chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: Right armpit, looks like a lymph node is swollen, about the size of a tennis ball; Right armpit is very tender; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Right on 20Sep2021 17:30 (at the age of 45 years old) as dose 1, single for COVID-19 immunisation at pharmacy. Medical history reported as none. No investigation assessment. There were no concomitant medications. Patient historical vaccine included Tetanus Vaccine on an unspecified date (it was several months ago) as single for immunisation and experienced got kind of ill. Patient did not received other vaccine within four weeks of COVID vaccine. The patient experienced right armpit, looks like a lymph node is swollen, about the size of a tennis ball, right armpit is very tender on 22Sep2021. Reported as, She had the first dose of the Pfizer-BioNTech COVID-19 Vaccine on Monday, the 20th. She got up this morning and her lymph nodes on her right armpit where she got shot was very tender and swollen with the size of a tennis ball. She called her doctor and was advised to contact Pfizer. Outcome of all the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Glycosylated haemoglobin
Clinical narrative: It spiked up my sugar; This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on 20Sep2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included type 2 diabetes mellitus (patient got rid of type 2) from an unknown date and unknown if ongoing. Concomitant medication was not reported. The patient experienced spiked up sugar and patient may had eaten too many carbs. Patient read the vaccine has sugar in it. Why is it in there and how much of it is in the vaccine. The patient underwent lab tests and procedures which included blood glucose: spiked up, glycosylated haemoglobin: 5.7 and glycosylated haemoglobin: its been going up to 150. The outcome of the event was unknown.  The lot number was not provided. Information on lot number has been requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A female patient, of an unspecified age, received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, Apr 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unknown route of administration, on an unknown date, single dose, for COVID-19 immunisation. Patient stated, she experienced adverse reaction after her second dose of Pfizer-BioNTech COVID-19 vaccine. She did not give a specific date she just said she got it in Apr. She said she has been tired all the time. She is over-heating. She is getting very hot. She has a fever and has not gone away since she got the vaccine Apr 2021. The outcome of the events reported as unknown. The lot number for (BNT162B2) not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue
Clinical narrative: the inside of my body feels like it is burning up, 24 hours a day, for month; I am very tired; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date in Apr2021, the patient experienced the inside of my body feels like it is burning up, 24 hours a day, for month; I am very tired. Last Name: Patient stated, you don't need my last name, I was just told that that I needed to call this number because I am having a reaction from the Pfizer vaccine and my doctors cannot figure out what is going on, so I am trying to call you guys cause everyone stops hands on me. When paraphrased that consumer has experienced side effects and wants to know about it, consumer stated, Yes and I want to know. I got my second vaccine on April, the end of April and the inside of my body feels like it is burning up, 24 hours a day, for month and I am very tired. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Therapeutic response unexpected
Clinical narrative: when he got the initial Covid dose and the booster dose; when he got the initial Covid dose and the booster dose; noticed the levels going down twice when he got the initial Covid dose and the booster dose; PSA level went down substantially for no other reason of why it happened twice, his levels went down at least 40%; This is a spontaneous report from a contactable physician (patient). A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and received second dose of BNT162B2 (lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single and received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunization. The patient medical history included prostate cancer. Concomitant medications were not reported. It was reported that, patient states he has had prostate cancer and has been on treatment on that. Wants to report an unusual thing the the Pfizer covid shot. His PSA was going up when on treatment and he stopped that because it kept going up. He noticed the levels going down twice when he got the initial Covid dose and the booster dose, his PSA level went down substantially for no other reason. He was on a chemotherapy treatment and had stopped it because it wasn't working, not for a period of time, but after he got the vaccines his levels went down at least 40%. Does not know the basis for this, but it's easy data to obtain. If Pfizer could get with the oncologists they can easily follow the data and do not have to draw bloodwork but complete a chart review on those who got the shot and compare data. Knows that there are some cancer treatments that are mRNA treatments and this struck up to be so unusual and weird to him. Thinks this would be a cheap study and be of benefit and be helpful if done. Clarifies he had prostate cancer prior, way before getting the vaccine. Has had it a few years. Again, mentions his PSA went down for no other reason of why it happened twice and it was weird to him since he had the vaccine. Wants Pfizer to do a therapy study. The patient underwent lab tests and procedures which included PSA (prostatic specific antigen): went down at least 40% on an unspecified date. The outcome of the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, Intestinal perforation, Sepsis
