chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Irritability, Nausea, Vaccination site rash
Clinical narrative: I woke up with rash around the vaccine injection site; Irritability within 1 hour of getting the vaccine; Nausea within 1 hour of getting the vaccine; Fatigue within 1 hour of getting the vaccine; The patient received the second dose of vaccination on 25Jun2021; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO198) via an unspecified route of administration in the left arm on 25Jun2021 at 09:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to lactose intolerant. Concomitant medication details were not provided. Prior to vaccination, it was unknown whether the patient was 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: EWO187) via an unspecified route of administration on 09Jun2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 25Jun2021 at 10:30, within 1 hour of getting the vaccine, the patient experienced irritability, nausea and fatigue. On 26Jun2021, the next day (24 hours later), the patient woke up with a rash around the vaccine injection site. 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 irritability, nausea and fatigue within 1 hour of getting the vaccine and rash around the vaccine injection site was resolving at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: had a little bit of a fever that lasted maybe four hours after receiving the Pfizer Vaccine; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient had a little bit of a fever that lasted maybe four hours after receiving the bnt162b2 vaccine. The caller stated that the report could be completed if necessary, for her husband. The caller stated that she did not have Vaccine card of her husband. The caller stated that she really did not want to complete the reports, it was not pertinent to the caller to complete the reports, if not pertinent to the company. The caller would prefer not to complete the reports and stated she did not have any of the information to provide anyway. The outcome of the event was recovered.  Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Enlarged lymph node same side vaccine was administered; This is a spontaneous report from a contactable consumer. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via intramuscular route of administration in the left arm on 24Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via intramuscular route of administration in the arm left on 02Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient received 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 27Apr2021, 3 days following vaccination, the patient experienced enlarged lymph node at the same side where vaccine was administered, which resolved within a few days. The event 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 event. The clinical outcome of the event enlarged lymph node same side vaccine was administered was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: discomfort in arm; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced discomfort in arm for a couple of days on an unspecified date. Outcome of event was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Haematuria
Clinical narrative: Unexplained hematuria 4 weeks after 2nd vaccine; This is a spontaneous report from a contactable consumer, the patient. A 65-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 on 24Mar2021 at 12:00 as a single dose for COVID-19 immunisation. Medical history included skin cancer and penicillin allergy. Concomitant medications included vitamin d nos (VITAMIN D). 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 25Apr2021 at 07:00, 4 weeks after second vaccine the patient experienced unexplained hematuria. 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 unexplained hematuria 4 weeks after second vaccine was unknown at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Vomiting
Clinical narrative: Vomiting; Nausea 8 days; Chills 8 days; Headache 8 days; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196), via an unspecified route of administration in the right arm on 18Jun2021 at 16:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, food allergy (wheat) and sulfonamide allergy. The patient did not receive any other medications in 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 4 weeks prior to the vaccination. On 19Jun2021, the patient experienced vomiting, nausea 8 days, chills 8 days and headache 8 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events vomiting, nausea 8 days, chills 8 days and headache 8 days were resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pyrexia
Clinical narrative: fever; migraine; This is a spontaneous report from a Pfizer-sponsored program Covax US Support. A contactable female consumer (Patient) reported.  A female patient of an unspecified age received first dose of BNT162B2 (solution for injection, lot number: unknown) via an unspecified route of administration, on 23Jun2021, as a dose 1, single for Covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date after her first dose, she experienced migraine and on 26Jun2021 (today), she was having a fever. She took naproxen 2 hours prior to this report (2 hours ago) but her fever was not coming down. She wanted to know if she can take Tylenol. The outcome of the event of fever was reported as not recovered, while the outcome of the event of migraine was unknown.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: sliver dollar size spot that was swollen; sliver dollar size spot that is hot to touch.; Very sensitive to touch; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 25Jun2021 at 12:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity and COVID-19. The patient was not allergic 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 included phentermine (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN) and unspecified thyroid medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Jun2021 at 10:00, the patient experienced sliver dollar size spot underneath the injection shot that was swollen and hot to touch. It was also very sensitive to the touch. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included application of ice as suggested by physician. The clinical outcome of the events sliver dollar size spot underneath the injection shot that was swollen and hot to touch, very sensitive to the touch was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Hot flush, Insomnia, Laboratory test
