chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; vomiting; Achy; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not reported), via an unspecified route of administration in arm left on 19Mar2021 17:15 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to food, medication or other products. Since the vaccination, the patient had not been tested for COVID-19. Patient was not diagnosed with COVID-19 prior to vaccination and post vaccination. On 19Mar2021 at 22:30, the patient experienced nausea, vomiting and achy. The patient did not receive any treatment for the events. The outcome of the events nausea, vomiting and pain was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.  Amendment (DSU) (28Jun2021): This follow-up report was being submitted to amend previously reported information: Dose description was updated from UNKNOWN DOSE NUMBER, SINGLE to DOSE NUMBER UNKNOWN, SINGLE. Event headache was deleted and updated as vomiting since source not reported headache as event per source event field adverse event nausea, vomiting, achy were updated. Event occurred country updated from UK to US for event Achy. Lead sentence updated as "This is a spontaneous report received from a contactable consumer to add word contactable".  Narrative sentence the patient did not have symptoms associated with COVID-19. Removed previously not reported on source. Narrative sentence Since the vaccination, the patient had not been tested positive for COVID-19 updated as Since the vaccination, the patient had not been tested for COVID-19. Narrative sentence the patient was treated with any medication for the events. Updated as the patient was not treated with any medication for the events. Final sentence updated as No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Fever chills headache for 12 hours occurring 24 hours after 2nd COVID injection
adult patient received a pediatric dose of Havrix; adult patient received a pediatric dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of underdose in a adult patient who received HAV (Havrix 720) (batch number 2k57n, expiry date 22nd December 2022) for prophylaxis.   On 2nd March 2022, the patient received Havrix 720. On 2nd March 2022, unknown after receiving Havrix 720, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details reported were as follows: The age at vaccination was not reported. The adult patient received a pediatric dose of Havrix, which led to underdose and adult use of a child product. The healthcare professional could not provide patient demographics. The consent to follow up was given.
Fussy, sleeplessness, maculor papulor rash entire body has a localized reaction also R lower thigh red-slightly raised 1 x 1/2cm with satellite lighter pink/red area measured 1.4 x 1cm (Varivax).
On 5/11/23 mom states child started with fever and rash on 5/10/23. Fever 101.8, rash little red spots that look like a bug bite and 1 that looks almost like a pimple.
Information has been received from a pharmacist concerning a female in her seventies, with no allergies, who on 04-MAR-2008 was vaccinated with her second dose of pneumococcal 23v polysaccharide vaccine. On 04-MAR-2008, the patient experienced an anaphylactoid reaction, which happened shortly after receiving pneumococcal 23v polysaccharide vaccine. It was reported that the patient was currently in the hospital with pneumonia and the anaphylactoid reaction was treated with IV corticosteroids. At the time of this report the patient was recovering and this will not prolong her hospitalization. The patient received her initial pneumococcal 23v polysaccharide vaccine 5 to 6 years ago with no problems. No product quality complaint was involved. Additional information has been requested.
SEVERE MIGRAINE; FLU LIKE SYMPTOMS; STOMACH PAIN; ARM SORENESS ON THE SURROUNDING TISSUE AROUND THE INJECTION; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, severe depressive disorder, generalized anxiety, alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. Concomitant medications included sertraline for antidepressant, ethinylestradiol/norgestimate for birth control, and salbutamol. On 25-MAY-2021, the subject experienced arm soreness on the surrounding tissue around the injection. On 26-MAY-2021, the subject experienced severe migraine. On 26-MAY-2021, the subject experienced flu like symptoms. On 26-MAY-2021, the subject experienced stomach pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe migraine on 26-MAY-2021, and flu like symptoms, stomach pain, and arm soreness on the surrounding tissue around the injection on 27-MAY-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Developed red papular rash on 10 m day after receiving immunization. Covered his entire body. Advised to take Alavert by PCP
firs dose was administrated ob November 2019 / late for the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. No adverse event was reported. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consented to follow up.
