chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hearing loss in her left ear and felt it was plugged up/Having problems hearing on the telephone and would have to switch to the right ear to hear a conversation; Hearing loss in her left ear and felt it was plugged up; This spontaneous case  was received on 07-Oct-2020 from other non-health professional (consumer)  and concerned a 62-year-old, female patient.   The patient had no relevant medical history and was not taking any concomitant medications. The patient reported never having any hearing problems and has not had a flu shot in over 20 years.  On an unspecified date in 2020 (reported as 04-Sep-2020 and 04-Oct-2020), the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: right deltoid, route of administration: not reported) for influenza prophylaxis. The batch number reported was 276578, expiry date: 30-Jun-2021.     On 06-Oct-2020 about 5 p.m., the patient experienced hearing loss in her left ear and felt it was plugged up. The patient was having problems hearing on the telephone and would have to switch to the right ear to hear a conversation. On the same date, before bed, the patient took a decongestant and was able to hear some better in the morning.   At the time of initial reporting on 07-Oct-2020, the patient had not recovered from the events.   The reporter did not provide a causality assessment.   The event of 'hearing loss unilateral' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: On an unspecified date in 2020, a patient was vaccinated with Flucelvax QIV vaccine. On 06-Oct-2020, the patient experienced deafness unilateral and ear discomfort. Reportedly, the patient had no relevant medical history and was not taking any concomitant medications. The patient reported never having any hearing problems and has not had a flu shot in over 20 years. Due to lack of information regarding temporal relationship, diagnostic findings, causality is unassessable.; Sender's Comments: On an unspecified date in 2020, a patient was vaccinated with Flucelvax QIV vaccine. On 06-Oct-2020, the patient experienced deafness unilateral and ear discomfort. Reportedly, the patient had no relevant medical history and was not taking any concomitant medications. The patient reported never having any hearing problems and has not had a flu shot in over 20 years. Due to lack of information regarding temporal relationship, diagnostic findings, causality is unassessable.
No additional AE reported; GARDASIL 9 was accidently administered to a two month old patient on Mar 3, 2022; This spontaneous report was received from certified medical assistant and refers to a 10-week-old patient (also reported as 2-month-old). The patient's concurrent condition, medical history and concomitant medications were not provided.  On 03-MAR-2022, the patient was accidently vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product administered to patient of inappropriate age), lot number: 1780867, expiration date 08-AUG-2023, dose/frequency reported as "once" (route of administration and injection site were not reported) for prophylaxis. No adverse event (AE) and product quality complaint (PQC) were reported.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 1:31 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The patient was given doses from a vial that were stored in an ultracold freezer which is colder than they should have been.It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was one month. On 19-Nov-2021, the Moderna COVID-19 vaccine vial went from the super cold freezer to the refrigerator. The vaccine was returned to the freezer/refrigerator/ultra cold freezer, or maintained at room temperature. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
Less than 4 months in between 1st and second booster doses of the Moderna Covid-19 vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 4 months in between 1st and second booster doses of the Moderna Covid-19 vaccine) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044C22A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 4 months in between 1st and second booster doses of the Moderna Covid-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 4 months in between 1st and second booster doses of the Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. The dose patient received on 31-Mar-2022 and 27-Jul-2022 was first and second booster doses respectively.  The arm that the patient received the first dose, second dose and first booster dose was not known. The patient did not experienced any adverse reactions with first dose, second dose and first booster dose . Treatment information was not reported.
sore arm; feels like a deep bruise that doesn't seem to go away; sore arm; feels like a deep bruise that doesn't seem to go away; This is a spontaneous report from a contactable nurse. A 47-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at a single dose COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced a sore arm. The patient stated that his arm right after the injection wasn't sore at all. He's had flu shots and stuff and the next day, his arm was pretty sore but it seemed to go away. However, if one pushes on his arm or punches on his arm, he can probably feel it. It's not aggravating or anything, it's just sore. He wanted to know if this was unusual to have this condition, a sore arm, this long after receiving the first vaccination. He was to receive his second vaccine on Monday, unknown date. His arm was not super sore but was still sore. It felt like a deep bruise, that doesn't seem to go away. The outcome of the events was not recovered.  Information on the Batch/Lot number has been requested.
