chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(Per mother), child went to ER 2-13-09 with LLQ pain had CT- Showed ovarian cyst was told by ER physician- was result of HPV immunizations. Laparoscopy for ovarian cyst 2-13-09.  4/10/09 Received hospital medical records of 2/13-2/14/2009. FINAL DX: ruptured left corpus hemorrhagicum; laparoscopy Records reveal patient experienced progressive left flank, nausea & LLQ abdominal pain x 1 wk.  Taken to OR for laparoscopic surgery.  Findings at the time of surgery include: ruptured corpus hemorrhagicum, blood clots in anterior & posterior cul-de-sac.  Did well postoperatively & d/c to home next day.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 30th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, fever, weakness and headache. On 1st August 2018, the outcome of the fever, weakness and headache were recovered/resolved. On 13th August 2018, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain, fever, weakness and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient planned to follow up with her physician on 30th January 2019. The patient reported that she heard from friends that people experienced arm pain. No further information was provided. Consent to follow up was provided.
broke out; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "broke out".  Additional information: Patient reported that she got the first two, but she does not want the other one. She had a problem with the first two and broke out for five months. She had both, she had the Pfizer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146370 Same patient/event, same vaccine but different doses;
Starting at 6am on 11/3/21.  Headache, fatigue, right knee pain, injection site pain, left shoulder pain, chills.
her body felt like it was 'on fire' Reports 10 pruney fingers; searing muscle pain; lots of sweat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4253307.  A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALECENSA. The following information was reported: BURNING SENSATION (non-serious), outcome "unknown", described as "her body felt like it was 'on fire' Reports 10 pruney fingers"; MYALGIA (non-serious), outcome "unknown", described as "searing muscle pain"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "lots of sweat".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Missed second dose, and its over 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose, and its over 42 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose, and its over 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose, and its over 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Patient presented to the ED on 3/14 11:30PM with difficulty swallowing.  Patient received Pfizer vaccine on 3/13 at 4:30pm.  Immediately afterward she had sensation of lip and tongue swelling.  She was given Zyrtec and monitored by the vaccination clinic for 30 minutes.  She was discharged from the clinic after improvement of systems.  Lip swelling presented on 3/14 at 2:00pm and she took Zyrtec.  At 10pm, patient felt sensation of swelling in throat and presented to ED.  EMS gave patient 50 mg IV Benadryl.   Patient discharged on prednisone.  Patient re-presented to ED on 3/16.  Allergic symptoms subsided, but patient complained of atypical chest pain with paliptations, tremulousness.  Suspect adverse reaction prednisone.  She was given cardiology referral for follow up if her symptoms persisted.  She remained in normal sinus rhythm with initial sinus tachycardia.  Was discharged home in stable condition and counseled to return to ED for any concerns.
Information has been received from a certified medical assistant (CMA) referring to a patient (6) of unknown age and gender. NO information regarding patient's relevant medical history, current condition and concomitant medication was provided. On 14-JAN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013206, expiration date 29-JAN-2017, dose and route were unknown. The vaccines were stored under 34.5 F (Min) and 47.9 F (Max) for 24 hours. There was no previous temperature excursion. It was called because of a "data logger". No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient received vaccine 10/16/13 but over the next 3 days pain started radiating from left arm to shoulder, neck, back and cuff of right shoulder and a left swollen wrist. Still has pain now 11/8/13. Has not seen a doctor, is waiting to see if it progresses.
Awoke 3:30 am next day(approx. 13 hours post injection)from sound sleep with strange feeling in my tongue. Felt swollen, but dont think it was, burning sensation on lateral borders and tip of tongue,extremely dry mouth.  Felt as though it had also been burned, and had a few white spots on tip, reddened borders on lateral aspects also, very scallopededges. Note I do have a fissured tongue but this reaction was unlike any I had ever had from eating certain foods that trigger any tongue response, and had not eaten anything night before to trigger this. Lasted a few days and progressively felt normal after 3-4 days.
