chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Signs and symptoms began early in the morning with nausea/vomiting/low grade fever (100-102)/ and severe pain. Was thought to be a virus by the parents. The next morning when attempting to get child out of bed, balance was affected and she could no longer walk as she had been able to for the last few years. Though out the next few days, symptoms waxed and waned but when it became apparent her condition was declining, not improving, parents took emergent action. Child's ability to communicate verbally began to decline and her full vocabulary of being able to talk in full sentences with great articulation was affected and she began to answer only yes or no questions. She was unable to hold her own head up, or lift her body. Her right was limp. Was taken to the emergency room early morning on Monday, the 21st. Transported to ambulance down to another Medical Center due its inexperience with pediatric patients" as told by the emergency room doctor. Underwent three abdominal ultrasounds, lumbar puncture, a head ct, a barium swallow, six iv sticks, blood work, and multiple possible but no concrete diagnoses until an MRI on the 24th of January, when severe cerebellum inflammation was discovered, explaining her lack of motor coordination and lack of speech. Per the neurology attending, cerebellitis often occurs after vaccinations, wherein parent mentioned that child had had flu shot within the last few weeks but asked "wouldn't that have been too long between vaccination and symptoms?" and the neurology team said no, "entirely possible reaction to the flu shot".
Pt developed diarrhea and vomiting and a fever of 101F, within 24 hours. Required hospitalization and IV fluids.
pain and stiffness. Hurts to abduct past 80%. Hurts when sleeping
Patient called and stated they were having itching and small rash with moderate pain at injection site. Advised patient to contact Dr. if worsened conditions. Advised treatment with ice pack to sore area and Benadryl to calm the itching and small rash. Patient did not notify of advancement of rash or allergic reaction past localized area.
Lt thigh red, swollen, itching, started 4-11-07. Mother told to use Benadryl, ice, Advil/Tylenol, come back in if gets worse.
Fever, Headache, Body Aches, tiredness × 2  days finds, Tylenol and ibuprofen
Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion. Exact date of administration not provided. Patient is asymptomatic. No additional AE. No PQC. Names of vaccines involved (including lot/exp) VARIVAX W02; No additional AE; This spontaneous report was received from Physician and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (exact date not provided), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #W025274, expiration date: 10-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided). The vaccine underwent a temperature excursion of 24.4 F for a period of 5 hours 51 minutes. The vaccine did not undergo any previous temperature excursion. The patient was asymptomatic and did not experience any adverse event.
Syncope less than 1 minute while sitting 2-3 minutes following administration of final vaccine-HPV. Patient aroused immediately afterwards after touching shoulder and calling her name. Provided oral hydration of water and monitored for an additional 15minutes. Following monitoring, escorted out of clinic accompanied by her family.
1/19/22: Patient admitted for: Acute cystitis without hematuria Sepsis with encephalopathy and septic shock, due to unspecified organism Hypoglycemia Elevated troponin Acute kidney injury COVID-19 positive
She was given all of her 3 year old shots except for the flu vaccine. Previously answered: Massive mass at injection site on left thigh. High fever. Eating habits declined rapidly. Mass got massively huge rapidly within that day. Screamed whenever I tried to barely touch it or apply any heat or something cold to it. Her scream was so pitchy sounding as if someone was murdering her. She would not smile for a very long time.
The night after the shot I felt dizzy, tired, and in two days nauseous, diarrhea, headaches,  I was unable to function any daily routine.  I had no appetite and still don?t have much of one 9 days later,
This spontaneous report was received from a nurse practitioner via company representative and refers to a female child of unknown age. The nurse practitioner had received a text message from a friend who informed about another friend's child. The patient's medical history, concurrent condition and concomitant medications were all unspecified. On unspecified date, the patient was vaccinated with GARDASIL (dose and lot number not reported) intramuscularly. The nurse practitioner stated the patient was otherwise healthy until she received the injection, but following vaccination with GARDASIL, the child began to experience multiple seizures (date unspecified), lasting up to 45 minutes. The patient sought medical attention - went to emergency room (date unspecified). The outcome of the event was unknown at the time of report. Causality assessment was not provided. No further information was provided. Upon internal review, the event seizure was determined to be medically significant. Additional information is not expected as the reporter did not wish further contact.
Employee complained of heat/ flush, tingling feeling and twitching of tongue 15 minutes after receiving vaccine. Resolved after 50mg Benadryl
Pt had limpness/hypotonic episode, redness in bilateral lower extremities, splotchy erythematous rash on abdomen for less than 1 min that occurred within few minutes of receiving vaccines, but then occurred again 2-3 hours again.
