chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient was administered with Monovalent vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was administered with Monovalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 19-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 21-Apr-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 21-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patient was administered with Monovalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was administered with Monovalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was administered with Monovalent vaccine).    No concomitant medications was reported. It was reported that they administered the Monovalent on 21-Apr-2023 to 2 patients and on 22-Apr-2023 to 1 patient. No treatment drug details was reported.
p/vax pt exp a varicella-like rash;pt sought unspecified medical treatment;
pt recvd vax; w/in 48 hrs, swelling, redness, itching,tenderness of most of upper arm of shoulder w/ 4-5cm area of central clear vesiculation;
Within 24-28 hours, rash on face started and is still present more than 2 moths later. In the past I was gluten sensitive, ever since my second dose, I am extremely sensitive to gluten and corn products.  Inflamation/boating immediately after eating certain foods (much more than in the past).  Frequent abdominal pain (on right side).  48 hours after vaccination, I started menstrating which lasted 21 days!  (I had just ended my period 2 days before recieving the vaccine)
I was on the beach and was suddenly overwhelmed with muscle weakness, excessive sweating, light headedness, and other symptoms.  Symptoms continued for the next two months, until I finally went to the emergency room and they admitted me for heart failure.  I had never had any heart-related symptoms.  I do not have a history of hypertension or coronary artery disease (still don't).  They found a blood clot in my heart during an echocardiogram.
Random, temporary buzzing or vibrating sensation in chest.  Sometimes also appears in upper arms, hands, neck and lower jaw.    Sometimes accompanied by a brief sensation of dizziness or disorientation.
chills, body aches, loss of appetite, headache, fatigue. Acetaminophen to relieve symptoms. When I awakened  Sunday morning, I felt much better. All of the symptoms were gone.
According to mother's report, Navontae ran a fever for 5 days after his second Pediarix.  Mom would give Tylenol but the temperature kept going back up until it was 105.  At that point Mom took the baby to the ER.  Motrin given and fever came down.
positive covid-19 test; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (positive covid-19 test) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Allergic reaction to drug (Patient is allergic to Penicillin and a second drug which the agent did not understand.).    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced COVID-19 (positive covid-19 test). The patient was treated with Blood pressure medication for Blood pressure, at an unspecified dose and frequency and Thyroid medication at an unspecified dose and frequency. At the time of the report, COVID-19 (positive covid-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, COVID-19: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was tested positive covid-19 test on 08-MAR-2021 and had started monoclonal treatment on 10-MAR-2021.
Patient complained of pain at injection site, traveled down arm.  Patient states it hurts like past rotator cuff injury.  Patient has seen orthopedist, had corticosteroid injection.
This spontaneous report as received from a consumer refers to her daughter of unknown age. In August 2012 (about a year ago (date unspecified)) the patient received the first dose of GARDASIL (lot #, expiration, route unspecified) and the second dose of GARDASIL in August 2013 (last week (date unspecified)). No adverse event reported. Additional information has been requested.
23oct96 mother reports that following the last vax pt had 3-4 hr of high pitched screaming & fever of 103 degrees; mom consulted the ER but was not seen by MD. referred to Dr. for further evaluation.
Other complications following immunization, not elsewhere classified, initial encounter on 2023-07-27.
Patient was administered the diluent without the antigen (powder). CDC was contacted and adviced to re-administer the vaccine after 28 days. and the pt. was informed.
Information has been received from a physician concerning a female patient who was vaccinated with a first and second dose of Gardasil. The patient developed a rash on her face after 1st injection. She developed a more extensive rash on her face after the 2nd injection. In both instances, the rash was isolated to only the patient's face. The physician was not planning to vaccinate the patient with the 3rd dose due to the adverse experience. Unspecified medical attention was sought. The patient was improving as of the report date. Additional information has been requested. Information has been received from a physician concerning a 24 year old female patient with a penicillin allergy who was vaccinated with a first dose of GARDASIL (lot #653978/0955P) intramuscularly in the left deltoid on 31-OCT-2206. About one and a half to two weeks after the first injection, on approximately 14-NOV-2006, the patient developed a rash on her face. On 05-JAN-2007, she was vaccinated with a second dose of GARDASIL (lot #6548851/1424F) intramuscularly in the left deltoid. On 18-JAN-2007, she developed a more extensive rash on her face. In both instances, the rash was isolated to only the patient's face. The physician was not planning to vaccinate the patient with the 3rd dose due to the adverse experience. Unspecified medical attention wsa sought. The patient was instructed to take BENADRYL as needed. The patient had recovered as of the report date. The patient was unable to keep an appointment for evaluation. Additional information has been requested.
