chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pain, Pain in extremity, Pyrexia
Clinical narrative: Arm pain; Chills; Fever; Severe body aches; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Oct2021 at 13:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) and eletriptan (MANUFACTURER UNKNOWN); both for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on unknown date and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 01Nov2021 at 03:45, the patient experienced arm pain, chills, fever and severe body aches. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain, chills, fever and severe body aches was resolved on an unknown date in Nov2021. The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Fatigue; Fever (100F); The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via intramuscular route of administration in the left arm on 03Nov2021 at 11:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and known allergies to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), amlodipine besilate (MANUFACTURER UNKNOWN), fluoxetine (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via intramuscular route of administration in the left arm on 02Mar2021 at 14:00 (at the age of 57-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via intramuscular route of administration in the left arm on 25Mar2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient previously also received ampicillin (MANUFACTURER UNKNOWN) taken for an unknown indication on an unknown date and experienced drug allergy. On 04Nov2021 at 07:00, the patient experienced fatigue and fever (100F) the following day. 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. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fatigue and fever (100F) were resolving at the time of this report.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: Experiencing sore right arm near injection site.; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 32030BD) via an unspecified route of administration in the right arm on 03Nov2021 at 18:30 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 03Feb2021 (at the age of 56-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 24Feb2021 (at the age of 56-years-old), as single doses for COVID-19 immunisation. On 04Nov2021, the patient woke up at 01:37 and noticed experiencing sore right arm near injection site. Soreness was minor and did not interfere with his daily tasks. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of event. The clinical outcome of the event experiencing sore right arm near injection site was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: he lost his son to an adverse event after receiving the Pfizer vaccine; This is a spontaneous report from a contactable consumer from Social media via Company Representative.   A male patient of an unspecified age received bnt162b2 (Pfizer Vaccine), 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.  The patient medical history and concomitant medications were not reported.  The reporter reported that a father who said he lost his son to an adverse event after receiving the Pfizer vaccine on an unspecified date with fatal outcome.  The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: he lost his son to an adverse event after receiving the Pfizer vaccine
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Headache, Nausea
Clinical narrative: Increased pain from cramps when menstruating requiring time off work; Headaches; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 09Apr2021 at 13:00 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. Medical history included celiac disease. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 19Mar2021 at 13:00 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. On 19Apr2021, the patient experienced headaches, nausea and increased pain from cramps when menstruating which required time off work. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headaches, nausea and increased pain from cramps when menstruating which required time off work were not resolved at the time of this report.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Pain, Pain in extremity
Clinical narrative: Severe Arm pain; Body aches; Chills; Felt bit tired; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer (Pfizer employee), the patient. A 57-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020) via an intramuscular route of administration in the left arm on 01Nov2021 at 13:00 (at the age of 57-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and had no 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 COVID vaccine. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an intramuscular route of administration in the left arm on 21Jan2021 at 16:45 (at the age of 56-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an intramuscular route of administration in the left arm on 10Feb2021 at 14:30 (at the age of 56-year-old), both as a single dose for COVID-19 immunisation. On 02Nov2021 at 11:45, the patient experienced severe arm pain, body aches, chills and felt bit tired. The patient had no fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe arm pain, body aches, chills and felt bit tired was resolved on an unknown date in Nov2021.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Myalgia, Pain in extremity
