chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at an internal medicine office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 05-JAN-2016, the patient was treated at the same internal medicine office for a persistent and severe vesicular rash, which was diagnosed as shingles. She was treated with valacyclovir (VALTREX) for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
FEVER; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
pt recvd flu vax & 8 days later exp a change in mental status characterized as confusion & severe agitation; CBC, SMA, Urine, culture & sensitivity, x-rays were unrevealing; episode attributed to dementia;
Pain with movement, without injury. Has tenderness to area from shoulder to lower part of humorous on left arm.
Information has been received from a company representative concerning a male twin who was vaccinated with a 0.5mL dose of varicella virus vaccine live. On approximately 18-JUL-2005, the patient was exposed to his father who had chickenpox. Subsequently, the boy developed a mild case of varicella after the exposure. No other information was available. The outcome was reported as recovering. There was no product quality complaint. It was also noted that the patient's brother developed varicella (WAES0508USA02064). No additional information is expected.
Awakened with a sharp pain in the left temple, (headache) which continued for several hours. Aspirin dulled it somewhat. High fever at the same time (4:30 PM) Very hot under blanket, upon removing blanket, severe chills. (Could not take temp. as my teeth were actually chattering together if I got out of bed. Fever lowered about 7:30 Am and stayed at about 100.1 throughout the day. (Last time I took temp. was at 10PM when it was at 100.) Joint aches throughout body. These eased during the day. Injection site and upper arm painful at the same time.
0807:  itchiness & sensation of heat in R arm ; sensation traveled down arm & across shoulder to L arm & bilateral ears
About 6-8 hours after receiving vaccine, had hypotensive/hyporesponsive episode: turned white, not breathing, hands/feet cold and purple, limp, eyes rolled back. Lasted about 10 seconds, recovered spontaneously. Seen in ER immediately afterwards. Normal exam; nothing done.
pain at site of injection at 24 hours post injection. Nausea, diarrhea, headache 24 through 48 hours post injection.
6 Month old received bexsero; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received Men B NVS (Bexsero) (batch number TP294, expiry date 31st October 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd December 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd December 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 Information: GSK receipt date: 12-Dec-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received a dose of Bexsero at an inappropriate age (younger than 10 years), which led to inappropriate age at vaccine administration.
On 10/13/09 Pt received influenza flu vaccine (Novartis, Exp 6/30/10, Lot 97841P2) at 7:30pm. She called back at 8:00 to say she had very dry mouth and raspy throat (no breathing problems) and was feeling chilled.  I told her to drive to ER room and if symptoms recycled to go in ER. She called back an hour later to say she was still having mild symptoms and was going to the ER. The next day she was doing fine. No treatment done at site of immunization.
At 1409 client reported he had one vomit episode in the restroom after receiving vaccine. At 1410 PHN arrived to observation area. Client sitting upright in chair, alert and oriented x4. 1410 vitals: blood pressure 114/81, pulse 63, oxygen sat 95%. Client reported "feeling fine". Client denied dizziness, blurry vision, nausea, shortness of breath at this time. Per client no medical history, no current medication and no known allergies. PHN  asked client to stay for 30 min observation and client accepted. RN stayed with client. Vitals at 1415: blood pressure 107/87, pulse 63, oxygen sat 97%. RN have client Capri-Sun and Goldfish, client began eating and client finished everything. Last vitals at 1425: blood pressure: 126/76, pulse 70, oxygen sat 98%. Client reported no complaints, was "ready to go home". Parents would drive client home today. PHN advised client to follow up with provider, gave V-Safe and gave ER precautions. Client left facility with steady gait at 1430.
After receiving vaccination patient stated a rash developed on arm and stomach. Facility called ambulance and patient was taken to hospital for observation
Patient was to receive Bivalent booster and instead received the monovalent pediatric dose.
A week of migraines; many painful acne cysts on face; yeast infections; sore breasts for 2 weeks and counting; multiple periods, 2 week early periods; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 37-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 05Jun2021 at 15:45 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 37-years-old). Medical history included patient had known allergies to dilantin and penicillin from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had not received any other vaccine in four weeks and other medications in two weeks. Patient had no covid prior vaccination and not tested for covid post vaccination. It was reported that after receiving the dose of vaccine on 06Jun2021 at 12:00 the patient experienced a week of migraines, many painful acne cysts on face, yeast infections, sore breasts for 2 weeks and counting, multiple periods, 2 week early periods. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient had not received any treatment for the events. The patient was not recovered from the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever 103 with chills 4 hours, then 102.4 another 4 hours.  Dizzy, headache, weak.  No food.  Water caused vomiting twice around 10 am.  Fever gradually went down over afternoon.  100 at 9 p.m.  Okay the following day.
