chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Multiple fever blisters persist on lips; Head cold symptoms; Dizziness; Sneezing; Congestion worsening; Booster, dose received: 3; This is a spontaneous report from a contactable consumer (patient) reported for herself. This is the first of two reports. A 69-years-old female patient (patient was not pregnant at the time of vaccination) received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 29Sep2021 at 13:00 pm (age at vaccination was 69 years) as dose 3 (booster), single for COVID-19 immunization. The patient's medical history included breast cancer and known allergy to shellfish. Concomitant medication included letrozole taken for an unspecified indication. The patient previously took macrobid [nitrofurantoin] and experienced drug allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 04Mar2021 at 13:00 pm (age at vaccination was 68 years) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 22Mar2021 at 00:00 am (age at vaccination was 68 years) as dose 2, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Sep2021, the patient experienced multiple fever blisters persist on lips and head cold symptoms- dizziness, sneezing, congestion worsening. The events did not result in doctor or other healthcare professional office/clinic visit or emergency room/department or urgent care. No treatment was received for the adverse events. The clinical outcome of the events multiple fever blisters persist on lips and head cold symptoms- dizziness, sneezing, congestion worsening was not resolved at the time of this report.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: reoccuring UTIs after the vaccine and had never experienced this in her past; This is a spontaneous report form a contactable Other Healthcare Professional. This Other Healthcare Professional reported for a female patient (reporter's mother) that: A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number were not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated on an unspecified date her mother had also had reoccurring UTIs after the vaccine and had never experienced this in her past. Outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Maternal exposure during pregnancy, Swelling
Clinical narrative: Swelling in injection armpit (Right); Pain in lymphatic chair area.; Pregnant at the time of vaccination with Gestation period of 23rd week; Booster dose; This is a spontaneous report from a contactable healthcare professional, the patient. A 35 year old, pregnant female patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection with Lot Number: FF2589) via an unspecified route of administration in the right arm on 12Oct2021 at 14:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included pregnancy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The last menstrual date of the patient was on 04May2021. The patient gestation period was 23 weeks. Concomitant medication(s) included influenza vaccine (INFLUENZA VACCINE) taken for immunisation on 08Oct2021. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Lot Number: EJ1686) via an unspecified route of administration on 10Jan2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, , Solution for injection with Lot Number: EL9264) via an unspecified route of administration on 31Jan2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 14Oct2021, the patient experienced swelling in injection armpit on right and pain in lymphatic chair area. The expected due date of the patient was reported as 08Feb2022. 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 (swelling in injection armpit on right and pain in lymphatic chair area). The clinical outcome of the events swelling in injection armpit on right and pain in lymphatic chair area was not resolved at the time of this report.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Back pain, Blood test, Ovarian cyst, Pain
Clinical narrative: Abdominal pain, back pain, pelvic pain, and side pain began around 2 pm on 10/31. Went to the Emergency Room around 7 pm. Ultrasound was performed. Diagnosed with ovarian cyst.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pelvic pain, Ultrasound scan abnormal, Uterine leiomyoma, White blood cell count increased
Clinical narrative: Abdominal pain, back pain, pelvic pain, and side pain began around 2 pm on 10/31. Went to the Emergency Room around 7 pm. Ultrasound was performed. Diagnosed with ovarian cyst.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Skin discolouration
Clinical narrative: 15 minutes after administration of vaccine (in left arm), patient began exhibiting rosy cheeks, and reported a burning sensation on the bottom of chin. Patient was then further examined and observed by staff for another 15 minutes. This did not get better or worse. No immediate action taken other than an additional 15 minutes observation. The mother instructed to administer Benadryl and/or if worsened take her child to the ER.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Chest tightness and mild difficulty with breathing.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Nasal congestion, Rhinorrhoea
Clinical narrative: Around the dates of vaccination(s), between 6th and 10th every month, my nose runs tremendously. Stuffy nose, watery eyes and constant nose blowing.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Ocular hyperaemia