fever 101 degrees (03/03/2021), for 5 days: headache, sore muscle & joints, queasy stomach, looser bowels
4-3 3:00PM R wrist swelled, rash red like sunburn  4-4 Tired; lack of appetite 4-5 Rash on chest, back, face  4-6 Dr. prescribed Benadryl every six hours.  4-8 Dr. prescribed Prednisone 4mg as rash was still there and I had swelling and rash on palms. Stopped Benadryl as I was jittery and in a fog  4-9 Swelling R hand and fingers, starting to itch all over body then get hives 4-11 Rash went away on chest, back, and face 4-12 Reported to Dr. that rash was still on palms and he sent me to Urgent Care. Took Zyrtec at night.  Urgent Care checked hands hands for numbness which I didn't have and said I must contact the CDC.  4-13 Finished Prednisone in the morning. Took Zyrtec at night. Stopped itching but rash continues on palms of hands- looks like sunburn.  4-14 Joint swelling when I woke up. Tingling in L fingers and hand, called Dr. He said that I'm retaining fluids from Prednisone and it's affecting my nerves.   Urgent Care, the pharmacy and Dr.  do not know how to help me. They can't tell me when my symptoms should go away or what I should be taking.  You can also call me on my cell?
This spontaneous case, initially received from other healthcare professional on 08-Oct-2018, concerns a 45-year-old, adult, female patient. The patient had no medical history. The patient did not receive any concomitant medications. Since an unspecified date, FLUCELVAX QIVc vaccine underwent first temperature excursion, probably at 30.9 Fahrenheit (explicitly coded as incorrect product storage) for approximately 08 hours (reported as worst-case scenario was 8 hours). On 04-Oct-2018, the patient was administered FLUCELVAX QIVc vaccine [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252659 and expiry date: 31-May-2019] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse events were reported. The reporter assessed this case as non-serious. This case 201804346 was cross-linked to case 201804345 due to same reporter.
2nd and 3rd dose with a half dose; pediatric dose administered to adult; Drug dose administration interval too long; 2nd and 3rd dose with a half dose; pediatric dose administered to adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 69-year-old male patient who received HBV (Engerix B) (batch number j7h4d, expiry date 7th April 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) (batch number 333m, expiry date 23rd March 2022) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received full dose on an unknown date).   On 7th April 2022, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 23rd September 2021, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 23rd September 2021, not applicable after receiving Engerix B and Engerix B Pre-Filled Syringe Device and unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On 7th April 2022, the patient experienced underdose, adult use of a child product and drug dose administration interval too long. On an unknown date, the outcome of the underdose, adult use of a child product, drug dose administration interval too long, underdose and adult use of a child product were 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: 22-Jun-2022 Reporters comment: The patient received 2nd and 3rd dose of Engerix B which were half of the dose. The half dose was because it was the pediatric dose of Engerix B. No adverse event was reported. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient received half dose of Engerix-B at second and third vaccination, which led to the underdose and adult use of a child product. The patient received 3rd dose of Engerix B later than the recommended schedule which led to lengthening of vaccination schedule.
4 x 2 1/2 redness/swelling/ hardness around injection site. Itch and pain present.
a 4 month old was given Fluzone Quadrivalent/no AE; Initial information was received on 10-Mar-2020 regarding an unsolicited valid non-serious case from a consumer.  This case involves a four month old male patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] for prophylactic vaccination (lot UJ305AA, expiry date-30-Jun-2020) via intramuscular route in the right thigh for prophylactic vaccination on 10-Mar-2020 (PT: Product administered to patient of inappropriate age)..  Medical history, past medical treatments, vaccinations and family history were not provided.  Patient also received Rotateq and Pentacel on 10-Mar-2020 as concomitant therapies (No dosing details were provided).   It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that the physician was aware but didn't order the medications.  At the time of report 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.
Sore arms no edema, no redness, tender to touch on left deltoid. Instructed mother to give Tylenol for the next 24 hours if soreness increases to contact MD. NBPH to contact individual next business day.
ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consumer reported for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number: EK5730; dosage form: injection) via an unspecified route of administration as injection to left arm on 24Dec2020 at 7:30 am at a single dose for COVID-19 immunization. Relevant medical history and concurrent conditions included slight hypertension from Jul2020 and ongoing. Concomitant medications included lisinopril from Jul2020 and ongoing for slight hypertension. The patient developed ball palsy, facial dropping which did not lasted long but she still had the painful shingles on 27Dec2020, after the first dose. She wanted to know the recommendations for taking the second dose which is due in 10 days. The patient wanted to know if she should receive the shingles vaccine. This caller was a lab tech who works in the healthcare industry and manages a medical office; but clarified she did not call on behalf of a healthcare professional. She was the patient who received her first dose of Pfizer SARS-CoV-2 Vaccine on 24Dec2020. She reported onset of what the Urgent Care Physician believed was Shingles on 27Dec2020. She called to ask if she should or should not receive the second dose of Pfizer SARS-CoV-2 Vaccine on 14Jan2021 as scheduled due to the Shingles. The Urgent Care Physician advised her to still get the second dose, as there was about a 1:10,000 chance of developing shingles with the vaccine. She reported shingles as a reaction subsequent to the Pfizer SARS-CoV-2 Vaccine. Initially on 27Dec2020 she developed sites of what she thought were canker sores or fever blisters in her mouth which had gotten pretty large and stopped her from being able to eat on 29Dec2020. Then on 30Dec2020 she developed sites on her face which have gotten scarily large; and was causing some deep nerve pain going to her eye and down her chin; the sites felt like lesions on her face with roots. The sites in her mouth were now completely gone; but the sites on her face are ongoing. Now it has kind of taken over her face. She saw the Urgent Care Physician regarding this who believed the sites to be shingles. She had never had fever blisters or shingles before this event. She was still kind of reeling. The report was reported as non-serious. The outcome of event ball palsy/facial dropping was resolved and of shingles was unknown.
