chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up with dizzy; Wake up with fever; Numbness across body especially legs and toes.; This is a spontaneous report from a contactable consumer. A 12-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the arm left on 16Jun2021 at 10:15 as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medications. The patient had no known allergies. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 25May2021 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Jun2021 at 06:00, the patient reported that she woke up dizzy, with fever and numbness across body, especially legs and toes. 6 hours after waking dizziness was less intense but toes and calves are still somewhat numb but feeling was improved. Therapeutic measures were not taken as a result of these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event woke up with dizziness, numbness and fever was recovering at the time of this report.   The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
fell down steps bruised self 9AUG96 & 12AUG96 & seen @ ER 14AUG96 w/swelling & deep purple areas, platelet count 4,000 dx w/ITP;
took the shot and got it/Suspected vaccination Failure; Got it anyways; itches off and on; Hurt at times; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and pain. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 19-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient took the Shingles shot and got shingles anyways and it was itches off and on and it hurt at times. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
11OCT93 fever 101, cold sx, ROM rx Amex; 12OCT93 cold limp not breathing x 15-30 sec; EEG, CBC, Blood cult, pneumonia, EKG & Exhocardiogram all nl;
Vaccinated with H1N1 1/6/10. Has felt fatigued, had elevated temps TM. 102 oral, malaise, nausea, decreased appetite, body aches and chills since then.
Breakthrough case of COVID-19 sore throat, congestion, running nose, fever, I coughed up a lot of phlegm, achy and fatigue. Still have sinus congestion and I am using nasal spray to help with that.
Systemic: Vasovagal reaction-Mild, Additional Details: ~5 minutes following vaccination pt told his father he started seeing "black spots" and fell. Denied headstrike. Returned to clinic where I gave the pt water, monitored BP and pt status for ~15 minutes. Pt left in stable condition, no longer experiencing any symptoms.
Approximately three hours after administration of the first dose in the COVID-19 vaccination series, I experienced difficulty breathing during exertion.  This was relieved at rest.  Walking 20 feet, for instance, returned the symptom of difficulty breathing.  This subsided by the next morning and did not affect my ability to sleep.
Patient reacted with a mild case of shingles on the forehead and side of head 7-10 days after receiving Shingrix. Patient was seen by dermatologist who then referred patient to the ophthalmologist as the Shingles had moved close to the eye. The ophthalmologist treated patient with Valtrex (1 tab every day), which patient is still taking. Patient has 98% recovered.
Heart palpitations, tachycardia. Holter monitor resulted PVC's and PAC's and tachycardia. Started on beta blocker.
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 52 years old male patient who was vaccinated with an expired dose of IMOVAX RABIES lot N1B05 and Exp. Date 26-FEB-2017 via unknown route in the right arm 05-Nov-2018. It was first dose at day 0. The patient's medical history not reported and concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunization. It was reported that, on 12 Nov 2018 and 03 Dec 2018 patient received second and third dose of rabies vaccine manufactured by GSK on day7 and day 28 respectively. It was an actual medication error case due to expired vaccine used.  It was reported that first dose of IMOVAX was expired when patient received it. Patient reported that he received 3 dose pre exposure series of IMOVAX for anticipated travel on 07 Jan 2019. His documents from the HCP office show the Day 0 dose had expired on 26 Feb 2017. No symptoms reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
BRIEF OVERVIEW: Admission Date: 9/4/2023 Discharge Date: Sep 6, 2023 Discharge Disposition:  home health care svc   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Weakness [R53.1] Fall, initial encounter [W19.XXXA] COVID-19 virus infection [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 90-year-old female with a past medical history of dementia, tobacco abuse and no neck mass and left lung cavitary lesion with no plans for further workup due to advanced age and comorbidities.  She presented with a chief complaint of increased falls at her assisted living facility.  She had been fatigued and weak.  She was brought to the emergency department.  She was hemodynamically stable.  Labs were unremarkable.  Her COVID-19 was positive on PCR.  She was on room air without respiratory symptoms initially.  She did develop a mild cough.  CT head and CT cervical spine was negative for acute process.  Chest x-ray showed no acute process, but showed known left posterior perihilar mass.  She was placed in observation status for PT/OT evaluation.  PT/OT recommended skilled nursing, but it was opted to take the patient back to her assisted living facility with additional physical therapy and occupational therapy services.  She did not require Decadron or remdesivir as she was not hypoxic.  She was discharged back to her facility on 09/06/2023.
I had elevated heart rate all day. I had shooting pains all over my body all day. I was dizzy. I had fever, sweats, chills.   I?ve had every vaccine known to man, this wasn?t a vaccine, this was poison. I have had Covid unconfirmed 2x prior. I know my body. This stuff is garbage.
Tested positive to Covid 19; Tested positive to Covid 19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two different patients (himself and his wife). This is the second of two reports.  This female patient (age not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration, in Apr2021 (16 or 17) for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The second dose was planned for 07May2021. Patient's husband asked if she could receive the second dose as she tested positive to COVID-19. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021493660 same reporter/product, different patient / event.