Clinical narrative: Patient reports burning feeling and redness in eye that did not go away for 7 days.  We reached out to patient after advising her to call her physician, and the symptoms seem to have resolved without dr's intervention. patient did not call physician.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: a pediatric dose of 0.2 mL from pediatric vile was given to patient instead of appropriate dose of 0.3 mL from adult vile.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Diarrhoea, Dyspnoea, Injection site pain
Clinical narrative: Difficulty breathing, tightness in chest, diarrhea, soreness at injection site
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Pt felt a pop when needle injected then noticed afterwards the site was high up on the deltoid near the shoulder. More painful than his first 2 moderna shots. I noticed the bandaid about an inch higher than it should be. 2 hours later he said his left upper arm hurt "like a broken bone would hurt". He took a motrin before dinner and again before bed. He is now sleeping.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Mood altered, Pain, Pain in extremity
Clinical narrative: My daughter had expected aches, fatigue, sore arm and headache for 2days. On the 3rd day she felt back to normal but that night she told me her heart was racing twice. She went on to have a panic attack which she has never had before.  The next night (4th night) she was abut hyper and happier but continues to say her heart is racing. She says she has never that before except for in an asthma attack.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Panic attack, Psychomotor hyperactivity, Therapeutic response unexpected
Clinical narrative: My daughter had expected aches, fatigue, sore arm and headache for 2days. On the 3rd day she felt back to normal but that night she told me her heart was racing twice. She went on to have a panic attack which she has never had before.  The next night (4th night) she was abut hyper and happier but continues to say her heart is racing. She says she has never that before except for in an asthma attack.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Beginning approximately the middle of October I started to significant hair loss. My hair is now visibly thinner on the top of my scalp.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever  sever chills. Fatigue
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Electric shock sensation, Hypoaesthesia, Magnetic resonance imaging, Neuralgia
Clinical narrative: One week after my second COVID-19 vaccine I began to have sciatica type nerve pain in my right leg. Six years ago I had hemi-laminectomy back surgery for a pinched nerve from spinal stenosis in the L3-L5 area due to excruciating nerve pain in my left leg. After the surgery, I was fine for 6 years. In March of this year, after my second shot, I began to get numbness and tingling in my right foot and searing nerve pain on the outer side of my lower right leg. I had an MRI that was evaluated by 2 surgeons. Although there are issues, neither one saw large changes or specific locations of impingement to warrant surgery at this time. But they cannot give a definitive reason for the inflamed nerve. I received an extremely
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: One week after my second COVID-19 vaccine I began to have sciatica type nerve pain in my right leg. Six years ago I had hemi-laminectomy back surgery for a pinched nerve from spinal stenosis in the L3-L5 area due to excruciating nerve pain in my left leg. After the surgery, I was fine for 6 years. In March of this year, after my second shot, I began to get numbness and tingling in my right foot and searing nerve pain on the outer side of my lower right leg. I had an MRI that was evaluated by 2 surgeons. Although there are issues, neither one saw large changes or specific locations of impingement to warrant surgery at this time. But they cannot give a definitive reason for the inflamed nerve. I received an extremely
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Raised and reddened are approximately 1.5"x 3" in size at the site of injection. Tender, itchy, and has deep tissue tenderness.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Raised and reddened are approximately 1.5"x 3" in size at the site of injection. Tender, itchy, and has deep tissue tenderness.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Tinnitus within 10 minutes of vaccination in right ear.  Mild-moderate for 0-4 months.  Extreme to excruciating months 5 to ongoing.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Heavy menstrual bleeding, Muscle spasms, Oligomenorrhoea
Clinical narrative: Two days after receiving the shot I started a heavy period and have not stopped for 3 months. My drs don?t know why and I have had strong cramping. I have not had a period in over 3 years
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea for fourteen days
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: I have hives on my feet, hands, arms, body.  The red patches come and go.  They are very itchy.  This started last night around 6PM on 11-16-2021 and continue as of this writing, at 1:00AM on 11-18-2021.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Capillary fragility, Injection site erythema, Injection site reaction, Injection site swelling, Rash pruritic
