chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US010743 is an initial spontaneous report from a health care professional received on 23 May 2014 with a follow up report received from the health care professional on 07 Jul 2014. This report refers to a 59 year old female patient. She was inadvertently vaccinated with only Men CYW-135 liquid conjugate component of MENVEO (batch number: X12024) intramuscularly into her right deltoid without reconstituting with Men A lyophilized component on 08 May 2014 at 05:30 PM. No adverse event reported following this medication error (inappropriate preparation of vaccine). Follow up report received from the health care professional on 07 Jul 2014: The patient's demographics, anatomical site of administration and the time of administration of MENVEO were updated.
pt recv vax 5SEP96 & 6SEP96 came to clinic w/red, swollen lt deltoid area, felt warm, c/o sore throat;nurse advised Ibuprofen & cool compresses;to ER 8SEP96 from 5-6PM given pred;returned to ER 11PM because could not breath;given med;
Tuesday from 12:30pm until 3:30pm patient had high-pitched scream cry for 3 hours. Rocked, nursed, soothed until she fell fitfully asleep. When she woke, her legs were very sore and didn't want to walk. Wed 7:40pm she started crying while standing after bathtime which escalated to her not breathing, turning blue, and passing out for about 30 second. Woke withing 15 seconds, confused and disoriented then started crying normally for a few minutes. Then she was fine and normal the rest of the night. Took her to ER and was seen around 11:30pm. All doctors and nurses said she was perfectly healthy with no issues. Saturday 7/10 at 7:50pm she started crying which escalated to her not breathing, turned blue, and passed out for 15 seconds. I blew in her face while she was turning blue and ran her feet under cold water. She was confused and disoriented for a few minutes then started to normal cry. Then she was fine the rest of the night.
pt reported twitching of arm starting on 11SEP98;by mid JAN arm began to be paralyzed & started to have diff breathing;unable to lift arm to hip level by APR99;lower lip drawn to rt, twitching now in leg,rt arm,face; ALS not r/o
sleepy; a slight fever; on 12/26/2019, a female patient was administered both Varivax and Proquad; This spontaneous report was received from a nurse and refers to a 12 month old female patient. The patient had no medical history, drug reaction and concomitant medication. On 26-DEC-2020, the patient was vaccinated with properly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # reported as S021296 ( verified to by invalid lot #), expiration date 15-JUL-2021 (strength, dose and route of administration were not reported), for prophylaxis. On the same day, the patient was vaccinated with properly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) lot # S012533, expiration date 20-OCT-2020 (strength, dose and route of administration were not reported), for prophylaxis (Overdose was coded, however the reporter considered as the events was not a result of an overdose - term not highlighted by the reporter). The vaccines was reconstituted with sterile diluent (strength, dose, route of administration, lot # and expiration date were not reported). On 26-DEC-2019, the patient was sleepy and had a slight fever. The outcome of the events was reported as recovered on 27-JUL-2020. The causality assessment was not provided.
Parents reported today as child's first COVID-19 vaccine to registration and to administering nurse.  Parent completed registration form and signed checking moderna, 1st vaccine, and NO - on history of previous COVID-19 vaccination.   Patient was not found on initial search of database during registration using name and DOB.  After vaccine administration, clinical team attempted to enter vaccine information into database and saw that patient had in fact received a two dose series of Pfizer vaccines in Nov and Dec 2021.  I called and spoke to patient's mother who had difficulty recalling his COVID-19 vaccinations in 2021.   She reported thinking that he needed this vaccine today because the "news said to get it."  I discussed the current recommendations for booster for his age in detail with her and explained the process for reporting the incident.  She expressed verbal understanding and had the opportunity to ask questions and had none.
PATIENT VACCINATED WHILE PREGNANT.  TO DATE NO KNOWN ACTUAL ADVERSE EVENT.
Narrative:  COVID INFECTION FOLLOWING COVID VACCINE SERIES  COMPLETION 10/16/2020 COVID positive (at Clinic Care, per progress notes)  01/16/2021 COVID vaccine dose 02/06/2021 COVID vaccine dose #2  05/24/2021 COVID positive (tested for pre-procedure screening) 05/25/2021  Assessed by Infection Control Provider and determined to likely be a persistent  positive from his previous positive result in October 2020-pt remained  asymptomatic
Patient states with in 5 minutes she felt an odd sensation across her body. She was dizzy and sleep. She waited for 30 minutes at the pharmacy and then proceeded home. She states at home within an hour her blood pressure spike to 151/85 and had a dull headache. She has itchyness at the site of injection. She was sleepy but could not sleep at night and still had a dull headache in the morning.
Mother called stating child had red swollen area and increased soreness to 2" below injection.  Mother was advised to take child to PMD.  Was prescribed Bactrim.  Now greatly improved.
I had a SIRVA Injection, at the Injection Site, which was run either by the State or the County. I have had constant nerve pain, somewhat lessened now, due to my appts with a physical therapist. It has been about eight weeks now, and I still am dealing with this adverse reaction and nerve pain now.
