chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started left calf pain on 11th March.  on 13th march developed tachycardia and high blood pressure  180/110 at home. I visited urgent care as there was a recent history of air travel.  Urgent care also BP was unusually high and directed me to go to ER to rule out DVT.   I regularly take my blood pressure medication and had taken the medication that day in the morning too.  In ER - D-dimer, EEG, BMP, CBC with differential, magnesium, and vascular ultrasound of the venous leg bilateral was done.  I was told that the results were all negative for DVT and everything looked normal. High blood pressure was unexplained.  I was asked to monitor my blood pressure closely and follow up with my general practitioner in 3 weeks.
On the same arm around the area lower than the armpit towards the breast she felt pain.; On the same arm around the area lower than the armpit towards the breast she felt pain. The caller thinks it was just the lymph nodes; having pain in her left arm, which is the arm she had her COVID vaccine in, under her armpit towards her breast area; This is a spontaneous report from a contactable nurse (parent). An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 24May2021 (at the age of 18-year-old) (Batch/Lot Number: EW0179) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient had no relevant medical history and no concomitant medications. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0165) on 03May2021 (at the age of 17-year-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The nurse was calling about her daughter who experienced some side effects after receiving the Pfizer COVID Vaccine on 24May2021. The daughter had the vaccine administered on the left arm. On the same arm around the area lower than the armpit towards the breast she felt pain. The nurse thinks it was just the lymph nodes and nothin to worry about but the daughter wanted to hear that from someone else and not form her. The nurse was asking if this what the daughter was experiencing was normal and was it the lymph nodes. The nurse further reported that her daughter was having pain in her left arm, which was the arm she had her COVID vaccine in, under her armpit towards her breast area and she was wondering if that was normal. The nurse stated that personally she thinks that it was from her daughter's lymph nodes but since the nurse was the patient's mom, she would rather hear this from someone else. The events started on 25May2021. The reporter considered the events as serious medically significant. The patient had not yet recovered from the events.; Sender's Comments: The events Breast pain, Lymph node pain and Vaccination site pain are assessed as possibly related to the suspect bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), based on strong temporal association.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.
This is a spontaneous report from a contactable nurse. A 12-month-old female patient received TRUMENBA (lot number: R47584, expiration date Jul2018), intramuscular in the right thigh on 07Feb2018 14:30 at 0.5 ml (also reported at 0.5 cc), single for routine vaccination at the physician office. Medical history included supplementation therapy. Concomitant medication included second dose of PEDVAXHIB (lot number: N013294, expiration date 28Feb2020), intramuscularly in the left thigh; first dose of HAVRIX (lot number: ZK374), intramuscularly in the right thigh; first dose of PROQUAD (lot number: N020007), subcutaneously in left thigh; all at unknown dose, single for immunization and ongoing multivitamins from 2017 as supplement.  It was reported that on 07Feb2018, the patient was inadvertently administered the wrong vaccine. It was also reported that the patient experienced drug administered to patient of inappropriate age as the patient was only 12 months old. The patient also has high fever and didn't sleep much on 07Feb2018. The adverse reactions started about 5 hours after being given meningococcal group b rlp2086. The outcome of the events was unknown.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high bp" (unspecified if ongoing), notes: (not on any listed "do not give with" meds except trazadone); "Known allergies: Penicillin" (unspecified if ongoing); "obesity" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; LISINOPRIL; HYDROCHLOROTHIAZIDE; GoLo supplement. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Mild increased; SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of suspected covid-19. Patient received other medication in 2 weeks was trazadone, GoLo supplement, Lisinopril, Hydrochlorothiazide. Severe altered bitter taste, nausea progressive with each dose, shaky and weaker with last 2 doses, loose stool and 1 diarrhea, mild fever after last dose, shortness of breath upon exertion. "Severe flu like symptoms last 48 hours of dose regiment. Improved 24 hours after last dose except still shaky with some weakness and SOB. (not diabetic) Mild increased BP. COVID 19 Treatment: Paxlovid. Treatment start date: 09May2022, treatment stop date: 14May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I did not have a reaction to the Moderna vaccine on 04/25/2023. On 05/25/2023, I started not feeling well with a bad cough. By 05/27/2023, the cough was worse with congestion. I was producing a lot of mucus. I went to an urgent care and received prescriptions for the infection. I did take a COVID-19 test at home on 05/27/2023 and it was negative.