Information has been received from a health worker referring to unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored (Merck) PROQUAD (lot # K025761, expiration date 06-JUN-2016, route not provided). No adverse experiences were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
On 4/18, I noticed the injection site was red, hot and swollen. The diameter was the size of a quarter.  On 4/19, 5am,  the diameter increased to a half dollar and was more red and swollen. It also started to itch. The swelling is the size of a golf ball and the rim of the rash is raised like a mosquito bite. On 4/19, 9pm, the rash has spread to 4.3 inches in diameter; extremely red, hot and itchy. Still protruding out the size of a golf ball.
Pt. arrived at the COVID vaccination mass clinic today for her 2nd Pfizer booster. Per the patient,  she requested to be observed in our observation area.  She was noted to have no past history of anaphylaxis, allergies to the vaccine or vaccine ingredients or any past reaction to any of her COVID vaccines.  She received her booster dose at approximately 1307.     When she was checked in to the observation area the patient explained to the observation nurse that she experienced chest tightness, SOB, a tickling cough and left arm tingling with her 2nd dose of Pfizer vaccine requiring 2 puffs of Albuterol.  She also explained that she has a history of chest tightness with exposure to cats and exercise but has no formal asthma diagnosis and no cardiac history.  Her 3rd dose of Pfizer (1st booster) occurred without incident.   While in observation, at approximately 1330, she noted a repeat of some of her prior symptoms, chest tightness 2/10 on 0-10 pain scale and was noted to have a dry cough.  The observation nurse gave the patient Albuterol 1 puff at 1335, repeated at 1340 and 1345.     At this time I was alerted to the situation, obtained vital signs, which were stable. Patient symptoms continued to improve.  1415 symptoms were completely resolved.     Nursing Assessment: Airway: Open, no visible oral/facial swelling noted, no wheezing noted per auscultation Breathing: Spontaneous, RR 18, unlabored Circulation: BP 134/84, P 79 regular, Sats 98% on RA, cap refill <2 sec, skin pink/warm/dry Disability: RASS 0, GCS 15, no deficits noted
After vaccines were administered, patient was sitting in a chair with mom's phone while sibling was being vaccinated. Patient was alert and oriented. Mom was holding sibling on her lap on exam table while myself and another nurse were each vaccinating and a third nurse was observing.  This was approximately 3-4 minutes after patient's vaccines were administered. Patient reportedly lost consciousness and fell over into a cabinet then slumped down onto the floor. Within 10-15 seconds, patient was crying and alert. She was laid on exam table for a brief examination. She was aware of her surroundings, diaphoretic and pale. A slight amount of blood was noted on left side of tongue in mouth but no other injuries were noted or palpated on head or body. Patient denied any pain or injuries. Within another minute, patient's color retuned to normal and patient was asking to go home. Mom was instructed to report incident to physician and to continue monitoring patient. After approximately 15 minutes, Mom left with patient.
diagnosed with Covid; diagnosed with Covid; dental issue; my mouth tastes funny; I have a low fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. An 80-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 18Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 79 years 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with Covid"; DENTAL DISCOMFORT (non-serious), outcome "unknown", described as "dental issue"; TASTE DISORDER (non-serious), outcome "unknown", described as "my mouth tastes funny"; PYREXIA (non-serious), outcome "unknown", described as "I have a low fever". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19, dental discomfort, taste disorder. Patient was diagnosed with Covid, asking about Paxlovid he was prescribed it, but also taking amoxicillin for dental issue. First dose of Paxlovid taken last night took the evening dose of Paxlovid. Patient states, his mouth tastes funny, he was also taking gluconate mouthwash also, and amoxicillin. Patient also had a low fever.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
It was reported that a pt (10 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested.
At approx 11:30pm my wife woke up and ran to the bathroom complaining of extreme nausea, fatigue, and back pain. While I was getting her tylenol she fainted, hitting her head on the floor. When she came to, she started experiencing the chills along with an irregular body temperature. I put blankets on her, gave her water, and tended to her eye. I was able to move her from the floor to the bed within 15 minutes. She fell asleep around 2am. She has been doing better but has been experiencing off & on headaches & nausea. We did not go to the doctor since we do not have insurance.
