chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 2 month old patient who was vaccinated with a 2ml oral dose of Rotateq (human bovine). Subsequently the patient vomited the complete dose. There was no time frame on when the event actually happened. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Neuropathy type symptoms (burning, tingling, pain, numbness, coldness) in both feet, lower legs, and hands intermittently, noticeable within a week or so after the first dose.
tired; swollen hand, fingers/swelling; vomiting; Soreness of both shoulders; headaches; Soreness of neck; doesn't feel well enough to work; cannot grasp things/cannot use left hand at all; Soreness of back; dizziness; pain on her whole left arm; sleeplessness; burning pain in arm of injection site; tingling in arm of injection site; numbness in arm of injection site/lack of circulation in arm of injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (tingling in arm of injection site), HYPOAESTHESIA (numbness in arm of injection site/lack of circulation in arm of injection site), NECK PAIN (Soreness of neck), INSOMNIA (sleeplessness) and MALAISE (doesn't feel well enough to work) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY XR) for an unknown indication.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 03-Feb-2021, the patient experienced PARAESTHESIA (tingling in arm of injection site) and HYPOAESTHESIA (numbness in arm of injection site/lack of circulation in arm of injection site).   On 07-Feb-2021, the patient experienced INSOMNIA (sleeplessness), AXILLARY PAIN (pain on her whole left arm) and VACCINATION SITE PAIN (burning pain in arm of injection site). On 08-Feb-2021, the patient experienced NECK PAIN (Soreness of neck), MALAISE (doesn't feel well enough to work), ADMINISTRATION SITE MOVEMENT IMPAIRMENT (cannot grasp things/cannot use left hand at all), BACK PAIN (Soreness of back), DIZZINESS (dizziness), VACCINATION SITE SWELLING (swollen hand, fingers/swelling), VOMITING (vomiting), ARTHRALGIA (Soreness of both shoulders) and HEADACHE (headaches).   On an unknown date, the patient experienced FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.   At the time of the report, PARAESTHESIA (tingling in arm of injection site), HYPOAESTHESIA (numbness in arm of injection site/lack of circulation in arm of injection site), MALAISE (doesn't feel well enough to work), AXILLARY PAIN (pain on her whole left arm) and VACCINATION SITE SWELLING (swollen hand, fingers/swelling) had not resolved and NECK PAIN (Soreness of neck), INSOMNIA (sleeplessness), ADMINISTRATION SITE MOVEMENT IMPAIRMENT (cannot grasp things/cannot use left hand at all), BACK PAIN (Soreness of back), DIZZINESS (dizziness), VACCINATION SITE PAIN (burning pain in arm of injection site), VOMITING (vomiting), ARTHRALGIA (Soreness of both shoulders), HEADACHE (headaches) and FATIGUE (tired) outcome was unknown. Not Provided    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.
Client reports having onset of pain to back of right knee, bruising, and swelling on 4/6/2021. She called teledoc on 4/9/2021, provider diagnosed her with superficial blood clot. Treating with applying warm compress to area. Client had onset of headache, dizziness, nausea, light headed, unsteady gait, vomiting, chills and sweats on 4/10/2021. Patient called teledoc on 4/14/2021, they recommended COVID-19 testing, results are negative on 4/12/2021. Symptoms ongoing since 4/14/2021, recommended she call provider regarding symptoms.
Severe headache,  fatigue and body aches for about 3 weeks. Three days after injection I experienced  diarrhea and vomiting for a day. That was followed by loss of taste for a few days and difficulty breathing for 5 or 6 days.
Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four years and two-month old female patient who was vaccinated with a 0.5 ml dose of ADACEL (lot number:U5770AA and Expiry date: 15-Sep-2019) via intramuscular route in the right arm instead of DAPTACEL on 03-Nov-2017. The patient was about to administer with fifth dose of DAPTACEL. The patient's medical history, previous medications and concomitant medications were not reported. The patient's concomitant medication included PROQUAD, IPOL and 0.5 ml dose of FLUZONE QUADRIVALENT (lot number, expiry date, dose in series, route and site of administration was not reported) on the same visit (date not reported). It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was not reported if the patient experienced any adverse event or not. 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. Follow-up report received from a nurse on 05-Sep-2018. The patient's age was reported. The patient's concomitant medications were reported. The vaccination details were updated. List of documents held by sender: none.
