chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sinus infection; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller called to ask if it was okay to get the second dose of Covid-19 vaccine scheduled tomorrow if she was currently on antibiotic due to sinus infection. Therapeutic measures were taken as a result of sinus infection. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Occurrence of a red patch on her right arm after her SHINGRIX shot Friday 05/04/2018. The area was red, tender, warm to touch and patient feels her arm was swollen. The reaction was noticed 10-12 hours after the vaccine was administered. No fever. Taking BENADRYL PRN and using cold compress on affected area.
Per patient she had swelling with the PNEUMOVAX 23 that resolved in 4 days.
Starting at approx. 3 PM on the day of my second injection I began experiencing fatigue and muscle pain coupled with tinnitus. These symptoms worsened over the next eight hours, and a fever came on long with nausea/vomiting. Today is the day after my second injection and the symptoms are still present, except for the nausea/vomiting.
Evening after shot had soreness  with warm to touch area below where vax was given. Slight stomachache and diarrhea below 12/18/2000 only. Today has right triangular area 4 x 31/2 below deltoid bruising no swelling or warmth.
Body aches, chills, severe leg pain, pain during urination, numbness in rectum, genitals, bottom of feet and abdomen.
She had been in for her 9mo well exam on 12/28/04 and was to receive her 6mo immunizations.  She received the Pediarix, Prevnar, Hib, and the Fluzone for influenza. That evening, at approximately 2100, she was taken to the local ED for a possible seizure and a fever up to 103.  With her evaluation at the ED she had a urine sample obtained by catheter that showed her to have a urinary tract infection.  It was unclear as to whether she had a primary seizure, or a seizure from the fever from the shots or a seizure from a febrile urinary tract infection.   She was fine on the day recheck in the office on 12/30/04.
Within 30 min of the shot, violent and repeated vomiting, fever, slept "like the dead" and had trouble waking him. Listlessness and will not eat. Could not keep anything down not even water or Motrin for fever. Gave him Pedialyte for dehydration (he vomited that too). When he didn't improve quickly (like from other vaccines), I called the doctor and took him in on 10/19/04. The doctor "insisted" it was the stomach flu and an ear infection, neither of which he had prior to the shot. No one at home or at school has the flu. This is unlike the other times he has had the flu in the past. Dr. gave him Motrin, an antibiotic and an antihistamine. I know this is not the flu because of the symptoms coming so soon after the shot. I want to know how to get help for him when the doctor will not admit it was the vaccination???????
Patient described experiencing itchiness in both forearms beginning 17 min post-vaccination (visibly red from patient scratching, no hives present); symptoms resolved after approximately 10 minutes.
Patient complained of  dizziness and giddiness. onsite EMS was called vitals BP 114/62  98% O2 HR 60 . Patient refused evaluation and care , released againt medical advice.
I started with diarrhea the following morning after the injection and then by Sunday I was having chest pain shortness of breath and had to go to the emergency room because I thought I was having a heart attack then I?ve been progressively having symptoms of pain to the left side where the injection was given in my arm to my lower left quadrant I?ve had severe both of stiffness muscle pain and this has been going on now since April 22
death Narrative: Patient received COVID vaccine #1 on 1/13/2021. On 1/19/2021, notes from primary care indicate advancing dementia and a urinalysis suggestive of a UTI, he was ordered a course of cefdinir and PCP at that time suggested long term care. On 2/1/2021, he was admitted to a facility for acute kidney failure and was also noted to have frequent falls at home, no scanned records from that hospitalization are available. On 2/7/2021, he discharged from that facility with home hospice. On 2/11/2021 at 0140, Patient passed away at home. No autopsy results available.
Swelling at site on right arm and swelling of her neck. Measle-type rash, onset of symptoms Friday 1/10/03. Pt's mother contacted MD. He prescribed Zyrtec 10mg 1 daily, Benadryl and Tagamet. Pt's mother called back on Monday 1/13/03 and MD ordered a 6 day DS of Steripred dose-pack.
Throat tickle; nml VS; normal exam. Took his own benadryl 50mg and observed for 20 additional minutes. Asymptomatic then; precautions given
fever; feeling sick; feeling cold; tired; This case was reported by a consumer and described the occurrence of fever in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced fever, feeling unwell, feeling cold and tiredness. On an unknown date, the outcome of the fever, feeling unwell, feeling cold and tiredness were unknown.   It was unknown if the reporter considered the fever, feeling unwell, feeling cold and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient experienced feeling of sick, cold, feverish and tried. The patient asked how long do the side effects last.
