chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated for oral, ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administration were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 15-MAY-2015 was vaccinated with a dose of oral, ROTATEQ (lot # K016313) (dose and route not reported) that was 87 hours temperature excursion. This lot was received on 08-APR-2015. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Patient developed on area of approximately 12 x 13 cm rash, erythematous, indurated, circular and raised portion near deltoid to show elbow
Slight headache that lasts about 5 min. Redness of area around site and is a little swollen and tender. Bandage taken off 10/20/15.
This spontaneous report as received from a registered nurse refers to a 9 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On unknown dates, the patients was vaccinated with the first and second dose of RECOMBIVAX HB (Lot number, expiration date, route and dose were not provided). On 14-OCT-2015, the patient was inadvertently vaccinated with an adult dose as the third dose of RECOMBIVAX HB 10 microgram (lot number, expiration date, route and dose were not provided). Concomitant medication was not reported. The nurse stated that there was no product confusion involved. No adverse symptoms reported. Additional information is not expected.
Patient received the second dose of the Pfizer Covid-19 vaccine on 6/14/2021. Upon completion of the patient?s 15 min observation period, she could not get out of the chair and could not move her legs. She stayed she felt tingling in her extremities. Patient saw her doctor who initially thought it was a neurological condition secondary to the vaccine, but upon multiples tests, it was found to be a subacute aortoiliac thrombotic occlusive disease. The patient had a fall associated to lower extremity tingling and cramping and dizziness on 7/22/21 and was brought to the ED. Patient was placed in ICU for seizures and hyperosmolar hyperglycemic syndrome. Pt was placed on Keppra 500mg twice daily to help with neurologic condition. Pt was discharged on 7/27/21. On 9/19, pt came back to the ED with bilateral lower extremity swelling and was told by Dr. to come in for surgery right leg revascularization procedure. She states she had right leg pain since approximately the time she got her vaccine, but ultrasound on 7/22 was negative for DVT. She went to an outpatient surgeon, who found the subacute aortoiliac thrombotic occlusive disease that progressed to DVT of the lower extremities and popliteal artery. Surgery was planned for 9/21/21. Patient went into surgery for bilateral iliac thrombectomies, bilateral iliac stents, right popliteal thrombolysis and stent, arteriograms, IVUS, via femoral access. After surgery leg pain was relieved. Patient is still hospitalized at the moment post-op.
3 inch long, 1.5 inch wide area of erythema on Rt. upper arm around area of injection, and inferiorly. Mom noticed redness last night 6/8/17.
Myalgia, Arthralgia, Fatigue, Muscle Soreness, no Appetitie Narrative:
24 HOURS AFTER SHOTS SHE BROKE OUT IN HIVES. GAVE BENADRYL EVERY 4 HOURS WITHOUT IMPROVEMENT SO WENT TO ER ON 8-28 AND WAS GIVEN PREDNASONE FOR 3 DAYS AND PEPSID FOR 5 DAYS. ARE STILL DOING BENADRYL EVERY 4 HOURS BECAUSE SHE BREAKS OUT IN HIVES AGAIN WITH OUT IT. EVEN ON BENADRYL HIVES RETURN WHEN SHE GETS COLD OR THE WIND HITS HER SKIN.
Patient experienced nonproductive cough, nasal congestion, rhinitis and mild headache over the following 8 hours after receiving the vaccination. Symptoms progressed to nausea and vomiting and shortness of breath over the next 36 hours. Initially seen and treated with MUCINEX/SUDAFED, ibuprofen and acetaminophen, the following day he was seen again and treated with ZOFRAN/albuterol. EKG and chest x-ray were performed on the second day which were normal.
14MAY97 tingling in feet 10PM;15MAY97 8AM numb for thighs to feet;6PM numb form stomach to feet, exhaustion;16MAY97 went to ER then to neuro where dx w/GBS:
PER FAMILY MEMBERS I WAS STUMBLING AROUND, BEHIND EYES FEELS LIKE THEY ARE NYSTAGMUS,  FEELING AS IF MY HEAD IS SPINNING INSIDE, DELAY IN WHAT I'M TRYING TO SAY AT TIMES, FEELS LIKE MY HEAD IS IN A FOG.
