chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 24-MAY-2016 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # L041626, expiration date: 20-APR-2017, dose was unknown) which was improperly stored (42.3 Fahrenheit (F) for 2 hours 15 minutes). No adverse events were reported. Previous temperature was not excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Developed Tinnitus in the left ear , this condition happened after more than a year or so.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 25-NOV-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 32F (0 Celsius) for 104 hours; also there were reported temperature of 48F (8.8 degree C). The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
2nd dose three weeks after the 1st; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised. Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was a pharmacist, who was calling on behalf of a colleague from a different facility who had an instance where an immunocompromised patient received second dose of Shingrix series three weeks after receiving the first dose, which led to shortening of vaccinations schedule.  The pharmacist did not have any further patient information, dosing dates, or lot number or expiration date information.  The reporter consented to follow up. The health care professional gave permission for follow-up and states she would try to find out patient and dosing information.
Approximately 3 minutes after walking to lobby with parents after receiving PCV 13 Vaccination Child had seizure like event with loss of consciousness, spasms and jerking of body and extremities. No loss of bowel or bladder. Father witnessed and picked child up before she fell and told the desk clerk "help, she is having a seizure" and the clerk called a code.  Two RN's responded, oxygen was placed on child via mask and child carried to exam table and placed on left side in rescue position with parents at child's side.  Brachial pulse obtained at 110 with 14 respirations.  Child is pale and lethargic, but is responding and "seizure" activity lasted less than one minute.  Parents refuse ambulance to be called.  Child was alert and whimpering and talking with mother within 15 minutes of event occurring.  Medical Director for PHD notified.  Parents advised to seek immediate emergency treatment if "seizure" occurs again before seeing PCP in the morning.  Referral faxed to PCP.
Breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of BREAST FEEDING (Breast feeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No medical history was provided by reporter.  No concomitant medication reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced BREAST FEEDING (Breast feeding). At the time of the report, BREAST FEEDING (Breast feeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pain, swelling, redness (mottling) from deltoid to bicep region.  Could not lift my arm by itself.  Ibuprofen 600 mg tid, cold compresses.  Duration is to present and taking gabapentin 100mg tid.  CONTINUAL TREATMENT TO DATE
developing a rash from head to toe noted as "welts the size of a half-dollar."; developing a rash from head to toe noted as "welts the size of a half-dollar."; This is a spontaneous report from a contactable consumer. A 24-year-old female patient (reporter's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), dose 1 via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's mother informed that her daughter received the first Pfizer COVID vaccine dose on 22Apr2021 and 4 days (26Apr2021) after the vaccine dose, the patient started developing a rash from head to toe noted as "welts the size of a half-dollar". The reporter informed that her daughter was supposed to get the second dose of the vaccine yesterday 13May2021, but the pharmacist did not want to give it to her without consulting with Pfizer first. The reporter wanted to know if her daughter could get the second dose of the vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PT. reports developing "hive-like" lumps along jaw line several hours after receiving injection. Outbreak was bilateral, whitish in color and non-itchy. Continues unchanged x 22 days.
Pt received first dose Moderna (Lot 038C21A) on 01 SEP 2021 (Left Arm via IM). Pt returned and accidentally given Pfizer as a second shot, instead of Moderna, on 19 OCT 2021. Pt was observed for 30 minutes after the second injection, at which time he did not develop any adverse reactions.
11/1 At work experiencing numbness of finger & toes didn't go to clinic. 11/6 Went to ER doctor d/c home. 11/8 Admitted to hospital. 11/10 Transferred to ICU bilat. paralysis below waist. Returned to work 1/3/2012.
On October 02, 2021 I was cooking in my kitchen and had chest pain. It was so bad that I sat down and  my husband called 911. Was transported to local Hospital by ambulance and from there I was flown to another Hospital for a  Non stem Heart attack with a SCAD of a LAD.
burning or discomfort in lungs; discomfort in throat; discomfort in nose; eye discomfort; coughing; trouble breathing; trouble talking; sweating profusely; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 24May2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included diphenhydramine, paracetamol, phenylpropanolamine hydrochloride (BENADRYL) and cannabidiol (MANUFACTURER UNKNOWN); both for unspecified indication and unknown start date. On 24May2021, approximately an hour after the shot, patient was driving home and suddenly experienced horrible burning/discomfort in lungs, throat, nose, and eyes. He started coughing and had trouble breathing/talking. He also started sweating profusely. He managed to drive himself to the hospital where he let the symptoms subside over the next hour. It felt like he had inhaled tear gas. He stated he never experienced anything like it before in his life. Within a few hours of the initial experience, he felt perfectly fine. Even the next day he had zero symptoms. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome for the events chest burning/discomfort in lungs, throat discomfort, discomfort in nose, eye discomfort, coughing, trouble breathing/talking and sweating profusely were recovered on 24May2021.   No follow-up attempts are needed. No further information is expected.