Clinical narrative: appendicitis; sepsis; bowel burst; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm right on 19May2021 12:00 (Batch/Lot Number: EW0171)(at age 53-years-old) as dose 2, single for covid-19 immunisation. Patient received the first dose on 26Apr2021 12:00 (lot number: EW0171) on the left arm at age 53-years-old. There were no other vaccine within four weeks. Medical history included atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication(s) included carvedilol (CARVEDILOL); digoxin (DIGOXIN); rivaroxaban (XARELTO); all taken for an unspecified indication, start and stop date were not reported. The patient experienced appendicitis, sepsis, and bowel burst on 22Sep2021 13:00. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for the events for 14 days. It was unknown if patient received treatment for the events. Outcome of the events was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, Vomiting
Clinical narrative: significant other had covid after getting the covid vaccine; COVID; He had mild cold; vomiting; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGL for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient had significant other had covid after getting the covid vaccine, he got over it and is now negative, he had mild cold, vomiting.  The outcome of events had significant other had covid after getting the covid vaccine was recovered; outcome of other events was unknown.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pityriasis rosea, Psoriasis, Rash
Clinical narrative: diagnosed with rosacea/Psoriasis; rash; diagnosed with rosacea/Psoriasis; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FD8448), via an unspecified route on 19Aug2021 (at the age of 54-years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications included Multivitamins from an unknown date and unknown if ongoing. On unspecified date, the patient received first dose of the vaccine five days later he developed a rash which has not gone away and was diagnosed with rosacea/Psoriasis and was told by his dermatologist the rash should go away within two months. Patient was past due on his second dose and missed dose because of this rash. Patient stated that "I just went to see my doctor today, he told me to talk to (Incomplete sentence) I went to see a dermatologist, he told me to talk to my primary physician and my primary physician wont give me any direction." Patient stated, "I tried an anti-fungal, I was given a diagnosis, I do not know if you want to get ahead with that or you want to continue with the question." The outcome of the events rash was not recovered, and other events was unknown.  Follow-Up (04 OCT2021): Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: diagnosis given is Bell's Palsy; This is a spontaneous report from a contactable consumer.  A non-pregnant 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 02Sep2021 12:00 (Batch/Lot Number: FC3182) as dose 1, single (at the age of 34 years old) for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medication included estradiol and meloxicam, both taken for an unspecified indication, start and stop date were not reported.  The patient previously took amoxicillin and codine linctus and experienced known allergies.  On 14Sep2021, 12 days after first shot, the patient experienced facial numbness/paralysis on one side of my face. On 20Sep2021 following an emergency room visit the diagnosis given is Bell's Palsy. The patient was given prednisolone. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a non-serious spontaneous report from a contactable Consumer. This 65-year-old female Consumer reported for herself. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: ER534, but she is not sure if it is an R), dose 2 via an unspecified route of administration, administered in Arm Right on 21Mar2021 (at the age of 65-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in Arm Right on 26Feb2021 (at the age of 65-years-old) as a single dose for covid-19 immunization. The patient had no other vaccine within four weeks. The patient developed shingles about a month ago, and has questions about the booster shot. She was on antibiotics now, but will be done before scheduled for the booster shot. She was wondering when she would be able to take the booster since she will be 66 next month and will qualify for it. Shingles: came down with it about 4 weeks ago. She was not breaking out anymore, but still experiencing pain. It has improved somewhat. It was in her eyes and she was having problems with eyes, ears, and facial pain. She was better than she was. No emergency room visited, but visited physician office- She has been seen by a couple of doctor's. No further information provided. Outcome of the event was unknown.  The lot number for, BNT162B2, was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain
Clinical narrative: Chills; Body aches; This is a spontaneous report from a contactable consumer (patient).  A 32-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 20Sep2021 between 16:00 and 17:00 (Lot Number: FF2588) as 1st single dose for COVID-19 immunisation. Medical history included ongoing asthma since she was a child and ongoing bad headaches, like migraines, for which she had not consulted any physician. There was no relevant medical family history. The patient's concomitant medications were not reported. There were no vaccinations within four weeks prior to the first administration of BNT162b2. The patient stated that on 21Sep2021 her body was in so much pain, having chills, whole body aches, she had no fever but felt like it. She specified that she could not stay still because her body hurt so bad, and it had gotten worse throughout the day. The patient was tearful while reporting the above side effects. There was no need for an emergency room visit not physician office visit. The patient had not recovered from the above described events.   Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Malaise, Myocarditis
Clinical narrative: His heart is being squeezed, she thinks may be its Myocarditis; Felt like someone was squeezing his heart; Still feeling bad; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program  support.  A 48-year-old male patient received  the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 21Sep2021 15:00 (Batch/Lot number was not reported) (at the age of 48-years-old)  as DOSE 1, SINGLE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient had no prior vaccination within the last four weeks. On 21Sep2021, the patient went to get his first dose of the Pfizer covid 19 vaccine and an hour later, felt like someone was squeezing his heart. The patient was still feeling bad. The reporter stated that  the pharmacist said it was all in his head, she did not refer to doctor or anything. It has been twelve hours and it was a constant feeling. The reporter stated that her fiance (patient) did not have a health care provider and they would have to seek ER or urgent care. The reporter states obviously this was an effect from the vaccine and asked if there was any coverage that is provided. This was something they were not expecting. The reporter stated that patient has been feeling like his heart is being squeezed, she thought may be it's myocarditis, she was not quite sure do she needed to make a report of this, she also wanted to know about if Pfizer has any assistance risk precast associated for taking treatment.  The reporter informed that reason for her call was  mainly because they had called to  pharmacist at the (Withheld) where he got the vaccination and he forced him that he did not  need to seek medical assistance nor for and that was all in his head, reporter just wanted to put it out there because Pfizer told reporter that he should be taking medical assistance, whereas the pharmacist saying otherwise so this is like a huge concern especially given that the vaccine is so new so what is the thing we should do and are the pharmacist are even been trained on telling patients what to do after administering this product.  Reporter stated further that her reason to call to figure out what we need to do, she was not calling just to report the fact that he was having issue, and wanted to know what the next step was. 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: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Hyperaesthesia, Muscular weakness, Nausea
Clinical narrative: Weakness in lower extremities; lack of sensation; hyper sensation; Unusual gait; Dizziness; nausea; vertigo; This is a spontaneous report from a contactable consumer (patient reporting for himself). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 09Apr2021 15:30 (batch/lot number was not reported) at the age of 32 years old, as DOSE 2, SINGLE for COVID-19 immunization. The vaccine was administered at a vaccine facility. Patient's medical history included ankylosing spondylitis from an unknown date. The patient was not diagnosed with COVID-19 infection prior to vaccination. Concomitant medication included hydrocortisone (HUMERA) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 19Mar2021 07:00 AM (batch/lot number was not reported) at the age of 31 years old, as DOSE 1, SINGLE for COVID-19 immunization. On 18Apr2021 08:00 AM, the patient experienced weakness in lower extremities, lack of sensation, hyper sensation, unusual gait, dizziness, nausea, and vertigo. The events resulted in doctor or other healthcare professional office/clinic visit and were reported as serious resulting in disability or permanent damage. Therapeutic measures were taken as a result of the events which included physical therapy. The patient has not recovered from the events. Since the vaccination, the patient has been tested for COVID-19; the Nasal Swab test on 30Jul2021 was negative and the Antibody test (Blood test) on 30Jul2021 was positive.   The batch/lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test, Sensory loss, Vertigo
