chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lot of itchy skin and it continued; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Aug2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications was not reported.  The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as dose 1, single for COVID-19 immunization. On 11Aug2021 the patient experienced lot of itchy skin and it continued. Therapeutic measures were taken as a result of lot of itchy skin and it continued. Patient stated that: I have taken a Benadryl (treatment) and I don't know if that's enough or do I need to go to see an Urgent Care person.  The clinical outcome of the event was Not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report as received from a nurse refers to a female patient in her 50's with no relevant medical history and no drug reactions and allergies. The nurse reported that about 10 years ago, approximately in 2004, the patient received Hepatitis B vaccine series (manufacturer unknown, RECOMBIVAX HB could not have be ruled out). On an unknown date, the patient had titers drawn which showed negative immunity. In approximately 2009, reported as "about 5 years ago", the patient had a booster dose of Hepatitis B vaccine (manufacturer unknown) RECOMBIVAX HB could not have been ruled out). On an unknown date, the patient had titers drawn which again showed negative immunity. On 31-MAR-2014, the patient was seen in the office and titers drawn performed again showed negative immunity. No treatment was given. Relatedness between event of Anti-HBs Antibody Negative and RECOMBIVAX HB was not reported. Additional information is not expected.
Patient outside of left arm where vaccine was given was red and swollen down to elbow. Patient was also complaining of cough.
This spontaneous report was received from a nurse refers to two patients of unknown age and gender. Medical history was not reported. The nurse informed that on 07-AUG-2014 the patients were vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J013315, expiration date: 18-OCT-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
2 hours after the injection, patient developed hives on arms/legs. She took a benadryl and symptoms resolved. She had no previous allergic reactions.
Information has been received from a registered nurse concerning a 24 year old male who on 3/6/02 at 5:10pm was vaccinated with the first does of measles virus vaccine live (#638832/0531L), intramuscularly in the right deltoid. There was no concomitant medication or illness at the time of vaccination. After being vaccinated, the patient was instructed to sit quietly for ten minutes. The patient was found by the reporting nurse "unconscious" on floor of room at 5:15pm. The patient was aroused within 30 seconds "when called." A physician had attended. The patient stated that he "went blank" and denied hitting head. The patient was released at 7:00pm from the doctor's office. The patient's vital signs were reported to be stable. On 3/7/02 there was no word from the patient since regarding other possible symptoms. The nurse felt that "the rest of the box of (measles virus vaccine live) should not be used and will discard it." It was also noted that the patient denied history of fainting spells, allergies etc. No further information is expected.
Dizzy attack, sudden onset with prior mild dizziness in prior days following taking of 4 oral doses of thyoid vaccine.
Mom reported to health dept 3 days after child received shots stating child had fever after receiving shots. She added fever child felt warm, was noted at night but appeared normal during the day. States Motrin helped somewhat but child started drooling on 3rd day after shots. Mom advised to take child to ER because she denied having med insurance. On follow up call mom reported child was fine, says she did not require ER.
Ringing in both ears.  Sought treatment at family doctor.  Ears appeared normal.  No treatement provided
pt recvd vax; devel swelling & redness which persists in the arm of inject, limits range of motion;
Breakthrough case admission after 2 vaccines Moderna 3/18/21 Lot# 044A21A;  Moderna 4/15/21 Lot# 025B21A
Admission for antineoplastic chemotherapy - US Guided Paracentesis; She was started on hydromorphone 2 mg PRN for abdominal pain. She received bevacizumab and tolerated well. She will discharge home after her second paracentesis. Hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date (reported as "a couple weeks ago"), the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming units (PFU) (dose, route of administration, lot# and expiration date were not provided) at an unspecified pharmacy. On an unknown date (reported as "a couple weeks ago"), the patient experienced a couple bumps. On 17-APR-2017, the patient presented to the pharmacy with a rash on his shoulder. Pharmacist stated, that the bumps almost look like mosquito or bug bites in a linear fashion, not resembling vesicles from shingles. There was no treatment given for the adverse event. No laboratory diagnostic studies were performed. The pharmacist stated, that the patient was referred to primary care physician. At the time of the report, the patient did not recover from the adverse event. The relatedness between the adverse event of rash on the shoulders and ZOSTAVAX was not reported. Additional information has been requested.
I started experiencing menstrual spotting about 36h following the second dose. I have had to wear a pad ever since this dose although my period was not scheduled to return for a few weeks following the dose. The blood is dark brown suggesting that it is old. It has continued, and I am now going on 10 days of symptoms.
Per patient via incoming call at office: ear pressure, fever, chills, runny nose, eyes watery.
Vaccine taken 8-19-11; pt. states site progressively worse daily: pt took BENADRYL and used topical anti-itch cream 8-22-11 - presented at the facility 8-25-11 with raised 100mm x 50mm red/rash site - localized fever and itching. Treated with MEDROL dose pack.
felt tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 09Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "felt tired".  Additional information: The patient received the second dose of BNT162B2 on 04Mar2021.   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-2021304462 Same reporter, drug, and events; different patient
facial itching, flushed.  IM Benadryl admined.  Patient felt better quickly.
