chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable Medical Assistant who reported on behalf of physician and from a contactable physician. A 64 years old female patient received PREVNAR 13 (Lot #: J67645, Exp date: 01Mar2016) on 16Dec2014 at 2.30 PM at 0.5 ml, single dose intramuscular in the right deltoid. Patient was vaccinated at private office and vaccine was purchased with private funds. The patient previously received a flu shot on unspecified date in Sep2014. Medical history included endocrine disease, hypothyroidism, hyperlipidemia, hypertension, thyroid tumor, hysterectomy and latex allergy. Patient had no smoking history, denied drug and alcohol use. Concomitant medication were not provided. No other vaccines were given same day nor in 4 weeks prior. On 16Dec2014 the patient experienced local swelling, arm was red and warm to touch localized to administration site. The patient experienced also aching (on a scale 0-10 she rated pain as 8). The patient reported to ER on Saturday 20Dec2014. Patient arrived ambulatory, gait was steady, she appeared comfortable, cooperative, alert, oriented to person, place and time, well-groomed, with arm, dry, normal in colour skin, mucous membranes pink, moist. Right upper extremity assessment findings included capillary refill less than 2 seconds, skin color red to right deltoid, skin temperature hot to touch, distal sensation intact, muscle tone normal, muscle strength 5, no edema present. The patient was not hospitalized. She was sent home, no treatment done per medical assistant. Medical assistant denied other symptoms on day of ER visit. IV therapy was indicated for hydration, established to the left hand using a 22 gauge catheter in one attempt. IV site was prepped with CHLORAPREP, saline lock was established, flushed with normal saline 10 ml. After procedure, there was no drainage at IV site, no swelling at IV site, no redness at IV site. IV was discontinued due to patient being discharged. The patient received prescription of oral acetaminophen at 650 mg, MOTRIN and PERCOCET. The patient received prednisone from 22Dec2014 to 24Dec2014. The patient recovered from the events on unknown date. Lab data included blood pressure at 158/94, pulse at 76, respiratory rate at 16, temperature at 97 (oral), pain: 8, O2 saturation at 98 in room air. On 20Dec2014 prothrombin time, basic metabolic panel and complete blood count with Auto Differential were measured. Follow-up (29Jan2015): Follow-up attempts completed. No further information expected. Follow-up (13Feb2015): New information from a contactable physician includes: medical history, vaccination time, concomitant medication, events clinical course, additional event, treatments received, lab data. Follow-up attempts completed. No further information expected.
Fever, upset stomach, muscle aches. Fever and muscle aches diminished after about 6 hours.
tingling on his back; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (tingling on his back) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PARAESTHESIA (tingling on his back). At the time of the report, PARAESTHESIA (tingling on his back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Child developed intussusception 7 1/2 weeks after receiving second dose of ROTATEQ. 6/18/08-records received for DOS 5/19-5/24/08- DC DX: Colocolic intussusception. One day history of lethargy and irritability. Diet refusal, non-bilious emesis and mucus bloody stool. Exploratory laparotomy and reduction. Post op abdominal pain with repeat ultrasound negative. Foley catheter placement.
Patient with Moderna COVID vaccinations who admitted to hospital with COVID complications and ultimately died on hospice services.  Hospitalist d/f note below:  "61 YO year old male with a history of polycystic kidney disease s/p renal transplant, left breast cancer, T-cell leukemia, T2DM, and hypertension who presented to the ED on 5/1/2022 with generalized weakness.    2 weeks prior to admission had exposure to a sick contact, since then experiencing generalized weakness and fatigue with chills, lightheadedness, shortness of breath, and a productive cough or thick, clear sputum. His brother, went to check on him the day of admission and found him in his room covered and feces and confused. Labs and chest xray were consistent with COVID19 pneumonia and he was treated with steroids, remdesivir and supportive treatment. Pulmonology was consulted which suggested starting anti-biotics for concerns of superimposed bacterial pneumonia and aggressive diuresis. Fungal cultures revealed a reactive Coccidiodes ab and he was started on voriconazole given his immunocompromised state, though there can be cross reactivity with histoplasma ab. He is DNR/DNI aggressive care so bipap,cpap were used for his oxygen needs. Throughout his course his respiratory status continually declined and he developed worsening kidney failure. Palliative was consulted to discuss goals of care. Brother is the patients POA and as the patients status continued to decline, family decided to transition to comfort care and hospice was consulted for GIP status, and was accepted. Patient will transition to hospice inpatient care. "  After admitting to hospice services patient died.
