chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling on her Knees/joint swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 27Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: JOINT SWELLING (non-serious) with onset 27Sep2021, outcome "unknown", described as "swelling on her Knees/joint swelling".  Additional information: Reporter wanted to know if swelling on patient's knees was normal from the booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2 hours after injection developed chest pressure cough. Chills and nausea, resolved on their own within several hours.
FROM DISCHARGE SUMMARY: "3 y.o. M who presented very ill and was ultimately found to have MISC based on lab work and was treated as such. His BNP maxxed out at 3155. TTE showed dilated L coronary system. Both of these, in addition to overall clinical picture, improved with IVIG, aspirin, steroids, and anakinra. TTE showed resolved dilatation and had some residual valvular disease that was improving on day of discharge. He is scheduled for follow up in both cardiology and rheumatology clinic. He also has PCP follow up scheduled. He will be discharged on low-dose aspirin, gastric prophylaxis, and oral steroids to be weaned/discontinued in outpatient clinic."
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates the patients were vaccinated with improperly stored doses of PROQUAD (lot # L030592 with expiration date 12-FEB-2017, lot # L007231 with expiration date 03-SEP-2016 and lot # reported as L051098 with expiration date 17-JUN-2017; dose and route of administration were not reported). No adverse effects were reported. The vaccines were stored in 11F for 24 hours. No previous temperature excursion was reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax & devel diarrhea, vomiting & swelling @ the inj site;
Patient is fully vaccinated.  Presented to the ED on 12/6/2021.  Vaccinated patient started having fever, cough, congestion and body aches beginning last 12/1/2021.  She was diagnosed with Covid last 12/2/2021.  She presents today with worsening dyspnea and fatigue and her oxygen level dropped down to 89% and her heart rte went up to the 130's with her home pulse oximeter with ambulation. Positive for chest pain, cough, diaphoresis, fever and headaches. Hypoxemia requiring supplemental oxygen Pneumonia due to COVID-19 virus: established and improving. Labs:  D-dimer 633, troponin normal, She will be discharged and go directly to the infusion center.She is instructed to return to the ED if her condition deteriorates in any way.
Neck Pain; Arm Pain; numbness in the fingertips/ left leg; sciatica pain; This case was reported by a nurse via sales rep and described the occurrence of neck pain in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 27J4P, expiry date 12th April 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 17th July 2018. Please refer the case US2019AMR131401).   On 26th October 2018, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced neck pain, pain in arm, numbness in leg and sciatica. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the neck pain, pain in arm, numbness in leg and sciatica were unknown.   It was unknown if the reporter considered the neck pain, pain in arm, numbness in leg and sciatica to be related to Shingrix.  Additional details were provided as follows: The patient experienced neck and pain in the left arm and also experienced numbness in the fingertips of the left hand and numbness in the left leg. On 14th February 2019, the patient went in to see her doctor and the doctor ordered lab work. Lab work came back normal. On 16th July 2019, the Patient went back to see the doctor and complained of sciatica pain.  Emergency room visit required. The reporter did not provide any additional details.
Patient called on 3/12/21 and complained about shoulder pain he referred to frozen shoulder pain.
3 ml dose of the Pfizer vaccine was administered without being diluted with 1.8 ml of saline solution. The County was contacted and informed of the situation. Doctor advised that the patient should seek no further medical attention, but to be made aware of the error, and to be told his arm would likely be very sore.
Patient developed fever Tmax 102.2 12 hrs following injection. Fever/chills symptoms x 36 hours. Decreased appetite. Redness and warmth of skin 9cm x 6cm at injection site, (R) deltoid. Seen today, temperature improved. Will continue to follow.
9/26/02 DTaP,Comvax, HB, Prevnar given evening of 10/1/02 clonic-tonic seizures continued to 10/2/02. Admitted to hosp for evaluation. 60 day follow up states: No longer our pt. An annual report received 10/24/2003 adds: Child died December 2002. Microcephaly, developmental delay, infantile myoclonic spasms.  Nurse follow up on 07/08/04 states: "Reflux, Splenomegaly, myoclonic seizures,  visual problems, microcephaly, hypotonia, developmental delay."