Patient with hx of bronchogenic carcinoma presented to ED at Hospital with SOB and feeling feverish.  During transport the patient was placed on oxygen.  Patient was admitted to hospital for respiratory failure; found to have progressive small cell lung cancer as well as post obstructive versus Covid-19 PNA.  He was oxygen replacement for illness, and completed 7 day course of ceftriazone and doxycycline.  Patient was also in Afib with RVR and converted with IV Bblocker.  On 02/18/2022 patient had sudden cardiopulmonary arrest and code blue was called, and patient expired on 02/18/2022.
In 2 hrs, right side of tongue swelled to roof of mouth, reddish purple and very sore and was reversed with antihistamine in 2.5 hrs.
Had a pretty strong reaction for about 4 days: fever and chills, very sore and hot arm, fatigue.
Faint, hot flashes, could not stand up without feeling ill.  Advised Health Department, No treatment from Health Department, advised other workers felt the same after injection.
On 7/20/22 sudden mild fever, muscle and joint pain,  chills, headache.  Resolved in 36 hours. Then on 8/3/22 the same symptoms occurred and was advised to go to urgent care,   Physicians assistant prescribed Deoxycycline antibiotic and blood test for Lyme disease as I had been hiking and found a tick in my home.  Tick was not engorged and I had no indication it had attached to my skin.  The blood  test I was told came back negative.
Patient received anthrax vaccine no. 6 SC in his left deltoid region on 10/27/04. On 10/28/04, he felt a burning/itching sensation at his site and noted a small knot at the vaccine site on 10/29/04. On 10/29/04, his main complaint is itching at site. He has had no toher pruritic lesions on his body. He denies any new onset systemic symptoms following vaccine receipt (fever, chills, body aches, headaches, congestion, swelling or itching of throat, lips or tongue, respiratory difficulty). He does not recall similar nodules at previous anthrax vaccine sites. He also reported left shoulder pain with onset around 31OCT and lasted about 1 week later.
10 x 8cm area of erythema/tenderness (L) deltoid area (-) fever. Located above the area the injections were given.
I began to see flashes in both eyes early October 2022 which began going away a couple weeks into October 2022. In place of the flashes I began to develop grey spots that occlude central vision partially. I still have this issue as of typing this.
Pain on the injection site one day after the injection; Swelling of lymph node below the left axilla
shingles, vaccine made it less severe/suspected vaccination failure; kidney stone; shingles on face and mouth; Kindney stone pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), renal stone (serious criteria GSK medically significant), shingles and renal colic. On an unknown date, the outcome of the vaccination failure, renal stone and renal colic were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, renal stone, shingles and renal colic to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient had the shingles vaccine and it might have made shingles less severe for him/her. The patient just recovered from shingles on his/her face and mouth. A place that didn't require clothes rubbing against shingles. Personally he/she thought pain from a kidney stone was worse. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. The patient's concurrent conditions and medical history were not mentioned. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dose, route and lot# not reported) for prevention against shingles. Concomitant therapy was not reported. The pharmacist reported that on an unknown date the patient developed a "blistering wound" on an unspecified part of his body and unspecified time after receiving a dose of ZOSTAVAX. The patient sought for medical attention by informing the pharmacist on an unspecified date. The outcome of wound complication was unknown. Causality statement was not provided by the reporter. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the two reports received from the same reporter.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated with her three doses series of GARDASIL intramuscularly on 20-NOV-2008, 22-MAY-2009 and 31-JUL-2009. No adverse effect reported. Additional information has been requested.
Mild headache staring at 6 pm 2-25-2021 followed by extreme headache at 8 pm with fever and chills and uncontrollably shaking. Disorientated and almost lost conciseness. Slept that night and Friday 26th, unusually tired. Did not seek medical help.
Sneezing bout  of 10-15 minutes following injection. Fine until after dinner when I felt a liqiud  draining in my right nostril. I suspected it to be mucous but was surprised when I wiped and blew my nose, red blood was on the tissue. It stopped  bleeding and no longer bled. No other symptoms occurred. The injection site was tender but no erythema. I have not had an episode of epistaxis in over a year.  Will be given 2nd dose on Teusday 3/16,21.
He has been having nausea since the day after he received his first Covid 12/23/2021. He still has nausea but started getting better on 1/10. No other symptoms noted. Mom states that he is eating and drinking okay and his nausea is usually worse in the morning before eating.  nurse spoke with PCP and nausea care in child.
Originally I only had a very sore arm.  On Friday afternoon, shortly after  getting off work my vertigo symptoms started - Bumping into doors and missing the countertop when trying to sit things down. By Saturday morning it was full blown Vertigo with dizziness and headache and severe ear pain. This continues to be a problem today.  Today is the first day of work I have missed with this and the symptoms have progressed so much that I can not drive at all and I can't walk in a straight line. I've had vertigo about 5 times in the lasat 10 years, but never this long or like this.
Ringing and popping in ears.  Balance problems.  Began first evening and continuing next day.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-MAY-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX, lot # K015308 with expiry date on 17-DEC-2015, (dose, strength and anatomical site were not reported). No adverse events were reported and no product quality complaint was involved. Additional information has been requested.
