chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient came in today for a booster; nurse was a new nurse she injected incorrectly; injecting only like one quarter even less than that of the dose/very small dose less than 0.1ml went in to the arm; rest of it just jugged out to the outside of the skin; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 82 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 16Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "a patient came in today for a booster"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 16Nov2021, outcome "unknown", described as "nurse was a new nurse she injected incorrectly"; UNDERDOSE (non-serious) with onset 16Nov2021, outcome "unknown", described as "injecting only like one quarter even less than that of the dose/very small dose less than 0.1ml went in to the arm"; EXPOSURE VIA SKIN CONTACT (non-serious) with onset 16Nov2021, outcome "unknown", described as "rest of it just jugged out to the outside of the skin".  Additional information: a very small dose less than 0.1ml went in to the arm so rest of it just jugged (sounds like but wasn't able to verify the spelling) out to the outside of the skin". Reporter thinks should re-give another dose because the first one was even less than one fourth. Reporter just wanted to know if there is any advice we can give her. Pfizer covid-19 vaccine confirmed (purple one).  The lot number for bnt162b2 was not provided and will be requested during follow up.
9/1/21 hx of HTN,DM, and GERD; presented w/ SOB
lt side of face became numb- & hot; dec in sensation for over 1wk;
This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received ENGERIX B pediatric (batch number UNK, expiry date 6th September 2014). Concomitant products included ENGERIX B pediatric. On an unknown date, the patient received the 2nd dose of ENGERIX B pediatric. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details provided: Expired ENGERIX-B given to a 2mo old male as 2nd dose in the series, a few weeks ago.
same big red rash to injection site arm with the second vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH ERYTHEMATOUS (same big red rash to injection site arm with the second vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (same big red rash to injection site arm with the second vaccine). At the time of the report, RASH ERYTHEMATOUS (same big red rash to injection site arm with the second vaccine) had resolved.            Concomitant medications included unspecified blood pressure medications.  The red rash resolved after 3-4 days.   She did not take any treatment medications for the adverse events.   This case was linked to MOD-2021-067353, MOD-2021-106494 (Patient Link).
Patient received his second COIVD vaccine on 8/21 and the following morning had an occipital headache that worsened as he stood up and radiated to the front.  He had some chest pain and mild dyspnea on 8/23.  On Tuesday his dyspnea worsened throughout the day as he was at school, and his mom took him to the ER at a different facility.  He received Toradol that took care of the headache prior to his transfer to HCF and has received ibuprofen and acetaminophen since admission.
complete body pain, fever, legs were killing her, back and neck, headache, thighs, and lower legs, when going to lay down it felt like pins and needles in legs, feet and ankles were swollen, ear ache, itching near vaccine site,
Treatment of COVID-19; Treatment of COVID-19; Moderna: and Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 12:00 as dose 4 (booster), single (Lot number: GM9694), in left arm and on 23Jan2023 as dose 5 (booster), single (Lot number: GL0446) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Jan2021 at 12:00 as dose 1, single (Lot number: 025L20A), in left arm, on 06Feb2021 at 12:00 as dose 2, single (Lot number: 042L20A), in right arm and on 23Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 037C21A). The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Oct2021 at 12:00, outcome "unknown", described as "Moderna: and Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. including Paxlovid from 05Sep2023 to 19Sep2023.
3/18 1pm headache, fatigue, sore arm. 3/19 2pm vomiting, headache, chills, body aches, upset stomach, sore arm. 3/20 8 am  vomiting, headache, chills, body aches, upset stomach, sore arm
felt dizzy shortly after vaccine but did not last long; This is a spontaneous report received from a non-contactable reporter (Consumer).  A 25 year-old female patient received bnt162b2 (BNT162B2) (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: DIZZINESS (non-serious), outcome "recovered", described as "felt dizzy shortly after vaccine but did not last long".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, chills, injection site reaction, loss of appetite (3 days) Narrative: The patient reported the following symptoms after her second dose of the Moderna COVID-19 vaccine:fever, chills, nausea, vomiting, body aches, headache not relieved with acetaminophen, and loss of appetite for 3 days. No other treatment was given besides acetaminophen.