My son developed a low grade fever from 99.5-100. degrees. He had chills, a severe pounding headache- where he was grabbing his head in pain with the throbbing and crying out.  He developed a rash on his chest, back of both arms and tops of thighs.  He also had nausea and dry heaves and some minimal vomiting, continued stomach cramping  and general malaise for at least 4 days. 11/16/09:  Primary Care records received for dates of service 9/16/09 to 9/22/09.  Assessment:  Pts. mother called to state that pt. experienced feeling sick to his stomach, headaches, broke out into a rash on both arms and legs, and ran a slight fever after receiving his vaccinations.  Also had pain in his right arm at injection site.
No adverse event noted. Patient is 17 years old (17.5) and the approved age for this vaccine is 18. This was inadvertently missed at check-in. Patient suffered no untoward effects
Pt with Right Shoulder Ache with movement, numbness in extremity, and pain at injection site (right shoulder).  Pt understands pain for several weeks is normal with tdap, pt still with pain/numbness at follow-up visit 10/18 and that continues to this date 11/17.  Pt specifically has trouble with right arm while driving, sleeping (dull ache) or lifting.
itching, lightheadness, nausea and vomiting. Began at 12:10 flu shot at 11:46. Given 8mg chlorpheniramine. 13:20 pt reports vomiting -states "feeling better". 13:25 8mg chlorpheniramine repeated due to vomiting.
Patient complained of numbness r shoulder blade and up right neck. Denies other symptoms. Reports same symptoms after first dose of Pfizer and lasted ~ 4 days after. Observed x 30 minutes.  BP 128/80  HR 71  sat 100%
Small area of shingles, lower abdomen shingles cleaned up, residual nerve pain under treatment. The event was one year after vaccinations.
Information has been received from a nurse practitioner concerning a 16 year old female with a history of seizures after unspecified vaccines (believed to be associated with pain of vaccination) who on 22-OCT-2007 was vaccinated intramuscularly with a 0.5 second dose of Gardasil. Concomitant vaccinations at the same visit included influenza virus vaccine (unspecified (unspecified) and Vaqta (MSD). On 22-OCT-2007 the patient had a "small seizure." The patient was kept at the doctors office for 30 minutes. On 22-OCT-2007, the patient recovered and was sent home. Upon internal review, "small seizure" was considered to be an other important medical event. Additional information has been requested.
Fatigue and slight headache 8 hours after vaccine, then progressing to stronger headache . Approximate total time of headache was 6 hours. I did not take any pain reliever. Also, slight muscle pain at injection sight. Felt perfectly fine the next day.
having chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 10:15 (Lot number: 30135BA) at the age of 25 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medication(s) included: Citalopram; Buspar; Cardizem [Diltiazem Hydrochloride]; Prenatal Plus; Vitamin D [Colecalciferol]; B12 [Cyanocobalamin]. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0183, vaccine location=Left arm, administration time=10:00), administration date: 26Aug2021, when the patient was 25 years old, for Covid-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 19Sep2021 04:30, outcome "not recovered", described as "having chest pain". The event "having chest pain" was evaluated at the emergency room visit. Therapeutic measures were not taken as a result of chest pain. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient started having chest pain on 19Sep2021. It was a sharp pain that lasted 5 seconds then a dull pain that has continued. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
3 hours after injection there was an uncomfortable and sustained increase in the ringing sound of the tinnitus I hear in both ears. The sound has ever reduced or subsided since that day.  I had no problem after my second shot or first booster, but when I received my second booster (pfizerFK9894 on 4/4/2022) I had another drastic increase in the sound of my tinnitus which has also not subsided and is so loud that I have difficulty masking it with sound machines   Almost intolerable
Fever, chills, swelling & redness at the injection,  muscle & joint aches, skin pain & sensitivity,  headache
severe fatigue, headache, abdominal pain/discomfort, all-over muscle and joint pain
I had a fever after receiving the vaccine for three days. Towards the end of May, I was feeling tired and out of breath. I went to the doctor and was diagnosed with anemia and my BNT was at 231. I did not receive any prescriptions to help with my symptoms. My BNT number has been fluctuating for several months. I have had to go to the emergency room for observation twice.
