chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chest hurts/Complained of intermittent left chest pain with exertion x 2 days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7-year-old male patient received BNT162b2 (BNT162B2), on 03Aug2022 as dose 1, single (Batch/Lot number: unknown) at the age of 7 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID 19" (unspecified if ongoing). There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 20Aug2022, outcome "recovered" (22Aug2022), described as "chest hurts/Complained of intermittent left chest pain with exertion x 2 days". Therapeutic measures were not taken as a result of chest pain.Additional information: Patient didn't receive any other medications in two weeks and other vaccine in four weeks. Patient had no known allergies. Other medical history was none. Patient Grandma reported that, 16 days after vaccination child was running and playing in the yard when he stopped, grabbed at left chest and stated "Grandma my chest hurts". Sat down and rested. Got up to play again and started running around, stopped and went to grandma and said "Grandma my chest hurts". Rested, pain resolved. When I picked him up (I'm mom) that evening I was told the above. Out of character for child to c/o chest pain. No significant previous health history. Grandma did not even know child had been vaccinated. Child wouldn't have known that's a potential adverse reaction Complained of intermittent left chest pain with exertion x 2 days. Symptoms fully resolved on their own after 2 days. Did not see health provider during those 2 days. Recently did have well child visit and physical exam was WNL Timing is a bit extended as compared to published data on chest complaints, however, wanted to report in case it was related to COVID vaccine. Patient didn't tested COVID post vaccination. This case was reported as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11/21/01 employee came to employee health office and stated she develoepd a rash on her neck and fast last Sunday and had now progressed to her chest, back, BUE's except palms and more faintly on BLE's. Rash is reportedly pruritic, hot, nonraised and reddish without open areas. Emploee saw doctor on this am for rash. Referred to FNP for consult. Saw FNP with assessment documented with "non-specific UH care." Put on Prednisone withdiscussion hydrocortisone cream and oatmeal baths . Potential allergic reaction.
Chest pain left side 4 days after vaccine.  EKG  11/3/2023 normal but nobsymptoms at time of ekg.
A female infant, who was five months of age at the time of the report, had received a first dose injection of PENTACEL (lot number, route, site and date of administration not reported) "months ago", and an unspecified amount of time later, she experienced persistent crying and a blackish-blue discoloration at the site. Outcome was not reported. It was not reported if the patient had any concurrent illness, past medical history or concomitant medications usage at the time of the event. Outcome was not reported. This patient subsequently experienced this same event after receiving ACTHIB, which has been captured in case number 2011-02903. Documents held by sender: None.
Foetal exposure during pregnancy; Low birth weight; This is an observational study case, initially received from other health professional on 04-Oct-2019, concerning a female, neonate subject, whose mother was a 28-year-old female of body weight 115 lbs, height 63 inches and body mass index (BMI) 20.4 and father 56-year-old, enrolled in a prospective observational safety study.   The mother's medical history included schizophrenia bipolar and trichomonas. The mother's past medication included Metrogel (metronidazole) for trichomonas. Concomitant medication included Prenatal vitamins (minerals not specified (nos), vitamins nos) for pregnancy and Zoloft (sertraline hydrochloride) for bipolar.   The mother's obstetrical history included two previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The mother used tobacco during pregnancy and the amount of consumption was reported as half pack per day. The mother did not use alcohol and illicit drugs during pregnancy.  The mother's last menstrual period (LMP) was on 14-May-2018 and type of pregnancy was singleton. The estimated date of delivery (EDD) and corrected EDD (CEDD) of subject's mother was reported as 18-Feb-2019.   On 21-Aug-2018, the mother underwent spinal muscular atrophy and cystic fibrosis mutation analysis and no MCMs were noted.   On 06-Sep-2018, the mother underwent ultrasound scan and Qnatal test and no MCMs were noted.  On 09-Oct-2018, at approximately 21 weeks of gestation, the mother was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-subunit, batch number: 252664, dose: 0.5 ml, route of administration, expiry date and anatomical location: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.   