chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a  5 year old is behind in vaccination schedule described as up until now they have had three vaccinations including 2- Pediarix and 1 dose of Pentacel/No AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a five years old patient (gender unknown) is behind in vaccination schedule described as up until now they have had three vaccinations including 2- pediarix and 1 dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included two doses of DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX).  It was an actaul medication error due to inappropriate schedule of vaccine administered.  No adverse event reported.  The patient was in need for Quadracel vaccine.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of document held by sender: none.
Information has been received from a physician concerning a 13 month old healthy male infant born at 38 weeks gestation by C-section with no allergies and no past medical history who on 01/11/2002 was vaccinated with a first dose of MMR. On 01/19/2002 the infant developed fever, tonic-clonic seizures, hypoxia. He was taken to the ER, intubated and then transported to another hospital and admitted with encephalopathy. He had a nasal swab sent for culture on an unspecified date that was positive for influenza A. He was discharged from the hospital on 01/25/2002 and readmitted on 02/02/2002 for positive seizure activity,  however the inpatient work-up showed no seizure activity. He was discharged to home on 02/06/2002. The physician reported that the infant is improving. Additional info has been requested.
Patient received the incorrect vaccine for age appropriateness. Patient is 4 years and 10 months old, should have received Baby Pfizer dose of 0.2ml. However, patient received Pediatric Pfizer lot number FT1551 dose of 0.2ml.    Patient was monitored by licensed RN for 30 minutes.  No signs/symptoms of adverse reactions were noted. Patient was offered hydration and accepted. Patient was running around, verbally communicating with parent, airway patent.  Patient's parent was notified and he was not alarmed. Parent stated he knows to provide them with Tylenol if needed for discomfort or fever. Parent was educated to call if there are any issues they were concerned about.
From history and physical 12/21/21:  Patient is a 61 y.o. female with a PMH significant for ESRD on HD M/W/F, diabetes mellitus type 2, HTN, HLD, chronic hypoxic respiratory failure on 2 L home O2, history of stroke who presents to the ED due to shortness of breath.  Patient reports recent exposure to COVID-19.  She was tested positive outpatient for COVID-19 on 12/14/2021, she was asymptomatic at that time.  She reports that she began to feel poorly over the next 4-5 days.  She complains of nonproductive cough, shortness of breath, low-grade fever, diarrhea, malaise, headache, change in taste.  Today, patient reports shortness of breath not relieved with her home oxygen.  Due to difficulty breathing she came to the ED.  Patient is a small amount of urine in has current complaints of dysuria.
patient came in to get Bivalent booster and signed that he had received 2 previous vaccines, but after giving the shot, hwe realized this was his first vaccine period!
This spontaneous report as received from a medical assistant refers to a 59 year old male patient with no pertinent medical history and no drug reactions/allergies. On 04-APR-2013 the patient was vaccinated intramuscularly with ZOSTAVAX (lot # J000445, expiry date 11-APR-2014). There was no concomitant medication. The patient developed tenderness at the injection site on an unspecified date in April 2013. No treatment was given for event. No laboratory diagnostics studies were performed. The outcome of tenderness at the injection site was reported as recovered/resolved. The patient had sought medical attention (unspecified how). Additional information has been requested.
HERPES ZOSTER IN 2 DOSE VARICELLA VACCINE RECIPIENT (UNILATERAL RASH IN ONE DERMATOME, NO PAIN, LASTED LESS THAN 4 WEEKS, NO ANTIVIRAL TREATMENT).
Case received Janssen vaccine in July 2021, then was hospitalized for COvid in March 2022. Hospitalized at: Hospita.  COVID-19 Assessment & Plan Pt had covid previously, and has J & J vaccine in 7/2021. Presented with several days of diarrhea, poss subtle left peri-hilar opacity but no respiratory symptoms and on RA. - hydrated and IVF d/c - Remdesivir, 3 days per ID due to low complexity COVID, completed 3/6 - d/c Dexamethasone as no hypoxia - up to chair, supportive management, IS as able
Could be shingles according to the Dr. but they are not sure; Redness / in the eye; Swelling in the eye; Soreness in the eye; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced shingles, eye red, eye swelling and soreness in eyes. On an unknown date, the outcome of the shingles was unknown and the outcome of the eye red, eye swelling and soreness in eyes were not recovered/not resolved.   It was unknown if the reporter considered the shingles, eye red, eye swelling and soreness in eyes to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix and after that experienced redness, soreness and swelling in the eye, could be shingles according to the physician but they were not sure. The reporter consented to follow up.