Clinical narrative: Itchy rash near moderna booster shot injection site. It also appears to be a bit swollen and red under the injection site a few inches and a burst capillary just below  the swelling.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Client reports that with second dose of Moderna COVID vaccine, he awoke the next day with a fast heart beat, lasting 30 minutes.  Client reports taking Tylenol and sleeping a few hours.  He awoke and fast heart rate had resolved.  Client denies  any shortness of breath,  no trouble breathing, no difficulty swallowing, no chest tightness.  Client did not follow up with primary care provider.  Client reports similar reaction when he "gets drunk" and wakes up the next morning "hung over".  Client denies medical conditions, not taking medications, denies allergies.  Client reports he had an EKG 7 years ago, was told results were normal.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Monoplegia, Pain, Pyrexia
Clinical narrative: I have a fever and cough really bad body aches and pains. My arm is dead and I can?t move it
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell?s palsy
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Tremor
Clinical narrative: The day after this 2nd vaccine shot, patient had a fever if 101 and was so exhausted that she slept  through the day. She started to feel better by day 5.   On the date on 10/13, which is listed for the adverse reaction, patient began having hand tremors. She could not stop the shaking. This lasted for approximately 3weeks. It has never disappeared completely but we thought since it was easing up she would be fine.  Today the shaking cane back strong  so we will be taking her to a doctor ASAP.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Heightened blood pressure 7 months later.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Shortness of breath started before chest pain. Chest pain was on the left side. Could not make it to urgent care but I am going for a check up 11/18/2021. No treatment other than hydrating, resting, monitoring blood pressure and oxygen saturation.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Diarrhoea, Disorientation, Dyspnoea
Clinical narrative: Chronic diarrhea after 48 still present. Headaches, weight loss, difficulty breathing, nausea, feeling of being disoriented.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Stool analysis, Weight decreased
Clinical narrative: Chronic diarrhea after 48 still present. Headaches, weight loss, difficulty breathing, nausea, feeling of being disoriented.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: facial numbness and tingling, onset the next day, lasted for 24 hours
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Electrocardiogram, Heart rate, Heart rate increased, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 21-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 12Sep2021 16:00 (at the age of 21-year-old) as dose 1, single for COVID-19 immunisation at Pharmacy. Medical history included pituitary tumor from an unknown date and unknown if ongoing, non-classic adrenal hyperplasia, idiopathic hypersomnia in long and potassium deficiency related heart arrhythmia from an unknown date and unknown if ongoing. Concomitant medication included JORNAY and prednisone taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of vaccination. The patient previously took fentanyl and experienced known allergies. Patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Sep2021 16:00, patient experienced racing resting heart rate, bronchitis and continued recurrent upper respiratory illnesses. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment was received for the events. Multiple medications for bronchitis, EKGs was taken. The patient underwent lab tests and procedures which included EKGs: Unknown Result on an unspecified date in 2021, Nasal Swab on 16Sep2021, 26Sep2021, 20Oct2021, and 22Oct2021 was resulted negative, heart rate racing resting on 12Sep2021. The outcome of event racing resting heart rate was recovered on unspecified date in Sep2021, event bronchitis was recovered on unspecified date in Oct2021, event continued recurrent upper respiratory illnesses was not recovered at the time of reporting.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Upper respiratory tract infection
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 21-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 12Sep2021 16:00 (at the age of 21-year-old) as dose 1, single for COVID-19 immunisation at Pharmacy. Medical history included pituitary tumor from an unknown date and unknown if ongoing, non-classic adrenal hyperplasia, idiopathic hypersomnia in long and potassium deficiency related heart arrhythmia from an unknown date and unknown if ongoing. Concomitant medication included JORNAY and prednisone taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of vaccination. The patient previously took fentanyl and experienced known allergies. Patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Sep2021 16:00, patient experienced racing resting heart rate, bronchitis and continued recurrent upper respiratory illnesses. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment was received for the events. Multiple medications for bronchitis, EKGs was taken. The patient underwent lab tests and procedures which included EKGs: Unknown Result on an unspecified date in 2021, Nasal Swab on 16Sep2021, 26Sep2021, 20Oct2021, and 22Oct2021 was resulted negative, heart rate racing resting on 12Sep2021. The outcome of event racing resting heart rate was recovered on unspecified date in Sep2021, event bronchitis was recovered on unspecified date in Oct2021, event continued recurrent upper respiratory illnesses was not recovered at the time of reporting.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pruritus, Urticaria
