chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and vomiting. On an unknown date, the outcome of the fever and vomiting were unknown. It was unknown if the reporter considered the fever and vomiting to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's husband developed a fever and severe vomiting after the dose of SHINGRIX. The reporter stated that although this did not appear to be a true allergic response, his physician advised against receiving a booster. The reporter asked what were GlaxoSmithKline's recommendations.
Localized induration, fever, chills, myalgia, BP stable, No anaphylaxis.
From 2/4-2/25/11 c/o sore throat, ear/sinus pressure, PND, HA - treated for sinusitis/URI with Z-PAK and AFRIN nasal spray 2/25/11. That evening went to ER for lac to finger being given Tdap vaccination by ER. The next morning (2/26/2011) he awoke with "severe" muscle and joint pain which was worse in bilateral shoulders, hips, knees and feet. He was actively shivering, felt chilled and sweating with malaise and headaches. He took ADVIL with some relief of symptoms. He awoke Sunday morning (2/27/2011 ~3am) complaining of a "rope being pulled thru middle of his chest squeezing his heart" stating it "was like he had a charlie horse in his chest". Position, warm shower or ambulation did not affect or relieve this pain. His pain resolved spontaneously about 20 minutes later peaking at 5/10 pain scale (still had above myalgia/arthralgia and malaise). This chest pain returned Monday morning (3/1/2011) at 9/10 pain scale which prompted him to go to nearby ED. His EKG showed NSR with "ST elevation V1-2, probable early repol pattern", normal CXR and elevated cardiac enzymes.
Autism due to the heavy metals in the vaccinations-Noticed brain injury. Toe walking, arm flapping, nonverbal after vaccines
Information has been received from a physician concerning a female nurse who on 06/10/04 was vaccianted with a dose of varicella virus vaccine, live. On 06/22/04,  the pt developed a rash described as urticaria all over her body. In areas such as her elbows, she had groups of lesions that appeared to form one lesion. Unspecified medical Tx was sought. A product quality complaint was not involved. Additional information is not expected.
Patient stated that approximately one hour after receiving her Fluzone Quad immunization today she was experiencing a local reaction that consisted of raised bumps (potentially hives). There was minor urticaria associated with the reaction as well. Patient was instructed to take Benadryl and/or Advil to alleviate the reaction along with a cold pack to soothe the area. Patient was also instructed to inform their Primary Care Provider or seek emergency treatment if the condition spread or worsened. Patient expressed understanding and was satisfied at the time with this solution. No further information/action has been presented at this time.
01/26/2005 12:30OPM - patient felt warm, fever at 6:00PM T 100.3, gave Tylenol at 10:00PM temp noted 01/27/2005 T 100.8, legs tender sore all day, screamed in pain when touched.  Tylenol given during day.  Site of injection no redness - 11/28/2005 tem 102.1, no tenderness with either leg.  Seen at Clinic.
Patient experienced a flushed face, tongue swelled and difficulty breathing approximately 1 hour after vaccine administered. Patient diagnosed with anaphylactoid reaction.  Received diphenhydramine 50 mg IVP, famotidine 20 mg IV push, and methylprednisolone 125 mg IVP.  Symptoms improved and patient discharged to home from ED.
Tdap given 03/30/2015, on 04/03/2015 had outbreak of painful erythematous rash on left neck and shoulder consistent with shingles -> given acyclovir for tx as within first 24 hrs presentation.
pt recv vax 8JUL96 & 18JUL96 pt exp fever of 101-104 which lasted for 3 days, devel a fine, red, pimply rash on torso, face, & arm;very irritable & fussy;pt fully recovered;
several hrs p/vax had an episode of irritability, turned pale & was limp, had fever; was aroused by parents & had no sequelae, no treatment required;
his injection site it is warm reddish purple and the size of the palm of her hand. Mom reports he did run fevers over the weekend starting 08/01/20.  Today 08/03/20  the fevers have stopped and it is no longer warm to touch. Still vary large bruise looking mark.  Patient was seen in clinic for evaluation 08/03/20, recommendation is to continue to watch and five ibuprofen as needed.
A few days after the shot I felt bad. About a month afterwards, I got pneumonia and went to the ER. During a chest x-ray, they found that my heart was enlarged. They sent me home and two weeks later I went to work. I started having chest pains, but I thought that I pulled a muscle at work. I went to the ER and was told about the inflammation of my heart and they thought I was having a heart attack. I also tested positive COVID  and was rushed to another hospital that was better staffed to treat people like myself. I was diagnosed with a leaky valve, arrhythmia, and myocarditis.
