chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Neck pain, Pain in extremity, Swelling face
Clinical narrative: After dinner time, about 6pm signs started showing: shallow breathing; Fast heartbeat; Weakness; Strong pain in arm; Strong pain in wrist; Strong pain in neck; Face and neck felt puffy; Feeling unwell; Tired; Joint pain; Awoke a few times at night with strong nausea; This is a spontaneous report received from a contactable consumer, the patient. A 40-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 21Apr2021 at 10:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included herpes (herpes virus infection) for which patient took valtrex occasionally. The patient had no known allergies to medications, food or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included valaciclovir hydrochloride (VALTREX) for herpes from unknown date and unknown if ongoing. On 21Apr2021 at 18:00, after dinner time, the patient experienced shallow breathing, fast heartbeat, weakness, strong pain in arm, wrist and neck, face and neck felt puffy, feeling unwell, tired, joint pain and awoke a few times at night with strong nausea. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were taken as a result of events strong pain in arm, wrist and neck, face and neck and joint pain which included treatment with paracetamol (TYLENOL) which helped with the pain. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shallow breathing, fast heartbeat, weakness, strong pain in arm, wrist and neck, face and neck felt puffy, feeling unwell, tired, joint pain and awoke a few times at night with strong nausea was resolved on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Dyspnoea, Headache, Hot flush
Clinical narrative: About an hour after -heart raced; Felt nauseous; Headache; Dizzy; Almost passed out hot flash; Felt like couldn't breath; Mild rash face/arm/legs/torso; A week later today still icky; Sore throat; almostpassed out; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 15Apr2021 at 12:30 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included below right below knee amputation, right arm amputation and stoma. The patient had known many allergies (unspecified) to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN), magnesium (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), alprazolam (XANAX) and tapentadol hydrochloride (NUCYNTA); all for unspecified indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 15Apr2021 at 13:30, about an hour after vaccination, the patient experienced heart raced, felt nauseous, headache, dizzy, almost passed out, hot flash, felt like could not breathe, mild rash on face, arm, legs, torso. A week later today still patient felt icky but had not major symptoms, but had little dizzy, sore throat and headache. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heart raced, felt nauseous, headache, dizzy, almost passed out, hot flash, could not breathe, almost passed out, mild rash face, arm, legs, torso, still icky, little dizzy, sore throat, and headache were resolving at the time of report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Palpitations, Presyncope, Rash
Clinical narrative: About an hour after -heart raced; Felt nauseous; Headache; Dizzy; Almost passed out hot flash; Felt like couldn't breath; Mild rash face/arm/legs/torso; A week later today still icky; Sore throat; almostpassed out; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 15Apr2021 at 12:30 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included below right below knee amputation, right arm amputation and stoma. The patient had known many allergies (unspecified) to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN), magnesium (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), alprazolam (XANAX) and tapentadol hydrochloride (NUCYNTA); all for unspecified indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 15Apr2021 at 13:30, about an hour after vaccination, the patient experienced heart raced, felt nauseous, headache, dizzy, almost passed out, hot flash, felt like could not breathe, mild rash on face, arm, legs, torso. A week later today still patient felt icky but had not major symptoms, but had little dizzy, sore throat and headache. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heart raced, felt nauseous, headache, dizzy, almost passed out, hot flash, could not breathe, almost passed out, mild rash face, arm, legs, torso, still icky, little dizzy, sore throat, and headache were resolving at the time of report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral swelling, Vaccination site erythema
Clinical narrative: Swelling of arm; Large red circle at the injection site; Severe pain in left hip/ left wrist.; Also severe pain in left hip and left wrist; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8727) via an unspecified route of administration in the left arm on 31Mar2021 at 12:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included losartan (MANUFACTURER UNKNOWN) for blood pressure from an unknown date and unknown if ongoing. The patient previously received doxycycline (MANUFACTURER UNKNOWN) and experienced drug allergy. On 05Apr2021, the patient experienced swelling of arm and large red circle at the injection site. The patient also had severe pain in left hip and left wrist. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with unspecified antibiotic . Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling of arm, large red circle at the injection site, also severe pain in left hip and left wrist was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Chills; body aches; joint aches; fever (102.7 F); This is a spontaneous report from a contactable consumer reported for a patient. A 40-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER2613, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 21Apr2021 at 09:00 am (age at vaccination was 40 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. The patient did not have any known allergies. The patient did not receive any concomitant medications or other medications in two weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EJ1985, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 30Mar2021 at 09:15 am (age at vaccination was 40 years) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. 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, the patient has not been tested for COVID-19. On 21Apr2021 at 23:00 pm, the patient experienced chills, body aches, joint aches and fever (102.7 F). The patient underwent lab test which included body temperature: 102.7 Fahrenheit (Fever) on 21Apr2021. No treatment was received for the adverse events. The outcome of the events was not resolved.   No follow up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Nausea, Pain, Sinus headache
