chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dates when patient was in hospital for Asthma exacerbation: 23 Aug 2022 to 25 Aug 2022; This spontaneous report has been received from a nurse via Pfizer (manufacturer control number: 202201151170) concerning a 9-year-old male patient.   Since an unspecified date in 2015, the patient was allergic to peanuts; and also presented asthma. The patient's concomitant medications, drug reactions or allergies were not provided.   On 11-AUG-2022, the patient received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe injection, 0.5 milliliter (ml) administered intramuscularly on the left deltoid as prophylaxis (lot number U019413 has been verified to be a valid lot number with expiration date on 01-NOV-2023) (vaccination scheme was not reported). ;and also with the first dose of COVID-19 vaccine injection 0.2 milliliter administered intramuscularly (IM) in the right deltoid, lot number: FL8094 (vaccination scheme, indication, and expiration date was not provided).   On 23-AUG-2022, the patient experienced asthma exacerbation (asthma aggravated) that required him to visited the emergency room; therefore, the patient was hospitalized from  23-AUG-2022. That day, laboratories were performed such as: RSV test, influenza test, COVID-19 test, which all came negative. The patient received treatment for the event such as steroids; thus, he was going to be seen by a pulmonologist and was doing much better; therefore, on 25-AUG-2022, the patient was discharged from the hospital. On 07-SEP-2022, the second dose of COVID-19 vaccine injection 0.2 milliliter administered IM in the right deltoid, lot number: FL2757 (vaccination scheme, indication and expiration date was not provided). By the reporting time, he was recovering from the event.   Causality assessment between the suspect therapy and the events was not provided.
The day after receiving my first vaccine, I began to develop a headache and fatigued. I was unable to move my left arm much higher than an inch or two. My arm pain got better after 24 hours, but the headache and fatigue persisted. I felt well enough to work on April 12, 13 and 14 and went outside my home on the 12, 14 and 15, interacting with other people while masked. On April 16, the extreme fatigue set in. I could not get out of bed. EXTREME. That entire weekend I stayed in bed with the chills and also developed nasal congestion that has persisted to the time of this writing (April 23). On April 19, I started spotting and started my period (old blood) two weeks early. That has for the most part subsided to the level of my usual discharge, though it is a bit heavier than normal.  Also on April 19, the sore throat and chest pain started. I went for a COVID test today. Negative result. Chest pain is similar in location and scope to when I suffered with pericarditis years ago.  Took a sick day off of work. Fatigue getting better, but very very wiped out by the end of the day. Brain is foggy.  April 20 - virtual visit with my primary doctor to discuss symptoms. Chest pain continually getting worse, harder to take a deep breath, like when the doctor asks to "take a deep breath and hold it," that really hurts. Can breathe regularly fine. But just sitting on the couch I'm in pain. Laying down hurts the most. Get bloodwork, chest x-ray and covid test done. All normal.   April 22 - Chest pain continues to get worse. Starting to cough. Go to Urgent Care  at request of primary care doctor. Another covid test done, xray taken, flu swab., EKG. All normal. They send me to emergency room at  Hospital additonal assessment. EKG, ultrasound of heart and lungs, bloodwork done, all normal. They send me home on ibuprofin and tell me to follow up with my cardiologist. They believe it to be presumptive pericarditis.
Presented to ED w/SOB; admitted for COVID-19 pna; tx w/abx, steroids, zinc, Singular; DC to SNF on baseline O2 @ 1L O2/NC
Approx 1 minute following vaccine administration, patient fainted and fell off exam table onto floor without warning. Patient did hit head.  Patient was unconscious for approx 10 seconds. When patient regained consciousness, he was unsure of what happened. Patient did remember getting vaccine but thought he fell asleep. He was slightly slow to respond to questions after regaining consciousness. Patient did become dizzy when sat up, became nauseous and vomited.
Extreme soreness in left arm for 3 days. Day 1 and 2, flu-like symptoms.