On October 17, 2006 I recieved my first dose of the Vaccine.  I felt fine afterwards other than being a little dizzy.  I was a normal 19 year old college student, working, and doing sports.  A month and a week after my first dose of the vaccine I was hospitalized with seizures. I had many tests done and continued to have seizures.  They said there was no apparent cause for my seizures.  I am now 21 years old and am living with epilepsy.  It has changed every aspect of my life.  I just recently heard a talk show on CNN talking about people who have recieved gardasil and have had adverse side effects including seizures.  Now I am on two different seizure drugs and am struggling through school and I can no longer hold a steady job due to driving restrictions, fatique,etc.  10/21/08 Reviewed multiple hospital admission & ER records of 6/27-12/30/2006. FINAL DX: focal to secondary generalized seizure disorder; panic disorder.  11/25-11/27/2006 Hospital admission s/p 3 new witnessed generalized motor seizures while sleeping & bit her tongue; followed by HA, stiffness & confusion.  Tx w/dilantin & folic acid.    12/2/06 Seen in ER for possible family witnessed seizures x 2, patient found to be incontinent, postictal, HA, blurred vision, nausea, anxiety.  Found w/muscle tension & hyperventilation.  Labs revealed toxic dilantin level, 26.2.  Meds adjusted & d/c to home w/o further seizure activity.  12/26-12/30/2006  FINAL DX: multiple spells, seizure vs pseudoseizure; borderline personality disorder w/somatoform features; hx of panic disorder. Admission for video EEG after having increased frequency of seizure activity at home despite therapeutic levels of meds.  Neuropsych consult done & referred to outpatient psych.  D/C to home w/o antiseizure meds.    10/31/08 Reviewed OB/GYN clinic records of 10/06-9/2008. FINAL DX:none provided Records reveal patient had LEEP done 5/23/08.  Had been on Yaz & changed to other BCP.  11/11/08 Reviewed neuro clinic records of 11/28/2006-9/19/2008. FINAL DX: epilepsy w/complex partial seizures Records reveal patient experienced frequent spells esp at night w/incontinence & at least one episode of tongue biting.  During the day w/HA, feeling hot, sleepy but difficulty sleeping, occ SOB, eyes flutter, posturing of extremities, off balance, bad taste in mouth, unable to think or talk,  anxiety, panic, depression & stress from her condition.  Records included hospital admit of 12/4-12/5/2007 after having several seizures in 1 day.  Meds were increased & d/c to home.  Continued to have migraine HAs. Meds & schedules were adjusted. 1/26/2010 Follow up: Seizures, headaches, dizziness, fainting, tingling of hands and feet, joint pain, migraines.
expired dose of Engerix-b; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received HBV (Engerix B pediatric) (batch number yl2l3, expiry date 14th October 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 18th October 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. but it could be 2 or 3 years The patient received an expired dose of Engerix-b, which led to expired vaccine used. The reporter did not consent to follow-up.
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were inadvertently vaccinated with improperly stored doses of GARDASIL 9 (lot#, expiry date, dose, strength, vaccination site, route unspecified). No adverse effect were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Lower extremity dermatitis to b/l legs. Also papules to wrist area b/l Pruritus present  treatment: antihistamines
This patient seized approximately 24 hours s/p receiving immunizations. Generalized tonic clonic movement, opisthotonic posturing, eye rolls, post-ictal, afebrile. Self resolved after treatment. The hospital in NICU at the time of events. No further Seizure activity.
Post vaccine varicella, child was seen in our office on 04/04/05 by DR and diagnosed with varicella. Had vaccine in 1997. Rash started 04/02/05 and spread to trunk, scalp, neck, and extremities. Had approximately 30 itchy lesions, mix of papules and vesicles with some crusting. Afebrile.
A 16yr old with underlying chronic health conditions  was administered a Moderna vaccine on 3/24/2021.  Patient's guardian requested that he be vaccinated under the current phase, which allowed 16yrs with underlying health conditions . We later learned this did not apply to the Moderna vaccine.  Pt did not present any adverse reactions after waiting 15 minutes.
3/21/2003 Pt seen in ER for cough, green nasal discharge and congestion. Started on Z pack and Allegra with no improvement. CXR showed L upper lobe infiltrate. On 3/26/2003 seen by PMD and given po Tequin amd Medrol dose pack. Seen in ER on 3/30/2003 with worsening sx and temp 101. Admitted to hospital with diagnosis of pneumonia and hypoxia. Had no cardiac sx. EKG nml except for non specific T wavw abnormalities. WBC=21,000, CXR showed COPD. Treated with IV antibiotics and steroids. VQ scan ruled out PE. Patient remains hospitalized.
