chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received an extra dose (first dose 1/29/21, next dose on 6/2/21) in error, with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Global Medical Information (GMI) inbound (reference number-00643752) and transmitted to Sanofi on 16-Jun-2021.  This case involves a patient (demographics not provided) who received a first dose (dose 1) of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination on 29-JAN-2021 and received next dose of suspect  DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: C5631AA and expiry date: 27-NOV-2021) via unknown route in unknown administration site for prophylactic vaccination on 02-JUN-2021 in error (Extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was case of actual medication error due to extra dose administered.  The reporter wanted to know are there any concerns or need for a repeat dosage or any additional monitoring is needed.  At, the time of reporting no adverse event is reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Information has been received from a registered nurse concerning a 21 year old female with sulfonamide allergy and no medical history reported, who on 03-SEP-2008 was vaccinated with the first dose of GARDASIL (Lot # 660612/0229X), 0.5 mL, into the left deltoid. There was no concomitant medication. On 09-SEP-2008, the patient called the physician with complaint of hives on face. The patient was treated with over the counter oral BENADRYL. The patient's outcome was not reported. Additional information has been requested.
Mother reports that child awoke that morning with "hives all over", describes as red and raised and large, as in some areas measure approximately 2 inches by 1 inch to the belly, diaper area, on the back and head and in the hair. No fever and maybe a little fussy. Went to an urgent care and was told likely not the vaccines causing the rash 2 days after, but could not be fore sure. Child was given a large dose of Benadryl and prescribed Prednisone and monitor for three days.
Red rash around injection site. Patient experienced a 2-inch rash around injection site following her first injection, within 1-2 days. It resolved on its own within a week. Parents did not report that, and forgot to mention this during second injection. Second injection was given into same arm as first. Post-second injection, patient has a 3-inch long red rash (from injection site, towards elbow; 1 inch wide) by Day 2. This has not been reported to patient's doctor yet.
Cranial nerve palsy (Third cranial nerve-oculomotor nerve palsy with pupil sparing)
1133  patient had been observed in clinic for 15 minutes and released.  She developed rash on face which became itchy.  Rash spread rapidly to arms  and patient began to breathe more rapidly than before.  Was concerned regarding her history of asthma.  Spo2 98% HR133  on RA.  BP 229/146.  She continued to have itchy rash and trouble breathing.  Was unable to treat with epinephrine due to BP.  ACLS unit activated and patient was transported to the ER with paramedic.
expired dose of Boostrix was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 67-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2ZF9N, expiry date 24-SEP-2023) for prophylaxis.   On 29-SEP-2023, the patient received Boostrix. On 29-SEP-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: expired dose of Boostrix was administered to a patient).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 29-SEP-2023 The reporter called to report that an expired dose of Boostrix was administered to a patient, which led to expired vaccine used. The reporter consented to follow up.
9/24/21-presents with congestion, body aches, ear pain, and headache that started on Wednesday. Loss of taste/smell started yesterday. She denies any sick contacts. She is fully vaccinated for covid. She has not had fever. She is not taking any medications for symptoms.  Review of Systems  Constitutional: Negative for chills, fever and malaise/fatigue.  HENT: Positive for congestion, ear pain and sore throat.   Respiratory: Positive for cough. Negative for sputum production, shortness of breath and wheezing.   Cardiovascular: Negative for chest pain and palpitations.  Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting.  Musculoskeletal: Positive for myalgias.  Neurological: Positive for headaches. Negative for dizziness and weakness.  Physical Exam  Constitutional: She is oriented to person, place, and time. She appears well-developed and well-nourished.  HENT:  Head: Normocephalic and atraumatic.  Right Ear: Tympanic membrane and external ear normal.  Left Ear: Tympanic membrane and external ear normal.  Nose: Mucosal edema and rhinorrhea present. Right sinus exhibits no maxillary sinus tenderness and no frontal sinus tenderness. Left sinus exhibits no maxillary sinus tenderness and no frontal sinus tenderness.  Mouth/Throat: Uvula is midline, oropharynx is clear and moist and mucous membranes are normal.  Eyes: Pupils are equal, round, and reactive to light.  Neck: Normal range of motion and full passive range of motion without pain. Neck supple.  Cardiovascular: Normal rate, regular rhythm, S1 normal, S2 normal, normal heart sounds, intact distal pulses and normal pulses.  Pulmonary/Chest: Effort normal. No accessory muscle usage. No tachypnea. No respiratory distress. She has rhonchi.  Abdominal: Soft. Bowel sounds are normal.  Musculoskeletal: Normal range of motion.  Lymphadenopathy:       Head (right side): No submental, no submandibular and no tonsillar adenopathy present.       Head (left side): No submental, no submandibular and no tonsillar adenopathy present.    She has no cervical adenopathy.  Neurological: She is alert and oriented to person, place, and time. She has normal reflexes.  Skin: Skin is warm and dry.  Take Tylenol/Ibuprofen as needed for body aches/fever/malaise. Drink plenty of fluids. Increase your intake of Vitamin C. Go to the Emergency room for any shortness of breath or difficulty breathing. Follow CDC guidelines for quarantine.