9 patients given vial of vaccine that was pierced and left at room temperature for 12 hours instead of 6 hours; Same vial pack in ice packs for 24 houirs and then was use for patients; A spontaneous report received from a nurse concerning Moderna vaccine given to 9 people left at room temperature for 12 hours and same vial was packed in ice packs for 24 hours used on patients   The patient's medical history was not included. Concomitant product use was not provided by the reporter.    On unknown date, the patient received their first dose of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, the vial of vaccine was pierced and left at room temperature for 12 hours instead of 6 hours. Additionally, the same vial was packed in ice packs for 24 hours and then was use for 9 patients.  It was questioned if this could affect the efficacy of the vaccine. Treatment information was not provided/ unknown.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the events was not reported.; Reporter's Comments: This report refers to a case of Out of specification product use and Product storage error for mRNA-1273, lot # not reported, with no associated AEs.
Greater than 35 days since first dose; Inadvertently administered dose to a teenager; Sore arm; Mild headache; This spontaneous case was reported by a health care professional and describes the occurrence of MYALGIA (Sore arm), HEADACHE (Mild headache), PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since first dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently administered dose to a teenager) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced MYALGIA (Sore arm) and HEADACHE (Mild headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since first dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently administered dose to a teenager). On 30-Jul-2021, MYALGIA (Sore arm) and HEADACHE (Mild headache) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since first dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently administered dose to a teenager) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Ischemic Stroke called 911 and was provided with an emergency ambulance to the hospital for medication treatment and next to physical therapy .
Day 8 following injection, injection site is newly red and inflamed and sore to the touch. It was fine before. ?Covid Arm?.
Looked sick; Vomiting/Threw up; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting/Threw up) and ILLNESS (Looked sick) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PROPRANOLOL HYDROCHLORIDE (PROPANOLOL BOEHRINGER), ESCITALOPRAM OXALATE (LEXAPRO), TRAZODONE, Risperidal and MELATONIN for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VOMITING (Vomiting/Threw up). On 19-Mar-2021, the patient experienced ILLNESS (Looked sick). At the time of the report, VOMITING (Vomiting/Threw up) and ILLNESS (Looked sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No laboratory details were  provided.  Treatment medications included Benadryl and Zofran.
double vision, little dizzy, headache - yesterday had her 2nd vaccine SYMPTOMS DURATION: 2 days.  Patient states she got her first COVID vaccine on 2/5/21 and had a slight headache but no other symptoms. Today, she was sitting the car when she started to have double vision. She reports dizziness/lightheadedness that is moderate. Patient states the double vision isn't everything but random things and at random times today. Denies dehydration, fever, or injection site abnormalities. No headache today. Reports that last week at her PCP's office her BP was slightly elevated and she thinks her BP may be elevated right now but does not have a cuff with her to check.       Went to the Emergency Department on 2.6.21 - admitted overnight until the 7th.  DETAILS OF HOSPITAL STAY: DX:   Diplopia [H53.2] Blurred vision, bilateral [H53.8] HOSPITAL COURSE:  1. Double vision post COVID vaccine. Unclear etiology or if related to vaccine reaction. Resolved. CVA ruled out. Could be migraine associated. Advised patient to talk to PCP about migraine prophylaxis and see ophthalmology as outpatient.  2. HTN 3. HLD   Advised patient not to drive till cleared by ophthalmology  Inpatient workup included myasthenia gravis panel which is still pending  The patient is a 78-year-old right-handed woman who received her first Pfizer COVID vaccination February 5. This morning she developed double vision.  Images were horizontal she does not know if they were binocular or monocular.  She saw couple with 1 child and it appeared that they had 2 children.  She looked at her son and saw 2 heads on 1 body.  She saw 2 traffic lights.  Each time she saw diplopia, it lasted for maybe 1 minute, and after blinking it went away.  The double vision was not associated with headache, facial numbness or weakness, numbness or weakness in her extremities, speech change or imbalance.  She recovered from each episode.  She has had torn retina twice in each eye.  Those were each associated with flashes of light in floaters.  She did not have a fever today.  She has never had double vision before.   Review of systems:  She admits to a history of headaches.  She said she had catamenial headaches and sinus headaches.
General body aches and pain, joint pain, tingling and numbness of hands fingers toes, Absence of sleep, night mares, anxiety, nervousness, eyes sensitive to light, lack of appetite, Skin soreness, skin Itch. 10/13/06 Received medical records from VA which reveal patient began treatment for depression in 2004 after returning from combat.  Same year noted rashes of forearms.  First c/o hip pain noted 1/06 & x-rays done at that time were WNL./ss
My armpit got very sore the day after the vaccine and then I also noticed rather substantial swelling.