Clinical narrative: extremely itchy palms; hives on arms, legs and back; Administered dose 1 and dose 2 Moderna and dose 3 BNT162B2; Administered dose 1 and dose 2 Moderna and dose 3 BNT162B2; Administered dose 1 and dose 2 Moderna and dose 3 BNT162B2; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 73-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration, administered in left arm on 22Oct2021 at 13:00 (at the age of 73-year-old) as dose 3 (booster), single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine administered was pharmacy or drug store. The patient's medical history included asthma from an unknown date and unknown if ongoing. He had known allergies to Iodine and contrast Die. He previously took cefepime hydrochloride (CEFEPIME) and experienced allergy. Concomitant medications within 2 weeks of vaccination were fluticasone propionate, salmeterol xinafoate (ADVAIR) 260/50, doxycycline (DOXYCYCLINE) and lisinopril (LISINOPRIL), more; all were for an unspecified indication and from an unknown date to unknown if ongoing. The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Historical vaccine included Moderna (MODERNA COVID-19 VACCINE) administered in left arm on 12Jan2021 at 13:00 (Lot No: 011L20A) as dose 1, single and received Moderna (MODERNA COVID-19 VACCINE) administered in left arm on 09Feb2021 13:00 (Lot No: 010M20A) as dose 2, single; both doses via an unspecified route of administration, for COVID-19 immunization (at the age of 72-year-old). It was reported that on 24Oct2021 at 20:00, 2nd evening after injection, the patient experienced extremely itchy palms, then within hours, hives on arms, legs and back. Patient did not receive any treatment for the event extremely itchy palms and hives on arms, legs and back. Outcome of the events extremely itchy palms' and hives on arms, legs and back' was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable consumer (patient herself). A 61-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0179), via an unspecified route of administration, administered in Arm Left on 05May2021 at 00:30 (at the age of 61 years old) as dose 2, single for COVID-19 immunization. Medical history was none. The patient does not have any known allergies. The patient concomitant medications included LEVOTHYROXINE, SIMVASTATIN, MONTELUKAST, and NAPROXEN. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8732), via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 12:30 am (at the age of 61 years old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine in last four weeks. The patient had no COVID-19 prior to vaccination. The patient has not been tested for COVID-19 after the vaccination. Four days after her 1st dose on 18Apr2021 09:00 AM she became itchy and broke out in hives on my knees and for arms that lasted about 2 weeks. She took Benadryl occasionally. After her second shot she broke out in hives the day after. Therapeutic measures were taken because of hives. The patient has taken Benadryl as treatment for the adverse event. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Urinary tract infection
Clinical narrative: urinary tract infection; headaches/ headaches was reported as worsened.; nausea; This is a spontaneous report from a contactable consumer or other non hcp. An 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FE3590; Expiration Date: Dec2021, NDC number: 59267-1000-1) via an unspecified route of administration in left arm on 19Oct2021 (at the age of 83-years-old) as dose 1, single for COVID-19 immunisation. The time the vaccination was given was reported as 3:30, 4 PM. Medical history was not reported. There were no concomitant medications. Historical vaccine included Flu shot which made her really sick at the onset age in 70s, happened about 3 or 4 years ago. History of all previous immunization with the Pfizer vaccine was reported as none. Additional vaccines administered on same date of the Pfizer vaccine was reported as none. Events did not require a visit to emergency room and physician office. Prior vaccinations within four weeks prior to the first administration date of the vaccine was reported as none. The patient experienced headaches/ headaches was reported as worsened on 19Oct2021 in the afternoon, urinary tract infection on 20Oct2021 and nausea on Oct2021. Headaches started happening shortly after the shot on 19Oct2021, and has happened pretty much since then, she was just trying to fight it off. Confirms ongoing, worsening. Patient stated she got her first Pfizer vaccine on 19Oct2021 and at the time she didn't know she had a urinary infection and so she didn't know, she kept having headaches really bad, so she didn't know if it was maybe from that or her urinary tract infection. Patient reported that her gynecologist diagnosed the UTI on 20Oct2021, and she started having nausea a couple days after the UTI was diagnosed. She was still taking antibiotics, has improved. Patient was experiencing headache and nausea. Added that she was taking Tylenol (dose unknown). Outcome of the event urinary tract infection was recovering, headache was not recovered while nausea was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: Injection site pain from booster shot; Booster; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose and second dose of BNT162B2 vaccine, on an unspecified date as a single dose for COVID-19 immunization. On an unspecified date, the patient experienced Injection site pain from booster shot. The outcome of the event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia areata