On 20 October 2009, I received the Seasonal Flu Mist. Following it, I went into work. I experienced no symptoms until later in the evening. I went to bed approximately 1030pm. Soon after, my head and hands began to itch terribly. I took some Benadryl and it stopped the itching and I went to sleep. The next morning I woke up and had welts on my hands with itching. I put some cortisone ointment on them and he helped for a short period of time. Later that day, my unit had training in the same location that the mist was given. While at training, I reviewed the reactions part of the brochure that was given with the vaccine. Upon seeing that my reaction was similar, I immediately went to the individuals giving the vaccine.  They informed me to go the closest medical facility. I was given Benadryl and cortisone and sent home. The following morning, I awoke with hives all over my face and they continuously itched.  I called medical, and was informed to put cortisone on and to come in. The cortisone relieved the itching and helped with the swelling. This continued on and off for about 3 weeks. The symptoms finally went away.
inapproproate schedule; no adverse event; This spontaneous report was received from a pharmacist and refers to a currently 29-year-old male patient. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.  On an unknown date, the patient was vaccinated at age 27 with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) one dose for prophylaxis exact dose, route of administration, lot number and expiration date were not provided.  The reporter would like to know what to do moving forward with the series/requires and alternate dosing schedule (inappropriate schedule of vaccine administered).
1 of 6 elderly pts who devel inject site rxn after flu vax with swelling & erythema. This pt has had flu vax each yr for several yr.
We both did come down with Covid-19 4 week's ago; We both did come down with Covid-19 4 week's ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 78-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), in 2022 as dose 1, single (Batch/Lot number: unknown) and in 2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "We both did come down with Covid-19 4 week's ago". Patient husband and herself have gotten all 3 of the Covid-19 shots last year (2022) ending with the booster in Nov2022. They both did come down with Covid-19 4 week's ago (Oct2023) just 5 days after getting the high strength flu shot that Dr's give the elderly.   The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5/BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300184856 same reporter/drug/event different patient;
pt recvd vax & had hard red indurated area x 4 wks; nickel size; tender; mild fever;
Started period Wed (4/21) following second dose on 4/17. I am only two weeks into my cycle (date of start of last period is 4/5.
Left deltoid increased swelling/redness/warm to touch/ tender/indurated 1 day post DTaP shot. Tx for cellulitis with Keflex x 7d
After leaving our office, pt went home and reported SOB/feeling like his throat was closing up. Felt sick for 2 weeks following vaccine.
The infant had a temp of 101 (R) 72 hours after immunizations. (3) afebrile seizures. 1st 80 hours after immunizations.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Fever on 05-22-2006 after shot TYLENOL given.  Red blotchy rash started 6 hours after the shots given.  Rash started at immunization site, but spread to entire body within 24 hours.  Rash took 3 weeks to disappear.
I miscarried after the vaccine, I've had one successful pregnancy and developed gestational diabetes at the time of pregnancy. I was due 10/23/2021 and miscarried at 3 months.
CLL (chronic lymphocytic leukemia) and it is at a state zero now.; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC LYMPHOCYTIC LEUKAEMIA STAGE 0 (CLL (chronic lymphocytic leukemia) and it is at a state zero now.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHRONIC LYMPHOCYTIC LEUKAEMIA STAGE 0 (CLL (chronic lymphocytic leukemia) and it is at a state zero now.) (seriousness criterion medically significant). At the time of the report, CHRONIC LYMPHOCYTIC LEUKAEMIA STAGE 0 (CLL (chronic lymphocytic leukemia) and it is at a state zero now.) outcome was unknown.            Concomitant medication was not provided. Treatment information was not reported.  Company comment: This is a spontaneous case concerning a male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Chronic lymphocytic leukemia stage 0. The event occurred unknown days after the first dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed or treatments received.  At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Chronic lymphocytic leukemia stage 0. The event occurred unknown days after the first dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed or treatments received.  At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Pain (severe) at inj site, no numbness and tingling in all extremities. High BP for her 137/94, usual 106/60. Blood sugar 164 down to 118 in 20 minutes (may not be same issue). Labored breathing, cold, sweaty, shaking.
This spontaneous report as received from a nursing supervisor refers to a patient of unknown age. On 07-AUG-2012, at time of the report the patient was in the office to receive the second dose of GARDASIL (Lot # unspecified) which would be late. The first dose was administered two years ago (in approximately August 2010). No symptoms reported. No other co-suspects were reported. No concomitant medications were reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Erythema and swelling on right deltoid area, site of varivax injection, 48 hours ago.
first noted headache ~24 hours after shots, along with left deltoid tenderness,  acetaminophen no help.  Worse during the night and the next m,orning so brought to my office at 8:00 AM
Seasonal Influenza Vaccine given 2/28/18. Already had seasonal Flu vaccine 11/22/2017.  No adverse reaction noted.
