chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was diagnosed with petechiae on 08/17/2021. I had blood test which was normal.  I went back to the doctors office a week later and I had a biopsy of my leg, diagnosed me idiopathic vasculitis. I was started on Prednisone medication for two weeks.  I am still having swelling on my left and right foot.
Patient received above vaccinations and staff advised patient to rest in exam room for 15 minutes prior to departure.  I was called to room several minutes later.  Per mom, child was feeling light headed after the vaccines so she advised him to go ahead and put his head between his legs.  He felt worse and slumped forward and fell off exam table onto the floor striking his head.  It is unknown to me how long he was unresponsive, but from observations from staff, was very little time.  When I arrived from next door exam room, his eyes were open, giving me eye contact but was not speaking.  He seemed mildly confused/dazed for about 3 minutes.  He also had pallor.  No cyanosis.  Regular breathing pattern.  No seizure activity.  Gradually he improved over several minutes and was oriented.  He was gradually repositioned every several minutes before departing office (i.e. sitting on floor against wall, sitting in chair, standing with mom and walking brief steps) to ensure he was no longer feeling lightheaded.  He complained of head pain and neck pain.  I advised observation for few hours at ER due to mechanism of fall and head trauma.  Parent complied and child was observed in the ER.   He had one episode of vomiting  en route to the ER.  He was at his baseline in the ER.  No neurological deficits.  No studies were done at the ER.  He received anti-nausea medication in the ER..  He was discharged home from the ER approximately 4 hours after incident.  Mom did not have follow up concerns of child after that day.
This is a spontaneous report obtained from a contactable nurse (patient) through a Pfizer sales representative. A patient of an unspecified age, gender, race and ethnicity received PREVNAR 13 single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced fever and pain. Clinical outcome of the events was unknown at time of this report.
pt recv vax 23DEC97 & onset ataxia (poor balance), falling off chair, walking into walls) 26DEC97;seen 29DEC w/LOM given Cefzil to ER 5JAN for ataxia
headache lasting 18 days after vaccination, affecting eyes, chills, calves sore on both legs
Patient experienced a syncopal episode post vaccination, accompanied by feeling hot and tachycardic. Prior to the syncope, she reported hyperventilating. She remained unresponsive for about 10 minutes and was brought to the ED. There she became responsive, and reported chest pain and had sinus tachycardia episodes. She also had lower extremity weakness. This has improved per the latest neurology notes. She also had a negative EEG. Unsure if this is an allergic reaction or if the syncope was due to hyperventilation.  Patient is currently on day 3 of hospitalization.
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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "herpes in another quadrant of my mouth that has not flared up in a decade" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "Autoimmune" (unspecified if ongoing); "oral mouth sores/ulcers." (unspecified if ongoing), notes: oral mouth sores/ulcers for 2 years; "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: 01Nov2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 Treatment". The patient underwent the following laboratory tests and procedures: Biopsy: inflammation; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had taken Pfizer Paxlovid as a treatment. Patient have had oral mouth sores/ulcers for 2 years. Patient was told it was oral Lechin planus. The Biopsy did not confirm, and only concluded it was inflammation. After taking Paxlovid, the ulcer healed. Patient had Known allergies Penicillin. Patient had taken other medication Gabapentin in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
FORGOT TO GET HER COME BACK TO GET THE 2ND; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, the patient forgot to came back to get 2nd dose of Shingrix.
This case is a part of 2 cluster cases and is linked to AER# 2013-07489 (same reporter, similar event after DAPTACEL (batch number: C4452AA), IPOL (batch number: J1028). Initial reprot received from a healthcare professional on 28 June 2013. A 05-year-old female patient, whose medical history and concomitant medications were not reported; had received fifth intramuscular dose of DAPTACEL vaccine (batch number - C4452AA) in right deltoid, fourth dose of IPOL vaccine (batch number - J1028, Route of vaccination was not reported) in left deltoid and MMR vaccine (Merck) (batch number - H020854, route of vaccination was not reported) in left deltoid, all on 26 June 2013. On 28 June 2013, two days after vaccination, the patient experienced red hot swelling at injection site right deltoid. Patient was to be evaluated and treated by physician on 28 June 2013. Corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the events was unknown. Documents held by sender: none.
Information has been received from a consumer concerning her approximately 5 year old son with no known allergies or pertinent medical history who on unspecified dates was vaccinated with a first and second dose of RECOMBIVAX HB (lot numbers reported as "4027K" and 638081/1667X or "1669K"). It was noted that the patient also received a dose of VARIVAX (lot # 635450/1142K) (date unspecified) and a first and second dose of MMR II (lot numbers reported as "1407K" and 646738/0819N or "0819D" (dates unspecified). It was noted that the patient received the vaccinations when "whatever the standard schedule for infants was. "There was no concomitant medication. It was reported that the patient was diagnosed with attention deficit hyperactivity disorder when he started kindergarten. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report, the patient had not recovered. There was no product quality complaint involved.