Received Hep A #2 at approximately 2pm then had fever approximately 2 hrs later & febrile seizure about 6 hrs later, seen at local ER with normal CBC, CXR, neg RSV & influenza.
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 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 28Feb2022 as dose 2, single (Lot number: FJ8757) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "Depression" (unspecified if ongoing); "known allergies: Eggs" (unspecified if ongoing); "Pain" (unspecified if ongoing); "Cough" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Sleep aid" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL taken for attention deficit hyperactivity disorder, start date: Aug2007; ZOLPIDEM taken for sleep disorder, start date: Aug2007; ZINC, start date: 31Jul2022; VITAMIN D3, start date: 31Jul2022; VITAMIN C [ASCORBIC ACID], start date: Jun2022; FAMOTIDINE, start date: Jan2020; PROMETHAZINE taken for cough, start date: 01Aug2022, stop date: 04Aug2022; TYLENOL taken for pain, start date: May2022; BUPROPION taken for depression, start date: Aug2007. Past drug history included: Hydrocodone, reaction(s): "known allergies: Hydrocodone"; Z pak, reaction(s): "known allergies: Zpak". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: took another at home test and it just came up positive; (31Jul2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
passed away-heart attack; This is a spontaneous report from a contactable consumer, the daughter of the patient from a Pfizer Sponsored program Pfizer First Connect.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 19Jan2021 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 24Jan2021, the patient passed away due to a heart attack.  It was not reported if an autopsy was performed.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away-heart attack
pt recv vax 10JUN97 & 16JUN97 devel a gen varicella-like rash, fever & sl stiffness of the neck;pt recovered from sx;
FIVE MINUTES AFTER RECEIVING VACCINATION, PATIENT FELT DIZZY AND PASSED OUT FOR APPROXIMATELY 30 SECONDS. NO NAUSEA OR VOMITING. PATIENT WAS MONITORED FOR 30 MINUTES AFTER INCIDENT BEFORE SHE LEFT THE PHARMACY.
No Additional AEs; that RECOMBIVAX HB was administered to 1 patient following temperature excursion.; This spontaneous report was received from physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-FEB-2023, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1 dose, lot #W011618, expiration date: 10-APR-2024, administered for prophylaxis (strength, and route of administration were not provided) (product storage error).  Administered dose of vaccine experienced the temperature excursion of 55.7 degrees Fahrenheit for 3 hours 10 minutes. There was no previous temperature excursion. There was no adverse event reported.
I had diarrhea Jan 2nd, low grade fever and just not feeling well, achy. I did a covid home test 1/3/22 it was negative. 1/5/22 early that morning 4AM my temp went up to 106 and I had my daughter take me to the ED. I saw dr. and they started an IV, drew blood, gave me Tylenol, 3 liters of fluid, septic workout. Next morning Thursday around 4/5am I had rapid heart rate and pressure and reported it to the ER staff. They did an EKG and found I was in atrial fibrillation that lasted half an hour. They moved me upstairs to a room. Cardiologist started me on Xarelto. Sunday I had wheezing with difficulty breathing and 92 o2. I saw pulmonologist while in the hospital and have follow-up. I was discharged Wed 1/12/22.
Patient called our COVID hotline number and states she was fine for the first 3 days after the booster dose but then on the 3rd day she started having arm pain, shoulder pain and wrist pain.  Patient did say she did some yard work the day before but her  other arm is not bothering her.  States there is not redness or swelling at injection site. Had her vaccine on 10/4/21 and today is 10/18/21.  States she was up last night with pain in her arm.   Referred to call her Primary care doctor for follow-up.
Received Covid-19 vaccination 01/06/2021. Starting on 01/11/201, developed redness, swelling, and soreness to the site.  Seen in clinic on 1/14/21. 8x8 cm red, raised, swollen and warm area to LT lower deltoid. DX: cellulitis.  Started on Duricef.  Elevate arm, apply warm compresses.  Return in one week for re-evaluation.
This case was reported by a physician via sales rep and described the occurrence of sleep restless in a infant patient who received ROTARIX. On 8th September 2015, the patient received ROTARIX. On 8th September 2015, several hours after receiving ROTARIX, the patient experienced sleep restless and inappropriate route of vaccination. On an unknown date, the outcome of the sleep restless and inappropriate route of vaccination were unknown. It was unknown if the reporter considered the sleep restless to be related to ROTARIX. Additional details were received as follows: The patient accidentally received the ROTARIX by injectable route instead of oral, leading to inappropriate route of vaccination. The reporter stated that, he was not sure what type of injection the patient received but it was not given orally. The day of vaccination, the patient had a restless nights sleep.
ALLERGIC REACTION IN BOTH EYES, ALLOVER RASH, WEAKNESS, NAUSEA, HEADACHE AND SWELLING.
Redness and swelling at injection site day after vaccination and again about 10-11 days afterward.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient received the first 2 doses in the GARDASIL (dose, route not reported) series on unspecified dates in 2008, and then received the 3rd dose (dose, route not reported) on 04-APR-2013. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.