VACCINE WAS ADMINISTERED OUTSIDE OF 2 HR ROOM TEMPERATURE WINDOW; VACCINE WAS ADMINISTERED OUTSIDE OF 2 HR; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-AUG-2021, the patient experienced vaccine was administered outside of 2 hr room temperature window. On 20-AUG-2021, the patient experienced vaccine was administered outside of 2 hr. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was administered outside of 2 hr room temperature window and vaccine was administered outside of 2 hr was not reported. This report was non-serious.
pt devel a pruritic rash on chest & abd 1 day p/vax;pt recovered as of the date of this report;this is one of four pt from this site to have an adverse exp p/flu vax;
This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. The pharmacist reported that these unspecified patients may had received improperly stored PNEUMOVAX23 (lot#, dose, route, not reported) on an unknown date. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Received AFLURIA influenza vaccination at my local Pharmacy, which I have never been to before. I received the injection in my left arm, and less than 30 minutes later felt numbing in my back left side, below my shoulder blade. I woke up today with pain throughout my left arm and slight numbness feeling thoughout that came and went throughout the day. I continuously felt the numbness in my back throughout the day as well.
Arthus reaction left arm; warm, red, tense entire upper arm. Hydroxazine, Orapred and Augmentin.
Dyshidrotic eczema formed overnight on both hands after vaccine; including tops of fingers, finger webbing, and palms. Any scrape, cut, or abrasion on both hands became red, swollen, and irritated almost immediately after vaccine.  Treating with steroid cream with little relief.   A rash formed around the vaccine area after the first dose two weeks after I received the vaccine.
Caller went on to report that she didn't have any pain in her arms but "I had flu like symptoms for a couple of days and that was it".; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Caller went on to report that she didn't have any pain in her arms but "I had flu like symptoms for a couple of days and that was it".  Additional information: The reporter reported that her husband (82 yo) received his second covid vaccine dose on 04Feb. She reported that 2 weeks later he began having some discomfort in his arm. Later it got worse with pain from his shoulder down to his fingers, his elbow swelled up and he couldn't put pressure on it. He's seen the doctor and had x-rays and they said he had bursitis and arthritis. He was placed on Steroids and then the following week they gave him an injection in his shoulder but he was still having some problems with it. The reporter went on to report that she became suspicious when yesterday her mother in law came over and reported that she received her 1st shot and was having so much pain in her elbow down to her fingers since the injection. The reporter reported that her mother in law already called in to report her symptoms. The reporter went on to report that she didn't have any pain in her arms but she had flu like symptoms for a couple of days and that was it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown date. On an unknown date, the patient was vaccinated with the third dose of 0.5 ml GARDASIL (lot# unknown)intramuscular. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, about 2 or 3 days later, the patient experienced numbness and weakness on the inside of the arm she got the shot in and outside of the same arm. The patient had sought medical attention via came into office. The nurse practitioner did a neurological exam on the patient and everything seemed fine. The outcome was unknown. Additional information has been requested.
Shortly after my shot I had a headache and it was not surprising as this had happened previously. On the next and I had a similar rash on my legs as with the J & J vaccine. I used a cream at my house but it did not help and it eventually went away after three weeks. I called my doctor regarding my cough and my stuffy runny nose which started within forty eight hours after the vaccine. The sinus drainage became an infection so I consulted my doctor.
lymphnode enlargement; 100 fever; general malais; Redness; swelling; received her 3rd dose; This is a spontaneous report from a contactable nurse (patient). This female nurse reported for herself that:  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date and patient previously received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Jan2021 for covid-19 immunisation. On an unspecified date on 2021, the patient experienced lymph node enlargement, 100 fever, general malaise, redness, swelling. Redness and swelling with lymph node enlargement, 100 fever and general malaise. Symptoms presented 24 hours after dose was administered The patient underwent lab tests and procedures which included body temperature: 100 on 2021. The outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have not had a asthma attack this severe in several years and actually have not had an attack of any kind in  a year. I woke up at 2:30 in the morning literally unable to get any oxygen into my lungs. My wheeze was so loud it woke my husband who rushed to get my emergency inhaler. It was so bad that if any more time had passed he would have called 911 but eventually the inhaler did help me. I ams concerned if this was a result of the Vaccine or a coincidence but people kept telling me I needed to notify CDC...so here I am.
A 12 year old male boy was bitten by a stray dog on 6/9/04. Wound toilet was done and vaccination with 4 doses of Rabipur started on 6/9/04. The other three doses he received on 12th, 16th, and on 23rd of June 2004. No information on RIG application available. The patient complained about fever on 22 and on 6/25/04. Delirium started on 6/26/04, lasting for one day. Patient was admitted with paralysis of left lower limb on 6/27/04. Suspecting typhoid, patient was given Monocef and Decandran. Delirium subsided. The patient died on 7/9/04. We are awaiting further information. Preliminary assessment. Seriousness criteria: hospitalization, life-threatening, death. Causality: not related. Addendum 8/13/04: We received information that the patient was not administered any immunoglobulins. Assessment: unchanged.
