chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker (medical assistant) referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The healthcare worker reported that doses of PROQUAD (Merck) (lot # K011316, expiry date 14-FEB-2016; lot # K005195, expiry date 10-OCT-2015; lot # was reported as K007977, expiry date 03-JUN-2016) (lot # K007977 is an invalid lot number for PROQUAD (Merck)) which was exposed to temperatures outside of the recommended range, had been administered to the unspecified patients on unspecified dates since 20-JUL-2015. At the time of the report, no adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Member called the Clinic and spoke to someone. They explained that he was experiencing a rash on his forearms and upper thighs that was not itchy after receiving the smallpox vaccine.  He also said that the vaccination site was not forming a scab. He told the patient to come to the clinic for further examination.  Upon examination, it was determined that he be seen by a provider at Medical Facility.
Patient reported that she received Moderna Covid vaccine on 03/27/2021. She reports that on 04/07/2021 she began to feel "stabbing like, intermittent" sensation in the right occipital region. She wen to the Emergency Department on 04/17/2021 and was diagnosed with Bell's Palsy.
Vaccine was provided past the beyond use date of 01/02/2022, VAERS has been submitted
1 week following 4 month check-up/vaccination visit, noticed significant reduction in language skills previously mastered and eye contact.
Hives began 5 hours after vaccination on upper body. Switched to lower body 8/14/08. Use of Benadryl and/or Zyrtec removes symptoms only as long as medicine in blood stream. Heat increases symptoms.
pt recv vax DEC96 & the following day pt c/o arm pain;later the same day pt suffered pain in all joints;pt also devel fluid around the left elbow joint;the nurses believes gave inj in the rt arm;it is not known whether tx or ER or MD visit
Paresthesias left upper extremity brrachial neuritis.   Follow up on 08/27/04 states: "While checking for pt whether we had a report on file I noticed that her DOB was entered wrong. It should be what is listed in box 3. See image for confirmation."
Dose 1 COVID on 2/27/21, dose 3 on 3/20/21, and dose 3 of COVID vaccine.  PAtient admitted with COVID acute resp failure on 11/5/21, and patient remains hospitalized on 11/9/21.
Initial overall body pain 3 days post immunization of shingles vaccine.  Given Tramadol for pain. Tingling in feet and arm.  Overall weakness, loss of appetite. Hospitalization on 4/23/07 for severe hypotension and hypokalcemia for five days.  Returned to hospital on 4/30/07 for another 5 days. Current stay at hospital 5/14/07 to present for orthostatic hypotension.  Elevated protein levels (120) in spinal fluid. Tentative prognosis is Guillan -Barre Syndrome.  MR received for admission 4/23-27/2007 for c/o body aches and weakness x 4 days.  Seen by PCP and BP was 74/48 so admitted with dx of hypotension, body pain, dehydration, recent neck surgery, R/O infection source.  PE significant for inability to sit up w/o c/o of dizziness/weakness, mild sinus mucus, c/o pain L arm, teeth , jaw and whole body, low BP (somewhat improved with IVF), and decreased POM of the neck 2' to cervical collar.  Discharge DX: S/P dehydration 2' to N/V, possibly viral syndrome with side effect from sulfa and Ultram.  S/P hyponatremia due to dehydration, resolved. R/O Viral syndrome. Gastroenteritis.   8/27/2007 MR received for DOS 5/14 to 6/30/2007 with initial c/o leg weakness, dizziness, and orthostatic symptoms.  Seen twice prior to this admission for same sx. PE (+) for L eyelid lag and some ptosis.  Bilateral weakness > in proximal muscles. Neuro consult 5/14/07 which notes tingling dysthesias, extremity weakness, hypotension, unsteady gait.  DX: Dysautonomia with symptomatic orthostatic hypotension. Anemia.   Pt transfered to nursing facility. 1/15/2010 Dr stil requiring medication for orhtostatic hypotension, but is greatly improved.