Patient with no significant past medical history. had an acute STEMI 4 days after receiving Phizer COVID 19 vaccine
Body chills, weak, tiredness, headache, joint pain, fever, muscle pain, injection site pain
2 episodes of fainting with shaking; 2 episodes of fainting with shaking; foaming at mouth; Fatigue; Body aches; Headache; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at age of 22-years, on an unspecified date (Lot number was not reported), as single dose for covid-19 immunisation. Medical history included narcolepsy, dysautonomia and Postural orthostatic tachycardia syndrome (POTS). The patient was not pregnant. Concomitant medications included modafinil. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at age of 22-years, as single dose in left arm, on 26Feb2021 at 10:00 for covid-19 immunisation and she experienced fatigue, arm pain, fainting, diarrhea, hot flashes after first dose all within 48 hours. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 2 episodes of fainting with shaking, foaming at mouth, fatigue, body aches and headaches after second dose all within 48 hours. Events outcome was unknown.  Information about lot/batch number has been requested.
Patient reported her arm is sore and swollen at injection site. Lymph node in armpit is swollen beginning a couple of days past injection date.
Presented with vaginal discharge and abdominal pain. Patient had first Covid vaccine the day before. Patient admitted. Category I, without contractions by report. ROM + negative, no evidence of LOF.  Discharge noted on exam. Cramping likely due to candida vaginal infection.  Patient also has a small, external, non-bleeding hemorrhoid. Of note patient is anemic, will not accept blood products. ER MD concerned about elevated D-Dimer, however with a negative troponin and bnp this is likely normal for third trimester of pregnancy.  Discussed with Dr, patient to follow up in clinic outpatient.
pt recv vax 3MAR97;that evening began to run temps & become fussy 4MAR97 started w/fevers of 104 & inconsolable crying;saw MD 4MAR; dx w/moderate rxn to pertussis vax;
Fridge Temp excursion on multiple dates, IPV administered and was not viable at time of vaccination.
This subject is a 79 year old female who died while enrolled in a Comparative Randomized Study of Safety and Immunogenicity Of A Non-Adjuvanted RSV Vaccine VS. An RSV Vaccine Adjuvanted With Aluminum Phosphate When Administered Concomitantly With A Licensed Influenza Vaccine in High-Risk Adults > or = 65 Years Of Age. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/21/03. The subject died on 1/13/04, 84 days post immunization. The investigator has not reported the causality. Additional info to follow when available. Additional information received 27Feb2004. The death was reported by the Investigator as not related to the study vaccine. Additional information received 10March2004. Copy of Death certificate received. Cause of death is not legible, no autopsy was performed. Additional information received by phone on 12Mar04. Verbal report from study coordinator that the cause of death was non-small cell lung cancer. Written following report requested. Additional information received 12Mar04. Written report: Diagnosis: Subject died on January 13, 2004. Manner of death-natural-Immediate cause-non-small cell lung Carcinoma.
I've had mild tinnitus for 20 years, only noticeable when very quiet, like at night when going to bed, but not severe enough to interfere with sleep. Ten days after the shot it was like someone flipped a switch and suddenly the tinnitus was a lot louder, to the point where it is always audible, even over other noise, and does interfere with sleep and concentration.
The evening of the vaccine visit in the morning, patient had left upper arm/deltoid pain, and pain on the left clavicular area up L neck to below L ear. Very tender over past 2 days. Has 2 posterior lymph nodes, very tender. No swelling, rashes, other areas of pain.
PATIENT STATED HER ARM STARTED SWEELING FROM INJECTION SITE TO ELBOW. PATIENT WAS IN CONTACT WITH PHYSCIAN AS WELL AND WAS PUT ON 2 ANTIBIOTICS PER PATIENT AND WAS TOLD TO MONITOR AND BE SEEN IF SWEELING DID NOT RESOLVE.
Patient received Pentacel immunization at 9:35 AM, and according to Mom the patient was screaming for several hours after getting the vaccine. Patient's left leg (where the vaccine was given) also swelled up. Tylenol dose was administered by Mom after talking to the nurses around 2:20 pm, and baby did eventually stop crying and fall asleep. Patient called back a couple hours later and baby was doing much better.
Brain fogginess, more than original Dx of ADHD.  No treatment for this.  Outcome: pending as this continues to be a current issue.
This case was reported by a consumer via call center representative and described the occurrence of burning leg in a 73-year-old male patient who received SHINGRIX for prophylaxis. On 23rd March 2019, the patient received SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced burning leg and pain burning. On an unknown date, the outcome of the burning leg and pain burning were unknown. It was unknown if the reporter considered the burning leg and pain burning to be related to SHINGRIX. Additional details were provided as follows: The patient received shot of SHINGRIX in the left arm. Twenty four hours after vaccination with SHINGRIX, the patient experienced burning sensation 2 inch forward to hip bone. The patient stated that this actually felt like shingles pain but no welt or blister was present.