I wake up I have numbness, no circulation  on the bottom of my leg/numbness of the leg; This is a spontaneous report from a contactable 61-years-old female patient who reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection; Lot number: EW0182) via an unspecified route of administration on 28May2021 (at the age of 61-years-old) in left arm as 1st dose, single dose for COVID-19 immunization. The patient medical history was none. The patient's concomitant medication included paracetamol (Tylenol 8 hour). On an unspecified date, in the evening around 3 after the vaccine, patient took a Tylenol right after and when she get home, she took a Tylenol again and went to bed everything was fine. On 30May2021, (Its yesterday morning early) and she had vaccine on Friday(28May2021) , when she woke up she had numbness, no circulation on the bottom of my leg. The patient received Motrin as treatment for event. There was no Investigation Assessment. Consumer was informed and provided the number of Medical Information. Second dose was scheduled on 19Jun2021. When probed for still experiencing the problem, Patient stated as Yes but not as much but it was still there. The outcome of event was not recovered.
I received my shot at a medical center. I had what is being described as a vasovagal response. Became flushed, weak, and lightheaded to the point of feeling faint. This was followed by a period of tachycardia and hypertension. HR 115 and BP 189/110. This began to fade after approx. 15-20 mins. I then tried to stand and walk and was again overcome by a wave of the same symptoms. I was then monitored for a period of an hour and released. I then had a third wave of the same symptoms after which I sought evaluation at the ER. I had a similar reaction to a tetanus booster in late 2018, but it was not nearly as intense as this was.
Shortly after receiving vaccine I had moderate COVID symptoms and my significant other tested positive for COVID 2 days later.  I figured I had it also, but I was just tested and my COVID-19 swab was negative.   My side effects following vaccination were fever (max 102.2), chills, fatigue and body aches.  The mild symptoms began the Saturday morning after the vaccine and included some fatigue and a headache.  By Tuesday night I was having more severe symptoms that lasted through Sunday 12/27.  My negative COVID test was performed on 12/30/20.
Initial report was received from a health care professional on 01 February 2012. A 4-year-old male patient had received a first dose of DTaP, sanofi pasteur Inc. (lot number, route and site not reported) on 29 December 2009. Five to six days after the vaccination, the patient developed a rash, which only involved the arm where he received the vaccination. It was described by the patient's mother as "red, flat, non-pruritic, coming and going (but not hives), with multiple red lesions that did not all look alike." The lesions did not itch and the patient did not have eye or mucus membrane changes. The patient was seen the next day (also reported as 05 January 2010) by his pediatrician who thought the rash was consistent with (c/w) erythema multiforme. The pediatrician described the rash as 5-7 irregular oval and circular lesions with red peripheral edges and clearing in the center. The rash resolved within 24 to 48 hours. No additional treatment was offered. At the time of vaccination, the patient was completing a course of amoxicillin for "? sinus infection." The patient was also on treatment with PROVENTIL, albuterol, FLOVENT and mometasone for "? reactive airway disease." The patient's 5-year-old sibling had autism. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Tinnitus for brief periods lasting a few seconds. At least once a week. Sister has it too!
Patient given 12+ dosing of 0.3ml.  Should have been the 5-11 dosing of 0.2ml.  No adverse reactions noted after 15 minutes.
First I started itching really badly starting in my head then working its way all over my body then my blood pressure went up to 158/108. Recheck and it was 158/98, went home and took some benadryl.
problem with arm she had the shot in; muscle weakness; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle weakness and arm discomfort. On an unknown date, the outcome of the muscle weakness and arm discomfort were not recovered/not resolved.   It was unknown if the reporter considered the muscle weakness and arm discomfort to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not provided. The patient received Shingrix and experienced muscle weakness, problem with arm she had the shot in and still having some side effects. No further information reported.
On the 18th I started to feel the symptoms of a rash. By Sunday 3/21/21 I had blisters on the rash. I when to my doctor who confirmed that I had Shingles. He prescribed the medication for shingles and I suffered for a week and a half till it was gone. I'm 44, perfectly healthy before the shot. I did suffer the flu like symptoms from the shot. It sucked.
Fever, chills, body aches, sore throat, runny nose, fatigue, loss of appetite. Alleviated with NyQuil on 6 hour intervals
Myalgia, Arthralgia, Fever, NauseaVomiting,  body aches, chills Narrative:
Pt recvd vax on 1JUN92 & while donating blood in JUL92 was found to have antibodies against the Hep C virus;
Fever, chills, induration @ inject site, myalgias for 24 hrs; DPH  & Pred given;
Case number PHEH2014US025151, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 10 years old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at ta dose of 0.5 ml on 22 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, dose, route and injection site were not reported). On an unknown date the patient experienced an injection site reaction after receiving ZOSTAVAX. On an unspecified date 4-5 days after the ZOSTAVAX injection, the patient experienced a red, raised area of swelling at the injection site. The unspecified patient returned to the pharmacy on an unspecified date to inform this pharmacist of this reaction to medical attention. The outcome and action taken was not provided. Additional information has been requested.