Information has been received from a literature article, concerning of 4,214 project-managed infants born to HBsAG-positive women, who completed 3 or more hepatitis B vaccine (recombinant) (manufacturer unknown) doses, 63.7% had reported post vaccination serologic testing (PVST) results, 13.3% had reported PVST results but infant age was unknown, and 23.0% had no reported PVST results. Of 2,683 infants with PVST results by age 24 months, 1.0% (28 infants) were infected and had Anti-HBs Antibody Negative. PVST is critical for guiding medical management of infants born to HBsAg-positive women, identifying infants with HBV infection and in need of further care, and monitoring progress toward the elimination of perinatal HBV transmission. Of infants with reported PVST results and date, HBV serology status was categorized as "protected" (anti-HBs-positive, HBs-Ag-negative), "HBV-infected" (anti-HBs-negative, HBsAg-positive; anti-HBs-positive, HBsAg-positive; or anti-HBs unreported, HBsAg-positive), "susceptible" (anti-HBs-negative, HBsAg-negative), or "indeterminate" (all other result combinations). A protective anti-HBs result was defined as >10mIU/mL. Records of susceptible infants were reviewed for revaccination and repeat PVST. This is one of several reports from the same literature source. Additional information has been requested.
Episodes of loss of vision in right eye.; Nausea; vomiting for 4 months; vertigo; This is a spontaneous report from a contactable consumer (patient herself).   A 38-years-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, formulation: solution for injection, lot number: EW0162, expiry date: not reported), via an unspecified route of administration in Arm Left on 07May2021at14:00 (age at vaccination 38 years) as single dose for COVID-19 immunization and second dose via an unspecified route of administration in Arm Right on 03Jun2021 at14:00 (Batch/Lot Number: EW0173) as single dose for COVID-19 immunization. The patient's medical history included penicillin allergy from an unknown date and unknown if ongoing. Patient had COVID prior vaccination. Patient had COVID tested post vaccination via nasal swab. The patient's concomitant medication included lamotrigine (LAMOTRIGINE) taken for an unspecified indication, start and stop date were not reported. On 10May2021 at 12:00, the patient experienced episodes of loss of vision in right eye, nausea, vomiting for 4 months, vertigo.  Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for 4 days. Therapeutic measures were taken for all the events (referalls to three doctors prescriptions for vertigo). The outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
It started it out as a runny nose and congestion which turned into a very bad chest cough and could not sleep at night. I went to urgent care on 12/01/2022 and a Z-PAK, inhalers and steroids.
Patient states injection site became red with pus, developed scab, picked scab off and went to PCP who determined scabbed area was infected. Given samples of cephalexin 250 mg three times daily for 7 days.
pt started having an itchy rash on 15MAY96 in the evening that cont to spread on 16MAY96;pt went to MD on 16MAY & was given Hydroxine;rash started on thigh & then went to lower legs, trunk, forehead & arms;
soreness injection site; feel tired; Headache; Chills; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248 and expiry date: Dec2021), via an unspecified route of administration on 12Jan2021 at 10:00 at a single dose on the right arm for COVID-19 immunization. The patient's medical history included diabetes from 1980 and high blood pressure from 1990. Concomitant medications were not reported. The patient's concomitant medications were not reported. On 12Jan2021, the patient experienced soreness injection site, feel tired, headache, chills, and was feeling unwell. The patient recovered from chills on 12Jan2021; recovering from soreness injection site and feeling unwell while the other events were not recovered.
I took a car trip up to the mountains. Every once in a while, my knees get fluid on them and swell up a little bit. That happened in that car trip. It was a 24 hours retreat. On Tuesday I noticed my leg had swollen all the way to the ankle. The next day I went to work which is like 45 miles away. I stood up and my knee got really tight. I called a nurse on the phone. She said they did not have any appointments and she recommended to go to the ER. I went to the ER and they did an ultrasound and they found a blood clot in the upper left leg and that there was a pool of blood behind that knee. They advised me to wear compression socks and elevate my leg for several days and follow up with my PCP. I saw my PCP about 6 days later and he released me from blood thinners, which they gave me at the ER. He said to let pain be my guide. My leg still swells up a little bit.