Flu shot given on 12/04/2001. Pt has been experiencing muscle soreness to left shoulder and back once a month.
Rigth arm swollen / right arm with hard bump; Rigth arm red; Rigth arm tender, painful; Rigth arm warm to touch; Labelled drug-drug interaction medication error; vaccine administered at inappropriate site; This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 16-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 7AR35, expiry date 30th June 2020) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number ABX6C1AA, expiry date 30th June 2020) for prophylaxis.   On 3rd September 2019, the patient received Fluarix Quadrivalent 2019-2020 season .5 ml and Bexsero .5 ml. On 3rd September 2019, unknown after receiving Fluarix Quadrivalent 2019-2020 season and Bexsero, the patient experienced labeled drug-drug interaction medication error and vaccine administered at inappropriate site. On 5th September 2019, the patient experienced extensive swelling of vaccinated limb, erythema of extremities, pain in arm and skin warm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities, pain in arm, skin warm, labeled drug-drug interaction medication error and vaccine administered at inappropriate site were unknown.   The reporter considered the extensive swelling of vaccinated limb, erythema of extremities, pain in arm and skin warm to be possibly related to Fluarix Quadrivalent 2019-2020 season and Bexsero.  Additional details were provided as follows: The patient received dose of Fluarix  tetra and Bexsero in the right deltoid on same day, at same site, which led to labeled drug-drug interaction medication error and inappropriate site of vaccine administration. The reporter stated that, the patient went to urgent care on 5th September 2019 for right arm swollen, red, tender, painful and warm to touch. The  patient follow up on 6th September 2019 at primary care provider for right arm swollen, red, tender and now with hard bump. The patient was seen and treated by provider. There was discrepancy in the suspect reported. The supect vaccine was updated as per sale's data sheet.
Patient said she had difficulty swallowing and speaking. 20-30 minutes after vaccine. Called 911 and pt went to hospital and was there for several hours. Husband of pt did say she has panic attacks.
rash; This is a spontaneous report from a non-contactable Other HCP (patient). A 40-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ek5730), intramuscular in left arm on 16Dec2020 10:00 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included none. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included influenza vaccine (FLU) on 01Dec2020 at single dose for immunization. The patient experienced rash (non-serious) on 16Dec2020 16:00. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of rash (Benadryl). The outcome of event was recovered in Dec2020.  No follow-up attempts are possible. No further information is expected.
Got the shot and still get Shingles/Suspected vaccination failure; Shingles, mild case; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received Shingles shot. The reporter stated that after received Shingles vaccine the patient still get shingles, but very mild cases. Follow-up would not possible as no contact details were available. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Information has been received from a company representative concerning her 9 year old son with no drug reactions or allergies, and a history of pharyngitis streptococcal who in "1999" was vaccinated subcutaneously with 0.5ml of RECOMBIVAX HB. Concomitant therapy included amoxicillin (+) clavulanate potassium. On 18-JUN-2007, the patient developed a breakthrough of varicella. The break out consisted of at least 150 lesions. Unspecified medical attention was sought. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
Employee felt flushed. Raspy voice and the feeling of facial swelling approx. one hour after flu vaccine on 10/01/2018. Received BENADRYL 50mg IM in Employee Health at 3 PM.