Clinical narrative: Mild to moderate fatigue; Mild muscle aches; Left arm soreness; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 330268D) via an intramuscular route of administration in the left arm on 03Nov2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic autoimmune hives and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included orlistat (ALLI), melatonin (MANUFACTURER UNKNOWN), probiotics (unspecified) and multi vitamin injection (MVI) (unspecified); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 08Apr2021 at 14:00 (at the age of 41-years-old) and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 29Apr2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 03Nov2021, approximately at 20:00, the patient experienced left arm soreness and was resolving as of 04Nov2021 at 17:00. On 04Nov2021, approximately at 12:00, the patient experienced mild to moderate fatigue and mild muscle aches and was ongoing as of 04Nov2021 at 17:00. 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 left arm soreness was resolving; while that of mild to moderate fatigue and mild muscle aches was not resolved at the time of this report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Maternal exposure during pregnancy, Vein disorder, Vulval disorder, Vulval oedema
Clinical narrative: The patient received the third/booster dose of BNT162b2; Maternal Exposure During Pregnancy, third trimester (35 weeks (Months 8-9)); Major swelling and bumps on one side of labia majora; Bumps on one side of labia majora; Veins also bulging out on same side in leg area; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old 35 weeks pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020) via an unspecified route of administration on an unknown date in Oct2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The last menstrual date of the patient was on an unspecified date in Feb2021. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications received within two weeks of vaccination included prenatal vitamins from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231), via an unspecified route of administration on an unknown date in Jan2021 (at the age of 35-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration on an unknown date in Jan2021 (at the age of 35-years-old); both as single doses for COVID-19 immunisation. On an unknown date in Oct2021, within one day of receiving booster (third vaccine), the patient experienced major swelling and bumps on one side of labia majora. The veins were also bulging out on same side in leg area. There were no changes reported in diet, activity, prenatal vitamins, other than receiving vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events major swelling and bumps on one side of labia majora; veins were also bulging out on same side in leg area was not resolved at the time of this report. The reported due date was on an unspecified date in Nov2021.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal pain, Paraesthesia
Clinical narrative: Sharp pain in left shoulder blade; gradually became weakness & tingling in left arm & hand; Tingling in left arm & hand; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 04Mar2021 (at the age of 20-year-old), as a single dose for COVID-19 immunisation. Medical history included high cholesterol and the patient's family had plenty of unspecified medical history. The patient had no 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 COVID vaccine. Concomitant medications included testosterone (MANUFACTURER UNKNOWN) and fluticasone propionate (FLONASE) and unspecified antihistamine; all for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 04Feb2021 (at the age of 20-year-old), as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, the patient experienced sharp pain in left shoulder blade, gradually became weakness and tingling in left arm and hand. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown whether any therapeutic measures were 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 sharp pain in left shoulder blade, gradually became weakness and tingling in left arm and hand was not resolved at the time of this report.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Blood immunoglobulin A decreased
Clinical narrative: Also 2 weeks after 2nd vaccine antibodies at 62 & 2 weeks before 3rd vaccine were at 43.; This is a spontaneous report from a contactable consumer(patient).   A 63-years-old male patient received bnt162b2 (Pfizer COVID 19), dose 2 via an unspecified route of administration, administered in Arm Left on 30Mar2021 13:00 at his 63-years-old (Lot Number: ER8727) as dose 2, single for covid-19 immunisation.  Medical history included CLL(chronic lymphocytic leukaemia) 2013 23% residual , Low platelets (75-90), Bicuspid Aorta ascending aortic aneurysm. Concomitant medication included tadalafil (TADALAFIL). Historical Vaccine included first dose BNT162B2(DOSE 1, SINGLE, Lot No: EN6205) on 06Mar2021 01:00 PM at his 63-years-old, Location of injection was arm Left for covid-19 immunisation.  The patient experienced 2 weeks after 2nd vaccine antibodies at 62 & 2 weeks before 3rd vaccine were at 43 on an unspecified date which resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness.  The patient was hospitalized from 27Oct2021 for 7 days.  He was admitted 27Oct2021 to Hospital 7 days & given IV antibiotics & daily Leukine injections to stimulate Neutrophils production. Outcome of event was recovered with sequelae.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Headache, Tuberculosis