Clinical narrative: Triggered Alopecia Areata. No previous history of autoimmune.; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not reported), via an unspecified route of administration, administered in left arm on 29May2021 at 10:00 (at the age of 31 years old) as a single dose for COVID-19 immunisation. COVID-19 vaccine was administered in Pharmacy or Drug Store. Lot number was not known due to Unable to locate or read the details. Medical history and concomitant medications were not reported. No previous history of autoimmune. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: not reported) in left arm on 01May2021 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination. The patient was not COVID tested post vaccination. On an unspecified date in 2021, the patient experienced Triggered Alopecia Areata. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with Vestibular Steroid topical for the event. The reporter stating the events as non serious. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable consumer (patient's mother). A 16-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications included prednisone and unspecified antihistamine taken for an unspecified indication, start and stop date were not reported. The patient experienced hives on an unspecified date. It was reported that after the first shot, the patient had hives. It was reported that she went to the urgent care, her primary doctor and also, the emergency room as that had been so severe. She was not responding to the usual course of an antihistamine and prednisone. The patient was miserable and would like someone to call her back with some suggestions to help. The adverse event resulted in physician office and emergency room visit. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Depressed mood, Illness, Immunisation, Memory impairment, Off label use
Clinical narrative: He stated he got ill on the third shot; He stated he got ill on the third shot; He stated he got ill on the third shot; Third dose: Pfizer Covid 19 Vaccine: damn near killed him, was down for 2 weeks; Third Dose: Pfizer Covid 19 Vaccine: 3 days of it he doesn't even remember it; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 65-years-old male patient received bnt162b2 (COMIRNATY; Formulation, solution for injection), dose 3 via an unspecified route of administration, administered in Arm Left on 02Sep2021 (Batch/Lot Number: FC3182, at the age of 65-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included rheumatoid arthritis from Feb2020 and ongoing, autoimmune disorder from Sep2005 and ongoing, hairy cell leukemia from 1992 to an unknown date, ongoing neuropathy peripheral and ongoing arthralgia. There were no concomitant medications. The patient previous took BNT162B2, solution for injection, Dose1, lot: EM9810, injection, left arm, unknown dosage at the age of 65-year-old on 19Feb2021 for covid-19 immunization and dose 2 on 17 Mar2021, lot: EM9810, injection, left arm, unknown dosage at the age of 65-year-old for Covid-19 Immunization with reaction Feeling abnormal. The patient reported that he got ill on the third shot and damn near killed him, He was down for 2 weeks after the third dose after 3 days of it he doesn't even remember it on 03Sep2021. The outcome of events he got ill on the third shot and damn near killed him, He was down for 2 weeks after the third dose after 3 days of it he doesn't even remember outcome of recovered on unspecified Sep2021  No follow-up attempts are needed. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Parosmia
Clinical narrative: My smell is affected. I keep smelling like medicine, similar to ben gay or hospital smell; dose 3,Immunisation; This is a spontaneous report from a contactable consumer (Patient) via COVID-19 per Regulatory Authority access. A 81-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration, administered in left arm on 26Oct2021 at 17:00 (age at vaccination 81-year-old) as dose 3 (booster), single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history included coeliac disease. The patients concomitant medications were not reported. Historical Vaccine include bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL1283), via an unspecified route of administration, administered in left arm on 06Feb2021 at 10:00 (age at vaccination 80-year-old) as dose 1, single and received BNT162B2, Formulation: Solution for injection, Batch/Lot Number: Not reported, Unable to locate or read the details), via an unspecified route of administration, administered in left arm on 27Feb2021 at 10:00 (age at vaccination 80-year-old) as dose 2, single both for COVID-19 immunization. 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 29Oct2021, the patient smell was affected. She kept smelling like medicine, similar to ben gay or hospital smell and on 26Oct2021 and received third dose on 27Feb2021 (Booster). Patient did not receive any treatment the events. The clinical outcome of the event patient smell was affected. She kept smelling like medicine, similar to ben gay or hospital smell was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Circumoral swelling, Lip swelling, Oral mucosal eruption, Pain in extremity
