chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she lost some weight; ulcer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: WEIGHT DECREASED (non-serious), outcome "unknown", described as "she lost some weight"; ULCER (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that caller was a consumer on behalf of his 65-year-old wife. He stated that she lost some weight because of an ulcer and now she weighs around 80 pounds. He wanted to know if, based on her weight, she could receive the second booster dose of Pfizer-BioNTech Covid-19 Vaccine. System e-transmitting potential AE. They were not sure if this would count as an AE. A 65-years-old female patient wants to get vaccinated with the second booster shot of Pfizer-BioNTech Covid-19 Vaccine. Her husband (the caller) stated that she had recently had an ulcer and lost some weight. Now she weighs about 80 pounds and wanted to know if there was a weight requirement for getting the vaccine. No specific information was found for the wife's age group, but they explained the caller, based on the attached document, that vaccine dosing in studies are routinely based on age, not weight since vaccines are typically administered based on age, not weight. Referred to HCPs.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1118AM 3 minutes after shots were given, patient felt nauseous, became weak and fainted on the exam table. She responded immediately to ammonia inhalant; her BP 120/76. Ice pack was applied to her head. She was alert in a few minutes sitting up and ready to leave.
1/2/22 pt presents to ED with SOB; O2 sats 68-71% with EMS; placed on O2; pt tested positive for COVID on 12/22/21; admitted to hospital; positive for PE; worsening kidney function; given dexamethasone and Lovenox; DNR; O2 demands increased; pt had a positive UC; condition worsened; transitioned to comfort care; pt passed away later in the day
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a non-health care professional (Office Staff). This case involves a 3 months old patient (gender unknown) who received vaccine FLUZONE PEDIATRIC. The patients past medical history, concomitant medication and family history were not provided. The patient did not receive any other vaccine. On an unknown date, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259JA, expiry date 30-Jun-2019 via intramuscular route in the left thigh. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that MA administer a FLUZONE Pediatric 0.25 ml to a 3-month child. The patient did not experience any adverse reaction after the injection. 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 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 documents held by sender- none.
On March 22, 2021, she noted a dry cough, chest and abdominal pain. Her PCP started her on omeprazole and an albuterol inhaler with improvement in the cough, but her abdominal pain worsened. She was hospitalized at Hospital from April 5-8, 2021 (4 days) with epigastric and right upper quadrant abdominal pain. A CAT scan angiogram of the abdomen and pelvis showed occlusive thrombus involving the main, left and right portal as well as the adjacent superior mesenteric and splenic veins. Her platelet count was normal. She was treated with IV unfractionated heparin transitioned to apixaban. I saw her as an outpatient today. She remains on apixaban and still has abdominal pain after eating.
Pain in injection site, headache, body aches, joint pain, fatigue, chills, fever, nausea, fainting, vomiting,
TOOK FOURTH DOSE ON DAY 8; This spontaneous case (PVX2019-1439) was received from a pharmacist on 04-Jun-2019. It describes a 16-year-old adolescent male consumer who "took fourth dose on day 8". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took the fourth dose of Vivotif on day 8. The first dose was taken on 27-May-2019 and the last dose on 03-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took fourth dose on day 8" was unknown.  Company's Comment: The causality of the event "took fourth dose on day 8" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took fourth dose on day 8" was considered as not applicable.
He got both PNEUMOVAX 23 and FLUZONE HD on right arm on 10/03/2017 and he came back on 10/05/2017 to pick up the antibiotic augmentin prescribed to him by walk in clinic he visited that morning for the adverse reaction he got from the shot. From what he showed me his right arm was  from the injection point down to his wrist was red and he said the redness had reached as far as his chest too. He also said he was not able to move his arm.
Case number PHHY2012US013388 is an initial literature report received on 14 Feb 2012. Authors published the adverse events following administration of H1N1 vaccine to pregnant women that were reported to Vaccine Adverse Event Reporting System. This case refers to an infant born to a 23-year-old female patient (see linked case: PHHY2012US013372), who was vaccinated with pandemic influenza vaccine (manufacturer and batch number: unknown) at 19 weeks of gestation between 01 Oct 2009 to 28 Feb 2010. The cleft lip was first detected during a a prenatal ultrasound examination at 22 weeks gestation. On an unspecified date the baby was born with a congenital anomaly cleft lip. The author's stated that, because cleft lip is embryologically determined during the first trimester of pregnancy, it is implausible to consider vaccination at 19 weeks gestation as a possible causative agent.
