chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Thyroid test spiked; Hot and cold flashes; Hot and cold flashes; Tired; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Mar2021 (Sunday) 18:30 (Lot Number: EN6205; Expiration Date: 30Jun2021) (at 63-year-old) at single dose in arm right for COVID-19 immunization. Medical history included mitral valve and atrial valve leaking from last year (2020), thyroid removed. No additional vaccines administered on same date of BNT162B2, no prior vaccine within 4 weeks, and no family medical history. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration Date: 30Jun2021) on 14Feb2021 18:30 at single dose in the right arm for COVID-19 immunization. She noticed on "Monday" (08Mar2021) she had some hot and cold flashes and she felt tired, which went away the same day. They always checked blood test for thyroid levels randomly because she had her thyroid removed in the past. It has been three months since the last test and the nurse called her "today"/ "this morning" (09Mar2021) to report the result was spiked (thyroid test spiked). She didn't know the actual result, just it was spiked. She usually took 125 mcg levothyroxine sodium (SYNTHROID) once daily by mouth. The events didn't require a visit to physician or ER, and no other relevant test. The outcomes of events tiredness, hot and cold flashes was resolved on 08Mar2021, while of event thyroid function test abnormal was unknown.
Patient with extensive PMH, with recent hospital admission for COVID PNA, reports back to Medical Center on 05/22/2022 with c/o SOB.  In the ED she was placed on BiPAP and given Lasix.  Portable chest xray demonstrated prior median sternotomy and left rib fixation.  Cardiac silhouette remained moderately enlarged, diffuse pulmonary vascular engorgement with bilateral mixed interstitial and alveolar infiltrates, favoring pulmonary edema as an etiology.  ECG revealed prior inferior infarct, RBBB.  She was admitted to the hospital and transferred to ICU where she required intubation.  On 5/28/2022 patient had cardiac arrest, started on amiodarone.  06/01/2022 family in agreement with DNR status, and patient expired on 06/03/2022.
expired dose of Daptacel was inadvertently administered to a patient , no adverse event; Initial information received on 20-May-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 24 months old female patient who was vaccinated with a 0.5 ml dose (fourth dose) of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5190AA and Exp. Date 24-Apr-2019) via intramuscular route in the right thigh on 17-May-2019.  The patient's medical history not reported and concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  It was an actual medication error case due to expired vaccine used.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
I had a sensation in my heart that caused my heart to race and feel uncomfortable. This feeling was similar to an episode I experienced in 2018 that was Atrial fibrillation. I had an EKG completed with my primary care doctor that confirmed I was experiencing Atrial fibrillation. I was wearing a heart monitor for 2 weeks when I experienced the Atrial fibrillation.
Patient received dose #2 of Pfizer vaccine on 6/6/2021 @ vaccination site and was notified by email that vial was left in freezer past recommended time frame. Medication expired beyond its freezer allowable date. Email recommended patient get re-vaccinated with dose again. Clinic re-administered dose on 6/12/2021 as recommended. No adverse reactions identified on site.
Upset stomach, headache, severe entire body aches short of breath, diarrhea, chest pressure, chills, fever and body weakness.  Talk to Dr. and she recommended to drink plenty of fluids, take Tylenol , and rest.
On 4/13 Patient underwent aortic root replacement with saphenous vein graft reconstruction of the right coronary artery. He had no prior coronary disease. This operation was done for an enlarging aortic root aneurysm in the setting of Marfan syndrome. The right coronary was anomalous and needed vein extension for reimplantation. He recovered very well and was seen in our clinic on 4/23, with no unusual findings. He had a normal echo, EKG and DVT study performed.   On 4/28 he had his first Moderna COVID19 dose. on 5/1, he developed malaise, myalgias, painful lymph nodes, chills, and chest pain. He called my clinic and was instructed to go to the ER, but then felt better and didn't go. He was then found unresponsive later that afternoon and was pronounced dead on arrival of EMS.
