chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of seizure in a 20-year-old female patient who received TWINRIX (batch number 3HG77, expiry date 3rd July 2020) for prophylaxis. On 29th June 2018, the patient received the 2nd dose of TWINRIX adult. On 29th June 2018, 45 sec after receiving TWINRIX adult, the patient experienced seizure (serious criteria GSK medically significant), fecal incontinence and erythematous rash. On an unknown date, the outcome of the seizure and fecal incontinence were recovered/resolved and the outcome of the erythematous rash was recovering/resolving. It was unknown if the reporter considered the seizure, fecal incontinence and erythematous rash to be related to TWINRIX adult. Additional details were provided as follows: The case was received from Office manager. The patient has no history of seizures. About 45 seconds after the TWINRIX vaccination was given, the patient went into a seizure. A bright red rash developed on bilateral, arms, face and chest. The rash dissipated as the patient came out of the seizure. When the ambulance arrived at 12:05pm to take her to the emergency room, her vitals were stable. The reporter read the notes to her but did not know what b by l stands for. She also did not know what time the vaccination was given.
Numbness to right side of upper body, arm, and face. Clammy, hot flashes, severe headache. Throat was swelling shut. Could feel it closing each time I swallowed. Emergency room gave steroids, Benadryl, and a coating for stomach.
Therapy non-responder; Overdose; Overdose; Overdose; underdose; Adult product administered to child; Adult product administered to child; Adult product administered to child; wrong vaccine administered; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 25-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis, HBV (Engerix B adult) for prophylaxis and HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B adult and the 2nd dose of Engerix B adult. On 7th December 1994, the patient received the 3rd dose of Engerix B adult. On 24th June 2019, the patient received the 4th dose of Engerix B pediatric (intramuscular) .5 ml. On an unknown date, unknown after receiving Engerix B adult, Engerix B adult and Engerix B adult and not applicable after receiving Engerix B pediatric, the patient experienced therapy non-responder, overdose, overdose, overdose, underdose, adult product administered to child, adult product administered to child, adult product administered to child and adult use of a child product. On an unknown date, the outcome of the therapy non-responder, overdose, overdose, overdose, underdose, adult product administered to child, adult product administered to child, adult product administered to child and adult use of a child product were unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B adult, Engerix B adult and Engerix B adult.  Additional details were provided as follows: The patient received Engerix B pediatric in left deltoid. She stated already had received three doses of the Engerix B adult, but after titers were obtained, the patient was found to be nonimmune and thus received the 4th dose of Engerix B pediatric, which led to underdose and Adult use of a child product. The patient was given a Engerix B pediatric vaccine instead of the Engerix B adult (1 ml) vaccine, which led to underdose and adult use of a child product.  The reporter gave consent to follow up.      Lab Comments: after titers were obtained, the patient was found to be nonimmune
Swelling and redness > 40 mm with tenderness in lymph nodes and injection area. Warm to touch.
8/11/201 PRESENTED TO ER REPORTED NAUEA, VOMITING AND DIARRHEA DX COVID POSITIVE. DISHCARGED HOME.  8/13/21 PRESENTED TO ER ADMITTED TO HOSPITAL IN PATIENT. BEGAN FEELING SHORT OF BREATH PROGRESSIVELY GETTING WORSE. DX COVID PNEUMONIA. ALSO REPORTED COUGH, DIFFUSE BODY ACHES, CHILLS. PLEURATIC CHEST PAIN, TIRED.  REQUIREING O2. 15L. BY 8/17/21 NEW ONSET OF ATRIL FIB. NOTED. 8/18/21 REQUIRING 100% NON RE BREATHER.  8/23/21 100% /40L VIA VAPOTHERM. ICU LEVEL OF CARE.  PATIENT INTUBATED ON 8/25/21. AFTER INTUBATION PATIENT WENT IN TO CARDIAC ARREST.  8/25/21 PATIENT DIED.
Patient received second vaccine one week too early.  Dose due on December 2, 2021.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. It was reported that the patient received 3 doses of GARDASIL 9 on a schedule that differed from the recommended dosage schedule. The dates of the patient's three doses were as follows: 03-MAR-2016, 10-MAY-2016, and 14-JUN-2016. No adverse effects were reported. No product quality complaint (PQC) was reported for GARDASIL 9. Additional information has been requested.
24 hours after vaccination patient noticed significant painful hives on left above elbow below vaccinated area. 48 hours after vaccination patient developed swollen lymph nodes left armpit. Lymph node pain persisted for 10 days and fully resolved in about 21 days.
No reaction 1 day after, 3/6/06 at 6:00pm, shallow breathing lasted 2 minis, nasal congestion, suction. Got stiff, eyes rolled few seconds, both arms limp. Called paramedics 6:05, came at 6:15 baby was ok when got there, take to ER vitals took, but did not stay brought her in next day.