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual was given vaccine at 3:30 pm. 20 minutes after receiving the vaccine individual developed itchy flushed on face cheeks, chest, and back. She was given Benadryl 50 mg IM in Right arm at 3:55 pm. 4:12 pm the itchy skin was less intensified and vitals were stable. Individual went home with family
Patient received only the diluent portion, received the adjuvant only; Patient received only the diluent portion, received the adjuvant only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 75PE7, expiry date 3rd June 2023) for prophylaxis.   On 31st March 2022, the patient received the 1st dose of Shingrix. On 31st March 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 05-APR-2022 and 06-APR-2022 Reporter's comment: The patient was there to receive his first dose of Shingrix was received first dose only with the diluent portion. The patient reached out to nurse via phone for guidance on what steps to take for re-administering first dose. A medical error took place. The reporter wanted to know if there was a range of time the patient needed to wait to receive his first dose after the error. The reporter was provided Medical Information's contact information. She said that she was able to get the information she needed. The reporter consented to follow up by email. Additional Supportive Information: The nurse reported that, the patient received first dose of Shingrix only with the diluent portion, which led to Inappropriate preparation of medication and inappropriate dose of vaccine administered.
Shots administered on 8/19/10 at 10:10am. Quarter-sized red area noted on (R) thigh around 8:30 pm on 8/19/10. Site warm to touch. Mom administered Ibuprofen for temp. reading of almost 101 degrees F, red rash noted on buttocks 6 inches x 6 inches in diameter on both sides of buttocks area. Sm red rash noted on (R) thigh near injection site. No bumps noted. BENADRYL administered for rash. No c/o itching. Instructed Mom to have her daughter seen by her pediatrician.
Patient claims Hives started around 1130  ( 1 1/2 hours after vaccine)
Patient came in on 8/12/08 for Gardasil and Varivax.  Patient was counseled for pregnancy.  Patient called on 5/21/09 and stated that she had been pregnant on 8/12/08 and did not know it.  She stated she had not missed her period yet when she came in for the vaccinations so she did not think she was pregnant at the time.  She delivered twin boys at on 3/23/09 but her EDC was 4/13/09.  Baby A weighed 5 pounds 10 ounces at birth and Baby B weighed 5 pounds 7 ounces.  Patient took Baby A to pediatrician on 4/27/09 with what she thought was a respiratory illness.  Doctor heard a murmur and upon further evaluation was admitted to hospital and flown to another hospital.  Infant was diagnosed with Total Anomalous Pulmonary Venous Return and had surgery on 4/29/09.  Infant was discharged from the hospital on 5/4/09.  Baby B was found to have an innocent heart murmur.  Patient also has a 5 year old son and 2 year old daughter who are healthy.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. On an unknown dates the patients received doses of ZOSTAVAX (dose, route of administration, lot# and expiration dates were not provided) that were exposed to temperatures outside of the proper storage range. No adverse effects reported. Additional information has been requested.
I started to have symptoms on 01/04/2022, I had a runny nose, sneezing, fever, chills, and lots of mucus in my throat. I went to urgent care on 01/06/2022 and I had a Covid-19 test and flu test done. The Covid test was positive and the flu test negative. They recommended over the counter medications. I took Flonase and Robitussin.
flu-like symtoms fever  body aches joint pain headache neck pain & stiffness fatigue nausea
Admit date:  7/30/2021 Acute hypoxic respiratory failure 91%.  Tested positive for COVID-19 7/27/2021. Diagnosed with COVID-19 pneumonia; treatment with Remdesivir and dexamethasone Note: patient previously vaccinated with Johnson & Johnson vaccine - given 4/3/2021.
vertigo diagnosis 2 weeks after vaccination. later pain in left ear and sore throat that is unpredictable in intensity or duration.
Pain, tingling, numbness, from my hand to upper arm at the area shot, nervous, restless, weakness of my whole hand/arm.