Clinical narrative: Intense wave of nausea; Diarrhea; Sinus headache; Body aches (concentrated in lower back, legs, and feet); Injection site soreness; Mild dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included mild asthma, fibromyalgia, IBS (irritable bowel syndrome), depression and anxiety. Concomitant medications included gabapentin (NEURONTIN), sertraline hydrochloride (ZOLOFT), levocetirizine dihydrochloride (XYZAL), ethinylestradiol/norgestimate (TRI-PREVIFEM) and colecalciferol (VITAMIN D3); all for unknown indications from unknown dates and unknown if ongoing. 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. The patient previously took chlorhexidine (MANUFACTURER UNKNOWN) and bupropion hydrochloride (WELLBUTRIN) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021, side effects began 14 hours after second dose, waking the patient up from sleep and the patient experienced intense wave of nausea, diarrhea, sinus headache, body aches (concentrated in lower back, legs, and feet), injection site soreness and mild dizziness. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intense wave of nausea, diarrhea, sinus headache, body aches (concentrated in lower back, legs, and feet), injection site soreness and mild dizziness was resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Intense wave of nausea; Diarrhea; Sinus headache; Body aches (concentrated in lower back, legs, and feet); Injection site soreness; Mild dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included mild asthma, fibromyalgia, IBS (irritable bowel syndrome), depression and anxiety. Concomitant medications included gabapentin (NEURONTIN), sertraline hydrochloride (ZOLOFT), levocetirizine dihydrochloride (XYZAL), ethinylestradiol/norgestimate (TRI-PREVIFEM) and colecalciferol (VITAMIN D3); all for unknown indications from unknown dates and unknown if ongoing. 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. The patient previously took chlorhexidine (MANUFACTURER UNKNOWN) and bupropion hydrochloride (WELLBUTRIN) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021, side effects began 14 hours after second dose, waking the patient up from sleep and the patient experienced intense wave of nausea, diarrhea, sinus headache, body aches (concentrated in lower back, legs, and feet), injection site soreness and mild dizziness. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intense wave of nausea, diarrhea, sinus headache, body aches (concentrated in lower back, legs, and feet), injection site soreness and mild dizziness was resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: My period is early. This is remarkable because I am on birth control; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the arm left on 06Apr2021 at 08:15 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any known allergies. 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. Concomitant medications included unspecified medication for birth control from an unknown date and unknown if ongoing. On 19Apr2021, the patient's period was early which the patient thought was remarkable since the patient was on birth control. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event period is early was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Cough, Dyspnoea
Clinical narrative: Fever, ~100F; Chills; Body aches; Shortness of breath; Cough; Headache; Injection arm painful to lift; Pain in muscles of back; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8936) via an unspecified route of administration in the left arm on 21Apr2021 at 11:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. 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. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533) via an unspecified route of administration in the left arm on 31Mar2021 at 11:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 08:00, the patient experienced fever, about 100 Fahrenheit, chills, body aches, shortness of breath, cough, headache, injection arm painful to lift, and pain in muscles of back. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, about 100 Fahrenheit, chills, body aches, shortness of breath, cough, headache, injection arm painful to lift and pain in muscles of back was unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, ~100F; Chills; Body aches; Shortness of breath; Cough; Headache; Injection arm painful to lift; Pain in muscles of back; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8936) via an unspecified route of administration in the left arm on 21Apr2021 at 11:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. 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. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533) via an unspecified route of administration in the left arm on 31Mar2021 at 11:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 08:00, the patient experienced fever, about 100 Fahrenheit, chills, body aches, shortness of breath, cough, headache, injection arm painful to lift, and pain in muscles of back. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, about 100 Fahrenheit, chills, body aches, shortness of breath, cough, headache, injection arm painful to lift and pain in muscles of back was unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Immediate onset of severe Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6202) via an unspecified route of administration in the left arm on 04Mar2021 at 08:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included tentative diagnosis of otosclerosis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included rosuvastatin calcium (CRESTOR), acetylsalicylic acid (ASPIRIN), famotidine (PEPCID AC) and oxazepam (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 06Mar2021 at 10:00, the patient experienced immediate onset of severe tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of immediate onset of severe tinnitus, visited to ENT on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event immediate onset of severe tinnitus was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: cramping with menstrual cycle; Bloating; Period heavier and longer; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 09Apr2021 at 11:30 (at the age of 31-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 to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamin c (MANUFACTURER UNKNOWN); vitamin d (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. On 18Apr2021, the patient experienced period was heavier and longer than it had been in 6 years. She also experienced bloating and cramping with menstrual cycle which was highly out of the ordinary for the patient. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/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 period heavier and longer, bloating and cramping with menstrual cycle was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: PPV, PNC13
Symptoms: Sleep apnoea syndrome
Clinical narrative: sleep apnea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for immunization. Medical history included heart issue, blood pressure abnormal (blood pressure), and thyroid issue. The patient's concomitant medications were not reported. The patient reported that 5 years ago, she had regular pneumonia shot and after that she developed a sleep apnea and her pneumonologist recommended that she get that Prevnar 13 booster shot. She was first a little weary about it but then she went ahead and got it. The outcome of the event was not recovered.   Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PPV, PNC13
Symptoms: Arthralgia, Fear, Neck pain, Swelling
Clinical narrative: sleep apnea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for immunization. Medical history included heart issue, blood pressure abnormal (blood pressure), and thyroid issue. The patient's concomitant medications were not reported. The patient reported that 5 years ago, she had regular pneumonia shot and after that she developed a sleep apnea and her pneumonologist recommended that she get that Prevnar 13 booster shot. She was first a little weary about it but then she went ahead and got it. The outcome of the event was not recovered.   Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Defaecation urgency, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: I got very tired within 10 minutes.; I started sweating profusely; Then I got the sudden urge to poop; As I walked to the bathroom I almost passed out from extreme dizziness; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 22Apr2021 at 15:30 (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 did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 15:30, the patient got very tired within 10 minutes, then the patient started sweating profusely, also got the sudden urge to poop and as the patient walked to the bathroom, he almost passed out from extreme dizziness. The patient continued sweating and being very dizzy for about 5 more minutes, then the patient felt better. 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 not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events very tired within 10 minutes, sweating profusely, sudden urge to poop and dizziness was recovered on 22Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: The day after ''my'' vaccine, about 30 hours after the shot, ''I'' began menstruating; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Apr2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune disorder and allergies to gluten. 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. Concomitant medications included melatonin (MANUFACTURER UNKNOWN), collagen (MANUFACTURER UNKNOWN), curcuma longa rhizome (TURMERIC), Vitamin d nos (MANUFACTURER UNKNOWN) and sambucus nigra (ELDERBERRY); all for an unknown indication from an unknown date and unknown if ongoing. On 16Apr2021 at 20:00, the patient experienced not so much adverse as weird. The patient always began menstruation on or around the full moon. The day after her vaccine, about 30 hours after the shot, she began menstruating, had not stopped yet. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event about 30 hours after the shot, she began menstruating was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood oestrogen, Blood oestrogen increased, Cervical discharge, Exposure to SARS-CoV-2, Ovulation disorder
Clinical narrative: felt similar ovulation type pain; estrogen level was tested per her request and was 314; cervical mucus change; exposed to COVID; felt like she ovulated; This is a spontaneous report from a contactable nurse received via COVID-19 Vaccine Adverse Event Reporting System. A non-pregnant 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 16Jan2021, at 14:30 (Lot Number: EL03248; at the age of 56 years old) as dose 2, single for COVID-19 immunisation. Medical history included postmenopausal for almost two years. The patient has no known allergies. Concomitant medication included multivitamin. She did not receive any other vaccines within four weeks prior to vaccination. The patient previously received first dose of BNT162B2, administered in the left arm on 26Dec2020, at 13:00 (Lot Number: EL0140; at the age of 55 years old) for COVID-19 immunisation. On 18Jan2021, the patient reported that she felt like she ovulated two days after the vaccine. She was 56 and almost two years postmenopausal. She was exposed to COVID in the first week of April2021 (her daughter was positive). On 01Apr2021, she felt similar ovulation type pain. On an unspecified date in Apr2021, her estrogen level was tested per her request and was 314. Normal level for postmenopausal woman is <32 (as reported). She has not had a period in two years. The patient had no other symptoms except cervical mucus change and has not had any hot flashes in at least two weeks. The patient was not diagnosed with COVID-19 prior to vaccination, and she has not been tested for COVID-19 since the vaccination. The patient did not receive any treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ovulation pain