Clinical narrative: got lightheaded; hot flashes; the hours of sleep I get are less and less/I cannot sleep; I am living miserable since; hot flashes along with migraines are an every day and night thing; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date in 2021 as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration in arm right on 11May2021 at 22:45 (at the age of 29-year-old) as a dose 1, single for COVID-19 immunization and experienced migraine, patient felt lightheaded, got hot flashes, the weeks that passed the symptoms grew stronger and more frequent and on came the sleepless nights with an outcome of not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. It was reported that, after getting her second dose, on an unspecified date in 2021, she again got lightheaded and hot flashes a few moments later. Stated that, it has now been weeks and the hours of sleep she get are less and less. Stated that, she cannot sleep and hot flashes along with migraines are an every day and night thing. The patient was been tested like a rat in a lab by doctors and they have no answers. She understood this was all new and there wasn't much research but she need help. Stated that, a mother of 2 experiencing this was not ideal. The patient need answers as fast advice on what to do. Stated that, was this happening to anyone else or just her. Stated that, she cannot comfortably recommend to others to get the vaccine when she was living miserable since. Stated that, the patient wanted help and any feedback would be greatly appreciated. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment was not received for the events. The device timestamp was on 28Jun2021. On an unspecified date in 2021, the patient underwent lab tests and procedures which included tested like a rat in a lab (Laboratory test), resulted as unknown results, they have no answers. The outcome of the events was not recovered.  Information related to batch/Lot no. was requested.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: got lightheaded; hot flashes; the hours of sleep I get are less and less/I cannot sleep; I am living miserable since; hot flashes along with migraines are an every day and night thing; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date in 2021 as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration in arm right on 11May2021 at 22:45 (at the age of 29-year-old) as a dose 1, single for COVID-19 immunization and experienced migraine, patient felt lightheaded, got hot flashes, the weeks that passed the symptoms grew stronger and more frequent and on came the sleepless nights with an outcome of not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. It was reported that, after getting her second dose, on an unspecified date in 2021, she again got lightheaded and hot flashes a few moments later. Stated that, it has now been weeks and the hours of sleep she get are less and less. Stated that, she cannot sleep and hot flashes along with migraines are an every day and night thing. The patient was been tested like a rat in a lab by doctors and they have no answers. She understood this was all new and there wasn't much research but she need help. Stated that, a mother of 2 experiencing this was not ideal. The patient need answers as fast advice on what to do. Stated that, was this happening to anyone else or just her. Stated that, she cannot comfortably recommend to others to get the vaccine when she was living miserable since. Stated that, the patient wanted help and any feedback would be greatly appreciated. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment was not received for the events. The device timestamp was on 28Jun2021. On an unspecified date in 2021, the patient underwent lab tests and procedures which included tested like a rat in a lab (Laboratory test), resulted as unknown results, they have no answers. The outcome of the events was not recovered.  Information related to batch/Lot no. was requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Pain, Pain in extremity
Clinical narrative: suffered through an intense migraine; Arm and body sore; Arm and body sore; Have pain, like an ice pick being shoved above eye close to the bridge of nose; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9261) via an unspecified route of administration on 04Feb2021 at 00:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included primary ciliary dyskinesia (PCD), kartagener's syndrome, chronic daily migraine, sulpha allergy, tuna allergy and the patient also had allergies to beta blockers, calcium blockers and other migraine preventative medications. The patient received unspecified 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Feb2021, the patient suffered through an intense migraine. No fever. Arm and body sore since that time, the patient had pain, like an ice pick being shoved above eye, close to the bridge of nose. It was constant for about 10 week and at the time of this report have a few days of relief. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event intense migraine which included treatment with unspecified migraine medications. The clinical outcome of the events suffered through an intense migraine, arm and body sore and event have pain, like an ice pick being shoved above eye close to the bridge of nose were resolved with sequelae on an unknown date in 2021.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: Swollen armpit - left arm. Very sore and hurts.; Swollen armpit - left arm.; Arm also hurt near injection spot.; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0196) via an unspecified route of administration in the arm left on 26Jun2021 at 10:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0187) via an unspecified route of administration in the arm left on 05Jun2021 at 11:45 (at the age of 44-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 27Jun2021, the patient experienced swollen armpit - left arm, very sore and hurt. The patient's arm also hurt near the injection spot. 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 armpit - left arm, very sore and hurt and arm also hurt near injection spot were not recovered at the time of this report.    No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood oestrogen, Blood oestrogen increased, Oligomenorrhoea
Clinical narrative: Not gotten my period for 65 days; Estrogen levels are exceedingly high; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received unknown dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient not gotten period for 65 days and estrogen levels are exceedingly high at 666 on an unspecified date. The patient underwent lab tests and procedures which included blood oestrogen which was exceedingly high at 666. The outcome of events was unknown.  Lo/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling, Tenderness
Clinical narrative: Very swollen in left armpit for several weeks; Sore and tender for weeks; Sore and tender for weeks.; This is a spontaneous report from a non-contactable other healthcare professional. A 34-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 an unknown date (at the age of 34-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced very swollen in left armpit for several weeks, sore and tender for weeks. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for reported events. The clinical outcome of the events very swollen in left armpit for several weeks, sore and tender for weeks were recovered on an unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tenderness
Clinical narrative: Localized swelling in left side of the neck down into the trapezius wrapping towards the clavicle; Area is firm and tender to touch not discolored orwarm.; This is a spontaneous report from a contactable other healthcare professional. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via intramuscular route of administration in the left arm on 26Jun2021 at 08:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic otitis media. The patient received hepatitis b vaccine rHBsag (yeast), hepatitis a vaccine inact (TWINRIX) on 07Jun2021. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW10179) via intramuscular route of administration in the left arm on 02Jun2021 at 08:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Jun2021 the patient experienced localized swelling in left side of the neck down into the trapezius wrapping towards the clavicle. The area was firm and tender to touch but not discolored or warm. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with BENADRYL and ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event localized swelling in left side of the neck down into the trapezius wrapping towards the clavicle and the area was firm and tender to touch but not discolored or warm was not resolved.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable nurse, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248) via an unspecified route of administration in the left arm on 08Jan2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Concomitant medication included vitamin d nos (MANUFACTURER UNKNOWN); taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH9899) via an unspecified route of administration in the left arm on 18Dec2020 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, approximately 4 weeks after second dose, the patient experienced tinnitus. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 09Apr2021, the patient underwent PCR (nasal swab) test for COVID-19 and the result was negative. No therapeutic measures were taken as a result of the event. The clinical outcome of the event tinnitus was not recovered at the time of this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Baseball size knot on arm; Swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 25Jun2021 at 10:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included COVID-19. The patient had a known allergy to peppers. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included XYZAL, Multivitamin, and Melatonin, all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0187), via an unspecified route of administration in the right arm on 04Jun2021 at 14:45 (at the age of 41-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. On 27Jun2021 at 04:15, the patient experienced baseball size knot on arm and swollen lymph nodes. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event baseball size knot on arm and swollen lymph nodes was not resolved at the time of this report.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Confusional state, Fatigue, Headache, Malaise