This is a spontaneous report from a contactable pharmacist. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration at single dose on 12Oct2017 for immunisation. The patient medical history and concomitant medications were not reported. In Oct2017 about a day or two later vaccination it started to itch and now it is red and warm. The outcome of the events was unknown.
24 hours - Redness and swelling at site of injection (Left arm) - eventually entire upper arm was swollen & red 48 hours after injection.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On 17-JAN-2015 (reported as about 1 week ago) the patient was vaccinated with M-M-R II, 0.5 ml, subcutaneous. Concomitant medication was not reported. The patient who was breastfeeding was administered with M-M-R II. No adverse effects reported. The outcome of the event was unknown. The reporter considered the event to be not related to M-M-R II. Additional information is not expected.
Accidentally received only the liquid portion; Accidentally received only the liquid portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA764A, expiry date 31st December 2023) for prophylaxis.   On 30th January 2023, the patient received the 2nd dose of Menveo. On 30th January 2023, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comments: The patient had accidentally received only the liquid portion of Menveo on 30th January 2023.  They gave the vaccine details, patient's details and requested information about how to proceed.  She accepted follow-up and provided her e-mail address so that the medical information could be sent. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient received only nly the Menveo diluent was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case had been linked with the case US2023015033, reported by the same reporter.; Sender's Comments:  US-GSK-US2023015033:Same reporter.
After injection, patient developed a half-dollar size lump (1/2 inch high) at the site of injection. Applied cold pack and gave 25mg dose of BENADRYL. No other symptoms. Patient waited 20 minutes in store. Swelling resolved within 90 minutes at home.
muscle pain in my chest and going down my rib cage; feet felt like ice; Calf muscle also hurt; could not find a comfortable way to sit or lie down; muscles still tingle a little bit; lost my appetite; tired; This is a spontaneous report from a contactable consumer or other non hcp. A 81-year-old male patient received first dose bnt162b2 (BNT162B2,  Formulation: solution for injection, Batch/Lot Number: EL9262 and Expiration date was not provided), via an unspecified route of administration, administered in Arm Right on 02Feb2021 15:30 ((age at vaccination 81-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included myelitis transverse. I had Transverse Myelitis 70 Years ago at age 12. No other allergies were reported. No covid was reported prior to vaccination. The patient's concomitant medications were not reported. No other vaccination in four weeks and no other medications in two weeks. On 11Feb2021 20:30, the patient experienced muscle pain in my chest and going down my rib cage, feet felt like ice, calf muscle also hurt, could not find a comfortable way to sit or lie down, muscles still tingle a little bit, lost my appetite, tired. The patient underwent lab tests and procedures which included sars-cov-1 test: unknown on 14Feb2021. Therapeutic measures were taken as a result of muscle pain in my chest and going down my rib cage, feet felt like ice, calf muscle also hurt, could not find a comfortable way to sit or lie down, muscles still tingle a little bit, lost my appetite, tired. The outcome of event was Not recovered/Not resolved.
After receiving MMR and Varicella and HIP and Prevnar patient got hives on trunk and face within 15 min.  Within 30 min had pulmonary wheezing but no Stridor-got dexamethasone and Benadryl and epinephrine.
Severe shaking (flailing of arms and legs) about 8 hours after the 2nd shot that lasted for 30 minutes.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 at 10:00 as dose 2, single (Lot number: EK9231) at the age of 79 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergy: Sulfa drugs" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "hiatal hernia" (unspecified if ongoing). Concomitant medication(s) included: HCTZ; BENAZEPRIL; ARMOUR THYROID; VIT C; VIT E [TOCOPHEROL]; VIT B6; VIT B12; FLU VACCINE VII, in Sep2021 as dose 1, single. Past drug history included: Morphine for Known allergies: morphine. Vaccination history included: BNT162b2 (lot number=ET1685,, administration date=20Dec2020,, administration time=10:00 AM, dose number=1,, vaccine location=Right arm}]), administration date: 20Dec2020, when the patient was 79-year-old, for Covid-19 immunization. The following information was reported: TREMOR (medically significant) with onset 21Jan2021 at 19:00, outcome "recovered", described as "Severe shaking (flailing of arms and legs) about 8 hours after the 2nd shot that lasted for 30 minutes.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2021) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of tremor.; Sender's Comments: Based on the available reported information, the causal association between the event tremor and the suspect drug BNT162B2 cannot be excluded.  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.