T98.8 approx 29hr p/vax lt thigh became very swollen, red, tender & hot to the touch, saw MD @ hosp ER & was adm;discharged 930AM 11APR99;to cont ATB;saw MD 13APR99 & was OK;
Extreme dizziness that lasted for about 15-20 seconds and then subsided. I did not mention to person who administered vaccine because the dizziness went away. I decided to report this after reading about the adverse effects felt by quite a few people at a vaccination site
Symptoms: Hives on neck, and back s/p Pfizer vaccine on 11/18/21 at 3pm. Tolerating PO. Mild abdomen pain at time of vaccine, but resolved. Denies new exposures. No v/d, lip swelling. No issues w/ vaccines in the past.  Treatment: prescribed diphenhydramine HCl 12.5 mg/5 mL liquid (diphenhydramine hcl) Take 10 ml by mouth every six hours as needed.
HCP reported administration of expired VARIVAX to a patient. No symptoms reported. VARIVAX previously experienced a TE (Case #02098347). New TE documented for escalation (Case #02432659). Obtained consent to contact HCP. No additional AE/PQC.  After; Expired vaccine used; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 20-JUL-2023, the patient was vaccinated  with an expired varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5ml dose, lot #U019906, expiration date: 24-JUN-2023 (strength, route of administration, and indication were not provided) (Expired vaccine used). No symptoms reported.  After the call, it was identified a miscommunication regarding information for expired administered products in which had a prior temperature excursion (Product storage error).  Unsuccessful call-back attempt was made.
Onset of urticaria which started same day as vax, on the thigh of injection and spread to abdomen  - blanch-like rash.  No dyspnea, no hypertension. Resolved with Benadryl, 1% HC cream, and cold compress.
Approximately 2 minutes after receiving the vaccine I felt flush, they way I describe it is the feeling you get when given IV contrast for an  imaging study. My hands were sweating and I felt a menthol like smell that traveled down my throat. After about 5-10 minutes a headache started which lasted throughout the evening. I took a benadryl about 15 minutes after receiving the vaccine and the symptoms started to improve. No swelling, difficulty breathing or rashes noted.
I started my period the day after the vaccine, midway through my normal and very regular cycle. My period was early after the first shot, too, and longer and heavier than normal. I also had normal side effects starting 10 hours after injection and lasting for about 30 hours; fever, chills, shaking, fatigue, nausea, muscle, and joint aches.
Mom reports that approximately 2-3 hours after vaccines child complained of feeling hot and had a temperature of 103 degrees. She is also complaining of vomiting. I spoke with her on 8/31/04.
Syncopal event after shot given . Clammy and diaphoretic , ashen appearance and announced he was about to pass out before he passed out . Has had between 15-20 similar episodes describable and recallable in his lifetime . Awoke after a brief 10 sec loss of consciousness. Felt immediately better and no different than any other episode that occurred after seeing needles and getting shots. Drank some water and dc home after observation . Drove himself home . No sequelae.