Clinical narrative: Malaise; Nausea; Headache; Confusion; Aches; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the right arm on 27Jun2021 at 11:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included attention deficit hyperactivity disorder (ADHD), depression and generalized anxiety disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included dexamfetamine sulfate, amfetamine sulfate, dexamfetamine saccharate, amfetamine aspartate monohydrate (MYDAYIS) from an unknown date for an unspecified indication and unknown if ongoing and venlafaxine (MANUFACTURER UNKNOWN), from an unknown date for an unspecified indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the right arm on 06Jun2021 at 13:00 (at the age of 17-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. On 27Jun2021 at 11:30, the patient experienced malaise, nausea, headache, confusion, aches, chills and fatigue. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events malaise, nausea, headache, confusion, aches, chills and fatigue were resolving at the time of this report.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Malaise; Nausea; Headache; Confusion; Aches; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the right arm on 27Jun2021 at 11:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included attention deficit hyperactivity disorder (ADHD), depression and generalized anxiety disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included dexamfetamine sulfate, amfetamine sulfate, dexamfetamine saccharate, amfetamine aspartate monohydrate (MYDAYIS) from an unknown date for an unspecified indication and unknown if ongoing and venlafaxine (MANUFACTURER UNKNOWN), from an unknown date for an unspecified indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the right arm on 06Jun2021 at 13:00 (at the age of 17-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. On 27Jun2021 at 11:30, the patient experienced malaise, nausea, headache, confusion, aches, chills and fatigue. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events malaise, nausea, headache, confusion, aches, chills and fatigue were resolving at the time of this report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Rash, Rash erythematous, Rash macular, Rash papular
Clinical narrative: a weird skin rash appeared in left forearm approximately 4-inches from left wrist; swollen and enlarged itself to appear almost raised off the skin; blister with a red rash about 1-inch in length, the red rash had a trail all the way down to elbow.; started as a blister with a red rash about 1-inch in length, the red rash had a trail all the way down to elbow; discolored and blotchy, still 1- inch in length; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EU0177) via an unspecified route of administration in the left arm on 08Jun2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Jun2021, within 1-2 hours of receiving the first vaccine, the patient experienced a weird skin rash appeared in her left forearm approximately 4-inches from her left wrist. It was swollen and enlarged itself to appear almost raised off the skin. It started as a blister with a red rash about 1-inch in length, the red rash had a trail all the way down to her elbow. The patient had taken a hot shower after getting home from receiving the vaccine, and was curious if the hot water triggered the rash. Another smaller blister formed in the rash days later. It had been more than 3 weeks now and the rash was still there. The trainings have subsided but there was still a very faint trail. Now the rash looked like a burn wound that was healed. It was very discoloured and blotchy, still 1- inch in length. There was still a very slight raising that she could feel when she track her finger over the rash. 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 a weird skin rash appeared in left forearm approximately 4-inches from left wrist, swollen and enlarged itself to appear almost raised off the skin, blister with a red rash about 1-inch in length, the red rash had a trail all the way down to elbow and the event discolored and blotchy, still 1- inch in length were not recovered at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in both ears; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Jun2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history included hypertension, thyroid cancer and penicillin allergy. Concomitant medications included levothyroxine sodium (SYNTHROID), hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ) and vitamin d nos (VITAMIN D), all for unknown indication and from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the right arm on 29Apr2021 at 10:00 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 4 weeks prior to the vaccination. On 12Jun2021, the patient experienced tinnitus in both ears. The patient underwent ENT and GP exam and no treatment was received. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tinnitus in both ears was not recovered at the time of this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204) via an unspecified route of administration in the  left arm on 24Feb2021 at 15:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Other medical history included hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, after two weeks of vaccination, the patient experienced shingles. Its reported as the vaccine weakened the patient immune system making it vulnerable to shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event of shingles and included treatment with tylenol and ibuprofen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event of shingles was recovered on an unknown date in 2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204) via an unspecified route of administration in the  left arm on 24Mar2021 at 15:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Menstruation irregular