Loss of balance, weakness in legs, difficulty walking up and down stairs (have actually fallen down stairs 2x?s) constant  numbness in hands, fingers, left thigh and left leg. Feel like I?m in a fog, body hurts all over more than ever, when rubbing leg it feels like a prickly sensation.
No symptoms or pain with initial injection.  I came home about 2 hours after the injection and took one 200mg ibuprofen and one 500mg acetaminophen and put an ice pack on the site briefly.  Later that afternoon I developed pain at the injection site that progressively got worse over the course of the evening so bad that I could not raise my left arm of touch the site.  I put an ice pack on again and that night I slept with a heating pad on.  I would rate the pain 8/10.  When I woke the next day the pain was still there, but not as severe.  I got in the shower and let the hot water beat on the injection site and that seems to help a lot.  The pain gradually lessened over the course of the day to a 2/10.  By the following day (3rd day post injection) the pain had completely subsided.  There was no redness or swelling at the site and I did not have any other symptoms other than the intense injection site pain.
Patient had been waiting for 30 minutes due to the shellfish allergy that requires an epipen.  After waiting her time she complained of the area itching and that it was hot to the touch. The area was red as well.
5/6/2023 - 5/22/2023 (16 days)  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Elevated troponin  Acute on chronic diastolic (congestive) heart failure (HCC)  Acute congestive heart failure, unspecified heart failure type (HCC)    HOSPITAL COURSE: 70-year-old woman with a history of CVA, heart failure preserved ejection fraction, hypertension, dysphagia, wheelchair-bound reported vascular dementia who presented on 05/06/2023 with poor intake over the preceding 4 days and troponin elevation in the setting of elevated systolic blood pressures after missing home medications.  She was seen by speech pathology noted to have significant dysphagia with esophageal stricture and CT neck and thorax was performed which revealed zenker's diverticulum.  GI was also consulted and recommended consultation with CTS before performing EGD, ultimately decided too high risk of perforation for EGD. Given her inability to take oral a corpak tube was placed to facilitate medications. CTS recommended outpatient follow up for endoscopic repair outpatient. They preferred cardiology optimization prior to this procedure, cardiology was consulted and obtained stress Echo which showed no evidence of ischemia. Patient did develop hypernatremia as well which improved with adjustment of free water flushes.   Family was agreeable to PEG tube.  IR was consulted and placed thison 5/15/2023   She developed hypoxia and left sided atelectasis.  She also developed a fever.  She tested positive for COVID 19 on film array.  Her husband was a sick contact.  She was started on Decadron which was discontinued after 2 days as she was not needing oxygen.  She will need to stay in the hospital for a total of 10 days in isolation which will end on the 21st of May.  She was discharge to assisted living facility stable on 5/22/2023
The pt. suffered vision loss, unbalance and stuttering and was diagnosed with cerebrovascular accident; Information has been received from a lawyer, regarding a case in litigation and concerning to a male patient (pt.) of unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. In or around 21-OCT-2017, the pt. was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt. suffered vision loss, unbalance, and stuttering, and was diagnosed with cerebrovascular accident. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using it. The pt. also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt. sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt. suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt. had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event cerebrovascular accident was not recovered. The reporter considered the event cerebrovascular accident to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered cerebrovascular accident to be disabling event.  Upon internal review, the event cerebrovascular accident was considered to be medically significant.
