chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lost the hearing in her left ear; became light headed; This is a spontaneous report from a contactable consumer (patient herself). An 82-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9269, expiration date was unknown), via an unspecified route of administration, administered in the left arm on 03Feb2021 at 15:45 as a single dose for COVID-19 immunization. The vaccine facility type was reported as "other." Relevant medical history included hydrocephalus condition, which was corrected with surgery and for which the patient was also wearing hearing aides; all from an unknown date and unknown if ongoing. The patient had no known allergies; however, she had seasonal allergies on occasion from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (PROTONIX) and simvastatin (ZOCOR); both taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. Right after the patient received her first vaccine dose (while at the clinic) on 03Feb2021 at 15:45, she became light headed. The next day, on 04Feb2021, she lost the hearing in her left ear. The adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. The patient was not recovered from the events.
LOW GRADE FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low grade fever was not reported. This report was non-serious.
Patient  stated on 10/14 she felt her left temple was very sensitive to the touch and she observed the area was also red. She also had sharp pains on her scalp. It was very sensitive it was very difficult to touch her hair. She experienced pressure on her left eye and had to go to her optometrist to get checked out. On 10/19 she saw the NP at her PCP's office who diagnosed her with shingles. Her scalp and forehead are irritated and she is still under treatment with her ophthalmologist. She states her scalp is still sensitive to the touch. It is like ten or more very painful sharp pain needles in her scalp that are hurting very bad and itches a lot.
Numbness to bilateral feet and hands. Nurse admin tdap on 8/27/18 with expiation date 8/25/17. Upon discovery per MD direction admin 2nd tdap on 8/29/18 with expiration date 10/01/20.
Patient brought this to our attention today 9/30/2019.  But complained of itchiness on her left arm the next day after getting the arm.  She then said it got swollen and bumpy spots appeared on her shoulder area.  She then said she developed a rash between both her legs, shoulder, thight and that it would itch a lot.  She said it has gotten a little better but rash is still there.  I recommended that she see her MD, Dr. since this has been going on since 9/11/19 to get proper treatment.  She has a visit with her MD last week but forgot to mention it to her.
Circumstance or information capable of leading to a medication error; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error).    No concomitant information was reported. No treatment information was provided.   Reporter did not allow further contact
Pt reports she had symptoms of congestion, sneezing and fatigue on 10/19/03 prior to vaccination. Vaccinated with flu and Pneumovax on left deltoid at 3pm on 10/20/03. Continued to have more fatigue, arm pain and cold symptoms 10/21/03 she was in bed, not feeling well, fever of 102 deg F with Tylenol. 10/22/03 fatigue and myalgia and red warm arm at vaccination site. 10/23/03 pt seen and treated with antibiotics for infection. Resolved by 10/29/03.
Information has been received on 24-JUL-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration were not reported) subcutaneous on or about 11-NOV-2015, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-DEC-2016, the patient was treated by a physician for the onset of a blistering vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir hydrochloride (VALTREX) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Information has been received from a Physician Assistant concerning an 8 week old patient who on 20-MAR-2009 was vaccinated with MMR II due to nursing error. No adverse effect was reported. Additional information has been requested.
This case was reported by a consumer who is also a healthcare professional and described the occurrence of decreased therapeutic response in a 33-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), Hepatitis B vaccine. Concurrent medical conditions included accidental needle stick. Concurrent medications included Birth control. On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown) and in 1997 the subject received a series of Hepatitis B vaccine (unknown). On 13 January 2010, approximately one and half years after vaccination with ENGERIX B and approximately 13 years after Hepatitis B vaccine series (unknown manufacturer), the subject experienced decreased therapeutic response. The subject reported she experienced a needle stick in the hospital, as protocol for needle sticks at her hospital; titers were drawn for hepatitis B. Her titers for hepatitis B were less than 0.1. The subject received one series of hepatitis B (unknown manufacturer) in 1997 and received another series that was ENGERIX B approximately a year and half ago. Relevant test results included Hepatitis B titer on 13 January 2010: less than 0.1.
