chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of epiglottitis in a 3-year-old male subject who was vaccinated with Haemophilius influenzae type b vaccine (Hib vaccine, manufacturer unspecified). The subject was fully immunized and otherwise healthy. At an unspecified time after vaccination with Hib vaccine, the subject presented to an outside facility with a sore throat and fever of about 39.44 deg C (abruptly 4 h prior to arrival). He had mild symptoms of clear rhinorrhea and nasal congestion for two days prior to presentation. The patient had no cough, stridor, trismus, neck stiffness, nausea, vomiting, diarrhea, or rash. Physical examination initially demonstrated mild trismus and pharyngeal erythema. After 2 h at the outside facility, he developed drooling and a muffled voice. A complete blood count showed a white blood cell count of 12.4 with 74 percent segmented neutrophils, and a blood culture was sent. A nasopharyngeal swab was positive for respiratory syncytial virus (RSV) but negative for influenza A and B. Monospot, rapid strep, and throat culture were all negative. He was initially in no respiratory distress, so a soft tissue neck film and a Computerized tomography of neck without contrast were obtained. The soft tissue neck film showed mild thickening of the epiglottis and aryepiglottic folds (this was confirmed on CT). During the next 3 h, the patient developed worsening odynophagia, inspiratory stridor, and wheezing. He was treated with SOLUMEDROL, salbutamol sulphate (nebulized Albuterol), RACEMIC EPINEPHRINE, and Ceftriaxone, with minimal improvement in his stridor. The patient was airlifted to the hospital presenting mild respiratory distress with inspiratory stridor and was in a modified sniffing position. He was taken immediately to the operating room. During induction of general anesthesia, he had moderate airway obstruction. Direct laryngoscopy revealed a beefy, red epiglottis. He was subsequently intubated without difficulty, and a swab culture was obtained from the epiglottis. The patient remained intubated for the next 40 h, while receiving Ampicillin/ Sulbactam and Vancomycin. On hospital day 2, he received intravenous Dexamethasone. On hospital day 3 he developed an air leak around his endotracheal tube and was successfully extubated. Blood cultures grew nontypeable H. influenza biotype I. The culture from the epiglottis grew normal flora. Antibiotic coverage was narrowed to only ampicillin/sulbactam. The subject's clinical status rapidly improved and he was discharged on hospital day 6. Evidence suggests that children may still be susceptible to H influenzae epiglottitis, despite receiving the recommended vaccination (1,3,4).
NO ADVERSE EVENT BUT WAS ADMINISTERED A A BOY WHO IS 17 YEARS AND 7 MONTHS. LABEL SAYS FOR OVER 18 YEARS
lost her sense of taste and smell; lost her sense of taste and smell; This is a spontaneous report from a non-contactable consumer.  A 78-year-old female patient received BNT162B2 (also reported as Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that after receiving the vaccine, the patient lost her sense of taste and smell on an unspecified date. The outcome of the events is unknown.  No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Subject in pneumococcal vaccine trial died approximately one month after vaccination alone in his home.  Cause unknown.  No autopsy. 1/18/08 Received death certificate which states COD as hypertensive cardiovascular disease & COPD as contributing factor.
Reported lightheaded, and dizziness. She had associated chills/tremblingVitals showed BP 89/80 Pulse ox 98% temp 97.4, Glucose 98 Pulse 65. Sent to the ED
PATIENT WAS VACCINATED OUTSIDE GUIDELINES.  PATIENT IS 17 YEARS OLD.   MODERNA IS LICENSED FOR AGES 18 YEARS AND OLDER.
Patient reported feeling dizzy, nauseated, and diaphoretic. Patient provided with water and car AC turned on Patient stated symptoms improved but boyfriend will be coming to pick her up to transport her home. Patient refused medical transport and signed AMA form.