On 06-Dec-2018 and 17-Jan-2019, the mother underwent ultrasound scan and no MCMs were noted.   At gestational age of 37.3 weeks, the mother vaginally delivered live female neonate. The characteristics of neonate included birth weight: 2155 grams, head circumference: 30.5 cm and length: 45.7 cm. Appearance, pulse, grimace, activity and respiration (APGAR) scores at one minute was 8 and at five minutes was 9. The neonate had no MCMs identified at birth.  At the time of initial reporting, the outcome of the event of low birth weight was not reported.  The case was assessed as serious and the reporter did not provide causality assessment.  This case is linked to the case 201905078 (the corresponding maternal pregnancy report).; Sender's Comments: Reportedly, the female neonate subject was delivered as low birth weight baby after foetal exposure during pregnancy with the suspect product Flucelvax QIVc. Chronology is plausible. Mother's medical history of trichomonas and tobacco use may provide alternative aetiology for the event. Causality was also confounded by use of concomitant drug, Zoloft (sertraline hydrochloride). Foetal exposure during pregnancy is assessed as not related per company conventions. Causal relationship between the suspect product and the event low birth weight baby is assessed as unlikely related.
On 1-7-22 at approximately 7:15 a.m., I was getting ready for work and curling my hair.  My heart rate became rapid and I immediately checked the same with a pulse ox, at that time the rate was 165.  My neck became tight, I was short of breath, severe headache.  After about 20 minutes my heart rate slowed to approximately 120.  At 9:00 a.m., I contacted my PCP and went to an office visit that day.  I had an EKG done in the office which I believe was around 100 at that time. I was diagnosed with tachycardia.   I  do not have any nor have I ever had any heart issues prior to this time.  My NP prescribed verapamil and later Metoprolol, which over the course of the last nine weeks the dosages have been adjusted.  Currently I am taking 1/2 of a 25 mg metoprolol in the a.m.   I continue to have irregular heart rates tachycardia 100+ and bradycardia anywhere between 40 and mid 50s.    I have  continued symptoms such as SOB, atrial flutter,  sensations of heart skipping, headaches that seem to be worse when my heart is fluttering.  carotid artery pressure.  Chest pressure and discomfort.
Pounding heart rate; rapid heart rate like it was pounding out of her chest; Felt faint; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3246), intramuscular in left arm, on 15Jan2021 at 14:15, at 0.3 mL, single, for COVID-19 immunization. The patient's medical history included attention deficit hyperactivity disorder (ADHD). The patient's concomitant medications included amfetamine aspartate monohydrate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (MYDAYIS), buspirone hydrochloride (BUSPAR), and ethinylestradiol/ norethisterone acetate (MICROGESTIN). The patient previously took cefotaxime sodium (OMNICEF) and amoxicillin sodium/clavulanate potassium (AUGMENTIN) and experienced allergies to both drugs. The patient worked on a COVID-19 study. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 18Jan2021 at 03:00 AM, the patient had a pounding heart rate beginning two days after vaccination and had felt faint. The patient received her first dose on Friday and then last night (3 AM; also reported as 2-3 AM) she started having rapid heart rate like it was pounding out of her chest. It woke her up in the middle of the night around 2-3 AM so it was this morning around 2-3 AM. The patient can still feel like her heart is pounding out of her chest, but it is improved a little bit since it began. It is a little better now but is still persistent. No treatment was given for the adverse events. The patient was not sure if that is something that has been reported before. She did not know what to do but she wanted to try to find out if it was because of the vaccine. The patient did report it online already, she did the event reporting, but she would be happy answer more questions. The patient has not been tested for COVID-19 post-vaccination. The patient was recovering from the events
Information has been received from a physician concerning an unspecified patient. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot number was not reported). Following the administration of the vaccine, on an unknown date the patient experienced Guillain-Barre syndrome (GBS). The physician reported that the patient's GBS "cleared up" on unspecified date. Upon internal review, GBS was determined to be an other important event. Additional information is not expected because the physician is not allowed to be contacted.