Clinical narrative: Weakness in lower extremities; lack of sensation; hyper sensation; Unusual gait; Dizziness; nausea; vertigo; This is a spontaneous report from a contactable consumer (patient reporting for himself). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 09Apr2021 15:30 (batch/lot number was not reported) at the age of 32 years old, as DOSE 2, SINGLE for COVID-19 immunization. The vaccine was administered at a vaccine facility. Patient's medical history included ankylosing spondylitis from an unknown date. The patient was not diagnosed with COVID-19 infection prior to vaccination. Concomitant medication included hydrocortisone (HUMERA) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 19Mar2021 07:00 AM (batch/lot number was not reported) at the age of 31 years old, as DOSE 1, SINGLE for COVID-19 immunization. On 18Apr2021 08:00 AM, the patient experienced weakness in lower extremities, lack of sensation, hyper sensation, unusual gait, dizziness, nausea, and vertigo. The events resulted in doctor or other healthcare professional office/clinic visit and were reported as serious resulting in disability or permanent damage. Therapeutic measures were taken as a result of the events which included physical therapy. The patient has not recovered from the events. Since the vaccination, the patient has been tested for COVID-19; the Nasal Swab test on 30Jul2021 was negative and the Antibody test (Blood test) on 30Jul2021 was positive.   The batch/lot number for BNT162B2 was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Blood sugar went up to 701; Extremely dizzy; This is a spontaneous report from a contactable consumer (patient's daughter). A 78-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine, lot number:) via an unspecified route of administration on Apr2021 as single dose for COVID-19 Immunization. Medical history included a previous open heart surgery and diabetic which was controlled with metformin and diet. He never had to take shots for his diabetes. He also had high blood pressure and a previous open heart surgery. Concomitants medications were none. The patient previously received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine) on an unspecified date for COVID-19 Immunization.  It was reported that after receiving the second dose in Apr2021, the patient's blood sugar went up to 701 and he was extremely dizzy and hospitalized for 3 days. He went in the hospital in May2021 or Jun2021. Since this happened, he now was having to take shots for his blood sugar. Outcome of the events was unknown.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Angioscopy, Back pain, Blindness, Cerebrovascular accident
Clinical narrative: bulges spondylosis; retinal revascularization; eye pressure: increased 24; feels like ovaries pain; loss of central L eye vision; diminished colors. loss of central L eye vision.; stroke; diminished colors. loss of central L eye vision. Couldn't drive as usual; severe back pain; leg heavyness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0183), intramuscular, administered in left deltoid on 11Jun2021 10:31 (at the age of 50-years-old) as dose 2, single for COVD-19 immunization. The patient's medical history was not reported. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (MOTRIN) taken for back, leg pain and limping from 25May2021 and ongoing. The patient previously received FLUARIX vaccine (Batch/Lot number: 59HN3), intramuscular, administered in right deltoid on 04Jan2021 for an unspecified indication; and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in left deltoid on 21May2021 11:52 (Lot number: EW0183) as dose 1, single for COVID-19 immunization and on 21May2021 experienced left eye central vision loss treated with Avastin eye injections, back pain/hip/knee pain, blurred vision thought needed new glasses, limping right leg. On 12Jun2021, the patient felt like she had ovaries pain. In Jun2021, the patient experienced diminished colors, loss of central left eye vision, couldn't drive as usual, severe back pain, leg heaviness, and she ended up in the ER after having a stroke. The patient had CT, X-rays, MRIs and saw Neurology, Ophthalmology. The patient was referred to "Ortho Phys med- Pain" had eye injection and will need more on a monthly basis. The event ovaries pain was reported as serious due to persistent/significant disability/incapacity. The patient underwent lab tests and procedures on 28Jun2021 which included CT scan head brain lumbar: normal, there was no mass and no stroke; and hip and knees x-rays were normal. Rheumatoid lab tests in Jul2021 was normal. On 27Aug2021, fluorescent angioscopy: left sub retinal revascularization and eye pressure: increased 24, comments: normal was 10-14. On 12Sep2021, MRI spine: bulges spondylosis, sub centimeter CSF cyst, comments: face and degeneration disc bulge, foramen narrowing. The patient did not report to physician yet and was more worried about vision and on and off limping, and constant back pain, will seek this week. The patient received treatment for the vision loss with Avastin 1.25 mg eye injection, intravitreal from 27Aug2021 and ongoing. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Computerised tomogram head, Dyschromatopsia, Intraocular pressure increased, Limb discomfort