BODY ACHE; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced body ache. On 16-MAR-2021, the subject experienced tiredness. On 16-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, tiredness, and headache. This report was non-serious.
Approximately 12-18 hours after receiving the 1st dose, I developed a minor skin rash on arms and legs. within 24 hours the rash became itchy with no relief.  72 hour began taking Antihstamine 25 mg every 4-6 hours and using  Diphenhydramin hyroclhoride !% cream.  No breathing or swallowing problems have been noticed.
This spontaneous report was received from a medical assistant regarding a 4 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 02-AUG-2017, the 4-month old patient was vaccinated with first dose of ROTATEQ (dose, route, lot# and expiration date unknown) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported.
1in x 1in red rash developed on 11/25/21. She reports no further symptoms other than the discoloration.
Infant experienced increased apnea, bradycardia, and desaturation requiring increased respiratory support.
Immediately after injection there was bleeding which was stopped by applying pressure and lifting the patient's arm. After bleeding stopped there was swelling around injection site and welt formed. Ice pack was applied and patient was monitored for 15-20 minutes. Swelling and welt had started to subside so patient was sent home.
Client developed chest tightness 30 minutes after receiving vaccine but did not report it to nurse in health unit. Came to health unit 11/8/06 complain of redness, swelling, pain and itching at site of injection (left deltoid). Doctor checked site-not infected. Area cleansed with alcohol, hydrocortisone cream and cold pack applied. Client did not divulge that chest tightness was still present. She apparently took Benadryl at home 11/8 and it went away. re-checked 11/9, local reaction diminished. No more chest symptoms.
68 year-old male recently diagnosed with dementia, presents emergency department with family concerning for worsening mental status over the last 2 weeks. According to family members, patient's blood pressure has been in decline over the last 1 month in duration has been having medications discontinued due to low blood pressure. Patient was having progressive worsening lower extremity edema and then had Lasix increased. According to family members, patient's mental status yesterday has been worse. Cardiopulmonary arrest in setting of progressive decline over 1 month. Cause of death uncertain. He appears to have been in cardiogenic shock occurring in the setting of multiple organ failure including AKI and liver failure. This may have by precipitated by acute cholangitis. The cause of his neurological decline is uncertain, but may relate to his COVID-19.
Dime size red welp on left upper thigh on injection site.  Warm to the touch, painful and itchy to patient.  Following morning, 06/10/2010, injection site had grown significantly was very warm to the touch, painful and itchy.  Returned to the clinic vaccine was received.  Was told to take Benadryl every 6 hrs. and prescription medication Cephalexin.  Told to give Dr. a call in the a.m. to let her know how the whelp was looking.  The following day, 6/11/2010 whelp had grown overnight.  Called Dr. at her clinic.  She had the patient come in and get a steroid shot in the arm and start on prescription steroids the following day along with current prescription of Cephalexin.
This spontaneous report as received from a nurse via a company representative refers to a 15 months old female patient. No information on the patient's pertinent medical history and concurrent conditions was provided. The patient had no drug reactions or allergies. On an unspecified date in approximately 2013 (reported as: "approximately 4 years ago"), the patient was vaccinated with VARIVAX, 0.5 ml, once, for prevention of chickenpox (route of administration, lot# and expiry date were not reported). Concomitant therapies included PREVNAR and hepatitis A vaccine, inactivated (manufacturer unknown). On an unspecified date in approximately 2013, after getting these vaccines, the patient became lethargic. The patient's parents sought medical attention and consulted the physician. Lab diagnostic or studies were not performed. The patient recovered after 4 days (exact date was not provided). The patient's physician believed that this event occurred because of VARIVAX, because since the event occurred, the patient had received PREVNAR and hepatitis A vaccine, inactivated (manufacturer unknown) with no adverse event. Product quality complaint (PQC) was not involved. The reporting nurse did not provide her causality assessment.
