chrisvoncsefalvay/vaers-outcomes huggingface dataset:
liver enzymes are a little bit high/high liver enzymes; diarrhea; fatigue; stiffness; This is a spontaneous report received from contactable reporter(s) (Other HCP).  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; methotrexate sodium (METHOTREXATE SODIUM). The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Remicade, notes: we did have to increase the dose of your Remicade in the past. The following information was reported: HEPATIC ENZYME INCREASED (non-serious), outcome "unknown", described as "liver enzymes are a little bit high/high liver enzymes"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; FATIGUE (non-serious), outcome "unknown"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiffness". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for methotrexate sodium was unknown.  Additional information: Age: 55-59 years. PT has high liver enzymes, diarrhea, fatigue, stiffness after receiving COVID vaccine, methotrexate. Um, now, we did have to increase the dose of your Remicade in the past. Um, I don't, uh, I mean, you're doing so well I'm not so sure it's worthwhile checking it. Your recent labs, your vitamin D looks great. Your blood counts look good. Your inflammatory markers are normal. Um, now your liver enzymes are a little bit high.   Follow-up attempts are completed. No further information is expected.
Muscle spasm on the L side of the neck and upper back.  This resolved with rest, warm compress and gentle stretching.  Soreness of the left arm as well as the L neck and scapular area continued for a few days after the event.
This spontaneous report as received from a register nurse refers to a 7 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 31-JAN-2014, the patient was vaccinated with dose 3 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
I have severe pain in the left side of my face.  The pain feels like a real deep ache.
On 07/19/2008 at approximately 11:50 a.m. Client (13 years of age) fainted during the placement of vaccines. Client received a Meningococcal and Varicella Vaccine to the left arm; she also received a Tdap Vaccine to the right arm when she lost consciousness and leaned forward in her seat. She was escorted to the floor where her legs were raised above the level of the heart. Client lost consciousness for approximately 8-9 seconds before she was alert to person, place and time. Client's vital signs were as follows: pulse 52/minute; blood pressure 98/52; and, respirations 12/minute. Client stated that she doesn't recall fainting. Client was not cold or clammy; however, she did appear somewhat pale. Client complained of feeling weak. Client's mother stated that client had not eaten breakfast. There are no reported illnesses and client is not taking any medications. Upon feeling better, client was assisted to a sitting position and then to a wheelchair. Client is not currently under a doctor's care and was advised to follow-up with her doctor. Client's mother refused emergency medical attention. The vaccines were administered at School. The vaccination was part of an outreach clinic put on by the Department of Public Health. Client's mother was given instructions to take client to the emergency room if client's condition worsens.
This is a spontaneous report from a contactable consumer (patient's parent) via a Pfizer sales representative. A 17-year-old female patient of an unspecified race/ethnicity received TRUMENBA, via an unspecified route of administration at single dose on 10Jan2017 (first dose) in the right arm and on 26Apr2017 (second dose) in the left arm for prevention of invasive Neisseria meningitis. The patient medical history and concomitant medications were not reported. The patient experienced severe headache, vomiting 12 times, severe pain at injection site, swollen arm, after each dose. The events were described as follows: Severe headache and vomiting started around the next day after receiving the first and second dose, started initially soon after 10Jan2017 but not on the 10Jan2017. These took longer to resolve then the pain and swelling. They also lasted another two days after the first dose, resolved but then the patient experienced it again with the second dose. Starting soon after the 26Apr2017 but not on the same day and they resolved another two days or so later. Severe pain at injection site and swollen arm started after receiving first dose on 10Jan2017. Lasted for a couple of days after first injection, resolved. Patient experienced these events again on 26Apr2017 after receiving second dose of product. Both resolved a couple of days later sometime in Apr2017. Swollen arm was the one she received injection in.
Sometime within 2 weeks of getting the first dose tinnitus set in both ears!  I have had this unrelenting condition ever since- every day.  I had an audiology check on 11/18/2021 which clearly showed a decrease in hearing function in both ears as a result of tinnitus.  This is in comparison to my hearing test from November, 2020, so affected hearing  is clearly documented.
Patient received immunization on 10/17/17 and had flu like symptoms for 3 days - went away. Now has an achy arm from shoulder to elbow of injection site. No pain. Pt. will get seen by PCP.
I had hydraded thoroughly the day before and day of my 2nd shot Pfizer vaccination, but still was so thirsty that evening that I kept waking up all night long every 90 minutes or so with a dry throat and mouth, craving water.  It subsided over the next day or two, but I had not heard of anyone else experiencing extreme thirst after vaccination so thought you should know.
Vasovagal reaction at time of vaccine administration, then developed red raised, urticarial rash from head to umbilicus.