developed blurred  vision 30 minutes after the dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 18 year-old female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "developed blurred  vision 30 minutes after the dose".  Additional information: Mother Calling on behalf 18 old daughter who received the Pfizer Covid vaccine on 14 Apr 2021 and developed blurred  vision 30 minutes after the dose. The reporter asked if this was a common side effect that has been reported  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It was reported that a 43 year old female pt received Fluzone on 10/23/03. An unspecified amount of time later, the pt developed a fever of 104 deg F and was taken by ambulance to the hospital. She was diagnosed with Stevens-Johnson syndrome. The pt died on 11/3/03. The reporter stated that the death certificate lists the cause of death as "toxic epidermal necrolysis and severe respiratory failure." No other info was reported. A telephone call was placed to the reporter on 11/7/03, to request copies of the death certificate and autopsy report if available and any additional info. Later that day, the reporter provided the lot number info. The product was administered IM in the left deltoid on 10/22/03. The pt was admitted to the hospital on 10/25/03. The primary physician's info and vaccine supplier were also provided. On 11/7/03, during telephone contact with the primary physician, it was reported that the pt was on several other medications at the time of vaccination, including amoxicillin and two new neurological medications. He could not provide any additional info at this time. Follow up on 11/17/2003: "From additional information received on 11/10/2003 from the initial reporter, it was reported that the patient died at a university medical center on 11/03/2003 at 8:38AM.  A copy of the death certificate was provided and the causes of death are listed as toxic epidermal necrolysis and Stevens-Johnson Syndrome.  The approximate interval between the onset of symptoms and death was noted to be one week.  No autopsy was performed.  The vaccine administrator and responsible physician's information were also provided, as well as the attending physician's name and contanct information from the hospital where the patient was treated.  The patient received the influenza vaccine on 10/22/2003 in the left deltoid.  E-mail correspondence with the attending physician at the hospital that same day stated that he felt that the physicians who were part of the original attending team admitting the patient to the hospital would best be able to answer requests for additional information.  He provided the names of the doctors and stated that the forwarded the request from AP, Inc. to these same physicians.  No other information was provided."  Follow up on 05/18/04 states: "Despite several attempts to obtain follow up information, no additional information was provided. This case is considered closed."
Injection site became itchy and tender. The site is hot to touch, rad and slightly swollen about an inch all the way around.
I got very sick after the 2nd covid shot and never fully recovered and we are a month and a half out now.  My neck and arm pit lymph nodes are very large and hurt a lot.  It is hard to swallow and if I do too much activity I get really sick.  Feel like I'm floating out of my body with nausea .  I'm very week and my lymph system is showing no sigs of getting better. I was tychacardic for weeks and wore a heart monitor for 14 days as well.
Patient returned to pharmacy on 9/29/17 complaining of redness, swelling, and pain at the injection site. The area of redness almost wrapped completely around her upper arm. Advised patient that it was most likely an injection site reaction and to take ibuprofen for the pain and BENADRYL for the reaction. I explained that if the redness worsened or if the area became more painful, swollen, red to follow up with her primary care physician.
This case was reported by a consumer via call center representative and described the occurrence of itching both hands in a 90-year-old female patient who received SHINGRIX for prophylaxis. On 21st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, 14 days after receiving SHINGRIX, the patient experienced itching both hands, erythromacular rash, skin scaly and patchy rash. On an unknown date, the patient experienced eye pruritus. The patient was treated with betamethasone. On an unknown date, the outcome of the itching both hands, erythromacular rash and skin scaly were not recovered/not resolved and the outcome of the eye pruritus and patchy rash were unknown. It was unknown if the reporter considered the itching both hands, erythromacular rash, skin scaly, eye pruritus and patchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced itching on the palms of both hands. This itching would come and go. She also developed red, scaly spots in between her knees and ankles, and one large patch on her right hip approximately two weeks after receiving the vaccine. She had itching in both eye for the last few months. Her dermatologist gave a lotion (she thought it was betamethasone) to put on the red, scaly spots. When she used the cream, the spots fade. The reporter gave permission to contact her dermatologist. This case has been linked with case US2019025959 and US2019025968, reported by the same reporter.
