chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse referring to a 17 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 19-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Information has been received from the mother of a consumer and a health professional for the pregnancy registry for GARDASIL, concerning a 17 year old female with pertinent medical history reported as unremarkable, who on an unspecified date in April 2008, was vaccinated with the first dose of GARDASIL, IM in the arm. There was no concomitant medication. On 22-MAY-2008 the patient received the second dose of GARDASIL. Subsequently, she became pregnant. The patient sought unspecified medical attention and had blood work. No results were provided. On 29-MAY-2008, the patient had a fetal ultrasound which revealed that the fetal pole was not identified and there was "no gestational sac." The patient's last menstrual period or weeks of gestation were not reported. The patient had a miscarriage on 11-JUN-2008. At the time of the report, the daughter was still having clots and bleeding due to the miscarriage, and was emotionally distressed. No other information was provided. Upon internal review it was determined that miscarriage was an other important medical events. Additional information has been requested.
patient had rash c/ second injection, but thought it was due to starting a new OTC product.  3rd immunization given, and rash reappeared.
29 days after I received my first  Pfizer vaccine dose, I developed pain and  inflammation of the right eardrum and had to go to the doctor to get prescribed eardrops called Ciprofoxacin and used it for 7 days, after which the pain subsided but the plugged up ears and heaviness in that ear remains.  After I received my second vaccine dose 32 days later, my other left ear developed the same symptoms of ear pain/inflammation of my eardrum three days after receiving the second vaccine dose.  I used Ciprofloxacin in that ear as well and the pain went away but the fullness and plugged-in ears remain.
big lump at injection site; Hives on one foot; This case was reported by a consumer via interactive digital media and described the occurrence of injection site lump in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2023, the patient received Shingrix. On 4th January 2023, 2 days after receiving Shingrix, the patient experienced injection site lump and hives. On an unknown date, the outcome of the injection site lump and hives were unknown.   It was unknown if the reporter considered the injection site lump and hives to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment: The case was received by consumer via interactive digital media. The patient reported that he/she received Shingrix vaccine on Monday. The patient stated that yesterday (day before reporting) observed a very big lump in the place where he/she received vaccine and a little hives in one of his/her foot. Follow-up would not possible as no contact details were available.
Runny nose, coughing, difficulty breathing, need to defecate, lip swelling and chest rash.
This spontaneous report was received from a physician and refers to a 15 month old patient of unknown gender. On 22-SEP-2014, the patient was routinely vaccinated with PROQUAD (Merck). Lot number reported as J0000140 is an invalid lot number for PROQUAD (Merck). The patient received PROQUAD (Merck) which had expired, expiration date was reported as 04-JUL-2014. No adverse event was reported. Additional information has been requested.
Pt developed symptoms about 8 minutes, post vax, according to the mother. She noticed after she walked out of the clinic, eyes watering, itching right eye, swelling and nose watery and itching. Treated with prelone, Benadryl.
12:00PM Lethargy, headache, took 200mg Tylenol. 1:30PM Lethargy, body aches, HA worse, fever 101F. 4:00PM Lethargy, extreme body aches, dizziness, nausea, vomiting, fever 102.7F, horrible HA. 7:00 PM same symptoms as above and fever now 103.7.  1:00AM 10/07/2015- fever 102 after Ibuprofen, other symptoms persist. 6:00Am-  Fever gone-Temp 98, mild body aches, lethargy continues, mild nausea, no appetite. 5:00PM-Starting to feel back to normal but still lethargic.
Caller states the patient is fine and nothing happened; A patient received the varicella vaccine and instead of it being reconstituted with diluent it was reconstituted with RETACRIT on accident.; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. Her concurrent coditions included hypothyroidism and seasonal allergy. The patient's medical history included delivery, she was a postpartum patient, right after had baby. Concomitant therapies included levothyroxine.  On 22-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, subcutaneously, lot #X010531, expiration date 11-APR-2025 (injection site was not reported) for prophylaxis.  A nurse who was giving the patient a varicella virus vaccine live (oka/merck)(VARIVAX), instead of mixing it with sterile diluent, mixed it with epoetin zeta (RETACRIT) and administered intramuscularly, later clarified subcutaneously. The reporter asked if there was any stability data or any information on what would happen. The patient was fine and nothing happened after it was administered. She was not typically on epoetin zeta (RETACRIT).
within one hour facial prickling sensation and mild dizziness -- by 6pm same day, moderate aching all over and moderate headache also.  Next day continued symptoms but milder and intermittent facial prickling
Patient started with redness and swelling on LA after receiving the 3rd dose of GARDASIL vaccine.  On 7/2/10 pt. started with symptoms of nausea and dizziness.  Pt was seen in office on 7/2/10 and EKG was ordered.
