chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female who sometime during the week of 31-DEC-2007 was vaccinated with the first dose of Gardasil 0.5 mL IM. As the patient was walking out of the office (approximately 31-DEC-2007), she passed out on the desk and hit her head. She went to the ER (details not provided). The outcome of the event was not reported. The physician stated that she thought it was a vasovagal reaction. Additional information has been requested. 07/08/08 Information has been received from a physician and a licensed practical nurse concerning a female student who on 27-DEC-2007 (previously reported as the week of 31-DEC-2007) was vaccinated intramuscularly in the right deltoid with her first dose of GARDASIL (Lot # 659439/1267U). On 27-DEC-2007, the patient experienced a vasovagal episode. As the patient was walking out of the office, she passed out on the desk and hit her head on the counter and the floor. The patient complained of a headache. The patient was immediately taken to the ER by a staff member. The patient had a fingerstick blood sugar performed in the office (136 mg/dL) and a blood test for hemoglobin level (11.7%). On an unspecified date, the patient recovered from the vasovagal episode; passing out and hit her head on the counter and floor and severe head pain. Additional information is not expected.
Left upper arm swollen, hard, red "itchy". Double the size of Rt upper arm.
Evening of immunization, child went to mother & stated "arm hurts." Mother noted redness, swelling, & warm to touch (R) upper arm. No fever, no change in behavior all day long. Good appetite. Mother did nothing. Reported to Public Health today (2 dys. later) Minimal swelling, pink in color, still with warmth. No fever. Behavior normal. Enc. to place cool cloth (R) upper arm 2-3 times a day until better. Return if symptoms don't subside.
Patient came to complain of being sick every month since receiving flu vaccine this past fall. Stuffy nose, cold symptoms.
Severe headache, chills, low-grade fever (but increasing slightly), muscle soreness at injection site.  Plan to rest and take Tylenol and monitor temperature.   I have notified my PCP.
Pt received Rabies #2 vaccine 7/10/07 7/11/07 woke up felt dizzy went to ER negative work-up -normal electrolytes, neg CT head time of antivent, did not help sys. 7/13/07 ra med clinic
Severe rash with some respiratory issues. Pt needed a neb and breathing treatment. Albuterol Sulfate 0.63 mg/3 ml, BROMFED DM 2 mg - 30 mg-10 mg/5ml & ORAPRED 15/mg/5ml.
chills, fever, headache, muscle ache, fatigue, dizziness, and developed Bell's palsy
Patient has mild eye redness since 04/17/21, no swelling.  Pt was advised to follow-up with PCP if symptoms don't improve
9x12 cm area of erythema/increased warmth at injection site.  Ice packs applied.  Recommend BENADRYL/TYLENOL or ibuprofen.
This case was reported by a physician via call center representative and described the occurrence of facial swelling in a 58-year-old male patient who received SHINGRIX for prophylaxis. On 28th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In December 2018, 7 days after receiving SHINGRIX, the patient experienced facial swelling, lip swelling, swollen mouth and red rash. On an unknown date, the outcome of the facial swelling, lip swelling, swollen mouth and red rash were recovered/resolved. It was unknown if the reporter considered the facial swelling, lip swelling, swollen mouth and red rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 58 or 59 years old. The patient received vaccine on left arm. It was reported that that 7 days after vaccination, the patient woke up in the morning and his face was swollen along with his mouth, lips and jaw. The patient also had a red rash on the chest and abdomen. The patient had not taken any new medications or changed anything other than received the SHINGRIX vaccine.
Expired Engerix B administered; This case was reported by a pharmacist via sales rep and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 19-Jan-2023. Reporter's Comments: The reporter agrees to follow up from GlaxoSmithKline. Additional Supportive Information: The patient received expired Engerix B vaccine, which led to expired vaccine used.
Patient received Pfizer COVID mRNA vaccine for booster dose.  Should have received Pfizer Bi-valent COVID vaccine for booster dose
I received my booster shot about 2 weeks ago. On Friday night of this week, I woke up dizzy. For the past 3 days I have had dizzy spells feeling as though I am going to faint or pass out. I have no history of fainting, no history of vertigo at all. This is the first time I?m experiencing this and shortly after my booster vaccine.
No adverse reaction, patient was given FLUCELVAX and she is under 18 years old.
mom states that 2 days p/pt recv vax pt broke out in little bumps on face & had a fever of 104 ax;took to ER but never saw ER MD;took back home & gave advil states child temp was nl next day;
fatigue; headache; muscle  ache; injection  pain site; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: El1283; expiration date: unknown), via an unspecified route of administration right arm on 12Jan2021 17:15 at SINGLE DOSE for covid-19 immunization. Medical history included diabetic, high blood pressure, high cholesterol, ADHD (attention deficit hyperactivity disorder), anxiety, depression and IBS (irritable bowel syndrome). The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included lovastatin (LOVASTAT), bupropion hydrochloride (BUPROPION HCL XL) and networking 750mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the Pfizer Covid 19 vaccine in a hospital. The patient experienced fatigue, headache and muscle ache and injection pain site on 13Jan2021 06:00 PM (18:00). The patient did not received treatment for the adverse events. The events were reported as non-serious. The patient has not been tested for COVID-19 since vaccination. The outcome of the events was recovering.
This spontaneous prospective pregnancy report as received from a Registered Nurse (RN) refers to a 16 year old female patient. The patient did not have a pertinent medical history and no drug reactions/allergies. On 08-JAN-2014 the patient was vaccinated with a dose of GARDASIL, 0.5 ml, intramuscular. There were no concomitant medications. It was reported that the patient was pregnant. The pregnancy was confirmed by urine pregnancy test, for which the patient sought medical attention. The patient became pregnant with Last Menstrual Period (LMP) of 26-DEC-2013 and Estimated Date of Delivery (EDD) of 02-OCT-2014. Initial exposure to GARDASIL was at 2 week(s). The pregnancy outcome was outcome pending. No Product Quality Complaint (PQC) and no adverse effects were reported because of this. Additional information has been requested.
Patient is an 86 y/o woman with a PMHx of COPD on 2L, HTN, hyperlipidemia, and hypothyroidism. She presented to the ED today (1/23) due to worsening shortness of breath, N/V, and decreased PO intake. She states she first started feeling ill 9 days ago, on 1/14. She initially felt congested and had a sore throat. She then developed N/V and shortness of breath. She was evaluated in the ED on 1/17 and tested positive for COVID that day. She was stable on her home O2 rate of 2L and was therefore sent home with supportive care. She has continued to worsen over the past 5 days with increased work of breathing/shortness of breath and N/V with decreased oral intake. She reports mildly elevated temp of 100.7 F at home.She has been generally weak and just overall feeling ill.  In the ED her BP is stable and she is afebrile. ABG on 2L with pH 7.49, pCO2 38, pO2 70, O2 sat 95% on 2L. She has had tachypnea/increased work of breathing so she was placed on 30L at 30% HHFNC. CXR shows patchy LLL airspace disease. CTA chest is negative for PE but shows patchy bilateral lower lobe airspace disease. Labs with WBC 10.64, Hgb 13, NA 139, K 4.2, BUN 11.4, Cr 0.9, glucose 100, procal 0.18. Hospitalist service contacted for admission.    PT IS INPATIENT AT THIS TIME.
I had fatigue, diarrhea, loss of appetite, fever of 101-102, and insomnia. I took an COVID-19 test at home and it was positive. I spoke with my doctor and they prescribed me Paxlovid. I also had to go to the ER to do several tests later on.
Woke up at 3:00 AM Wed. with aches all over my body. I had fever and took Tylenol. The following day, I took Tylenol whenever the aches starting come back. The following day I was just worn out. By Friday, I was able to resume my normal activities.
Severe swelling, hot to touch & redness at injection site, outside of what would be viewed as "normal". Pt. did not seek medical attention, but complained of "flu-like" symptoms.
day p/vax pt left arm became red & inflamed, warm to touch. 7/21 using arm w/o problems, on exam 9x11cm erythema & sl warm to lt deltoid 4x5cm area of induration w/o tenderness- getting better
This spontaneous report was received from an office manager via Pfizer regarding a 6-month-old female patient. It was reported that patient had no vaccinations in the previous 4 weeks. The patient's medical history including any illness at the time of vaccination were reported as none. The patient's concomitant medications and current conditions were unknown. On an unknown date, the patient was vaccinated with ROTATEQ (lot # R015607 and expiry date: 21-APR-2020) via oral route for prophylaxis. On an unknown date, the patient received vaccine which had undergone temperature excursion (product storage error) and no adverse events had been reported (no adverse event). The outcome of product storage error and no adverse event was unknown.
headache, fever, chills, nausea, body aches, sore arm,  muscle spasms- hands and arms contracting (hands in fists and arms to chest like you see in individuals with CP) unable to move for 10+ minutes
dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (dizziness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (dizziness). The patient was treated with VITAMIN C [ASCORBIC ACID] ongoing since an unknown date for Adverse event, at a dose of 1 dosage form; VITAMIN D [VITAMIN D NOS] ongoing since an unknown date for Adverse event, at a dose of 1 dosage form; UBIDECARENONE (COQ10 [UBIDECARENONE]) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form; MAGNESIUM GLYCINATE ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and VITAMIN B NOS ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, DIZZINESS (dizziness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient also reported using light blocking glasses and cutting out diet soda.   This case was linked to MOD-2021-232182, MOD-2021-232185 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: Gj3277), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: Er2613), in left arm, on 11Apr2021 as dose 2, single (Lot number: Er8729), in left arm, on 22Oct2021 as dose 3 (booster), single (Lot number: Fh8027), in left arm and on 13Apr2022 as dose 4 (booster), single (Lot number: Fo9989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Unspecified anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19 including Paxlovid from 20Jan2023 to 25Jan2023.
I had a terrible migraine on March 9th and again on April 6th.  I haven't had a migraine in 10 years.  I have also been experiencing daily shortness of breath to the point that I have to use my inhaler each day.  I have never had to do this.  My asthma is uncontrolled usually.  I had extreme fibromyalgia pain and dizziness for three days following my 2nd dose.  I had extreme arm swelling on the day of both of my injections.  The injection site was also red and hot.
Headache within 5 minutes. SOB within 30 minutes of injection lasting over 2 hours.
Swollen left arm for three days and counting, pain in the left side of neck for two days, pain in sinuses and teeth along with extreme headache that started 15 hours after shot that lasted about 7 hours.
Has history of aversion needles and lightheadedness, has recurrence of lightheadedness, no syncope or falls,  taken  to a  private section of the facility. Vitals WNL.
pt recv vax 15APR97 & 2hr p/vax pt started to feel funny;5hr post vax pt started feeling dizzy & tired & went home to take a nap;
Major buildup of earwax in both ears within a few days after the second Moderna shot. Symptoms included pressure in both ears and partial hearing loss within 5-10 days and emergence of tinnitus in the right ear. A visit to an immediate care facility confirmed significant earwax blocking ear canal. The RN removed earwax from both ears and prescribed Debrox, which I used daily for several weeks after the visit at the clinic. Hearing improved, but tinnitus in the right ear remains (high pitched ringing in the right ear), although it is somewhat less severe than a few months ago. No obvious obstruction or inflammation recently.
Left arm broke out  in hives, weakness in arm, SOB, feeling faint. Received Epi-Pen at site of vaccine then transported to ER where she was prescribed methyprednisol and Claritin.
Fever of 103F, chills, body aches, headache, nausea for first two days. Day 3-4 mild fever up to 100F, chills and body aches on and off. Day 5 felt normal again.
Given MENACTRA, TDaP and IPV on 6-27-17. Presented to the office on 6-30-17 with URI, pharyngitis, and generalized rash. Dx: viral rash, food allergy vs. reaction to vaccine.
10 p/vax pt devel fever 105f accompanied by seizure. seen in ER, dx otitis media.
Around 8:30pm I started feeling mild aches and chills, went to bed and awoke at 11:53pm to severe aches and chills and mild nausea, low grade fever, sore/bruised shot injection site, and headache. Shortly after I started vomiting approximately 4-5 times within a 30 minute timeframe, when the slightest sip of water triggered another vomiting episode I decided to go to the ER out of fear because I didn?t know what was happening. I checked into the ER at 2:54am and checked out at 4:55am. While there I was given 2 bags of IV and 2 injections of anti nausea meds. When I returned home I was able to fall asleep at which time I had recorded my temperature at 100.9 degrees. When I woke up the following day, I had mild exhaustion and a headache  throughout the day. When I woke up on day 3 (today) I had a slight headache and slight congestion.
Within 5 hrs of vaccination, developed acute and persistent tinnitus. Also some loss of hearing acuity.; Within 5 hrs of vaccination, developed acute and persistent tinnitus. Also some loss of hearing acuity.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in right arm on 15Apr2021 14:00 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Apr2021 19:00 within 5 hrs of vaccination, the patient developed acute and persistent tinnitus and some loss of hearing acuity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications the within 2 weeks of vaccination. Adverse event result in doctor or other healthcare professional office/clinic visit. Patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, patient has not been tested for COVID-19.  Information on the lot/batch number has been requested
Injection site soreness, full body ache, chills. Took 2 Aleve gel caps @ 8pm and went to bed. Woke at about 5 am on May 1st  and took 2 more Aleve gel caps and went back to bed. Woke at 8am feeling almost 100% better.
Paraesthesia, numbness of lower extremities, ascending to abdomen. No muscle weakness, started on 9/21/10 and persisted. No falls. No respiratory failure. IV Immunoglobulins for 5 days prior.