Approx 10-14 days after immunization, mother noticed rash on right thigh.  Patient seen 9/10/02 in office.  Vasicular rash / cellulitis on right thigh in area of VZ immunization.  Patient otherwise asymmtomatic.  Patient started on 7 dy course of keflex and told to keep rash covered until all lesions scabbed over.  Also instructed to RTC if rash not better in 1 week or worsening.
sore arm at injection site; COVID-19; Fever; Chills; drenching sweats; general feeling "similar to the flu"; A spontaneous report was received from a physician concerning a 61-year old, male patient who experienced fever, chills, drenching sweats, sore arm at injection site, general feeling "similar to the flu", and COVID-19 swab test which was positive.   The patient's medical history included current conditions did not feel quite normal on 22 DEC 2020, myalgia on 22 DEC 2020, and temperature of 98-99 which is high. The patient's medical history included ongoing current conditions of occasional dry cough beginning on 22 DEC 2020 and fatigue beginning on 22 DEC 2020. Concomitant product use was not provided by the reporter.   On 22 DEC 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the Right Deltoid for prophylaxis of COVID-19 infection.   On 22 DEC 2020, the patient woke up and did "not feel quite normal." He experienced myalgia, occasional dry cough, fatigue, and a temperature of 98-99 which was high for him. At approximately 18:30 on 22 DEC 2020, the patient received the first dose of mRNA-1273. After receiving the vaccine, he experienced a temp of 99.9F, reaching a maximum of 101F, fever, chills, drenching sweats, sore arm at site of injection, and a general feeling similar to the flu.   He received a positive COVID-19 swab test on 23 DEC 2020. On 24 DEC 2020, the patient continued to feel much better. His temperature had been below 99F since the evening of 23 DEC 2020. He continued to experience a slight cough and slight fatigue. He continued to take ibuprofen occasionally, and he continued to monitor his O2 levels which remained normal. Treatment for the events included ibuprofen, paracetamol, aspirin, acetylsalicylic acid, risperidone, quercetin, and turmeric.   Action taken with mRNA-1273 in response to the events was not reported.   The events chills, drenching sweats, sore arm at injection site, general feeling "similar to the flu", and COVID-19 swab test which was positive were considered resolving on 24 DEC 2020.  The event fever was considered resolved on 23 DEC 2020.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of COVID-19 is assessed as unlikely related. The patient had cough, fever, fatigue and myalgia before the administration of vaccine.
Fever, chills,sweats, nausea, swollen lymph nodes, larger more persistent lymph node swelling in arm with vaccination site
I slowly started loosing my ability to smell just after the vaccine. It continued till I have almost no sense of smell. I also have developed a constant cough.
Janssen COVID-19 vaccine EUA Patient presented to hospital after crushing chest pain and syncopal event.  Found to be hypotensive and hypoxic and echocardiogram revealed RV dilation and dysfunction with clot visualized in R atrium of heart.  Patient received IV alteplase followed by start of IV heparin infusion.  Currently intubated in ICU, on 3 vasopressors for shock.
Approximately 4-5 minutes after receiving the vaccine: patient reported feeling war, decreased hearing, slight nausea, ringing in her ears nd tingling in her upper extremities. Able to stand and transfer to wheel chair ro exam table. Supine with knees bent up; cool cloth to forehead and back of neck. Unable to obtain a BP initially; then @ 11:09 a.m. BP 76/49 95% on RA; HR 57bpm. 11:15 a.m. BP 101/68 98%; HR 76bpm; 11:20 a.m. -feeling better and sipping water. 11:30 a.m. BP 114/75 97% on RA HR 89bpm. Drank a bottle of water. Stable and able to sit with legs dangling. 11:40 a.m. able to stand and then sit in observation area - left with a friend - feeling well.