Patient developed red itchy spot on injection site, 3-4 inches in size. Experienced malaise next day muscle pain. Fully recovered next day.
t99;1 to 1 1/2inch knot on hip, hard, red & warm to touch;
W/in 5 min I began experiencing itchiness of the face and nose, half fever style. Because of poor time planning on the county's part, I wasn't able to stay fir observation. By the time I drove 20 min home, the itch had spread to the most sensitive (eczema prone) regions and was all over my body within an hour. I took 4 benadryl,  1 every 2 hrs, for the rest of the evening. Slept 13 hrs through night, didn't need another benadryl until after showering. Itch continues but at a much lower level.
death Narrative:  Pt attended arthritis clinic appt 0900; labs shortly after; rec'd vaccine in clinic ~ 1113; seen on surveillance camera walking to parking garage ~ 1145; medical center rec'd call from wife ~ 1900 that pt never returned home; police found vehicle running in parking garage, code called, pt obviously deceased by that time 1930, body sent to medical examiner for autopsy.
Developed Bell's Palsy on right side of face; right eye and face were drooping as well as blurred vision in right eye; saw eye doctor on 9/25/12; he diagnosed Bell's palsy. Went to primary care physician on 10/1/12. He concurred with diagnosis, but was sure the condition is only transient. As of today, 10/5/12, it is almost entirely gone. He is also convinced it probably has nothing to do with the flu shot, but thought it would be appropriate to inform you of the occurrence since it happened so soon after the flu shot.
Patient received 4th dose (second booster) of pfizer covid 19 vaccine.  The first 3 were the orange cap and this last dose was the gray cap.  Patient says she had no issue other than minor arm pain following first 3 doses.  Following this 4th dose, after about 2-3 days she developed a small rash on left arm which then spread to several other parts of the body.  She used neosporin cream and hydrocortisone cream OTC and rash on body subsided.  After about 14 days she developed redness, swelling, and pain on the right side of her face.  Within a day or two of this, she called the CDC, left a message, and has not heard back.  She also called Pfizer but did not understand what they were telling her.  She came back to my pharmacy today, about 5 to 6 days after latest symptoms began.  She denies any other symptoms.  She brought medication in with her which consisted solely of a couple different OTC vitamin supplements.  She denies any prescription medication usage.  I recommended that if symptoms worsen, she report to urgent care, otherwise I recommended she call her family doctor on Monday if it does not begin to subside.
Extreme fatigue that lasted 36 hours Extreme chills WITH NO fever that lasted 12 hours
For Moderna COVID-19 Vaccine: the second shot led to significant issues at the 24 hour mark (post injection period). Symptoms were: full body aches, recurring chills with very cold extremities, extensive hyperalgesia, shooting pain from neck down to feet, and high fever of 102F. Symptoms lasted for a total of 12 hours.
patient received MENQUADFI vaccine within one year of age/ NO AE; Initial information regarding an unsolicited valid non serious case was received from other health care professional via the regulatory authority (Reference number: 00748364) and transmitted to Sanofi on 31-Aug-2021.  This case involves a 16-year-old male patient who was given MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] too soon after his last dose (inappropriate schedule of product administration).  Medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  No other vaccines.  On 30-Aug-2021, the patient received 0.5 mL total dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [strength: standard, frequency: once lot U7218AA, expiry date: 22-Feb-2024] via an intramuscular route in left deltoid site for prophylactic vaccination.  It was reported ''The caller wants to know if we have any recommendations for a patient who was given a MENQUADIFI too early? See the additional event details field for more info. Additional Description of event Adverse events: Patient given a dose of MENQUADFI too soon after his last dose.'' Patient age less than 1 year enter as 2 month and 4 month, etc. Many pediatric vaccines need month for age. Dose 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.5mL strength: standard except for Fluzone HD. Vaccine was not used for first time.  This was actual medication error case due to drug dose administration interval too short.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I began to feel about an hour after the vaccine, a scratchy throat and a dry cough formed. It continued to get worse for two weeks. My arm was sore for about 3 weeks and I was extremely fatigued. I then had a telehealth visit with my doctor. They gave me 5 day course of 50 mg Prednisone to help with symptoms. Symptoms are beginning to subside however I do need to use the inhaler everyday. Trouble with breathing is very prevalent.
health issues regarding stress-induced seizures (I believe incl upon waking up) and other potential issues.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient in her mid 20's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "severe allergies to mold and potentially other things" (unspecified if ongoing); "severe allergies to mold and potentially other things" (unspecified if ongoing); "I believe they also have ADHD" (unspecified if ongoing). The patient took concomitant medications (reported as unsure but likely yes and Likely is on medication to manage the disorders and allergy issues). Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown, Batch/Lot number unknown), administration date: 2021, for COVID-19 immunization. Reporter stated it may have been Pfizer and patient was likely vaccinated by spring/early summer. The following information was reported: SEIZURE (disability, medically significant) with onset 2021, outcome "unknown", described as "health issues regarding stress-induced seizures (I believe incl upon waking up) and other potential issues." Reporter cannot remember all explicit issues of patient, but was impacting daily life activity. Seems like patient was doing better now as she had resumed what seems like normal activity, but cannot confirm details. Reporter forget if patient sought medical attention.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother states that one week after influenza vaccine on 10/31/05 (given in right thigh he began having swelling and redness to right knee, subsequently diagnoses with JRA by DR (as a out PT) (of note a older sib subsequently diagnosed with JRA a few months later.)
