chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First dose: Tired in the evening of the same day.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Mar2021 10:00 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL; VIT D. The following information was reported: FATIGUE (non-serious) with onset 18Mar2021, outcome "recovered", described as "First dose: Tired in the evening of the same day.". Therapeutic measures were not taken as a result of fatigue.  Additional Information: No other vaccine in four weeks. No covid prior vaccination No covid tested post vaccination and also no known allergies.  Query: Please see the attached source document. The Pfizer Drug safety unit recently received the attached report submitted by you. Your awareness date provided as 08Apr2021, while submitted this report on 10May2021. which is a delay per Agency.  This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Please kindly further confirm the PRD and the delay reason for this report.  Response: The delay was due to a) instructions at the first vaccination to not report any side effects if minor within 24 hours so waited a couple of days to monitor any side effects and b) I mistakenly thought I had submitted the report but realized later that I started it but never submitted it.  No follow-up attempts are possible. No further information is expected.
Pt recvd 3 doses of Engerix-B vax & did not respond; Booster dose of Engerix-B given 1APR92;
Radical nerve pain across my abdomen and groin area. Pain in my left lower leg. Dr. put me on  medication believe it was carbamazepine 200 mg. Pain went away in leg after about 3 days and abdomen in about 7-9 days. One of the problems of being specific is that when I contacted you and then you sent me the way to contact you on 9.26 could not enter your site because it was insecure and neither web browser would let me in.
4/13/2021 From patient c/o of left leg pain and swelling s/p J&J vaccine on 4/03/21 from her local pharmacist. Patient states the the pain and swelling has increased over the last couple of days. She states she does have a history of varicose veins. Advised patient that due to receiving the J&J vaccine within the past 3 weeks, she should proceed to the nearest ER for evaluation. Patient was resistant to going to ER due to her uninsured status and asked that I contact her PCP for a second opinion. A message was sent to physician who agreed patient should be evaluated in the ER. A return call was made to patient, and again it was reiterated that she should proceed to the ER and the risk associated with not proceeding as instructed. Patient agreed to be evaluated in the ER.
Urticaria. Developed clear rhinorrhea "cold symptoms 1 day after immunizations.
Severe tinnitus; This is a spontaneous report from a non-contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm on 04May2021 13:15 (at the age of 74 years old) as dose 1 single for COVID-19 immunisation. The patient is not pregnant at the time of vaccination. The patient has no known allergies and no other medical history. The patient has no COVID prior to vaccination. Prior to vaccination, the patient has not been tested for COVID-19. Concomitant medication included atorvastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07May2021 09:00, the patient experienced severe tinnitus. The event resulted in Doctor or other healthcare professional office/clinic visit. No treatment was given in response to the event. The outcome of the event was not recovered. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient had just finished recieving his covid-19 vaccination from vaccinator. At the time of patients fainting I was mixing up covid-19 vaccinations when the technicians said we need you to come out here because a patient is having a seizure, When arriving on the scene I found patient unconsious on the floor face down, while assessing the scene I noticed some blood on floor. I tried to look for any trauma, patient was breathing and I tried to awaken him. I told someone to call 911 and contact a store manager. Then all of a sudden he popped up and sat up like nothing happened. I then noticed the brusing on his nose and asked for an ice pack and a bottle of water. Patient knew his name, was coherent, and seemed to be fine. I stayed with patient until paramedics arrived. Paramedics did a thorough examination and everything checked out. Patient waited for parents to arrive instead of going with paramedics. Vaccinator stayed with patient till his parents arrived.
Pt felt pain at injection site last evening, felt she was running fever so took TYLENOL and applied ice to area. Less swollen today. Area red swollen, hot to touch - 9"x7" will continue ice and TYLENOL. Will report tomorrow.
Woke up at around 1:35am 1/26/2021 with muscle aches and chills. Felt a low grade fever but did not take temperature. Treated with 2 extra strength Tylenol. Woke up at 7:00am 1/26/2021 with muscle aches and chills still present. Fever felt gone. At around 8:30am 1/26/2021, had an episode of diarrhea. Took 3 200mg ibuprofen to treat symptoms.