Within minutes of Flu vaccine c/o itching. Referred to internal medicine given Benadryl 15mg PO, within 10 minutes c/o throat closing, difficult to breath, given Epi 0.3 ml, no relief. Was referred to ER.
seizures; soreness; extreme fatigue; injured; illness; This is a spontaneous report from a contactable consumer, the patient. This 56-year-old non-pregnant female patient the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 08Apr2021 13:30 (at the age of 56-year-old) as single dose for COVID-19 immunization. Medical history included seizure (not medicated), asthma, allergies, deprived of nightly decent sleep (from 24/7 low frequency torture by neighbor's ventilation system), and allergies: DILANTIN (phenytoin sodium), "1 other seizure drug" and sulfonamide drugs. The patient was receiving unspecified concomitant medication(s). The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 18Mar2021 13:30 (at the age of 56-year-old) as single dose for COVID-19 immunization. On 11Apr2021 00:30, the patient experienced seizure. On an unspecified date in Apr2021, she also experienced the soreness, extreme fatigue, injured and illness. The clinical course was described as follows: "I suffer from occasional seizures for which I am not medicated and I had one after midnight 2 days after the vaccination. Other symptoms were just soreness and extreme fatigue. I suspect this seizure is due to my lack of oxygen from my laying in bed the next day in this case but wanted to report it in case it matters. I normally suffer seizures very rarely and always in bed at 3 or 4 a.m. at times when I am sick or lacking sleep. This time I had my seizure in the bathroom and I am afraid I have no further information except that I likely only had one since I was missing from the bedroom for less than an hour as near as we can tell. I woke up on the floor injured and unaware of my surroundings. I have never had a seizure while awake before unless it was a second one. I have been deprived of nightly decent sleep by several neighbors for over 3 years now by a low frequency noise from a pot grow ventilation system that has caused me illness and was bad near the time of vaccination." No treatment was received for the adverse events. The clinical outcome of the seizure, soreness, extreme fatigue, injured and illness was resolving.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
VACCINE REFROZEN; REFROZEN VACCINE ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 42 year old female. 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, batch number: 212A21A, expiry: 20-MAY-2022) dose was not reported, administered on 30-NOV-2021 for prophylactic vaccination.  Age at time of vaccination 42 years old. No concomitant medications were reported. On 30-NOV-2021, the patient experienced refrozen vaccine administered to patient. On an unspecified date, the patient experienced vaccine refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the refrozen vaccine administered to patient and vaccine refrozen was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220538437, 20220538379, 20220537688, 20220537507, 20220538480, 20220537341, 20220537444, 20220538292, 20220537548, 20220538411, 20220539045, 20220538425, 20220538316, 20220538210, 20220538149, 20220538573, 20220537356, 20220537532, 20220538428, 20220538238, 20220538428, 20220538573, 20220538437, 20220538758, 20220537532 and 20220537356.
Dystonia; This is a spontaneous report from a contactable consumer (patient).   A 21-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02May2021 (Lot Number: EW0170) as single dose (at the age of 21-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Apr2021 (Lot Number: EW0151) as single dose (at the age of 21-years-old) for COVID-19 immunization. He also received the Pneumococcal vaccine in 2020 (Further clarification unknow, suspect captured as per Verbatim) for immunization and experienced swelling up of the arm and high fever. The patient experienced dystonia on 03May2021. The patient stated, "I was just trying to find out information about people having a weird side effect with the second vaccine. About a couple of months ago I was administered to the hospital, they say a weird side effect dystonia that's what they called it? Which in general was basically the body no longer responding to inputs from brain and just a causing like major weird muscular effect were similar to cramps it set up all around body so you can't step in the board and that was exact and I was waiting to see if I was going to have it again in case it wasn't the Pfizer vaccine but over the course of three months (Further clarification unknown) and for long its been and had the vaccine the second one I haven't had any effects from it. I haven't had no other signs of 'handback' (Further clarification unknown) issue so I feel like it might be the vaccine." The patient was hospitalized for dystonia from 03May2021 to 03May2021. The outcome of the event was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Chest pain for two days after 2nd vaccination. Chest pain resolved with ibuprofen.
Narrative:  Pt had received two covid vaccine EUA (J&J) on 4/2/2021 and 11/10/2021 at location. Pt died at community hospital on 9/15/2022. No information is available regarding circumstances of this death. Likely the vaccines were not the cause of this patient's death given the long length of time between date of vaccines given & date of death.
Tingling (pins and needles) in left hand, Left foot and Right hand. Occasional tingling in tongue/ Pins and needles in left calf. and left arm.; Pain behind left knee; Numb fingers left hand.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 30Mar2021 (at the age of 43-year-old) as a single dose for COVID-19 immunization. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient had tingling (pins and needles) in left hand, left foot and right hand. The patient had occasional tingling in tongue, pain behind left knee and numb fingers of left hand. The patient also had pins and needles in left calf and left arm. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling (pins and needles) in left hand, left foot and right hand, occasional tingling in tongue, pain behind left knee, numb fingers of left hand, pins and needles in left calf and left arm was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected
5X3 cm Erythema, very itchy, red and raised around injection. Lesion continued to increase in size. Rechecked 24 hour later, put on KEFLEX. 2 days later not hot, not swollen, decreased size, only slight.