Patient received moderna vaccine on 2/3/21 and 3/3/21. Presented to ER on 1/24/22. She was admitted with altered mental status on 01/24/22. In the ED she was noted to be hypoxic and was diagnosed with COVID 19 pneumonia. She has now completed antibiotics course and Decadron, and hypoxia is resolved. She did have a large right-sided malignant pleural effusion and underwent thoracentesis. She remains on CPAP at night. Received doxycycline, ceftraixone, and remdesivir during admission. Discharged on 2/14/22
After receiving vaccine, pt c/o being nauseous, pt asked for water, water given, pt then said, " I think I want to lay down", pt assisted to the floor to lay supine with legs elevated.  Paramedics and onsite doctor notified to come to the area, V/S 118/70, 60, 100%, pt then was assisted to a sitting position while on the floor, given fruit snack and additional water, pt then was assisted to sit in a chair, followed by standing position.  Pt was able to tolerate the change in postions well.  Pt was then taken to the 30 minute observation via wheelchair for monitoring.  He left in a personal vehicle with his father at 2:00p in stable condition.
tested positive for Covid test; tested positive for Covid test; difficulty breathing; chills; fluctuating fever; nausea; weakness; weakness/extreme fatigue; loss of taste and smell; loss of taste and smell; muscle pain; cough; sore throat; nasal drip; dizziness; fast heartbeat; injection site pain; anxiety; crying; This is a spontaneous report from a contactable healthcare professional. This 21-year-old female patient reported for herself that she received BNT162B2 1st dose on 31Dec2020 10:00 AM intramuscular at left arm for COVID-19 immunisation. Medical history included known allergies: Penicillin and Covid-19. Concomitant therapy included BC as reported. The patient experienced difficulty breathing, chills, fluctuating fever, nausea, dizziness, weakness, fast heartbeat, tiredness, loss of taste and smell, muscle pain, injection site pain, anxiety, cough, sore throat, nasal drip, crying, extreme fatigue, Etc on 31Dec2020 at 06:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency. The patient was hospitalized for 1 day and received treatment included blood thinner rivaroxaban (XARELTO) and had 2 weeks quarantine. The patient had Covid prior to vaccination and tested positive for Covid test post vaccination on 01Jan2021. The outcome of the events was not resolved.  Information on Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the suspected LOE, SARS-CoV-2 test positive and the other reported events due to temporal relationship.  Of note, it is reported that the patient had history of COVID 19 infection prior to the vaccination.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  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.
Dev. swelling at injection site next morning. By 24 hrs, golfball size, by 72 hrs softball size, red, sl. itching. Took BENADRYL 25mg PO x 3, TYL x 1. Diagnosis is: delayed local reaction.
diarrhea; This is a spontaneous report from a contactable consumer (patient). This 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 03Mar2021, and the second dose of BNT162B2 (lot number unknown) via an unspecified route of administration on 01Apr2021, as single doses for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported he received the first dose on 03Mar2021 and about 10 days to 2 weeks later he experienced diarrhea. It was reported the diarrhea had continued to "this day," as of (16Apr2021) and had still not gotten better two weeks after he received his second dose on 01Apr2021. He reported he was aware that it could be a side effect that may last for one to two days but was wondering if there had been any reports of diarrhea lasting this long of a period. The clinical outcome of diarrhea was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Made her MS worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s).  A 57-year-old female patient received BNT162b2 (BNT162B2), on 04May2021 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "Allergy: Penicillin" (unspecified if ongoing); "skin cancer" (unspecified if ongoing); "lumps in right breast (had outpatient procedures twice)" (unspecified if ongoing); "irritable bowel disease (had it whole life)" (unspecified if ongoing); "60% hearing loss (left ear)" (unspecified if ongoing); "double vision (nerve damage in the right eye, use glasses with prism)" (unspecified if ongoing); "bowel problems" (unspecified if ongoing); "bladder problems (have to focus and push)" (unspecified if ongoing); "so many lesions on neck" (unspecified if ongoing); "lesions on neck, spine and brain" (unspecified if ongoing); "spine and brain (about 20 lesions per CT scan)" (unspecified if ongoing); "sleeping difficulty" (unspecified if ongoing); "headaches once in a while" (unspecified if ongoing); "occasional falls" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's family history included: "multiple family members with MS (from mother's side)" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYZINE; MELOXICAM; CBD & MAGNESIUM. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "Made her MS worse". The patient underwent the following laboratory tests and procedures: Biopsy breast: Unknown results; Computerised tomogram: 20 lesions, notes: spine and brain (about 20 lesions per CT scan). Clinical course: The patient reported that she refused the booster because she felt the COVID-19 vaccines made her MS worse. Her doctor said that the COVID-19 vaccines would "probably" not help her, but recommended she get them.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300122996 same patient/AE, different drug dose;
Sore arm, aches and soreness in body, fatigue, waking during night. At 2 am, took 400 mg of advil.
Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL TARTRATE.  Clinical course: The patient stated she got the COVID vaccine (clarified as Pfizer Covid-19 vaccine) earlier today and she was like having chest pain right now. She did not know if it was like relation to it or should she just call emergency room right now or what she should do. Other medical condition: Consumer stated, "heart palpitation (Not appropriately clarified hence tab left unchecked)." Reassurance: Consumer stated, "No, she think that was it for now."   The following information was reported: CHEST PAIN (non-serious), outcome "unknown".  No follow-up attempts are needed. No further information is expected.
low-grade fever, severe arm pain that woke patient from sleep, headache. patient took tylenol which helped to resolve symptoms.
localized erythemaa, tenderness, swelling that has progressed over the past 3 days currently approximately 4 x 5 cm.  Patient denies fever, chills, sweats.  There is no lymphangitis or lymphadenitis noted.
Pain on arm of injection; Fever; Nausea; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on arm of injection), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Slight headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes, MULTIVITAMIN [VITAMINS NOS] for Vitamin supplementation.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced PAIN IN EXTREMITY (Pain on arm of injection), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Slight headache). At the time of the report, PAIN IN EXTREMITY (Pain on arm of injection), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included Diabetes Medications. Treatment information was not reported.
Pt received 3 Pfizer Covid vaccines, one at a pharmacy and two at another facility. Dates of vaccination were 1/9/21, 2/1/21, 1/28/21. No adverse effects noted. Not discovered until 8/26/21 that pt received 3.
patient was given ONE COVID vaccine as second dose today.  Pt received a different brand vaccine for first dose
lower body, leg muscle aches began 7 days after vaccine, sore throat, fatigue.
Headache, Arthralgia,  Chills, Fatigue, Injection site pain, Swelling at injection site Narrative:  Other Relevant History:
This spontaneous report as received from a Registered Nurse refers to a 17 weeks old patient. The reporter reported that the patient was received first dose of ROTATEQ, oral (lot # was unknown) on 15-OCT-2012 when they were 17 weeks old. No adverse effect reported. This is one of the two reports from the same source. The other report was captured in MARRS # 1211USA010105. Additional information has been requested.
Patient arrived for dose 2 vaccine and did not have Vaccine Card.  First dose was not confirmed (Pfizer on 4/23/21 at event).  Patient received Moderna after 25 days from Pfizer dose.  CDC considers vaccination series complete at this time.
Severe headache; Muscle pain; Joint pain; occasional spasms; Temperature that fluctuated between 99-101.2 for approximately 15 hours; Attempting to work, but finding, have to triple check all typing as not able to focus and type correctly as can normally; Very drowsy still after sleeping on and off for over 30 hours.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 29Mar2021 at 10:00 (at the age of 51-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 19Apr2021 at 10:30 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included ADHD and basal cell nevus syndrome (history of numerous basal cell cx's). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) 50 mg daily and naproxen sodium (ALEVE) 1 pill 2 nights before; both from unknown dates for unspecified indications. The patient previously took levofloxacin (LEVAQUIN) and fluorouracil (EFUDEX); both on unknown dates for unspecified indications and experienced drug allergy. On an unknown date in 2021, the patient experienced severe headache, muscle and joint pain with occasional spasms and temperature that fluctuated between 99-101.2 for approximately 15 hours. Attempting to work, but finding, have to triple check all typing as not able to focus and type correctly as can normally, very drowsy still after sleeping on and off for over 30 hours. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On an unknown date, the patient underwent lab test and procedure which included body temperature and result was shown as 99-101.2 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache, muscle and joint pain with occasional spasms and temperature that fluctuated between 99-101.2 for approximately 15 hours. Attempting to work, but finding, have to triple check all typing as not able to focus and type correctly as can normally, very drowsy still after sleeping on and off for over 30 hours were resolving at the time of this report.    No follow-up attempts are needed. No further information is expected.
he got 5 shots of Pfizer vaccine for Covid and he just recently got Covid last six or seven days; he got 5 shots of Pfizer vaccine for Covid and he just recently got Covid last six or seven days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID. The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "he got 5 shots of Pfizer vaccine for Covid and he just recently got Covid last six or seven days". Clinical course: Caller said he got 5 shots of Pfizer vaccine for Covid and he just recently got Covid last six or seven days. The last date of his vaccination was 21Sep2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient brought to ED due to what he described as indigestion not improving over time.  Diagnosed with ST elevation MI on EKG.  4 stents were placed in the RCA, EF at 50%.  Given Brilenta and admitted to ICU. Discharged and placed on atorvastatin and ticagrelor.
This spontaneous report as received from a healthcare worker refers to a 27 years old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with GARDASIL injection (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Additional information is not expected as a healthcare worker declined to participate in adverse event collection process.