Clinical narrative: discomfort in her stomach, like nausea; Weakness; severe headache; This is a spontaneous report from a contactable Nurse. This 74-year-old female Nurse (Patient) reported that: A 74-years-old female patient received bnt162b2 (BNT162B2; solution for injection; Batch/Lot number was not reported)), dose 1 via an unspecified route of administration, administered in arm right on 08Mar2021 11:00 (at a age of 74-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included mycobacterium tuberculosis complex test positive from an unknown date and unknown if ongoing Verbatim: Positive for tuberculosis, ongoing blood cholesterol increased Verbatim: elevated cholesterol  from nine years, ongoing atrial fibrillation Verbatim: Atrial fibrillation from four years, parathyroid gland operation from an unknown date and unknown if ongoing Verbatim: surgery for a parathyroid gland tumor  seven years ago , heart rate irregular from an unknown date and unknown if ongoing patient taking. The patient experienced severe headache on 09Mar2021. On 10Mar2021 discomfort in her stomach, like nausea, weakness. Patient reported that, Monday morning she received the first dose of the Pfizer COVID 19 vaccine on 08Mar2021 at 11:00AM in the right arm. The next day she had a severe headache at night in the right side of the head only. She took aspirin and it helped the headache. Wednesday, she noticed discomfort in her stomach, like nausea, but she didn't throw up; and weakness; and the headache off and on. Adds the discomfort was more general, it was not exactly in her stomach, she ate and everything. She is concerned if she should get the second dose or not. Adds she is most concerned about the headache and she doesn't know if it is related to the vaccine or not. She was scheduled to receive the second dose on 29Mar2021. The patient underwent lab tests and procedures which included tuberculosis: positive on Tested positive 44 years ago. Therapeutic measures were taken as a result of severe headache. does not have vaccination card or information to provide , lot or expiration date. Outcome of the event headache was recovering, discomfort in her stomach, like nausea was recovered on 11Mar2021, weakness was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Day after second dose had a low fever; fatigue; swollen lymph nodes in the left side of neck; left arm swelled at injection site and raised 2" diameter; painful to touch; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 24Mar2021 at 12:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included food allergy (many, not anaphylactic) and 14 years of Lyme disease; treatment successfully completed 3 years ago. The patient did not receive any concomitant medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the arm left on 03Mar2021 at 13:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation and on 03Mar2021after vaccination of first dose, the patient experienced sore arm for 24 hours. 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 24Mar2021 at 19:00, the patient experienced left arm swelled at injection site and raised 2 diameter and painful to touch. On 25Mar2021, 1 day after vaccination, the patient experienced low fever, fatigue and swollen lymph nodes in the left side of neck. The patient did not receive any treatment for the events reported. 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 vaccination site swelling and painful to touch was recovered on 26Mar2021 at 19:00, after the duration of 2 days. The clinical outcome of the events low fever, fatigue and swollen lymph nodes in the left side of neck was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated to add Vaccine Facility Information and Concomitant Therapy was ticked as None.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersomnia, Pain assessment
Clinical narrative: Slept for 23 hours straight afterwards; Painful headache behind left eye; Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ENG202) via an unspecified route of administration in left arm on 25Feb2021 at 16:00 (at the age of 48-years-old) as dose 1, single for covid-19 immunization. The patient medical history included psoriatic arthritis. Patient was known allergic to penicillin and sulfa drug. The patient previously took acetylsalicylic acid (Aspirin) and experienced allergy. Concomitant medication included apremilast (OTEZLA). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 25Feb2021 at 16:00, patient experienced painful headache behind left eye for 20 minutes on scale of 8/10, pain subsided to 2/10 pain scale from 20 minutes to next 24 hours. Patient took ibuprofen (MANUFACTURER UNKNOWN) and acetaminophen (TYNENOL) for pain. After 24 hours pain subsided to 0/10. The patient was extremely tired and slept for 23 hours straight afterwards. The patient underwent lab tests and procedures which included pain assessment: 8/10 on 25Feb2021, 2/10 on 26Feb2021, and 0/10 on 27Feb2021. It was reported that the events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and treatment included ice pack, water, GATORAID, ibuprofen (MANUFACTURER UNKNOWN) and acetaminophen (TYNENOL). The clinical outcome of the events extremely tired and slept for 23 hours straight afterwards were recovered with lasting effects on an unspecified date in 2021 and headache was recovered on 27Feb2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021386691 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes in body; This is a spontaneous report from Pfizer Sponsored Program. A contactable female consumer (Patient) of an unspecified age received bnt162b2 (Pfizer Covid-19 mRNA Vaccine, Formulation: Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rashes in body. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headaches; fever; This is a spontaneous report from contactable consumer (patient) via a Pfizer sponsored program  Support.   A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration on 22Apr2021 on last Thursday as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, after vaccine, the patient experienced headaches and fever. The patient wanted to know if side effects would go away or he had side effects for rest of his life. At the time of this report, the outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body pain; Some headache; Fever; Soreness of arm; This is a spontaneous report received from a contactable consumer (parent). A 17-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: LW0161), via an unspecified route of administration, administered in arm left on 16Apr2021 at 09:30 (age at vaccination 17-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. No additional administered vaccines were reported. Prior vaccinations within 4 weeks and adverse events following prior vaccinations were reported as none. Family medical history relevant to adverse events was reported as none. On 16Apr2021, the patient experienced soreness of arm. On 17Apr2021, the patient experienced body pain, some headache and fever. The patient underwent lab tests and procedures which included body temperature: 100 degrees on 17Apr2021 and 102 degrees on 22Apr2021. Adverse event did not require a visit to emergency room or physician office. Reported that the patient's fever was very high this morning, 22Apr2021. Parent reported that the patient's temperature was 102 on morning of call, 22Apr2021 and reported that the patient has missed 2 days of school. Reporter inquired if it was normal to have a fever for so many days after the COVID-19 vaccine. Patient reported that she no longer has a headache. Patient reported that the headache lasted from 17Apr2021 until probably the next day, 18Apr2021, or maybe Monday 19Apr2021. Patient reported that the headache did not last for very long. Patient reported that the body pain comes and goes with the fever. Patient initially reported that the body pain was about the same or maybe worse, but then stated that because her fever was getting higher, the body pain was worse. Patient reported that her second dose of the COVID-19 vaccine is scheduled for 12May2021. Therapeutic measures were taken as a result of the events which included treatment with Motrin every 4 to 6 hours, sometimes alternating with Tylenol. The outcome of the events (body pain, fever) was not recovered, event (Soreness of arm) was recovered on 17Apr2021, and event (headache) was recovered on 19Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lethargy, Pain in extremity
Clinical narrative: Sharp pain under left elbow, second vaccine; Arm hurt, second vaccine; Lethargic, second vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 16Apr2021 (at the age of 60 years old) as DOSE 2, SINGLE for covid-19 immunisation. Previously the patient has received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 25Mar2021 as DOSE 1, SINGLE for covid-19 immunisation which leads to Arm hurt, back of left arm and Lethargic. The patient medical history and concomitant medications were not reported. Caller states his left arm, where he got the shot, on the second day hurt (On 16Apr2021). Caller mentions that he had pain in his arm after the first vaccine, but that was to be expected. Caller also states he was lethargic after both vaccines. Caller states, under his left elbow, there is a sharp pain for 5 days, it is not killing him, but it is persistent, still present, and not going away (on an unspecified date) Caller states that everyone told him that their arm is uncomfortable, and they feel off for a couple of days, after the vaccine. Caller states, everyone he knows, his age or older, said the same thing. Caller states he had the arm pain, but two days later, the left elbow pain gave him pause and concern. Also, Caller states he did not feel like himself for a day or two. The outcome for the event Arm hurt, second vaccine was recovered and for the event Lethargic, second vaccine, Sharp pain under left elbow, second vaccine was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Fine Rash/rash in her hair; This is a spontaneous report from a contactable consumer or other non hcp. A 95-year-old female patient (consumer) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via an unspecified route of administration, administered in Arm left on 11Feb2021 (age at vaccination: 95-year-old) as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via an unspecified route of administration, administered in Arm Right on 04Mar2021 as dose 2, single for covid-19 immunization. Medical history included ongoing food interaction. Concomitant medication included bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10), via unspecified route of administration from unknown date and ongoing at unknown dose and frequency for an unspecified indication; TREXAR Herb Type Pill, via unspecified route of administration from unknown date and ongoing at unknown dose and frequency for an unspecified indication. On an unspecified date in Mar2021, patient experienced fine rash/rash in her hair. Patient got the second shot, she didn't know that if she broke out in a rash she should get to the hospital or something. States she had a fine rash that started about two weeks after she got the shot. Patient started on her legs and then worked itself all the way up her body, but it was not all over her body at one time. Patient had rash in her hair. Unknown but probably in the morning when she got out of bed. States she has had the shingles before and she thought it was the shingles, located where shingles had been and assumed it was the shingles coming back, not severe but just itchy. The outcome was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Feeling jittery, Hypertension, Palpitations, Paraesthesia
