chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: feeling incredibly sick; achy muscles; nausea; diarrhea; foggy memory; extreme fatigue; very bad headache; sore neck muscles; sneezing; runny nose; brief periods of rapid heart rate; no appetite; Sometimes it felt like a specific part of body was under attack, i.e. GI tract, various muscle groups, sinuses; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 26Mar2021 at 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included cervical fusion C3-C7. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (ADVIL) both for an unknown indication. The patient's history of allergies to medications, food or other products was not reported. 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 27Mar2021 at 10:00, approximately 20 hours after injection, the patient experienced feeling incredibly sick with no fever, but achy muscles, nausea, diarrhoea which still continued, foggy memory, extreme fatigue, very bad headache, sore neck muscles, sneezing, runny nose, brief periods of rapid heart rate, no appetite and sometimes it felt like a specific part of the body was under attack, i.e., GI tract, various muscle groups, sinuses. The patient reported that likely forgot some symptoms, but these ranks among the worst that patient ever felt in life without running a high fever. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events feeling incredibly sick, achy muscles, nausea, diarrhoea, foggy memory, extreme fatigue, very bad headache, sore neck muscles, sneezing, runny nose, brief periods of rapid heart rate, no appetite, felt like a specific part of my body was under attack, i.e., GI tract, various muscle groups, sinuses was resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Malaise, Memory impairment, Myalgia, Nausea
Clinical narrative: feeling incredibly sick; achy muscles; nausea; diarrhea; foggy memory; extreme fatigue; very bad headache; sore neck muscles; sneezing; runny nose; brief periods of rapid heart rate; no appetite; Sometimes it felt like a specific part of body was under attack, i.e. GI tract, various muscle groups, sinuses; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 26Mar2021 at 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included cervical fusion C3-C7. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (ADVIL) both for an unknown indication. The patient's history of allergies to medications, food or other products was not reported. 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 27Mar2021 at 10:00, approximately 20 hours after injection, the patient experienced feeling incredibly sick with no fever, but achy muscles, nausea, diarrhoea which still continued, foggy memory, extreme fatigue, very bad headache, sore neck muscles, sneezing, runny nose, brief periods of rapid heart rate, no appetite and sometimes it felt like a specific part of the body was under attack, i.e., GI tract, various muscle groups, sinuses. The patient reported that likely forgot some symptoms, but these ranks among the worst that patient ever felt in life without running a high fever. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events feeling incredibly sick, achy muscles, nausea, diarrhoea, foggy memory, extreme fatigue, very bad headache, sore neck muscles, sneezing, runny nose, brief periods of rapid heart rate, no appetite, felt like a specific part of my body was under attack, i.e., GI tract, various muscle groups, sinuses was resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: feeling incredibly sick; achy muscles; nausea; diarrhea; foggy memory; extreme fatigue; very bad headache; sore neck muscles; sneezing; runny nose; brief periods of rapid heart rate; no appetite; Sometimes it felt like a specific part of body was under attack, i.e. GI tract, various muscle groups, sinuses; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 26Mar2021 at 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included cervical fusion C3-C7. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (ADVIL) both for an unknown indication. The patient's history of allergies to medications, food or other products was not reported. 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 27Mar2021 at 10:00, approximately 20 hours after injection, the patient experienced feeling incredibly sick with no fever, but achy muscles, nausea, diarrhoea which still continued, foggy memory, extreme fatigue, very bad headache, sore neck muscles, sneezing, runny nose, brief periods of rapid heart rate, no appetite and sometimes it felt like a specific part of the body was under attack, i.e., GI tract, various muscle groups, sinuses. The patient reported that likely forgot some symptoms, but these ranks among the worst that patient ever felt in life without running a high fever. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events feeling incredibly sick, achy muscles, nausea, diarrhoea, foggy memory, extreme fatigue, very bad headache, sore neck muscles, sneezing, runny nose, brief periods of rapid heart rate, no appetite, felt like a specific part of my body was under attack, i.e., GI tract, various muscle groups, sinuses was resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Nausea