This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0150), at the age of 84, via an unspecified route of administration, right arm, on Apr 5, 2021, at 08:45, single dose, for COVID-19 immunisation. Medical history reported as none. The patient did not have a history of allergies to any food, medications or other products. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On an unknown date in Apr 2021, patient was vomiting and had heart rate up to 125 beats for 8 hours. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures taken for the events. The clinical outcome of vomiting and heart rate up to 125 beats  for 8 hours recovered on an unknown date in Apr 2021. No follow-up attempts needed. No further information expected.
Patient stated she got dizzy while she was exercising on Thursday 1/4/19. She stopped and sat down for a minute. She got back up and continued to work out. As she was going home after class, she had a wreck in her car. She passed out.
She got her vaccine, her bicep was very swollen and very puffy and it looked like there was fluid underneath the bicep.  Along with that had constant pain, and even when she reaches for things her arm is weaker and is limited on the use of her arm due to the pain.  She cannot sleep as she cannot get comfortable and using her left arm more due to the pain.  She is going to a pain doctor now, and her other doctors have said that they have seen this before.  She is still having the pain which has been the same for close to 8 months now.  She did go to her doctor, went to an orthopedic doctor who gave her two cortisone shots within a 3 week period and that did not help the pain.  She was not happy with that ortho and went to another one, had an MRI, x-rays and nothing is showing up.  the one doctor suggested that she may have gotten nicked by a needle and gave her Meloxicam and a steroid and that did not help.  She is on Naproxyn which does not help.  She has just gone to a pain management doctor and they are going to do another MRI and if there is nothing there then they suggest that she see a neurologist.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 02-JAN-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates between July 2015 and 11-SEP-2015, these patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L010595, expiration date: 12-NOV-2016, strength, dose and route unknown) (incorrect product storage). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Immediate symptoms: Muscle aches local to injection. 24 hours later: Muscle aches across body, headache, lack of mental clarity, fatigue, 101.2 fever, all lasting approximately 6 hours until sleep. After 8 hours of rest: Muscle aches across body, fatigue, reduced fever.
Pt recv vax on 3/23/99; on 3/30/99 pt exp urticarial rash w/ agitation; tx= Hydroxyzine
Vaccination date: 11/13/18. I am still experiencing side effects at the time of this reporting. About 11/14/18 I started feeling tired and I had joint discomfort but now swelling. I also was experiencing headaches. I had a general sense of malaise and by 11/17/18 I was spiking a temperature up to 102.3. Today my temp so far is 99.6. I typically have been feeling worse in the evening. I have been taking acetaminophen. I am somewhat better than I was 2 days ago but not dramatically so.
Headache within 30 mins of administration and throat tightness. Went home generalized rash next day. Took 1 capsule Benadryl. Seen in ER on 1/6/10 given Allegra. Seen in clinic on 1/10/10 with no improvement in rash so placed on Medrol. Rash improved within 1 day on medication.
low blood pressure, lightheadedness started 9/17/20201 on about 10:00 am,  On Saturday 9/18/2021 between 2 2:30  I went to urgent care  the doctor said that because my blood pressure was low and because I was having palpitations that I needed to be seen in the Emergency dept. While there they did and EKG, Chest X-Ray, checked my blood pressure lying down, sitting and standing, which was still low when lying down and sitting , they also did blood work.., they still weren't able to tell me why my blood pressure was low and why I was lightheaded
Information has been received from a medical assistant concerning a 66 year old male patient with a medical history of "vessel bypass" who on 28-FEB-2011 was vaccinated with ZOSTAVAX (Merck) (lot # 669405/1416Z, expiration date 21-JAN-2012). On 09-MAR-2011, the patient experienced neck, shoulder and ear pain after vaccination with ZOSTAVAX (Merck). The patient called the office reporting those events. The patient had a cough when vaccinated. No labs/diagnostics studies were performed. The patient's neck, shoulder and ear pain persisted. The patient was not given treatment for the event. The patient would be seen in the office on 16-MAR-2011. Follow-up information has been received from the medical assistant concerning the 66 year old male patient with chronic obstructive pulmonary disease (COPD) and a history of heart problems (stent inserted in 2006), who on 28-FEB-2011 was vaccinated with ZOSTAVAX (Merck) (lot # 669405/1416Z, expiration