Clinical narrative: circumoral rash around her mouth; swollen lip; circumoral swelling around her mouth; Sore arm; This is a spontaneous report from a contactable Nurse (the patient's mother).  An 18-year-old female patient  (the reporter's daughter) received the second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine),  via an unspecified route of administration on 30Apr2021 (Batch/Lot Number: EW0170) as a single dose for COVID-19 immunization.  Medical history included , Klippel-feil syndrome from 11May2003 and ongoing The patient was probably 7 or 8 years of age when this was diagnosed , oculoauriculovertebral dysplasia from 11May2003 and ongoing The patient was probably 7 or 8 years of age when this was diagnosed, ongoing asthma,  spinal fusion surgery from 2016 to an unknown date, craniofacial deformity from an unknown date and unknown if ongoing, abnormal organ growth from an unknown date and unknown if ongoing.  The patient's historical vaccinations included the first dose of  bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine (Lot number ER8727 expiration date unknown) on 09Apr2021 for COVID-19 immunization. There were no concomitant medications. The patient experienced circumoral rash around her mouth on 30Apr2021 with outcome of recovered on 30Apr2021,  swollen lip on 30Apr2021 with outcome of recovered on 30Apr2021, circumoral swelling around her mouth on 30Apr2021 with outcome of recovered on 30Apr2021, and  sore arm on an unspecified date in Apr2021 with outcome of recovered in Apr2021.  The events were considered medically significant.; Sender's Comments: As there is limited information in the case provided, the causal association between the events circumoral rash around her mouth, swollen lip, circumoral swelling around her mouth and sore arm and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Immunisation, Lymphadenopathy
Clinical narrative: swollen right lymph node (armpit); red hot, firm patches appearing on upper right arm; red hot, firm patches appearing on upper right arm; Entire right arm aches from shoulder to hand; general body ache; exhaustion; chills; Dose Number 3; received flu vaccine same day of covid vaccine; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration, administered in right arm on 30Oct2021 at 02:30 (at the age of 54-year-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization at Pharmacy or Drug Store; influenza vaccine (FLU), via an unspecified route of administration administered in right arm on 30Oct2021 (Lot number was not reported), as dose 1, single for immunization. The patient was not pregnant at the time of vaccination. Medical history included essential tremor and mild oral allergy to walnuts and eggplant. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]), naproxen sodium (ALEVE), lithium, propranolol and levocetirizine. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date, (at the age of 54-year-old), as dose 1, single for COVID-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date, (at the age of 54-year-old) as dose 2, single for COVID-19 immunization. Patient was not received any other vaccine four weeks prior vaccination. The patient not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination. On 30Oct2021, the patient had dose number 3 and received flu vaccine same day of covid vaccine. On 31Oct2021, the patient experienced general body ache, exhaustion and chills. On 02Nov2021 at 05:00, the patient experienced swollen right lymph node (armpit), red hot, firm patches appearing on upper right arm and entire right arm aches from shoulder to hand. Patient was not hospitalized for the events. Seriousness of the events reported as non-serious. Event resulted to visit doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Product use issue, Rash
Clinical narrative: swollen right lymph node (armpit); red hot, firm patches appearing on upper right arm; red hot, firm patches appearing on upper right arm; Entire right arm aches from shoulder to hand; general body ache; exhaustion; chills; Dose Number 3; received flu vaccine same day of covid vaccine; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration, administered in right arm on 30Oct2021 at 02:30 (at the age of 54-year-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization at Pharmacy or Drug Store; influenza vaccine (FLU), via an unspecified route of administration administered in right arm on 30Oct2021 (Lot number was not reported), as dose 1, single for immunization. The patient was not pregnant at the time of vaccination. Medical history included essential tremor and mild oral allergy to walnuts and eggplant. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]), naproxen sodium (ALEVE), lithium, propranolol and levocetirizine. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date, (at the age of 54-year-old), as dose 1, single for COVID-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date, (at the age of 54-year-old) as dose 2, single for COVID-19 immunization. Patient was not received any other vaccine four weeks prior vaccination. The patient not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination. On 30Oct2021, the patient had dose number 3 and received flu vaccine same day of covid vaccine. On 31Oct2021, the patient experienced general body ache, exhaustion and chills. On 02Nov2021 at 05:00, the patient experienced swollen right lymph node (armpit), red hot, firm patches appearing on upper right arm and entire right arm aches from shoulder to hand. Patient was not hospitalized for the events. Seriousness of the events reported as non-serious. Event resulted to visit doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Immunisation, Oral discomfort, Oral disorder, Oral pain