I95.9 HYPOTENSION 4/22/2023 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION J96.00 ACUTE RESPIRATORY FAILURE 4/21/2023 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION I95.9 HYPOTENSION 4/22/2023 HYPERCALCEMIA J96.00 ACUTE RESPIRATORY FAILURE 4/21/2023 HYPERCALCEMIA I95.9 HYPOTENSION 4/22/2023 OSTEOMYELITIS OF RIGHT FOOT J96.00 ACUTE RESPIRATORY FAILURE 4/21/2023 OSTEOMYELITIS OF RIGHT FOOT
pt cried cont for 1 1/2 hrs p/inject refused supper; c/o pain in rt arm for 10 days would not use arm, improved w/APAP; 12 days p/inject c/o legs aching for 2 days;
Pt received Twinrix vaccine.  2 hours after the vaccination, she developed Hives on neck, arms, trunk of body.  Nasal congestion also occurred.  She took Zyrtec at that time, and 4 hours later the symptoms were gone.
Headache, fever up to 102, chills, major diarrhea, vomiting.  I lost 3 lbs. Tested negative with the rapid COVID test.
Left arm swelling, redness and warm and pain. These symptoms started with in 6 hours after she was given PPV23. Patient was advised to take BENADRYL 50mg-4 x's a day.
I had SSRI withdrawal brain zaps; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 05May2021 at 15:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, colectomy (two colon resection) and total abdominal hysterectomy with bilateral salpingo-oophorectomy. Concomitant medications included citalopram (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC), pantoprazole (MANUFACTURER UNKNOWN) ,loperamide hydrochloride (IMODIUM) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) from unknown date for unknown indication. It was reported that the patient had no allergies to medications, food, or other products.  The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021 at 17:00, the patient experienced had SSRI withdrawal brain zaps. The patient reported that after the 2nd dose, patient had SSRI withdrawal brain zaps, but patient had not missed or taken the citalopram late, that occurred for about 30 hours total, and began within about two hours of the vaccination. The patient did not receive any treatment for the events. The events do not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event SSRI withdrawal brain zaps was on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
multiple autoimmune disease including AMAG with pernicious anemia; AMAG with pernicious anemia; aclasia; methocylic colitis; some eye disease; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC GASTRITIS (multiple autoimmune disease including AMAG with pernicious anemia), PERNICIOUS ANAEMIA (AMAG with pernicious anemia), OESOPHAGEAL ACHALASIA (aclasia), COLITIS (methocylic colitis) and EYE DISORDER (some eye disease) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHRONIC GASTRITIS (multiple autoimmune disease including AMAG with pernicious anemia), PERNICIOUS ANAEMIA (AMAG with pernicious anemia), OESOPHAGEAL ACHALASIA (aclasia), COLITIS (methocylic colitis) and EYE DISORDER (some eye disease). At the time of the report, CHRONIC GASTRITIS (multiple autoimmune disease including AMAG with pernicious anemia), PERNICIOUS ANAEMIA (AMAG with pernicious anemia), OESOPHAGEAL ACHALASIA (aclasia), COLITIS (methocylic colitis) and EYE DISORDER (some eye disease) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
severe inflammatoryreaction that was greater than 10cm with redness and pain; severe inflammatoryreaction that was greater than 10cm with redness and pain; severe inflammatoryreaction that was greater than 10cm with redness and pain; had a little fever; This spontaneous case was reported by a physician and describes the occurrence of INFLAMMATION (severe inflammatoryreaction that was greater than 10cm with redness and pain), ERYTHEMA (severe inflammatoryreaction that was greater than 10cm with redness and pain), PAIN (severe inflammatoryreaction that was greater than 10cm with redness and pain) and PYREXIA (had a little fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (severe inflammatoryreaction that was greater than 10cm with redness and pain), ERYTHEMA (severe inflammatoryreaction that was greater than 10cm with redness and pain), PAIN (severe inflammatoryreaction that was greater than 10cm with redness and pain) and PYREXIA (had a little fever). At the time of the report, INFLAMMATION (severe inflammatoryreaction that was greater than 10cm with redness and pain), ERYTHEMA (severe inflammatoryreaction that was greater than 10cm with redness and pain), PAIN (severe inflammatoryreaction that was greater than 10cm with redness and pain) and PYREXIA (had a little fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.   Reporter did not allow further contact