Patient describes, chills, nausea and a headache along with fatigue. Also describes flu like body aches
Arm hurt a little; Itchy area under her ear on the right side of her neck; lymph nodes in my neck were not swollen any more; Swelling around the shot area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt a little), PRURITUS (Itchy area under her ear on the right side of her neck), THERAPEUTIC RESPONSE UNEXPECTED (lymph nodes in my neck were not swollen any more) and VACCINATION SITE SWELLING (Swelling around the shot area) in a 71-year-old female patient who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt a little), PRURITUS (Itchy area under her ear on the right side of her neck), THERAPEUTIC RESPONSE UNEXPECTED (lymph nodes in my neck were not swollen any more) and VACCINATION SITE SWELLING (Swelling around the shot area). On 07-Feb-2021, PAIN IN EXTREMITY (Arm hurt a little) had resolved. On 08-Feb-2021, PRURITUS (Itchy area under her ear on the right side of her neck), THERAPEUTIC RESPONSE UNEXPECTED (lymph nodes in my neck were not swollen any more) and VACCINATION SITE SWELLING (Swelling around the shot area) had resolved. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.       no concomitant medications are provided by the reporter.   This case was linked to MOD-2021-086945 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: follow up information received on 21-apr-2021, added information as Your interpretation of my original feedback is incorrect .when she received 1st dose of vaccine lymph nodes in my neck were not swollen any more. she did have swelling around the shot area and I felt stinky but nothing else.after second dose of vaccine swelling around my hips and knees went way down. but the reduction in swelling of my joints was wonderful relief.
Caller is nephew of patient. Patient was admitted to Hospital on 2/15/21 with Covid like symptoms and decreased O2 sat. He tested positive for Covid 2/15/21. Treated with Remdesivir. Patient status continued to decline and he passed away in hospital 2/22/21 0612.
noted hard lump at injection site, warm, redden, sore Headache, very tired
Patient received HD FLUZONE on 9/12/12, on 9/16/12 he returned to pharmacy because his arm was red, itchy, and hot to touch.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. In June 2013, the patient was vaccinated with the first dose of GARDASIL 4 injection (lot # H021346 with expiry date: 01-OCT-2015) and on 11-AUG-2015, with the second dose of GARDASIL 4 (lot # K016966 with expiry date: 10-MAY-2017). The following vaccination the patient received was a dose of GARDASIL 9 (lot # reported as 1013429 with expiry date: 21-JUL-2017). No concomitant medications were reported. No adverse events were reported. Additional information has been requested.
DEATH; STROKE; This spontaneous report received from a consumer concerned eight patients with unknown race and ethnicity. The patients' weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients had stroke and died after getting the Janssen Covid-19 vaccine, the patients died from unknown cause of death and it was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0.20210516928-covid-19 vaccine ad26.cov2.s-Death,Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Pt administered pneumococcal vaccine in the morning on 4/27/06.  Several hours later, in the afternoon, pt noted redness, swelling and pain at injection site that was also spreading to axilla.  By evening pain had become so bad patient found it difficult to move affected arm. On 4/28/06 pain, redness and swelling continued to worsen and patient had low grade fever.  Patient took aspirin 325mg in the morning and evening with no symptom relief.  On 4/29/09 again took aspirin 325mg twice daily and began to have some symptom releif throughout the day.  On 4/30/06, symptoms had completely resolved.
The afternoon post vaccination I developed injection site soreness and fatigue. That evening about 13 hours later I develops chills, rigors, fever, myalgia, light headedness, headaches, palpitations, fatigue.
After the vaccine was given we went out to the waiting room to get proof of the vaccine for the school.  Patient went and sat down as I went to the receptionist for the print out.  As I was waiting I turned around and patient was face down on the floor.  I ran over to her and she was stiff and unconscious. I turned her over some and was yelling and telling he to wake up.  At that point Dr.  made it out and patient looked up at me and ask why I was yelling.  I asked if she was ok and she just acted confused.   I asked patient if she could get up and patient said no.  Dr. did some kind of test on her phone and checked her blood pressure and heart and said everything was ok.  But patient was still confused and didnt seem to be able to get up, Dr. had the medical assistant get a wheelchair.  I could see a red mark on patient head where she hit the floor.  Dr. got an ice pack for he head.  Dr. asked if I wanted her to call the ambulance and i said if she cant help her.  That's when the medical assistant came with the wheelchair.  So Dr. said let me check her again and still patient said she couldn't walk so I lifted/help patient get into the wheelchair.  Dr. checked her and said everything looked ok, and said take her to the emergency room.  I took patient to hospital  and at this point patient was able to walk.  The hospital ran more test and said she was ok, and released patient.
Dizziness, Myalgia, Arthralgia, CoughWheeze & NauseaVomiting
Vaccine administered at 0924; 30 minute observation due to past history of allergic reaction to tetanus vaccine; 0948, pt notified RN of tickle in the back of her throat; 0951 VS taken and WNL, remained with tickle in throat.  1016 pt reports having muscle cramps on back of neck, radiating to shoulders; VSS  1026 pt reported new onset chest pain; pt agreed that symptoms were progressing and epi pen was administered at 1031, 911 called.  1034, pt reported improvement; 1036, 911 arrived and pt transferred to ED
joint pain; headache; muscle pain; nausea; fatigue; weakness; This is a spontaneous report from a contactable other Health Care Professional. A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that on an unknown date the patient after receiving second dose of covid vaccine, last Thursday for the following 3 days she had joint pain, headache, muscle pain, nausea, fatigue, and weakness. The worst day was Saturday. She stated she has returned to about 90 percent baseline, still some muscle weakness. She has not updated MD. The outcome of the event muscle weakness was not recovered and unknown for other events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
After both vaccine doses, patient had a seizure. Seizures are occurring exactly around a month time.
allergic reaction to "regular" flu shots; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from consumer/non-hcp.  This case involves an unknown age female patient who had allergic reaction to "regular" flu shots after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, batch number, expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (immunization).  On an unknown date the patient had allergic reaction to "regular" flu shots (hypersensitivity) (unknown latency) following the administration of influenza vaccine.  Reportedly, Consumer states that she has allergic reaction to "regular" flu shots. She does not know which flu vaccine she received when she had the reactions.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (allergic reaction to "regular" flu shots).  At time of reporting, the outcome was Unknown for the event allergic reaction to "regular" flu shots.
Patient was given Pfizer Covid 19 vaccine initially 21 May 2021 and second dose 10 Jun 2021 - both with LOT EW0179. he says sometime in JUN 2021 , he started having dyspnea on exertion, which worsened during a fitness test 1 NOV 2021 - at which time he was diagnosed with pulmonary embolism
Fever, vomiting, exhaustion, chills, stomach pain, diarrhea, brain fog, Nasty rash all down my arm, body aches/pain, joint pain
Information has been received from a physician concerning a 10 year old male who on 27-JAN-2000 and 07-MAY-2004 was vaccinated with the first and second doses of MMR (lot# not reported). On 23-NOV-2009, body temperature was performed and the patient did not have a fever. On 01-JAN-2010 the patient experienced parotitis. On 23-NOV-2009. IgM was performed and came back <1:10, IgG was performed and came back 3.94, and serum amylase was performed and came back 190. At the time of the report, the patient's outcome was unknown. Follow-up information was received from a physician who reported that on 07-DEC-2009 (previously reported as 01-JAN-2010), the patient experienced mumps and was diagnosed on 09-DEC-2009 (previously reported as 23-NOV-2009). The patient was afebrile and had left parotitis. On 10-DEC-2009, the first blood work was taken (results were not provided). This is one of several reports from the same source. No further information is available.
Angioedema   day after 2nd shot developed a swollen red right 2nd digit , seen by er dr next day worse was sent to rheumatology for consult, next worse sent to er was evaluated and sent home , at 2 am next day 2/12 was admitted to hospital with worse   Narrative:   day after 2nd shot developed a swollen red right 2nd digit , seen by er dr next day worse was sent to rheumatology for consult, next worse sent to er was evaluated and sent home , at 2 am next day 2/12 was admitted to hospital with worse s/s
Localized swelling and erythema, numerous clear vesicles (<50) localized to injection site
26mar90 pt vax hepta B. 30mar90 pt ex lethargy, night sweats, chills and hot flashes.  2 week later sx resolved and pt devel low grade fever which lasted 24-48 hrs.
mom reports 5hr & 20min of inconsolable crying/screaming starting 2 1/2-3hr p/vax;
Information  has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the patients were vaccinated with improperly stored PEDVAXHIB (lot # L038501, expiration date 16-AUG-2018 and lot # L030869, expiration date 08-JUN-2018) (dosage, strength and route unknown) (temperature: -10 degree Centigrade, time frame: over a two day period with a cumulative of 12 hours (2 cycles). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever at 103 Severe body aches Cold sweats  Dizziness Happened at night
dizziness/worse when she is sitting or lying down and then gets up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness/worse when she is sitting or lying down and then gets up) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 039A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced DIZZINESS (dizziness/worse when she is sitting or lying down and then gets up). At the time of the report, DIZZINESS (dizziness/worse when she is sitting or lying down and then gets up) had not resolved. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
ok for 1st 24 hrs then devel intense crying for 1 1/2 -2 hrs @ a time; parents state would fall asleep then wake up & repeat process until seen in office Saturday AM; afebrile; no local react;
Information has been received from a physician concerning 2 patients, who, in April 2013 (six months ago), were vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously (lot # not provided). It was reported that, on an unspecified date in 2013, the patients developed redness at the injection site. They were localized issues. The outcome for redness at the injection site was unknown. Relatedness between redness at the injection site and ZOSTAVAX was not reported. This is one of two reports from the same source. Additional information has been requested.
Shingles looking rash on back of neck. Sore then itching, still there today. Have photo.
Local reaction, red raised rash, left deltoid area, warm to touch. Tx Benadryl and cool compresses.
Information has been received from a Registered Nurse referring to a 9 week old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 22-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K025002, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial case was retrieved from the scientific literature on 30 January 2012. An unidentified patient (gender, age and date of birth not reported) had received a 0.5 milliliter (mL) dose intramuscularly in the deltoid of FLUZONE, sanofi pasteur Inc., lot number U239AA (date of administration not reported) and one day after vaccination experienced acute appendicitis and was hospitalized for two days (dates not reported). The patient's outcome was not reported. Documents held by sender: none.
Received 4 vaccines @ 9:30 AM on 1-7-08. At 10:30 pm fever of 104.4. Mother put baby in tepid bath, gave Tylenol and fever dropped to 101. Continues with 101 fevers @ 24 hrs. later. Referred to Pediatrician. Pediatrician beleives fever from a "cold" and not related to vaccines.
pt states that she has sore left arm.  Pt has metal screws and plates in her left ankle and later that night after getting the vax she got severe shooting pain in left ankle.  This pain lasted about 15 or 20 minutes. Today 4/7/2021 about 11 AM she started feeling like she has an exposed nerve in her mouth.  She said the pain traveled through her mouth, to her ear, then to her head.  She says it is now numb and tingling.  She has a rod in her femur to her hip and so far has not had any pain in that location.   Pt says called her PCP and she was instructed to take Tylenol or go to the ER if her pain persist.
soreness in arm, achey arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm, achey arm) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in arm, achey arm). At the time of the report, PAIN IN EXTREMITY (soreness in arm, achey arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt recv vax 23JUN98 & 30JUN98 pt exp localized rxn of redness, swelling & erythema;
Hours 6 to 18 -Worse than usual headache on the front and top of my head.   Hours 24 to 36 - Acute pain in left lower back / kidney area Hours 36 to 48 - Acute pain in right lower back / kidney area
At the 12 hour mark, a numbness and tingling from the waist down began. It lasted for 3 full days and the pain was not resolved by movement or repositioning my legs. It was incredibly frightening to feel this pain and not have full feeling of my body from the waist down for 3 full days. Fever and chills also set in at the 12 hour mark and lasted for a total of 36 hours.
A few days after the booster started with cough then stated to get pain in flank. The cough went away in about 2 weeks but the pain remined intermittent. Thought it was a pulled muscle from coughing. Then stating around Jan 3rd 2023 the pain became more consistent, Mid January I was more fatigued to the point didn't want to drive  and by Jan 26th pain was worse. On Jan 29th broke out in a rash where the pain was. Saw Dr and was diagnosed with shingles.