Clinical narrative: bulges spondylosis; retinal revascularization; eye pressure: increased 24; feels like ovaries pain; loss of central L eye vision; diminished colors. loss of central L eye vision.; stroke; diminished colors. loss of central L eye vision. Couldn't drive as usual; severe back pain; leg heavyness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0183), intramuscular, administered in left deltoid on 11Jun2021 10:31 (at the age of 50-years-old) as dose 2, single for COVD-19 immunization. The patient's medical history was not reported. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (MOTRIN) taken for back, leg pain and limping from 25May2021 and ongoing. The patient previously received FLUARIX vaccine (Batch/Lot number: 59HN3), intramuscular, administered in right deltoid on 04Jan2021 for an unspecified indication; and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in left deltoid on 21May2021 11:52 (Lot number: EW0183) as dose 1, single for COVID-19 immunization and on 21May2021 experienced left eye central vision loss treated with Avastin eye injections, back pain/hip/knee pain, blurred vision thought needed new glasses, limping right leg. On 12Jun2021, the patient felt like she had ovaries pain. In Jun2021, the patient experienced diminished colors, loss of central left eye vision, couldn't drive as usual, severe back pain, leg heaviness, and she ended up in the ER after having a stroke. The patient had CT, X-rays, MRIs and saw Neurology, Ophthalmology. The patient was referred to "Ortho Phys med- Pain" had eye injection and will need more on a monthly basis. The event ovaries pain was reported as serious due to persistent/significant disability/incapacity. The patient underwent lab tests and procedures on 28Jun2021 which included CT scan head brain lumbar: normal, there was no mass and no stroke; and hip and knees x-rays were normal. Rheumatoid lab tests in Jul2021 was normal. On 27Aug2021, fluorescent angioscopy: left sub retinal revascularization and eye pressure: increased 24, comments: normal was 10-14. On 12Sep2021, MRI spine: bulges spondylosis, sub centimeter CSF cyst, comments: face and degeneration disc bulge, foramen narrowing. The patient did not report to physician yet and was more worried about vision and on and off limping, and constant back pain, will seek this week. The patient received treatment for the vision loss with Avastin 1.25 mg eye injection, intravitreal from 27Aug2021 and ongoing. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging, Ophthalmological examination, Retinal vascular disorder, Rheumatoid factor
Clinical narrative: bulges spondylosis; retinal revascularization; eye pressure: increased 24; feels like ovaries pain; loss of central L eye vision; diminished colors. loss of central L eye vision.; stroke; diminished colors. loss of central L eye vision. Couldn't drive as usual; severe back pain; leg heavyness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0183), intramuscular, administered in left deltoid on 11Jun2021 10:31 (at the age of 50-years-old) as dose 2, single for COVD-19 immunization. The patient's medical history was not reported. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (MOTRIN) taken for back, leg pain and limping from 25May2021 and ongoing. The patient previously received FLUARIX vaccine (Batch/Lot number: 59HN3), intramuscular, administered in right deltoid on 04Jan2021 for an unspecified indication; and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in left deltoid on 21May2021 11:52 (Lot number: EW0183) as dose 1, single for COVID-19 immunization and on 21May2021 experienced left eye central vision loss treated with Avastin eye injections, back pain/hip/knee pain, blurred vision thought needed new glasses, limping right leg. On 12Jun2021, the patient felt like she had ovaries pain. In Jun2021, the patient experienced diminished colors, loss of central left eye vision, couldn't drive as usual, severe back pain, leg heaviness, and she ended up in the ER after having a stroke. The patient had CT, X-rays, MRIs and saw Neurology, Ophthalmology. The patient was referred to "Ortho Phys med- Pain" had eye injection and will need more on a monthly basis. The event ovaries pain was reported as serious due to persistent/significant disability/incapacity. The patient underwent lab tests and procedures on 28Jun2021 which included CT scan head brain lumbar: normal, there was no mass and no stroke; and hip and knees x-rays were normal. Rheumatoid lab tests in Jul2021 was normal. On 27Aug2021, fluorescent angioscopy: left sub retinal revascularization and eye pressure: increased 24, comments: normal was 10-14. On 12Sep2021, MRI spine: bulges spondylosis, sub centimeter CSF cyst, comments: face and degeneration disc bulge, foramen narrowing. The patient did not report to physician yet and was more worried about vision and on and off limping, and constant back pain, will seek this week. The patient received treatment for the vision loss with Avastin 1.25 mg eye injection, intravitreal from 27Aug2021 and ongoing. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Spinal osteoarthritis, X-ray limb, X-ray of pelvis and hip