New onset runs of tachycardia either SVT atrial fibrillation. Heart rate up to 165, typically 140s, 4-5 episodes. First 10/16/23. 5th episode 11/5 and associated with severe dizziness leading to an ER visit and new diagnosis of atrial fibrillation., starting diltiazem, and referral to cardiology.
A nurse reported that a 7 month old female pt received an injection of Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) vaccine and developed pneumococcal meningitis. The pt received the third dose on 19Jan04. Relevant medical history was not provided.  Indication for Prevnar was immunization. Product was administered on 19Jan04. Dose regimen was 1 dose. Concomitant medications were not reported.  Concomitant vaccines administered on 19Jan04 included the third dose of diphtheria and tetanus toxoids and pertussis (manf unk) and the third dose of haemophilus influenzae b (manf unk). On 03Mar2004, a female pt developed pneumococcal meningitis. On the same day a blood culture was performed; results were not available. The following day, she was hospitalized. A CSF culture was performed; the results were not provided. The reporter indicated that the pt survived. No additional information was available at the time of this report. See related case(s): HQWYE652709MAR04 (adverse event, expedited).
SHIVERS; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic reaction to penicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. Concomitant medications included ibuprofen. On 05-JUN-2021, the subject experienced shivers. On 05-JUN-2021, the subject experienced nausea. On 05-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shivers, and the outcome of nausea and fever was not reported. This report was non-serious.
Wheezing; Cough; Profound sleepiness; This is a spontaneous report from a contactable other healthcare professional (HCP). A 52-year-old female patient received the first dose of bnt162b2 (lot number: EK9231), intramuscular on the left arm on 24Dec2020 at 11:30 at a single dose for immunization. Medical history included HBP, asthma, radicular pain and migraines. The patient's concomitant medications were not reported. The patient previously took tetracycline and experienced drug allergy. The facility where the most recent COVID-19 vaccine was administered was at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 and has not been tested for COVID-19. On 26Dec2020 at 05:00, the patient experienced wheezing, cough and profound sleepiness, and was prescribed Proair Inhaler as treatment for the events. The outcome of the events was not resolved.
Patient states that she has pain at the injection site and did not immediately associate the pain with the vaccination, however, she states that the pain in her muscle at the injection site has not gone away after the vaccination.
per our records, pt had a positive COVID test on 1/18/22 with the ordering facility being Hospital; requested records, but they did not find records of pt between 1/12/22 - 2/1/22; per death certificate, pt passed away of acute diastolic congestive heart failure and COVID 19 viral infection; attempted to get a fax number to request records but the phone line continued to be busy, I tried for 2 days.
Postherpetic Neuralgia; Herpes Zoster; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. On an unknown date after receiving the vaccination, the patient suffered an outbreak of a painful blistering rash. As a result of these symptoms, the patient presented to a medical provider and was diagnosed with herpes zoster accompanied by postherpetic neuralgia. The patient had continued to suffer the effects of herpes zoster and postherpetic neuralgia (not recovered). Causality was not reported.   Additional information has been requested.
Swelling and pain in the left armpit radiating down the arm to the elbow.; Swelling and pain in the left armpit radiating down the arm to the elbow.; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 14:30 (Lot number: FJ8762) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU; VALTREX; SPIRONOLACTONE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3249, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 19Jan2021, when the patient was 27 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK9231, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 31Dec2020, when the patient was 27 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 14:30, outcome "unknown", described as "booster"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 08Dec2021, outcome "not recovered" and all described as "Swelling and pain in the left armpit radiating down the arm to the elbow.". The event "swelling and pain in the left armpit radiating down the arm to the elbow." and "swelling and pain in the left armpit radiating down the arm to the elbow." was evaluated at the emergency room visit. Therapeutic measures were taken as a result of swelling, axillary pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Other medications in two weeks: Valtrex, oral birth control, spironolactone.  No follow-up attempts are possible. No further information is expected.
Flu shot administered by local Pharmacy. Child coming into clinic the next day with symptoms of soreness, redness and swelling of left deltoid.
Developed a runny nose and very frequent sneezing that I had never had before; helped a little by anti-allergy pills.  This had almost stopped before the second shot when they started again.
broke in hives on back and legs; itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and URTICARIA (broke in hives on back and legs) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Urticaria (with really severe hives took 2 years to control it.). Concurrent medical conditions included Glaucoma. Concomitant products included BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN) for Glaucoma, HYDROCHLOROTHIAZIDE, CITALOPRAM, LEVOTHYROXINE and NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (itchy). On 06-Mar-2021, the patient experienced URTICARIA (broke in hives on back and legs). At the time of the report, PRURITUS (itchy) and URTICARIA (broke in hives on back and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Took a medicine, OTC chlorodyne (generic) as Treatment drug.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 49-year-old male patient who received HAV (Havrix) (batch number 532H4, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 12th September 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's comments:  The nurse reported that the patient received an expired dose of Havrix. The vaccine administration facility was the same as primary reporter. The reporter was consented to follow up. Additional Supportive Information: The patient received expired Havrix, which led to expired vaccine used.