chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt like sinus symptoms and congested; respiratory symptoms; puffy nose; left wrist feels like broken and can't even lift things; area beneath pinky is very sore; Itching; Vaccination site erythema; headache; left wrist feels like broken and can't even lift things; felt a scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (felt a scratchy throat), SINUS CONGESTION (felt like sinus symptoms and congested), RESPIRATORY SYMPTOM (respiratory symptoms), SWELLING (puffy nose) and MUSCULAR WEAKNESS (left wrist feels like broken and can't even lift things) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history information was reported.  Concomitant products included AMLODIPINE BESILATE (LODOPIN [AMLODIPINE BESILATE]) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (felt a scratchy throat). On an unknown date, the patient experienced SINUS CONGESTION (felt like sinus symptoms and congested), RESPIRATORY SYMPTOM (respiratory symptoms), SWELLING (puffy nose), MUSCULAR WEAKNESS (left wrist feels like broken and can't even lift things), PAIN IN EXTREMITY (area beneath pinky is very sore), PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Vaccination site erythema), HEADACHE (headache) and ARTHRALGIA (left wrist feels like broken and can't even lift things). The patient was treated with GUAIFENESIN (MUCINEX) for Cough, at a dose of UNK dosage form. At the time of the report, OROPHARYNGEAL DISCOMFORT (felt a scratchy throat), SINUS CONGESTION (felt like sinus symptoms and congested), RESPIRATORY SYMPTOM (respiratory symptoms), SWELLING (puffy nose), MUSCULAR WEAKNESS (left wrist feels like broken and can't even lift things), PAIN IN EXTREMITY (area beneath pinky is very sore), PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Vaccination site erythema), HEADACHE (headache) and ARTHRALGIA (left wrist feels like broken and can't even lift things) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Dose 2 details added, event added-itching, vaccination site erythema for 1st dose.
bloody stool; Yeast infection; swollen upper eyelid; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 17:00 at the age of 31 years old (Batch/Lot Number: Unknown) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The patient experienced yeast infection, bloody stool, swollen upper eyelid on 13Apr2021. The patient did not receive treatment for the events. The outcome of the events was not recovered.  Information about Lot/Batch number is obtained. Additional information has been requested.
12/24/21 presents to ED for "worsening kidney function". PMHx of "ESRD s/p renal transplant 12/15/2021".
Information has been received from a licensed practical nurse concerning an approximately 11 year old patient who on 1-FEB-1998 was vaccinated with a dose of VARIVAX (Merck). On approximately 01-NOV-2006 the patient experienced 20 varicella lesions. At the time of the report, the patients' outcome was unknown. This is one of several reports received from the same source. No further information is available.
I received a Moderna covid vaccinel-about 12 h later i developed a fever or 102 profound Weakness and ws unable to get out of bed without assistance. This gradually improved over 24-48 8h year prior-About a year prior to this I got a Pfizer Covid Booster and had similar symptoms
This medically confirmed spontaneous report (initial receipt 28-Oct-2014) concerns a 48 year old male patient. On 26-Oct-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-Oct-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-Oct-2014, the patient received temperature excursioned AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. No adverse reactions were reported since administration. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Information has been received from a health professional concerning an 8 yr old female who at the age of 12 months in approx 1999, was vaccinated with a 0.5mL SC dose of varicella virus vaccine live. There was no concomitant medication. On 13Feb06 the pt experienced breakthrough chickenpox with 20-30 lesions for 2 days and was treated with acyclovir. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
This spontaneous report as received from a other health professional refers to a 18 month old male patient who on 11-JAN-2013, was vaccinated with the first dose of VAQTA (dose and lot number not reported) and on 12-JUL-2013, was vaccinated with the second dose of VAQTA (dose and lot number not reported). Additional information has been requested.
16 YEAR OLD PATIENT RECEIVED BOOSTER OF PFIZER WITHOUT BEING ELIGIBLE.
This spontaneous report was received from a pharmacist referring to a 68 year old female patient. The patient's medical history included chickenpox at 45 years of age and prior outbreak shingles. On 18-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J004267, expiration date 12-JUN-2014) 0.65 ml, subcutaneous (site of administration not reported). The pharmacist reported that on 18-NOV-2013, the patient experienced the injection site was itching, painful, red and swollen after she received ZOSTAVAX and a blister appeared on 21-NOV-2013. The patient called pharmacist but didn't received any treatment for the adverse events, but she was advised to call her healthcare professional. The outcome of blister and injection site was itching, painful, red and swollen was unknown. Healthcare professional was interested in VZV analysis. