particularly left eye) were not recovered at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: Awful; Growing pain in left ear; Excessive pressure in ear; Excessive pressure behind eye (particularly left eye); Little eye pain; Dry eyes; 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 31Mar2021 at 15:15 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, nerve damage from child birth, C-section, reactive hypoglycemia, gluten intolerance and migraine with aura. The patient had allergy to pineapple, some adhesives and some more (unspecified). The patient received other unspecified medication within two weeks of vaccination. The patient previously took rofecoxib (VIOXX), phenazopyridine hydrochloride (PYRIDIUM), diphenhydramine hydrochloride (BENADRYL) all on an unknown date for unknown indication and experienced drug allergy. The patient previously took influenza vaccine (flu shot) (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced allergy to vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 20:00, the patient experienced growing pain in left ear, excessive pressure in ear and also behind the eye particularly the left eye. The patient felt like there was expanding cotton or something in left ear which was trying to burst forth from head. At the same time, the patient also experienced dry eyes and little eye pain. It got steadily worsened all day until around 13:30 on 01Apr2021, the pain and other symptoms were just blossomed (as reported). The patient felt like the ear drum would explode or something and felt awful. The events resulted in doctor or other healthcare professional office/clinic visit. The doctor had advised the patient to report the events. The patient was advised to take ibuprofen (ADVIL) and loratadine; pseudoephedrine sulfate (CLARITIN D) for the events and to wait. The clinical outcome of the events little eye pain, dry eyes, awful, growing pain in left ear, excessive pressure in ear and excessive pressure behind eye (particularly left eye) were not recovered at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 16:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date. Patient had allergies to medications, food, or other products which were unspecified. Concomitant medications included levothyroxine sodium (SYNTHROID) and vit b complex (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, after 2 days of vaccination, the patient experienced slight itching and rash on left arm, tummy and back of torso. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events itching and rash was resolving at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Didnt hurt much; This is a spontaneous report from a contactable consumer, the parent. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the arm left on 01Apr2021 at 03:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was 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 four weeks prior to the vaccination. On 01Apr2021 at 03:45, after the vaccination, the patient was feeling fine and it was easy and fast and didn't hurt much (pain). The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken as the result of adverse event. The clinical outcome of the event didn't hurt much (pain) was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: Sinus headache; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 16:45 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. The patient medical history included sinus headache (happens less than two times a year). The patient had known allergies which include penicillin allergy and common seasonal and household allergies. 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 left on 09Mar2021 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any medication 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. On 31Mar2021 at 15:00, the patient experienced sinus headache just under 24 hours 1 day after vaccination. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as a result of sinus headache and included treatment with regular strength tylenol. The clinical outcome of the event sinus headache was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Telangiectasia
Clinical narrative: 12 narrow broken blood vessels under my breasts; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 31Mar2021 at 11:00 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. Medical history included stage 4 metastatic bone cancer and patient was undergoing treatment. The patient was allergic to penicillin. Concomitant medications included apalutamide (ERLEADA) for unspecified indication. The patient previously received the first 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 14:00 (at the age of 70-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 12:00, the patient experienced 12 narrow broken blood vessels under breasts. The patient did not receive any treatment for the event. The clinical outcome of the event narrow broken blood vessels under breasts was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache for 15 hours now.; Some nausea.; This is a spontaneous report from a contactable consumer, the patient. A 64-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 arm left on 30Mar2021 at 13:30(at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccination four weeks prior to the COVID-19 vaccination. The patient had no known allergies. On 31Mar2021 at 10:00, the patient experienced headache and vomiting. It was reported that the patient was experiencing headache since 15 hours. 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 event headache and vomiting was resolving at the time of the report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Pain, Vaccination site pain