He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all/His wife also experienced similar symptoms; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all/His wife also experienced similar symptoms; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all/His wife also experienced similar symptoms; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all/His wife also experienced similar symptoms; He is experiencing general body pain specifically on shoulder, feeling like he has a fever - headache, no energy at all/His wife also experienced similar symptoms; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported similar events for himself and wife. This report is for wife. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 19Mar2021 as dose 1, single and dose 2 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 10Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that reporter and his wife received both doses of the Pfizer COVID 19 vaccine 1st dose 19Mar2021 and 2nd dose was 10Apr2021, not exactly sure of the schedule as he did not have his card with him. Reporter was experiencing general body pain specifically on shoulder, feeling like he has a fever-headache, he had no energy at all, asking for recommendations on what to do with the symptoms and if they need to consult their doctor, his wife (patient) also experienced similar symptoms. The patient underwent lab tests and procedures which included body temperature: feeling like he has a fever on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101046973 same reporter, events, diff pt
Started with back pain that increased until I went to the ER. I was told I had a kidney infection but no UTI. The pain continued at increasing levels (it was too painful to even sit up). I was diagnosed with an Acute Kidney Injury. Was given antibiotics. I was unable to work or even walk properly for 3 months. My lower back was in an extreme amount of pain. Narcotics didn't even take the pain away.
Patient noted redness around injection sites. It was swollen - hot for a few days. Seems to be improving now, 2 days after administration. Noticed it at both sites.
Patient reports that within 24 hours of receiving injection she developed rash extending over her neck torso and contralateral arm from which she received the injection. She also felt fatigued and generalized body aches. Symptoms resolved within 72 hours. This was her second injection.
Initial information received on 17-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 years 8 month old patient who received dose of 0.5 ml of vaccine QUADRACEL (batch number: C5500CA, expiry date: 16-Aug-2020) (route not reported) in the left arm on 29-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as no other vaccines. It was a case of actual medication error due to Inappropriate age at vaccine administration. It was not reported if any adverse event was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Initial report received from a health care professional on 07 September 2012. 6 female patients of unspecified demographics, with no reported medical history and concurrent conditions, had received an intradermal dose of FLUZONE ID (Lot number: UT4472AA) on 06 September 2012. On 07 September 2012 i.e. within 24 hours of vaccination, all 6 patients had grade 3 erythema. The patients had put band aid over the injection site post vaccination. The outcome of grade 3 erythema was not reported. No treatment was given till the time of this report. List of documents held by the sender: None.
Fever 103, body aches, blotchy redness, and severe swelling to right upper arm especially near & surrounding PPSV injection site.  7/2/09 Hospital records received DOS 6/18/09 to 6/20/09. Assessment: Post-Operative Fever. Patient presented with fever nausea, vomiting, abdominal pain, passing gas. Right arm swelling at the site of vaccine injection.  ICD-9 Codes: 780.63, 789.07, V45.79
J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/13/2023 ESOPHAGEAL DYSKINESIA
Pt in office to have labs drawn following yesterdays office visit.  Pt stated while in the lab that she had an injection yesterday and that her left arm was now red, swollen, warm and sore.  NP was called into look at the patients arm.  Per NP patient was given Benadryl LOT: 162435 EXP: 06/2019 NDC: 0904-5306-61.  Red raised warm area was circled and measured.  Measurements are 7 3/4 inches vertically and 4 1/4 inches horizontally.  Immunization information Pneumococcal Vaccine Pneumovax 23 lot: R011632 EXP: 02/20/2020 NDC: 0006-4837-01 administered in Left Deltoid.  Reaction reported at www.vaers.hhs.gov.  Patient instructed to take benadryl every 6 hours as needed and use warm/cold compresses.