Flu like symptoms; Breathing never came back to where it was before had the vaccine/breathing got a little bit worse; Breathing never came back to where it was before had the vaccine/breathing got a little bit worse; got more labored that she can't walk  across the room without being tired; got more labored that she can't walk  across the room without being tired; Caller had Severe COPD; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on 11Mar2021, as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a dose 1, single for COVID-19 immunization. On an unspecified date the patient experienced some flu like symptoms that she mentioned to resolve within a few days. Reportedly the patient stated that the reaction lasted two days after receiving the second covid dose.  She had severe COPD and she noticed that after getting vaccinated, her breathing got a little bit worse. Her breathing got more laboured that she can't walk across the room without being tired. She mentioned that it still has not resolved. She has never changed anything in her routine to have possibly caused except for the vaccine.  The patient also stated her breathing has never come back to where it was before she had the vaccine.  The patient queried have you had any other complains or anyone else that has had this problem. She went online to try and complete the report. Every time she got down to her doctor information and scrolled to choose the country, it would kick her out. Outcome of the event was recovered for the event flu like symptoms and for all other events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
VISION TROUBLE; UNCOMFORTABLE SLEEP; I THOUGHT I WAS HAVING A STROKE/FELT VERY BAD JUST ODD AND STRANGE; SMELLING SMOKE; PAIN AT THE TOP OF HER HEAD/INSTANT WORSE MIGRAINE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included: stroke. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-MAR-2021, the patient experienced pain at the top of her head/instant worse migraine. On an unspecified date, the patient experienced vision trouble, uncomfortable sleep, i thought i was having a stroke/felt very bad just odd and strange, and smelling smoke. The action taken with covid-19 vaccine was not applicable. The patient recovered from pain at the top of her head/instant worse migraine, vision trouble, uncomfortable sleep, and smelling smoke, and the outcome of i thought i was having a stroke/felt very bad just odd and strange was not reported. This report was non-serious.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 61-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FC3184), at the age of 61, on Oct 1, 2021, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient developed a rash (patient broke-out in a rash all over her body), onset Oct 2, 2021, with outcome of unknown. No therapeutic measures taken as a result of rash. Additional information: Patient stated, "I received the Pfizer the day before yesterday. I am a having a reaction. I am breaking-out in a rash all over my body. I was not taking any treatment, but I was going to go to the emergency room." No follow-up attempts possible. No further information expected.
The pharmacy was unusually busy this day since boosters had just been approved and also flu shots were just starting to be advertised and so people were now asking for them, so it was very busy with immunizations that morning. I entered the vaccine room and was engaging in small talk with patient and his spouse. I did not verbally confirm with patient which vaccine he was to receive that day. I immunized him with the Moderna vaccine and then he and his spouse left the store. Once they left the immunization room, I was finishing (filling in my name, signature, lot numbers and expiration and so on) and I saw the pre-printed vaccine information had a volume of 0.7ml instead of 0.5ml (which is the volume for Moderna). I then knew I had given the wrong vaccine; the vaccine he was supposed to receive was the Fluzone HD for patients 65+ years old. Several hours elapsed between discovering this and contacting the couple -- I was highly upset and was worried I would start crying while on the phone with them and also I was seeking advice from my RXM on how to proceed with internal error reporting and also how to explain what had happened to them. In the meantime I checked his profile and saw that this was his third dose of the Moderna and his second dose was in March. I called the patient's wife and left a voicemail with her requesting she call us back at her earliest convenience so we could discuss her and her husband's visit to the pharmacy earlier that day. Several hours later she called us back and patient was in on the call for a bit too. They expressed that they were not upset and mainly wanted to get clarification on when they could get their flu shots with respect to timing relative to the Moderna. Patient is planning on coming in later in the week to receive his flu shot and update his COVID vaccine card with his third dose information.
A subject received Tice BCG and developed a burning feeling with voiding and had a lot of pus and WBC's in urine on 09/17/2002 on the third day after the last instillation, but was afebrile.  Subject received a treatment for 6 weeks about 6 months ago and now received a second series for 3 weeks (once a week).  No antibiotics were given and the patient's symptoms have resolved.
lt arm - large 3''x2'' swollen area, painful, hard, no fever.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 05-NOV-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose,  lot # R000554 with expiration date 08-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: E2B Linked Report: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Since getting the 2nd shot I have been fatigued and have had dizzy spells.; Since getting the 2nd shot I have been fatigued and have had dizzy spells.; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0165) via an unspecified route of administration in the left arm on 10May2021 at 09:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation. Concomitant medications included flecainide (MANUFACTURER UNKNOWN)  and metoprolol (MANUFACTURER UNKNOWN); both for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0161) via an unspecified route of administration in the left arm on 21Apr2021 at 08:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14May2021, since getting the second shot the patient felt fatigued and had dizzy spells. The patient did not receive any treatment for the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the fatigued and dizzy spells was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient had severe redness on the arm which got vaccinated. He took tylenol and applied ice packs. He also stated that he had slight pain on his arm for 4 days. He had to go to his doctor and got a prescription for an antibiotic