This spontaneous report as received from a 39 year old male patient with FLEXERIL allergy. On 12-MAR-2013 the patient was vaccinated with ZOSTAVAX (route, dose and lot # were unknown) in the right arm. On 12-MAR-2013, the patient noticed a few bumps on his neck, injection site swollen, warn and hard to the touch the rash was from the right side going across shoulder to the left side and down almost to the injection site. Next day on 13-MAR-2013 his physician instructed to take BENADRYL and if rash did not go away by 14-MAR-213 to call physician back for further instruction for treatment. The patient was prescribed the KEFLEX and MEDROL 4 mg for the reaction to ZOSTAVAX, the patient also stated a second vaccine was given in the same arm on the same day it was called Tetnus (with whooping cough) he believed it was called T-dat diphtheria, pertusis) however this site of the ZOSTAVAX was the only site that felt warm to the touch, swollen and hard lump. No lab diagnosis studies performed. The patient had sought medical attention. The outcome of events was unknown. The relationship between events and ZOSTAVAX was unknown. Additional information is not expected.
Patient is pregnant and received the 1st dose of Moderna vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant and received the 1st dose of Moderna vaccine) in a 30-year-old female patient (gravida 3, para 1) who received mRNA-1273 (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion on 15-Apr-2017 and Delivery (Live full-term birth) on 18-Jan-2018. Concurrent medical conditions included Drug allergy (to augmentin) and Shellfish allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. The patient's last menstrual period was on 24-Sep-2020 and the estimated date of delivery was 01-Jul-2021. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant and received the 1st dose of Moderna vaccine). The patient received mRNA-1273 beginning around the  fifteenth week of the pregnancy.  On 06-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant and received the 1st dose of Moderna vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2020, Pregnancy test: poitive (Positive) positive.     The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
5/3/10 - Left facial droop. 5/10/10 - small improvement - eye patch at school. Treated with steroids and acyclovir. 5/24/10 - symptoms improved.
pt recvd vax & had a rash over entire body; afebrile; not seen in office; on picutres of rash (taken by pt's mom), rash appears like a flat rash w/irregular shapes;
10/20 Had severe abdominal pain and went to ER. There, I had a Abdominal and Transvaginal Ultrasound. There were also blood and urine test. After this discovery, follow up was scheduled for 12/14/2021 Ovarian Cyst ruptured and a few fibroids was left. Birth control was prescribed to prevent future cyst development.
No Additional AE; a patient was inadvertently administered PROQUAD after it suffered a TE.; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 03-OCT-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHa) (involved lot # was x014623, expiration date: 18-NOV-2024 [verified to be valid]); 0.5 ml/ series, administered for prophylaxis (strength, and route of administration were not provided). Temperature excursion was -14 degree Celsius (C) and time frame was 40 hours 0 minutes 0 seconds. There was no previous temperature excursion nor report of adverse effect or product quality complaint involved.
Numbness on left side of body (face, arm, leg)  onset at 12:25pm approximately 3 hours after leaving vaccination facility. Dizziness. Heart palpations. Numbness subsides 24 hours later, and had tingling sensations in left hand/ fingers 6 days later.
Patient developed a headache 1 day after administration. The headache did not go away until 23 days later. She developed muscle weakness on day 13. Headache was so severe on day 17 she went to instacare clinic, and then went to ER where they did bloodwork labs, brain scan, and a lung scan. Nothing abnormal. Was given oxycodone, morphine for pain. Also took ibuprofen and TYLENOL for pain. On day 23 symptoms disappeared.
This spontaneous report was received from currently 66-year-old female nurse, who was reporting on herself via a company representative. No information regarding the patient's concurrent conditions, medical history and concomitant medications was reported. On an unknown date, (reported as "at the age of 60"), the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). The patient was unsure how the vaccine was stored and at the time of the report she wanted to receive a second dose  of ZOSTAVAX. The patient asked what are the side effects of receiving a second dose of ZOSTAVAX. Additional information has been requested.