Clinical narrative: bulges spondylosis; retinal revascularization; eye pressure: increased 24; feels like ovaries pain; loss of central L eye vision; diminished colors. loss of central L eye vision.; stroke; diminished colors. loss of central L eye vision. Couldn't drive as usual; severe back pain; leg heavyness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0183), intramuscular, administered in left deltoid on 11Jun2021 10:31 (at the age of 50-years-old) as dose 2, single for COVD-19 immunization. The patient's medical history was not reported. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (MOTRIN) taken for back, leg pain and limping from 25May2021 and ongoing. The patient previously received FLUARIX vaccine (Batch/Lot number: 59HN3), intramuscular, administered in right deltoid on 04Jan2021 for an unspecified indication; and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in left deltoid on 21May2021 11:52 (Lot number: EW0183) as dose 1, single for COVID-19 immunization and on 21May2021 experienced left eye central vision loss treated with Avastin eye injections, back pain/hip/knee pain, blurred vision thought needed new glasses, limping right leg. On 12Jun2021, the patient felt like she had ovaries pain. In Jun2021, the patient experienced diminished colors, loss of central left eye vision, couldn't drive as usual, severe back pain, leg heaviness, and she ended up in the ER after having a stroke. The patient had CT, X-rays, MRIs and saw Neurology, Ophthalmology. The patient was referred to "Ortho Phys med- Pain" had eye injection and will need more on a monthly basis. The event ovaries pain was reported as serious due to persistent/significant disability/incapacity. The patient underwent lab tests and procedures on 28Jun2021 which included CT scan head brain lumbar: normal, there was no mass and no stroke; and hip and knees x-rays were normal. Rheumatoid lab tests in Jul2021 was normal. On 27Aug2021, fluorescent angioscopy: left sub retinal revascularization and eye pressure: increased 24, comments: normal was 10-14. On 12Sep2021, MRI spine: bulges spondylosis, sub centimeter CSF cyst, comments: face and degeneration disc bulge, foramen narrowing. The patient did not report to physician yet and was more worried about vision and on and off limping, and constant back pain, will seek this week. The patient received treatment for the vision loss with Avastin 1.25 mg eye injection, intravitreal from 27Aug2021 and ongoing. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rectal haemorrhage
Clinical narrative: Spotting and Blood from Rectum; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer (manufacturer control number 21K-163-4081234-00).   Solicited report by a consumer of an adult female with an event of non-serious spotting and blood from rectum with HUMIRA (adalimumab). There was no reported medical history. On an unknown date in 2021, the patient experienced spotting and blood from rectum. PFIZER BIONTECH COVID-19 VACCINE (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown date the patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot number unknown, expiration date unknown; 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot number unknown, expiration date unknown. Reaction(s): Rectal bleeding - (Rectal haemorrhage) with outcome of not recovered/not resolved. Reaction: Rectal bleeding - (Rectal haemorrhage) with start date unknown in 2021 and stop date unknown. Suspect drug(s): HUMIRA (solution for injection in pre-filled pen) (adalimumab), unknown; daily dose reported as citrate free; route of administration was subcutaneous; indications for use was moderate to severe ulcerative colitis; therapy dates were unknown; product-reaction level: drug: HUMIRA (solution for injection in pre-filled pen) (adalimumab), unknown; action(s) taken with drug was unknown. Suspect drug(s): PFIZER BIONTECH COVID-19 VACCINE (tozinameran); daily dose was 1 in 1 once; route of administration for 1st and 2nd dose was intramuscular; therapy dates/duration of 1st dose was on 13Sep2021 to 13Sep2021; indications for use was covid-vaccination; product-reaction: drug: PFIZER BIONTECH COVID-19 VACCINE (tozinameran), unknown; action(s) taken with drug was unknown. Other relevant history was not reported. Concomitant drugs and dates of administration were not reported. Causality for HUMIRA (adalimumab): The reporter's causality for the event spotting and blood from rectum was not provided. Causality for PFIZER BIONTECH COVID-19 VACCINE: The reporter's causality for the event rectal bleeding-rectal haemorrhage was reported as probable.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer. A 47-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FC3184; expiration date: Oct 31, 2021), at the age of 47, via an unspecified route of administration, in left deltoid, on Sep 19, 2021, single dose, for COVID-19 immunisation. Medical history included subclinical hypothyroidism from Jan 2020 to an unknown date. There were no concomitant medications.  The patient previously took the first dose of BNT162B2 on Aug 24, 2021 for COVID-19 immunization; and experienced lymph node swelling in neck, normal lethargy and nausea. On Sep 21, 2021, patient experienced swelling to lymph nodes at the clavicle and axillary areas, which was reported as worsened. The patient reported after the first dose, she had lymph node swelling in neck only and it was very mild. It started the second day after getting it. After the second dose, it was much more severe. It looks like a baseball is in her armpit. There is a chain of lymph nodes in her neck. 4 of them inflamed, and able to see them. The outcome of the events: not recovered.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test, Thrombosis
