chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient developed a macular rash over his entire body; HCP was administering a dose of MMR II when the patient knocked the syringe out of her hand, possibly causing administration of a partial dose; This spontaneous report was received from a physician regarding to a male patient of unknown age. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On 10-APR-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter, lot # S0185595, subcutaneously (expiration date and anatomical location not provided); and with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL (lot # S025913, expiration date not provided, but upon internal review stablished as 20-AUG-2021) (route of administration and anatomical location not provided) both as vaccination. The reporter stated that when the health care professional (HCP) was administering measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), the patient knocked the syringe out of her hand, which possibly caused the administration of a partial dose (incorrect dose administered). On the same date, several hours of receiving the vaccinations, the patient developed a macular rash over his entire body. Medical attention was sought in physician's office at the time, but not treatment was given. At the reporting time, the patient had not recovered from the macular rash.   The causality between macular rash and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck)(VARIVAX) was not reported.  Lot number S0185595 is an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 29-NOV-2012, the patient was vaccinated with a dose of PNEUMOVAX23 (lot# 669776/0614AA) which had expired on 27-SEP-2012. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
pt recvd 2nd dose of Hep B vax 06JUL89, & on 13JUL89 devel profuse pruritic rash on face & trunk p/ doing yard work. Tx w/ hydrocortisone & terfenadine.
pt vomited once on 3APR94; high fever ranging between 102-104 starting on 3APR94 & lasting for the next few days; convuls (body shaking vigrously) between 5APR94 & 7APR94; crankiness persistent high pitched crying; MD dx sl ear infect & sz
Booster; Crohn's disease; This is a solicited report received from contactable reporter (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4186548-00 (AbbVie).  Solicited report from the (private) by a consumer of an adult female with an event of non-serious Crohns symptoms with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced Crohns Symptoms. PFIZER BIONTECH COVID-19 VACCINE (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 27Feb2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/ Biontech. On 19Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/ Biontech. On 28Aug2021, patient received 3rd dose COVID-19 Vaccine manufactured by Pfizer/ Biontech. The causality assessment per reporter for the event Crohn's disease with BNT162B2 was reported as reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: As there is limited information in the case provided, the causal association between the events Immunisation and Crohn's disease and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Pt. presented w/ extensive rash(4X6 ")redness,edema at injection site (right deltoid).  Father reports swelling, itching and pain within 8 hours of injection. Parent reports temp of 100.6 orally resolved with Motrin given.
Severe headache, fever, nausea, vomiting, tachycardia, lower back pain, testicular pain.
Pt recv vax on 8/24/98; on 8/25/98 pt exp swelling of left arm from elbow to shoulder with warmth & erythema.
