chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting 06/09/2022, I developed a scratchy throat, runny nose and a cough. I tested positive for COVID-19 with an at home test on 06/11/2022. These symptoms lasted for about 3 days. After 2 weeks, I was scheduled to go back to the hospital to volunteer. On 06/28/2022, I started having an elevated heart rate: 110-115BPM, shortness of breath, syncopal episode (where I passed out) and a fever of 101.5, chest pressure in the left chest area. I notified my PCP and was instructed to go to the ER. I was admitted to the hospital the same day. I stayed there until 07/09/2022. I was diagnosed with Myocarditis, Bacterial Pneumonia, Sepsis and Coronary Artery Disease. I was still positive for COVID-19 on 06/28/2022. On 07/01/2022, they took me off of isolation for COVID-19 because they thought I was no longer contagious with it. I was discharged with the following medicines: SYNTHROID; vitamin D; calcium; multivitamin; baby aspirin; LASIX; prednisone; acidophilus; spironolactone; metoprolol; CRESTOR; budesonide nebulizer treatment; ipratropium nebulizer treatment. Also, they noticed that my inflammatory markers were significantly elevated so they were trying to rule out an autoimmune response but they were never fully able to.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported). Concomitant therapy included simvastatin (manufacturer unknown). On an unspecified date, the patient experienced polymyalgia rheumatica. No further information was provided at this time of reporting. The physician would like additional information on the incidence and resolution of polymyalgia rheumatica associated with ZOSTAVAX (Merck) from clinical studies and post marketing events. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Misadministration of vaccine HAVRIX. Pt. was vaccinated with PEDIARIX and ACTHIB on 12-10-12. HAVRIX given instead of PREVNAR 13. Parents notified on 12-11-12. No adverse effects reported at this time.
Information has been received from a physician concerning a 13 year old female patient who on 19-APR-2007 was vaccinated with a dose of Gardasil. Patient developed dizziness and weakness after the vaccine was administered. Unspecified medical attention was sought was unknown. Additional information has been requested.
Initial sore arm, similar to first dose.  Continued for over a month.  Discussed with coworkers, some had lingering pain, others did not.  Mine has now lasted for almost 9 months with little to no relief despite over the counter medications, exercise, stretching, heat/cold application, etc.
Site: Redness at Injection Site-Mild, Additional Details: no redness at ijection site. pateint called after went home saying he had fever bilster came up after vaccines in his lower lips.
No additional AE was noted; Caller states a 6 month-old patient was inadvertently administered a dose of the vaccine GARDASIL 9.; This spontaneous report has been received from a medical assistant, referring to a 6-month-old male patient. The patient's concurrent conditions, pertinent medical history, concomitant medication, previous drug and/or allergy reactions were not reported.  On 06-AUG-2021, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter, (vaccination scheme, route and anatomical location of administration were not provided; lot # 1687290 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 06-SEP-2022) as prophylaxis (Product administered to patient of inappropriate age). The patient remained in the office for observation after vaccination and no additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 4 (booster), single (Lot number: 6h9697) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: tested negative for six days; negative, notes: tested negative for six days; negative, notes: tested negative for six days; negative, notes: tested negative for six days; negative, notes: tested negative for six days; negative, notes: tested negative for six days; positive, notes: positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received antiviral covid 19 treatment with Paxlovid from 05May2023 to 10May2023.
rash / on her left arm; pain on her left arm; has not received her second dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 1st September 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash, pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the rash and pain in arm were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the rash and pain in arm to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported for the 1st dose.  The age at the vaccination was not applicable for 2nd dose. The patient received dose of Shingrix vaccine in left arm and experienced rash and pain on her left arm. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was told by her HCP to receive her 2 doses of Covid vaccine after her first dose of Shingrix. The patient was unsure of the type of Covid vaccine and specific dates but received 2 Covid vaccinations. The caller wished to remain anonymous and does not give permission to follow up. The patient did accept Medical Information telephone number to share with her health care professional. The reporter did not consent to follow up.
BODY ACHES, HEAD ACHE AND SWEATING RESOLVED 3/5. SORE /PAIN IN INJECTION SITE RESOLVED 3/5 Narrative:
The injection site itched for 3 days and there was a large red spot - 3 inches by 1 1/2 inches that lasted for many weeks. I still have the spot, it is lighter in color and smaller. My doctor had no explanation for this, when I saw him on August 26, 2011.
Muscle and joint pain at 3hrs post injection (injection site also). 12hrs Post injection woke with headache, dizzy, severe muscle, skin, and joint pain, nausea, tiredness and brain fog from all the rush of symptoms.
Injection site is red. Left side armpit has a lump. And armpit is stinging and hurting.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm, as dose number unknown, single (Batch/Lot number: unknown), in left arm and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid for COVID 19 Treatment. The treatment start date was 08Jul2022 and stop date was 12Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Difficulty breathing, hoarseness, sore throat, cough, headache, fatigue, weakness and all over body aches.
Pt received pneumo vaccine on 9-19-11 to left deltoid, approx 5hr later started w/ adverse reaction. Reports redness, swelling, pain and dec. ROM due to pain. Today's symptoms slightly improved. Also reports having chills/fever during the night, along w/ pain RAD up left side of neck. Denies C/P, PALP, SOB.
blurred vision in the left eye cleared up; "slowly the blur came back"; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Mar2021 at 09:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included blurred vision. Concomitant medications were not reported. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, it was reported that the patient was positive, although temporary, and reported that the patient had blurred vision in left eye and after the vaccine shot, her blurred vision in left eye cleared up, but then slowly the blur came back. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event blurred vision in the left eye cleared up was recovered on an unknown date in 2021 while the event blur came back was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Side effects began few hours after receiving the Covid-19 Janssen vaccine. Side effects included suddenly freezing followed by full body shivers, hallucinations, extreme thirst, woke up feeling extremely hot as if overheating but no sweating, confusion, headaches/migraines, nausea, and muscle tightness.
Information has been received from a registered nurse and a physician concerning a 7 year old white female patient with juvenile rheumatoid arthritis who on 8/17/98 was vaccinated with a first dose of varicella virus vaccine live (lot # unknown). It was noted that the patient had been vaccinated by another health care provider. On 8/15/04 the patient presented with over 100 vesicular lesions and a moderate fever. She was diagnosed with severe varicella. The patient recovered on 8/22/04. There was no product quality complaint reported. Unspecified medical attention was sought. No additional information is expected.
Pain and swelling, malaise, dizziness, weakness, insomnia, headache, tingling, sharp chest pain, shortness of breath, arm feeling cold, cough, myalgias and arthralgias. Numbness and weakness of left hand, flu-like symptoms, palpitation, back pain, "though coming slowly".
Patient had a episode of syncope and vomiting. Had to call 911, but patient refused to go to hospital. Patient said he has passed out in the past when gives blood.
No adverse event noted.  12  y/o dosed with Pfizer 5-11. Minor presented to clinic with consenting adult for scheduled vaccination. Requested  and registered patient for Pfizer 5-11. Age ineligibility for requested vaccine missed by clinical staff. Participant under dosed with Pfizer 5-11. This error was not caught until 12/12/21. when a 5-11 clinic. It when it was identified someone above the age of 12 was registered to receive their second dose of Pfizer 5-11.   The legal guardian of the patient was called. Te parent indicated they were aware and requested the 5-11 vaccine for their child given his "smaller stature" and "cardiac history issues". There was concern over giving him the 12+ dose.  Parent informed the vaccine authorized for their child's age is the Pfizer 12+, and that his second dose should be with the appropriately authorized FDA vaccine. Offered to provide the parent with local clinics currently administrating the vaccine. Parent refused.   Child is stable and doing well post vaccination.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 08-MAR-2018 the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The Oka/Merck VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
(R) thigh with erythema- 4 inches or 10cm in diameter. No vesicles, no open skin, no petechia, no joint swelling, no fever.
Severe arm pain at site of Zostavax injection and an extremely red left eye. Went to doctor.  Have cellulitis infection at injection site.  Very high blood pressure from the infection caused subconjunctival hemorrage in left eye.  Given Rx of Doxycycline for infection.
Pt developed redness and swelling on the injection site immediately (2x3 cm). She spiked 102 deg fever on 11/2/07 at 8 am. She has muscle aches.
No additional AEs; Caller reported vaccine administered after temperature excursions.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.     On 07-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # X006983, expiration date 07-MAR-2025, 0.5 milliliter, intramuscular) after temperature excursions for prophylaxis (product storage error). Temperature excursion was 18.3F for 1 hour and 5 minutes. No previous temperature excursion. No adverse event was reported.
Approx 7 pm 10/3/07, had fever (approx 103), chills, headache & body achiness over entire body fro approx 12 hrs.  Tylenol every 4 hrs - 7 pm until 7 am (extra-strength).  Bedrest & tired during am of 10/4/07; pm - weak.  Better 10/5/07.  Injection site slightly tender post injection- some itching, no swelling
Patient began having coughing, dyspnea, tongue tingling within 1-2 minutes of vaccine. Treated with Epinephrine and Benadryl injections. Transported via EMS to local ER. Given more Benadryl and steroids IV.
Day one (11 hrs post vaccine) nausea, just feeling foggy (12 hrs post vaccine) uncontrollable shaking/chills. No fever. Intermittent searing joint pain- like my sciatica was firing through my hips, legs and arms. Throbbing headache. Leg cramps- those I found concerning as I was aware of the more benign side effects .Lasted several hours. (20-44 hours post vaccine) brain fog. It gradually began to clear . Felt like I had a hangover and no sleep.  Then randomly- I fell 6/6 at about 845am... 46 hours after the vaccine. I never fall. I did not trip. I did not have the sensation of falling. I was walking and then down on the pavement outside a clients house (I?m a visiting nurse) it concerned me because I checked the area for trip hazards and there were none.