I have limited mobility and deep inflammation in both of my shoulders.  I saw my Dr., who then, referred me to a physical therapist to try and regain some mobility.
My arm had initial bruising after a day or two, During that time I also began to have diarrhea and a scratchy throat. However now the scratchy throat, fatigue, has passed however the diarrhea is still persisting. I am taking over the counter diarrhea medication.
Diarrhea at 11:30, woke up at 3:00AM 10/11/2011 with whelps, wheezing, severe itching all over, vomiting, and swollen lips.  Benadryl 50mg, Phenergan 25 mg, and 4 puffs albuterol inhaler.  Mom is an RN so I stayed the rest of the night with her in case I got worse.
Fever 103-104, began 8/6/07 and lasted until 8/10/07. Vaccine given 7/31/07. Patient also developed rash on 8/10/07 and was diagnosed with Roseola.
Date of Admission: 1/16/2023 Discharge Date: 1/20/2023 COVID positive 01/16/2023 PRESENTING PROBLEM: Weakness Lacunar infarction Cerebrovascular accident (CVA), unspecified mechanism COVID-19 Lacunar stroke   HOSPITAL COURSE: The patient is a 79yo female who presented to the hospital with weakness and falls. She was actually evaluated for the same in December at another hospital's ED and had elevated blood pressure but normal CT and negative MRI.   On presentation to the ED, she was noted to be confused and found to be COVID positive. CT with age indeterminate right basal ganglion lacunar stroke. She was admitted for further stroke workup. On her initial hospital day she remained confused and had difficulty with ambulating, falling to the right especially, but echo essentially normal and MRI with only 2 tiny strokes in right MCA territory. She was not hypoxic with her COVID and was not started on any specific therapy for this.    She initially qualified for acute rehab but then began to rapidly improve. She returned to her baseline mentation and her ambulation improved. She no longer qualified for acute rehab but PT/OT cleared for home care and home therapy.    Per neuro consultation, no additional antiplatelet agents given that the patient already takes Xarelto. Given her history of PCI and now CVA,will increase atorvastatin to 80mg.   During her admission, she became bradycardic so her metoprolol was initially held, then adjusted down to 12.5mg from 25mg BID and she seemed to tolerate this well.    Electrolytes were monitored and repleted PRN throughout the admission. Patient clinically improved and hemodynamically stable for discharge.  Discussed plan of care discharge with patient including outpatient follow-up PCP within 7 days. Patient voiced understanding was agreeable with plan of care discharge.
Swollen throat/glands, runny nose, chills, weakness, cough, muscle aches, SOB with activity.
This spontaneous report was received from a healthcare worker (reported also as radiology tech/vaccine coordinator) referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date in October 2016 (reported as "between 06-OCT-2016 and 21-OCT-2016"), the unspecified number of patients were vaccinated with improperly stored dose of GARDASIL lot # K010215 and expiration date 05-MAY-2017 (dose and anatomical location were not reported). No adverse effects were reported. Excursion details: Temperature/time" -0.1 C for 8 hours and 15 minutes. No previous excursions. With a data logger involved. No product quality complaint (PQC) was involved. This is one of several reports received form the same source. Additional information has been requested.
Client called on 02/01/2023 to report rash and severe itching the day after receiving her second dose of HPV9. Reports rash is all over body and itching is not relieved by Benadryl. Scheduled to be seen by medical provider on 02/02/2023 for evaluation.
