chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no AE occurred; VAQTA inadvertently administered to a 10 and a half month old patient; This spontaneous report as received from a nurse referring to a 10 month old patient. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.     On 11-AUG-2021, the patient was inadvertently administered hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, lot # T037788, expiring on 30-APR-2022, for prophylaxis (dose, route and site of administration were not reported) too early, at 10 and a half month of age (product administered to patient of inappropriate age).  No adverse events occurred. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T037788; expirationdate: 30-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
There was not an adverse event.  The patient came in asking for pneumovax 23, but Shingrix was mistakenly given in its place.  The patient has already had both recommended doses of Shingrix previously on 11/12/19 and 2/26/20.  So, this dose was her third dose of the vaccine.
Extreme Nausea, Leg aches, fever, chills, Fatigue and weakness, extreme headache, vomiting, fainting, pressure in head, bleeding/nosebleed, cough and congestion
only hurt if i pressed on the exact spot the needle went in for the second dose; This is a spontaneous report from a contactable other-HCP (patient herself). A 33-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in arm on 28Jan2021 10:15 as 2nd dose, single dose for COVID-19 immunization. Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was 33-years-old and was not pregnant at the time of vaccination. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 07Jan2021 as 1st dose, single dose for COVID-19 immunization. Patient did not had any side effects after the second dose, the injection sight barely hurt and her arm was killing her for 2 days after the first dose, but only hurt if she pressed on the exact spot the needle went in for the second dose on an unspecified date in 2021. She questioned, was it normal to have zero side effects for the second dose. She read all these people having effects with second dose, and she was perfectly fine which made her worried maybe she was injected with a bad batch of the vaccine.   Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. Patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (dose and route not reported, lot # M006139 and expiration date 13-MAY-2017). The vaccines were exposed to 46.9F for 1 hour and 15 minutes. No previous temperature excursion was reported. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
No issues before shot, 2 weeks later after shot, voice went hoarse, voice was lost, muscles in throat and around voice box became swollen/ tense. Muscles in neck would not relax.  After visiting multiple doctors, it was confirmed I did not have any sickness, or infection. Vaccine caused Muscle Tension Dysphonia. Issue is still not resolved, issue is still ongoing. Has made me lose time at work, multiple trips to specialists, physical therapy and voice therapy.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative who reported the same events for two different patients. This is the first of two reports. A male patient of unspecified age and ethnicity received TRUMENBA in May2016, at 0.5 ml, single. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced red spot on the arm that was large, visible, tender to the touch and very painful and rashes, all in May2016. Red spot was really big and it was like covering up whole top half of the arm where they were injected. The events lasted approximately for 5 days. The reporting nurse believed that red spots were due to the vaccine, as developed after being vaccinated.
approximately 15 minutes following administration of vaccine patient notice throat " feeling funny" and her voice was raspy sounding. Neither symptoms was present prior to receiving the vaccine.  Patient was examined by physician, put on continuous SpO2 monitor and directly observed by an RN for 30 minutes. Patient was also given Diphenhydramine 50 mg orally.  No additional symptoms developed. Patietn was bale to be discharged to home with instructions to monitor symptoms and report to clinic as needed.
experiencing bronchitis; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date: unknown) via an unspecified route of administration on 27Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced experiencing bronchitis. She had an appointment for the second dose; however, she experienced bronchitis and her doctor said she needs to cancel the second dose and had it rescheduled for at least 1 or 2 weeks. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Painful, reddened and hard at injection site. Fever 102.3, chills, aches. General not feeling well.