HMS DISCHARGE SUMMARY -- Hospital    Admitted: 10/12/2023 Discharge Date: 10/15/23    PCP Handoff    Recommended Outpatient Testing o None   Results Pending At Discharge o None       Clinical Summary   Patient is a 31 y.o. female patient of DO with history of persistent recurrent asthma, headaches presented to Hospital with cough and shortness of breath.   Moderate persistent asthma with acute exacerbation COVID-19 infection Acute hypoxic respiratory failure - resolved X1 week flulike symptoms, sore developing shortness of breath Chest x-ray in the ED no acute findings Dropped to 89% in the ED requiring 2 L nasal cannula Cont albuterol inhaler, start home dulera, singular, cont decadron Cont remdesevir  Weaned to room air today both at rest and with ambulation for >2 hours Discharge with Decadron to complete a 10 day course   Thrombocytosis Platelets on admission 499 Baseline platelets 450-500 Has seen Dr. outpatient No current malignancy concerns Likely to increase in setting of reactive state   Possible adrenal insufficiency Last admission 08/2022 had cortisol level a.m. of 1.0 We will need to await retesting after completion of steroid regimen and patient Patient states her PCP was not concerned but states was not re-checked outpatient Likely outpatient follow-up after steroid use is finished.    History of headaches Can utilize headache cocktail if needed Currently not in exacerbation Last saw neurology 10/31/2022 was recommended to stop tobacco use, started on Topamax 50 mg twice daily, magnesium, B2, co-Q10 Never started taking the Topamax as her headaches generally resolved without Rx medication   Morbid obesity BMI 46.99 Counseled on diet and lifestyle modifications Nicotine dependence 0.1 packs/day smoker Greater than 3 minutes spent on counseled on cessation NRT if needed
Got the vaccine at 10pm woke up with a sore arm. After 50 hours started getting chills, fever, headache, and hives ALL over body. It was SO bad it reached my scalp ears feet fingers too. I couldn't sleep at night. I took benadryl and Tylenol.
WORSENED METALLIC TASTE IN MOUTH; WORSENED TINNITUS; MUSCLE WEAKNESS; FEVER; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no history of ear problems.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced muscle weakness. On 10-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced worsened metallic taste in mouth. On 12-APR-2021, the subject experienced worsened tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle weakness, and fever on 11-APR-2021, and had not recovered from worsened tinnitus, and worsened metallic taste in mouth. This report was non-serious.
Vaso-vagal episode due to bearing down and hyperventilation in the setting of receiving three vaccines: HPV #1, Hep A #1 and Influenza.
Day after receiving vaccine, patient notes progressive leg swelling, facial puffiness, and feeling of neck fullness. He estimates he has gained about 20 pounds. On 4/11, he was seen at an emergency room and diagnosed with new onset nephrotic syndrome.
This spontaneous report was received from a 33-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-JAN-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, lot # and expiration date not reported) intramuscularly (IM) in the right buttock for prophylaxis (Product administered at inappropriate site). No additional adverse event (AE) was reported.
Patient states reaction started after taking shower. Both legs became red, itchy and hives. Time of incident was 10:00am on 7/18/02. Reaction stayed below both knees.
Right upper arm swollen, warm to touch, red, (fever 101-102 at home per parent), oral temperature today 99.1 F.
After the vaccines were administered patient started fainting while was on the chair. Dad held him and he was conscious and awake. his lips started swelling. Father requested to call paramedics. when they came in they check his Sugar level it was 104. his blood pressure was low and few minutes later it was normal according to the paramedics. Patient came in without breakfast
Child's grandma/guardian stated that client began stuttering her speech almost immediately after receiving vaccine. Child is also in a "daze" off and on and has difficulty finding the words to speak per grandma's report. Child also had a 102.0 fever that was treated with Tylenol.