Sharp pain in groin area that would last 1-2 seconds and intermittent on frequency.  It seems like it might be where a lymph node is located. Frequency has reduced since day of vaccination
Around 6pm I woke up from a nap and had hives all over my back and front side of my body. I had hives on the insides of my legs. They were red big and itchy. I took benadryl for the night and zyrtec the next morning. The hives were gone by the next day in the afternoon.
devel high pitched shrill scream & red swollen leg to below knee @ DTP site; scream lasted 1 1/2 hrs;
Patient had nausea, slight headache, and was sweaty after 15 minutes of her 1st dose of Moderna vaccine. Her BP= 166/105 and was retaken a few minutes and it was 170/108.  Patient was sent down to nurse treatment for further evaluation. Patient denies any shortness of breath or chest pain. Patient was awake and alert.
Rash bilateral arms and feels flushed to neck, arms, chest and legs.  To ER.  Bronchospasms x 1/2 hr.  ER - IV - Solumedrol, Benadryl and Epinephrine.  Then Steroids x 4 days and Zyrtec TID, Zantac TID and Benadryl PRN.  In ER x 2 hours.
My daughter received the vaccine, among others in the 18 month vaccine schedule. She had never been sick prior, then not even 48 hours later, she had a high fever, was lethargic, developed a rash and was ill for an entire week. The pediatricians office ?normalized? her illness as a reaction to the MMR shot. After the rash and fever subsided, she did not sleep for two weeks. Several nights not even for an hour.  During this time she also cried every night at bedtime, when previously always went down without a fuss. Two months later, she developed a limp for several days, of which no doctor was ever able to explain.
Woke up in the middle of the night after receiving the vaccination with itchiness/irritation on the back left side of my head.  In the next couple of days, it got worse (including painful to touch) and spread over left side including head, ear, neck, shoulder and chest.  Went to doctor and she said I had shingles.  Since I had chicken pox as a child and they share a virus, shingles can be triggered by the vaccine she told me.  I was prescribed anti-viral and steroids and it took about three weeks to heal.
Noted "rough patch" on skin while washing her back in the shower. Rough patch is at left lower back to left of midline. Also noted bilateral pedal edema. 7/8 and 9 has headache, generalized body aches "like a virus", bilateral pedal edema persists but improved, original "rough patch" persists but less red, site stings and itches. 7/9 Had an appointment with her oncologist (well check) he agrees with patient that it is shingles.
10 hours s/p vaccines c/o nausea; lower abdominal cramping, back "nerve pain". C/O sulfa in Hep B vaccine that she is allergic to.
pt recvd vax 12FEB96 & presented w/inj site reaction described as cellulitis;adm to hosp for treatment w/ATB
The patient has pain in the injection site, questionable abdominal pain, and a fever of 103.
Patient presented 9/22/06 today with the clinical disease chicken pox.  Patient received Varicella vaccine on 12/18/1996.
The first round of this vaccine in 2019 was fine - in fact, it halted my annual multiple episodes of pneumonia and bronchitis and overall, I was healthier. A year later I had the 2nd round of the pneumonia vaccine but had a strange reaction with SEVERE pain at the site of the shot to the point where I couldn't move my arm due to pain, or sleep, or dress / undress for 12 hours. It was 12 hours of EXTREME PAIN and immobility.  The pain began to decrease at 6am, around 12 hours after the vaccine, and gradually regained movement of my arm and cessation of pain.
Patient received Adult Pfizer diluted with 1.3ml (pediatric dose) of diluent instead of 1.8ml.