Clinical narrative: jittery feeling; fingers and lips tingling; fingers and lips tingling; heart racing; blood pressure really high; This is a spontaneous report from a contactable consumer (patient) reported for self.  A 64-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unknown date in Apr2021 as DOSE 1, SINGLE (at the age of 64), dose 2 of BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 30Apr2021 as DOSE 2, SINGLE (at the age of 64) both for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced jittery feeling, fingers and lips tingling, heart racing, blood pressure really high all on an unknown date in Apr2021. Patient reported that she got the first dose of the Pfizer Covid 19 vaccine three weeks ago and received her second dose and noticed the symptoms on same day of the first dose or the next day, said it went away after two weeks, it happened again a couple of hours after the second dose and was asking if taking Benadryl would be helpful. Her cardiologist said she could take it and it would be like an antidote and when probed it was reported that they don't have information on if Benadryl was helpful for others or not. The events were reported as non-serious. The patient underwent lab test includes blood pressure: really high. The outcome of events fingers and lips tingling was recovered on an unknown date on 2021 while the other events was recovered with sequel.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: jittery feeling; fingers and lips tingling; fingers and lips tingling; heart racing; blood pressure really high; This is a spontaneous report from a contactable consumer (patient) reported for self.  A 64-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unknown date in Apr2021 as DOSE 1, SINGLE (at the age of 64), dose 2 of BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 30Apr2021 as DOSE 2, SINGLE (at the age of 64) both for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced jittery feeling, fingers and lips tingling, heart racing, blood pressure really high all on an unknown date in Apr2021. Patient reported that she got the first dose of the Pfizer Covid 19 vaccine three weeks ago and received her second dose and noticed the symptoms on same day of the first dose or the next day, said it went away after two weeks, it happened again a couple of hours after the second dose and was asking if taking Benadryl would be helpful. Her cardiologist said she could take it and it would be like an antidote and when probed it was reported that they don't have information on if Benadryl was helpful for others or not. The events were reported as non-serious. The patient underwent lab test includes blood pressure: really high. The outcome of events fingers and lips tingling was recovered on an unknown date on 2021 while the other events was recovered with sequel.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Swelling
Clinical narrative: With the second dose she presented the same symptoms on the left arm and inflammation on the back on the same side; Had swollen on the back on right side and now, she has swollen on the left side; This is a spontaneous report from a contactable Other Health Professional (nurse). A 57-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection; batch or lot Number: EW0161) via an unspecified route of administration, administered in right arm on 25Apr2021 (at the age of 57 years) as dose 2, single for COVID-19 immunization. The patient has no medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot Number: EN6206) via an unspecified route of administration, administered in right arm on 04Apr2021 (at the age of 57 years) as dose 1, single dose for COVID-19 immunization and experienced inflammation and swelling on back. She started feeling the issues on 7 like 72 hours after the vaccine. On unspecified date, with the second dose she presented the same symptoms on the left arm and inflammation on the back on the same side and had swollen on the back on right side and now, she has swollen on the left side. Reporter (Nurse) calling on behalf of aunt who received a Pfizer vaccine on 04Apr and she got the second dose on 25Apr. After the first dose, she presented with an inflammation on the back on the same side as the dose (not clear) and with the second dose she presented the same symptoms on the left arm and inflammation on the back on the same side. Reporter wanted to know if it was normal. No treatment received for the events. The outcome of the events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Muscle aches; Joint aches (in both hands); Headache; neck pain; Chills; Fatigue; body aches; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (Lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced muscle aches, joint aches (in both hands), headache, neck pain, chills, fatigue, and body aches. Therapeutic measures were taken as a result of chills and body aches. Patient took treatment Tylenol for the body aches and chills. It was reported that, patient didn't take the temperature, so did not know if had a fever. The outcome of all the events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be requested. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Neck pain, Pain