4 yrs old child was by mistake given FluBlok /no AE; Initial information regarding an unsolicited valid non-serious case was received from an other health care professional via Medical Information (MI) (Reference number- 00332565) and transmitted to Sanofi on 26-Oct-2020.  This case involved a 4 year old female patient who by mistake received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] prefilled syringe (frequency- once, standard dose, batch number-UJ448AB, UJ448A expiration date- 22-Mar-2021) via intramuscular route at right deltoid for prophylactic vaccination on 26-Oct-2020 (Product administered to patient of inappropriate age)  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Patient did not received any concomitant vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration (latency- same day).  No adverse event was reported.  Reporter asked about expected reaction and if any death was reported due to this error.  Disclaimer- 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 Disclaimer: 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.
40-50 mins after shot, had difficulty swallowing, tongue felt swollen, sore throat, some face swelling.  I went to the urgent care parking lot and sat for 30+ minutes in case symptoms worsened.  Symptoms did not get progressively worse, I returned home and began to improve 8 hours later. Had slight symptoms for another 24-36 hours.  I saw my doctor on 3/1/21
24 hours after shot I am dizzy, no appetite and somewhat nauseous.    A strange shooting discomfort in upper abdomen
This spontaneous report as received from a pharmacist refers to 2 unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with ZOSTAVAX (route, dose, lot # and expiration date were not provided). On  unknown dates, following the administration of ZOSTAVAX, the patients developed herpes zoster referred as shingles. At the time of the report, the outcome of herpes zoster was unknown. Additional information is not expected as no reporter details were provided.
Patient was administered adult dose (30mcg) rather than appropriate pediatric dose (10 mcg) of Pfizer COVID-19 vaccination.
Rash Silver-dollar sized, red raised area @ injection site, tired, and chills  Narrative:
No additional AE was reported; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 30-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) for prophylaxis (lot # T001211 was verified to be valid, expiration date reported and established as 12-JAN-2022); (dose, frequency, route of administration and vaccination site were not provided).  The administered dose of vaccine experienced a temperature excursion of 50.7Fahrenheit degrees for 30 minutes. There was no previous temperature excursion. The patient did not experience any additional adverse reactions. Digital Data Logger was involved.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA000462:
Per vaccine recipient, "I got sick last night after getting the COVID shot that I got yesterday morning. I had a fever of 102, my blood pressure was really high, 175/100, my muscles and joints hurt, and it was really weird, the bottoms of my feet felt like I was walking on broken glass. They felt really hot too. I soaked them in cold water and that helped some, but they feel hot again now. My blood pressure has come down some too, but it's still 149/90 this morning (the day after receiving the vaccine)."
just a small rash around the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 92-year-old female patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster) , single (Lot number: FC3189) at the age of 91 years for covid-19 immunisation. The patient's relevant medical history included: "Painful hip" (unspecified if ongoing), notes: she has any kind of shot was the last week in May2022. Had a Kenalog injection for a painful hip. Concomitant medication(s) included: ELIQUIS; KENALOG 40 taken for arthralgia, start date: May2022, stop date: May2022. Vaccination history included: BNT162b2 (Dose 1:, Date: 06Feb2021, LOT: EM9809), administration date: 06Feb2021, when the patient was 90-year-old, for Covid-19 immunization; BNT162b2 (Dose 2:, Date: 03Mar2021, LOT: EN6198), administration date: 03Mar2021, when the patient was 90-year-old, for Covid-19 immunization. The following information was reported: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "just a small rash around the injection site". The event "just a small rash around the injection site" required physician office visit.  Additional information: There was no other conditions, no investigations. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Emergency Room visit. No Prior Vaccinations (within 4 weeks) and no list of any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No other reactions prior vaccinations. No Family Medical History Relevant to adverse event.