This is a 40 year old male who was in his usual good health when he received his first anthrax vaccination, typhoid, non-primary smallpox and influenza vaccination on 09 October 2003. He deployed on 01 November 2003. He arrived on 06 or 07 November 2003. He had no problems following this set of vaccinations. He denies any fever, chills, nausea, vomiting or diarrhea. In December 2003 he states he began an intensive physical training program which included running an average of 3-5 miles per day 5-7 days per week, 100 push-ups and 100 sit-ups per day without any difficulty. He relates that he ran a 5 kilometer run in 22 minutes without difficulty. On 17 January 2004 he received his second anthrax vaccination. He again denies any fever, chills, nausea, vomiting or diarrhea. He continued his fitness training regimen without difficulty. He received his third anthrax vaccination on 02 February 2004. He experienced increased tenderness in his vaccinated arm. He developed a large knot on the inside of the vaccinated arm which persisted for approximately four weeks. He began noticing that he felt stiff and it became difficult to run. He states that he "could not stretch out the stiffness". He reports that his legs began to ache and he developed low back pain. He even borrowed a heating pad from the chaplain to sleep on so he could relax. By the time he returned home he had lost his will to exercise, stating "it [exercising] was more agony than it was worth". Upon returning home he developed pain in both feet. He states that he lives in a two story house with hardwood floors and cannot walk on them barefoot because of the pain. He also has great difficulty getting up and down stairs. His leg pain persisted. On 12 April 2004 he was diagnosed with left testicular cancer (seminoma), had left orchiectomy on 15 April 2004. He underwent seventeen (17) radiation treatments of abdomen which he completed on 18 June 2004. In addition, his oncologist noted an enlarged left supraclavicular lymph node. It was biopsied and found to be from an inflammatory process. In the process of the biopsy, his trapezius branch of the spinal accessory nerve was damaged. He is experiencing some atrophy in left shoulder. Beginning in early August 2004 he began having leg cramps that occurred twice awake him from his sleep. This subsided, however on the 25th of August he was awakened by pain and spasm in his calves, legs, thighs, abdomen and buttocks, which has persisted. He has also been experiencing numbness in both his hands and carpel tunnel-like symptoms. He is also having some difficulty swallowing, seems like there is resistance He contacted the doctor and saw her on 27 August 2004. His creatine kinase was elevated. She is concerned that he may have a myositis. He is to have an EMG done on 03 September 2004.
The patient reported that her arm is red and swollen and warm on 8/16/21.  She received her vaccine on 8/13.  It was originally hard to the touch near the injection site, which has lessened.
The certified medical assistant (CMA) reported that the following improperly stored doses of vaccines were administered to unspecified patients on unspecified dates: 3 doses of ROTATEQ (reported as "ROTATEQ suspension 2") (dose, route, lot# not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Patient received Pfizer COVID vaccine on 1/21/21 (lot # EL1284), 2/11/21 (lot # EN6201), 11/4/21 (lot # FH8020), and Moderna COVID vaccine on 5/21/22 (lot # 037A22B). Patient resides at a long-term care facility for advanced dementia and was on hospice. On 10/22/22, patient admitted to CCU with high flow nasal cannula for acute hypoxemic respiratory failure due to COVID-19, severe sepsis 2/2 Pneumonia due to COVID-19 virus, and acute encephalopathy. Patient was transferred out from CCU to med/surg unit on 10/13/22. Patient was discharged back to long-term care facility on 10/17/22.
4/1/21 - When data logger was downloaded to order vaccines on 3/31/21 it was noted for an alarm on 2/9/21 for excursion on 34.5 F for 20 minutes.  On 2/9/21 Frozen moderna was placed in the vaccine refrigerator to thaw. Called to report excursion and check on vaccine stability with each manufacturer.
Per information from others involved EMS administered second dose Vaccine to recipient based on information given by the facility as to what the recipient needed
Vomiting; Advil for migraines - no medication today; BP 141/98; HR 108; RR 20; T 36.8, SpO2 97% -- > (12 minutes later) BP 126/89; HR 91; RR 18
Less than 24 hrs after Tdap and meningococcal vaccine received, pt began with vomiting, severe headache, Temp of 104 degrees.  Went to ER.  Given IV fluids & was in ER 5 hrs.
HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
About 2 weeks after being vaccinated, I developed shingles. It kept me from work for about 7 days, had to talk to the doctor and take valacyclovir.
Starting after picking her up from school, she seemed lethargic. Later, she developed a fever and was continuing to be lethargic. I gave her TYLENOL and a popsicle. I kept her from school the next day due to a mild fever. I gave her TYLENOL that evening and the next day she did not have a fever but was slightly lethargic. On 07/07/22, she tested negative on at at-home COVID-19 test. On 07/08/2022, she tested negative on another at home test. Later that day, she tested negative at the doctors office for COVID-19. I brought her to the doctor's office solely to get the COVID test in office since its more sensitive and accurate with results. The doctor saw a few white spots in her mouth and thought she likely some virus. She tested negative also for flu and strep as well. After the doctor's office visit, she felt fine and back to her normal self.
On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause.    She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects.  On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for.  Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital.   Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure.  Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken.  Despite these medical interventions and pharmacological interventions, the pressure did not subside.  A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain.  The craniotomy was able to reduce the pressure but it was too late.  There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes.     The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months.
aches and pain in left shoulder, pain in left thumb joint; little bubble on her left forefinger by the tip; This is a spontaneous report from a contactable consumer (patient).  An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced aches and pain in left shoulder, pain in left thumb joint that she had to tape up, a little bubble on her left forefinger by the tip. She took 2 paracetamol (TYLENOL). All these symptoms appeared on the left side which was also the side she received the injection. The aches have subsided, gotten better; however, she can't lay on her left shoulder. Her 2nd dose is scheduled for 29Mar2021. Outcome of event "aches and pain in left shoulder, pain in left thumb joint" was recovering, while other event was unknown.  Follow-up attempts have been completed; information about lot/batch number cannot be obtained. No further information is expected.
Erythema and edema left arm; lump at site. Round, red, warm 8.5cmx8.5cm. Treatment with cold compresses, Clarinex 5mg QD
Full body hives that subside with 24hr xyzal and zyrtec and return with the same intensity within 24 hours. Hives are just beginning to subside now. 6 months after vaccine booster dose
Rash on stomach after 3-4 days. Rash subsided after a day. New big rash near the vaccination site after a week of vaccination
I had an extensive oral surgery about 36 hours after getting the vaccination. I had non profuse bleeding after the surgery. I experience a condition called Liver Clot (currant jelly clot). This condition and the bleeding continued for over 5 days following the surgery or 6.5 days after the vaccine dose 1.
Patient discharged after (31 hour ) admission. Patient was admitted for malaise, fatigue and Covid (+). He was put on oxygen intermittently, but walking sats stable 92-96. He was given MAB's, supportive care and improved the next day such that he felt well enough to go home. He was found to be persistently in atrial fibrillation; echo showed preserved EF, with no thrombus; Ziopatch was applied and he was advised to follow up with PCP concerning these results, as well as to discuss his understandable hesitancy with being on Eliquis, though he agrees to take it for now. He also has sutures in place on his left cheek, he wishes these to be removed, as he won't be able to enter his surgeon's office for this d/t Covid. They are removed without issue. He is discharged to home with his daughter, in stable condition.    New Medications: Eliquis 5mg twice daily.
(+) vomiting 5/13 Dx: Intussusception -> (Had surgery 5/14/13 Laparotomy for reduction).
LYMPHNODE ENLARGED ON L INGUNAL REGION ABOUT 1CM IN DIAMETER MMR GIVEN SQ IN L THIGH
symptoms - mouth got very dry, trouble breathing, felt like throat was closing.  Treatment - 0.3mg epi IM right thigh, Benadryl IV, steroids
3 days after receiving the first covid pfizer shot i started experiencing vertigo like symptons - feeling very dizzy, felt like the entire room was spinning aggressively when lying down, rolling over in bed, getting up from lying down position, or tilting my head upwards (e.g. quickly looking up at high cupboard)
Physician dx pertussis. Pediatric pulmonologist Hospital states Classic signs and symptoms of pertussis. Zithromax given by pediatrician 2 weeks prior to referral to pulmonologist.