Clinical narrative: bouts of nausea and stomach cramping; bouts of nausea and stomach cramping; Eventually the cramping turned in to violent diarrhea; high fever with chills; high fever with chills; waves of tiredness; This is a spontaneous report from a contactable consumer, the patient. An elderly non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 26Mar2021 at 17:45 as a single dose for COVID-19 immunisation. Medical history included pre-diabetic and pace maker. The patient received unspecified medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 05Mar2021 at 16:30 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 COVID vaccine. On 27Mar2021 at 02:00 the patient experienced bouts of nausea, stomach cramping, violent diarrhoea, high fever, chills and waves of tiredness that come for no apparent reason. 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 reported event. The clinical outcome of the nausea, stomach cramps, diarrhoea, fever, chills and tiredness was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: bouts of nausea and stomach cramping; bouts of nausea and stomach cramping; Eventually the cramping turned in to violent diarrhea; high fever with chills; high fever with chills; waves of tiredness; This is a spontaneous report from a contactable consumer, the patient. An elderly non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 26Mar2021 at 17:45 as a single dose for COVID-19 immunisation. Medical history included pre-diabetic and pace maker. The patient received unspecified medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 05Mar2021 at 16:30 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 COVID vaccine. On 27Mar2021 at 02:00 the patient experienced bouts of nausea, stomach cramping, violent diarrhoea, high fever, chills and waves of tiredness that come for no apparent reason. 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 reported event. The clinical outcome of the nausea, stomach cramps, diarrhoea, fever, chills and tiredness was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Arm pain near site of shot; feverish; exhaustion; chills; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on 01Apr2021 at 10:45 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history and concomintant 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 02Apr2021, the patient experienced arm pain near site of shot, feverish, exhaustion and chills. The clinical outcome of the events arm pain near site of shot, feverish, exhaustion and chills was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Lethargy, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Terrible pain in left arm; Sore throat; Runny nose; Grogginess; Lethargy; Fogginess; Wobbliness; Mild general achiness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male 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 01Apr2021 at 17:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as no chronic health conditions. The patient did not have any known allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of COVID-19 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 COVID-19 vaccination. On 01Apr2021, the patient experienced terrible pain in left arm, sore throat, runny nose, grogginess, lethargy, fogginess, wobbliness and mild general achiness. The patient did not receive any treatment for the reported events. 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 clinical outcome of the events terrible pain in left arm, sore throat, runny nose, grogginess, lethargy, fogginess, wobbliness and mild general achiness was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Somnolence, Tremor
Clinical narrative: Terrible pain in left arm; Sore throat; Runny nose; Grogginess; Lethargy; Fogginess; Wobbliness; Mild general achiness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male 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 01Apr2021 at 17:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as no chronic health conditions. The patient did not have any known allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of COVID-19 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 COVID-19 vaccination. On 01Apr2021, the patient experienced terrible pain in left arm, sore throat, runny nose, grogginess, lethargy, fogginess, wobbliness and mild general achiness. The patient did not receive any treatment for the reported events. 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 clinical outcome of the events terrible pain in left arm, sore throat, runny nose, grogginess, lethargy, fogginess, wobbliness and mild general achiness was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Malaise, Nausea, Pain
Clinical narrative: Light headed; Body aches; Malaise; Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 32-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 13:45 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included sjogren's syndrome. Concomitant medications included sertraline hydrochloride (ZOLOFT), celecoxib (CELEBREX), fexofenadine hydrochloride (ALLEGRA), hydroxychloroquine sulfate (PLAQUENIL) and probiotic, all from unknown dates and for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208 ) via an unspecified route of administration in the left arm on 09Mar2021 at 16:45 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies.  The patient did not receive any other vaccines within four weeks prior to the COVID-19 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 14:00, the patient experienced light headed, body aches, malaise, headache and nausea. The patient received tylenol as the 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 event light headed, body aches, malaise, headache and nausea was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) in the left arm on 31Mar2021 at 14:30 (at the age of 36-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 levothyroxine sodium (SYNTHROID) for unknown indication within two weeks prior to COVID-19 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 02Apr2021 at 16:00 the patient experienced nausea and diarrhea. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events nausea and diarrhea were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: After the first does started having heartburn and intensified greatly after the 2nd shot; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6199) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 41-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6208) on 01Apr2021 (at the age of 41-years-old) as a second dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not have any history of heartburn or acid reflux. The patient did not receive any medications within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 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 22Mar2021, around 2 weeks after first dose of vaccination, the patient started experiencing heartburn which was intensified greatly after the second dose of vaccination. The patient had varying degrees of intensity of heartburn every night and some during the day. The patient did not receive any treatment for the reported adverse 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 heart burn was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This is a spontaneous report from a contactable consumer (patient mother). A 24-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Apr2021 (at the age of 24-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received his first covid vaccine dose on Friday, 02Apr2021. Afterwards he went out to celebrate that he got the shot, and on Tuesday, 13Apr2021 he tested positive for covid. The patient was currently on isolation. They wanted to know, if after the first shot if you contract covid how long you should wait until you get the second shot. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: Headaches; This is a spontaneous report from a Pfizer. A contactable nurse and a contactable 71-year-old male consumer (patient) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at dose number unknown, single for COVID-19 immunisation and started to receive tofacitinib citrate (XELJANZ 5 mg, tablet; lot number: ED8423) via an unspecified route of administration from Mar2021 and ongoing, at 5 mg with unknown frequency for an unspecified indication. The patient medical history and concomitant medications were not reported. On unknown date, the patient reported he got headaches every time he took the medication. Patient stated it took about 3-4 hours. The patient reported since starting on tofacitinib citrate 5 mg tablet he had been experiencing headaches and had also received the COVID-19 vaccine. The adverse event was reported as non-serious. The action taken in response to the event for tofacitinib citrate was unknown. The outcome of the event was not recovered. No further information provided. Reporter considered the event caused by suspect product.  No follow-up attempts are needed. No further information is expected.  Follow-up (21May2021): New information reported from a Pfizer the same contactable nurse included: additional suspect drug (BNT162B2), tofacitinib citrate formulation and lot number, information about the event previously reported.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever; ache;  This is a spontaneous report from a Pfizer-sponsored program.  A contactable nurse and  a 70-year-old female patient reported  that she received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation and palbociclib (IBRANCE), oral from Apr2020 (Batch/Lot number was not reported; Expiration Date: 31May2022) to an unspecified date, at 125 mg, 1x/day(for 21 days) for breast cancer.   The patient medical history was not reported. Concomitant medications included calcium carbonate (CALCIUM CARBONATE) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported; letrozole (LETROZOLE) taken for an unspecified indication, start and stop date were not reported; vitamin C [ascorbic acid] taken for an unspecified indication, start and stop date were not reported.    The patient previously took naproxen and experienced hypersensitivity.    The patient experienced fever (non-serious) on an unspecified date with outcome of unknown , ache  (non-serious) on an unspecified date with outcome of unknown.  The action taken in response to the events for palbociclib was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: hands hurting more; This is a spontaneous report from a Pfizer-sponsored program received from a contactable nurse and a consumer (patient's spouse). A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at dose number unknown, single for COVID-19 immunisation and started to receive tofacitinib citrate (XELJANZ XR 11 mg tablet; expiry date: 30Jan2023) orally on Aug2020 at 11 mg once daily for psoriatic arthritis. Medical history was not reported. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT 160-4 mcg), vitamin D (vitamin D NOS 10 mcg tablet), calcium 250mg tablet, magnesium 100 mg tablet, fludrocortisone acetate, hydroxychloroquine sulfate (PLAQUENIL 200 mg tablet), prednisone 10 mg tablet, ibandronate sodium 150 mg tablet. The patient took COVID vaccine and doctor (MD) advised him to discontinue tofacitinib citrate for 7 days. The patient had been complaining of hands hurting more. MD was aware. The action taken with tofacitinib citrate was unknown. The outcome of the event was unknown.   No follow-up attempts possible. information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Muscle spasms, Polymenorrhoea, Premenstrual dysphoric disorder
Clinical narrative: Menstruated a week early; Extreme cramping; Period stopped then started again; PMDD symptoms; This is a spontaneous report from a contactable consumer(patient) reported for herself that. A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:00(Age at Vaccination: 46) (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient past Medical history included Pyridium Allergy, Sulfonamide allergy, migraine, ongoing premenstrual dysphoric disorder PMDD, bipolar disorder, Bipolar NOS, attention deficit hyperactivity disorder and osteoarthritis. Concomitant medication included erenumab aooe (AIMOVIG), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion (BUPROPION), trazodone (TRAZODONE). 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 vaccine within 4 weeks prior to covid-19 vaccination. On 22Apr2021 at 13:00, the patient experienced Menstruated a week early one day after second shot, Extreme cramping, period stopped then started again and PMDD symptoms won't go away. The patient is treated with Toradol injection. The event outcome was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Platelet count decreased