Patient had pain in joints or lower extremities. Skin of both legs was reddened and painful to touch. When he came to pharmacy on 11/3, the pharmacist contacted PCP & had pt go in for evaluation. Per pt's chart, pt is suspected of having allergic arthritis possibly unrelated to vaccination.
soreness at the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had soreness at the injection site. The reporter asked could a heating pad be used for soreness at the injection site of a Shingrix vaccine.
12 day p/MMR pt had undocumented fever, then the next day day devel mild rash which porgressed to generalized, maculopapular rash; poss allergic rash, ?erythema multiforme or urticarial rash;
I got 4 shingles on my stomach each about 1 1/2 inches.  Hurt for two weeks eventually started to heal.  Felt like sandpaper on my stomach when healing and completely healed within a month.
2 days post vax, pt developed localized swelling and redness with warmth to left leg. The following day swelling and redness increased to 11cm with surrounding vesicles. Parent also noted behavioral changes post vax, i.e. biting and  hitting family members.
The client fell outside the facility, client states he missed the stairs and was not dizzy, claims he just wasn't looking. The doctor on site was called to assess him and advised the patient to go to the hospital for a complete body check-up. The Patient refused and insisted on going home. The charge nurse called him on his cell phone two hours later to follow up and check on him. The patient stated he was completely fine.
Initial report received from consumer's sister on 05 November 2013 and on 07 November 2013. A 50-year-old female patient whose medical history and concomitant medications were not reported, received ADACEL (lot number U4689AA, expiration date unknown) intramuscularly and administration site was deltoid on an unknown date. Also patient received influenza (flu vaccine) (lot #, expiration date, route and administration site were unknown). On an unknown date, the patient's injection site was red, swollen, itchy and hard. Reporter stated that the patients symptoms were resolving without any medical intervention. Laboratory investigation and corrective treatment were not reported.  Documents held by sender: none
Loss of smell and of some taste. Tested positive for Covid-19 3 days later, but pharmacist said I should make the report in case it?s somehow related to the vaccine.
This spontaneous report was received from a health care professional referring to a 61 year old patient of unknown gender. Information about the patent's medical history, concurrent conditions and concomitant medication was not reported. On 08-NOV-2016, the patient was vaccinated with an expire dose of ZOSTAVAX 19400 "PFU" lot # L027322 with an expiration date 21-OCT-2016 (concentration, dose and route of administration were not provided. No adverse effects were reported. Additional information has been requested.
Syncopal episode at home lasting a couple minutes - taken to ER. Received IVF. No medications received.  Fully recovered within minutes of the episode.
Vaccine 1/28/04 pt reports redness (L?) thigh 1/28. 1/29 visit friend 1/30 vomited seemed limp "out of it" trying to. Event approx. 30 min seen in local ED ok by.
This spontaneous case, initially received on 01-Jun-2017, was reported by other health professional (registered nurse) and concerns students in an academic campus, who received flu vaccine. This case deals with nineteenth of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns 15-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 24-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX Commercial season. Therefore no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (QAIR number: 1022277) received from quality assurance department on 29-Jul-2017: QA investigation results were updated. Narrative amended accordingly. Non-significant case correction received on 10-Aug-2017: Corrections were made in the narrative and case comment.
I received the first vaccine and had an arthritic flare up in  my left wrist.  My doctor gave me prednisone (60 mg) for a month and then it took six weeks to wean off the prednisone.    I received the second vaccine and a week later,, my hair started to fall out in clumps from 6/25/21 to present.
Profound local reaction with swelling, pain, a toxic feeling of weakness, fatigue, malaise and low grade temp. 3x3" circular area (5 days later) on arm of induration, discomfort to touch with slight ? in heat. Positive rubor. No infection-local reaction. Zyrtec 10mg qhr.
No adverse effects COVID 19 vaccine given >12 hours from drawing. Vaccine was drawn, stored in refrigerator overnight. given to patient the following afternoon. Manufacturer notified. Awaiting guidance re. patient.
Approx 40 min after YF injection client driving home began having symptoms of sore throat, itchiness & need to clear his throat. Within 15 min after that he began to experienced chest tightness & throat tightness & difficulty breathing. Taken by mom to urgent care & given IV prednisone, BENADRYL, epinephrine. Discharged about 3-3 1/2 hrs later with ZYRTEC & BENADRYL.
Very large welt appeared at injection site 8 days later. It was itchy and sore. Accompanied by extreme fatigue which went away in a week with extra sleep. Welt went away in 3-4 days
COVID positive on 1/29 w/isolation through 2/6. Presented to mass vaccination event on 2/4 and denied being positive on entry and on screening. Upon documentation entry noticed pt was positive. Chart review also revealed recent dx of pneumonia. Enhanced ADR surveillance initiated w/Tele Health visit on 2/5. Pt reported slight cough, body aches, SOB, trouble sleeping, decreased appetite, and pain at injection site.