Clinical narrative: The day I received my second vaccine I started menstruating. I have an iud and had not had a period prior to this episode for 8 months. I had a abnormally heavy period lasting 6 full days of saturatin; I had a abnormally heavy period lasting 6 full days of saturating tampons; The day I received my second vaccine I started menstruating. I have an iud and had not had a period prior to this episode for 8 months.; This is a spontaneous report from a contactable nurse (patient).  A 35-year-old non-pregnant female received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via intramuscular route of administration, on right arm on 12Jan2021 11:00 (age at the time of vaccination was 35-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medication was not reported. The patient had allergy to penicillin. Previously the patient received first dose of bnt162b2 (COMITNATY, Solution for injection, Batch/Lot number was not specified) via intramuscular route on right arm on 21Dec2020 at 09:00 (age at the time of vaccination was 35-year-old) as single dose for COVID-19 immunization. The patient did not COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not any other vaccine in 4 weeks. On 12Jan2021 14:00, the patient experienced, the day I received my second vaccine I started menstruating, I have an iud and had not had a period prior to this episode for 8 months and I had a abnormally heavy period lasting 6 full days of saturating tampons. I continue to have a monthly period to this day following the vaccine. The iud was still in place. Patient did not receive any treatment. Outcome of the events was recovered with sequel.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: She had an allergic reaction to the Pfizer covid vaccine; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller said that she had an allergic reaction to the Pfizer Covid vaccine on unknown date, Caller wanted to know if it was possible to had an allergic reaction after five days of taking the vaccine. The outcome of the event was reported as unknown.  Information on the Batch/Lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Vaccination site pain
Clinical narrative: Frequent involuntary painless muscle spasms throughout body, particularly in the foot; Pain at injection site; Myalgia/ Muscle soreness in upper body; This is a spontaneous report from a non-contactable consumer, the patient. A 15-year-old patient of unspecified gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Jun2021 at 14:00 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Jun2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On an unknown date in Jun2021, the patient experienced frequent involuntary painless muscle spasms throughout body, particularly in the foot, pain at injection site, myalgia and muscle soreness in upper body. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of event painless muscle spasms throughout body, particularly in the foot, pain at injection site, myalgia and muscle soreness in upper body were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Influenza like illness, Nasal congestion, Pain
Clinical narrative: Weak; Achy; Mild congestion; Mild flu-like symptoms; Took temperature and it was slightly elevated; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in May2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications included lisinopril dihydrate (LIZINOPRIL) and gliclazide (CLARITIN), both taken for unspecified indications from unknown dates. 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 left arm on 17Apr2021 at 08:30 (at the age of 62-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 17May2021 at 04:30, 2 weeks after the second vaccine, the patient experienced that he was weak, achy and had mild congestion. The patient took aspirin and it helped. On18May2021, the next day it was diminished and on 19May2021, the second next day it was gone. On an unknown date in 2021, 2 weeks later at the time of this report, the patient had the same albeit milder symptoms. This time the patient took temperature and it was slightly elevated. The patient took aspirin which again helped. The patient thought about it after and wished he had taken temperature during the first episode because he believed it to be mild flu-like symptoms. After the second time, the patient started to research and had not found anything like this, but at least wanted to let someone know about the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with aspirin. The clinical outcome of the events weak, achy, mild congestion and flu-like symptoms were resolved on 19May2021 and the same albeit milder symptoms along with temperature slightly elevated were resolved on an unspecified date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Acarodermatitis
Clinical narrative: Rash on shoulders and privates, legs, chest itches like mad; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 21Jun2021 at 17:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Patient had no other medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cannabis sativa (MARIJUANA) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Jun2021 at 03:00, the patient experienced "rash on shoulders and privates, legs, chest Itches like mad". The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported event which included treatment with cream for scabies. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event of "rash on shoulders and privates ,legs, chest itches like mad" was unknown at the time of this report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Stomach pains; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 36-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 19Jun2021 at 13:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to citrus. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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. On 20Jun2021, the patient experienced stomach pains and vomiting and the patient could not keep anything down. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events stomach pains and vomiting was recovering at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.