Clinical narrative: Dizzy; labored breathing; headache; body aches; soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6955) via an unspecified route of administration in the left arm on 26Mar2021 at 17:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any other medications within 2 weeks of vaccination. The patient did 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: EN6199) via an unspecified route of administration in the left arm on 05Mar2021 at 17:45 (at the age of 65-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 26Mar2021 at 17:00, the patient experienced dizzy, labored breathing, headache, body aches, and soreness at injection site. and it was felt like he had hit by a truck within seconds and most symptoms had passed in intensity during 15 minutes waiting period. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events dizzy, labored breathing, headache, body aches and vaccination site pain were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration on 31Mar2021 at 09:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 12:00, the patient experienced metallic taste in mouth. 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 metallic taste was recovering at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Neck pain, Pyrexia, Swelling, Vaccination site rash
Clinical narrative: Rash near the site of the shot; Swollen neck; Swollen neck that led to pain when moving; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old male patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204), via an unspecified route of administration in the right arm on 31Mar2021 at 13:30 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to amoxicillin. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive 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 tested for COVID-19. On 31Mar2021, the patient experienced rash near the site of the shot, swollen neck that led to pain when moving and swallowing, chills and fever for the first night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as the result of rash, swollen neck, neck pain, chills and fever. The clinical outcome of the events rash near the site of the shot, swollen neck, neck pain, chills and fever were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleed a few hours after injection; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 01Apr2021 at 08:30(at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient has no allergies to medications, food, or other products. Concomitant medications included duloxetine hydrochloride (CYMBALTA), gabapentin (MANUFACTURER UNKNOWN) and lisdexamfetamine mesylate (VYVANSE) all since an unknown date taken for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 16:30 a few hours after injection the patient experienced nose bleed. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event nose bleed was recovered on 01Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling/ Slight tingling on skin all over; slight numbness on face; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737) via an unspecified route of administration in the left arm on 01Apr2021 at 16:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to aspirin (MANUFCATURER UNKNOWN). Concomitant medication included omega-3 (MANUFCATURER UNKNOWN) for an unknown indication. 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 01Apr2021 at 16:45, the patient experienced tingling and slight numbness on face. The patient had slight tingling on skin all over. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of slight tingling on skin all over and numbness in face was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dry eye, Headache, Hot flush
Clinical narrative: Headaches; hot flashes; dry eyes; burning sending under skin on location where received fillers smile lines, cheeks; This is a spontaneous report from a non-contactable consumer, the patient. A 40-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 30Mar2021 at 09:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 10:15, the patient experienced headaches, hot flashes, dry eyes, burning sending under skin on location where received fillers smile lines, cheeks. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headaches, hot flashes, dry eyes and burning sensation was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingly (tightness) ) on right face cheek area, forehead (right side), down cheek to the right side of upper and lower lips and felt it toward right ear. Everything was on right side of face; This is a spontaneous report from a contactable consumer. A 53-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 arm right on 01Apr2021 at 14:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included alpha1 carrier and migraine. It was unsure if the patient had any allergies. Concomitant medications included sumatriptan succinate (SUMATRIPTAN) indicated for migraines, multi vitamin and other unspecified medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 (also reported 02:45), the patient experienced tingly (tightness) on right face cheek area, then it went to forehead (right side), then it went down her cheek to the right side of her upper and lower lips and she also felt it towards her right ear. Everything was on the right side of face, almost exactly separated at the very center of the face. Therapeutic measure was taken as a result of event tingly and included treatment with benedryl. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event tingling was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain
Clinical narrative: chills; Severe; Soreness at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 30Mar2021 at 09:00 (at the age of 43-years) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Concomitant medications included ethinylestradiol, etonogestrel (NUVARING) taken from unknown date and for unknown indication. The patient had no allergies to medications, food, or other products. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on 11Mar2021 at 09:00 (at the age of 43-years). 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 soreness at the injection site and on 31Mar2021, at 02:00 the patient experienced chills and severe fatigue. The patient did not receive any treatment for the events. The clinical outcome of the events soreness at the injection site, chills and fatigue was resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Fatigue; Flu-like symptoms; This is a spontaneous report from a contactable physician, the patient. A 46-year-old-male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 31Mar2021 at 14:30 (at the age of 46-years-old), as a single dose for COVID -19 immunisation. Medical history included hypocholesteremia. The patient was unknown about the allergies to medications, food, or other products. Concomitant medication included atorvastatin calcium (LIPITOR) of 10mg and clomiphene (MANUFACTURER UNKNOWN) of 50mg; both for unknown indications from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 10Mar2021 at 14:30 (at the age of 46-years-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. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 00:00, the patient experienced fatigue and flu-like symptoms. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure was taken as a result of fatigue and flu-like symptoms and included treatment with ADVIL of 400mg. The clinical outcomes of the events fatigue and flu-like symptoms were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: During the vaccine, the nurse struggled with getting the medication to release from the syringe.  It took multiple attempts of moving the needle while injected and pushing the plunger forcefully to get medication to be injected.; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), via an unspecified route of administration in the left arm on 01Apr2021 at 17:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to food, medications, or other products. 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. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 17:30, during the injection of the COVID-19 vaccine, the nurse struggled with getting the medication to release from the syringe. It took multiple attempts of moving the needle while injected, and pushing the plunger forcefully to get medication to be injected. The patient was uncertain if he received the entirety of the whole vaccine syringe, or if he got the complete dose. No other reactions had occurred since the injection and the patient felt normal. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event product administration error. The clinical outcome of the event product administration error was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Chills, Cough, Fatigue
Clinical narrative: Inappropriate schedule of vaccine administered; Extreme armpit pain; extreme low back pain; headache; nausea; fever; chills; slight cough; extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 40-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 30Mar2021 at 15:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, obesity. The patient had known allergies to penicillin and cephalosporins. Concomitant medications included magnesium lactate (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPRIN) for unknown indication from an unspecified date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Em9809) via an unspecified route of administration in the right arm on 12Mar2021 at 08:15 (at the age of 40-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 30Mar2021 at 20:00, the patient experienced extreme armpit pain, extreme low back pain, headache, nausea, fever, chills, slight cough and extreme fatigue. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event extreme armpit pain, extreme low back pain, headache, nausea, fever, chills, slight cough and extreme fatigue was resolving at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Nausea, Pyrexia
Clinical narrative: Inappropriate schedule of vaccine administered; Extreme armpit pain; extreme low back pain; headache; nausea; fever; chills; slight cough; extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 40-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 30Mar2021 at 15:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, obesity. The patient had known allergies to penicillin and cephalosporins. Concomitant medications included magnesium lactate (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPRIN) for unknown indication from an unspecified date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Em9809) via an unspecified route of administration in the right arm on 12Mar2021 at 08:15 (at the age of 40-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 30Mar2021 at 20:00, the patient experienced extreme armpit pain, extreme low back pain, headache, nausea, fever, chills, slight cough and extreme fatigue. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event extreme armpit pain, extreme low back pain, headache, nausea, fever, chills, slight cough and extreme fatigue was resolving at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pruritus
Clinical narrative: Tongue was tingling; Arms and chest has a itchy feeling with no hives; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8732) via an unspecified route of administration in the right arm on 26Mar2021 at 14:15 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma, breast cancer 8 years ago and sulfonamide allergy. Concomitant medications included amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL), vitamin d nos (MANUFACTURER UNKNOWN) and daily vitamins. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 14:30, about 5 minutes after first shot the patient's tongue was tingling and shortly after that about 45 minutes to 1 hour, arms and chest had an itchy feeling with no hives and lasted for 6 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient took her singulair allergy medication and itchy feeling seemed to subside and no other therapeutic measures were taken for the reported events. The clinical outcome of the event tingling tongue was recovered on an unknown date and the event itchy feeling with no hives that lasted for 6 hours, was recovered on 26Mar2021.    No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain
Clinical narrative: Body aches; joint pain; Slight headache; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration on 30Mar2021 at 00:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, hypothyroid, rheumatoid arthritis (RA) and depression. Concomitant medications were not reported. The patient previously received paracetamol; dextropropoxyphene hydrochloride (DARVOCET) and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient had body aches, joint pain and slight headache. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events body aches, joint pain, slight headache and included treatment with paracetamol (TYLENOL) and ibuprofen (ADVIL). The clinical outcomes of the events body aches, joint pain and slight headache were resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning feet syndrome, Burning sensation, Erythema, Myalgia
Clinical narrative: constricted throat; Body and muscle aches; Feverish, but no fever; Body and muscle aches; the pins and needles feeling, and the red hands; pins and needles feeling, and the red hands; burning and tingling sensation in the legs and back; burning and tingling sensation in the legs and back; the pins, needles, and burning sensation on the bottom of her feet; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), (Batch/Lot number:ER8730 & Expiry date not reported) via unspecified route of administration in left arm on 26Mar2021 16:10 (at age of 55-year-old) as dose 2, single for COVID-19 Immunization. Patient medical history and concomitant medications not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), (Batch/Lot number: ENG202, Expiry date not reported) via unspecified route of administration in left arm on 26Feb2021 (at age of 54-year-old) as dose 1, single for COVID-19 Immunization. On 26Mar2021, Patient experienced had a severe reaction, but it did not require and epipen. She ended up in the emergency department and required Benadryl as she had a constricted throat. Her symptoms resolved as soon as she received Benadryl and steroids via IV. Patient after returning home she had severe body aches and muscle aches to the point that getting to the bed from her recliner was difficult, and she was down all weekend. She felt feverish but did not have a fever. She checked her temperature, and it was 98F. On an unspecified date in Mar2021, Caller states she had pins and needle feeling, and burning and tingling in her legs and back. In addition to the bottom of feet, she also had pins, needles, and a burning sensation that lessened as of this morning. Caller states the pins and needles feeling, and the red hands are ongoing since the first covid19 vaccine, on26Feb2021, and are persisting since the second covid19 vaccine. Caller states the burning and tingling sensation in the legs and back were ongoing since the first covid19 vaccine and worsened since the second covid19 vaccine. Caller also states the pins, needles, and burning sensation on the bottom of her feet started 3 weeks after the first covid19 vaccine, on 19Mar2021, and the sensation worsened after the second covid19 vaccine and was ongoing. Patient was referred to allergist. Patient underwent lab test and procedure include body temperature was 98F on unspecified date. Treatment received for constricted throat. The Outcome of events was constricted throat recovered on 26Mar2021, Feverish, but no fever recovered on 27Mar2021, body aches and muscle aches are recovering, and other events are not recovered.     No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pyrexia, Throat tightness
Clinical narrative: constricted throat; Body and muscle aches; Feverish, but no fever; Body and muscle aches; the pins and needles feeling, and the red hands; pins and needles feeling, and the red hands; burning and tingling sensation in the legs and back; burning and tingling sensation in the legs and back; the pins, needles, and burning sensation on the bottom of her feet; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), (Batch/Lot number:ER8730 & Expiry date not reported) via unspecified route of administration in left arm on 26Mar2021 16:10 (at age of 55-year-old) as dose 2, single for COVID-19 Immunization. Patient medical history and concomitant medications not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), (Batch/Lot number: ENG202, Expiry date not reported) via unspecified route of administration in left arm on 26Feb2021 (at age of 54-year-old) as dose 1, single for COVID-19 Immunization. On 26Mar2021, Patient experienced had a severe reaction, but it did not require and epipen. She ended up in the emergency department and required Benadryl as she had a constricted throat. Her symptoms resolved as soon as she received Benadryl and steroids via IV. Patient after returning home she had severe body aches and muscle aches to the point that getting to the bed from her recliner was difficult, and she was down all weekend. She felt feverish but did not have a fever. She checked her temperature, and it was 98F. On an unspecified date in Mar2021, Caller states she had pins and needle feeling, and burning and tingling in her legs and back. In addition to the bottom of feet, she also had pins, needles, and a burning sensation that lessened as of this morning. Caller states the pins and needles feeling, and the red hands are ongoing since the first covid19 vaccine, on26Feb2021, and are persisting since the second covid19 vaccine. Caller states the burning and tingling sensation in the legs and back were ongoing since the first covid19 vaccine and worsened since the second covid19 vaccine. Caller also states the pins, needles, and burning sensation on the bottom of her feet started 3 weeks after the first covid19 vaccine, on 19Mar2021, and the sensation worsened after the second covid19 vaccine and was ongoing. Patient was referred to allergist. Patient underwent lab test and procedure include body temperature was 98F on unspecified date. Treatment received for constricted throat. The Outcome of events was constricted throat recovered on 26Mar2021, Feverish, but no fever recovered on 27Mar2021, body aches and muscle aches are recovering, and other events are not recovered.     No follow-up attempts are possible. No further information is expected.