Headache, vomiting, leg cramps (tylenol, and fluids  lasted 2 and half hours with great fatique following
Soon after vaccination developed warm red area at site of MMR and VARIVAX shots. Child fussy no hives. Borders marked in ink; observed for 30 min. no increase in size of red area. Local vaccine reaction.
This spontaneous report as received from a nurse via company representative refers to a nurse's son, a child patient of unknown age. On approximately 15-AUG-2013 (reported as 3 weeks ago) the patient was vaccinated with the second dose of VARIVAX (Merck), injection (dose, route, lot number and expiration date not provided). Concomitant therapies included meningococcal vaccine (manufacturer unknown), first dose of GARDASIL, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) and first dose of hepatitis B vaccine (manufacturer unknown). On approximately 16-AUG-2013 (reported as formed one day post vaccination) the patient experienced severe local injection reaction, a large, hard lump that was red and hot to touch. All symptoms resolved within one week's time. A treatment was given for adverse event: CLARITIN or BENADRYL and supportive care (unspecified). Relatedness between vaccination with VARIVAX (Merck) and severe local injection reaction, a large, hard lump that was red and hot to touch was not reported. Additional information has been requested.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-MAR-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 632 hours, with the lowest recorded temperature of 34 degrees Fahrenheit and the second lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 10 weeks old female patient who received a dose of PENTACEL C5545AA, 06-Oct-2019, in the left thigh on 11-Sep-2018, which was incorrectly reconstituted. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation; and ROTATEQ for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that the liquid portion was not given at all and the lyophilized powder portion was reconstituted with 0.5 NS/ 5 ml. Liquid lot number: C5408AB and Lyophilized Powder: Lot C5545AA, expiry date: 06-Oct-2019 for both. It was reported the patient did not experience any adverse event. 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. List of documents held by the sender: none.
606 doses were given after expiration date; Product storage error; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
epilepsy; Information has been received from an office manager from a medical facility via a company representative reporting on the daughter (of unknown age) of the owner of the facility. The reporter did not know the patient's concurrent conditions, medical history, or concomitant medication.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On an unknown date, the patient experienced epilepsy. It was unknown if treatment was given for the adverse event. The office manager stated that according to the owner of the facility, the quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) vaccine "triggered epilepsy in their daughter," so their facility would never provide vaccinations for patients as directed by the owner of the facility.  The outcome of epilepsy and the causality between the event and the vaccine was not provided.  Upon internal review, epilepsy was considered to be medically significant.
Mom described "jerking movements" of entire body w/high temp of 103 w/APAP q 4 hrs; Also reported high-pitched crying for several hrs; referred to MD no sx of neurological problems @ present;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 13-OCT-2016, at a pharmacy, the patient was inoculated (by an unspecified person) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-OCT-2016, he was treated by a physician assistant at an Urgent care facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The male patient has been prescribed Famiciclovir (as reported) for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Positive rapid test for COVID; Positive rapid test for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EM9809), on 06Nov2021 as dose 2, single (Lot number: EN6203) and on 08Dec2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Nov2022, outcome "recovering" and all described as "Positive rapid test for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Nov2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
This spontaneous report as received from a licensed visiting nurse refers to a 7 months old female patient. The patient was inadvertently vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot # 0555AE: expiration date 14-DEC-2014) on 22-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
At 11:20am on 2/28/2021 I started running a fever of 103 then 108.  My fever went down around 8pm.  I started experiencing extreme pain in my Achilles tendon and pain in my left hip.  I had diarrhea and fatigue.  Went telehealth visit on 3/1 and was advised that those are normal side-effects and to use my inhaler.  Slowly things started getting better.  Felt weary on 3/2 and I had a numb feeling on my big toe and my fever broke.
Within 15 minutes I had trouble breathing. I really wanted to be vaccinated, so I didn?t tell anyone, left the pharmacy where I had it done and waited in the parking lot. I couldn?t breathe well, my legs were shaking, throat tightening, nose running, and everything went white and I nearly fainted. I waited for 3 hours and felt better to drive. The next day it happened again, so I went to the hospital. They gave me a steroid. I felt better, but still had symptoms of throat tightening, light headedness, my heart was racing, legs shaking for 10 days. On day 4 I think I went to see a HCP and she recommend I see an allergist. The allergist did a skin test. I had a mild histamine reaction to polyethylene glycol, which would mean an injection might result in a more severe reaction.
Vfib cardiac arrest admitted to the ICU one week after receiving second dose of Pfizer vaccine. Unclear if related to vaccine administration but pt is 22 years old with no prior cardiac history.  Pt still currently admitted but recovering.
Brief syncopal episode, fell from chair, struck head on floor, suffered small laceration and abrasion to left eyebrow.