Patient says that after her injection, that spring, she began to notice bruising;  small clusters of bruises on her arms and legs.  She has never had this before.  She is concerned it is related to the vaccines.  No pain but unsightly. Various sizes. Appear and disappear spontaneously.   She says she told a nurse twice . I see a nursing note of this June 8, 2021. She told me  in Feb 2022 ,as her new primary.  I did labs then; all normal.  Review of labs in past show findings below. She did receive Iron infusions x 2 summer 2021 and had egd/c-scope in Sept 2021 which showed large hiatal hernia but no bleeding, no polyps. Says the rash occured again in Fall 2021. Is concerned about it.  On exam, looks like purpura.
The first day 1/07/21 I started with a pain on my throat , my throat felt really sore however I was still able to eat . The following day 1/08/21 I still had a sore throat I was able to eat , but at the end of the night I got a fever me temperature was 102.0 . I knew all these symptoms were normal but being that on 1/09/21 It was painful for me to swallow I went to immediate care where they said I still had a fever and told me I had a swollen tonsil on the left side of the mouth which is also the side I received the vaccine on. I still continued to have a fever . Saturday night I noticed I had gotten some small sores on my mouth also on the left side . On Sunday I had loose stool , but I have been eating very soft foods because of my throat . Which then I went to go see a dentist and she said they appeared to be fever blisters , those popped I have a couple on my tongue as well . As of today my throat pain feels to be getting better .I did start a oral mouth rinse also for the sores
Pt complained of pain and rash and swelling in all upper arm right side. She experienced red and hot rash underneath the injection site. Redness and swelling lasted up to 1 week after the shot of PRVENAR13. Pt took BENADRYL. Symptoms subsided after 7 days.
Fatigue; Myalgia; Headaches; Shivering; Fever; Insomnia; constipation; gas; Severe shortness of breath; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta) inhalation powder for drug use for unknown indication and fluticasone fur+umeclidinium+vilanterol ellipta dry powder inhaler device (Trelegy Ellipta Dry Powder Inhaler Device) inhaler (batch number unk, expiry date unknown) for drug use for unknown indication.   On 8th March 2022, the patient received the 1st dose of Shingrix. On 7th March 2022, the patient started Trelegy Ellipta 200 mcg/mg at an unknown frequency and Trelegy Ellipta Dry Powder Inhaler Device. On 7th March 2022, not applicable after receiving Shingrix, immediately after starting Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device and immediately after starting Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device, the patient experienced shortness of breath. On 15th March 2022, the patient experienced fatigue, myalgia, headache, shivering, fever, insomnia, constipation and gas. The action taken with Trelegy Ellipta was unknown. On 7th March 2022, the outcome of the shortness of breath was recovered/resolved. On an unknown date, the outcome of the fatigue, myalgia, headache, shivering, fever, insomnia, constipation and gas were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, myalgia, headache, shivering, fever, insomnia, constipation and gas to be related to Shingrix, Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device. It was unknown if the reporter considered the shortness of breath to be related to Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details reported were as follows: This case was reported by the patient. A week after receiving Shingrix, the patient developed fatigue, myalgia, headaches, shivering, fevers, insomnia and GI symptoms like constipation and gas.  The patient reported that none of the symptoms had resolved. He provided medical advice disclaimer and referred to healthcare professional.  On the before receiving Shingrix, the patient took a sample of TRELEGY from his healthcare professional and he developed severe shortness of breath right after taking it.  The patient used his rescue inhaler and the symptom resolved.  Permission to contact healthcare professional was given. The consent to follow up was given.
Right upper arm swollen, red warm to touch.  Ice, Benadryl every 6 hours.  Tylenol if needed to at home.  Returned to office 03/23/2006 given Zyrtec.
Dizzy spells/ aggravating; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy spells/ aggravating) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history is provided by the reporter.  Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy spells/ aggravating). At the time of the report, DIZZINESS (Dizzy spells/ aggravating) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  Patient stated  he was not going to get the second dose until he gets the event under control.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up received on 20-APR-2021 contains no new information.
injection site still sore and red after injection ( 11/6) fatigue and heaviness (11/4) headache (11/4) random shooting nerve pain left foot ( 11/4,11/5)
At 10:00pm, patient reported high fever (but did not take his temp), chills, shivering, soreness, cramping (muscle) all over body, nausea, burning sensation on urination. Patient states he felt better 16 hrs., after the shot.
Stated tongue feeling big and coming through her teeth. States she cannot take epinephrine.  Benadryl 25mg PO given at 1322.  Symptoms began to improve within minutes.  Symptoms reported by patient to have resolved.  Left with her husband at 1355.  Instructed to seek medical care if symptoms return and to follow up with her primary care physician before receiving her second dose.