This spontaneous report as received from a pharmacy technician concerning a currently 16 months old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 26-MA-2014, the patient was vaccinated with VARIVAX (Merck) lot #J007955; expiration date 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
I received my 2nd Moderna Covid-19 vaccine shot on April 30,2021. On May 3, 2021 I had pretty bad disequilibrium hit me for the first time in my life. It happened after driving a semi/ tractor trailer for over 30 constant miles at highway speeds. It felt like the truck was tilting over and sliding across the road. Of course this sensation happening during a rain storm made matters worse. I didn't know what was going on. I pulled over and collected myself and started back out. The symptoms would come up ever so often and I would pull over if it got bad. I went between thinking the steering on the truck was coming apart or it was me.I spent the next couple weeks taking days off, trying to rest and see if that helped. I would do short delivery runs in the truck and nothing would happen. But once I would do a load that was over 30 minutes of constant highway speed and I changed lanes of went around a curve, that feeling of tilting would come back. I changed trucks just to see if it was my assigned truck or not. Nope, it's me. I've been through vestibular  therapy since my trip to an ENT  doctor almost a couple weeks after this first started. The ENT diagnosed me with left peripheral vestibulopathy and otolith dysfunction. They didn't disagree with me drawing a line between the vaccines and my condition. They actually said there's been an uptick in patients since around March 2021. This is about the same time the ramping up of vaccinations started. The ENT doctor didn't discourage my linkage either and said that things would become more clear with data.
Information has been received from a consumer concerning her friend's son, a 7 year old male who on an unspecified date was vaccinated with MMR II. Subsequently the patient developed autism right after receiving the vaccine. The patient was not functioning as normal kid as per the reporter. The patient's autism persisted. Upon internal review, autism was considered to be an other important medical event. This is one of the several reports from the same source. No further information is available.
Adverse reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th December 2019, the patient received Shingrix. On 12th December 2019, 5 days after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's wife. The patient had receive the Shingrix vaccine and then he experienced adverse reaction. The reporter denied consent to follow-up.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; ILL; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: Overweight. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number unknown) dose was not reported, 1 total, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection. She had developed symptoms. Fortunately, she had not been hospitalized at that point but she had been very ill. Laboratory data (dates unspecified) included COVID-19 virus test (NR not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, suspected covid-19 infection and ill was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190272. This case, from the same reporter is linked to 20210839107.; Sender's Comments: V0: 20210841062- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination 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
Fever that lasted 2 days straight. Even with children's Motrin and Tylenol, fever reached 104.8 at 4 am two days after shots were received. The fifth shot was Pneumococcal Conjugate and the manufacturer was WYETH-LEDERLE. The vaccine name was not listed on the drop menu.
Received vaccine shot around 9:45 AM on Friday 4/16/21. Around 1:00 PM same day, I began to experience arm soreness at the injection site (right upper arm) that worsened throughout the day. Around 5:00 PM same day, I began to feel body aches and muscle cramps throughout my torso (worse on right side than on left side), headache, skin sensitivity to touch, and fatigue. During the night, I developed a fever (99.5 degrees). All symptoms lasted until early afternoon on Saturday 4/17/21, then began to wane in the evening. By the morning of Sunday 4/18/21, I felt fully recovered.
Felt fatigued and spacey. One sided underarm pain on same side as injection.  Also had occasional nausea.
Itchy red rash approximately 24 hours after vaccine administered. Benadryl given at night with kenalog cream applied during day.
This report was received from a licensed practitioner nurse referring to a 21 month-old child of unknown gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 17-JUL-2015, the patient was administered an improperly stored dose of LIQUID PEDVAXHIB injection (lot # K026533, with expiration date: 07-AUG-2017; dose, frequency and route were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.