chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse referring to a 15 years old female patient. The patient's drug reaction/allergies and current conditions included mupirocin calcium (Bactroban) hypersensitivity, however the patient did not have any previous medical history. On 16-MAY-2017 the patient was vaccinated with GARDASIL 9 lot number N000326, expiration date on 14-OCT-2017 (dose and route of administration were not provided) for prophylaxis. The patient had none concomitant medications. On 16-MAY-2017, within 30 seconds to a minute after receiving GARDASIL 9, the patient experienced losing consciousness, therefore, she was monitored during 45 minutes.     The patient sough medical attention, lab diagnostic studies were not performed, the patient did not receive treatment for the event, however she had recovered. The causality assessment between GARDASIL 9 and the event was unknown at the time of reporting. Upon internal review, the event of losing consciousness  was determined to be medically significant. Additional information has been requested.
His neck has been killing him; the top of his shoulder and is going to his neck and he can't get any relief from that like it won't stop hurting; His neck has been killing him; the top of his shoulder and is going to his neck and he can't get any relief from that like it won't stop hurting; This is a spontaneous report from a contactable consumer (wife) reporting for a patient (Husband). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, NDC number, UPC number and Expiry date are unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history included back (back disorder) from an unspecified date. Concomitant medication included cyclobenzaprine (CYCLOBENZAPRINE, NDC number, UPC number and Expiry date are unknown) taken for back (back disorder), start and stop date were not reported. Reporter (Wife calling on behalf of her husband) stated that she was actually on hold for her husband (Initial captured as UNKNOWN). He is the one that got the vaccine, is that okay? He had a conference call. He was on hold for so long, he gave the phone to her. She asked, So, do you need his information then? He filled out the form online too. But he got the vaccine on Friday and then on Saturday he started getting (incomplete sentence). On an unspecified date, the patient experienced his neck has been killing him since Saturday like it started on the top of his shoulder and is going to his neck and he can't get any relief from that like it won't stop hurting. So, we just did not know if he could take a, he has Cyclobenzaprine, a muscle relaxant for his back, like he normally takes for his back and he has not been taking since he got his vaccine on Friday. So, we did not know if that was something she could take or if that would react with COVID Shot?" The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Information has been received from a licensed practical nurse concerning a 13 year old female with no known allergies or pertinent medical history who was vaccinated SC with 0.5 ml first and second doses of Varivax on 30-JAN-2006 (lot# 650234/0913R and 10-MAR-2006 (lot#648936/0114R) respectively. There was no concomitant medication. Subsequently the patient had negative titers. No symptoms have been reported. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Local redness, swelling (Right deltoid); Body ache; chills; headache; sweating.
This spontaneous report as received from a nurse refers to a 2 years 1 month old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) Liquid PEDVAXHIB, injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contaca6t details were provided.
Pt received her 2nd covid vaccine on 9/10/21 at 1700. She reports she had apt to donate plasma on 9/11 but center was not able to perform plasma donation due to fever of 102-103 F BP of 180/110.  Pt took her BP meds, but her Bp did not respond and she remained febrile at home.  She  reports she fell asleep after this and was not able to wake up. After multiple family members tried to reach the employee, the fire department had to come to her home and break down the door to access her as she was not responsive. Once she was woken by fire department she was incoherent and had to be taken to the emergency dept for treatment. Temp was 101.8 and Bp remained in 180s/110s HR in 120s .  She was given tylenol in the ER, labs were drawn and CXR performed.  She is not sure how long she was in the ER, but she regained normal mentation, BP was in 140's and tests negative so MD released her to home She reports that the physician in ER told the her  that she probably had a reaction from the covid vaccine.
Information was received on 11-JAN-2017 from a registered nurse via a company representative regarding a male patient.  Medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that the patient received his first dose of GARDASIL intramuscular in 2014, and he received his second dose of GARDASIL intramuscular in 2015 (considered inappropriate schedule of vaccine administration). Action taken was not applicable and the outcome was unknown. No further information was provided. Additional information has been requested.
Circular area 2" in diameter, mildly reddened & hot to touch. Tenderness under (L) axilla. Also itchy.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug allergies were not reported. On unknown dates the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K026386 with expiration date of 15-DEC-2016, lot# L011084 with expiration date of 01-APR-2017, dose, strength and route unknown). This is one of several cases reported from the same reporter. Additional information has been requested.
Shingles/rash on the right side of back and chest, headache and burning sensation at the location of rash; Post herpetic neuralgia/burning sensation at the location of rash; Information has been received from a lawyer regarding a case in litigation which referred to a male patient (pt) of unknown age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. In or around 22-MAR-2018, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) and for routine health maintenance (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), he suffered a rash on the right side of back and chest, headache and burning sensation at the location of the rash and was later diagnosed with shingles (herpes zoster) and post herpetic neuralgia (PHN). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, his symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). In addition, the pt sustained severe and permanent personal injuries. Further, the pt had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), he had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster and postherpetic neuralgia were considered as disabling events by the reporter.
Information has been received from a licensed practical nurse concerning a 12 month old male with no pertinent medical history nor allergy who on 16-JUN-2009 was vaccinated subcutaneously with 0.5ml dose of VARIVAX in the left thigh (lot #657720/0358Y). There was no concomitant medication. The patient developed a red bump on his left thigh after vaccination. On 24-JUN-2009 the patient's mother contacted the physician's office and on 25-JUN-2009 the patient was seen in the office. No lab diagnostics studies were performed. At the time of reporting the patient's outcome was unknown. Follow up information has been received from the licensed practical nurse concerning the 12 month old male patient who on 16-JUN-2009, at 10:00 a.m., was vaccinated subcutaneously with the first 0.5ml dose of VARIVAX into the left thigh (lot # 657720/0358Y). There was no illness at time of vaccination. On 23-JUN-2009 the patient developed red area on his left thigh which was measuring 1cm x 1.5cm. It was not hot or tenderness. At the time of this report, the patient's outcome was unknown. Additional information is not expected.
this 4mo old pt recvd DTP/OPV/HIB on 1OCT; exp fever of 101-103 on 2-4OCT; in addtl was fussy, irritable w/high pitched cry; some loose stools were reported as well as dec appetite; during the time of fever, was unconsolable;
consumer was only given Dtap and IPV component of the pentacel Vaccine, as doctor forgot to mix the HIB component with no reported adverse event; Initial information was received on 18-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19 months old male patient who received only dtap and ipv component of the diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] as doctor forgot to mix the hib component with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Aug-2023, the patient received dtap and ipv component of the dose 4 of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection at dose of 0.5 ml (lot number: UJ876AA, expiration date: 19-Mar-2024) via intramuscular route in the left thigh for immunization (immunisation) as doctor forgot to mix the hib component with no reported adverse event (product preparation error) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event consumer was only given dtap and ipv component of the pentacel vaccine, as doctor forgot to mix the hib component with no reported adverse event.   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 the 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.
Foot and ankle swelling 4 days after 1st injection, which is ongoing.  Visit to vein doctor on 4/15 and diagnosed with blood clot in left ankle.  Put on blood thinners and told to wear compression socks.
red raised macular rash on legs, face and trunk. Treated with Benadryl. Follow up as needed per Dr.'s office
Patient said she experienced burning later that night, then swelling. We I saw patient next day she had a 5cm firm round raised knot on her right shoulder, slightly warm to touch.