This case was reported by a healthcare professional and described the occurrence of injection site reaction in a 4-year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On 6 April 2006 the subject received his 5th injection of Infanrix (lot number AC14A006BA, expiration August 2006) at a dose of 0.5 ml in the left arm. On 7 April 2006, at 1:00 in the morning, 11 hours after vaccination with Infanrix, the subject awoke with a localized reaction to the Infanrix injection, which included swelling at the injection site, injection site pain, heat at the injection site (hot to the touch) and excessive crying (crying more than usual). The symptoms were resolved at the time of reporting. The nurse advised the subject's mother to apply cold compress and to use Tylenol as treatment of the symptoms. The healthcare professional considered the events were probably related to vaccination with Infanrix. No additional information was reported regarding this event. Dates and times of previous Infanrix injections were not reported.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. 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) dose was not reported, frequency 1 (total) administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected immunological vaccine failure. On an unspecified date he underwent an Antibody test  which was Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210637986. This report was associated with product quality complaint: 90000183547; Sender's Comments: V0:20210637750-COVID-19 VACCINE AD26.COV2.S-SUSPECTED IMMUNOLOGICAL VACCINE FAILURE. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Patient felt very week, could not walk, had to sit down, was sweating. Breathing was normal. called  911, who reported normal oxygenation, pulse, pressure was 140/90. Patient refused to go with ambulance
Initial report received from another manufacturer (document number 45214356), who received the report from a health care professional.  A female patient (age not reported) with a history of penicillin allergy, had received an influenza vaccine (manufacturer, lot number, route and site of administration not reported) on an unspecified date in 2004 and an unspecified amount of time later, she developed angioedema and neuropathy.  No further information was provided at the time of the report.  Documents held by sender:  None.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing), notes: known allergies Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Body aches, headache, fatigue Sat ? Sunday.  Resolved by Sunday afternoon.
9/17/21: Patient arrived at the ER due to acute onset SOB the morning of presentation. She reports feeling well the day prior. Notes she stopped taking warfarin 2 days ago.  In the ED she was tachypneic, tachycardia, INR >13, BG 500, pH of 7.22, Bicarb of 5, K of 6.1, WBC 20, Cr 1.21 (baseline 1.1), LA 4.1, BHBT elevated. CXR showed diffuse b/l infiltrates. She was started on glucommander, and sepsis protocol for HCAP and placed on NC.  Upon arrival to the ICU pt was placed on BiPAP due to resp distress without improvement and was subsequently intubated shortly after arrival. In addition Kcentra was initally ordered for elevated INR 2/2 warfarin. 9.29 :  She is still on ventilator support.  FiO2 of 40%.  Good urine output.  She has been placed on IV antibiotics.  Chest x-ray is been improving.  Sodium level is high at 153 mEq per L.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 20-DEC-2017, the patient was vaccinated with improperly stored dose of ZOSTAVAX lot number reported as N025701, expiration date reported as 16-DEC-2018 (dose, route and siute of administration were not reported) for prophylaxis. The sterile diluent (manufacturer unknown) was stored properly. The vaccine underwent a temperature excursion of 15 to 46 degrees Fahrenheit. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA014306:
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021621A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was in 2020 and the estimated date of delivery was 14-Aug-2021. On 09-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable No concomitant medication were reported No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: pregnancy report received on 12-APR-2021.
Mother reported Pain injection site 45 min after HBV given. Swelling, redness site within several hours. Extreme fatigue 3-4 hrs later, slept 12 hrs. Small red rash right upper arm - 24 hrs after inj. Mother gave ASA 325mg (and was counseled about Reyes syndrome risk). 11/18/05 PGM state fine
I contracted influenza B and covid. Diagnosis was made on January 4th, 2021.
DIARRHEA; This spontaneous report received from a patient via a company representative via social media concerned a 78 year old of unspecified 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, and batch number were not reported) 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 patient experienced diarrhea. Treatment medications (dates unspecified) included: silver. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea. This report was non-serious.
- Muscle pain around the inoculation area; - About 12 hours after the shot, my stomach started feeling upset then I threw up. The vomiting happened about half a dozen times over a period of roughly 2 hours. For the reset of the evening, I was feeling feverish and did not sleep well, if at all. Feeling exhausted in the morning. Had to skip work to get some rest.
injection dates: 3/30/21, 5/4/21, 11/6/21, 3/31/22 10 days ago new onset right hemifacial pain. Seen by PCP and found to not have an inner ear infection per scope but the ear canal was sensitive and placed on a course of Augmentin. No improvement noted. The right temporal head regions is sensitive to the touch. He has some moderate to severe shooting pain deep within the ear that can shoot into the V1 distribution. Duration is about 5 seconds and frequency is several times per day. No change in severity/frequency since onset. Swallowing can be a trigger but nothing else has been noted. No vision changes. No dental pain. MRI showed advanced global atrophy but no nothing to explain the face pain
Headache; Joint pain; Extreme fatigue; Chills; This is spontaneous report from non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 13:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included eczema, idiopathic intracranial hypertension and asthma. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), diphenhydramine hydrochloride (BENADRYL), furosemide (LASIX) and levocetirizine dihydrochloride (XYZAL) for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 17:45, the patient had experienced headache, joint pain, extreme fatigue and chills. Adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events headache, joint pain, extreme fatigue and chills was resolving at the time of report.  Information about lot/batch number cannot be obtained. No further information is expected.
