chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving VARIVAX states that there have been administered doses.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No additional information regarding patients' medical history, concomitant medication and concurrent condition was provided.  It was reported that temperature excursion was intermittent beginning from 28-JUL-2020, but not previously reported. Since 30-JUL-2020, the patient was administered with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002843, expiration date 23-JAN-2022, exact dose and route of administration were not reported; and lot # S032357, expiration date 14-OCT-2021, 0.5 ml, route of administration were not reported for prophylaxis. Digital Data logger was involved. The vaccine was stored at the temperature that was reported as from minus 14 Celsius degree to minus 10 Celsius degree (maximum minus 9.5 Celsius degree) for 38 hours and 30 minutes. There was no previous temperature excursion reported.
Patient is fully vaccinated and boosted 12/7.  + for COVID on 12/11/2021 and 12.16/2021.  Hospitalized from 12/11- 12/17/2021.Admitted with SOB, hypoxia and COVID 19.  Acute respiratory failure with hypoxia.  CXR: Patchy left upper lobe and lingular segment of airspace disease likely infectious in etiology as well as minimal bibasilar lung atelectasis. Right upper lobe patchy airspace disease as well. No acute pulmonary embolism present. Cardiomyopathy, nonischemic. Echocardiogram demonstrated moderately reduced left ventricular function with a left ventricular ejection fraction 34%. She will require workup for cardiomyopathy with consideration of an. Patient received LifeVest .  Treatment for pneumonia: oxygen,  decadron, breo inhaler, remdesivir, albuterol nebulizer. + for Elevated troponin:  ASA and statin.  ESRD: Hemodyalisis.   discharged home.
ED visits/Hospitalization within 6 weeks of receiving COVID vaccination. Admission 3/14, presently admitted. Second dose received 6/4.
This spontaneous report was received from a physician concerning a patient of unknown age and gender. It was reported that the interruption in the vaccination schedule for GARDASIL (lot number, expiry date, dose and route unspecified) between the first and second doses also happened (dates of vaccination were unspecified). No concomitant therapy was reported. This is one of the two reports from the same source. Additional information has been requested.
Patient received dose 2 of the Pfizer COVID vaccine (lot EW0191, exp 9/2021) at approximately 1500. Patient left after his 30min observation period, walked to his car, then returned to the POD reporting dizziness and headache at 1538. Patient sat down in observation area and PHN and Paramedic. Vital signs: blood pressure 128/84, respirations 16, pulse 78, O2 98%. PHN encouraged patient to stay for 30min from report of symptoms. Patient reported allergies to nuts and seafood. Medical history includes asthma, medication includes albuterol as needed. Patient reported doing football conditioning exercise in the mprning then having a snack at 11am. Patient reported he did not drink enough fluids during exercising. At 1555, patient reported improvement in symptoms. Vital signs: blood pressure 138/82, respirations 16, pulse 76, O2 97%. Patient consumed granola bar, goldfish, juice, and water. PHN offered patient Benadryl but patient declined. PHN educated on following up with provider and when to call ED. Patient reported he wanted to leave against medical advice. Patient planned to get food and his wife would drive him home. Patient left walking with steady gait at 1556.
He had a high fever, a seizure and turned blue. He was rushed to the ER by ambulance. It was horrific.
Information has been received from the mother of a consumer concerning her 15 year old daughter with an allergic reaction to Septra and an allergy to Suprax who on 06-DEC-2006 was vaccinated with Gardasil. Concomitant therapy included Augmentin and Flonase. On 06-DEC-2006 the patient experienced soreness at injection site for a day or two. In February 2007, the patient was vaccinated with her second dose and experienced soreness at injection site for a day or two. On 05-MAY-2007 the patient was vaccinated with her third dose of Gardasil. On 23-MAY-2007 the patient experienced swelling in the injection arm and tenderness in the injection arm. And on 24-MAY-2007 the patient's arm turned red. The patient's swelling and tenderness in the injection arm and reddened arm persisted. It was reported that the patient sought unspecified medical attention. No further details were provided. Additional information has been requested. This is in follow-up to report previously submitted on 5/24/2007. Information has been received from a mother concerning her 15 year old stundent daughter with no medical history or illness at the time of vaccination and with allergies to SEPTRA and SUPRAX who on 04-MAY-2007 was vaccinated intramusculary into the left deltoid with a third 0.5ml dose of GARDASIL (lot# 655617/ 1447F). It was noted that the patient received her first dose of GARDASIL on 06-DEC-2006 and experienced soreness at injection site for a day or two. In addition, the patient was vaccinated with her second dose of GARDASIL in February 2007 and experienced soreness at injection site for a day or two. Concomitant therapy included FLONASE. On 11-MAY-2007 the patient developed a stuffy nose, was dizzy and had an upset stomach. On 19-MAY-2007, the symptoms remained and AUGMENTIN 875 mg BID was prescribed. On 23-MAY-2007 the patient's arm turned red. On 25-MAY-2007, an MRI of the shoulder was preformed and showed cellulitis and fasciitis of the left deltoid with a focal myositis and early abscess. The patient was switched from AUGMENTIN to Clindamycin. On 27-MAY-2007, the patient recovered (also reported as "almost 100% resolution"). No product quality comlaint was involved. Additional information is not expected.