DROP HIM OFF WITH SITTER AFTER VACCINE SHE STATED HE WAS JUST CRYING NOT EATING WHEN HE WAS WITH ME HE STATED PROJECTILE VOMITING CRY WAS VERY WEAK, PALE, AND LETHARGIC LISTLESS NOT ACTIVE HUGE BALL OF MASS WHERE INJECTIONS GIVEN RED HOT TO TOUCH. TOOK HIM TO ER THAT EVENING. BUT LEFT AFTER NURSE DID EVALUATION DUE TO WAITING FOR 3 HOURS. THE NEXT MORNING TOOK HIM TO DR TO REPORT THAT HE HAD A REACTION TO VACCINATION. THEY TREATED HIM FOR DEHYDRATION AND TOLD ME TO GO TO HOSPITAL. BECAUSE SHE SAID ALL BABIES GET A LITTLE SICK AFTER INJECTIONS SO THAT WASN'T UNCOMMON WENT TO ER BECAUSE I WAS SCARED THAT MY CHILD WAS GOING TO DIE AND AFTER SEEING THE DOCTOR THERE HE TREATED FOR DEHYDRATION AND SENT US HOME AGAIN HOME CALLED THE DR ON THE 5TH STILL CONCERN ABOUT MY BABIES HEALTH HE FOLLOWED UP WITH ME ON JULY 7 BABY HAD FEVER 101 STILL LETHARGIC NOT EATING PALE BUT THEN HE WAS TREATED FOR THRUSH. I CALLED ONE OTHER DAY AND THURSDAY AND HE TOLD ME TO CONTINUE WITH PEDIALTY AND ON SATURDAY MY HUSBAND TOOK HIM BACK TO ER AND WE REFUSED TO MOVE UNTIL THEY FOUND SOMETHING WAS WRONG WITH MY SON AND THEY DID HE WENT TO SURGERY DUE TO A HEMORRHAGE IN HIS HEAD WE STATED IN THE HOSPITAL FOR ABOUT 2 WEEKS IN ICU. AND TO THINK THIS LITTLE ANGEL WAS ABSOLUTE PERFECT UNTIL HE RECEIVED HIS 4 MONTHS VACCINATIONS. HE CONTINUES TO SEE DR. AND GET HIS CAT SCAN EVERY 3 MONTHS TO MONITOR HIS HEAD CONTINUES TO GROW. MY SON HAS NOT RECEIVED ANOTHER INJECTION AND CONTINUES TO BE ALMOST PERFECT WITH A LARGE HEAD. 11/25/09 Hosp. recs received for date 7/12/09 to 7/23/09. Duplicate records received 11/30/09. DX: subacute and chronic subdural hematoma, s/p rt. front subdural drain, retinal hemorrhages. Presented to ER w/ persistent fussiness, emesis x2 occasions at ER and dx w/ viral syndrome. Parents stated when sx continued again took pt to ER for 3rd time and had CT performed which showed subdural bleed. Assessment: large head w/ prominent forehead, anterior fontanelle bulging, pulsating small nodule palpated on the occiput, unable to fully move left eye laterally. Pt was taken to OR and subdural drain placed, removed on 7/20. Ophthalmologist consult while in hosp. showed bilat retinal hemorrhages, left sixth nerve palsy 11/25/09 ICD9 codes: 432.1,852.1, 378.54, 362.81, E928.9, E849.9, V65.3.
42 YEAR OLD MALE WAS DIAPHRETIC AFTER RECEIVING VACCINE.  HE WAS ALSO TALKITIVE AND ALERT.  ON SITE EMS RESPONDED.  BP 104/80  HR 71 PULSE OX 96% GLUCOSE 82 MG/DL His wife got in the drivers seat and left for home
This spontaneous report was received from a physician via a company representative concerning a 12 year old female patient with no pertinent medical history and no drug reactions or allergies. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 27-AUG-2013, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). There were no concomitant medications. On 27-AUG-2013, a few minutes after receiving the vaccination, the patient had a glazed look and her arm went limp. The patient also either fainted or had a seizure (exact diagnosis was unspecified as the physician did not know which one was the diagnosis for the patient). The patient then urinated on herself. The patient was monitored for 30 minutes. No treatment was provided. No lab tests were performed. On 27-AUG-2013, the patient was recovered from all the events. The relatedness for all the events was unknown for GARDASIL. Upon internal review the seizure was considered as medically significant. Additional information has been requested.
On 05/29/22 he woke up a bit tired, but he had been in a parade the previous day in hot weather so I didn't think too much of it. He had a low grade fever that we treated with alternating Tylenol and Ibuprofen. I also gave him extra Vitamin C at that time. He was tested for COVID-19 on the third day at a local clinic and he was positive. By the time we received his PCR test results though his symptoms were improving to the point where medical intervention was not necessary. He only ran a fever for 2 days but was fatigued and had sinus like symptoms for around 4 days.
I had a slight fever, body aches and headache for 2 days, after each dose.  Tinnitus, which I've had a few times over the years, started about 10 days after my first dose (01/18/21). I received my 2nd dose on 02/15/21.  The tinnitus has continued, about 4-5 days per week.  I have seen my ENT  twice.  He suggested I try melatonin.