Running nose, sneezing, sore throat, no temp, positive covid home test. Possible covid rebound. Tested positive for covid two weeks earlier and recovered.; Running nose, sneezing, sore throat, no temp, positive covid home test. Possible covid rebound. Tested positive for covid two weeks earlier and recovered.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: en6205), on 22Mar2021 as dose 2, single (Lot number: er8727), on 27Sep2021 as dose 3 (booster), single (Lot number: 301458a), in right arm and on 30Mar2022 as dose 4 (booster), single (Lot number: fjs682) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "liver issue" (unspecified if ongoing); "kidney issue" (unspecified if ongoing). The patient did not have known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovered" (2022) and all described as "Running nose, sneezing, sore throat, no temp, positive covid home test. Possible covid rebound. Tested positive for covid two weeks earlier and recovered.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: positive covid home test; (unspecified date) Unknown results, notes: Indication= Covid-19 treatment; (Jun2022) Positive, notes: Tested positive for covid two weeks earlier and recovered. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 23Jun2022 to 27Jun2022.
Information has been received from a health professional concerning two patients who were vaccinated with varicella virus vaccine live (Oka/Merck). Each experienced a local reaction at injection site. The patients' outcomes were unknown. There was no product quality complaint. This information is on of several reports from the same source. No further information was available.
aphasia; TIA or mild stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY), in Oct2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant) with onset Oct2021, outcome "unknown", described as "TIA or mild stroke"; APHASIA (non-serious), outcome "unknown". Clinical Course: Reporter was actually asking if pfizer boosters contain choline esters. He said that his wife had received the 2 pfizer vaccines, had not received any boosters. He would like to know whether any of the boosters or the new vaccine contains any choline esters. They were thinking of traveling to another state and if it turns out that they would been required have been current on their vaccinations, then either they were go to got his wife vaccinated with one of our boosters or present information about why she could not got one of those boosters. He added that his wife had the 1st 2 vaccines, had the last of the 2 vaccines in oct2021. And about 2 1/2 to 3 weeks later she had a TIA or mild stroke. They had not knew at the time he said. She had aphasia so she was having trouble finding the right words when she spoke, otherwise she was okay. They had not knew at the time but they knew that the vaccine contains the phosphocholine. His wife called the (name withheld) and asked them whether it was safe for her take it. They told her that it was such a minute quantity that other people who had problems tolerating choline esters had not had a problem with it. But other people were not his wife and said she was not gone to take the new formula. He was asking if the new formula was used for people who had the 1st 2 pfizer vaccines but no boosters, or what vaccine was offered to people who had the 1st 2 pfizer vaccines and not had the boosters.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
2.5-3" slightly raised red, warm to touch mark on left arm (near injection site) on day 8 post vaccine injection. Shape is irregular. Monitoring redness and symptoms.
w/in 2min of vax pt still in office became flush & devel gen rash/erythematous, raised;then began c/o SOB, wheezing & resp distress;EMS was contacted & pt was taken to local ER;
was sore/still hurts when lifting to a high elevation; couldn't eat; couldn't sleep; couldn't get her shirt off; The arm was bruised and at present; This is a spontaneous report from a contactable other health professional.  A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration in arm in Oct2020 at single dose for immunization, diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) via an unspecified route of administration in arm in Oct2020 at unknown dose for immunization.  The patient's medical history and concomitant medications were not reported. It was reported in Oct2020, she received "3 vaccinations in one day." Per caller she received "Tdap in one arm and in the other arm the 65 Plus flu shot and the pneumonia vaccines."  Per the caller, 3 hours after getting the vaccinations she "was sore, couldn't eat, couldn't sleep, couldn't sit, couldn't get her shirt off." The arm was bruised and at present, the caller stated her arm "still hurts when lifting to a high elevation." The outcome of the events was unknown.  No follow-up attempts are needed; information about batch/ lot number cannot be obtained.
Pt injected at 1210.Alerted staff at clinic her complaints of not "feeling well" Some itchiness on roof of mouth and tongue. Mettalic tase in her mouth. Skin was warm and dry. Pulse was between 110-120. Pulse ox 99. Bp 140/?.  Client reports history of anxiety and did feel anxious. C/O feeling "funny" Stated some disorientation that she could not explain. After monitoring patient for 30 minutes symptoms did not subside, EMS called and client was transferred to local hospital. Client was encouraged by EMS to use her epi pen , but client refused. Benadryl was offered by clinic staff, she refused as well because she stated she has taken her Claritin.
Swelling of the left thigh, pain with ambulation.  No fever, fatigue or other systemic symptoms.  Swelling decreased the following day.  On examination 2 days after administration, thigh circumference 29.5 cm vs 28 cm on right, ambulating well, no indication of infection.