one day after: sore arm   two days after: numbness and tingling in hand and elbow of left arm (my shot was in the left upper biceps)
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 58 year-old patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 03Mar2021 11:30 (Lot number: EN6203) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Flu vaccine", start date: 18Jan2021, stop date: 18Jan2021. Family history included: "High Blood pressure" (unspecified if ongoing), notes: Lisinopril; "Diabetes" (unspecified if ongoing), notes: metformin hcl,Pioglitazone. Concomitant medication(s) included: METFORMIN HCL taken for diabetes mellitus (ongoing); LISINOPRIL taken for hypertension (ongoing); PIOGLITAZONE taken for diabetes mellitus (ongoing). Vaccination history included: Bnt162b2, administration date: 10Feb2021, for COVID-19 immunization, reaction(s): "Injection site pain", "Injection site pain, swelling". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Mar2021, outcome "recovered" (05Mar2021), described as "Injection site sore". Therapeutic measures were not taken as a result of vaccination site pain.Additional Information: Vaccine name: Flu vaccine, Manufacturer: Unknown, Batch/Lot: Unknown, Route: Intramuscular, Anatomical site of injection: Left shoulder, No. of previous doses: 1. Additional Information reported as Excruciating pain. Dose#01 Information: Date/Time: 10Feb2021/ 12;30 PM, Anatomical site pf injection: Left shoulder, Route of administration: Intramuscular and Batch/Lot number: EL8982. No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist concerning a patient who was vaccinated with PNEUMOVAX (lot # 662664/0981X). Subsequently the patient experienced cellulitis and was admitted to hospital. The patient was still hospitalization at the time of reporting. Follow up information has been received from the pharmacist reported that the 45 years old patient (date of birth unknown to reporter) who was vaccinated with PNEUMOVAX on 17-JUL-2009. The pharmacist did not know if the patient received any concomitant vaccinations at the time of the vaccine administration. The patient developed cellulitis (date unknown to the reporter). The patient was not hospitalized. It was unknown if the patient recovered. Follow up information has been received from a physician reported that on 29-MAY-2009 (not on 17-JUL-2009 as previously reported), the patient received PNEUMOVAX and concomitantly received in the same arm a Tetanus vaccination (manufacturer and lot number unknown to the physician). The patient also received a Hepatitis A, (manufacturer and lot number unknown to the physician) and Hepatitis B, (manufacturer and lot number unknown to the physician) in the other arm. The onset of cellulitis was 30-MAY-2009. The patient was seen by the physician on 02-JUN-2009. The patient started treatment for cellulitis on 02-JUN-2009. The patient was placed on therapy with AVELOX. The patient had recovered. This is one of several reports from the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. Additional information has been requested.
Patient was brought to the ED by EMS on 1/31/23 for evaluation of increased weakness over the past month. She has fallen twice in the past month due to weakness. Her family reported that the patient has not been eating or drinking well for the past week. A COVID PCR test performed in the ED resulted positive. She was admitted for observation 1/31/23 - 2/2/23. At discharge, the generalized weakness was thought to be multifactorial and secondary to COVID, possible UTI, and her age. Patient has received the primary COVID vaccine series and one booster dose.
Patient here for second dose COVID-19 Pfizer Vaccine. At the time of vaccination, patient reported experiencing nausea approximately two hours after first dose. Patient was advised to report symptoms to the observer in observation area. After approximately 20 minutes, patient stated that she was not feeling better. Nurse brought patient back to recovery room. Nurse took patient's vitals q15minX3. Patient stated that blood pressure was elevated from her baseline. Patient also stated that she felt warm and nurse gave her an ice pack. Patient reported that her husband was coming to transport her home. Patient advised of emergent symptoms and to report to Urgent Care or ED if symptoms worsened. Patient informed that an incident would be filed with VAERS and that she may be contacted.
Went to hospital on second episode. They called it hives. I had Petechiae and my face was the size of a pumpkin. My immunologist said it was definitely caused by the vaccine.
sore arm; bitter taste in her palate; feel weird her palate; lips shaking; anxious when biting her teeth; fever; chest pain; her ears shutting and then opening; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DYSGEUSIA (bitter taste in her palate), PALATE INJURY (feel weird her palate), LIP DISORDER (lips shaking) and ANXIETY DISORDER (anxious when biting her teeth) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PALATE INJURY (feel weird her palate), LIP DISORDER (lips shaking), ANXIETY DISORDER (anxious when biting her teeth), PYREXIA (fever), CHEST PAIN (chest pain) and EAR DISCOMFORT (her ears shutting and then opening). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and DYSGEUSIA (bitter taste in her palate). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), DYSGEUSIA (bitter taste in her palate), PALATE INJURY (feel weird her palate), LIP DISORDER (lips shaking), ANXIETY DISORDER (anxious when biting her teeth), PYREXIA (fever), CHEST PAIN (chest pain) and EAR DISCOMFORT (her ears shutting and then opening) outcome was unknown. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-079041 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079041:second dose
24 hrs after injection, rash developed on patient's torse and back. Took Benadryl and called to report. Was told to notify physician.