date 21-JAN-2012). On 09-MAR-2011, the patient complained of pain in his left arm, where ZOSTAVAX (Merck) was administered, as well as pain in his left ear. The patient then presented to the office on 16-MAR-2011 for an unrelated reason and noted that he still had the pain but it was improving. Follow up information was received from a physician concerning a 66 year old male ex-smoker (quit 1994) with dyslipidemia, diabetes mellitus type 2, chronic obstructive pulmonary disease, coronary artery disease, family history of cardiovascular disorder, family history of cancer and a family history of diabetes and a history of coronary artery bypass graft 4 vessel (JULY 2010), coronary stents x 3 (2006), appendectomy, MVA with wired jaw and tracheostomy, right ankle repair and right lower quadrant abscess with incision and drainage (FEBRUARY 2010) who on 28-FEB-2011 was given a dose of ZOSTAVAX (MERCK) (lot 669405/1416Z) subcutaneously in left arm. Concomitant medications included aspirin; fish oil; LIPITOR; losartan (manufacturer unknown), metformin (manufacturer unknown), metoprolol succinate extended release tablets; NITROQUICK; RANEXA; and TYLENOL ARTHRITIS. The patient had no know drug allergies. On 16-MAR-2011 the patient presented to his physician's office to follow up on pain in the left trapezius muscle area soon after getting a dose of ZOSTAVAX (MERCK). The patient was positive for joint pain. The patient was diagnosed with cervicalgia. The patient reported that his pain had been improving. It was unknown whether the patient had recovered from left ear pain, injection site pain or shoulder pain. It is unknown whether the patient received treatment or had any tests performed. The doctor reported he reassured the patient that cervicalgia was not due to the shingles vaccine. It was noted during the physical exam that the patient had a right lower quadrant incision with opening and packing. There was no drainage noted and the erythema had resolved. Additional information has been requested. All available medical records will be provided upon request.
Information has been received from a woman working in a physician's office concerning a child who was vaccinated with a dose of Varivax. "Very recently", in 2006, the patient experienced breakthrough chickenpox. It was reported that the child was being boostered. It was also noted that the child was in an unspecified stage of breaking out with lesions. It was reported that the patient's experience was currently ongoing. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up from a physician indicated that he was aware of the breakthrough of chickenpox at the local school, but had "no idea" about any additional information. Additional information is not expected.
I played in a softball game beginning at 7:30 PM. I felt tired and nauseous at the beginning of the game, and 15 minutes later I vomited. I felt very weak, drowsy, tired, and nauseous throughout the rest of the evening. I was sure to drink plenty of fluids including a Gatorade and lots of water. Tiredness, mild headache, and periodic nausea continued over the next 60 hours.
Itchy rash left arm; Warm to the touch rash left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash left arm) and FEELING HOT (Warm to the touch rash left arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A/026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced RASH PRURITIC (Itchy rash left arm) and FEELING HOT (Warm to the touch rash left arm). At the time of the report, RASH PRURITIC (Itchy rash left arm) and FEELING HOT (Warm to the touch rash left arm) outcome was unknown. Unknown          No concomitant medications provided.  Treatment included Calamine lotion and cortisone cream   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non-Significant follow up appended
Sore arm, severe headache, achy body, chills, high fever that lasted  3 days, coughing up large chunks of phlem. After my fever broke on the 4th day I went to an urgent care and they say I have an upper respiratory infection so I am now on Augmenten and Benzonatate but I am still coughing badlands can't sleep well (it is only day two of being on medication but I feel like a lot of pressure is on my chest, they didn't take x-rays, just listened with a stethoscope). I am exhausted and now my ribs hurt from all the coughing.
Vaccine administration error- 15 year old patient received his Pfizer booster after 6 months from his Pfizer primary series. Currently, Pfizer booster is approved only for those 16 y/o +. Patient is not immunocompromised either. Patient and parent were notified of the error and did not expressed any concerns.
Patient experienced guillain barre syndrome.  Her symptoms started with tingling in toes on 9/30/2020. She went to the ER on 10/4/2020 with numbness in Arms and legs thinking it was a stroke.  Hospital sent her home since it was not a stroke.  She went to hospital on 10/16/2020 with paralysis and started IVIG treatment for 3 days. She was Discharged 10/20/2020.  The family has applied for help with paying for the treatments.