Clinical narrative: PE; blood clots; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FA7484), administered in left arm, on 27Jul2021 at 10:00 (at the age of 60-years-old) at dose 1, single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), high blood pressure, chronic sinusitis and gastrooesophageal reflux disease (GERD). The patient had not known allergies and had not COVID prior vaccination. Concomitant medications included lisinopril, pantoprazole, rosuvastatin calcium (CRESTOR), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); all reported as other medications in two weeks. The patient developed pulmonary embolism (PE), blood clots 7 days later, on 03Aug2021 at 15:00 and was admitted to hospital. The events resulted in emergency room/department or urgent care visit and hospitalization for 2 days in 2021. The patient had been tested for COVID post vaccination, on 16Sep2021, via nasal swab COVID test, rapid PCR: negative. A treatment was administered for the events and included ELIQUIS blood thinner. The patient was recovering from the events.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: peripheral neuropathy; This is a spontaneous report from a contactable physician. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 68-years-old, via an unspecified route of administration on 26Jan2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021, as dose 1, single for COVID-19 immunization. Post vaccination he experienced peripheral neuropathy on an unspecified date in 2021. He did not explain detailed specifics or if this has resolved. Soon after he developed peripheral neuropathy and it may or may not be related. He has been to a few neurologists and been evaluated and has been told it could be related. He would like to know if this has been reported and if Pfizer has any information. The outcome of the event was unknown.; Sender's Comments: Based on the information available and temporal relationship, a causal association between BNT162B2 and the reported peripheral neuropathy cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Psychotic disorder
Clinical narrative: he was in a psychotic state for 6hours; This is a spontaneous report from a contactable consumer or other non healthcare professional. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation  The patient medical history and concomitant medications were not reported. The patient experienced psychotic state for 6 hours on an unspecified date with outcome of unknown.   Consumer is calling for information on the Pfizer-BioNTech Covid19 booster dose. As per caller he have comorbidities and he's eligible for the booster dose. He didn't have problems with the 1st shot which was last 11Mar2021, but on his 2nd shot on 01Apr2021, he had some side effects mentally, he was in a psychotic state for 6 hours and he wants to know if the 3rd shot will give him the same reaction. He had some reactions to Shingrix shot before, he wants to know if there would be any interaction once he get the booster dose of the Pfizer-BioNTech Covid19 Vaccine.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pharyngeal swelling, Urticaria, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Huge swollen arm at vaccine site; Huge swollen arm at vaccine site, red and swollen, very itchy; Huge swollen arm at vaccine site, red and swollen, very itchy; swollen throat; dry cough; hives on legs; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Sep2021 14:00 (Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization at the age of 25 years old. The patient was not pregnant at time of vaccination. Medical history reported as none. Concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) and birth control taken for an unspecified indication, start and stop date were not reported. The patient previously had BNT162B2 dose 1 on unspecified date for COVID-19 immunization. The patient experienced huge swollen arm at vaccine site, red and swollen and very itchy on 20Sep2021 07:00. The patient also experienced swollen throat, dry cough and hives on legs on 20Sep2021 07:00. The patient was given a steroid called Dexamethason as treatment. The events resulted in doctor's office/urgent care. The patient has not been COVID-9 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The outcome of the events was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Huge swollen arm at vaccine site; Huge swollen arm at vaccine site, red and swollen, very itchy; Huge swollen arm at vaccine site, red and swollen, very itchy; swollen throat; dry cough; hives on legs; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Sep2021 14:00 (Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization at the age of 25 years old. The patient was not pregnant at time of vaccination. Medical history reported as none. Concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) and birth control taken for an unspecified indication, start and stop date were not reported. The patient previously had BNT162B2 dose 1 on unspecified date for COVID-19 immunization. The patient experienced huge swollen arm at vaccine site, red and swollen and very itchy on 20Sep2021 07:00. The patient also experienced swollen throat, dry cough and hives on legs on 20Sep2021 07:00. The patient was given a steroid called Dexamethason as treatment. The events resulted in doctor's office/urgent care. The patient has not been COVID-9 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The outcome of the events was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.