32 y/o F vaccinated on 10/25/2010. 2 days post injection patient developed vertigo, and her hand went numb. Pt. sought treatment in the ER and was DX with vertigo. Symptoms gradually decreased each day. All symptoms resolved within 15 days. Pt states "I have seen my primary doctor twice and now am seeing an ENT. They think it might be a viral infection in my head (acoustic nerve) and I have a EMG scheduled for next week and once that test is finished we will probably do an MRI." Patient has received the flu shot 5+ times in the past with no h/o adverse reactions.
No additional adverse events reported; received a dose of Gardasil 9 on 06/01/2021 and another dose was given again a couple days later on 06/03/2021 by mistake; This spontaneous report was received from a nurse, concerning a 23-year-old patient of an unknown gender. No information about the patient's concurrent conditions, drug allergies, concomitant therapies or medical history provided.  On 01-JUN-2021, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) prefilled syringe, and on and 03-JUN-2021, received another dose of (GARDASIL 9) prefilled syringe; both vaccine, at a dose of 0.5 milliliters (ml) as prophylaxis (lot number T025367 has been verified to be valid, expiration date reported and validated as 18-NOV-2022) (route of administration, anatomical sites of vaccination and vaccination schemes were not reporter) by mistake (inappropriate schedule of product administration). No additional adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T025367; expirationdate: 18-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
A few hours after getting the vaccine, my arm became very sensitive and was painful to touch. I have had similar experiences like this in the past with other vaccinations. Later, I experienced fatigue, major headaches, chills, and reached a fever of 102 degrees F.  The chills fever started about 30 hours after receiving the vaccination. My fever reached 102 about 31 hrs after experiencing chills.
Presented to ER on 11/28/21. For some unclear reasons, patient has missed dialysis for 9 days.  He  says at least 3 or 4 dialyses he has missed.  Comes in because of worsening  shortness of breath with a cough productive of a sputum, occasionally yellow.   No fever, chills.  No chest pain per se.  No nausea, vomiting, or diarrhea.   The patient has been fully vaccinated against COVID-19 and has gotten the  booster shot as well, but  he tested positive now for COVID-19 here  on 11/28/21.  His chest x-ray showing some fluid overload and concern for bilateral ground-glass opacities. Patient had a cough with sputum, was started on ceftriaxone. No oxygen requirements. Admitted on 11/28/21 for worsening shortness of breath secondary to fluid overload with possible pneumonia. Discharged on 12/6/21
My staff pharmacist gave 0.2 ml of Pfizer adult covid19 vaccine to a twins 10 Years 11 months 25 days years old while they were supposed to get Pfizer Pediatric shot 5-11 years old. When I arrived afternoon to the pharmacy and learned about what happened, I called the mom and they told me the kids are doing well after the shot. I apologized and disclosed what happened.
Arm swelled tremendously, was red and hot. I had chills, fever and body aches. My arm was extremely painful and sore for several days.
Pt. states that after the 1st dose of J&J 08/02/2021, started experiencing at the injection site (swollen, blackish circle), extreme pain at the injection site, chills (shaking), fever (105.0), muscle aches, and  extreme migraine lasting a couple hours. Preciously had a bad spell Covid +. Still experiencing symptoms, planning Primary visit.
pt woke @ 4:57 acted like wanting to choke then collapsed, became pale, limp, diaphoretic et unresponsive;woke up crying for a few seconds then collapsed again;this happened 5x's; amb was called & pt sent to ER-hospitalized x 23hrs
Initial information received on 10 October 2012 from a patient's parent. An 18-year-old male patient received a dose of MENACTRA (lot number U4256AA) intramuscularly in the arm on 27 July 2012. The patient was autistic and had a history of seizures. Concomitant medications included DEPAKOTE, KEPPRA, and KLONOPIN as needed for seizures. The patient had no illness at the time of vaccination. The patient's parent reported that her son was very sleepy on 29 July 2012 and slept all day. He went to summer session at regular time the following day, 30 July 2012, and returned home at regular time at 12:30 pm. He went into his room and played computer games. At 3:30 pm the patient was found with his head slumped on his computer. Cardiopulmonary resuscitation (CPR) was initiated and emergency services (911) was called. The patient was transferred to the hospital and CPR continued for 45 minutes before the patient was pronounced dead. An autopsy was completed, but no results were provided at the time of this report. Documents held by sender: none.
Extreme fatigue, increased muscle & joint pain, felt sick, no appetite, and had chills. Imm. site was stiff w/ some swelling
Approximately 2 minutes after administration pt. stated she felt hot , had chest tightness, and it was becoming difficult to breath as if her throat was closing. These symptoms reversed in 1 min with no treatment.