Patient received vaccines approximately 12:30 pm 4/5/12 - Has H/O partial complex seizures, forgot to take LAMICTAL 4/5/12. On 4/6/12, had seizure at 3:00 AM and 5:00 A.M, each lasted 2 minutes. Witnessed by mother. Back to baseline in 15 mins.
Patient was vaccined on 01/25/13, monitored for 15 mins at the clinic before being released. Patient stated she noticed erythema to left arm that night, and on 01/26/13 she noticed a lump and continued erythema  (5in x 2ins per patient report) which continued for 2 days, 02/03 patient reports some redness and itching while lifting boxes on 02/03/13. Denies any itching today (02/04/13) states some achiness to arm otherwise she report feeling okay. Patient came by clinic and reported this to the pharmacist on 02/04/13, and I called her after returning to the clinic at 2:48pm to inquire about what happened and type of reaction.
pt recv vax 2JUN98 day of vax pt had lt arm redness & warmth;mom states size of quarter on 2JUN98 & now entire upper arm from shoulder to elbow has erythema & some swelling;pt has been fussy & had problems sleeping 2JUN98 w/some improvement
Patient states she had a sore should for 3 weeks after vaccination due to vaccine being administered too high on her shoulder.
something crawling inside her body abdominal pain which lead to cervical  and brain cancer stage 4
Pt. fainted a few minutes after her flu vaccine. Ammonia capsule activated. Pt. immediately opened her eyes. She was alert and oriented x 3. Moved to cot. Knees elevated. BP 90/60 HR 80 Resp 20. Pt given OJ to drink and continued to monitor. No s/s of distress were noted.
TINNITUS beginning 6 hours after injection. After 3  weeks 50% improved Narrative:
Patient was found unresponsive at his facility with agonal respirations with bilateral pulmonary embolisms. Patient was found to be Covid positive on admission. Not currently on oxygen
6 days after receiving the RotaTeq vaccine, my son's bowel pattern changed DRASTICALLY. He was having a BM approximately once a week, with a consistancy not quite as thick as peanut butter. Six days after he receive the vaccine, he began to have much looser stools, and the frequency jumped to as many as 7 movements per day. Over the next 8 days, it got looser and looser, until there was more clear liquid than "solid" yellow in his diapers. His pediatrician refuses to admit it could be related to the vaccine, and refused to see my child. We are now 17 days into this new pooping schedule, and it shows very little sign of improvement yet. I am at my wits end with the runny poo, and am switching pediatricians and making an appointment for Monday to have a stool sample cultured. I'm quite worried about my son. If he happens to finish a BM during a diaper change, it looks like sputum, not poop. I've read elsewhere that diarrhea is a side effect of this vaccine, but 2 1/2 weeks of diarrhea is a bit drastic. The CDC said to report any changes in bowel movements to the Doctor, but the Doctor has blown it off, so I'm taking it a step further.
Information has been received from a medical assistant via agency referring to a 7 year old female patient. The patient had no relevant medical history, past drug history or concomitant medications. On 14-JAN-2015, the patient was vaccinated with a dose of with PROQUAD (Merck), lot # K007798, expiration date 29-NOV-2015, 0.5 ml, subcutaneous for her history and physical appointment, that had undergone a temperature excursion. The excursion that occurred was at 23 degrees Fahrenheit for up to 2.5 weeks. The patient's relevant laboratory data was unknown. As of 16-JAN-2015, it was unknown if the patient continued on the PROQUAD (Merck) vaccine and the outcome of receiving the PROQUAD (Merck) vaccine that had undergone excursion was unknown. This is one of several report from the same reporter. Additional information has been requested.
Received vaccine 2/8/13 developed rash. Went to ER on 2/10/13. Monitored, given BENADRYL & discharged.
Patient arrived after 3 minutes c/o dizziness. VS = 113/79, HR - 86, RA 100. Pt fully examined s/s of stroke or anaphylaxis, patient observed for another 5 minutes and began c/o itching to neck and throat. Pt developed a cough. O2 sat remain 100% RA. Pt accompanied to ER by RN.
Immediately after receiving DTaP IPV and MMR, patient began having difficulty breathing and wheezing which required albuterol treatment, benadryl, and prednisolone.  Patient recovered fully.
Pt states she had significant soreness, redness and swelling to pneumococcal vaccine site and pain of 6 on scale of 0 to 10 making it difficult for her to sleep last night.
Pain and aches in all joints. Pt. had to stay home from work but did not take any pain relievers. No fever, cough, bruising or pain at injection site. Headache also reported.
Very tired, feverish, aches in joints. Flu-like symptoms for two days. Just rested and took Ibuprofen.
patients receives booster dose after more than 30 days of refrigerator storages; patients receives booster dose after more than 30 days of refrigerator storages; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (patients receives booster dose after more than 30 days of refrigerator storages) and POOR QUALITY PRODUCT ADMINISTERED (patients receives booster dose after more than 30 days of refrigerator storages) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033h21a, 016c21a and 016c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (patients receives booster dose after more than 30 days of refrigerator storages). On 01-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients receives booster dose after more than 30 days of refrigerator storages). At the time of the report, PRODUCT STORAGE ERROR (patients receives booster dose after more than 30 days of refrigerator storages) and POOR QUALITY PRODUCT ADMINISTERED (patients receives booster dose after more than 30 days of refrigerator storages) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no allergies related to medications, food and other products. Patient had no covid 19 positive test or diagnosis. Patient did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. The vial was initially stored in the refrigerator on 26 Jan 2022 and did not undergo any temperature excursions.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-498889 (Patient Link).