Clinical narrative: Extremely extremely low platelets count numbers; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's wife). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6205) via an unspecified route of administration on 11Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (lot number: EL9267) administered on 18Feb2021 for COVID-19 immunization. On an unspecified date, the patient experienced extremely extremely low platelets count numbers. Reporter stated that my husband got a bad side effect from the COVID 19 Vaccine. I was wondering if you have heard of anymore side effects like my husband had. Reporter wanted to know if Pfizer knows about this and what you recommend doing. Asked if reporter also experiencing side effects: Reporter stated, I do not think that I am but I never had a blood test. He was having weekly blood test that so alright. The patient lab tests and procedures which included extremely extremely low platelets count numbers and weekly blood test that so alright on an unspecified date. The clinical outcome of the events was reported as unknown.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, X-ray
Clinical narrative: Kind of tired for a couple of days after the first dose of the Covid Vaccine; This is a spontaneous report from a contactable consumer. This case is related to first dose. This consumer (patient) reported herself that a 66-years-old female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EN6200, NDC number/ Expiry Date: Unknown), via an unspecified route of administration in left arm on 26Feb2021 (at the age of 66-years-old) as single dose for COVID-19 immunisation. The patient took Covid Vaccine because she feels everyone should get it. The patient's medical history was stenosis in back and arthritis had these condition for years and were ongoing, spinal fusion this was done about 13 years ago. In November and December of 2020, she had COVID 19. Concomitant medications were not reported. The patient received Influenza vaccine (No product details known by caller, batch/lot number not provided), via an unspecified route of administration on an unknown date as historical vaccine for Immunisation and experienced little stroke, lost use of left side and fell after Flu Vaccine (states was about 25 years ago). Additional no other vaccines administered on same date of the Pfizer suspect. There was no prior vaccinations (within 4 weeks). In Feb2021, the patient experienced kind of tired for a couple of days after the first dose of the Covid vaccine. Stated it might have started the evening of the vaccine or the next day, she cannot remember. The patient underwent lab tests included: Blood test with result WBC's elevated and x-ray with unknown result. The outcome of the adverse event "Kind of tired for a couple of days after the first dose of the Covid Vaccine" was recovered in Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Dizziness, Dyspnoea, Fatigue
Clinical narrative: I was horrified the first night after the dose; I had 3 migraines in the middle of the night; I did not eat, I could not eat; I had shortness of breath; dizzy; I slept most of Saturday and Sunday; weak; still felt more fatigued; I had very extremely strong headache, much stronger than any that I have when I had them;; This is a spontaneous report from a non-contactable consumer (patient). A 63-years-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: ER8727 and Expiration Date: 31Jul2021), via an unknown route of administration on 02Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of bnt162b2 (Lot Number: EN6203 and Expiration Date: Jun2021) on 11Mar2021 (at the age of 63-years-old) for covid-19 immunisation and experienced vomiting the first night. Had an underlying condition; the first shot that she took made her condition episodes longer and much more intense. She was extremely fatigued; like not getting out of the bed for days. On an unknown date in Apr2021, the patient was horrified the first night after the dose, she had 3 migraines with aura in the middle of the night. Then she took the vaccine on Friday at 12 noon (EST). So Friday night into Saturday she had 3 migraines overnight with aura, the next day she was in bed Saturday and half of Sunday. She did not eat, she could not eat, that she had extremely strong headache, much stronger than any that she have when she had them. She could not eat and she was very weak and dizzy. Then Saturday night she went to get some groceries and she should not have been standing out, she was so weak and dizzy. She stated that feeling, just she do not know and slept most of Saturday and Sunday. By Sunday night she started to feel a little bit better. She went out for a walk and got another migraine. She took Aleve as a treatment and that helped her. But she still was (incomplete sentence). She had shortness of breath and then on Monday Morning she still felt more fatigued and then Monday afternoon on Tuesday, she was feeling better. But the shortness of breath, some weakness continued for may be another week. She was trying to remember, then she started to be able to eat by Sunday night. But Saturday and Sunday she could not eat all and did was sleep all day and she had very strong headache. She had a terrible migraine. Outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021523852 same patient/drug, different dose/event
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Headache, Hypersomnia, Migraine