A report was received from a health care professional on 3OCT2003 concerning 4 vaccinees of unspecified demography who experienced unspecified adverse events 2 to 3 days after receiving fluvirin on an unknown date in 2003. Since 18SEPT2003 the reporter had received 4 adverse event reports associated with Fluvirin administration. It was not reported if the vaccinees had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending: See Ref: PJP200301080,  RJP200301081, RJP200301082
Hospitalization due to COVID 19 Reported per Janssen COVID-19 Vaccine EUA
pt recv vax & short time p/vax pt exp neuromuscular that put pt in a wheelchair;the reporter stated that the pt was improving & it was felt that pt was temporary;
sore arm; little tenderness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and TENDERNESS (little tenderness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and TENDERNESS (little tenderness). At the time of the report, PAIN IN EXTREMITY (sore arm) and TENDERNESS (little tenderness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Pain at injection site within 3 minutes of injection, then nausea, followed by chills and fever, tiredness, body aches and pain,  flushing of skin on face, ?today is day 2 and pain in arm lessened?overall symptoms a little, little bit less than yesterday?however I had to take a nap because of feeling lethargic ?2.5 hours and it?s now 6:12 pm and I?m ready for bed.
Dizziness, nausea, headache on the evening of the vaccine administration and has occurred with each GARDASIL vaccine but has lasted longer with each vaccine. This incident lasted 8 days required office visit, passed out in office and could not get her to wake up. Started IV fluids transferred to emergency room. She is mildly dehydrated, blood sugar was 60.
Client reports day after 2nd dose she had very sharp headache, a temperature of 103.5, chills, cough.  This persisted for 2 days.  On day 3 her temp was 101.5.  By day 4 no temp.  Fatigue and weakness lasted for a week.
mom report no s/s prior to vax;w/in 20-30min mom noted inconsolable cry scream of short duration approx 1min;febrile 101.6;pt appeared dazed (glazed look) eye looked funny rolled back;also jerking movement of legs & rt arm during sleep;
Headache, Fever, CoughWheeze, FATIGUE AND SHORTNESS OF BREATH Narrative: PATIENT W/ ASTHMA SX DAY OF RECEIVING VACCINE. REPORTED ASTHMA ATTACK OVER AA YR AGO. COVID TESTS DONE ON 1/19/21 & 12/18/20 BOTH NEGATIVE. PT HAD (-) CXR . MET WITH ALLERGIST ON VIDEO CALL PT RECEVING NEB TX EVERY 6 HOURS.DENIES HX OF SVT AND IS FOLLOWED/MANGED BY CARDIOLOGOIST.
8 pm on Mon 12/28 started with sore arm at injection site and sore joints 2;30 AM on Tues 12/29 woke up feelin fluish no fever(100.7)all over body aches took motrin , tylenol went back to bed for the whole day woke up on Wed 12/30 no more body aches but have a headache took tylenol then motrin some relief
Puffiness of both eyelids bilaterally, hives on cheeks and ear pinna, start with difficulty breathing, mom heard wheezing. Decreased air exchange before EPIPEN & albuterol, all symptoms went away after tx. N.B. local reaction around MMR, VARIVAX.
She states that today, 26MAY2022, she still does not feel up to her normal self; Tired; Eight hours after the 2nd booster, she felt sick and she was sick all day; She was feeling Cold; Shaking inside and outside; No energy; Slept all day; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Eight hours after the 2nd booster, she felt sick and she was sick all day), FEELING COLD (She was feeling Cold), TREMOR (Shaking inside and outside), ASTHENIA (No energy) and SOMNOLENCE (Slept all day) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 031A21A, 014M20A and 031H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, the patient experienced IMMUNISATION REACTION (Eight hours after the 2nd booster, she felt sick and she was sick all day), FEELING COLD (She was feeling Cold), TREMOR (Shaking inside and outside), ASTHENIA (No energy), SOMNOLENCE (Slept all day) and FATIGUE (Tired). On 26-May-2022, the patient experienced FEELING ABNORMAL (She states that today, 26MAY2022, she still does not feel up to her normal self). On 25-May-2022, IMMUNISATION REACTION (Eight hours after the 2nd booster, she felt sick and she was sick all day) had resolved. At the time of the report, FEELING COLD (She was feeling Cold), TREMOR (Shaking inside and outside), ASTHENIA (No energy), SOMNOLENCE (Slept all day), FEELING ABNORMAL (She states that today, 26MAY2022, she still does not feel up to her normal self) and FATIGUE (Tired) had not resolved.            No concomitant medication reported.  Eight hours after the 2nd booster, patient felt sick and was sick all day. Patient was feeling cold, shaking inside and outside, tired, no energy and slept all day. Patient stated that today ,26MAY2022. Patient still did not feel up to the normal self. The patient reported that due to event experienced could not celebrate birthday which was on 26-May-2022. Patient did not contacted the doctor.  No treatment medication details reported.