no adverse event to the vaccine, but patient admitted to the Adult Care Unit for COVID related reasons on 11/14/2023.  Patient was receiving dialyis on the same day and reported cough & chills, and fever of 100.5.  He was sent to ED after dialysis session.   Per evaluating ED physician:  He has a bump total bilirubin likely secondary to cirrhosis.  Urine showed pyuria, negative nitrites.  He has no urinary symptoms, but with a recent perinephric abscess this raises the question of whether or not there could be a complication or residual infection.  This prompted an MRI of the abdomen with and without contrast after discussion with radiology Dr., who confirmed this would be the best imaging modality to confirm the presence or absence of an abscess.  Ultimately, the MRI came back showing what appears to be a small fluid collection, smaller than before but still present in the perinephric area, raising the possibility of an abscess.  He does not have any back pain now, whereas before that was his presenting complaint.  At this point I cannot rule out the possibility that this is an infectious process contributing to the fevers he came in for today.  I had a discussion with Dr. of hospital medicine with regard to reasonable dispositions, 1 being transferred down to hospital for further evaluation and treatment.  Unfortunately I cannot share images with them from our system, but the best I can tell, looking through faxed over paperwork, the perinephric fluid collection resolved on subsequent CT scans performed while he was down at the hospital.  If it is felt that the collection is noninfectious, then sending him would risk an unnecessary flight and transportation back.  The other option would be admission to this facility, with monitoring of blood cultures, potential repeat imaging and discussion with Dr. whether or not this would be a collection amenable to drainage here.  In talking with patient, he prefers the latter option, which I think is reasonable.  I am currently waiting for another Dr., speak with patient about these options in person, so at this point since he does not appear to be systemically ill or toxic I will hold off on the decision to start antibiotics empirically.  He remained stable from a respiratory standpoint. Patient tested positive for COVID 11/14/23.
Sjogren disease; my blood count is 2.2 exceptionally low; still felt horrible, terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (first dose was on 06Dec2020 Lot EW0173), administration date: 06Dec2020, for Covid-19 immunization; Bnt162b2 (Second dose lot EW0153), for Covid-19 immunization; Bnt162b2 (Third dose on 2021 FL3197), administration date: 2021, for Covid-19 immunization; Bnt162b2 (Fourth FM9992), for Covid-19 immunization. The following information was reported: SJOGREN'S SYNDROME (medically significant) with onset 2023, outcome "unknown", described as "Sjogren disease"; BLOOD TEST ABNORMAL (non-serious) with onset 2023, outcome "unknown", described as "my blood count is 2.2 exceptionally low"; FEELING ABNORMAL (non-serious) with onset 2023, outcome "not recovered", described as "still felt horrible, terrible". The patient underwent the following laboratory tests and procedures: Full blood count: (2023) my blood count is 2.2 exceptionally low.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300128996 same reporter/patient/product, different dose/event.;
pt devel rash in genital area 5/15 spread to  neck arms legs face. 101 fever next day for 2 days. loss appetite. md recommended benadryl  5/18/99 plus f/u visit.
Minor muscle pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "Minor muscle pain".  Additional Information: Patient had minor muscle pain after 1st shot. Nothing after shot 2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT'S MOTHER STATES THAT CHILD HAS HAD DIARRHEA ALL DAY, FEVER OF 101, AND SWOLLEN ARMS
a few hours later she was fatigue, the next day there was sore muscles and the arm was sore, the soreness of muscles were gone but the arm was more swollen. There is no pain unless pressing directly on it but there is swelling.