My symptoms started on 06/19/2022, I woke up with a sore throat, coughing and nasal congestion. As the day went on, I had more coughing and chest congestion. I did a home test for COVID-19 and the result was positive. I called my doctor and left a message. He called back later, and I explained my symptoms and that I tested positive, he prescribed PAXLOVID. I began taking an over-the-counter cough medicine and TYLENOL. There was a mix up with the prescription, so I started it on Monday 06/20/2022. I felt worse on Monday, very tired, coughing, nasal and chest congestion, low or no fever, low appetite and my stomach felt queasy; my oxygen was good as I had monitored it. Once I started to take the PAXLOVID I gradually started feeling better. Fortunately, I slept well each night. I believe it was Wednesday, 06/23/2022 I had a video chat with my doctor who was checking in with me. I kept feeling better although tired. The cough medicine helped a lot. I believe I had another virtual visit on 06/25/2022. I told my doctor how much better I was feeling, and I continued to improve each day. I had one more virtual visit on 06/28/2022, I was told that some people have a rebound case of COVID-19 after finishing the PAXLOVID about the 10-14th day afterwards. I was feeling back to normal by the 10th day. I tested days 10-14 all came back negative, and my oxygen level has remained high.
BUD Date 04/07/2022 administered on 04/11/2022. Pfizer could not provide stability data beyond 04/09/2022 and recommended re-vaccination
Beginning on Tuesday 9/18 late afternoon I began to not feel well and was very tired and a little achy. Every day from Wednesday through Tuesday 9/25 I experienced chills all day and about 2-3 p.m. began feeling extremely achy, headaches and fatigue. Today, 9/26 is the first day that I have felt somewhat better and am not in pain from the aches. I have taken only ibuprofen to manage the symptoms and the dosage ranged from 400 mg to 800 mg.
because of pandemic did not receive second dose; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report.  The patient received one dose of the Shingrix vaccine and because of the pandemic the 2nd dose was not received within 6 months interval. It had now been 1 year and 4 months since the first dose.
total body rash starting on lower back 5/28 and proceeding up back to scalp, around sides of body, around armpits, groin, under stomach fold, behind ear lobes. Mild to moderate itchiness. Bloomed to bright red on back. mild fever up about 2 degrees for me from my usual 97,2 to 99.6. Went to ER 5/31 and was held for 2 days while it was investigated. No infectious disease or blood diseases found. Treated at first with IV benedril and then prednesone with relief of itch and gradual fading of rash. some fungal infection found in skin folds and treated. Fever manifested mostly on first day. Sent home second day with script for prednesone, anti-fungal cream and pepcid. Rash gradually going away with current treatment. Final dx was rash reaction post JJ shot. .
3 dose 3rd 27 Oct 1t 9:45AM. 11:15PM severe chills for 3 days and could hardly walk, had migraine for 3.5 days thought the night. That am, saw black floaters on my peripherals and fluid behind my right eye, immune systems is   Had nausea. Water was draining for my left ear and flashing flickering light, even with the lights off. Diarrhea for two days. Virtual visit with the nurse and practitioner. Take muscle relaxant and pain pill. Going to eye doctor on 17Nov2021 and I am in back brace
Pt has red rash on L arm and feels warm. 4/5cm erythema L upper arm with mod swelling.
Twice since I have had the moderna covid vaccine my arm has muscle has been easily injured. Leaving me with limited use for at least a week. I had my second shot on Feb. 3 2022. Didn't bother going to the doctor.