Patient was given 2nd dose 3 days earlier than the acceptable time frame (2nd dose given 21 days after 1st dose). Current guideline does not suggest re-administration of the 2nd dose. Patient was informed. No adverse reactions reported by the patient.
temperature excursion; route of administration:IM; This spontaneous report was received from another health professional and referred to a 13-month-old male. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-FEB-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, with a reported valid lot #W006412, and a validated expiration date of 23-FEB-2024, administered intramuscularly (Incorrect route of product administration) into the right thigh for prophylaxis (strength was not provided). The vaccine had a temperature excursion (unspecified) and the temperature change was detected with a data logger.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 67 year old female. Initial information was processed along with the additional information received on 10-MAY-2021 and 11-MAY-2021. The patient's weight, height, and medical history were not reported. The patient was not pregnant at the time of reporting and had a family history of confirmed covid cases. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, 1 total administered to left arm on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAY-2021, the patient got tested for SARS-CoV-2 IgG antibody test (NR: not provided) which came out negative. The patient experienced  confirmed immunological vaccine failure. The patient had no adverse effects from the vaccine and would like to get the vaccine again if possible. The patient had her blood tested so that she could donate if she had antibodies. Per patient only 4 among them haven't been infected as they were the older ones, so maybe its just lifestyle. The patient inquired if she could get the second dose of the vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments:Covid-19 vaccine confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
3" x 2 1/4" light red outer ring with 1" x 1 1/4" dark red warm firm center on L outer thigh. To give Benadryl Q 6-8 hours per swelling/itching.
pt recv vax 10JAN97 & 14JAN97 pt devel approx 20 lesions on back & peri-rectal area;subsequently 60-70 lesions devel & were described as a little itchy;it was reported that the lesions have resolved;
Pt vaccinated with DTP became very somnolent within 30 minutes, difficult to arouse, vomited 4 times; normal within 1 1/2 hr after injection.
Started with fatigue and sore throat next day, that evening i had blisters on back of tongue , inside lips and gums (blisters/bumps lasted for weeks), next day i had low grade fever, chills, burning in chest,  chest congestion, cough, head congestion  and mild sob, following that was increased heart rate, palpitations and fatigue that lasted about 2 weeks. Symptoms all resolved on their own , I was advised by PCP not to get second dose of vaccine.
Strong metal taste in the mouth approximately 2 hours after vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 25Mar2021 at 15:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine headaches and Gastroesophageal reflux disease (GERD. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and an unknown if ongoing. The patient previously took paracetamol / oxycodone hydrochloride / oxycodone terephthalate (PERCOCET), topiramate (TOPAMAX) and cefalexin monohydrate (KEFLEX); all for unknown indications on an unknown date and experienced drug allergy. On 25Mar2021 at 17:30, approximately 2 hours after vaccination, the patient experienced strong metal taste in mouth. It had not dissipated after 3 full days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event strong metal taste in mouth was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
grand mal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 07Nov2021 (Lot number: FJ1611) at the age of 20 years as dose 3, single for covid-19 immunisation. Relevant medical history included: "Grand mal seizure", start date: 01Aug2021 (ongoing); "Grand mal seizure", start date: 14Jun2021 (ongoing), notes: (Name withheld) had her first seizure near 1month after dosage. She has continued to have then. Dates are from seizure related ER visit. She is still following up with neurologist'. Concomitant medication(s) included: LEVETIRACETAM taken for generalised tonic-clonic seizure, start date: Dec2021 (ongoing). Vaccination history included: Bnt162b2 (Dose: 2, Anatomical location: Arm, Route of administration: Intramuscular, Lot number: EW2167), administration date: 11May2021, when the patient was 19 years old, for Covid-19 immunization; Bnt162b2 (Dose: 1, Anatomical location: Bicep, Route of administration: Intramuscular, Lot number: EW0170), administration date: 17Apr2021, when the patient was 19 years old, for COVID-19 immunization; Flu, administration date: 11Jul2021. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovering", described as "grand mal". The patient was hospitalized for generalised tonic-clonic seizure (start date: Dec2021). The event "grand mal" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: unknown result. Therapeutic measures were taken as a result of generalised tonic-clonic seizure. Clinical information: Pertinent details: (Name withheld) had her first seizure near 1month after dosage. She has continued to have then. Dates are from seizure related ER visit. She is still following up with neurologist. No family history of seizure or epilepsy. Relevant test: Variety during ER visit. Specific relevant test for thromboembolic events with thrombocytopenia: Unknown. The patient's mother is completing this as I am the one who pays (Name withheld) medical bills, have been responsible for transport now she cannot drive. (Name withheld) had her 1st seizure in 1 month after her vaccine. She has had light seizure plus several grand mal seizures in the last year. She is now on anti-seizures meds but not allowed to drive for 6 months after the most recent seizure, she has had to move her college classes to online only and stop working until she can drive.  Follow-up attempts are completed. No further information is expected.