Clinical narrative: Small oral lesions developed on the underside and tip of the tongue as well as the soft palate under the tongue; A burning sensation is occurring throughout my mouth, tongue, and throat making it painful to eat or drink; A burning sensation is occurring throughout my mouth, tongue, and throat making it painful to eat or drink; A burning sensation is occurring throughout my mouth, tongue, and throat making it painful to eat or drink; throat making it painful to eat or drink; painful to eat or drink; the patient received third dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 24-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: FE3590, Expiration date: not reported) via an unspecified route of administration, administered in arm right on 01Nov2021 (at the age of 24-years-old) as dose 3 (booster), single for covid-19 immunization. Medical history included fibromyalgia from an unknown date 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 COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccination within 2 weeks vaccination. Patient had no known allergies. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number: ER8734, Expiration date: not reported), via an unspecified route of administration in the right arm on 27Mar2021 (at the age of 24-years-old) as a dose 1, single for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number: EW0162, Expiration date: not reported), via an unspecified route of administration in the right arm on 17Apr2021 (at the age of 24-years-old) as a dose 2, single for covid-19 immunization. On 01Nov2021, the patient received third dose of vaccine (coded to booster). On 02Nov2021, the day after the vaccine, patient experienced small oral lesions developed on the underside and tip of the tongue as well as the soft palate under the tongue, burning sensation occurred throughout her mouth, tongue, and throat making it painful to eat or drink. The events were reported as non-serious. No Prolonged hospitalization and the patient did not received treatment. The patient will seek medical evaluation if events do not resolve. Device date was reported as 03Nov2021. The outcome of all the events was reported as not resolved or gotten better.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Tongue discomfort
Clinical narrative: Small oral lesions developed on the underside and tip of the tongue as well as the soft palate under the tongue; A burning sensation is occurring throughout my mouth, tongue, and throat making it painful to eat or drink; A burning sensation is occurring throughout my mouth, tongue, and throat making it painful to eat or drink; A burning sensation is occurring throughout my mouth, tongue, and throat making it painful to eat or drink; throat making it painful to eat or drink; painful to eat or drink; the patient received third dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 24-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: FE3590, Expiration date: not reported) via an unspecified route of administration, administered in arm right on 01Nov2021 (at the age of 24-years-old) as dose 3 (booster), single for covid-19 immunization. Medical history included fibromyalgia from an unknown date 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 COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccination within 2 weeks vaccination. Patient had no known allergies. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number: ER8734, Expiration date: not reported), via an unspecified route of administration in the right arm on 27Mar2021 (at the age of 24-years-old) as a dose 1, single for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number: EW0162, Expiration date: not reported), via an unspecified route of administration in the right arm on 17Apr2021 (at the age of 24-years-old) as a dose 2, single for covid-19 immunization. On 01Nov2021, the patient received third dose of vaccine (coded to booster). On 02Nov2021, the day after the vaccine, patient experienced small oral lesions developed on the underside and tip of the tongue as well as the soft palate under the tongue, burning sensation occurred throughout her mouth, tongue, and throat making it painful to eat or drink. The events were reported as non-serious. No Prolonged hospitalization and the patient did not received treatment. The patient will seek medical evaluation if events do not resolve. Device date was reported as 03Nov2021. The outcome of all the events was reported as not resolved or gotten better.  Follow-up attempts are completed. No further information is expected.