Very fatigued, body soreness, vertigo, headache, and extremely nauseous.
Lingering pain in the arm; on the 4th night, unable to sleep because of the heat in the arm, itchiness, and tender to the touch.  Have raised blotches under my belly button area all across my stomach and it is itchy.
This spontaneous report as received from a nurse practitioner refers to a 45 year old female patient. In 2012, the patient lost 160 pounds. None concurrent conditions were not provided. On 21-OCT-2014, the patient was vaccinated with a dose of M-M-R II subcutaneous in the upper left arm, 0.5 ml, lot # K005175, expiry date 10-APR-2016. None concomitant medication was reported. On 21-OCT-2014, the patient experienced some tenderness at her injection site of the posterior aspect of the left upper arm since she received her dose of M-M-R II. On Friday, 31-OCT-2014, the patient noticed that the tender area had developed "a hard ball, like a knot under the skin", and the patient sought medical attention by calling the nurse practitioner on Monday, 03-NOV-2014. The patient was examined by the nurse practitioner who describes "the knot" as large-sized and hard. The reporter stated that the patient had some excess adipose tissue beneath her skin. The patient reported that the knot "was not obvious", but the patient developed a fever between 99 degrees F to 101 degrees F on Monday and Tuesday 03-NOV-2014 and 04-NOV-2014. At the time of this report, the patient was currently in the nurse practitioner's office for a follow-up examination. None lab diagnostics studies were performed. The outcome of the patient noticed that the tender area had developed "a hard ball, like a knot under the skin/the knot as large-sized and hard and a patient experienced some tenderness at her injection site was reported as not recovered. Additional information has been requested.
Patient received duplicate dose of PREVNAR 13. Had received dose previously on 11/18/15. Age of patient at time of event: 69 years. Type of Event: Extra dose.
The day after receiving vaccines, patient came to the school health suite complaining of pain in both arms. School nurse administered 650mg Acetaminophen. Patient returned after 2 hours saying that acetaminophen did not help arm pain, and was now complaining of headache. Patient dismissed from school early. Patient returned to school the following day (2days after receiving vaccines).
Pain, neuropathy in right arm after vaccination in right arm (10 days later). Diagnosed with Parsonage-Turner Syndrome.
Vomiting, tachycardia, stomach cramping, migraine, loss of bladder control, low spo2, difficulty breathing, dizziness, blurred vision, hearing reduction
refrigerator containing Ipol went down to 29.1F. After that excursion, injections administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2020SA038302, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038348, 2020SA038349, 2020SA038350, 2020SA038351, 2020SA038466, 2020SA038467, 2020SA038468, 2020SA038469, 2020SA038470, 2020SA038471, 2020SA038472, 2020SA038473 and 2020SA038474 (same reporter).  This case involves a 3 month old patient of unknown gender who received 0.5 ml first single dose of IPV (VERO) [IPOL] lot PIF541M (Expiry date 07-Dec-2020) via unknown route in the left deltoid for Prophylactic vaccination.  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), HEPATITIS B VACCINE (HEPATITIS B VACCIN), HIB VACCINE (HIB), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was an actual medication error case due to Product storage error temperature too low (Product storage error).  Patient did not have adverse event at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in 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.
Rash on forearms, the following 10/08 rash spread to chest, neck, face and back. "Tickling" sensation in throat and mild wheezing. Started taking BENADRYL. Seen by PCP on 10/11/2016 and was started on prednisone & VISTARIL at night for itching.
Body aches, cough, headache, loss of taste and smell, congestion, weakness and tired. Symptoms were pretty bad for 2-3 days and I started feeling better now they returned again yesterday and are worse than they were initially. I hadn't lost my sense of taste and smell until yesterday.  I started to take the antiviral panlavid for 3 doses and it made me really sick so i stopped it. Then the only other medication i've taken is tylenol and tessalon pearls for the cough.