Chronic pain in the Rt arm injection site x 7 months.  Chronic pain when lifting, stretching and reaching at the injection site.
Patient developed itching in left arm soon after he had the IPOL and MMR.  Later that day he developed a rash and welts on entire left upper arm.  On 9/12/08, he was seen in the office for swelling, redness, warmth and itching entire left upper arm.  It is all local, no difficulty breathing.  Will re-evaluate 9/15/08.
Pain when moving arm in a "chicken wing" motion hurts when lifting arm above shoulder, cannot reach out towards the side.
Patient mentioned general itching (not localized); said it wasn't bad but she was still itching today and believes the event is related to the vaccine. She said she reported the information to an agency and said they are checking on her periodically. She said she has tried Claritin and it hasn't helped much. We recommended Benadryl or Hydrocortisone cream and let her know that she may have an allergy to an ingredient of the vaccine and since the reaction was not severe it should not affect her second dose. She will let us or her primary care doctor know how the Benadryl works for her or if she needs further treatment.
Chill, fever, fatigue, headache; symptoms lasting 24 hrs with no treatment given
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 50-year-old male patient who received RABAVERT (batch number 628011A, expiry date unknown). The patient's past medical history included animal bite. Concomitant products included immunoglobulin human anti-rabies (HRIG). On 19th June 2017 19:00, the patient received the 1st dose of RABAVERT 1 ml. In June 2017, 12 hrs after receiving RABAVERT, the patient experienced muscle cramp. On 19th June 2017, the patient experienced heaviness of head. On 19th June 2017 21:00, the patient experienced influenza-like symptoms, malaise, dizziness and tiredness. On an unknown date, the outcome of the influenza-like symptoms, muscle cramp, malaise, dizziness, tiredness and heaviness of head were recovering/resolving. The reporter considered the influenza-like symptoms, muscle cramp, malaise, dizziness, tiredness and heaviness of head to be almost certainly related to RABAVERT. Additional details were reported as follows: The patient received RABAVERT for post exposure treatment after bat encounter. The symptoms included the patient's head feeling heavy which continued through the day after the vaccine such that he was not able to work. Along with the RABAVERT the patient received the Human Rabies Immune Globulin in his foot which was the site of exposure. Two hours after receiving RABAVERT, the patient experienced influenza-like symptoms, malaise, dizzy and tired.
Ringing in the ear; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in the ear) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Ringing in the ear). At the time of the report, TINNITUS (Ringing in the ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided. The reporter stated that her ENT doctor said she had a handful of patients that have reported the same symptoms as her ringing in the ear after receiving the vaccine. No further information provided. Vaccine manufacturer was unknown.   This case was linked to MOD-2021-359898 (Patient Link).
Patient presented w/101 degree fever, red, swollen arm (R) and shoulder. Patient is achy, queasy, in pain since 5 AM 9/29/17 exhausted and feels like he has a terrible flu.
PAIN EVERYWHERE; SHORTNESS OF BREATH; HEADACHE; MUSCLE ACHES ALL OVER BODY; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight was 120 pounds, and height was 64 inches. The patient's past medical history included back surgery, and hysterectomy, and concurrent conditions included spinal stenosis, asthma, pain, gastrointestinal disorders, and uterine cancer, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid/caffeine/paracetamol for pain everywhere, shortness of breath, headache, and muscle aches all over body. On 01-JUL-2021, the subject experienced pain everywhere. On 01-JUL-2021, the subject experienced shortness of breath. On 01-JUL-2021, the subject experienced headache. On 01-JUL-2021, the subject experienced muscle aches all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, muscle aches all over body, shortness of breath, and pain everywhere. This report was non-serious.
Pt. developed diffuse urticaria approximately 3 hrs. after receiving influenza vaccine, no prior egg allergy (+) hives.
Glandular fever, high fever. Difficulty swallowing, body aches and pains.