Affected patient monitored for 48Hrs in conjunction with a doctor. Patient returned to work after vaccine.  All symptoms consistent with expected Pfizer-BioNTech - Comirnaty side effects.
FEELING UNDER THE WEATHER; Body aches; Chills; Fever; This is a spontaneous report from a contactable consumer (patient) and nurse, based on information received (manufacturer control number: EC-2020-083234). A male patient of unspecified age received the second dose of BNT162B2 (UNSPECIFIED TRADE NAME; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation; and lenvatinib mesilate (LENVIMA 10 mg; lot number 1080976; expiration 30Aug2023) orally from 24Oct2020 at 10 mg daily for renal cell carcinoma. Medical history included pulmonary embolism, cardiac issues, and nephrectomy all from unknown dates and unknown if ongoing. Concomitant medications included vitamins, loperamide hydrochloride (IMODIUM), iron, and paracetamol (TYLENOL), all from unknown dates for unknown indications. The patient previously received codeine, lansoprazole, amoxicillin and clarithromycin, all from unknown dates for unknown indications and experienced drug allergies. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported feeling under the weather following the second COVID-19 shot, further reported as body aches, chills, and fever on unspecified dates. The action taken with lenvatinib mesilate was temporarily withdrawn on 18Feb2021 for 2 weeks. The clinical outcomes of the body aches, chills, fever, and feeling under the weather were not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a consumer concerning hr school age daughter with a history of getting a fever about once a month, who on 15-OCT-2008, was vaccinated with GARDASIL (lot # not provided). Concomitant therapy included influenza virus vaccine (unspecified). On 15-OCT-2008, within one hour after the vaccination, the patient experienced fever and sore throat. The fever is continuing at the time of the report on 16-OCT-2008, and was recorded as 102 degrees F. The patient's sore throat persisted. The patient did not seek medical attention. Additional information is not expected.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING DRUNK (felt "buzzed up") and SWOLLEN TONGUE (histongue started getting thicker and swelled up and interfering with his talking.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FEELING DRUNK (felt "buzzed up") and SWOLLEN TONGUE (histongue started getting thicker and swelled up and interfering with his talking.). At the time of the report, FEELING DRUNK (felt "buzzed up") and SWOLLEN TONGUE (histongue started getting thicker and swelled up and interfering with his talking.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Information has been received from a female consumer concerning her adult son with ventricular septal defect who in 1964 was vaccinated with MMR. Subsequently, the patient developed an adverse reaction and reportedly almost lost his life. No product quality complaint involved. The reporter considered adverse reaction to be immediately life-threatening. No further information is available.
Received 2nd booster on Wed. 7/6 arm sore. Woke up Thursday morning with dizziness, headache. Tried to go about my day but experienced nausea and vomiting 3 times. Took to bed. Friday morning called Dr who said symptoms would subside. Bed-ridden and Fri. evening experienced vertigo. Saturday Dr prescribed meclizine 25mg every 6 hours. After 3 doses, I was able to get out of bed for extended time, Sunday too. Monday morning still having a dizzy feeling but feeling somewhat better. Dr said to try to taper. I went 25 hours without dose but felt a bit worse. Now (Wed-Fri)  back to dosing every 8-10 hours. 9 days post booster, head still dizzy, balance off, not feeling like I can drive or resume normal activities. Signed up for vestibular therapy.  I can't believe this happened!
Extreme blurred vision, light sensitivity, and eye pain the next day. Eye muscles were inflamed and pupils had delay in reaction to light. Have to wear sunglasses even inside due to light sensitivity, otherwise I get very nauseous. Has lasted over a week and have had to see ophthalmologist twice. Got steroid eye drops to take 4 times a day for 2 weeks.
The next day after the Varicella chicken pox vaccine was administrered, chicken pox like bumps started appearing on the whole left side of my daughter's body (leg, arm, shoulder and back). Baby isn't cranky but the the bumps are spreading.
COVID PCR was positive on March 28th, however she also had a positive COVID test in February and this is likely residual since she has not had any acute change in her symptoms, rather her respiratory symptoms have been gradually progressive.