Injection site pain, fatigue, headache, upset stomach, sweating, chills, lightheadedness, dizziness.
Within 20 minutes of vaccination I was wheezing and not breathing well. Over the course of several hours it got worse. I went into the doctor and my blood pressure was severely elevated and I wasn't breathing well. I had to go back 2 more times over the next 2 days for cortisone shot, breathing treatments, etc. I'm still breathing rough sometimes.
"Pt  stated pt got 1st covid vaccine Pfizer 5/19/2021 at vaccine site and pt feels lethargic and dizziness that pt said pt almost feels ""pass out"", fatigue after covid vaccination.  Noted pt has runny nose after covid vaccination. Noted no known allergies. Pt shown 2 s/sx of covid vaccine side effect after evaluations. recommended pt to call 911 or go to ED d/t evaluations of screening. Pt is educated covid vaccine side effects. Pt agreed and verbalized understanding. Pt said pt will go to nearest ED
This spontaneous report as received from a physician via a company representative refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (strength, dose, route and site of administration were unspecified). It was reported that, on an unknown date, the patient "still ended up getting shingles". The outcome of the events was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information had been requested.
patient presented to office today for c/o ear pain and noted to have right arm erythema at injection site. Redness, swelling and induration noted from top of deltoid to just above elbow. Redness extends around the patients arm. Patient was placed on a course of cephalexin to treat the reaction as well as ear infection. Redness outlined with black pen and parent to monitor for worsening sx. will call parent to f/u on status on 10/12/23
no adverse side effects; one month old patient received 2 doses of Recombivax in the hospital; This spontaneous report was received from a medical assistant and refers to an 1-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported. On 23-JUN-2020, the patient was in the hospital and received 2 doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (for both lot #, expiration date, strength, dose, site and route of administration were not provided) for prophylaxis (extra dose administered). No adverse side effect was reported.
Patient has immunization on 3/25 - was fed 30min later well about 1 hour later, patient seemed  jerky to parents and patient would jerk with slightest of touch. Patient had Temperature of 101 24 hours later. Patient given Tylenol; Temperature our office 2hr later 99.6/ Patient seen with nl exam on 3/26 except HR 160
About 5-10 minutes after the vaccines pt. became hyporesponsive and hypotonic with bradychardia <50 and shallow respirations, appeared pale with cap refill >4s. Pt immediately was brought into room and stimulated with poor response and BVM respirations with O2 given for about 1 minute. Pt's HR, respiration, color and cap refill returned to normal with improved interactivity. 911 called in the meantime and arrived about 10 minutes after initial presentation. By that time pt was doing well.
5 minutes after patient received vaccine he started to become lightheaded, dizzy, tingling in bilateral arms, pale, diaphoretic and hypotensive. Pt leaned forward out of chair and got on the floor, BP 74/46 P 52 O2 sats 96%, pt remained alert and oriented speaking in clear full sentences. Pt remained in this state for approx 20 min, symptoms started to subsided and by approx 1 hour after injection pt BP was 119/74 and all symptoms had resolved and patient was released to home care.
Severe memory problems; short term memory significantly decreased; frequent loss of thoughts and events which are recent; unable to recall significant information; must write thoughts or tasks down immediately to remember the majority of items to be accomplished. Symptoms have mildly increased after continued Anthrax series. Physician recommended completion of this form.
Pt was "dizzy" after vaccination, felt better after approx 1/2 hour. Also felt "tingling" in feet. Approx 2 hours after shot, stated that "eyes were hurting", she needed to blink a lot and was sensitive to the light. By 4 PM, c/o being very weak. This weakness continued through next day. By 3 AM c/o diarrhea and frontal and temporal headache. Next day 9/18/03 c/o sore joints (wrists and elbows).
The patient presented to Emergency Department with lethargy, confusion, and hypoxia. Upon presentation to the ED, the patient tested positive for COVID-19 (04/29/21). The patient is currently being treated with dexamethasone and remdesivir.