One of five pt who experienced swelling of injection site and fever (1-3 days) after immunization.
noted immediate development of swelling right at the site of the injection on right deltoid - slightly warm, 3 cm in diameter, non fluctulant, no streaking;  no respiratoyr distress, no hives, no systemic symptoms.   drew a line around the redness and asked patient to put cool compresses on it, monitor for worsening or genrealization, other skin findings.  no change after 30 minutes.
patient hospitalized with severe diarrhea and dehydration after two doses of PR-V (RotaTeq); date of dose 1: 17 June 2008; date of dose 2: 27 August 2008; date of hospitalization 28 September 2008; hospital stay will be at least 5 days; stool rotavirus antigen positive in lab at hospital  10/7/08 Reviewed hospital medical records of 9/28-10/2/2008. FINAL DX: dehydration w/electrolyte abnormalities; gastroenteritis; rotavirus antigen(+) Records reveal patient experienced vomiting, watery diarrhea, fever, irritability, increased sleep, UOP decreased, decreased activity, pale & sunken anteriorfontanelle x 2 days.  Family had been ill w/similar symptoms.  Tx w/IVF until electrolytes corrected then transitioned to oral.  Improved & d/c to home w/PCP f/u.
about 10 minutes after the vaccine, at about 4pm patient reported sore throat, numbing at the bottom of chin, cold feet.
Sore mouth; fever 100.6 this afternoon; no appetite; hard, red area on right arm.
DTap and IPV on Monday in right thigh - started swelling and got bigger overnight. Patient states hurts when touched. Right upper thigh with circular errythemic area increased. Warmth to touch measuring 7 cm tender to touch. Amoxicillin Rx given See p.n.
The arm with the injection started itching on the 8th day. The arm also is swollen at the injection site.
swollen lymph node under left arm pit; This is a spontaneous report from a contactable patient. A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) via unspecified route of administration in the left arm on 17Mar2021 at 1700 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient has no medical history and no known allergies to medications, food or other products. The patient did not have any concomitant medication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch no: Unknown) via unspecified route of administration in the left arm on 23Feb2021 at 1700 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient did not have COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested positive for COVID-19. On 19Mar2021, the patient experienced swollen lymph node under left arm pit. No therapeutic measures were taken for the event. The clinical outcome of the event swollen lymph node under left arm pit was not recovered at the time of this report. No follow up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.
Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Within minutes after getting the Pfizer vaccine in his left arm, patient reported numbness and limpness in left arm.  He was having difficulty lifting his arm, and when I asked him to squeeze my hand he was unable to squeeze it.  I instructed his guardian to immediately take him to emergency/urgent care.  Patient was not having any additional symptoms when they departed the pharmacy.  I will follow up with the patient at end of day.
36 hours after dose administered - Pt experienced numbness and pain in the left face and neck. Burning and paresthesias of the left hand.  11/18/09:  Primary care records received for date of service 11/13/09:  Dx:  H1N1 Vaccination reaction, trigeminal neuralgia and brachial neuritis.  Assessment:  Presents with c/o numbness and pain in left face and left anterior neck as well as burning and paresthesias in the left hand.  Sx. have decreased over the last couple of days, but have not resolved.
p/vax pt woke w/chills (bad);took APAP which helped but presented to clinic c/o myalgia, malaise & feeling chills were returning;local induration rt deltoid;ecchymosis w/induration lt deltoid;tx APAP PRN;recovered;
Client started getting pale and sweating. He would not talk.  Had his head down. Got him water. Took vitals his heart rate was in the 30's and at times oxygen sats were in the 70's. Put a cold wet wash cloth on his neck. No rash noted. Heart rate and oxygen slowly started to go up. He started talking and being "himself" again.
