chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a 11 year old female with asthma, reflux disease and anxiety disorder and no drug allergy or reaction who on 17-DEC-2010 was vaccinated with the first dose of GARDASIL (lot # not reported). Concomitant therapy included MENVEO (also reported as MENZEO) and Tdap (manufacturer unknown) and other unspecified medications. Two days later, on 19-DEC-2010 the patient experienced numbness and pain in both legs. The patient was examined in the emergency room on 19-DEC-2010, but not admitted. On 20-DEC-2010, the patient saw the nurse practitioner at the office. The patient was followed up by neurology for about a month. The patient was not given treatment. Blood tests and an MRI were performed with unspecified results. On an unspecified date, the patient recovered. Additional information has been requested.
Case completed  primary Covid vaccine series in Feb 2021, then was hospitalized for Covid in October 2021  * Pneumonia due to COVID-19 virus Assessment & Plan Onset of symptoms 10/11. Tested positive 10/15. Admitted 10/19/ Vaccinated. Was about to get booster but got sick first. Initially on 15L. Worsened, has been on high flow, started on baricitinib. No home O2 requirement prior to this admission. - Date of onset 10/11 - should be OK to come off isolation on Nov 1 - Continues on dexamethasone - 10-day course complete the 28th but will continue as she remains on HFNC - Continues on baricitinib to complete 14-day course - Still needing high-flow oxygen but needs trending down dramatically as of 10/31 - Discussed proning, position changes   Acute kidney injury  Assessment & Plan Creatinine up to 1.4 on admit from 0.8 at baseline. Losartan and chlorthalidone were held. Renal function recovered. Unclear if due to Covid, hypovolemia, or both. Placed back on home antihypertensives. Subsequently received several doses of furosemide, creatinine increased back to 1.6. Stopped home antihypertensives again, gave 500 cc fluid, stopped lasix. Improved.   Acute respiratory failure with hypoxia  Assessment & Plan Due to Covid-19. See related problem for treatment. - Continue HFNC - Tried some lasix to see if this helps, caused AKI. -Down to 4 L NC at rest on 11/2, possibly home 11/3 if maintains wellness.
At 1238 pt stood up c/o dizziness.  Pt. refused to sit down for 3-5 min.  After pt sat down, CFD took @1243 BP 99/65, HR 95.  Pt drinking Gatorade, states he was diabetic and hadn't eaten today.  At 1247 BP 97/60, HR 94.  At  1249 HR 94, BP 103/68, BS 147  Pt states he was feeling better and wanted to go home.  Pt left @ 1252.  BS 147, BP 103/68
Rash near injection site. 5 Palms in size. Red. Itchy. Welts
Headache Soreness at injection site, Fatigue, Myalgias Narrative:
This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 77-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date unknown) for prophylaxis. On 22nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 2 days after receiving SHINGRIX, the patient experienced swelling arm, fatigue, erythema of extremities and mental distress. On 22nd May 2018, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the swelling arm and fatigue were recovered/resolved and the outcome of the erythema of extremities was recovering/resolving and the outcome of the mental distress and incomplete course of vaccination were unknown. The reporter considered the swelling arm, fatigue, erythema of extremities and mental distress to be related to SHINGRIX. Additional details was received as follows: The patient received SHINGRIX in left deltoid. The health care professional (HCP) was not able to provide the expiration date of the SHINGRIX. The HCP also said this experience was very mentally and emotionally stressful for the patient. The HCP stated that the patient's physician told patient to not to receive 2nd dose of the series, which was sounded like the patient would not finish the series, which led to incomplete course of vaccination. The patient visited physician for these adverse events.
Started having shortness of breath a couple hours after vaccine, then some fatigue and headache. Woke up next morning with sore arm, worsening headache and fatigue. Those side effects dissipated as the day went on, next day arm still a little sore, but by afternoon, felt back to normal.
Unknown what if any adverse event may have occurred.   This report is being submitted following a periodic review of death certificates .    Death certificate for this individual indicates "COPD - Decline Acutely After COVID Vaccine 1st Dose" in   "PART II. OTHER SIGNIFICANT CONDITIONS contributing to death but not resulting in the underlying cause"
This spontaneous report as received from a consumer regarding her daughter refers to a female patient of unknown age. No information about medical history, concurrent conditions were reported for the patient. On an unknown date in September 2013 the patient was vaccinated with first dose of GARDASIL (dose strength, route unspecified). The patient then received her second dose of the GARDASIL on an unknown date in September 2014 and third dose on 27-JAN-2015 (Inappropriate schedule of drug administration). The outcome of event reported is unkown. No product quality complaint was involved. Additional information has been requested.