On 11/19/2003 mother reported that child ran fever 104-105 on 10/18/2003 and 10/19/2003 with lethargy, fever completely gone by Tuesday 10/21/2003.  Child seen both days in ER.  Mom gave Tylenol for fever.
seizure about 2 hours after event, per mother also with increase in salivation and groaning.  Benadryl has helped, is being monitored
Narrative: Pt. received 2nd dose of Pfizer COVID-19 vaccine on March 8, 2021 and soon afterwards developed diarrhea. Was admitted to hospital 3/11/21 with generalized weakness and dehydration, likely due to diarrhea. Quickly resolved with IV fluid administration.
pt states arm started itching soon p/vax;about 10AM on 8APR98 that evening noticed upper arm swollen & light rash on arm especially by site;next day sx subsiding recv no tx;
Rapid heart rate,  dizziness , chills , headache at front and back, body aches,
04/18/22 presents to EC ED for "Chest Pain". PMHx of "HTN, CKD, breast cancer s/p mastectomy and chemo"
Information has been received from a female (age not reported) with a history of Bell's palsy, herpes virus infection and allergy to sting and bites which have repeatedly resulted in major inflammations, welts, heavy itching and even infection, who on 09-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  "On approximately 10-AUG-2007 the patient reported that her arm was painful and inflamed.  On approximately, Saturday 11-AUG-2007, the inflammation covered an area about 6" x 4".  It was deep red surrounded by deep pink with a white edge, painful and swollen.  The patient reported she iced it over the weekend, and planned to call her doctor by the following Monday morning if the inflammation had not diminished.  On approximately, Monday 13-AUG-2007, it seemed a bit easier, but by afternoon the pain had increased - a mildly itchy, peculiarly stinging pain she evaluated at about 6 out of ten - so a nurse practitioner looked at it, deciding it was a localized reaction to the shot and prescribing Motrin and more icing, which helped.  The patient reported that by approximately 17-AUG-2007, the affected area was flat, with just a stain of darker skin where the deep red had been.  It was still somewhat painful, as is the muscle, which hurts when she has to reach high for something.  No further information is available.
The next morning after the shot the patient experienced extreme heat in head and neck as well as flu like symptoms with chills. Nerve endings on fire in the stomach and under the breast area. Very painful to the touch.
pt recv vax; w/ 5-10 mins became somnolent & extremely pale;physical exam performed;nl lung exam,nl sinus rhythm,but marked pallor; 15 mins later color returned;sent home; PAR PC stated pt had another pallor episode, otherwise nl;
Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533), via an unspecified route of administration in left arm, on 19Apr2021 at 03:30 PM (15:30), as second dose, single, for COVID-19 immunization. The patient's medical history herpes (for 31 years), possible exposure to HPV from 20 years ago (2001), and allergies to sulfa. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (Lot Number: EP7534) on 29Mar2021 at 03:15 PM at the age of 58 years for COVID-19 immunization (left arm). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 01May2021 at 12:30 PM, the patient came down with Bell's palsy. The event resulted in doctor or other healthcare professional office or clinic visit. Treatment received for the adverse event included acyclovir and prednisone prescription. The patient considered the event as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.
Started with pain in hips and headache. The pain in the hips developed into pain up and down spine and into base of skull. The headache has not gone away in two weeks. Heart palpitations and speeding heart beat started around 10 September. The pain progressed to its worse on  17 September. All of the above plus heavy lower abdominal pain. Went to Urgent care on 16 September for ekg and urine analysis. The ekg was done three times because first showed abnormalities and they kept moving proves until they got a normal reading. Urine analysis showed blood in urine and inflammation markers. Was put on antibiotics for a uti but was called back to stop antibiotics as the uti culture came back negative. No explanation for blood in urine. 20 September started excruciating pain in right foot, both shins and arms. I would wake up from the pain at night.  Over the counter pain medication did not help alleviate pain. Noticed bruises on both arms, legs and right armpit/shoulder blade as well. 23 September - shooting pain from base of skull down both arms. This has been continues until this report on 27 September. 25 September my left thigh went numb for 30 mins. Saw pcp twice more urine analysis and blood work was ordered . Waiting for the results.
Patients hand began tingling before flu shot but after flu shot both hands became involved. Now arms are also involved. Guillain-Barre suspected.