3 weeks later- still intermittent headaches, chills, heaviness, stomach ache, fatigue, arms ache
Approximately 6 hours after injections I began to have body aches. The next morning (12/24/21) I had a fever of 101.8 and began to have extreme fatigue. I went to work (I am a Registered Nurse working in a ICU) took my temp around 0900 (this is post 800mg ibuprofen) and my fever was now 102.1. I took 1gm of Tylenol and reported signs and symptoms to my charge nurse. Shortly after 1000 I began to have extreme headaches, overwhelming bouts of fatigue, and began to feel faint. My blood pressure was 100/50 and pulse was 115. I had several episodes of dizziness upon standing. I felt that, at this time, I was not fit to work my shift. I notified my charge nurse and left work early ( I have a very strong support system at work). I drove home and slept for the next 14 hours. When I woke up on Christmas morning I felt better but not 100%. Looking back on the previous day I realized there were parts of the day I do not remember at all - I did not remember charting that I did on my patients, I did not know where certain items I had were placed, I did not remember if I took medicines after I left work. The total time of not feeling well lasted about 72 hours.
Arm injection given on swollen, redden, warm to touch. Pt states began 1 hr after injection. Waited til next day to report when swelling got bigger, arm tighter. Came in next day for steroid injection, orders for Xyzal, benadryl and oral steriods. Came back next day after treatment for re-assessment. Swelling improved considerably per doctor's assessment.
Posterior neck lymphadenopathy; Fever (low grade); Papular rash on trunk/lower extremities; Start 24 hours ago
Mom reports after completing Screening Checklist for Contraindications to Vaccines for Children and Teens (Immunization Action Coalition) "she got her shots on Tuesday and then by early Saturday morning she had "severe diarrhea" "lost weight" "went through 4 bags of diapers with diarrhea episode lasting into the next week; "took her to see Dr. on Monday 04/16/18" "unsure if vaccine related" babe continued to be ill and was taken back to Dr. on Thursday 04/19/18 and diagnosed with ear infection at that time" Mom also reported "family history of intussusception" "babe had sister with epilepsy, dad and brother have "Tourettes"Mom reports that babe is well today, however vaccinations withheld at this time. Awaiting response from Immunization Division. Babe was "full-term C-Section delivery' birth weight 6lbs, 19 1/2 In; last month (May) weight per mom was 10.13 lbs. Babe is breast/bottle fed- per mom. Babe appeared alert, made eye contact and smiles to verbal stimulation.
chest pain; severe headache; muscle pain; she has felt real, real sick,; she does not feel well; She has so much pain; joint pain; back pain; chest pain unbearable/generally lots of pain/headaches were so bad; This is a spontaneous report from a contactable nurse (patient). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on 09Feb2021 (age at vaccination was 71 years) as dose 1, single for COVID-19 immunisation. The patient has a history of bad reactions to other vaccines, Graves' disease, rheumatic fever and multiple allergic reactions to multiple stuff; all were from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient received the first dose of the vaccine 09Feb2021 and patient didn't feel well and was not doing so well. On an unspecified date the patient had so much pain, specifically severe headache almost every day, muscle pain, joint pain, back pain, chest pain, and generally lots of pain. The headaches were so bad that she can't even talk and she finds the chest pain unbearable. The patient has felt real, real sick, since getting her vaccine on 09Feb2021. The patient finds that it was not a regular kind of pain and was unusual because it started gradual. The patient did not do anything and that this came in after the vaccine. The patient second shot was in a few days, 02Mar2021, so patient was asking if she should still take the second dose. The patient doesn't feel like she wants to go because she does not feel well. The patient knows many of her friends that tolerated the vaccine pretty well, and the patient knew that patient could have some reaction to it, but the patient was on the third week of symptoms now. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Seizure activity, foam coming from mouth, decreased respirations noted by mother.  Baby had good color and respirations upon arrival to ER.  NSR, O2 sat 99%, T98.3. No treatment.  No further seizure activity since.
nausea, headache, threw up entire meals for 2 days by the third day I was feeling better.  Tiredness still lingers.
pt recvd flu vax & approx 5 hrs p/2nd dose devel hives which occurred first @ the inject site (golf ball sized welt), then generalized throughout body w/in an hr; pt devel an ear infection on 30NOV92;
Patient recieved Flu vaccine at 12:30 PM 18 OCT 10 with no immediate reaction. PT presented to clinic at 2:11 PM on 19 OCT 10 stating that 7 hours after recieving the shot he began to have nausea with vomiting, lightheadedness, hot flashes, and fatigue which lasted roughly 6 hours. pt states that last episode of vomiting was at 1:00 AM on the 19th. Patient was discharged from Clinic at 2:44 without treatment after assessing that he was recovering from incident. Pt stated that he felt better today prior to leaving.