aches in her finger; she couldn't breath; earache; aches in her toes; a really bad cough; Wheezing; throaght felt like it was constricting; every single bone was hurting; muscle, joint pain all over body; joint pain all over body; she had a headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (aches in her finger), DYSPNOEA (she couldn't breath), EAR PAIN (earache), PAIN IN EXTREMITY (aches in her toes) and COUGH (a really bad cough) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had Covid in December 2020, with mild symptoms.). Concurrent medical conditions included Asthma (pulmonary embolism/ admitted into hospital) since 12-Jul-2021 and Nerve pain. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) from 2005 to an unknown date for Asthma, GABAPENTIN from 2019 to an unknown date for Nerve pain, SERTRALINE HYDROCHLORIDE (ZOLOFT), BUSPIRONE, QUETIAPINE FUMARATE (SEROQUEL), DOCUSATE SODIUM (COLACE) and HYDROCHLOROTHIAZIDE for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (aches in her finger), DYSPNOEA (she couldn't breath), EAR PAIN (earache), PAIN IN EXTREMITY (aches in her toes), COUGH (a really bad cough), WHEEZING (Wheezing), THROAT TIGHTNESS (throaght felt like it was constricting), BONE PAIN (every single bone was hurting), MYALGIA (muscle, joint pain all over body), ARTHRALGIA (joint pain all over body) and HEADACHE (she had a headache). At the time of the report, PAIN IN EXTREMITY (aches in her finger), DYSPNOEA (she couldn't breath), EAR PAIN (earache), PAIN IN EXTREMITY (aches in her toes), COUGH (a really bad cough), WHEEZING (Wheezing), THROAT TIGHTNESS (throaght felt like it was constricting), BONE PAIN (every single bone was hurting), MYALGIA (muscle, joint pain all over body), ARTHRALGIA (joint pain all over body) and HEADACHE (she had a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she thought she was having a heart attack at the time of events. Treatment information included pain medicine. Patient had change in status of chronic condition pulmonary embolism/ admitted into hospital      Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Patient demographic details were updated, medical history added, concomitant medications updated, new events Muscle,Joint pain,every single bone was hurting,throuaght felt like it was constricting,wheezing.
:I'm calling to report that I administered 1 dose of Moderna Covid-19 Vaccine (Monovalent) 2 days beyond manufacturer expiration date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (:I'm calling to report that I administered 1 dose of Moderna Covid-19 Vaccine (Monovalent) 2 days beyond manufacturer expiration date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (:I'm calling to report that I administered 1 dose of Moderna Covid-19 Vaccine (Monovalent) 2 days beyond manufacturer expiration date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (:I'm calling to report that I administered 1 dose of Moderna Covid-19 Vaccine (Monovalent) 2 days beyond manufacturer expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (:I'm calling to report that I administered 1 dose of Moderna Covid-19 Vaccine (Monovalent) 2 days beyond manufacturer expiration date.).    No concomitant medications were reported. No treatment medications were reported.
Pt's husband called our office at 4:30pm on 10/16 and reported her R arm was swollen and quite painful. It resolved in a few days with ice and ibuprofen.
got sick, did all kinds of tests and narrowed it down to the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 76 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick, did all kinds of tests and narrowed it down to the shot". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd vax on 21JUL92 & approx 12 hrs p/vax devel a rectal temp of 103; pt was fretful & moaning but had no other sx; 22JUL92 seen by MD; 23JUL92 was afebrile & had recovered;
The vaccine he received has made him very fatigued; This is a spontaneous case from the, initially received from other non-health professional via The Agency (reference number: SEQW20-00216) on 30-Mar-2020, concerning a male patient of unknown age.  The patient's current condition and concomitant medications were not provided.  On unknown date, the patient was administered Fluad TIV [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; batch number, expiration date, route of administration, dose and anatomical location: not reported] for unknown indication.  On unknown date, unknown amount of time after vaccination, the patient was very fatigued.  At the time of this report, the outcome for the event of 'fatigue' was not reported.  The case was assessed as non-serious.  The reporter stated the vaccine made him very fatigued.  Company comment: The event of 'fatigue' is considered related to Fluad TIV.; Reporter's Comments: The reporter stated the vaccine made him very fatigued.; Sender's Comments: The event of 'fatigue' is considered as related to Fluad TIV.
Patient said she started feeling swelling in mouth and was having shortness of breath.  She called her Doctor who prescribed her a steroid.  After 2 days she said the symptoms subsided.
He had fever the same day in the afternoon until Friday 12. High fever over 105 degrees F. We went to the pediatric (doctor), but he don't pay attention to child. So we went on Tuesday at medical center because the child don't eat, drink juice or water. And he was vomiting. He have high fever, fussiness, tiredness and don't eat nothing.
MMR vaccine administered 1/28/15. Pt. experienced low grade temp that PM. Rash appeared on 1/31/15-entire body. No illness noted at time of immunization. 2/3/15-c/o cough-non productive. Runny nose green/yellowish in color.
About 1 hour after receiving the HPV injection pt got a severe headache, vomited and developed red spots on his face. Symptoms lasted for about 2 hours.
not diaphoretic, BP unknown. Was answering open-ended and close ended questions. Patient did not have anything to eat of drink since yesterday. Denied any pain. Was not shaking. Wife said he wasn't acting normal. Talking in a slow, but not slurred speech.