received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; Inappropriate dose of vaccine administered; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix. In June 2021, the patient received the 2nd dose of Shingrix. In April 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In June 2021, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received the 1st dose of adjuvant suspension only, and came back 2 months later and only administered the lyophilized powder mixed with normal saline. No adverse events reported by patient. This was 6 of 9 linked cases reported by same reporter for different patients. The reporter consented to follow up.   Follow up information received from sales representative on 25 June 2021: The reporter stated that, the health care professional mixed the adjuvant portion with saline solution and administrated it as a first dose and later reconstituted the powder portion with saline solution as second dose. The event inappropriate preparation of medication for 1st dose updated to wrong solution used in drug reconstitution as stated that the health care professional mixed the adjuvant portion with saline solution. The reporter did not know exact date, patient's involved and outcome.  No further events were reported. The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR138554:Same reporter US-GLAXOSMITHKLINE-US2021AMR138553:Same reporter US-GLAXOSMITHKLINE-US2021AMR138546:Same reporter US-GLAXOSMITHKLINE-US2021AMR138552:Same reporter US-GLAXOSMITHKLINE-US2021AMR138555:Same reporter US-GLAXOSMITHKLINE-US2021AMR138557:Same reporter US-GLAXOSMITHKLINE-US2021AMR138558:Same reporter US-GLAXOSMITHKLINE-US2021AMR138559:Same reporter US-GLAXOSMITHKLINE-US2021138628:FU1-deleted
Sleepiness, Muscle weakness, tiredness for 24 hours;was administered Tylenol at bedtime once
no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 01-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
HD Flu shot was administered accidently on 10/19/2022 at approx 4pm after patient had already riecieved a flu shot in last 10 days
TEMPERATURE EXCURSION IN REFRIGERATOR UNIT FOR 18 MONTHS; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The drug was associated with Medication error. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced temperature excursion in refrigerator unit for 18 months, and out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and temperature excursion in refrigerator unit for 18 months was not reported. This report was non-serious.
On 2/19/2023 at 1:15 pm, I received both the flu vaccine and Tdap. The following morning at 5 am, I experienced symptoms including bilateral ringing, also known as tinnitus,  pain in both arms at the injection sites, and dizziness. Over the next few days, the tinnitus went from bilateral to unilateral moving to my left ear, and I also experienced fullness in that ear. Despite attempts to schedule appointments with several ENT doctors, I was only able to secure an appointment on 3/6/2023. During the appointment, I underwent a hearing test which revealed SSHL. The doctor recommended a series of 3-4 tympanic steroid injections and oral prednisone. Since then, I have received three tympanic steroid injections and completed a 14-day course of prednisone, but I continue to experience tinnitus in my left ear and SSHL.
Patient developed right hip pain, limping and symptoms of transient synovitis 6 days after vaccination.
Patient had Covid-19 last year. After the vaccine she began with expected side effects or body aches and low grade fever. Almost 24 hours later she had itching over her whole body. She went to the emergency room where they gave her an injection of Solu-Medrol and Benadryl. she followed up with her primary care office 5/20/21
Patient described left arm pain and discoloration (black/blue), nausea, and chills which lasted 3 to 4 days. Both injections were given in the left deltoid.
Pneumo vaccine. 4 hrs. later had noticed it was sore, noticed it was red and swollen that night, really swelled 4/11/17.
Patient developed chest pain and headache, She experienced swollen joints, too.  We recommended she contact her MD. She was checked out by her MD on 8/4. Her  symptoms subsided by 8/5
Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Reportedly, 168 doses or vials were initially stored in the refrigerator on an unknown date.  The vial did not undergo any temperature excursions.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains no new information
Fever for a day after the second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever for a day after the second vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PYREXIA (Fever for a day after the second vaccine). In March 2021, PYREXIA (Fever for a day after the second vaccine) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-373761, MOD-2021-373777 (Patient Link).
Sore throat, headache, sinus pressure and congestion, fever, chills, generalized aches, malaise, nasal discharge, for past 72 hours, and still not feeling well, sore throat and nasal congestion continue.  Started on an antibiotic today after doctor visit.
Joint pain, headache, dizziness, fatigue, injection site red, warm, painful, with quarter-sized lump.  Facial erythema on left side.
My arm was sore and achy, my joints hurt, double COVID pneumonia was in hospital for a week in 12April 2021. Joints hurts till today. Was bed ridden.
devel a gen red rash on 14SEP96;no fever;rash was present on chest, face, abd, arms, legs, back;no itching;rash began to subside 17SEP96 per pc to mom;
This spontaneous report received from an office manager referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-FEB-2017, the patient received an improperly stored VARIVAX (dose, frequency not reported) (lot: M032493, expiry date: 06-NOV-2018). Temperature was in the range of 6F to 14F for 1 hour time frame. There was no previous temperature excursion. VARIVAX was reconstituted with a sterile diluent. Office manager confirmed that the sterile diluent did not undergo temperature excursion. No adverse effects reported. Additional information has been requested.
Lump on right calf 8 days after injection.  Right ankle swelling 10 days after.