Redness, itching, swelling, warmth. Hard lump. Went to Dr. & got KEFLEX for 10 days (250mg QID).
Information has been received from a physician concerning a 57 day old male patient who on 20-APR-2011, was vaccinated with the first dose of ROTATEQ (lot number: 669827/0257AA, expiration date: 28-OCT-2012), 2 ml, orally. On 20-APR-2011, after receiving ROTATEQ, the patient experienced "loose stools for 1 month". The patient was seen by a gastroenterologist. Therapy with ROTATEQ was discontinued. At the time of the report, the patient recovered from loose stools (on 20-MAY-2011). Follow up information has been received from the physician concerning the 59 day old male patient with no illness at time of vaccination, who on 20-APR-2011 experienced non bloody diarrhea (4-8 per day) and fever (100 degrees max) for 10 days. On 05-May-2011 hemoccult test, stool O and P (stool ova and parasites) test and rotavirus antigen by enzyme immunoassay (x2) were performed which showed a negative results. It was reported that the patient recovered by 19-MAY-2011. No further information is available.
Left arm pain on movement, nauseous, trouble breathing and swallowing water, swollen lips, hoarse voice, tongue feeling thick. Administration of EPI 0.3 mg IM, TORADAL 15 mg IV; ZOFRAN 4mg IV; DECADRON 10 mg IV; BENADRYL 25 mg IV
Redness around eyes; throat closing; trouble breathing (started about 3 hrs after shot given)
Pt develop rash/allergic itching on face and head by 11-3-13. Has subsided since then on 11-6-13 eyes are swollen. Pt was advised to see MD and to take antihistamine, took CLARITIN.
Within 10 minutes, area around injection site became red & hot to the touch. Gave pt diphenhydramine 25mg and put cold pack on site.
SWELLING, REDNESS, ITCHING, WARMTH.  PATIENT STATES SHE TOOK BENADRYL AND IT GOT BETTER.
was tired; had a lack of energy; sore throat; she felt like she had a virus; sinus issues; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included drug allergy.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced tiredness, loss of energy, sore throat, viral infection and sinus disorder. On an unknown date, the outcome of the tiredness, loss of energy, sore throat, viral infection and sinus disorder were recovered/resolved.   It was unknown if the reporter considered the tiredness, loss of energy, sore throat, viral infection and sinus disorder to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received flu vaccine and felt like had a virus, was tired, had a lack of energy, sore throat and sinus issues.  The patient reported these events would last a few days to a week and then resolved. The patient reported usually received the flu vaccine in the left arm 90 percent of the time.  The patient did not know the name of the flu vaccines received and did not had lot number or expiration date information to provide. The reporter did not consent to follow up. This case linked with US2020AMR219428 and US2020AMR219429, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR219428:season 2012-2013 US-GLAXOSMITHKLINE-US2020AMR219429:season 2013-2014
This spontaneous report was received from a medical assistant and refers to a currently 11 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L024993 with expiration date 17-SEP-2017, (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Sometime end of August, He started rolling his eyes, but we thought it was just something he was doing. Later he started shaking his head involuntarily. During the month of November, when he started shaking his head so many times and clenching, it concerned us. When we read online, it sounded like Tics. Thinking back, it all looks like it started after vaccination.
Patient notes having  syncopal episode a few minutes after having vaccination. He admits that this occurs every time he gets shots and gives blood. His seat was placed in recumbent position. He was slowly responsive on initial assessment. VSS. Patient was observed for 30 minutes, during this time he took in juice pouch and water. On re-evaluation patient states he felt much better.
The vaccinating pharmacist had administired the Moderna vaccine to the patient.  Upon data entry, which took place after the vaccination, the pharmacist realized the patient was only 17 years and 6 months old which does not fall under the criteria for vaccination guidlenes as per the CDC and FDa.  The patient and the patient's mother was informed immediately of the incident.  The supervising pharmacist (myself) contacted Moderna's Vaccine reporting team and informed them of the incident.  The patient has been found to be safe and asymptomatic so far.  We will call the patient's mother weekly to check in on his health.
Patient presents to clinic with left leg redness and swelling.  (8.5cm x 5.8cm area).  Received PrevNar vaccine on 04/29/2003.  No fever noted.  Diagnosis: Localized PrevNar reaction.  Treatment: Benadryl liquid as occasion requires.