This spontaneous report as received from a registered nurse refers to unspecified number of patients. Nurse reported that improperly stored PROQUAD (Merck) (dose, route, lot # and expiration date not provided) was administered to some patients. Nurse believed that a total of 32 patiens received either improperly stored VARIVAX (Merck) or improperly stored PROQUAD (Merck). The PROQUAD (Merck) was exposed to the same conditions as the VARIVAX (Merck) both vaccines were stored in the same freezer. A medical assistant reported that the VARIVAX (Merck) had multiple excursions since June 2013 reaching a highest temperature of -10C for a total time of 864 hours. The reportee did not think that the overall average temperature for the VARIVAX (Merck) had remained between -50C and -15C. She reported that the VARIVAX (Merck) was also exposed to 8C for 24 hours on an unspecified date. MARRS#1311USA002616. No symptoms reported. Additional information has been requested.
Resident did not exhibit any side effects from the vaccine.  Staff spoke with him in his room at approximately 7:20am and returned to his room  just a few minutes later and he was unresponsive.  When the RN got to the room he had CTB.  Physician  documented heart failure and end stage kidney disease on the death certificate.
Very Sore Arm, Headache, Muscle Aches, Extreme Fatigue
At 12:30 PM patient laid down for a nap he offered no co at that time, at 2 PM I (wife) found patient unresponsive no pulse no respiratory effort. His skin was cold and moteled I dailed 911 and began chest compressions as instructed by 911 operator. I never got a pulse first responders and also worked on patient and transfered him to hospital he was pronounced dead at 2:08 pm on 09/07/2011.
During injection, needle came loose from syringe and approximately a quarter of the dose was lost/not injected.
allergy, itching at the site, throat/tongue neck itching.  set in approx 15-30 minute after injection
Extreme stomach pain. Throat swelling so could not breath.  Rash covering entire body. Swelling in feet, face and genitalia.  Itching.  All symptoms came on within 30 minutes. Parents gave me an over-the-counter medication they found in the rental house where we were staying, that had an antihistamine ingredient and they called emergency. We drove to meet the ambulance as I wasn't able to breath. I vomited a number of times before we met the ambulance, about 20 minutes. The amublance then took me to the Hospital. Allergic Reaction-Major.
Received 2nd booster of the Pfizer vaccine 05/20/2022. Adverse event began 05/23/2022. I had just gotten off an airplane about 08:00PM MST after a 2 hour flight, I went to ER at a local hospital with shortness of breath and low O2 level. They did a CT scan and found a blood clot in my left lung. It required a radiological procedure and a catheter in my lung. TPA was used to dissolve the clot. I was admitted for 4 days, I was discharged on 05/27/2022. I am doing better and I see my PCP tomorrow (06/10/2022) It has been recommended I see a cardiologist and a hematologist because I am on a blood thinners now.
pt recv vax & w/in 20min pt became dizzy, SOB, felt feverish & flushed;pt exp chest pain, pulse 84 & uncomfortable;to hosp c/o chest pain, dizziness, SOB, n/v;given 02;diaphoresis
Acute nausea, fever and headache 3 hours after vaccination. Fever up 2 degrees until 5 AM 10/21/03. All of this could have been due to immune system response!
I developed reactive arthritis in my fingers 1 week after the second Moderna vaccine.  I continue to have reactive artiritis , swelling, pain, redness, in my finger joints.  I also became infected with Covid in July 2021.  The vaccine did not work.
Patient received an expired vaccination. After administration upon lot look up, the vaccine had expired on 2/6/2023, but administered 2/15/2023
Extreme chills for 2 hours, deep sweat over night, extremely tired 1 1/2 days
Headache, Myalgia, Arthralgia, Fever, Fatigue, Chills Narrative:
Approximately 2 hours following receipt of GARDASIL #2, patient developed hives all over body-face, no shortness of breath. Mother denied other new exposures. Resolved with BENDARYL. Lesser hives recurred subsequent 2 days.
I scheduled my 8 year old daughter for her second covid vaccine appointment. She received the vaccine on 02/22/22 and on 02/24/22 I received a call from a Doctor to check on my daughter because she had received the wrong vaccine, he apologized and told me the made a mistake and gave my 8 year old daughter the shringrix vaccine. The vaccine should only be used on Adults over 50 and I don?t know what side effects this is going to cause my daughter this mistake should have never happened.