Woke up in the middle of the night with headache and chills. DR called at 8am, and client advised to take Tylenol which he did headache subsided by 12 noon but felt generally crappy thru 08/25/05.
9-1-2021 shingles  in 5 places arm - behind knee - right shoulder - left arm near wrist on bottom 10-5-2021 shingles everywhere - right lower arm, left side waist wrapped to back bone and went down left leg all the way to shin, right leg upper thigh, right leg front from knee to shin, left side eye, left side under chin
He was inadvertently given the Janssen vaccine ( at the age of 13) instead of Pfizer vaccine.
Tested positive on 22Aug2023. Cold-like symptoms started on 20Aug2023; Tested positive on 22Aug2023. Cold-like symptoms started on 20Aug2023; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5, lot unknown reason: Unable to locate or read the details), on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Aug2023, outcome "not recovered" and all described as "Tested positive on 22Aug2023. Cold-like symptoms started on 20Aug2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Encounter Background Information: Presents with hx "anaphylatic Rx" to Yellow fever vaccination in 1989. Described rx as sob and passed out 2 hours after multiple vac. Pt doesn't remember any other symptoms, had paniced, no cp, rash, itch, tight throat, n/v/d, dizziness, etc.  Was taken to hospital and observed for few hours and released. Remembers no meds given. Received 4/26/1989: YF, typhoid, oral polio, TD.   Did received typhoid/td in 1991, 1994 and 1999 w/o reaction.  Allergy to eggs as child (n/v/d).  Began eating hardboiled eggs age 20 w/o rx--bad taste in mouth only no reaction.  Received IM influenza 12/27/05 w/o reaction, however has a mild cold since 12/23-24/05.  PMH: albumenuria, appendicitis, knee surgery 2004, acid reflux.  FHX: paternal GF had YF (?vac or dis) and developed hodgkins.   Also request to know as being given cortisone shots, can he receive smallpox vaccine?  Yes.  Advised to stay off steroid injections for 2 weeks for best results and do not take until scab falls off.  Pt received oral polio, yf, td, typhoid: Box 13 will not accept unknown names of manufacture of oral polio when submitted.
103 .5 fever; dehydration; muscle aches; vomiting; weakness; This is a spontaneous report from a contactable Nurse. A 38-year-old female patient (no pregnant) received 2nd dose of BNT162B2 (lot number=ENS318) Intramuscular on 03Mar2021 10:00 AM on Left arm for COVID-19 immunisation. Medical history was Fibromyalgia, allergic to insect stings and fleas. No other vaccine in four weeks. Other medications in two weeks included venlafaxine hydrochloride (EFFEXOR), gabapentin, cefixime (FLEXERIL), and hydrocodone bitartrate/paracetamol (NORCO). Historical Vaccine was 1st does of BNT162B2 (lot number=ENS 318) Intramuscular on 10Feb2021 11:00 AM on Left arm for COVID-19 immunisation. Patient experienced 103 .5 fever, dehydration, muscle aches, vomiting and weakness from 03Mar2021 06:00 PM with outcome was recovering. Events resulted in Emergency room/department or urgent care, Hospitalization (1 day). Treatment included IV fluids, Tylenol, Zofran. Drew labs which were normal. No covid prior vaccination. Covid test post vaccination: Nasal Swab Negative on 04Mar2021, PCR Result Pending.  No follow-up attempts possible. No further information expected. Information on lot# already obtained.; Sender's Comments: Based on the close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported fever, dehydration, muscle aches, vomiting and weakness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.