Pt. states that after receiving the 1st dose of Phizer 02/08/2021, started experiencing symptoms 02/08/2021 that evening of headaches, pain throughout the body, chills, dizziness, fever lasting 6 days, weakness (Treated with Benadryl), tongue and lip swelling. Swelling subsided within a week's time but still continuing to experience dizziness, body aches, and allergic reaction to new foods. (Tip of the tongue or lips) begin to swell or tingle.
Mild headache at bedtime the day of vaccination.; Difficulty falling asleep; This is a spontaneous report from a contactable consumer, the parent. An 18-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via unspecified route of administration in left arm on 25Mar2021 at 13:00 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. The patient medical history included kawasaki disease at the age of six years in 2008. The patient was allergic to salicylates and milk products. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN) and vitamin C (MANUFACTURER UNKNOWN) all were taken for unspecified indication and from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 25Mar2021 at 21:30, the patient experienced mild headache at bedtime on the day of vaccination and difficulty falling asleep. It was reported that, the patient had mild, but less, headache upon waking. The patient did not receive any treatments for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events mild headache at bedtime and difficulty falling asleep were recovering at the time of this report.   No follow-up attempts possible. No further information expected.
Information has been received from a registered pharmacist (R.Ph) concerning a 60 year old female with a history of cancer who on unspecified date, was vaccinated a dose of ZOSTAVAX (Merck) subcutaneously (lot # not reported). It was reported that the patient experienced a raised, red rash at the site injection site which went away soon after. No treatment was given for the adverse event. The patient received an unspecified medical attention. At the time of the report, the patient had recovered. Follow up information has been received from a registered pharmacist concerning a 60 year old retired female who had cancer 4-1/2 to 5 years ago (approximately in May 2006). On 23-MAR-2011, the patient was vaccinated with the first dose of ZOSTAVAX (Merck) at 17:00 subcutaneously and outer aspect of left upper arm (lot number: 669187/1543Z) (dose not reported). No illness at the time of vaccination. On 24-MAR-2011, "next day", the patient presented redness around injection site. Also it was noticed that the patient did not seem concerned and injection site was visually checked twice. No relevant diagnostics test and laboratory data were performed. At the time of the report, the patient had recovered on unspecified date. Additional information is not expected.
Repoter called on behalf of the customer to report an AE for GARDASIL 9. The customer was not on the line. The customer reported she administered GARDASIL 9 to an 11 year old patient, and the patient had syncope 1 minute after receiving the dose. The cus; the patient did bump her head during the episode of syncope; Information has been received from a nurse via a company representative referring to a 11 year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-NOV-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, anatomical location and administration route) for prophylaxis.       On the same date (16-NOV-2022), 1 minute after receiving the dose, the patient had a syncope. The reporter stated that the patient did bump her head during the episode of syncope. The nurse said the doctor examined the patient, and the patient recovered the same day (on 16-NOV-2022). The outcome of syncope was reported as recovered and for the head injury was unknown.  The causality assessment between the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events was not provided.    Upon internal review, the syncope was considered as a medically significant event.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # L040460, expiration date 27-MAY-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 80 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Fever, chills, extreme fatigue--Friday 8/20/21 Redness, hot to touch and swelling, soreness spreading across upper arm and toward elbow--8/21/21 Redness, hot to touch and swelling, soreness spreading across upper arm and toward elbow--8/22-23-24/21
On 8/5/2021- severe vertigo and severe headache; it got worse with each day. The first set of symptoms lasted 16 days. I had severe vertigo where I couldn't get out of bed for 8 days. My blood pressure  went to- 178/88 - it skyrocketed to that. And had headaches, too. I had a rash all over my body. I went to my family doctor for these symptoms. There was never a break from these. They gave me medicine - Meclizine - for vertigo which did help. I never had vertigo before or had to deal with headaches like that before either. The vertigo resolved after the 16 days. The blood pressure currently is running 140/80  (I'm usually 90/60 - I've never had blood pressure issues before.) I was out of work for 8 days. They are just waiting with the blood pressure to see if it will come down. Then: in the next 13 days after that: Electrical shocks in my body; pins and needles; itchiness so bad. I developed a red ring under my breast in the center. My doctor said it was more inflammation from my skin. Gigantic big circle. I have pictures of this. Saw a neurologist and they thought it was skin issues. They thought it was skin and not neurologist. For the rash - no treatment. That red circle has gone away - it lasted about a week. The electrical shock feeling and the pins and needles symptoms lasted 13 days. Last thing I developed, is skin issues. A lot of skin inflammation. I'm still having problems with my skin. On the right abdomen - it looks like a gigantic bruise but it didn't hurt. I went to Dermatologist. She took a biopsy and sent out - a sudden loss of my pigmentation color - from some kind of trauma or a drug reaction is what the results said. It is about 10 inches wide. I may never get my original skin color back there. I have pictures of that as well. They don't want to put a bleaching cream because of all the trauma to my skin right now. My skin has been very irritated. Very different than what it was before. The doctors don't have treatment for things since this is a new vaccine. I didn't have any fevers and I haven't been sick with anything for 2 years.