No adverse effects reported.; Medical assistant states patient received 3 doses of GARDASIL 9 however, doses were a year apart; This spontaneous report was received from a medical assistant concerning a currently 30-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and past drugs or allergies were not reported.  On an unspecified date in 2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9); on an unspecified date in 2018, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration) and on 18-OCT-2019, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), (lot number 1602283 has been verified to be a valid lot number, expiration date reported as 15-AUG-2019, but upon internal validation established as 18-AUG-2021), (anatomical locations, strengths, doses, routes of administration and frequency were not reported for any of the doses; lot numbers and expiration dates of the first and second doses were not provided); all vaccines were administered as prophylaxis.  No adverse effects were reported.
Pt c/o severe right-sided chest pain unrelieved by over the counter pain meds. Weakness and numbness in Rt arm and hand. !2/04/09 Neurology Consult records received for DOS 10/05/09. Pt presents with right arm weakness and pain.  Pain has improved but lingering weakness in finger muscles. Referred for Physical therapy. Assessment: right brachial plexopathy  12/08/09 PCP Medical records received for DOS 09/11/09, 09/14/09, 09/25/09, 10/09/09  Pt. presents with severe right chest wall pain radiating to right arm and hand.  Also c/o 4th finger numbness right hand. Progressively increased pain and weakness. Assessment: intense right chest wall pain; hypertension; right upper extremity neuropathy, progressive
increased glucose levels, treated with insulin.  Patient suspected DKA and went to E.R.  Patient experienced vomiting and dehydration
The night of the injection started having pain in the shoulder and got worse. Went to ER 9/21/2017 and was given ABX. Then got better after a week then got worse 4-5 weeks after that to the point she couldn't raise her arm up. She was admitted to the hospital toward the end of November and kept for 4 days. Gave ABX and gave MRI, xray, cat scan. It got better the middle of December. Has a little lingering pain.
Hives noted on both arms, below injection site. Pt denied any shortness of breath. V/S stable. BENADRYL 50 mg IM.
Fever Chills Soreness of muscles Fatigue Headache Slight difficulty breathing Nausea  All occurred next day
Headache, neck pain, fever 100, body aches. (RD) Tx with KEFLEX.
pins and needles, started in my left arm, on my extremities and starting up my torso, skin felt like it was crawling, irregular heart beat, lowered heart rate, low blood pressure, swollen eyes, throat clamping up, pain in left ear and around left ear in the neck, headache. The tingling started in the afternoon within an hour after the vaccine, and very slowly, slowly, slowly increased the next day and in the evening it got intolerable.  They put me on an IV and within minutes it all started to go away.
12hours after the vaccine, I woke up at 1AM with a  really weird dream, Headache and fever. I couldn't get up and felt like a wanted to vomit and nauseous. I vomiting , I sipped Gatorade and ginger ale. I was out of it. I slept.  GI - direahha into the afternoon. I finally stopped vomiting. I had anti vomiting meds. I went to bed that night and the next I woke and felt like I could run a marathon Teledoctor  on 2nd.
felt Nauseous; dizzy; numbness on my left side; tingling on my left side; sores on my face; Also have had low; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2020, the patient received the 1st dose of Shingrix. In August 2020, immediately after receiving Shingrix, the patient experienced nausea, dizziness, numbness, tingling, skin ulcer and feeling unwell. On an unknown date, the outcome of the nausea and dizziness were recovering/resolving and the outcome of the numbness, tingling, skin ulcer and feeling unwell were unknown.   It was unknown if the reporter considered the nausea, dizziness, numbness, tingling, skin ulcer and feeling unwell to be related to Shingrix.  Additional information was received as follows: Age at vaccination was not reported but was taken as an adult as per vaccine indication. The patient had first dose of Shingrix on 6th August 2020 and immediately felt nauseous and dizzy, but it eventually passed. Last few days the patient had tingling and numbness on the left side and the patient was beaking out with sores on the face.  The patient also have had low. The patient questioned whether the patient was gettinng Shingles.
Pt received 4th Covid vaccine (2nd booster).  She was not eligible based on age.  Not immunocompromised.    Spoke with pt 24 hours later.  Complains of mild body aches, similar to side effects from other Covid vaccine doses.  She is at work today.
L arm erythema ~15x10cm, seen by ER on 8/1 BACTRIM started, f/u at PCA on 8/4 with decrease of erythema.