I had an achy throat.  I started running a low grade fever.  I had body aches.  My symptoms weren't real severe just very annoying. I was extremely tired and overall sick feeling. I would get heart palpitations and at the same time my oxygen level would go down according to my pulse oximeter.  My eyes were really blurry.  They put me on Paxlovid and my symptoms started to go away except I was really tired.  Three days after the Paxlovid ended I came down with COVID part 2.  The main symptoms of that were the heart palpitation with low oxygen and low heart rate.
Leukopenia. Received redraw 2 months after initial labs and still low. Another redraw 02/2022 and still low.
Pt had maculopapular rash over trunk, back face, and proximal limbs. She also had anterior cervical and post auricular lymphadenopathy.
Periods have been irregular the past 3 rounds. Very heavy flow, very bad cramps, less time between.
Large (20cmx15cm) erythematous, hot, swollen lesion on Right upper thigh.
side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; side effects / All of the listed on this web site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient for self. The age at vaccination was not reported. The patient experienced every side effect listed on website. No further details were provided.
had a very sore arm and neck few hours after shot (9am). I could barely move my neck. I took a   1/2 pill of Tizanidine 4pm tablet. (so 2 mg) at 6pm. sore am and neck became much better.  I was sitting around for hours working on my PC, then around 2am. My skin instantly felt like I had the worst sunburn of my life, and my entire body was shaking and shiving and I couldnt control it at all. I was shaking violently. I tried to lay down thinking maybe It was a fever and I suddently got cold. But I wasnt cold. Just insanely hot and shaking violently laying down made it worse.   My spouse transported me to the ER.
uveitis (red eyes 2-3d after the shot and worsening in the next 7d before leading to blurry vision which requires medical attention. Steroid drops were prescribed and the symptoms subsided significantly but the patient is still using steroid drops 7d after first receiving treatment)
Information has been received from a nurse concerning an 18 year old female who on 06-APR-2007 was vaccinated with her second dose of Gardasil. Concomitant therapy included NUVARING. On 06-APR-2007, right after receiving the vaccination, the patient experienced a lot of pain and 2 days later developed a hematoma on her left deltoid arm of 3.5 cm in size. It was reported that the patient sought unspecified medical attention. The patient's pain and hematoma persisted. No further details were provided. Additional information has been requested.
On the 8th day. I developed a big lump at site of injection. Hot itchy. The day before I developed pain in right shoulder joint.   I have itchy burning pain in site and also right hip. Burning  itchy pain. I can?t see anything. Site is hot.  Not I can?t lift my shoulder on right arm.
COVID-19; COVID-19; Vaccination adverse reaction; Inflammation; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not aplicable). The reporter is the patient. Other Case identifier(s): 22K-163-4292525-00 (Agency).  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2020 (Batch/Lot number: unknown) to 2021 at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 24Jan2022, outcome "unknown" and all described as "COVID-19"; VACCINATION COMPLICATION (non-serious) with onset Mar2021, outcome "unknown", described as "Vaccination adverse reaction"; INFLAMMATION (non-serious) with onset Mar2021, outcome "unknown", described as "Inflammation". The action taken for adalimumab was dosage permanently withdrawn on 2021.  Causality for HUMIRA (ADALIMUMAB) The reporter's causality for the event(s) of COVID-19 VACCINE TRIGGERED SOMETHING, INFLAMMATION WITH COVID-19 VACCINE and CONTRACTED COVID was not provided.  The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was Possible at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  Clinical course:Solicited report by a consumer of a 47 year old male with events of non-serious COVID-19 VACCINE TRIGGERED SOMETHING, INFLAMMATION WITH COVID-19 VACCINE and CONTRACTED COVID with HUMIRA (ADALIMUMAB). There was no reported medical history. In Mar2021, the patient experienced COVID-19 VACCINE TRIGGERED SOMETHING and INFLAMMATION WITH COVID-19 VACCINE. On 24Jan2022, the patient experienced CONTRACTED COVID. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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