chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 month old received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 21st January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 7-Dec-2022 Reporter's comment: The reporter consented to follow-up. The case was for 4 of 5 linked patients reported by same reporter. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2022183610:Same reporter US-GSK-US2022183609:Same reporter US-GSK-US2022183611:Same reporter US-GSK-US2022183615:Same reporter
Large increase in my pre-existing tinnitus in my left ear; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and tinnitus. The patient had no known medication allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient experienced large increase in his pre-existing tinnitus in left ear. The adverse events had not resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care. The patient did not receive treatment for the reported event worsening of tinnitus. The clinical outcome of tinnitus was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient states several days after vaccine he began to have lightheadness, headache, fatigue, and inability to concentrate. He called us after a couple of weeks and reported. I suggested he go to MD which he did and they found nothing but, he still felt bad and insisted it was from the vaccine. I had him schedule an appt with our medical director and he was seen on 8/9 with no abnormal results.
I started with excessive coughing, it slowly progressed to weakness and trembling. By Monday 12/14/2009 the shaking was so bad that I went back to the doctors where he perscribed me Levaquin. The shaking and weakness is still present almost 2 weeks after initial injection.
Numbness in the feet, then progressed to the legs, hands, arms, face and lips.
Pt. felt very tired, weak - almost fainted - had trouble standing up - said was having some shortness of breath - we called 911. Paramedics came & checked all vitals - everything seemed ok. Pt stayed in store from 30-45 minutes - said felt fine. Husband came & picked her up.
Patient developed a wheal at injection site. Slight nodule possible. Hasn't worsened since Tuesday. Recommended ice, TYLENOL/Ibuprofen, Antihistamine, and HC cream if necessary. Follow up with physician if no improvement. No fever or warm to the touch of area. Small black/blue mark below shot.
At 3:15 PM, pt entered observation immediately after receiving his second dose of the Moderna CV 19 vaccine. Pt reported to the RN that he was feeling dizzy (Client reported feeling dizziness after receiving his first dose as well.).  Pt also complained of piercing headache above his left eye and pain on the right side of his neck. The pain radiated down his entire left side of his body. The pt also felt tingling in the arm he received the vaccine in.  Vitals were initiated and water was provided to the pt. Ice packs were applied to the patients forehead and nape of the neck where he felt the pain.  Vitals NOT within normal limits. O2 saturation fluctuating and blood pressure was a bit elevated.  Pt reports having a history of hypertension, but could not accurately recall having taken the medication that morning. EMS was activated at 3:35 PM because the pts O2 saturated was fluctuating dangerously and interventions were not successful in relieving the patients symptoms.  Vitals were taken approximately 10 minutes apart. Vitals were not WNL. Pt continually reported that the pain was increasing and beginning to feel unbearable. It was noted that the patient had increasingly poor circulation in the arm he received the injection. O2 was taken on the opposite arm and saturation levels appeared normal.  EMS at 4 PM. Vitals were taken, all WNL. Patient left with EMS at 4:05 PM and was transported to Hospital.
Initial unsolicited report received from a pharmacist on 15 September 2015. This case involves a 73-year-old female patient who was vaccinated with a dose FLUZONE HD [batch number: UI427AA, expiry date: 28 March 2016, dose, dose in series were not reported) via intramuscular route in left deltoid on 15 September 2015. The patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On 15 September 2015, few seconds following the vaccination, the patient had blood after the injection and than feels a lump 2cm at the injection site light blue under the skin. Laboratory data and corrective treatment were not reported. The patient was not recovered from the event. List of documents held by sender: none.
Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 49 years old female patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant.therapies taken. On 13-Sep-2018, the patient received 0.5 ml single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ006AA (expiry date: 14-Apr-2019) in the right deltoid. It was a case of actual medication error due to Inappropriate age at vaccine administration. It was unknown whether any adverse event occurred or not. 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.
Patient falsified DOB when registering for vaccination, stating the minor was 07/13/2002. Guardian consented to the vaccination. Health department verified with statistical records that the patient's actual DOB is 07/13/2003 which made the vaccine a contraindication. No known adverse reactions noted.
The day following vaccination patient developed red spots on stomach. She went to doctor that same day (9/5/2019) and was given steroids. The following day the red spots continued to spread to arms, neck and legs. She then went back to the doctor Saturday 9/6/2019 and her dose of steroids was increased. Then later that day she notified me at the pharmacy.