He started feeling bad around midnight 9/3-9/4/2021, he vomited, tiredness, dizzy, shortness of breath, fever, chills. His mother gave him Tylenol. He slept most of the day. Mom reports he was irritable when he was awake but he slept most of the day. Started feeling better around lunchtime on Sunday, 9/5/2021.
From telephone contact at manufact. on 19Jun2002, it was reported by a nurse that apprx. 11-12 pts with large local reactions after receipt of 4th and 5th doses of Tripedia vaccine series. Four different lot numbers were involved. She stated that all of these reports were reported to VAERS, some local reactions included entire limb. Additional information received from follow up correspondence on 21Jun2002 regarding each pt. P 3 4 A female, apprx. 5 years old received 5th dose of DTAP(Tripedia), 4th dose of IPV(IPOL), and 2nd dose of MMR vaccines on 17Apr2002. Pt developed a large local reaction of redness and tender to touch on left arm on 19Apr2002. Pt recovered. Case closed. See reports U2002-00454, U2002-00546, U2002-547 and U2002-00549 to U2002-00555, from same facility.
Within days, after my first dose, I started having really bad pain in my hands and thumb area with a lot of weakness. I went to an orthopedic Dr. and he diagnosed me with arthritis and gave some medication and a topical cream. He also gave me a hand splints.  Plus he gave me a steroid shot in my wrist area.  The pain went away a little and then it came back after my second dose. It started to go away and I got my 3rd shot and it came back with a vengeance. I am still dealing with this at this time.
received a total of two-doses of Fluzone High-Dose a day apart/no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 73 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] twice a day apart.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant therapy was received.  On 01-Oct-2019 and 30-Sep-2019, the patient received doses of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ246AA via intramuscular route in the left arm...  It was of actual medication error case due to extra dose administered.  It was unknown whether vaccines were used or not.  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.
No adverse effects; a patient received an improperly stored ROTATEQ; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications and drug reaction or allergies was provided.     On 05-NOV-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S010564, expiration date 17-JAN-2021, dose was not provided) orally for prophylaxis. The vaccine underwent excursion with temperature 47.1 Fahrenheit degrees for 30 minutes. There was a previous excursion with temperature 32.9 Fahrenheit degrees for 24 hours. The call was placed because of data logger. No adverse effects were reported.
235 Patient complained of non-raised rash to legs 253 non-raised rash to right arm 255 non-raised rash to left arm 305 welts noted to legs and right shoulder 310 patient complained of heaviness to chest and reddening noted above eye brows BP 122/84 HR 76 O2 sat 100% 315 Benadryl 12.5mg liquid given orally 317 BP 119/74 HR 60 sat 100% 319 decrease redness and itchiness 322 129/80 hr 75 335 bp 105/79 hr 68 o2 sat 100%   No redness or welts present at this time
I had started getting real server headaches to wear I could leave the house only for doctor appts, it has affected my eye sight. I have real bad dizzy spells to where I was blacking out and falling. I've have broke a few toes and fracture many. Could not get my blood pressure to a safe level every time I went to the doctors, So I went to the doctors about my headaches they took my blood pressure and they could not get a good reading they tried a few times this was in June 22nd or 23rd 2021. They sent me to the ER and they did a CT scan and it should that I had a brain bleed so they flight life me to the local hospital and then they did blood work at the hospital and my platelets were done to 4 or 40. I've had to take so many different meds to try and fix the platelet level. I had to have chemo treats for a month. We are still dealing with this issue and it's been over a year. It affected my memory. I still have dizzy spells. I have good and bad days, so right now we are trying out a vitamin shot. I have been diagnosed with ITP..
approximately 10 days after the first shot i began to have heart palpitations, hot flashes, chills, nausea, headache, dry mouth, fatigue, increased urination. Day 11 was the worst.  Day 12 I felt 90% better.
Patient's arm was bruised and sore. She said it was hurting the day after and that it was not hurting today (11/7/18). Stated that it only hurt when applied pressure to arm and that fever was only around shot area.
My baby almost immediately became fussy and then had a fever for 24 hrs reaching 104. I had called the clinic they suggest ER but I knew to alternate ibuprofen and acetaminophen- She was extremely fussy during event. Filed complaint online -but don't think you received it.
Heavy rash on chest and belly. Apply calamine lotion and hydrocortisone and the area clear and get better the next day,
Initial report received from a health care professional on 25 May 2010: This adolescent was vaccinated with MENVEO, batch no: 027011, expiry date: Aug 2011), (dose: unknown) intramuscularly for immunization on 25 May 2010. The patient was administered MENVEO that was not reconstituted before administration and the lyophilized portion was not administered. No adverse event had occurred.
Right arm deltoid area 8 cm width x 7 cm length; slightly warm to the touch; slightly erythemous; slightly tender. Prescribed: apply ice to the area; Motrin 600 mg one tab po every 8 hours as needed for pain & Keflex 500mg one cap po 4 times daily by Dr.
Breakthrough case admission after 3 vaccines Moderna 1/28/21 Lot# 007M20A;  Moderna 4/8/21 Lot# 018B21A;  Moderna 12/14/21 Lot# 029H21B