This infant had no fever. 4 days of irritability, inconsolable, sleep loss, and emesis.
Arm pain and heart arryhthmia started the night of vaccination.  Has had arrythmia in the past.  She called cardiologist who said to come in if arrhythmia persists.  Felt better when I called on 3/30/19.  She did not go to cardiologist.
Pt recvd Engerix-B MAY90, JUN90, & OCT90; Titers performed JUN91, revealed pt was a non responder; tx will give booster dose;
Patient incorrectly received the orig. Pfizer vaccine. Patient's intended vaccine---Pfizer Bi-valent!!! Again, incorrectly received the orig. Pfzier and NOT the intended vaccine--Pfizer Bivalent!!
pt recv vax 1AUG96 & 21NOV97 pt devel chickenpox;pt had numerous lesions;
mild stroke; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as vaccine. Medical history and concomitant medications were not reported. On an unspecified date, the patient had a mild stroke after the 1st vaccine and she's asking if she could go early to facility for the second dose. The outcome of the event was unknown.  Information about lot/batch number has been requested.
3:11PM PT. GOT FIRST DOSE MODERNA VACCINE  3:15 WHILE WALKING TO OBSERVATION AREA PT. STATED"I FELT DIZZY AND MIGHT FALL.LVN HELD PT. AND WITH PT.APLLE JUICE GIVEN.PT. STATED TONGUE FELT NUMB BEFORE TAKING APPLE JUICE.PT.ALERT ORIENTED MOVING ALL EXTREMITIES.TEAM ALERT CALLED. 3:20 PM V/S B/P 141/97 HR=101 R=20 PT. REFUSED EPI IM.OBTAINED VERBAL ORDER FROM DR. BENADRYL 25MG ORAL TO GIVEN NOW. LVN GAVE MEDICATION. 3:31 EMS AND FIRE ARRIVED REPORT GIVEN TO PARAMEDIC.PT. REMAINS A/O NAD.PT.
The patient received 0.25ml fluzone quadrivalent; swelling that could blister over the size of her palm at the deltoid injection site; swelling that could blister over the size of her palm at the deltoid injection site; Initial information was received on 01-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a female patient (age unspecified) who had a swelling that could blister over the size of her palm at the deltoid injection site (swelling and vaccination site reaction) after she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The past vaccination included 0.25 mL dose of  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] in the deltoid not specified (NOS) for prophylactic vaccination (assumedly 10 years ago) and the patient had swelling that could blister over the size of her palm at the deltoid injection site (swelling) after vaccination.  Medical treatments, concomitant medications and family history were not provided.   On an unknown date, the patient received a 0.25 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiry date not reported) via an unknown route in the deltoid not specified (NOS) for prophylactic vaccination.  On 01-Oct-2020, the patient developed a non-serious swelling that could blister over the size of her palm at the deltoid injection site (swelling and vaccination site reaction) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  She has not had a flu shot in 10 years because she had the same reaction with her last Fluzone Quadrivalent in past and was remembering it now.   It was a case of vaccine underdose as the patient received 0.25 mL dose of Fluzone Quadrivalent (latency same day).  The patient questioned if Fluzone Quadrivalent-No Preservative, Fluzone Quadrivalent-Trivalent, and Flublok contains Formaldehyde and asked which flu vaccine was indicated for patient's over 65 years of age.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment for swelling and vaccination site reaction.  At the time of report, the outcome of swelling and vaccination site reaction was unknown.  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 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.  There will be no information available on the batch number for this case.
At 1225pm patient sat down for 30 minute observation post Pfizer vaccination #1. Pt c/o fast heart rate. BP 125/113. P 147. O2 sat 100%. Pt breathing rapid and shallow. C/o anxiousness. EMS at side of patient assessing. AT 1235pm BP 142/106, P 134 02 100sat . EMS calling Truck. 1240 Pt escorted by EMS via wheelchair to ambulance to be transported to hospital for evaluation.