4/8/2004 0400 my son awoke with a fever of 101.6, a racing heart beat & tremors. Called doctor was advised to administer Tylenol. Baby had low grade fever through the morning.
Expired dose used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 10-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 23-MAR-2023, the patient received the 1st dose of Havrix. On 23-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 23-MAR-2023 A nurse called in to report that an expired dose of Havrix was given on 23-MAR-2023 and provided the reporter information about the patient and vaccine. The Vaccine Administration Facility was the same as Primary Reporter. Consented to follow up. The patient received a Havrix vaccine which was already expired, which led to expired vaccine used.
one was positive (fully vaccinated w Comirnaty - 10 y ); one was positive (fully vaccinated w Comirnaty - 10 y ); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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 "unknown" and all described as "one was positive (fully vaccinated w Comirnaty - 10 y )". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202200009245 Same reporter/drug, similar event, different patient
This study case was received from the investigator in a trial on 04 April 2012. A 24-year-old male subject received the following vaccinations: On 24 January 2012: an injection of ACAM2000 (lot number not reported) and on 04 January 2012: an injection of anthrax 2 (manufacturer and lot number not reported). The subject had no significant medical history. On 04 February 2012, the subject had an abnormal Troponin I of 06.89 and a normal electrocardiogram (ECG). On 04 February 2012, the subject was diagnosed with acute pericarditis, unspecified, unspecified disease of pericardium and non-specific myocarditis. The outcome was not reported. Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
ringing in the ear; I have difficulty sleeping and functioning during the daytime.; That was interfered with his concentration and sleep; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 11Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 11Apr2021, In the evening his ear had started ringing. It has gotten worst since Sunday to Tuesday. Since Tuesday to till now the level of severity was the same. Patient had difficulty in sleeping and functioning during the daytim. He could not turn it off. He stated that was really started affected his life in a negative way. He was heard that as he was talked. That was interfered with his concentration and sleep. That was a noise which most people called it ringing in the ear. He stated that was both high and low pitch and it was very detrimental to his life. He could be in an ambient noisy area such a coffee shop, he will hear it. In a quiet place he was heard. Patient wanted to know he put his hands on the ear or he heard that. On an unspecified date, the patient experienced ringing in the ear, I have difficulty sleeping and functioning during the daytime, it interferes with my concentration. The outcome of the events was unknown.   No Follow-up attempts are needed. No further information is expected.
In the afternoon, patient could not raise arm over shoulder due to pain; pain got progressively worse. Cold-like symptoms started the next day including coughing, could hardly breathe because of so much mucus.  Patient to Mucinex, Benadryl and Nyquil to help alleviate symptoms.   It took 3-4 weeks to get some relief and then another round of symptoms started. Two weeks after vaccination date pain got so bad that went to ER (Hospital) and received a cortisone injection.  During regular monthly checkup with PCP, patient mentioned to doctor the issues he was experiencing and he prescribed Prednisone2 rounds-- to help with inflammation.   Joint pain was bad on neck, left side, hip and right right shoulder.  Doctor suggested to just treat cold symptoms with over the counter medicines but did take a chest x-ray to rule out pneumonia.     Patient started to have join pain more than usual and it lasted for a long time; it started easing up by December 7th. Nowadays, pain continues on left side but not as bad and occasionally on right shoulder but it is almost gone. Patient recovered completely except for gravelly voice, recovery at 95%.  Joint pain is back to normal thresholds before the shot.