Clinical narrative: Muscle aches; Joint aches (in both hands); Headache; neck pain; Chills; Fatigue; body aches; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (Lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced muscle aches, joint aches (in both hands), headache, neck pain, chills, fatigue, and body aches. Therapeutic measures were taken as a result of chills and body aches. Patient took treatment Tylenol for the body aches and chills. It was reported that, patient didn't take the temperature, so did not know if had a fever. The outcome of all the events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be requested. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Malaise, Pain
Clinical narrative: high fever; headache; body ache; chills; felt like she has been run over; deathly ill for 8-9 days; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 03Mar2021 as dose 1, single for covid-19 immunisation. Medical history included epstein-barr virus infection from an unknown date and unknown if ongoing past medical history of Epstein Barr, chronic asthma and on oxygen , asthma from an unknown date and unknown if ongoing past medical history of Epstein Barr, chronic asthma and on oxygen therapy from an unknown date and unknown if ongoing. On 03Mar2021, she was deathly ill for eight to nine days. She experienced high fever; thought she may have to go to the emergency room twice but did not go. She experienced headache, body aches, chills and felt like she had been ran over. Symptoms started the night of the vaccine. She called her doctor that night, but the doctor suggested not going to the emergency room and only to take Tylenol and Aleve. Patient asked, Is it too late to get the second shot, Are there any reported deaths with the vaccine, What is the efficacy of one dose. She stays quarantined and only sees her husband and her son who are fully vaccinated. Can they spread it to her, Are side effects from the second dose worse than the first dose. She had not received her second shot. She received treatment for the events. The outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: high fever; headache; body ache; chills; felt like she has been run over; deathly ill for 8-9 days; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 03Mar2021 as dose 1, single for covid-19 immunisation. Medical history included epstein-barr virus infection from an unknown date and unknown if ongoing past medical history of Epstein Barr, chronic asthma and on oxygen , asthma from an unknown date and unknown if ongoing past medical history of Epstein Barr, chronic asthma and on oxygen therapy from an unknown date and unknown if ongoing. On 03Mar2021, she was deathly ill for eight to nine days. She experienced high fever; thought she may have to go to the emergency room twice but did not go. She experienced headache, body aches, chills and felt like she had been ran over. Symptoms started the night of the vaccine. She called her doctor that night, but the doctor suggested not going to the emergency room and only to take Tylenol and Aleve. Patient asked, Is it too late to get the second shot, Are there any reported deaths with the vaccine, What is the efficacy of one dose. She stays quarantined and only sees her husband and her son who are fully vaccinated. Can they spread it to her, Are side effects from the second dose worse than the first dose. She had not received her second shot. She received treatment for the events. The outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Heart rate, Hypoaesthesia
Clinical narrative: Chills; Panting; Numb fingertips and feet; Slightly nauseated; Felt weird; Three urination between 10:30pm to 2am (very abnormal); felt tired and wiped out; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration on 12Apr2021 10:30 (at the age of 46 years old) as single dose for COVID-19 immunization. Other medical history included was none. Concomitant medication(s) included atorvastatin. Historical vaccine included: The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not re-ported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and experienced just a sore arm. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. On 26Apr2021 22:15, the patient felt weird, panting, numb fingertips and feet, slightly nauseated. On 26Apr2021 22:30, the patient experienced chills and got very bad, No fever but big chills. On 27Apr2021, 2:30am: the Pulse was 100bpm and felt off chills were gone. On 26Apr2021, the patient experienced three urinations between 10:30pm to 2am (very abnormal), for next-16 hours the patient felt tired and wiped out and next day (27Apr2021) was fine. The patient underwent lab tests and procedures which included heart rate was 95 bpm on 26Apr2021 and heart rate was 100 bpm on 27Apr2021 at 2:30 am, oxygen saturation: 99 % on 26Apr2021. The reporter assessed the events as non-serious. The patient did not receive any therapeutic measures for the events. The outcome of the events felt weird, panting and chills was recovered on 27Apr2021, and the other events was recovered on unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.