Severe vomiting and diarrhea started Monday night and continued throuout Tuesday.   Serve body aches in the back,   lungs, and legs starter early Tuesday morning and continued until I got medication for the pain on Tuesday afternoon.
Information has been received from a medical assistant concerning a "60+" year old male who "about one month ago" on approximately 18-JUN-2007 was vaccinated SC with a dose of Zostavax (Oka/Merck).  Subsequently the patient experienced arm swelling, flu-like symptoms and "pus" in the deltoid area of the injection site arm.  Unspecified medical attention was sought.  Subsequently the patient recovered.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Initial and follow-up information has been received from a medical assistant concerning a 75 year old male with no known allergies or pertinent medical history who on approximately 13-JUN-2007 at 9:45 was vaccinated SC in the left arm with a first dose of ZOSTAVAX (Oka/Merck) (lot # 657764/0584U). There was no illness at the time of vaccination. On 15-JUN-2007 at 16:30 the patient experienced arm swelling, localized erythema, flu-like symptoms (including a temperature of 99 degrees) and "pus" (also reported as a "waxy like substance") that was squeezed from the injection site. Unspecified medical attention was sought. On 18-JUN-2007 the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information is not expected.
Five minutes after getting my vaccine, I got a major migraine headache on the way home. I have an inner thigh blood bubble since then and a headache daily. I was never told to sit down for 15 mins after receiving the shot.
Right after the injection i felt my body get very hot and tingly. I got sick but i didn't pass out.. With cool wash cloth crackers and water it went away after 10 minutes. I hadn't eaten before I came in and I was nervous also. An hour later I started feeling the heat through my body again, but not as bad. I started getting a horrible burning in my stomach. It lasted around 4 hours. The other side effects were the temperature, flu like symptoms, and tiredness .
syncopal episode; mild seizure activity; This is a spontaneous report from a contactable healthcare professional. A 43-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ew0161) at the age of 43-years-old, intramuscular in left arm on 20Apr2021 at 11:00 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. He has no COVID prior to vaccination and denied being allergic to anything. There was no other vaccine in four weeks and no other medications in two weeks. The patient received his first dose of COVID-19 vaccine in a workplace clinic on 20Apr2021 and experienced syncopal episode with mild seizure activity at 11:15, within the 15-minute period post vaccination (as reported). No treatment was given in response to the events. It was unknown if the patient was tested for COVID post vaccination. The outcome of the events was unknown.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on close temporal relationship and lack of alternate explanation at this time. However, the information provided is very limited and does not allow for a complete medical assessment. Case will be  reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 25-MAR-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot #: T013204, expiration date: 03-DEC-2021 or lot #: T013546, expiration date: 28-OCT-2021 (two lot# of vaccines have been reported, no information of which one was administrated to the patient); dose, strength and route were not reported) for prophylaxis.          The vaccines underwent temperature excursions and were stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002974: US-009507513-2104USA002975: US-009507513-2104USA002973: US-009507513-2104USA002971: US-009507513-2104USA002963: US-009507513-2104USA002972: US-009507513-2104USA002978: US-009507513-2104USA002980: US-009507513-2104USA002981: US-009507513-2104USA002982: US-009507513-2104USA002983: US-009507513-2104USA002984: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
3 days p/vax devel fever of 101 & had vomiting, diarrhea & stomache cramping; pt was put into the hosp because can not care for self because has a broken vertabrate L1 fracture; no skin react;
Vaccine given 10/17/2003. Seen in our office 10/22/2003 with rash ? with a few small chickenpox lesions.
Chest pain for over a week (right in my heart). My best guess is pericarditis. It made exercise very uncomfortable and I was always conscious of it. I took a lot of anti-inflammatory pills which helped some. After about nine days the pain went away.
Patient received Kinrix at the age of 4 months, which is not recommended for his age..  I called patients mother 12/13/2022, stated that he was fine, sleepy, no fever, no crankiness, no redness or rash, appetite good.
left side, swollen axillary lympnodes, tenderness. Done after 4 days. Relieved by Tylenol or advil.