Information regarding Flu Mist was received from a healthcare professional regarding herself, a 37 year old female, who experienced accidental exposure and developed a dry "hacky" cough after administering Flu Mist. The pt experienced accidental exposure and developed a dry "hacky" cough in November, 2003. She reported that this occurred approximately 2 days after she administered Flu Mist to several people. she did not receive Flu Mist. Related cases: See HQWYE460108DEC03 and HQWYE46008DEC03. No additional info was available at the time of this report.
Initially complained of left arm heaviness with 20 later progressed to bilateral jaw tightness,mild dizziness,denied CP , SOB. Handover to parametics,placed on cardiac monitor, NSR 78, EKG completed . BP 149/82 HR 78 O2  99%, skin dry. Shortly  after jaw pain subsided along with dizziness. PRN angio placed in right AC by parametics. Patient declined nurse to call her family member and transported to BMC- ER  fully alert and oriented x3.
My antidepressant, Sertraline has stopped working. After the shot, my eyes got blurry. About 5 days later I thought I had a headache from sinus. After medication and doctor visits, it is not sinus. No appetite. shaky, insomnia, no interest in ordinary activities. Constant headache. Feel very sick.
Feeling paralyzed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARALYSIS (medically significant), outcome "recovered", described as "Feeling paralyzed". Clinical course: While talking to (pharmacy name withheld) about Paxlovid a pharmacy technician said a patient had reported feeling paralyzed after taking a vaccine. Pharmacy technician directed patient to report the incident to Pfizer. Patient only reported during a flu shot appointment that after getting a Pfizer Vaccine he felt paralyzed and then recovered. Product confirmed as Pfizer COVID-19 Vaccine. Patient reported the event to the reporter during a different appointment for a flu shot. Confirmed the flu shot was not the vaccine that caused the patient to feel paralyzed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
relapsed AML post mRNA-1273 vaccination; This literature-study case was reported in a literature article and describes the occurrence of ACUTE MYELOID LEUKAEMIA (relapsed AML post mRNA-1273 vaccination) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE MYELOID LEUKAEMIA (relapsed AML post mRNA-1273 vaccination) (seriousness criterion medically significant). At the time of the report, ACUTE MYELOID LEUKAEMIA (relapsed AML post mRNA-1273 vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ACUTE MYELOID LEUKAEMIA (relapsed AML post mRNA-1273 vaccination) to be related.    No concomitant information were provided. No treatment information reported. Blood specimens were collected from patients prior to the and second vaccine doses (Days 1 and 29) and ~28 days after the second vaccine dose (Day 57) for antibody analyses. Two-step ELISA was performed, measuring IgG responses.SARS-CoV-2 antibody positivity rates were compared using the Fisher exact test or Chi-square test.  Company Comment - This case concerns a patient of unknown age and gender with no relevant medical history of who experienced serious unexpected event of acute myeloid leukaemia. The precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided nor was provided vaccination start date. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. Furthermore, very limited information regarding patient's medical history and concomitant medications was provided. The reporter assessed the event as related to the suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2022: Follow up received by safety 06-Jan-2022 included an Email from two regulatory authorities and contains authors information.; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical history of who experienced serious unexpected event of acute myeloid leukaemia. The precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided nor was provided vaccination start date. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. Furthermore, very limited information regarding patient's medical history and concomitant medications was provided. The reporter assessed the event as related to the suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report was received from a physician via a company representative concerning a 91-year-old female patient. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX and sterile diluent for prophylaxis (dose, route of administration, lot number and expiration date were not reported for both products). On an unknown date, the patient had a shingles outbreak along her face and the patient developed a post-herpetic neuralgia as a result of the shingles. There was no product quality complaint involved and no additional information was given. The outcome of the events and the causal relationship between the events and the vaccine were not reported. Additional information is not expected because there was no consent to contact the physician.
On 07/28/2000 the patient developed varicella vesicles over his entire body. The patient was also vomiting. On 07/31/2000, the patient was seen by a physician and diagnosed with chickenpox. On 08/10/2000 the patient recovered.