Clinical narrative: I was horrified the first night after the dose; I had 3 migraines in the middle of the night; I did not eat, I could not eat; I had shortness of breath; dizzy; I slept most of Saturday and Sunday; weak; still felt more fatigued; I had very extremely strong headache, much stronger than any that I have when I had them;; This is a spontaneous report from a non-contactable consumer (patient). A 63-years-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: ER8727 and Expiration Date: 31Jul2021), via an unknown route of administration on 02Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of bnt162b2 (Lot Number: EN6203 and Expiration Date: Jun2021) on 11Mar2021 (at the age of 63-years-old) for covid-19 immunisation and experienced vomiting the first night. Had an underlying condition; the first shot that she took made her condition episodes longer and much more intense. She was extremely fatigued; like not getting out of the bed for days. On an unknown date in Apr2021, the patient was horrified the first night after the dose, she had 3 migraines with aura in the middle of the night. Then she took the vaccine on Friday at 12 noon (EST). So Friday night into Saturday she had 3 migraines overnight with aura, the next day she was in bed Saturday and half of Sunday. She did not eat, she could not eat, that she had extremely strong headache, much stronger than any that she have when she had them. She could not eat and she was very weak and dizzy. Then Saturday night she went to get some groceries and she should not have been standing out, she was so weak and dizzy. She stated that feeling, just she do not know and slept most of Saturday and Sunday. By Sunday night she started to feel a little bit better. She went out for a walk and got another migraine. She took Aleve as a treatment and that helped her. But she still was (incomplete sentence). She had shortness of breath and then on Monday Morning she still felt more fatigued and then Monday afternoon on Tuesday, she was feeling better. But the shortness of breath, some weakness continued for may be another week. She was trying to remember, then she started to be able to eat by Sunday night. But Saturday and Sunday she could not eat all and did was sleep all day and she had very strong headache. She had a terrible migraine. Outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021523852 same patient/drug, different dose/event
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Amenorrhea; This is a spontaneous report received from a contactable consumer or other non-heath care professional. A female patient of an unspecified age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA 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 immunization. The patient medical history and concomitant medications were not reported. The patient experienced amenorrhea on an unspecified date. Caller states that she was calling about the covid Vaccine and reporting multiple patient adverse events. Reports that last Friday on 07May2021 he heard about a patient she has had 3 patients phone in about Adverse events with the covid 19 shot, they complain of amenorrhea and not had their periods in 3 months. States that he called the office, as he was working from home and spoke with the clinic manager that was working remotely. He informed clinic manager the need to collect the data on this and appreciates her cooperation, the Clinic manager states that she she will go in the office and fill out any paperwork needed on this. States that he has no patient details to provide, he has No initials, height, weight, ages. When queried if he knew the patients sex, he states that it was a gynaecologic office and there complaining about amenorrhea. States that he would had reported it earlier but he did not had information to report with, the office was closed, he got a hold of the office clinic manager in the morning today, and they were not wanting to be cooperative. States has no further information to provide. The outcome of the events was reported as unknown.   No follow-up attempts are needed, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021532361 same reporter/drug/event, different patients;US-PFIZER INC-2021532362 same reporter/drug/event, different patients
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Vaccination site pain
Clinical narrative: Caller mentioned that her sister had developed a hard, sensitive pink and painful feeling on the injection site; injection site area is hard, pink and painful; injection site area is hard, pink and painful; injection site area is hard, pink and painful; This is a spontaneous report from a contactable consumer. This consumer female (patient's sister) reported for her 42-year-old female consumer (patient) who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 09May2021 (at 42-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She also mentioned that when her sister previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization AND experienced minimum pain. Her sister has been putting cold compress to ease the pain as well. On an unknown date caller mentioned that her sister had developed a hard, sensitive pink and painful feeling on the injection site. Caller had an understanding that people may have varying reaction to the vaccine and she also said that she had solicited some information from their friends and some of their friends who got either the Moderna or Pfizer COVID19 vaccine had experienced these side effects for at least 7 days. In line with this, caller wanted to know as to how long these side effects normally last. So that they may know as to when they might need to consult a physician. She also mentioned that she got her 1st dose and had experienced minimal pain. She was wondering if she might experience the same side effect as her sister's for her 2nd dose scheduled on 01Jun2021. The event outcome was unknown.  Follow-up (12May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer female (patient's sister) reported that:  Reporter declined to submit a report about patient. Reporter states that there is no problem, and she does not have anything to report. Reporter states these are pretty common side effects. Reporter thought calling the manufacture would be simple, and she could have her question answered, but this is not simple. Reporter thinks that this was pain.  No follow-up attempts were needed; information about lot/batch number could not be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Extrasystoles