Clinical narrative: felt similar ovulation type pain; estrogen level was tested per her request and was 314; cervical mucus change; exposed to COVID; felt like she ovulated; This is a spontaneous report from a contactable nurse received via COVID-19 Vaccine Adverse Event Reporting System. A non-pregnant 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 16Jan2021, at 14:30 (Lot Number: EL03248; at the age of 56 years old) as dose 2, single for COVID-19 immunisation. Medical history included postmenopausal for almost two years. The patient has no known allergies. Concomitant medication included multivitamin. She did not receive any other vaccines within four weeks prior to vaccination. The patient previously received first dose of BNT162B2, administered in the left arm on 26Dec2020, at 13:00 (Lot Number: EL0140; at the age of 55 years old) for COVID-19 immunisation. On 18Jan2021, the patient reported that she felt like she ovulated two days after the vaccine. She was 56 and almost two years postmenopausal. She was exposed to COVID in the first week of April2021 (her daughter was positive). On 01Apr2021, she felt similar ovulation type pain. On an unspecified date in Apr2021, her estrogen level was tested per her request and was 314. Normal level for postmenopausal woman is <32 (as reported). She has not had a period in two years. The patient had no other symptoms except cervical mucus change and has not had any hot flashes in at least two weeks. The patient was not diagnosed with COVID-19 prior to vaccination, and she has not been tested for COVID-19 since the vaccination. The patient did not receive any treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Tremor
Clinical narrative: 90 minutes of continuous, uncontrollable, chills-shakes, about 12 hours after vaccine injection; 90 minutes of continuous, uncontrollable, chills-shakes, about 12 hours after vaccine injection; Also had 24- 36 hours of constant, severe headaches which started about 12 hours after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Mar2021 at 08:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 at 20:00, about 12 hours after vaccine, the patient experienced 90 minutes of continuous, uncontrollable, chills-shakes and also had 24-36 hours of constant, severe headaches. 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 90 minutes of continuous, uncontrollable, chills-shakes were resolved on 29Mar2021; while that of the event had 24-36 hours of constant, severe headaches was resolved on an unknown date in 2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Apr2021 at 08:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 10:45 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient had no known allergies to medications, food or other products. 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. Concomitant medications included atorvastatin calcium (LIPITOR) for unknown indication and birth control (MANUFACTURER UNKNOWN) medication; both from unknown dates and unknown if ongoing. On 07Apr2021 at 13:00, the patient experienced extreme fatigue. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme fatigue was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Flushing, Inflammation, Nausea
Clinical narrative: only more severe redness to face, both sides of hands. Redness appeared on throat and arms 2nd day; Redness appeared on throat; very flushed; heated face and top and bottom of hands; Very hot touch to skin; Extreme itching on top and bottom of hands/extreme itching on the back; Extreme itching on top and bottom of hands, swelling; Extreme itching on top and bottom of hands, swelling and inflamed; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). This 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8735) via an unspecified route of administration in the left arm on 17Apr2021 at 13:00 (at 50-years-old) as a single dose for COVID-19 immunisation. Medical history included unconfirmed COVID infection in early Mar2020 to Mar2020; migraines and gastroesophageal reflux disease (GERD) reported as minor, both from unknown dates and unknown if ongoing. Concomitant medications included plecanatide (TRULANCE), lansoprazole (PREVACID), colecalciferol (D3), turmeric (curcuma longa rhizome), and fish oil, all from unknown dates for unknown indications. Prior to vaccination the patient was not diagnosed with COVID-19, had not received any other vaccines within 4 weeks of the COVID vaccine, and had no known allergies. It was reported that 4 days post-vaccination, also reported as 14Apr2021 at 12:30, the patient was very flushed and heated face and top and bottom of hands, further reported as very hot touch to skin. The patient experience extreme itching on top and bottom of hands, swelling and inflamed as well as extreme itching on the back. Two hours later, nausea and vomiting. The events resolved with 1 tablets of diphenhydramine hydrochloride (BENADRYL) after 6 hours. The same symptoms happened the next day only more severe redness to face, and both sides of hands. Redness appeared on throat and arms second day, with more nausea and vomiting. The patient went to the emergency room for treatment. The patient was treated with anti-nausea medications mixed with diphenhydramine hydrochloride in an intravenous (IV) solution. The clinical outcomes of the events were recovering. Since vaccination the patient had not been tested for COVID-19.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pharyngeal erythema, Pruritus, Skin warm, Vomiting