03/21- Soreness in arm, 03/22- Fatigue, 08/11/2021- fever, chill, 08/13/2021 Loss taste and smell for a month, 09/13/2021- Sharp pains everywhere. Difficult to walk,
10/6 mother reported  patient ha a red area l deltoid warm to the touch for 1 wk after vaccination.
Tuesday night June 6th I had a sore throat. The next morning I had a low grade fever but increased to 101.8 during the day.  I registered for the PCR online. I got notified at 4:02pm that it was positive. My doctor called and prescribed me Paxlovid. I began taking it on June 8th and continued for 5 days. I also had a slight headache that was short-lived twice during the infection. I slept almost continually for about 3 days. I just didn't feel right. I couldn't describe what hurt, I just knew I didn't feel right. Also, on the following Monday I began to have tightening in my chest and on Tuesday it was worse. I visited the doctor. The PA noted that wasn't anything that indicated that I had a problem. She prescribed ibuprofen when I woke up in the morning and when I woke from my nap to fight inflammation. As of today I feel recovered except for that I am sleeping more at night.
Pt. states at 7 pm she noticed she had hives, a couple minutes later her tongue and throat started to swell for the next 12hr. Pt. stated she took I tab of L-lysine which did not help.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. Patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown dates, unspecified number of patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot number, Expiry date, dose and route were reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
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 with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations 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 ROTATEQ (lot No. 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.
mom stated that pt had devel a rash on back 215 or 230, it covered entire back; mom stated that first it looked like a sunburn & some raised areas noted;  blotchiness;
(02/15/2021): vaccine (02/16/2021) : severe body aches and weakness, increased congestion and mucous production.  (02/16-17/2021) : death possibly during the night
Pt received vaccine 2/18. 2/21 returned to office with redness, soreness, systemic itching. Dx with allergy to TDAP. Pt advised to take CLARITIN 10mg q day until resolved.
Left deltoid slightly swollen, armpit swollen, red, hot & pink. Right armpit is swollen. Itching at injection site. BENADRYL given orally.
5/12/2008 7:45 PM patient had a seizure lasting 1-2 min.(patient no prior seizure hx) Paramedics called. Parent states cool compresses applied. Paramedics state temp 101.2 F, eyes fixed and dilated for 20 minutes. Transported to Sparrow Hops ED. Chest xray, CT scan, Labs normal. Sibling (sibling has prior seizure hx--not assoc. with immunization)brought to ER with seizure 2 hrs later. Both children dischared home on antibiotic. Although parents state no evidence of infection found. History as reported by father. Did not remember patient's birth weight. Father has history of febrile seizures as child, patient's older sibling has had 5 seizures and is being medically evaluated and has begun treatment for seizure activity.  3 previous doses of Dtap and 2 previous pedvax hib
Accelerated heart rate 144-197 bpm (4/16/07 - 4/19/07), rapid breathing, temperature 101.4 (by temporal scan with Tylenol), .3ml infant Tylenol repeated doses.
p/vax pt  exp pain over all muscles & aches for 1day; pt also later devel shingles on lower back & groin area & exp severe pain; pain & numbness in rt leg also associated w/shingles; shingles required pt to get epidural nerve block as out p
3 days in bed  102 fever. Body ache , masses, very sick feeling inyetnslly
I started to have abdominal pain about four months after getting the third dose of the vaccine. It was in the right center of my abdominal pain. It was a constant pain and a feeling of pressure that was there all the time. It was worse after I ate something. It has been identified as a possible autoimmune Hepatitis. That has been ruled out but they said it also looks like it is a drug induced Hepatitis. I do not take any medications so that does not make sense. The pain and discomfort has lessened over the course of a month. I am taking more Prilosec and Iron Supplements because I was showing some Anemia.
On 04/28/2022, I had a PCR test done since my wife was not feeling well. Her PCR test came back positive on 04/30/2022 and mine came back negative. I got the 2nd booster on 05/01/2022 and the following day I ended up testing positive (05/02/2022). The first two days, I had some flu-like symptoms (congestion, headache, fever, body aches and diarrhea) and my doctor has me on Paxlovid which has helped. I have some congestion currently but nothing like before Paxlovid.