She reports that immediately after vaccine was administered, she felt left arm pain, couldn't breath well, with blurry vision. She was observed in the office, and her symptoms improved, but states her blurry vision (resolved next day) and arm pain persisted. Her mother drove her home from the appointment that day. 1-2 days later, she reports that she developed severe headaches that were nearly daily for 3 months, and since then has intermittent headaches that require ibuprofen. She felt her throat was swollen and she felt "immobile" for a week after the vaccine was given and was unable to participate in volleyball at the time.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T021639, expiration date: 21-DEC-2021, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This solicited case was received from the investigator in a trial on 17 April 2015. A 30 year-old male subject whose past medical history included high blood pressure and cardiomyopathy was found to have hypertrophic obstructive cardiomyopathy on 13 March 2015, 23 days after the subject had received the following vaccines on 18 February 2015: an injection of Smallpox (Vaccinia) Live Vaccine, (number, route and site of administration not reported), Rabies Vaccine (reported as Rabbies - IM (4)), (manufacturer, lot number, route and site of administration not reported), and MMR (2) (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal ECG (electrocardiogram) on an unreported date. Troponin I, lumbar puncture and MRI of the brain, spinal cord and heart were not performed. An ECG on 27 February 2015 was abnormal. Treatments were not reported. Adjudication Follow-up Report. 9 Days Post Vaccination. Outpatient Visit Patient with history of murmurs presented for a cardiac examination. Labs and CXR were normal but abnormal EKGs showed inverted T-wave activity. Recommend cardiac evaluation. CXR - (Normal) PA/LAT shows satisfactory inspiration with no evidence of active pulmonary disease. The cardiac silhouette is normal with no evidence of enlargement and mediastinum, great vessels, pleura, diaphragm, and bony thorax are unremarkable. EEG1 - (14:20) Sinus bradycardia with sinus arrhythmia, rightward axis, and T wave abnormality with QT-QTc = 432/427ms EEG2 - (14:22) NSR, sinus arrhythmia, rightward axis, and T-wave abnormality with QT/QTc = 420/446ms EEG3 - (14:24) NSR with left posterior fascicular block, T-wave abnormality, and QT/QTc = 422/471ms. 23 Days Post Vaccination Cardiology Visit Patient has history of LVH without evidence of HOCM on stress ECHO done on April, 2014. A/P - Cardiomyopathy hypertrophic with an IVSD = 1.6 and mild SAM without outflow tract obstruction (mean gradient = 4 mmHg). 30 Days Post Vaccination. Cardiology Visit Chief compliant is evaluation of hypertrophic cardiomyopathy. ECHO demonstrated hypertrophic cardiomyopathy with LVEF = 55% and septal wall = 1.8 cm. Left atrium was mildly enlarged at 4.3 cm, myocardial perfusion study with an anteroseptal fixed detect and an LVEF = 53%. No hypotension and/or drop in BP noted on the treadmill test. Patient remains asymptomatic with no SOB, chest pain, or syncope. 33 Days Post Vaccination. Outpatient Visit Patient was screened for cardiovascular disorders. Holter monitor was unremarkable with no episodes of non-sustained ventricular tachycardia. The subject's outcome was not reported. Additional information  will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
No adverse event.  This is only to report that the child's parent requested to varicella & that I administered it in school setting.  Later, on data entry, notation on data shows that child had chickenpox 1/9/98.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 05-DEC-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. this is one of several reports received from the same source. Additional information has been requested.
Patient was diaphoretic, nauseous and felt weakness. EMS attended and cleared patient.
01/02/2022: Event occurred after 2nd vaccine.   89-year-old female presents to the emergency department via EMS secondary to a fall.  Was unwitnessed but she lives in assisted living . Denies Symptoms: no abdominal pain/ no chest pain/ no chills/ no cough/ no discharge/ no fever/ no headache/ no nausea/ no rash/ no shortness of breath/ no URI symptoms/ no vomiting/ no weakness 01/07/2022- remains in hospital.  01/06/2022;  Plan 1: Patient is vaccinated and completed her 2 shot series with Pfizer and also received her booster Decadron 6 mg daily remdisiver 1/4/21 Improve now on 4 L of oxygen via nasal cannula
positive COVID-19 test; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a female patient of an unknown age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided.  After 1st dose had tested positive for covid. Outcome of the event was unknown.
The night of the evening (around 8 pm) I started having extreme chills. The next morning I woke up my face was very swollen & red. I was having difficulty breathing. It was like I had been stung by a bee. I took couple of benadryl and used nebulizer. Also had mild headache. I have notified my PA of this reaction. Used Ventolin throughout day and took tylenol.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 22-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Expired product has been administered to consumer with storage error. No concomitant and treatment information provided.
Bruising, lump, and pain around shot area around 2.5 inches in diameter.  Legs feel heavy.  Still present after a week.