Clinical narrative: Missed heart beat.  Every 17 or 18th beat on Sunday following the Thursday dose.; 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 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 25Mar2021 at 14:30 (at the age of 65-years-old) (Batch/Lot Number: ER8733) as dose 2, single for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other. Medical history included sleep problems, sleep apnea and large prostate all from an unknown date and unknown if ongoing. Patient had known allergies to drugs paclitaxel (PAXEL) and ketoconazole (KETOCONAZAL). Concomitant medication included alfuzosin (received within 2 weeks of vaccination) taken for an unspecified indication, start and stop date were not reported. Past drug events included known allergies to drugs paclitaxel (PAXEL) and ketoconazole (KETOCONAZAL). Historical vaccine included previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 04Mar2021 at 14:30 (at the age of 65-years-old) (Batch/Lot Number: En6204) as dose 1, single for covid-19 immunization and did not experience any adverse reaction. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. The patient reported he experienced 'missed heartbeat, every 17 or 18th beat on Sunday following the Thursday dose' on 28Mar2021 at 10:00. The event did not result in emergency room/physician office visit. The patient was not treated for the event. The event was assessed as non-serious by reporter. The outcome of the event was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Joint stiffness, Peripheral swelling
Clinical narrative: neighbor had swelling in his knuckles, got tight; neighbor had swelling in his knuckles, got tight; This is a spontaneous report from a contactable consumer. This is report 2 of 2. This case is for the reporter's neighbour.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported),via an unspecified route of administration on an unspecified date as Dose number Unknown, Single for COVID-19 immunization. No medical history reported. No concomitant medication reported. The reporter states his neighbour had swelling in his knuckles, got tight. Reporter says he has no numbers for the vaccine taken. He had his Pfizer vaccine over a month ago. His neighbour said,Its not bothering me now(3-4 days ago). The outcome of Events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Malaise, Pain
Clinical narrative: Body aches; Head aches; Generally not feeling well; This is a spontaneous report from a Pfizer sponsored program  received from a contactable other healthcare professional and a non-contactable pharmacist. A 57-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at dose number unknown, single for COVID-19 immunisation and started to receive tofacitinib citrate (XELJANZ XR 11mg) on 03Feb2021 at 11 mg. Medical history and concomitant medications were not reported. Patient reported to pharmacist that after having the COVID vaccine she had body aches, headaches and generally not feeling well while taking tofacitinib citrate and COVID vaccine. The action taken with tofacitinib citrate was unknown. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19, UNK
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program XELSOURCE.   A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), on an unspecified date as single dose for covid-19 immunisation and tofacitinib citrate (XELJANZ XR 11mg), via an unspecified route of administration from an unspecified date to an unspecified date at 11 mg unknown frequency for an unspecified indication. The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced shingles.Patient had to go off of tofacitinib while getting the Covid Vaccine and later she came down with shingles.The outcome of the event was unknown. Action taken for tofacitinib was post-therapy.No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, Fatigue, Neutrophil count, Neutrophil count decreased
Clinical narrative: got the covid vaccination during this time, which could contribute to the lowANC; fatigued; lost all of my hair; This is a spontaneous report from a Pfizer Sponsored Program . A contactable 67-year-old female consumer reported that she started to receive palbociclib (IBRANCE) from Mar2021 at 125mg (frequency unspecified) for an unspecified indication. She also received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient had a fantastic time on palbocilcib, she was taking 125mg starting this past March. On 01Jun2021 her ANC was 1100 and she was able to resume palbociclib. Two months prior to that, she was at 900 and she had to wait resuming palbociclib. She got the COVID vaccination during this time, which could contributed to the low ANC. She was starting fatigued on and off, she lost all of her hair and hair was coming out, so she was taking vitamin D2 and vitamin B12. Action taken with palbociclib in response to the events was unknown. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue for about 24 hrs; This is a spontaneous report from a contactable pharmacist (Pfizer employee). A 16-years-old patient of an unspecified gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,Formulation: Solution for injection, dose 2 (Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date (at the age of 16-years-old) as a Dose 2 Single for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced fatigue for about 24 hrs. The outcome of the event was resolved on an unspecified date in 2021.