FLUZONE HDQ administered to an 8 year old patient with no adverse event; Initial information received on 11-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and other healthcare professional via regulatory authority (under reference 00806950).  This case involves a 8-year-old patient (unknown gender) who received QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) [product administered to patient of inappropriate age].  The patient medical history, past medical treatment, vaccination, concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to Inappropriate age at vaccine administration (same day latency).  It was reported "pharmacist reports that another pharmacist administered the FLUZONE HDQ to an 8 year old and is requesting any information about it. He also asks for information regarding under 65 administered."  At the time of reporting, no adverse event was 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 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.
Urticaria no change in blood pressure, no respiratory distress. Epinephrine x 1 IM, Diphenhydramine PO x 1.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 61-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 20th April 2018 01:30, the patient received the 1st dose of SHINGRIX .5 ml. On 20th April 2018. several hours after receiving SHINGRIX, the patient experienced chills, headache and influenza. In April 2018, the outcome of the chills, headache and influenza were recovered/resolved. The reporter considered the chills, headache and influenza to be related to SHINGRIX. Additional details were provided as follows: The patient experienced adverse event in the evening of vaccination day. The patient described it as feeling like she had the flu. The symptoms were resolved by Sunday night of that week.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
pt devel fever of 104 3 1/2 hrs p/vax w/resulting dehydration; fever uncontrolled by APAP; adm to hosp for rehydration discharged p/36hrs; pt recovered; fever persisted for 36hrs; adm 6SEP; d/c 17SEP;
Redness, swelling, warmth, pain, and itching to left posterior arm, 8/19/10 BENADRYL syrup given at home 8/19/10.
plum sized, hot, hard lump on my left arm where I got the shot; plum sized, hot, hard lump on my left arm where I got the shot; It is sore if I touch it or move a certain way.; I am a little worried that this is infected, because it's starting to itch a little.; off label use; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 17:30 (Lot number: FE3590) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), administered in arm right, administration date 18Nov2021 (Batch/Lot number: unknown) as 0.5ml for immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "edema in ankles" (unspecified if ongoing); "Known allergy: Latex bandaids itch" (unspecified if ongoing), notes: Latex bandaids itch; "Known allergy: Fake gold and silver" (unspecified if ongoing), notes: Fake gold and silver. Concomitant medication(s) included: ESTRADIOL; PROGESTERONE; IRON; PRILOSEC [OMEPRAZOLE]; MELATONIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Right), administration date: 10Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Right), administration date: 13Mar2021, for COVID-19 immunization. The following information was reported: VACCINATION SITE WARMTH (non-serious), VACCINATION SITE MASS (non-serious) all with onset 22Nov2021, outcome "not recovered" and all described as "plum sized, hot, hard lump on my left arm where I got the shot"; PAIN IN EXTREMITY (non-serious) with onset 18Nov2021, outcome "not recovered", described as "It is sore if I touch it or move a certain way."; PRURITUS (non-serious) with onset 18Nov2021, outcome "not recovered", described as "I am a little worried that this is infected, because it's starting to itch a little."; OFF LABEL USE (non-serious) with onset 18Nov2021, outcome "unknown", described as "off label use"; PRODUCT USE ISSUE (non-serious) with onset 18Nov2021, outcome "unknown", described as "Product use for unapproved combination". Therapeutic measures were not taken as a result of vaccination site warmth, vaccination site mass, pain in extremity, pruritus.  Additional information: With the two previous shots, she did not have these symptoms and was a little worried that this was infected. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccine facility type was Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with the first and second dose of RECOMBIVAX (strength, dose, route and lot # not reported). It was reported that the patient was late getting third dose of RECOMBIVAX (strength, dose, route and lot # not reported), no adverse symptoms reported. This is one of the 2 reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a consumer refers to a male patient of unknown age. The patient was vaccinated with dose 1, of a dose of ZOSTAVAX (subcutaneous, lot number and dose not reported). The patient explained that after receiving ZOSTAVAX he developed a very sore spot on the top of the back of his head within a week of getting the vaccine. The patient stated that the spot was "like a hot iron the size of a silver dollar" and had intense burning and pain. The patient also developed raised scabs. The patient stated that it is really painful and difficulty to deal with. The patient was prescribed various pain killer medications (unspecified) and underwent an MRI (date and result not reported). On an unknown date the condition had returned two weeks after it disappeared with the same symptoms. The physician prescribed anti-viral medications (manufacturer unspecified). The outcome of patient developed a very sore spot on the top of the back of his head and raised scabs is unknown. The patient's treating physician thinks that this event is caused by ZOSTAVAX. Additional information has been requested.
After the vaccin, 2 days of pain at the injection site, then swelling of the lymph node under the left armpit 3 days after the vaccine. On the 4th day, a sharp pain settles between the armpit and the breast, on the 5th day, the lymphatic gland has returned to its normal size and a smaller pain still exists near the breast. Tomorrow will be the 6th day.
fever, muscle aches, sore throat, cough, headache, fatigue, nasal congestion
After receiving the vaccination, her arm started to swell at vaccination site.  By the evening of 10/14, her arm was very swollen from shoulder to elbow, with redness, itching, hot to the touch, and general malaise. Still swollen when she came to pharmacy to inform us of her reaction on 10/16.