.5 cm x 6 cm erythematous and swollen lesion on left upper arm. Slightly tender and warm to touch. Two injection marks seen within circular lesion. May have ibuprofen PRN pain/swelling. Ice to lesion PRN. Oral BENADRYL PRN itching.
Pt reported that he felt dizzy as he stood up from observation chair. Vitals: 11:20 122/84,63, spo2 98% -- > 114/76,63, 99% Pt given water.  Pt stable and released from the vaccination site @11:29
Hives on legs, arms and trunks. No respiratory distress, no difficulty swallowing. Benadryl 20 mg QID PRN hives. Pt's symptoms resolved. Pt is a recent immigrant and had delayed immunizations, requiring vaccines to register for school.
pt recvd 2 doses of Engerix-B; 1 wk p/2nd dose c/o stiffness in the joints of arms & legs; pt is unable to work but seems to be improving; adverse exp required an ER or MD visit;
I woke up on 4th with pins and needles in my hands and I called the doctor's office. They said that I was crazy and nothing was going on with me and call back in a week even though the receptionist at the office had just said they were getting all kinds of calls about it.. For the next week, my hands and my feet were tingling intermittently. I went to the doctor on Friday, June 11th. They did a full metabolic panel - all came back fine. The next morning, June 12th, I felt my face was numb. I called doctor and she said it was anxiety. So my hands were pins and needles. The face numbness was new. I see a naturopath and I told her and she said it was call for concern and she looked at labs and told me to call doctor back and she mentioned that she had seen all kinds of people with these symptoms. My anxiety is super high. I'm not usually an anxious person. I have high blood pressure. I have joint pain in my hands - if I take Naproxen. If I take Aleve the joint pain goes away. I feel like my face is dragging but when I call in the mirror it looks fine. That's the feeling of numbness says my naturopath - and that's the same with my lips. I feel like I have some brain fog and I've been stumbling over words. That happens about once a day. I have a doctor's appt on Friday for blood pressure. I did not have blood pressure before this. Usually my blood pressure is 126/90 (when normal) and it's tracking at 143/103 and 140/100 ever since I had the vaccine.
Day of vaccine: Typical light chills and fatigue Within 12 hours of vaccine:  Psoriasis flare impacting whole scalp (not typical for previous year), and spreading to right ear and left side of neck. Ear and neck responded to over the counter topicals. Scalp has still not returned to pre-vaccine condition. Sudden onset of nocturnal waking/insomnia, with symptoms persisting for three weeks post-vaccine. No prior nocturnal waking or insomnia during prior 12 months (no continued insomnia during lifetime prior to vaccine.) Vivid and unusual dreams followed by nocturnal waking between 2-3:30 am. Calm state of mind (no racing thoughts or feeling of anxiety)  but unable to fall back to sleep until 5 am on 2/3rds of the night (and on 6 documented nights, no return to sleep at all.)  Resulting day time fatigue significantly impacted work and ability to drive. Sought out medical help at an outpatient clinic. Unable to find cause outside of vaccine. After three weeks, nocturnal waking decreased. Twenty-five days post-vaccine, sleep pattern returned to normal.