client being to complain of feeling clammy, and hot, stated that she was nauseated
had t103 ax 3AM 29AUG95 then devel diarrhea & coughing during the day; went to clinic but nothing found; to hosp 29AUG95 6PM because T101.6R & pt was gagging;mom told fever probably D/T DTP; 1SEP95 had runny nose & cough
Information has been received from a physician concerning a 26 year old female at a high risk to allergies, with penicillin allergy and a history of hospitalization with a reaction to sulfur from ingestion of it. On 23-MAR-2009 the patient was vaccinated with one dose of GARDASIL. On 24-MAR-2009, the next day, the patient called the office stating she had a hard time breathing, her tongue and throat started to swell. The patient went to the doctor's office and the doctor diagnosed the patient with an allergic reaction. The doctor gave the patient 10 mg montelukast sodium and 4 mg cyproheptadine hydrochloride. The patient then went to the hospital and they gave her a BENADRYL shot. At the time of this report, the outcome was unknown. Upon internal review, the patient's allergic reaction treated with BENADRYL shot was considered to be an other important medical event. Additional information has been requested.
pt had been sleeping-cried out-mom went to child;pt was standing in crib (stiffly) arms extended/palms up;mom states pt's eyes rolled back & pt began twitching & shaking;did not lose consciousness;mom called MD-no immed f/u;
Patient received Flu vaccine on Thu 10/23/15. Fri 10/24/15 arm was red, inflamed and swollen. Mother gave applied cold compress. Sat 10/25/15 arm was more red and swollen. Mom gave pt 2 doses of BENADRYL during the day. Sun AM 10/26/15 pt woke up and arm was red and now had blisters and increased pain. Mother then took pt to urgent care center and they were concerned for cellulitis so they told mom to go to ER. Pt see in ER and given steroids IV and PEPCID. D/C'd home on oral steroids, BENADRYL and PEPCID. In office pt w/swelling and blisters decreasing.
Injection site was size of a half dollar, beet red, felt hot, felt tough or hard.  Immediate area surrounding injection site was noticeably pink, about 2.5 inches in diamter.  Annoying headache.
Pt states her right arm is red and swollen in area where YELLOW FEVER vaccine was given, area is slightly painful and itchy. She also experienced headache and queasy feeling in stomach, no vomiting. Today swelling has decreased redness still spreading a bit. Headache less and queasy feeling decreased.
Headaches (2/11/21 to present day) , dizziness (2/11/21 to present day), nausea (2/11/21 to present day) , foggy brain (2/11/21 to 3/8/21), fatigue (2/11/21 to present day). Treated with Zyrtec and nsaids. Very little relief with both treatments. And PCP stopped all medications two weeks apart, but still currently having symptoms.
06/07/02 fever noted, Tylenol given. Very fussy on 06/07/02 afternoon. 06/08 red "speckles" noted on face, arms, torso. 06/09 in am numerous speckles over entire body and by pm large hives appeared over entire body, became large welts (cont'd p.2) 06/11 still has symptoms.
Patient started having chest pain with associated shortness of breath, the day after receivine smallpox vaccination.  Symptoms are not dependant on level of activity. 7/14/08-records received-C/O shortness of breath on 4/28/08 started day after smallpox vaccine. Precordium chest pain with palpitations rarely with dyspnea and worse with bending over.Atypical chest pain. 6/20/08-improved with Prilosec. However, during a run felt palpitations and winded.
Right arm- swollen and spreading outward, hot to touch, and painful- itching also.
This is a spontaneous report from a contactable nurse. This nurse, a Pfizer internal colleague, reported events on three patients. This is the second of three reports. A 52-year-old female patient received a dose of PREVNAR 13 intramuscularly in the left deltoid of pneumococcal infection on 09Mar2012. No other vaccines administered on same day. Relevant medical history and concomitant medications were unknown. On 10Mar2012, the patient experienced red raised rash a six inch in diameter at the site of injection. Relevant lab data was unknown. No treatment required. The outcome of the event is ongoing as on 06Apr2012. Follow-up (06Apr2012): New information received from the same contactable nurse includes: reaction data. Follow-up (27APR2012) Follow-up attempts completed. No further information expected.
Arm pain and swelling, extreme fatigue, headache, swollen lymph nodes in clavicle area, muscular aches
Information has been received from a 95-year-old female consumer with arthritis, post herpetic neuralgia following shingles (began on 08-SEP-1992) and an allergic reaction to an antibiotic that "made her sick to her stomach", who on 25-JAN-2007 was vaccinated with a single dose of Zostavax (Oka/Merck).  She reported that the vaccine was given, "to possibly reduced the pain from post herpetic neuralgia (PHN)".  There was no concomitant medication.  On 25-JAN-2007, "one day after receiving Zostavax (Oka/Merck) the patient complained that her urethra and vagina were on fire".  It was reported that this reaction lasted for two weeks and she recovered.  The patient also reported that she still has PHN after receiving Zostavax (Oka/Merck).  No medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
1st dose in 2019, not received the 2nd; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 0.5 ml on 19th August 2019 in an unknown arm intramuscularly).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in 2019, not received the 2nd).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 07-MAR-2023  The patient reported he did not believe he received the second Shingrix vaccine.  The patient did not want to share his date of birth (DOB). Till the time of reporting, the patient did not receive 2nd dose of Bexsero, which led to incomplete course of vaccination. The reporter did not consent to follow-up and did not give permission to contact HCP.