12/18/22 presents to EC ED for "weakness, fatigue, shortness of breath". PMHx of "CAD CHF A. fib, recently diagnosed DVT, PE on Eliquis, abdominal aortic aneurysm, hypertension hyperlipidemia, COPD, NPH GERD"
pt recvd 1 dose of Engerix-B on 12JUN92 & devel a severe h/a; On 13JUN92 also had vomiting & dizziness; tx none;
Light headed / dizzy; Numbness in left arm, from the injection site all the way down her arm to her hand; Very week / couldn't get off the couch; Felt sick; Sick to her stomach; Couldn't eat; Overall sick feeling; Nauseous; Arm was a little achy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to her stomach), DYSPHAGIA (Couldn't eat), MALAISE (Overall sick feeling), ASTHENIA (Very week / couldn't get off the couch) and MALAISE (Felt sick) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little achy). On 26-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Sick to her stomach), DYSPHAGIA (Couldn't eat), MALAISE (Overall sick feeling) and NAUSEA (Nauseous). On 28-Feb-2021, the patient experienced ASTHENIA (Very week / couldn't get off the couch), MALAISE (Felt sick) and VACCINATION SITE HYPOAESTHESIA (Numbness in left arm, from the injection site all the way down her arm to her hand). On 02-Mar-2021, the patient experienced DIZZINESS (Light headed / dizzy). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Sick to her stomach), DYSPHAGIA (Couldn't eat), MALAISE (Overall sick feeling), ASTHENIA (Very week / couldn't get off the couch), MALAISE (Felt sick), DIZZINESS (Light headed / dizzy), PAIN IN EXTREMITY (Arm was a little achy) and NAUSEA (Nauseous) outcome was unknown and VACCINATION SITE HYPOAESTHESIA (Numbness in left arm, from the injection site all the way down her arm to her hand) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
flushing, palpitations and diarrhea following first dose Pfizer vaccine 3/12/21 with persistent symptoms x 3 days and then with recurrence and new symptom of tinnitus 7 days later which subsequently resolved
I developed a cough on 01/06/2021 that progressed on the 7th; 8th; 9th and the 10th was resolved.
This spontaneous report was received from a Licensed Nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date (reported as "on unknown recent dates") the patient was administered an improperly stored dose of PROQUAD injection, subcutaneously, for prophylaxis (dose and anatomical location were not reported). The lot number was reported as N014366 with expiration date on 09-MAY-2019, which is not a valid lot number for the product. No adverse effects were reported for the patient after the administration of PROQUAD.  The vaccine underwent a temperature excursion of 14.9F for 12 hours and 6 minutes and no previous temperature excursions were reported. The reporter stated that the call was because of a data logger.   This is one of two reports received from the same reporter (MARRS #1801USA001507); Sender's Comments:  US-009507513-1801USA001507:
Within 5 minutes of getting shot, my right forearm and hand tingled, turned red and started swelling. Next, I felt dizzy and light headed. A nurse then placed a BP cuff on me and measured my BP at 185/150. My oxygen level was 98. My face, neck and arms turned very red and my face - cheeks, nose and lips started to swell. They gave me apple juice and crackers. After about 45 minutes, my right arm was normal, the color in my face, neck and arms returned to normal, my BP was 150/90. My cheeks, nose and lips remained swollen. After another hour passed, I felt ok, so I left. I took Zyrtec and then Benadril, but they didn't help. My doctor prescribed prednisone but took me off of it after 3 days as it had no affect. After a week, the swelling in my cheeks and nose subsided, but as of today 5-6-21 my lips are still swollen.
he might have been exposed to Covid around the same time as getting the vaccine; This is a spontaneous report received from a contactable consumer (reporting for himself). A 54-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number Expiry date was not reported), via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunization. The patient medical history was and concomitant medications were not reported. It was reported that patient received his first dose of the BNT162B2 03Mar2021 and then found out the on 04Mar2021 that he might have been exposed to Covid around the same time as getting the vaccine. He wants to know if he can get the second dose of the vaccine since this has happened. Can this affect the vaccine and can he get the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.