Intense Left Arm Pain and Swelling lasting more than one week. Pain disrupting sleep and day to day activty.
day 7 post vaccination woke with headache, as the day progressed tightness of the chest, but no difficulty breathing.  day 8 post vaccination large welt - 1 inch in diameter appeared  around 2 pm in the afternoon, slight itchy,  firm to touch, redness, and slight discomfort in muscle  left arm  day 9 post vaccination, welt still present, redness, not as firm as day 8, more discomfort in the muscle of the left arm
Headache, Myalgia, Arthralgia, Rash, NauseaVomiting, CHILLS, AND PAIN, REDDNESS, SWELLING, ITCHING, AND WARMTH AT THE INJECTION SITE Narrative:  Other Relevant History:
palpitations, flushed, pre-syncopal. Evaluated by EMS-Cleared
Patient was sitting in observation area. Complaints of feeling light-headed. Complaints of redness to right forearm. No redness noted, Alert and oriented. Declined lying down on cot. Snack provided. States feeling better.
Difficulty breathing, took antihistamine , continuation of difficulty/labored breathing 2 days later, but not as severe
Bell's palsey right side. Sharp pain in jaw, front of ear, headache over right eye. Advil releaved pain. re-eoccured in jaw and eye once also relieved with Advil. Eyebrow droop lasted 1 week. All symptoms gone after 1 week following dose 1 of Pfizer vaccine.  Symptoms re-occurred following dose 2 of Pfizer vaccine which was on 2/20/2021. Began with right eyebrow droop 1 day/evening after vaccination. Next day right side headache, ear ache face pain. Advil relieved pain which recurred several times each time Advil wore off. Now 4 days after vaccination and symptoms seem to be lessening. Continue to have eyebrow droop.
,Vaccinated Monday, developed muscle pain, headache and headache by Tuesday, fatigue later Tuesday  as well, continued with fatigue, headache and muscle pain Wednesday and Thursday side effects greatly decreased
25 March 2021  Woke up with severe pain, left chest, breathing was fine, however, it was very painful to breath, laugh, cough or sneeze and walking. It was painful to roll out of bed each morning at least for a week or so. I live with the pain/discomfort for a few days, thinking it would get better.   30 March 2021  I called my PCP, who had no appointments, I ask the appointment person to have someone from her office call me. They call back later in the day and said that the dr was fully booked and ask if I was willing to see someone else, answer was yes.  see continuation page
Face itchy; L arm Itchy / Face itchy; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRURITUS (Face itchy) and INJECTION SITE PRURITUS (L arm Itchy / Face itchy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 23-Feb-2021, the patient experienced PRURITUS (Face itchy) and INJECTION SITE PRURITUS (L arm Itchy / Face itchy).   At the time of the report, PRURITUS (Face itchy) and INJECTION SITE PRURITUS (L arm Itchy / Face itchy) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
very agitated, unusually low blood sugars, feeling of something crawling under her skin, picking at and cutting fingers
Resident received step one of Moderna Vaccine on 01/05/2021 which was within 14 days of receiving PPSV-23 on 12-26-2020 No adverse reactions observed within 48 hours after receiving vaccine
swelling and redness from site of injection to elbow and fever the night of injection day.  Fever alleviated the next day but  swelling and redness remain although improved
A 37 year old female was hospitalized on 04/27/01 for neck stiffness, myalgia, nausea, and tiredness. She had received an accidental overdose of RabAvert for post-exposure prophylaxis. The patient received post-exposure prophylaxis because she was bitten on the hand by a skunk (she raises skunks). On 04/27/01, the patient received 5 cc of RabAvert (lot #277011) instead of human rabies immune globulin (HRIG); 1 ml was given subcutaneously in each of the 2 fingers that were bitten, and 3 ml was given intramuscularly in the deltoid region. The patient was exposed to rabies 2 years ago, but never received post-exposure immunization. The patient's physician stated that the 5 vials of RabAvert, which were obtained from the Texas Dept Of Health, were held together with a single rubber band. He believed that this may have confused the nurse who administered simultaneously, and thereby resulting in overdose. The patient developed myalgia, nausea, neck stiffness, and tiredness following the injections on 04/27/01. She also had a sore deltoid muscle at injection site. She was hospitalized overnight for observation and was discharged from the hospital on 04/28/01. As of 04/30/01, her symptoms had improved considerably. After consultation with the Texas Dept of Health, the physician elected to continue the patient's treatment course with RabAvert. She received 1 ml intramuscular injections on 04/30/01 and on 05/04/01. The patient was then transferred to another physician for care, and the reporting physician expects that the patient will complete the course of RabAvert.
Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and gender patient who received vaccine IMOVAX RABIES lot N1B051M, expiry date 26 Feb 2019 via unknown route in unknown administration site on unknown date. The patient's past medical history, concomitant medication and family history were not provided. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to vaccine under dose, exposure via skin contact, syringe issue. It was reported that IMOVAX dripped on the patients arm during administration. The patient got only 3/4's of the dose. It was leaking from where the needle attaches. Unknown if it was cracked because it had already been discarded. It was unknown whether patient experienced any adverse reaction after the injection. 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 sender - none.
patient reports feeling like she has a fever, but did not check temperature. also complains of soreness and body aches.
Initial unsolicited misuse report received from the literature on 20 February 2017. This case involves an 18-month-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, dose and route of administration was not reported), in the left buttock on an unknown date. It was reported that patient was fully vaccinated, with routine vaccines at 12 months of age administered in the left thigh. Patient's medical history and concomitant medications were not reported. On an unknown date following the vaccination, the patient presented to emergency room with a rash on the left lower extremity, red patch near the site of vaccination. The patch became raised and spread down the left thigh over the course of several days. On an unknown date, 1 week; post vaccination on examination patient was afebrile, well-appearing, had multiple discrete clusters of monomorphic pink to violaceous papulovesicles with surrounding erythema scattered across the left buttock, thigh and upper calf, some with central punctate hemorrhagic crust (eruption continued to spread down his left thigh over the next 2 days). On an unknown date, following the vaccination patient was presumed with cutaneous bacterial infection and was diagnosed with Herpes zoster. It was reported that patient did seem uncomfortable when getting dressed. It was also case of vaccine administered at inappropriate site as influenza vaccine was administered one week prior to presentation in the left buttock. Relevant laboratory test included direct fluorescent antibody of a vesicle confirmed the presence of varicella-zoster virus (VZV) and some unspecified test. Patient received corrective treatment with acyclovir(deffered), cephalexin and mupirocin. Outcome of the events was recovering (patient's eruption was asymptomatic and improving by the time that test results were available). Upon internal review the case was considered as serious because of important medical event Herpes zoster. Documents held by sender: none. Sender's Comments: Patient was vaccinated with influenza vaccine and develops herpes zoster and vaccination site erythema. Time to onset is compatible, but additional information regarding patient past medical history, history of herpes infection, immune status, past vaccination history and its tolerance, etiological work up and investigation results to rule out the alternative cause are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
On April 5,2021 at 7AM both of my feet & ankles were severely swollen. I could not see my ankle bones or foot veins,  I was in no discomfort . The swelling started to decrease by noontime.  I had no treatment.
MORE MILD THAN IT WOULD HAVE BEEN HAD I NOT BEEN VACCINATED; A PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 0.5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced more mild than it would have been had i not been vaccinated, and a pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the more mild than it would have been had i not been vaccinated and a pain was not reported. This report was non-serious. The report was associated with product quality complaint: 90000186436.
Pt. rec'd 12 mo immunizations in office on 3/04/16. Seen again 3/09/16 for c/o rash (pink papular) on trunk. Other s/s -> fussy, cough, runny nose, fever (100.5-max), sneezing. Dx as URI/cough/vaccine-related rash. (Viral illness) tx with TYLENOL/MOTRIN PRN. Return if fever > 5 days or worsening.
Information has been received from a nurse practitioner concerning a female who an unspecified dates was vaccinated with the first and second doses of GARDASIL.  After the second dose the patient developed "sleep paralysis" who was diagnosed after a patient was seen at sleep lab.  The patient will not receive the third dose of GARDASIL.  Upon internal review, sleep paralysis was determined to be an other important medical event.  Additional information is not expected as the nurse practitioner requested not to be contacted.  8/29/08 Reviewed neuro medical records of 5/22/2008. FINAL DX: isolated sleep paralysis Records reveal patient experienced HA 2 years prior after 2 concussions 1 month apart from sports injuries w/resultant diagnosis of postconcussion syndrome & migraines.  Tx w/Keppra & Topamax, Elavil, Imitrex among other medications.  Currently gets HA once every 2 weeks that are less severe & respond to Advil.  Was having spells of sleep paralysis for over 1 year w/waking & unable to move arms or legs & unable to speak which last for about 1 minute about once a month.  Has abnormal & restless sleep, tired during the day.  Neuro exam was WNL on 5/22/2008.