Left eye brow pain; pain that radiates from both sides of eye brow; Left eye brow sensitivity /The upper bone structure around my left eye socket has one specific spot that is sensitive and even more sensitive to pressure put on that spot; This non-serious case was reported by a consumer via call center representative and described the occurrence of eyebrow pain in a male patient who received Herpes zoster (Shingrix) (batch number 5777F, expiry date 30-MAY-2024) for prophylaxis.   On 23-MAR-2023, the patient received the 1st dose of Shingrix (right deltoid). On 18-AUG-2023, 148 days after receiving Shingrix, the patient experienced eyebrow pain (Verbatim: Left eye brow pain ), radiating pain (Verbatim: pain that radiates from both sides of eye brow) and hyperesthesia (Verbatim: Left eye brow sensitivity /The upper bone structure around my left eye socket has one specific spot that is sensitive and even more sensitive to pressure put on that spot).  The outcome of the eyebrow pain, radiating pain and hyperesthesia were not resolved.   It was unknown if the reporter considered the eyebrow pain, radiating pain and hyperesthesia to be related to Shingrix.     It was unknown if the company considered the eyebrow pain, radiating pain and hyperesthesia to be related to Shingrix.   Additional Information: GSK receipt date: 25-AUG-2023 The upper bone structure around the patient left eye socket has one specific spot that was sensitive and even more sensitive to pressure put on that spot.  The pain permeates further out when area was pressed.  The patient had left eye brow sensitivity to touch causing pain that radiates from both sides of eye brow. The left eye brow pain was not resolved. When explaining to the cardiologist in an appointment today (on the day of reporting) had and asked if had the shingrix shot.  The physician said the shingrix vaccine could affect the nerves around the eye and the bone structure around the eye. The scheduled to take 2nd dose in the next day (day after visiting the physician).  The physician did not want to recommend that I did or did not take the second dose. The reporter consented to follow up.
This spontaneous report received from a medical assistant referred to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients received RECOMBIVAX (Lot number: M022077, Expiry date: 10-MAR-2017) (dose, frequency were not reported) which was improperly stored. No adverse effects reported. Causality assessment was not reported for the events. This is one of the several reports received from the same reporter. Additional information has been requested.
pt exp hives w/itching p/vax approx 1hr 15min;hives-face-neck, arms, abd, throat a little tight;DPH given;
cervical dysplasia; positive for HPV; Information has been received from a nurse practitioner via company representative concerning a female patient of unknown age. The patient's concurrent conditions, medical history, historical drugs, and concomitant medications were unknown.  On an unspecified date (reported as when the patient was 12), the patient was vaccinated with the three-dose series of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), administered intramuscularly, to prevent human papillomavirus (dose, anatomical location of administration, lot number and expiration date were not reported).  The nurse practitioner stated that a female patient came into the office on an unknown date and this patient tested positive for human papillomavirus and cervical dysplasia. The outcome for Human papillomavirus test positive and cervical dysplasia was unknown. The patient did not have an overdose.  The reporter did not provide the causality assessment between Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb vaccine (GARDASIL) administration and, Human papillomavirus test positive event and cervical dysplasia.  This is one of several reports received from the same reporter.
extreme mucous production; uncontrollable cough; This is a spontaneous report from a contactable nurse. An adult male patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) intramuscular, administered in Arm Right on 09Apr2021 (Lot Number: ER8733) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if patient had COVID prior to the vaccination. Patient has no known allergies. It was unknown if patient had any other vaccine in four weeks. It was unknown if patient had any other medications in two weeks. The patient took the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. On 09Apr2021, 20-30 min post vaccine, patient developed an extreme mucous production and uncontrollable cough; O2 sat 98% percentage. MD (Medical doctor) administered diphenhydramine (BENADRYL) and dexamethasone (DECADRON). EMS (Emergency medical services) called to transport patient to ED (emergency department). Patient was discharged home after ED visit; no issues reported from patient after follow-up call from MD. It was unknown if patient got COVID tested post vaccination. The outcome of the events was recovered.; Sender's Comments: Based on the information currently available,The casual association between the reported event "extreme mucous production and uncontrollable cough" and suspected vaccine BNT162B2 cannot be completely excluded.  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.