Tested positive/covid test result=Positive; Tested positive / covid test result=Positive; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2022 12:00 (Lot number: 3302500) at the age of 64 years as dose 3 (booster), single, administered in arm left, administration date 25Mar2021 12:00 (Lot number: EP6955) as dose 2, single and administered in arm left, administration date 04Mar2021 12:00 (Lot number: EN6203) as dose 1, single for covid-19 immunisation. Relevant medical history included: "A fib" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; APIXABAN; FLECAINIDE. The following information was reported: IMMUNISATION (medically significant) with onset 11Jan2022 12:00, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant) with onset 17Jan2022, outcome "unknown", described as "Tested positive/covid test result=Positive"; COVID-19 (medically significant) with onset 17Jan2022, outcome "recovering", described as "Tested positive / covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  Clinical Course: No other vaccine in four weeks. No covid prior vaccination. Tested covid positive post vaccination  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE, IMMUNISATION, COVID 19 and the suspect drug BNT162B2.
Patient received Pfizer for his first vaccine dose, and then Moderna for his second dose, mistakenly, because he was scheduled for second dose in the afternoon but came in the morning instead, when Moderna shots were being given, and nobody noticed until afterwards.  He reports he felt quite tired for a couple days after the shot.
Instant effect of chest tightness; Palpitations; Increased HR; Dizziness; Blister like rash; excessive phlegm/mucus; excessive phlegm/mucus; Nausea; Vomitting; Diarrohea; body/joint pain; joint pain; Headache; High temperature; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0177), via an unspecified route of administration, in arm left on 27Jul2021 at 08:45 (age at vaccination 53 year) as dose 1, single for covid-19 immunisation. Medical history included non-seasonal allergies, anxiety, overweight and arthritis in multiple joints. The patient had Covid prior vaccination. No other vaccines were received in four weeks. Concomitant medications included sertraline; clonazepam (KLONOPIN); acorus calamus, bacopa monnieri, celastrus paniculatus, centella asiatica, evolvulus alsinoides, foeniculum vulgare, glycyrrhiza glabra, myristica fragrans, terminalia arjuna, withania somnifera (COGNIUM); cetirizine since an unknown date. The patient was allergic to Dilaud and Albuterol. On 27Jul2021, the patient experienced instant effect of chest tightness, palpitations, increased hr, dizziness, and several hours later blister like rash, high temperature nausea, vomiting, diarrhea, body/joint pain, severe headache and excessive phlegm/mucus. The patient underwent lab tests which included body temperature as high on 27Jul2021. The patient was tested for Covid tested post vaccination via Nasal Swab on 28Jul2021 with result as Negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events with Z PAC. FLUTICAZONE. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
One of five pt's, immunized from same vial of DTP, devel a high fever (103-104) & irritability w/in 12 hrs p/vax; Tx APAP & tepid bath; pt's also recvd HIB-TITER/OPV;
Pt states next day after injections of Flu vaccine and pneumo vac had 105 degree fever orally, did not go to ER or call provider. Each day thereafter fever decreased and local reaction at site of injection, left arm redness and swelling per patient. Pt states recovered completely. Pt stated had chills and sweating also.
Tinnitus  After an evaluation, my primary doctor gave me a steroid prescription. When that didn't work, he sent me to an ENT who put me on a strong steroid prescription (which I am in the last week of taking--no real change yet). I was also given an audio test that showed my hearing was generally in good condition.
Information was received on 15-FEB-2019 from a lawyer regarding a case in litigation regarding a male patient, history not specified. On or about 24-SEP-2012, at age 69, the patient was prescribed and administered ZOSTAVAX at a pharmacy by a pharmacist for the prevention of shingles and zoster related conditions. On an unspecified date the patient was treated by a physician at an urgent care for the following injuries resulting from ZOSTAVAX use: shingles. The outcome of shingles was not specified. Additional information has been requested.
NERVOUS; MUSCLE ACHE; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non smoker. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-SEP-2021, the patient experienced nervous. On 16-SEP-2021, the patient experienced muscle ache. On 16-SEP-2021, the patient experienced headache. On 16-SEP-2021, the patient experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from muscle ache, headache, and fatigue, and the outcome of nervous was not reported. This report was non-serious. This case, from the same reporter is linked to 20210936062.
Reported by RN school nurse. Left deltoid area red, hot to touch, edematous area measures 2 1/2"x3". She called child's mother and referred to their private doctor for evaluation.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "History of lymphoma (CHL)" (unspecified if ongoing). 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took the Paxlovid treatment from 16Aug2023 to 20Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300285829 same patient, different drug/event;