PATIETN DEVELOPED TONGUE SWELLING AFTER RECEIVING COVID PFIZER INJECTION.  EPINEPHRINE WAS ADMINISTERED AND THE ISSUE RESOLVED.
rash-red blanching lesions occipital adenopathy;fever to 100; APAP given;
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Jul2021 (Lot number: EW0217) at the age of 24 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.The following information was reported: HEADACHE (non-serious) with onset Jul2021, outcome "recovered" (2021), described as "headache"; FATIGUE (non-serious), outcome "recovered", described as "tired/He was feeling so tired"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest pressure/felt something in his chest"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "chest pressure went to my back"; PYREXIA (non-serious) with onset Jul2021, outcome "unknown", described as "fever"; CHEST PAIN (non-serious) with onset Jul2021, outcome "recovered", described as "Chest pain"; BACK PAIN (non-serious) with onset Jul2021, outcome "recovered" (2021), described as "Back Pain"; CHEST DISCOMFORT (non-serious) with onset Jul2021, outcome "unknown", described as "Pressure"; FEEDING DISORDER (non-serious) with onset Jul2021, outcome "recovered", described as "was not able to eat"; ILLNESS (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "he became ill, he felt bad". The events "headache", "tired/he was feeling so tired", "chest pressure/felt something in his chest", "chest pressure went to my back", "fever", "chest pain", "back pain", "pressure", "was not able to eat", "he became ill, he felt bad" and "he became ill, he felt bad" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, fatigue, chest discomfort, musculoskeletal discomfort, pyrexia.Additional information: Is report related to a study or programme- No. Patient clarified he went to the Emergency Room on 21Jul2021. Patient confirmed he received the second dose on 25Jul2021. He asked the physician about if okay to get, about if knew felt bad with first one, and physician okayed to get second dose. The patient did not administer additional Vaccines on Same Date of the Pfizer Suspect.No follow-up attempts are possible. No further information is expected.
Patient presented to the same vaccination site as she received 1st dose.  Patient was asked if she received Pfizer or Moderna and answered "Pfizer" as she thought she received Pfizer for 1st dose.  Patient did not have her CDC dose reminder card.  She was guided to the Pfizer second dose documentation station, where the nurse documenting the vaccination did not heed the Epic alert that first dose was Moderna and Pfizer was being documented for 2nd dose.  Patient was directed to the Pfizer vaccine administration station and received Pfizer for dose 2 instead of Moderna.  The pharmacist in charge discovered an additional Moderna dose in inventory and discovered the potential error.  The pharmacist called the patient who described the events reported above and confirmed the error. The patient was educated that the current guidance is to not repeat dose 2 as both vaccines are mRNA vaccines.
developing a small lump under my left arm that hurts, in the armpit, If I lay on it with my arm up high, it hurts; developing a small lump under my left arm that hurts, in the armpit, If I lay on it with my arm up high, it hurts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 (Lot number: 33130BA) as dose 3(booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: AXILLARY MASS (non-serious), PAIN (non-serious), outcome "unknown" and all described as "developing a small lump under my left arm that hurts, in the armpit, If I lay on it with my arm up high, it hurts". No follow-up attempts are needed. No further information is expected.
My question is to find out if this could be a side effect of getting the vaccine or not?It seems to be persistent though each day less in pain as long as I use Tumeric.   Pain under Left Shoulder Blade radiates to Left Arm outter under muscle / roves to wrists / roves to shoulder muscle by neck. Comes and goes during the day. Wakes me up at night.  Initally it was severe pain subsiding to an ache still roving never stationary. I manage it with Supplements of Tumeric.
Information has been received from a licensed practical nurse concerning an 18 week old female who on 19-JUL-2007 and 26-SEP-2007 was vaccinated with her first and second doses of Rotateq. On 27-SEP-2007 and on 05-OCT-2007 the patient developed mucus and blood in stools. On 06-OCT-2007 the patient was seen in the physicians office. Otherwise the patient was content and did not appear to have pain. The patient's outcome was unknown at the time of this report. There was no product quality complaint. Upon internal review blood in the stool was determined to be an other important medical event. Additional information has been requested.