Headache, generalized muscle soreness, loss of appetite, fever (low grade 99.3), malaise began about 4-6 hours after injection.
mom called 11MAY93 cyst devel p/inject; seen by MD 13MAY93 had appt; dx granuloma;
Pt alerted circulating RN that she was feeling tightening in her throat. Pt mentioned that she wanted to walk to the room because she was not feeling dizzy. Pt was asked about any heart problems and she responded that she has a pacemaker. Pt was taken to a private room  for further monitoring and observation.  Patient asked about history of  this problem, to which she replied that this has never happened before. Patient mentioned that her allergic reactions typically consist of a rash or hives.   Vitals were taken and recorded. BP was initially high at 180/80. Pt declined admission to the emergency department.   Pt awake and alert, good historian.  No difficulty speaking or breathing. No shortness of breath, denied chest pain, reported "tightness" and pointing to neck area.  Pt described, "feels like I have phlegm there."  Denied water.  No drooling & speech clear.  No numbness to extremities or aching to shoulders, no nausea, no dizziness.  Pt ok to sit up and accepts water at 11:38AM (20 minutes following initial incident), denies food and juice. Swallows multiple sips without difficulty. Pt denied throat tightness or pain.   EMTALA Form completed. Pt education performed regarding potential side effects of COVID-19 vaccine and sources of information going forward.   11:43AM pt feels comfortable to walk and wants to go home.    Pt discharged to home ambulatory, stable VS and states understanding of plan of care after COVID 19 vaccine today.
Chest pain shortly after the vaccination. Swallowing and throat. Long lasting and was sent to the emergency room. Labs and EKG were normal. Sore throat lasting up to five days after the vaccine. Tightness in throat and chest experienced
acute onset of vomiting & bloody stools;dx w/intussusception;resolved w/barium enema;
Pt had swelling, redness and pain over left deltoid the day after vaccine was given. Is also having intermittent shooting pain, numbness/tingling in left arm as well.
101.9 temperature for ~36 hours; body aches, severe pain in left arm at injection site (Prevnar 20 and meningococcal group B) for ~72 hours; began 7-day course of amoxicillin
Patient had syncope approximately 5 minutes after receiving second dose of Pfizer Covid Vaccine. Brother was with him as he had been dizzy for first dose. Brother alerted pharmacy, we applied ice pack and cold cloth, gave patient gatorade and water and positioned him to help with blood return (knees up). Patient fully recovered and left without further incident or complaint.
-numbness to extremities -dizziness -nausea TEMP: 98.2 P: 67 O2 SATS: 98% @ RA RESP: 18 BP: 120/80
On .4/19 I started to feel fatigue in my legs  04/20 it got worse in the legs 04/21 I came to work I worked through out the day with pain in my legs it hurt to walk it hurt to sit down the pain in my leg was getting worse  04/22 the pain got really bad I got up in the middle of the night to use the bathroom and I could feel my legs , my legs got really heavy and it felt like I had Charlie horses from my ankles up to the top of my thigh and I could not stand up. So I went to the ER and I got blood work done and I was told something about my CK levels were extremely high and that's when I was admitted. The day that I got the vaccine I got really dizzy during that 15mins that they make us wait and I felt very sick While I was admitted my CK levels kept going up the doctors told me that I had something rhapdomysosis , the pain got worse and the doctor increased my level of fluids and they did and ultra sound on my legs to check for blood clots and they kept increasing my levels of fluids and once I was let go from the doctor I did have to keep going back to keep getting my blood check. I did continue to feel muscle weakness in my legs while I was home. I did go back to the doctor 05/14 for muscle weakness I was given as bag of fluid.. After that any time I stand too long or I am working out I can no longer work out for as long as I can. I can no longer work out for longer then 15mins because of the pain in my legs. I suffer at night time now with muscles spams now they happen all throughout the night. I had very low potassium
After getting her flu shot she was standing up watching her dad get the flu shot and she passed out.
Patient called 12/26/19 to report continued throbbing pain on the immunization side, especially when laying down.  States it is difficult to put on socks in the morning and that pain is getting worse as time goes on.  She also stated concern over receiving Boostrix vaccine one month earlier on 10/10/19 and Fluzone HD on 9/19/19 and inquired if there was any correlation.
Erythema and tenderness at injection site, 4cm x 12cm of right arm.  Follow up 06/05/2000: "Patient recovered from adverse event."