Severe Sore throat, terrible body aches, chills, low grade fever 99,9, unable to eat, tired, headache, head and neck feels swollen all started to progressively get worse about 48 hours after administration. Worst sore throat ever experienced. ?On fire? and benzocaine spray made it worse
ABOUT 1/2 HOUR AFTER THE VACCINATION THE PATIENT REPORTED THAT HE WAS FEELING LIKE AN ALERGIC REACTION WAS STARTING AND LIKE HE MAY BE EXPERIENCEING A LITTLE SWELLING AND DIDN'T WANT IT TO PROGRESS TO DIFFICULTY  BREATHING.  50 MG OF BENADRYL WAS TAKEN AT 4:30 PM AND THE PATIENT WAS MONITORED BY A PHARMACIST FOR 30 MINUTES AT WHICH TIME HE FELT LIKE IT WAS SUBSIDING.  AT 5PM HE WAS MOVED FROM THE IMMUNIZATION ROOM TO THE GENERAL POST COVID VACCINATION AREA AND MONITORED.   THE PATIENT HAD BROUGHT AN EPI-PEN WITH HIM TO THE APPOINTMENT BUT IT HAD EXPIRED IN 2014.  WE CALLED HIS PRIMARY CARE WHO PRESCRIBED A NEW EPIPEN RX FOR THE PATIENT WITH INSTRUCTIONS THAT IF ANY FURTHER SYMPTOMS STARTED THE PATIENT SHOULD GET EMERGENCY SERVICES.  AT 6PM THE PATIENT SAID HE FELT WELL ENOUGH TO LEAVE.
Medication error. Mother made aware of error MMRV and Varicella administered simultaneously.
injection site reaction Narrative:  Patient states itchiness and soreness in arm. Symptom ongoing but better since yesterday.
This spontaneous report as received from a Licensed Practical Nurse refers to unspecified patients of unknown age and gender. The nurse reported that on an unknown date these unspecified patients received improperly stored PROQUAD (Merck) (lot#, dose, route, indication not reported) exposed to -9C for an undetermined timeframe. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Case number PHEH2016US023396 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 31 year old patient whose gender was not specified. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 30 Jan 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
painful and debilitating rashes and shingles across her body, was diagnosed with herpes zoster; loss of hearing; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On 15-MAR-2019, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) at medical center, for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Approximately 10 days after receiving the vaccine, patient suffered painful and debilitating rashes and shingles across her body, was diagnosed with herpes zoster, and subsequently developed loss of hearing. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in the physical injuries identified above and limitations not present prior to using the vaccine. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of loss of hearing and herpes zoster was unknown. The lawyer considered loss of hearing and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Upon internal review, loss of hearing was considered to be medically significant.
Pt received the flu vaccine the day prior to reporting to the ER.  Pt's caregiver c/o redness, swelling and pain to LUE at the site of injection
Chills, aches, headache, fatigue, cough, sore arm, nausea, dizziness started at 5pm and progressed throughout the night. Continued throughout all of Thursday, the day after the vaccine. Today on Friday I?m feeling much better yet still light headed, fatigued and have a cough
Pt recovering from cold on day of vaccination. 5 days later kept feeling worse. Went to ER. Examined and given prescription for 2-pak. pt appears to be fully recovered. Puffiness of lymph node above left collar.
Some of her friends said it was painful and hurt the arm; Some of her friends said it was painful and hurt the arm; some of her friends said it was painful and hurt the arm; This spontaneous report was received from a consumer referring to an unspecified number of patients of unknown age and gender. The patients' pertinent concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patients were vaccinated with zoster vaccine live (manufacturer unknown) as prophylaxis (concentration, dosage, vaccination scheme frequency, route of administration, anatomical location, lot number and expiration date were not reported).   On an unknown date, some of the reporter's friends stated that when they received the zoster vaccine live (manufacturer unknown) it was painful and hurt the arm (pain, vaccination complication, pain in extremity).   At the time of this report, the outcome of the events was not reported.  As the reporter stated that the vaccination it was painful, the events pain and vaccination complication were considered related to zoster vaccine live (manufacturer unknown), and the causality assessment between the event pain in extremity and the suspect vaccine was not reported.   This is a non-valid case due to lack of patients' identifiers.; Sender's Comments:  US-009507513-2103USA003063:
Patient received PREVNAR, PEDIARIX and PPD. About 10 minutes after receiving vaccines, patient complained of abdominal and throat pain. Patient was pale and sweaty too. No presence of hives. Lung sounds clear. Doctor examined patient. Patient was given BENADRYL upon request. 10 mL/25mg given by doctor.
Apparant SIDS/Post Mortem Exam Pending. 9/14/09 Autopsy Report Received DOD 3/27/09 - Sudden unexpected death of infancy while co-sleeping. Manner of death undetermined.
Nearly blacked out/passed out after I woke up on 2/14 Sluggish with chills and aches the rest of the day Noticed enlarged lymph node in the left arm pit region on 2/15
I had flu like symptoms for the first three days.  On the fourth day, I woke up feeling like my chest was paralyzed and an elephant was sitting on my chest. It was very difficult to breathe.   Three months after the injection, my chest still feels paralyzed with a weight sitting on it.  I reported it to my doctor at the end of March during my annual physical.