I had a migraine for 4 days, body aches, chills, sore arm where I got my vaccine, tiredness, and now after a week of the injection I have a red rash on my arm where the vaccine was given its very swollen and I'm in a bit of pain.
Patient is suffering from Guillain Barre Syndrome. The patient presented about 9 days after flu vaccine administration with symptoms of weakness in his lower extremities and lower back pain.  The patient is currently intubated due to respiratory failure and has had 5 days of high dose IV immunoglobulin with no improvement. The patient is finishing his last round of plasmapharesis in the next day. During his time at the hospital he experienced elevated blood pressure which was hard to treat, he also had an increased core temperature for a couple of days. 12/17/07-records received for DOS 10/22-11/25/07-DC DX: Guillain-Barre syndrome. Persistent encephalopathy seconary to Guillain-Barre syndrome. Respiratory failure requiring mechanical ventilation. Death.  Presented to ED with severe back pain with increasing weakness. Back pain started on 10/21/07-Low back pain with some numbness and tingling in legs. Today unable to get up.  PE: mild quadriparesis along with mild sensory changes at distal extremities.Treated with IVIG. 5/15/09 Death certificate states COD as respiratory failure due to Guillain Barre syndrome.
Cellulitis (R) upper arm 4"x6". Pt seen 11/9/16 in office. He was Rx'd Cephalexin. On 11/18 mom reported child was well and cellulitis completely cleared.
Chills/soreness/body aches/fatigue/hot flashes continuous from 4 hours since shot lasting >48 hours
pt recv vax 18JAN96 & 1FEB96 pt devel a rash of 1 lesion;4FEB96 there were 12 lesions;It was reported pt was not febrile;
a burning sensation on their arms after the VAXNEUVANCE injection/ slight burning sensation few minutes/trival burning sensation; This spontaneous report has been received from a nurse referring refers to 65-year-old male patient. The information on the patient's concurrent conditions, concomitant therapies or pertinent medical history was not provided.  On 26-JAN-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) a dose of 0.5 ml, administered intramuscularly (IM) in right deltoid, lot# W021512, expiration date 10-AUG-2023 for prophylaxis.  On 26-JAN-2023, the patient complained of a slight (also reported as trivial) burning sensation on his arm after the pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection for few minutes. The event resolved within 10 minutes. There was no medication error.  The nurse reported that the event was attributable to the pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE).  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2301USA009692:
Pfizer vaccine was administered outside of the clinic - reported by patient  ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/3/2021 COVID-19 PNEUMONIA
Patient verbalized lightheadedness.  She was evaluated by onsite Fire Rescue and released to go home at 12 pm.
Lightheaded, sweating, blurry vision. Vitals wnl. Given juice and water.
2 hours after vaccine given, experienced jerking in arms, legs were weak, nausea and vomiting and itching, Now, 1 week later, I have a rash on left arm and face
Patient has headache and pain at injection site for 3 days after injection. Those resolved on the 3rd day, but then patient noticed pain in the elbow joint of the right arm (opposite from her injection site). This pain has persevered for 2 weeks. The pain is only when patient extends her arm. It does not occur at rest. The area is not warm to the touch and no redness is apparent at the site.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
18 year old male consumer received the Menactra via subcutaneous (SQ) route; Initial information received on 25-Jun-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional via phone.  This case involves a 18 years old male patient who was vaccinated with 0.5 ml second booster dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number: U6346AA and expiry date: 30-Aug-2020) via subcutaneous route in right arm on 03-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to inappropriate route of vaccination.  It was unknown if any adverse event occurred or not following the vaccination.  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.   Documents held by the sender: none.
"Covid Arm" - slightly red and swollen. Appeared on Saturday (1/30) evening. Size about the diameter of a baseball. No treatment given. By Monday, 2/1, grew in size; shape now oval, length approx 6 inches, width varies from 2 to 3 inches. Started to itch slightly at approx 9:00 PM.  Took2 Benadryl liqui-gels at approx 11:00 PM.  At 10:00 AM on 2/2, size remained the same, and red coloring started to  fade. By 10:00 PM on 2/2, the size grew about 1/2 inch in both length and width. Took 2 more Benadryl liqui-gels at 10:00 PM. By 1:00 a on 2/3, there is no change.