Patient admitted to the ED, who tested positive for covid-19 for further management of acute abdominal, low back, spinal, and neck pain with multiple other complaints.   She was found to have MRSA bacteremia secondary to Infective Endocarditis complicated septic pulmonary emboli. Patient cultures became negative on 09/10 and ID recommended an extended course of IV antibiotics due to difficulty clearing cultures (9/10-11/05).   Viral pneumonia secondary to SARS/COVID-19 pneumonia - patient was isolated   Constitutional: Positive for appetite change, chills, fatigue and fever.  HENT: Positive for rhinorrhea. Negative for congestion, sneezing and sore throat.   Gastrointestinal: Positive for abdominal pain, diarrhea, nausea and vomiting. Negative for constipation.   Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
I got my JAB around 2:30 on Wednesday, August 25. Yes, I was a little anxious not in a good way, but I did it. First sign of trouble may have been when I got up from the chair after the JAB, I had a splint second of dizziness, but brushed it off as normal, because this does happen to me when I get up too fast due to low blood pressure.  *(1) I was brought to waiting area for a 15 minute watch period. I set my phone for 15 minutes and felt ok during this time, just anxious to leave, concerned about what I have done. Was it smart or not.  As I walked out of the building to my car, I started feeling tingling in lower face. As I drove out of town it got worse but not overly concerning yet. I had numbness/tingling on both sides of lower face. During this time he called me, and I told him I was considering staying in town, but decided to drive home, and if it continued or got worse, I would go the ER. The sensation lasted for about 30-40 minutes I kept checking my smile for any changes during this time. It felt like after a dentist numbs your mouth for dental work and it's wearing off, just before you can eat again without biting one's lip or tongue. For the rest of Wednesday night, I can't say if there was a strange feeling or not, but I was a bit anxious.   Thursday morning, I woke up about 5:00am and knew something just didn't feel right with lower face, especially right side. When I finally checked in the mirror I noticed two reddish spots on the right side of my face near the mouth, one of these spots had a slight indentation, plus from nose to the mouth region I noticed wrinkles that were more defined. I took pictures to see the changes. Finally, at 7:20am I decided to go to Urgent Care before work instead of waiting to see if feeling subsided and face changes would reverse themselves. But I thought I remembered from my previous Bell's Palsy episode (at the time I couldn't remember date, but now I know it was 2002 diagnosed by Dr.) that treatment needed to start soon after episode so that damage would not be permitted (that episode was more severe affecting my smile.)  When I got to the hospital, I went to Urgent Care but was sent to ER. I was very anxious at time and being sent to ER made it worse (see my experience with ER to why my anxiety was high), it was obvious because I was not thinking clearly (but your staff wouldn't have known that), I kept my foot moving, and kept moving my hand cause beeps with oxygen, pulse monitor. I did mention to the nurse I was having anxiety issues over this.   I am grateful I took pictures, because it keeps reminding that it wasn't just in my head, because I had the feeling that is what the staff thought, especially seeing it was hard see the difference.   Later when I was able to review what the ER wrote I began angry, that's when I decide to take report on my own. They wrote information of events wrong, ER doctor stated he told me it wasn't due to vaccination. He never said that to me. His notes stated because symptoms began 2 hrs after vaccination  (which was wrong time frame).  Reason I'm upset, because CDC site even states side effects can take up to 48 hours to happen.
severe illness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "severe illness".  Additional information: Calling about the Pfizer COVID-19 vaccine. The reporter added that she lost her nephew due to a severe side effect and a heart attack after getting the vaccine and her niece got a severe illness from taking bad shots of the vaccine. The reporter also said why we are giving this to people and it's having side effects because it was not tested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 27-FEB-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 intramuscularly, lot # L014458, expiry date 11-FEB-2017 (anatomical location and dose were not reported). No adverse events were reported. Additional information has been requested.
GIVEN A PEDIATRIC PFIZER VACCINE WITHOUT DILUTING. AS OF YESTERDAY, PATIENT IS FINE. IN CONTACT WITH MOM YESTERDAY, AWAITING UPDATE TODAY.
Pt vax w/1st & 2nd doses 28Aug96 & 02Oct96. Pt 1 wk pregnant @time of 2nd dose. Pt delivered boy baby (7lb2oz) 06June97.Birth vaginal & no med. Apgars 7 @1min. & 9 @5min. Baby had some difficulty with the swallowing reflex.