He has had issues with being off balance before so he does not know if it is anything to do with the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 10:00 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sore back" (unspecified if ongoing); "Stem cell transplant" (unspecified if ongoing), notes: 3 years ago. Concomitant medication(s) included: ALEVE taken for back pain; XANAX, start date: 2011.  The following information was reported: BALANCE DISORDER (non-serious), outcome "unknown", described as "He has had issues with being off balance before so he does not know if it is anything to do with the vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that he and his family received the first Pfizer vaccine at 10 AM. He wanted to ask a question, the doctor had him on, he was treating him for a sore back and he had taken, no one said anything about it but he does his own research (as reported). He had taken a 12 hour Aleve on Sunday night at 9:20 and also took a 12 hour Aleve in the morning on Sunday as well but the amount of time between the last dose of Aleve and the vaccination was 36 hours. He talked to 2 pharmacists that said that should not be a problem and a cousin of his who was a ER doctor to check with them and he did not think it would be a problem but he wanted to make sure with Pfizer. He wanted to know was there enough time between those or could there be any problem with the time between the medication and the vaccine. The patient was being monitored because he had a stem cell transplant 3 years ago and someone was supposed to come out Friday and do blood work and then came out the following Friday and checked him for the condition he had. It was him asking them to come out and check on him and do blood work on him because he can't leave the house. He was there with his wife and son. His son had down syndrome and he had the shot and his wife had her shot and she had Alz, he said those were just the first letters of the word, he did not want to say the whole word out loud but it was regarding her memory. He already had taken medicine from Pfizer. He was taking 1.5 mg of Xanax XR (Pfizer brand) and he reported that he can't take generic because it caused him issues. He clarified that was the 1 mg. He did not have any bottles of generic Xanax XR to provide any generic name NDC lot expiration. He said that was a long time ago. He had not taken the generic for years he had been on the brand product since 2011.  No follow-up attempts are possible. No further information is expected.
sore arms; sweat; body aches; eyes are hurting and blurring; eyes are hurting and blurring; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arms), HYPERHIDROSIS (sweat), PAIN (body aches), EYE PAIN (eyes are hurting and blurring) and VISION BLURRED (eyes are hurting and blurring) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020 and Pneumonia in October 2020. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and ZINC for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arms), HYPERHIDROSIS (sweat), PAIN (body aches), EYE PAIN (eyes are hurting and blurring), VISION BLURRED (eyes are hurting and blurring), PYREXIA (fever) and HEADACHE (headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arms), HYPERHIDROSIS (sweat), PAIN (body aches), EYE PAIN (eyes are hurting and blurring), VISION BLURRED (eyes are hurting and blurring), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Added treatment medication from initial source. FU amended.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache and fever are consistent with the known safety profile of mRNA-1273.
Vaccine administered 10/28 - pt reports rash all over body starting 10/29. Started CLARITIN per MD recommendation. Rash almost gone when I checked in with her 11/1.
Pt was in his usual state of health when he received his four year DTaP, IPV, MMR vaccine. He walked to the parking and then  within five min c/o difficulty breathing. He was given Albut+Benadryl+steroids for aching, rash, hypoxia. He improved.
This spontaneous report was received from a registered nurse referring to an 11 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 07-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008666:
1 day p/vax pt devel an inj site rxn characterized by a 6cm by 8cm area of redness & swelling;
This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L036437, expiration date: 18-MAY-2017, 0.5 ml, route of administration was not reported). It was reported that a pharmacist administered PNEUMOVAX 23 to a patient with a cracked syringe. No adverse effect was reported. A product quality complaint was filed for this defect. Additional information is not expected, as there was no consent to contact the physician.
Ha, myalgia, fatigue, congestion, neck pain, decreased hearing on R side, numbness to r side of tongue.
44 year-old male with a past medical history most significant for OSA, chronic back pain, PTSD and traumatic brain injury. The patient received the Moderna vaccine on 1/4/22. He presented to the hospital on 3/11/22 and reported that he started having an intractable headache 4 to 5 days back. He explained his headache as burning, nonradiating 10/10 in intensity associated with neck pain. He also complained of photosensitivity but denied neck rigidity. Complaint chills, rigor and loss of appetite. The burning sensation kept him awake due to the pain, but after a few days it began to lessen in pain.
Pt recvd 2 doses of Engerix-B & devel swelling on rt side of the face w/lymphadenopathy 48 hrs p/1st dose; w/in 1 hrs following 2nd dose devel same sx; looked like a classic case of the mumps; also ear pain;