No additional adverse event was reported; The vaccine had temperature excursion of 47.9°F on 01-DEC-2022 and then was administered to the patient; This spontaneous report was received from a certified medical assistant and refers to a 15-month-old female patient with not concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies reported.      On 01-DEC-2022, hepatitis a vaccine, inactivated (VAQTA), lot # reported as W006596, expiration date 11-OCT-2024 had temperature excursion of 47.9 Fahrenheit degrees (°F) for 47 minutes.  On 15-DEC-2022, the patient was vaccinated with an  improper store third dose of hepatitis a vaccine, inactivated (VAQTA), intramuscularly in the right thigh , lot # reported as W006596, expiration date 11-OCT-2024 for prophylaxis (quantity dose was not reported) ((improper storage of product in use).  No additional adverse event and not product quality complain were reported.  Lot number W006596 is an invalid lot number for hepatitis a vaccine, inactivated (VAQTA).
After receiving my 2nd Pfizer COVID shot, I did not have a menstrual cycle for three months and I was always regular.   After my Pfizer COVID booster shot that was administered on  11/1/2021, my left arm is still sore to this day and three weeks after the booster, I experienced excruciating nerve pain to my pelvic and perineal area that cannot be explained.  This pain still exists to this day.  I do not know if there is a correlation with the vaccine throwing my menstrual cycles out of whack for months and then the nerve issues to my pelvic area but it is very coincidental.
Unusual feeling. Back pain. Hair loss. Runny nose. Itching in area of shot.
On November 8, I began to experience intense and annoying muscle twitching in my left arm. The first episode did not cease for approximately 3 hours. The twitching continued in my left arm and then proceeded to move to other parts of my body (calves, face, abdomen, feet and buttocks) where it varies in intensity and duration. I am still dealing with these mystery twitches. They are most notable at rest. My doctors have indicated that they are benign. They may be related to the vaccine given the onset and its proximity to the Pfizer booster I received.
I had my first dose of Moderna Monday, 3/1/2021, in my left arm.  My arm was sore but not red, for about 2 days.  After that I was fine.  Yesterday, I noticed a little itching at the injection site.  Today it is red and warm.  I am having no other adverse effects.   My husband had an appointment with his cardiologist today, and I asked the doctor to look at my arm.  He said to put ice on it, and keep an eye on it; if it didn't look better by tomorrow, he said to call my doctor.  He also said if I developed a fever to go to Urgent Care or ER.
her lips were fairly large/the initial swelling, her lips go down and the last 5-7 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-011922-1308 (Galderma).  A 46 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 46 years as dose number unknown, single for covid-19 immunisation; hyaluronic acid (RESTYLANE), first regimen from 25Jun2021 (Batch/Lot number: unknown) to 25Jun2021 at 0.5 mL single, second regimen from Jul2021 (Batch/Lot number: unknown) to Jul2021 at 0.5 mL single and third regimen from 06Dec2021 (Batch/Lot number: unknown) to 06Dec2021 at 0.1 mL single; botulinum toxin type a (BOTOX), first regimen from Jun2021 (Batch/Lot number: unknown) to Jun2021 and second regimen from Sep2021 (Batch/Lot number: unknown) to Sep2021. Relevant medical history included: "general cleaning" (unspecified if ongoing), notes: No dental procedure other than a general cleaning. Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR]; VENLAFAXINE. The following information was reported: LIP SWELLING (non-serious), outcome "unknown", described as "her lips were fairly large/the initial swelling, her lips go down and the last 5-7 days". The action taken for hyaluronic acid and botulinum toxin type a was unknown.  Additional information: On 25Jun2021, the consumer was injected with Restylane, 0.5 ml in upper and lower lip. The consumer reported that it looked good for a month or so, then nothing. In Jul2021, 0.5 ml Restylane was injected, and again, the consumer reported that it looked good for a month and then nothing. On 06Dec2021, the consumer went to a different doctor, and was injected with 0.1 ml, of Restylane Kysse, and reported that initially, her lips were fairly large, and looked good for 3-4 weeks. Within the last week and half, the consumer reported that it looks like I had nothing done, and that after the initial swelling, her lips go down and the last 5-7 days, dramatic change, went down super. Acyclovir 400 mg daily and Venlafaxine 75 mg daily reported as concomitant medications. No medical history or allergies were reported. The consumer has had Botox in the forehead in Jun2021 and Sep2021. Pfizer Covid vaccination received in Feb2021, no booster. No dental procedure other than a general cleaning.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt c/o of pain to right lower leg then rash w/ blisters appeared next day and spread to right upper flank. Pt c/o shooting pains through back and pain to right axilla and breast area.
30 to 45 minutes after getting vaccine, pt began to experience: itching all over body, throat closing, lips swelling. Pt went to ER and was given IV benadryl and steroid. Pt has to continue to take benadryl every 4 hours due to itching