Clinical narrative: only more severe redness to face, both sides of hands. Redness appeared on throat and arms 2nd day; Redness appeared on throat; very flushed; heated face and top and bottom of hands; Very hot touch to skin; Extreme itching on top and bottom of hands/extreme itching on the back; Extreme itching on top and bottom of hands, swelling; Extreme itching on top and bottom of hands, swelling and inflamed; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). This 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8735) via an unspecified route of administration in the left arm on 17Apr2021 at 13:00 (at 50-years-old) as a single dose for COVID-19 immunisation. Medical history included unconfirmed COVID infection in early Mar2020 to Mar2020; migraines and gastroesophageal reflux disease (GERD) reported as minor, both from unknown dates and unknown if ongoing. Concomitant medications included plecanatide (TRULANCE), lansoprazole (PREVACID), colecalciferol (D3), turmeric (curcuma longa rhizome), and fish oil, all from unknown dates for unknown indications. Prior to vaccination the patient was not diagnosed with COVID-19, had not received any other vaccines within 4 weeks of the COVID vaccine, and had no known allergies. It was reported that 4 days post-vaccination, also reported as 14Apr2021 at 12:30, the patient was very flushed and heated face and top and bottom of hands, further reported as very hot touch to skin. The patient experience extreme itching on top and bottom of hands, swelling and inflamed as well as extreme itching on the back. Two hours later, nausea and vomiting. The events resolved with 1 tablets of diphenhydramine hydrochloride (BENADRYL) after 6 hours. The same symptoms happened the next day only more severe redness to face, and both sides of hands. Redness appeared on throat and arms second day, with more nausea and vomiting. The patient went to the emergency room for treatment. The patient was treated with anti-nausea medications mixed with diphenhydramine hydrochloride in an intravenous (IV) solution. The clinical outcomes of the events were recovering. Since vaccination the patient had not been tested for COVID-19.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Gout
Clinical narrative: Severe gout in left foot on the sixth day after vaccine. History of previous gout flare up especially after anesthesia but it was never this severe; Unable to walk for 4 days; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 12:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, heart disease, unspecified on an unknown date and gout since an unknown date. 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. Concomitant medications included blood thinner (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing and also received unspecified concomitant medications for blood pressure on an unknown date. The patient previously received first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 12:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 08:00, the patient experienced severe gout in left foot on the sixth day after vaccine. History of previous gout flare up especially after anesthesia but it was never this severe and unable to walk for 4 days. It was reported that patient read an article written by a doctor who observed gout in several patients after they received second COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of gout aggravated and unable to walk and included treatment with colchicine (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event unable to walk was recovered on 23Apr2021, after the duration of 4 days and gout was recovering at the time of reporting.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: I started my menstrual cycle a few hours after injection.; This is a spontaneous report from a contactable consumer, the patient. A 21-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 18Apr2021 at 15:15 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC) and bupropion hydrochloride (WELLBUTRIN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took etonogestrel (NEXPLANON) implant which prevents her from having a menstrual cycle. On 18Apr2021 at 22:00, a few hours after injection, the patient started menstrual cycle. She had a Nexplanon implant which prevented her  from having a menstrual cycle. This was her first menstrual cycle in a few years. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event a few hours after injection the patient started menstrual cycle was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Menstrual cycle began heavily 2 days after receiving my second vaccine. It was not due to come for another 2 weeks, and I am never this early; Menstrual cycle began heavily 2 days after receiving my second vaccine; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 16:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression, premenstrual dysphoric disorder (PMDD) and allergy to penicillin. Concomitant medications included citalopram hydrobromide (CELEXA) from an unknown date and unknown if ongoing for an unknown indication. 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 17Mar2021 at 04:30 (at the age of 37-year-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 17Apr2021, 2 days after the second vaccination, the patient's menstrual cycle began heavily. It was not due to come for another 2 weeks and reported that the patient's menstruation is never this early. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events menstrual cycle began heavily and it was not due to come for another 2 weeks and is never this early was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.