After my vaccine I immediately experienced fever, body aches, chills, was dehydrated have a paralyzed vocal cord. I went to the hospital since I am pregnant to check on my baby and myself. I have not fully recovered from my vocal cord. At the hospital a rapid Covid test was performed along with a flu swab and lab work.
1. Fever for approx 16 hours 2. Sore arm for over 48 hours 3. redness, pain, injection site (still present 60 hours post injection) 4. Itching at injection site- started at 48 hours post injection
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jan2022 at 13:00 as dose 3 (booster), single (Lot number: 33036BD) at the age of 49 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information:Patient took Paxlovid for COVID 19 treatment from 21Jun2022 to 26Jun2022. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Previously patient had received a COVID-19 Vaccine. COVID rebound 3 days after final dose of Paxlovid. Cough, congestion, severe headache, fatigue. Relatedness of drug to reaction(s)/event(s): COVID-19, SARS-CoV-2 PCR test positive: Source of assessment: RA Result of Assessment: D. Unclassifiable.
Initial information received on 03-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 weeks old female patient who experienced received a dose of vaccines PENTACEL lot C5466AB via intramuscular route in the left thigh and ADACEL lot U5581CA via intramuscular route in unknown administration site on 02-Aug-2018 at the same time. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTATEQ for Immunisation; and PREVNAR for Immunisation. It was a case of actual medication error due to Inappropriate age at vaccine administration and extra dose administered, as a 12 week old baby was given PENTACEL and ADACEL at the same time. It was unknown if the patient experienced any adverse event or not. 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. Documents held by sender: None.
Approximately 10 minutes after the vaccine I got SOB, could feel my heart pounding. Felt like I was going to faint. I was diaphoretic and pale.  I just happened to be with a physician who monitored my pulse which was rapid but quickly slowed back down to a normal rate. Occurred over several minutes and subsided without any intervention.
Patient DOD 4/19/21 Death Certificate Line A ?Adverse effect of Covid19 vaccine-5 day interval onset and death? Line B ?Anorexia nervosa? Line C ?Recurrent Major Depressive Disorder?  Received her second Moderna dose from our Mobile team on 4/14/21    Since then I spoke with Dr. (Mobile); clients PCP, several times regarding this event.  His nurse got an email from client on 4-12-21 that client had vaccination planned on 414 and may need to reschedule medical appointment planned 4-16 if she felt bad. The client was encourage to get vaccine and to keep appointment for Friday April 16th.  The client  emailed the office at approx 0300 Friday morning  April 16 to cancel appointment because she felt to poorly from vaccination shot to come in  (fevers; body aches). Dr next heard from police officer on Monday April 19th that she was found dead in her home. He requested the Medical Examiner (ME) evaluate but this request was denied. The client lived alone. Dr contacted family members but they did not have much interaction with the client and had no significant information to contribute. Dr said he speculates that the patients underlying anorexia nervosa likely put the client in a critical nutritional deficiencies / electrolyte imbalance condition and the side effects of vaccination were too much. He felt compelled to complete the death certificate as he did because the ME declined the case.   From vaccine mobile team notes:  team was there2-3:30pm. All the answers to the health screening questions for the patient were "no" except for "have you ever had a severe allergic reaction to something?" To that question the answer was "yes.   Immunization Information System record - lot # is underlined:  Coronavirus COVID-19, mRNA,LNP-S,PF, 03/17/2021 1 of 2 100 mcg/0.5mL Full 022M20A IM LA   Coronavirus COVID-19, mRNA,LNP-S,PF, 04/14/2021 2 of 2 100 mcg/0.5mL Full 006B21A IM LA
This spontaneous report was received from a healthcare professional refers to a 78 year old female patient with hypercholesterolemia and no drug allergies. On 10-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot No. J001698, exp. 08-MAY-2014), 0.65 ml, subcutaneous in the left arm. Concomitant therapies included CRESTOR. On 11-JUL-2013, the patient developed a fever and redness, pain, swelling and warmth of her left arm at the injection site. The patient was treated with ADVIL and ice pack on left arm at injection site. No labs diagnostic tests were performed. The patient was seen at the reporter's office on 03-SEP-2013, at that time no redness or swelling was noted at the injection site, but the patient continued to have pain in her left arm at the injection site. The outcome of fever was not reported. Relationship between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
I experienced a rapid heart beat shortly ( about 3 min) after receiving the vaccine. It lasted about two minutes and resolved by itself. I did not alert the staff in the observation room because it came suddenly and it didn't last a long time.