given Hiberix reconstituted with sterile water; given Hiberix reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 594CF, expiry date 13th July 2022) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that,the patient received dose of Hiberix that might had been incorrectly reconstituted with sterile water instead of saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The HCP (health care professional) did not have specific patient information or dates administered at the time of report.  The HCP stated that the specific lot was administered over a range of a couple of months. The reporter consented to follow-up. This is one of 8 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR024234:Same reporter US-GLAXOSMITHKLINE-US2022AMR024235:Same reporter US-GLAXOSMITHKLINE-US2022AMR024236:Same reporter US-GLAXOSMITHKLINE-US2022022662:Same reporter US-GLAXOSMITHKLINE-US2022AMR024237:Same reporter US-GLAXOSMITHKLINE-US2022AMR024238:Same reporter US-GLAXOSMITHKLINE-US2022AMR024240:Same reporter US-GLAXOSMITHKLINE-US2022AMR024241:Same reporter
This spontaneous case, initially received on 09-Apr-2018, was reported by other health professional and concerns a 3-year-old male patient. The patient historical condition included delayed speech prior to vaccination. The patient was not taking any concomitant medications. On 04-Apr-2018, the patient was administered with FLUCELVAX QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: thigh, batch number: 195236, expiry date: 31-May-2018). A 3-year-old male patient received FLUCELVAX QUADRIVALENT. No adverse effects were noted. The reporter assessed the case as non-serious. Non-significant follow-up received from the on 20-Apr-2018: The reporter confirmed that, the patient experienced delayed speech prior to vaccination and no adverse effects were noted. Amended narrative accordingly.
Zostavax vaccine given IM instead of subq.  Pt did wait 15 mins but pt left before I was able to check his arm.
Adverse event; epigastric pain; pelvic pain; unspecified hyperlipidemia; acute upper respiratory tract infection; pain joint, leg/ knee pain; abdominal pain; Insomnia; Autoimmune hemolytic anemia; Information has been received from medical records, concerning a case in litigation and refers to a 58-year-old female patient (pt). Her past vaccination included Tdap on 23-JUN-2011. On 11-JAN-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) 0.65 mL, lot # 1253AA, expiry date was not reported but upon internal validation was established as 01-NOV-2012 (route of administration and vaccination site were not specified) for prophylaxis. On 13-MAR-2012, the pt had a hospital discharge follow-up (dates and reason for hospitalization were not reported). On 22-MAR-2012, the pt presented for hospital discharge f/u and was diagnosed with autoimmune hemolytic anemia. On 22-MAY-2012, she presented for routine general medical examination, autoimmune hemolytic anemia and unspecified insomnia. on 17-MAR-2014, she was diagnosed with abdominal pain. On 24-MAR-2014, she presented for abdominal pain. On 24-APR-2014, she had routine general medical examination and screening for diabetes mellitus. She was also diagnosed  with insomnia. On 23-JUL-2014, the pt was seen for knee pain (pain in joint). On 15-DEC-2014, she was diagnosed with acute upper respiratory tract infection and insomnia. On 25-FEB-2015, she presented with abdominal pain. On 26-MAY-2015, she was diagnosed with unspecified hyperlipidemia. On 29-AUG-2015 and 10-JUL-2015, she presented with abdominal pain. On 24-OCT-2015, she was diagnosed with abdominal pain and pelvic pain. On 06-SEP-2017, she was diagnosed with epigastric pain. On 21-SEP-2017, she was diagnosed with unspecified abdominal pain. The outcome of the events and the causality assessment were not provided.    Upon internal review, the event of autoimmune hemolytic anemia was determined to be medically significant.   All available medical records will be provided upon request.
Pt received 2nd dose of Pfizer COVID 19 vaccine  9/4/21 Left arm at pharmacy.  Around this time developed severe left shoulder pain.  No redness or swelling, had some positive response to medrol dose pack. Will now see a sports medicine specialist to further evaluate. Prescribed gabapentin for pain   First dose Pfizer COVID 19 vaccine 8/10/21 did not produce significant arm pain symptoms.
I had a little arm and low-grade fever for about 24 hours. In 02/2023 I had pain and numbness in my right shoulder and arm.  I had a couple of tests, and it was determined to be brachial plexitis.  I am on gabapentin to help with my symptoms.
Report 200000302261 describes injection arm swelling in an 8 year old vaccinee of unspecified sex who received Engerix-B. Allergies, medical history, and concomitant medications are not specified. On an unspecified date, the vaccinee received the unspecified dose of Engerix-B. Subsequently, the vaccinee experienced injection arm swelling. Symptoms resolved. As of 09/29/2000, the outcome of the event is resolved.
Fever of 101.5, muscle aches, congestion, headache, sore throat. Took Tylenol.