This spontaneous report as received from a nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with PROQUAD which had been stored improperly. No adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Since flu vaccination right arm tender. Few hours later gnawing ache right deltoid "Like someone punched arm" no fever. By Thursday 02/14/08 late PM increase pain, woke up Friday AM increase pain/unable to stretch right arm. Took Tylenol. Referral given for evaluation at pvt. MD.
breast cancer; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (breast cancer) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced BREAST CANCER (breast cancer) (seriousness criterion medically significant). The patient was treated with Radiotherapy (Radiation therapy) for Breast cancer. At the time of the report, BREAST CANCER (breast cancer) had not resolved.            Patient reported that was diagnosed with breast cancer recently, after received 2 doses of the Moderna COVID-19 vaccine.  Concomitant product use was not provided by reporter.  On 14-Mar-2022, patient wis going to start radiation for cancer. The cancer diagnosis was early, so patient was just doing radiation.   Patient was scheduled to get a booster dose this Thursday. Patient heard that the booster can inflame lymph nodes and cause problems with diagnosis and asking when radiation started patient can get booster dose or not.  Company comment: This is a spontaneous case concerning a 61 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, event of breast cancer, approximately 9 months after the second dose of mRNA-1273 vaccine. She reported she is starting radiation therapy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 61 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, event of breast cancer, approximately 9 months after the second dose of mRNA-1273 vaccine. She reported she is starting radiation therapy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Severe vertigo and increase in Blood pressure to 140/90 ( normally it is 100/60) and increase in pulse rate sporadically to 120 bpm ( normally 58 bpm). Severe vertigo lasted about 7 days, but vertigo has persisted for over 3 months and still persists, along with headaches at the back of the head. Also, shortness of breath began with first dose in March of 2021, and was made worse with the booster.
She got her vaccine and started having immediate pain in her back.  It got worse in the evening, and her temperature has been going up and down.  Her temperature has not been measured.  She is currently 6 weeks pregnant.  She does not know if she is having reactions to the pregnancy or from the vaccine.  This morning she was freezing cold with shivering.  She put a lot of blankets on her and got in the tub and put hot water in it.  Her teeth were chattering, and her head was hurting as well and could not get warm.  She drank some tea and then got too hot.  She did not want to take any medication due to being pregnant.  She is still having intermittent fever and having the chills/sweats.
Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced TENDERNESS (Tenderness). On 18-Jan-2021, TENDERNESS (Tenderness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was unknown whether other vaccines were given one month prior to Moderna COVID-19 vaccine. Patient had never been tested positive for or diagnosed with COVID. It was reported that recent change in status such as improvement or worsening of the current condition high blood pressure was unknown. It was unknown whether the patient had sought medical care for the adverse event. It was unknown whether the patient had experienced a similar event in the past.  It was reported that the patient was not under any concomitant or regular medication.  No treatment medications were reported.   This case was linked to MOD-2022-492313, MOD-2022-492314 (Patient Link).
Booster; top of my front tooth started, kind of slightly stinging; my face is just slightly feeling a little tight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 04Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VIRUS VACCINE) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 04Jan2022, outcome "unknown", described as "Booster"; TOOTHACHE (non-serious) with onset 04Jan2022, outcome "unknown", described as "top of my front tooth started, kind of slightly stinging"; REDUCED FACIAL EXPRESSION (non-serious) with onset 04Jan2022, outcome "unknown", described as "my face is just slightly feeling a little tight".  Additional information: Consumer reported that patient got the Pfizer COVID booster today and the minute patient got the shot the top of his front tooth started, kind of slightly stinging. It has 'concerned' patient ever since like face is just slightly feeling a little tight so  wanted to know if patient could take a Valium (Suspect captured for MI query only) because if patient ever had an allergic reaction in the past it always affects his face (Further clarification unknown).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Received Infanrix instead of Tdap vaccine; 29YO received infanrixby error; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 29-year-old male patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th January 2023, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 10th January 2023, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 2-Feb-2023 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received Infanrix vaccine instead of Tdap vaccine by error at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.