Hospitalized 11/6/2021; COVID-19 positive 11/6/2021; fully vaccinated  Discharge Summary                                                   Discharge Information:   Procedures to be scheduled by PCP: None Results/Procedures requiring PCP followup: None Admission Date: 11/6/2021 Discharge Date: 11/09/2021 Admitting Diagnoses: COVID-19 Details of Hospital Stay PRESENTING PROBLEM:  Acute respiratory disease due to COVID-19 virus  COVID-19 [U07.1] HOSPITAL COURSE: a 75 y.o. female  who presents to hospital with cough and dyspnea with a positive COVID-19 test..  Patient was sent in from her home after concerns of increasing cough ?raspy? and exposure to COVID-19.  Patient was exposed on 11/1 started having symptoms on 11/02 and tested positive on 11/04.  She was given monoclonal antibodies on 11/01 after positive test. She was admitted and started on dexamethasone.  She did not receive remdesivir.  Her oxygen was weaned to her baseline requirements and she was watched for an additional day to ensure stability.  She did have a positive MRSA screen and received a single dose of vancomycin, but after discussion with ID it was felt that this did not represent acute infection and antibiotics were discontinued.  She was at her baseline mental status and doing well so she was discharged back to her AFC home with outpatient follow up.  She will self isolate through 11/12.  Readmission today 11/16/2021 note: CHIEF COMPLAINT: COUGH Assessment/Plan  DIAGNOSIS at time of disposition: 1. Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present  2. Pyelonephritis  3. Nephrolithiasis  MEDICAL DECISION MAKING: Patient brought in by ambulance with complaints of low pulse ox at home, patient is nonverbal at baseline which limits the history.  On exam she appears to be chronically ill but is in no acute distress.  She is tachycardic, maintaining her pulse ox on 2 L baseline nasal cannula.  Blood pressure remained stable.  She is afebrile here. Patient's workup is remarkable for a significantly elevated white blood cell count, urinalysis grossly positive for infection.  Patient does also have an elevated D-dimer, and in the setting of her recent COVID-19 diagnosis and immobility she was scan to rule out PE.  I did follow through the remainder of her abdomen pelvis due to meeting septic criteria with a white count and tachycardia, this shows findings concerning for pyelonephritis as well as a stone.    Patient was fluid resuscitated with 2 L which is greater than 30 mL/kilogram.  Her lactic acid is normal.  She was started on Rocephin for antibiotic coverage, but did add zosyn with findings of infected stone and pyelonephritis.  On multiple re-evaluations she continued to maintain her pulse ox, continued to be in no acute distress.  I discussed by phone with Urology who is recommending transfer downtown for Urology to be available for care.  I talked to the hospitalist by phone who accepts her for transfer.  Patient's guardian is in agreement with the plan, she was transferred in stabilized condition.
This spontaneous report as received from a pediatrician, participating in market research, refers to a female pre-adolescent patient of unknown age who on an unknown date, was vaccinated with the first dose of GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. Pediatrician reported that the patient experienced "dizziness" and "faintness" in the pre-adolescent girl after receiving first in a series of three injections of GARDASIL vaccine. The patient was taken to a nearby emergency room (ER), where she recovered (also reported as recovering) after a few hours and went home. The patient received the rest of the series without incident. The relationship between "dizziness" and "faintness" and GARDASIL was reported as related. No diagnostic tests were performed. Additional information is not expected.
pregnancy; arm pain at injection site; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) and VACCINATION SITE PAIN (arm pain at injection site) in a 36-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 15-Mar-2013 and Pregnancy on 05-Jul-2017. Concurrent medical conditions included GERD. Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for GERD, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Supplementation therapy.    On 28-Dec-2020 at 2:19 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Aug-2020 and the estimated date of delivery was 12-May-2021. On 28-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) and VACCINATION SITE PAIN (arm pain at injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 28-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved. On 29-Dec-2020, VACCINATION SITE PAIN (arm pain at injection site) had resolved.        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.   No treatment information was provided.; Reporter's Comments: This is a case of product exposure during pregnancy with  an associated Adverse event of vaccination site pain for this 39-year-old female. The Adverse event of vaccination site pain is assessed as possible. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Chest pain that resolved on its own Myocarditis, treated with NSAIDS and 24 hour hospitalization for observation Normal Echo
pt mowing lawn, became overexerted, coughing, throwing up; went to ER; kept overnight, released;
Redness, swelling, and itching around the site of the injection;  Continuing to get larger on 8/8/21;  Treatment, taking allergy medication (zyrtec)
Client received Sinovac COVID vaccine, no reaction. Sinovac vaccine unavailable in the US, Janssen given as an alternative on 08/18/21.