This spontaneous report was received from a nurse refers to a 15 year old female patient. On 20-DEC-2012 the patient was vaccinated with GARDASIL (dosing regimen unspecified) dose 3. It was reported that nurse states on 20-DEC-2012 a patient was vaccinated with the third dose of GARDASIL too early. Patient was vaccinated with GARDASIL first dose 22-AUG-2012, second dose 25-OCT-2012 and the third dose of GARDASIL on 20-DEC-2012. Nurse states patient vaccinated at another health care facility. No adverse effects reported. The outcome of patient was vaccinated with the third dose of GARDASIL too early and no adverse effects reported is unknown. No product quality complaint involved. This is one of several reports received from the same source. Additional information is not expected.
Incomplete dose; A spontaneous report received from a consumer concerning a 76-year-old female patient who received the first dose of Moderna COVID-19 (mRNA-1273) vaccine and received incomplete dose.   The patient's medical history was not reported. Concomitant medication was not reported.    On 18 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch #: 025620A) intramuscularly for prophylaxis of COVID-19 infection.   On 18 Jan 2021, When the nurse administered the vaccine, the patient was told that she was only going to receive a 0.25ml dose. The patient did not experience any side effects from the vaccine but would like to report that she did receive an incomplete dose.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event was considered resolved on 18 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 vaccine, batch number 025620A, with no associated AEs. Causality of these events is not applicable.
The pt complained of initial swelling at injection site. 45 minutes post vax, the pt experienced swelling of tongue and throat. Pt took Benadryl on own and went to the clinic. Was given Solumedrol (IV).
PT's mother stated her daughter and her were pilling potatoes when she turned and said she felt faint. PT then fainted. Mother caught her after she hit her head on multiple surfaces. PT was unconscious for around 3 minutes. EMS was called/attempted to take BP (EMS struggled to fine one). Eventually, pt was aroused and taken to hospital. PT had a CT done and was told she didn't have a seizure & referred to a neurologist pt's mother report doctor had said she called the specialist who they referred her to and told them he didn't think she had a seizure. Pt & mother came to our health department to get a second opinion on the situation.  Pt's mother did report when her daughter was knocked out she was jerking/twitching.
PATIENT WAS ADMINISTED HEP A VACCINE ON 8/1/2006. ON 08/06/2007 PRESENTED IN OUR OFFICE WITH ALMOST HIVE-LIKE RASH SCATTERED THROUGHOUT HER ENTIRE BODY.  FEVER STARTED THE DAY AFTER THE ABOVE INJECTION OF 101-102 BUT ONLY LASTING 24 HOURS.
Patient on the floor. Hands were cold, face was cool and pale. She was conscious, but was in an out of consciousness for about a minute. She had urinary incontinence. I checked for a pulse and found one. She had good breathing. She began speaking within 1-2 minutes, just seemed a bit confused and tried to get up. We would not let her get up. She asked for water, which we denied. Emergency was called, and paramedics took her to the hospital. Father reported that at hospital, bloodwork was normal and doctor suspects reaction was an anxiety-based reaction post-vaccine.
Fever with a Tmax of 102 F, persisted for one day, afebrile (98.5 F) since 08/06/2014 10 pm.
Approx 1 mo p/recvd flu vax, pt devel rt sided weakness w/inappropriate speech on 14DEC91; on 16DEC91 speech became appropriate but rt sided weakness continues w/rt hand weakness;
Fever up to 101° so far. Also chills, sweats, ache at injection site.
Initial information has been received from a healthcare worker concerning a 17 year old female patient with no known pertinent medical history who on 10-AUG-2009 was vaccinated with the first dose of GARDASIL. The healthcare worker reported that on 11-AUG-2009 the patient did not feel well and since then had had falling episodes up to 3 times a day. Follow-up information has been received from a physician's assistant who reported that after received the vaccine the patient was experiencing syncope. The physician's assistant mentioned that the only other medication the patient was on was the birth control OCELLA (manufacturer unspecified). At the time of reporting the patient had not recovered. The patient sought medical attention by seen in the office. Follow up information has been received on 15-SEP-2009 from a physician assistant who reported that "the patient had some laboratory work which showed the patient had mononucleosis". Additional information has been requested.
Patient received Pfizer Covid-19 Vaccine dose #2 after BUD-expiration date. Doctor recommendation is for patient to be revaccinated. Patient's parents were informed of the adverse event and Doctor recommendations.  No symptoms or sign were reported by parents in reference to this event.
small/ medium sized hives appeared on upper left arm, left elbow, left forearm, right upper arm, lower back and right cheek around 8:30pm and took benadryl at 9:30pm and hives started to disappear.