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 26-FEB-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -2.77 Celsius Degrees for 192 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Red itchy hard patch around needle site, today is 18/April it is now bigger and has blisters will go to Doctor tomorrow, it hurts and burns also. Feel hot and icky!!
Within hours of the vax, the pt experienced generalized body hives. An ER or doctor visit was required and the pt was treated with diphenhydramine hydrochloride (Benadryl) on 8/15/00. As of 8/15/00, the outcome of the event is unresolved.
itching all over body and tongue feeling tingling  at 10 minutes after vaccine given, rash noticed next morning seen next day at 1100 am and mild rash and itching
upper respiratory viral infection; This is a spontaneous report from a contactable pharmacist.   A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Reporter stated he had a patient that was supposed to receive her second shot of Pfizer covid vaccine on the day. Stated 3 days ago, on 19Oct2021 she had an upper respiratory viral infection and was currently being treated with Medrol dose pack. She was negative for covid 19 infection. Reporter wanted to know the information receiving covid shot while on medrol. Reporter also stated it was a corticosteroid and could impair the immune system and queried that were there any contraindications. Response: General Drug Interactions (v11.0) -Systemic corticosteroids administered short term (<14 days) for treatment of an acute illness had to be discontinued for at least 28 days before study intervention administration. The report was not serious. Patient underwent lab test and procedures which included on an unspecified date Covid 19 result was negative. Therapeutic measures were taken as a result of the events which included Medrol. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Hives on scalp, ears, eyes, neck, arms, hands, torso, buttocks, legs, feet - they appear sporadically with no triggers and remain for 15-20 minutes. They appear in lines, circular patterns, or big welts. Itching feeling is similar to bad mosquito bites. Scratching inflames skin and makes the hives unbearable.
low fever of 99.6 F, very tired, slight nausea, soreness at injection site
I experienced swollen lymph nodes on the left side along with soreness at the injection site. The swelling lasted 8 days.
exposure to freezing temperatures; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 48-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number KN5VR, expiry date 16th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 24BM2, expiry date 30th June 2022) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B) for prophylaxis.   On 16th September 2021, the patient received Boostrix, Boostrix Pre-Filled Syringe Device, FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Boostrix, Boostrix Pre-Filled Syringe Device, FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device and Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were reported as follows: The reporter called due to their discovery that, the patient was inadvertently administered on 16th September 2021 the vaccines that were in the temperature excursion, which led to incorrect storage of drug. This patient was administered both the Flulaval and Boostrix vaccine on the same day. The agent informed pharmacist the vaccines should be discarded due to exposure to freezing temperatures 31.5 Fahrenheit for 13 hours. The reporter did not consent to follow up. This is 1 of 7 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021198149:same reporter US-GLAXOSMITHKLINE-US2021198148:same reporter US-GLAXOSMITHKLINE-US2021198144:same reporter US-GLAXOSMITHKLINE-US2021198142:same reporter US-GLAXOSMITHKLINE-US2021198139:same reporter
Site redness and pain; started on Keflex 500 mg TID for 7 days on 7/21/23
Pt. states to have a bruise a day or two after injection. She came back 5-11-17 and still has a bruise. She said it never faded or went away. Stayed the same.
Information has been received from a physician concerning a 12 month old pt with an unremarkable medical history and no known drug allergies who on 22Oct2003 was vaccinated IM (also reported by physician as SC) in the left thigh with a first dose of varicella virus vaccine live. There was no concomitant medication. On 06Nov03 the pt developed a localized rash at the injection site. The physician described the rash to the left thigh, the site of the injection, to have approximately 6 small vesicles (one of which appeared crusted over). The physician reported she gave the pt acyclovir (Zovirax) ointment to treat the rash. The physician indicated it is unknown as to whether the patient recovered. It was noted the patient was not ill at the time of vaccination, had no adverse events following prior vaccinations and there were no relevant diagnostic tests or laboratory studies performed. There was no product quality complaint reported. The physician indicated there is no additional information. No additional information is expected.
Hyporesponsive, hypotonic, flaccid, pale, mottled 2 hrs after dose given;
Extremely bad flu like symptoms including headache, fever, cough, runny nose, sneezing, tired, insomnia, nauseous. First symptoms occurred on Thursday Oct 5 after vaccine administered on Tuesday Oct 3. Shot was in left arm and there was some tenderness for several days at the shot area. not certain that symptoms are directly related to the vaccine. Fact that I have not had any illness of this kind for the past year, and that the symptoms are occurring shortly after the vaccine, makes me suspect that it is possibly related to vaccine.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included INSULIN, LISINOPRIL, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), AZELASTINE and FAMOTIDINE (PEPCID AC) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-256801 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: follow up received on 13-JUL-2021 contains concomitant medications