14-15 days after receiving vaccines she started having tingling in right hand and foot. Next day same thing on left side. Also some numbness in extremities.  Gradually got worse over the next several days.  Felt like "electricity shooting out".  Numbness also went up her back. Went to MD on Feb 12. Blood tests ordered.Liver enzymes were elevated so Hepatitis blood tests done.  On Feb 15 brain MRI done which showed nothing.  Next day, Feb 16 went to ER because of increased tightening of muscles in chest (diaphram area). Dr.'s focused on heart and gallbladder.  She and husband went home and started looking up things on internet.  Found symptoms of Guillain Barre which fit perfectly so the next day (Sunday, Feb 17) drove to the ER there so she could see a neurologist.  A spinal tap was done and another test on a special machine which confirmed diagnosis of Guillain Barre. She was hospitalized that night until Friday the 22nd.  There she received large daily doses of immune globulin.  As of March 18, she is feeling better.  The tingling and numbness is still there but is decreased.  Dr. told her it should be gone by 6 months. 4/4/08 Reviewed hospital medical records of 2/17-2/22/08. FINAL DX: Guillain Barre syndrome Records reveal patient experienced progressive weakness, numbness & tingling of both right upper & lower extremity x 9 days followed by same on left side x 8 days with gait disturbance & balance difficulty x 2 days.  Had chest tightening x 4-5 days w/progressive fatigue & SOB.  Exam revealed distal sensory loss, areflexia, markedly weak hamstring muscles.  Admitted for IVIG x 4-5 doses.  Neuro consult done. Progressed & d/c w/continued home health PT.  7/11/08 Reviewed PCP medical records of 2/12-6/19/2008. FINAL DX: Guillain Barre syndrome, resolving Records of 2/12/08 reveal patient experienced weakness, pain, decreased appetite, LBP, LUQ abdominal pain & numbness of hands, feet & tongue for approx 2 wks. Appearance was extremely tired & stressed.  DTRs diminished or absent in LEs.   Follow-up: Still having some tingling in fingertips and toes -off and on. Happens more when she exercises. States it is about only 5% of what is was in the beginning.  Still has tingling and numbness in fingers and toes on both sides of body but states is 50-75% less than in the beginning. Also occasional feelings of "electricity" mostly around nose area. She believes it all will be gone within 2 more months.
Pt reported itchiness and redness to right anterior thigh. Injection sight on left arm. Mild redness to thigh noted on assessment. No other rashes, redness, swelling, noted anywhere else on her body. Pt denies SOB or hoarseness. Injection site wnl. No redness or hives noted at or around Injection site. VS stable: BP 120/77, P 72, O2 Sat 100% on room air. Pt reports improvement of symptoms with time. Reduced itchiness. Pt advised to take Benadryl when she gets home. Pt sent home in no accute distress. Educated about signs and symptoms of severe allergic reactions and when to seek emergency services.
Mild Fever, sore throat, cough - cold flu like symptoms. Chest congestion. Arm at injection sight became red, warm, swollen and very red from 4hrs after shot through 3 days. Still some redness today. Cold and flu symptoms seem to be related to shot.
Initial report received from a health care professional on 30 October 2013. Over 50 male and female adult patients, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (lot number UT4719BA) (route and site of vaccination not reported) on 2013. On an unspecified date, after receiving vaccine patients experienced redness and swelling, itching, and heat, grapefruit, burning during injection and hard knot at the injection, lasting over a week. Corrective treatment was not reported. At the time of this report the outcome of adverse events were resolved. Documents held by sender: none.
Patient received vaccination at approximately 3:52pm, stood waiting for his sister and mother to receive their immunizations. Collapsed and hit head hard on floor at 3:54pm. 911 call contacted at 3:57pm with EMS en route at 4:00pm.  Patient was conscious and breathing immediately after.  Patient could move finger/arms and legs. Patient able to verify date and location he was at.  EMS arrival at 4:10 pm. Vitals good, vision good, and Blood glucose 97.  Hospital transport declined by mother who was with patient the entire time. Ice pack was given by official for bruise on head. No other pain reported by patient. Patient was able to sit up, stand, and walk away on own accord.
This case was reported by a sales representative and described the occurrence of not responding to the therapy in a 32-year-old male subject who was vaccinated with hepatitis B vaccine recombinant (Engerix B, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. On 22 July 2008, the subject received 1st dose of Engerix (adult dosage). On unspecified dates, the subject received the 2nd dose and 3rd dose of Engerix B. On 16 April 2009, 42 days after vaccination with Engerix B, the subject experienced not responding to therapy. A product complaint was associated with this event. The immunization series was reported to be delayed. At the time of reporting the event was unresolved. The sales representative received an email from a doctor's office. Vaccine was purchased through Henry Shrine and 42 days after all seven subjects were given the 3rd dose of Engerix B, a lab assay was completed. The lab reported that all seven subjects were non-reactive to hepatitis A and B. The healthcare professional believed that the event was caused by a quality issue. No other quality issues identified. The sales representative reported the event as "lack of effect".