Headache, Myalgia, Fever, injection site discomforts (right arm red, hot, swollen and painful, c/o insomnia Narrative:
pt recvd flu vax & pt devel wheal, accompanied by swelling, pain & heat;
fever 102; headache; tiredness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 102), HEADACHE (headache) and FATIGUE (tiredness) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02UM20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PYREXIA (fever 102), HEADACHE (headache) and FATIGUE (tiredness). At the time of the report, PYREXIA (fever 102), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (Inconclusive) body temperature 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines include tachycardia medication and  lungs medication treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
2/16/21 Received #1 dose of Moderna. on 2/17/21, fever 99.6. and injection site soreness. 2/21/21 c/o intense itching at injection site, all toes very sensitive to touch (socks, shoes, bed sheets irritated to touch. 2/25/21 Injection site area red "the size of a grapefruit", warm to touch, feels hard when palpated along w slight swelling. 2/26/21 all symptoms getting better
Vaccine administration error - needle detached from syringe and less than half of vaccine was injected into arm.  Patient is being offered to receive a repeat second dose.
Acute itchy rash with raised welts starting on forearms and gradually moving to upper arm, chest, stomach and legs.  Dr. prescribed Prednisone and Claritin during the day and Benadryl in the evenings.  Took it for a week with no improvements.  Today the Dr. prescribed Zyrtec and Pepcid
No pain at time of injection at all.   My arm started getting sore and painful to move after about 4 hours.  Then uncontrollable shivering,chills, fever, body aches, head ache, muscle spasms and pain, sore throat, extreme fatigue, nausea, loss of appetite starting about 7:00pm on the night of the vaccination and continuing all the following day (3/30)  I took Tylenol and slept all day.  Today, (3/31) some diarrhea, slight head ache, but all other symptoms are gone.
chest pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 15Apr2021 at first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient expressed her concerns about getting the second dose of vaccine on 06May02021 because she experienced chest pain on an unspecified date in 2021. The outcome of this event was unknown at the reporting time.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT WAS ADMITTED ON 2/1/21 TO MEDICAL CENTER. HE WAS PREVIOUSLY INCARCERATED AT FACILITY. WHILE AT FACILITY, HE HAD RECEIVED THE PFIZER INJECTION ON 1/19/21. THE NURSE AT MEDICAL CENTER WAS UNAWARE AND ADMINSITERED THE MODERNA COVID-19 VACCINE. STAFF WAS UNAWARE THAT HE HAD RECEIVED THE PFIZER VACCINE INITIALLY IN JANUARY. NO ADVERSE REACTION NOTED AFTER RECEIVING DIFFERENT MANUFACTURED VACCINE.
It got to 217/99; I got really red; This is a spontaneous report received from a contactable consumer (Patient). A 79-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 09Feb2021 at single dose for COVID-19 immunization. Patient's medical history included Cancer, asthma. Concomitant medications included letrozole taken for neoplasm malignant, gabapentin, montelukast taken for asthma. Patient received the first dose after half an hour the patient had such subjective symptoms as red, blood pressure had gotten very high after half an hour of Vaccination. It got to 217/99 having somewhat high blood pressure but not that high. Patient went to the emergency room at a hospital they put me on EKG machine to monitor my heart and took some blood samples. Benadryl was given as treatment. The outcome of the events was unknown.
19MAR93 TC from mom reporting pt broke out in hives; pt did not have any difficulty breathing or show any other sx; 20FEB93 TC from mom-pt broke out w/hives Sat AM; taken to MD; MD thinks hives realted to Ceclor-ATB changed;
Fatigue, chills evening after vaccination; morning after vaccination pt reported still feeling fatigued and then blacked out in the morning falling and breaking her hip in 3 places requiring surgery and hospitalization for 7 days. Patient states since returning from hospital she has had intermittent dizziness/light headedness, strange nausea sensation/chest tightness that comes on suddenly and at random.
The evening after injection given pt developed rash at injection site. Next evening rash spread to entire body and became itchy. 48 hrs after inject pt developed flu-like symptoms.