complained of a sore arm; This is a spontaneous report from a other healthcare professional. A 20-year-old non-pregnant female patient received an unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: unknown) via intramuscular route of administration in the left arm on 20Mar2021 at 14:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not provided. Concomitant medication taken in two weeks included medication for birth control (MANUFACTURER UNKNOWN) on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 21Mar2021 at 11:00, patient complained of a sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event sore arm. The clinical outcome of the event sore arm was recovering.  Information about lot/batch number cannot be obtained. No further information is expected
Stuffy nose; Can barely breathe; Headaches; Sinus infection; This case was reported by a consumer via patient support programs and described the occurrence of sinus infection in a 51-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Advair HFA (received 10 years before from the time of reporting, refer linked case US2019AMR214034) and Ventolin HFA (received 10 years ago from the time of reporting, refer linked case US2019AMR214034).   On an unknown date, the patient received Boostrix .5 ml, Engerix B and Shingrix .5 ml. On an unknown date, less than 2 years after receiving Boostrix, Engerix B and Shingrix, the patient experienced sinus infection, nasal stuffiness, difficulty breathing and headache. On an unknown date, the outcome of the sinus infection was recovered/resolved and the outcome of the nasal stuffiness, difficulty breathing and headache were unknown.   It was unknown if the reporter considered the sinus infection, nasal stuffiness, difficulty breathing and headache to be related to Boostrix, Engerix B and Shingrix.  Additional case details were reported as follows: The reporter who is a consumer was reporting a case for herself The age at vaccination was not reported, however the patient could be 49 or 50 years old. In 2018, the patient received Boostrix, Engerix-B and Shingrix. The patient had a sinus infection for about a week.  Her symptoms from the sinus infection included a stuffy nose, she could barely breathe and she had headaches.  No more information was given. The reporter consented to follow up.
covid 19; covid 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Lot number: CUS5815) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Known allergies: Banana" (unspecified if ongoing); "Known allergies: Papaya" (unspecified if ongoing); "Known allergies: Kiwi" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Positive; (18May2022) Negative; (27May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Arm completely cramped up immediately; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2020 06:30 (Lot number: EL0140) at the age of 37 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "allergies: Sulfur drugs" (unspecified if ongoing), notes: allergies: Sulfur drugs, Only thing that I'm allergic to is Sulfur and I turn red with that.; "red" (unspecified if ongoing), notes: allergies: Sulfur drugs, Only thing that I'm allergic to is Sulfur and I turn red with that.; "Arthritis in hips" (unspecified if ongoing), notes: Arthritis in hips. The patient's concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious) with onset 30Dec2020 07:00, outcome "recovered" (30Dec2020), described as "Arm completely cramped up immediately".  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. After the 1st dose patients arm completely cramped up immediately for a half hour and slowly went away after an hour.   No follow-up attempts are possible. No further information is expected.
Corona Virus Concern     just got home and was around several people that were positive; had a rapid positive test yesterday; fever yesterday     HPI Patient presents to the emergency Department secondary to a positive rapid Covid test yesterday. Patient also has fever at home as well as mild cough. Denies any respiratory distress. Patient is fully vaccinated. He returned home and was in contact with others tested positive. He denies any nausea or vomiting. No chest pain. No other complaints.
This spontaneous report as received from a medical assistant refers to a patient of unknown age with no drug reactions or allergies and with no medical history provided. The reporter stated that on 17-APR-2014, the patient was inadvertently vaccinated with ROTATEQ 2 ml, oral liquid (lot# H016250), that had expired on 27-MAR-2014. There was no adverse effects reported. No concomitant medications and no diagnostic tests were mentioned. Additional information has been requested.
Rheumatoid Arthritis with first X-ray from foot pains on May 10.  May 29, admitted to ER for left face, left arm, and left leg turning numb.  Oct, blood test show severe rheumatoid and antibodies levels.  Extreme pain in neck, both full arms to fingers, right knee and both feet and all toes.
Chills; Annoying headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. Historical vaccine of BNT162B2 for COVID-19 immunization and had sore arm after the first dose, felt very tired after it. She provided information on adverse events for second dose of her own. The patient stated after second dose she had chills on first day, annoying headache for 1 week. Now she was fully recovered but she wouldn't go for a third dose if that's required. She did better when she had COVID than with the vaccine. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Loss of twins - one potential vanishing twin in May of 2021 and missed miscarriage of remaining twin in June of 2021. Conceived within two week window of receiving vaccine
Soreness started in fingers and elbow joints and then to hip, knee and foot joints about one month after second shot - I walk 2 miles every day and play golf  - was unable to walk or play golf for 4 weeks - slowly getting better - joint pain mostly subsided and have started a slow walk and up to over 1/2 mile ? just reporting for data purposes.
Having intermittent chest pain starting 2 weeks following vaccine administration when he contracted COVID-19 disease. EKG normal, exam normal except for reproducible chest pain with palpation consistent with costochondritis.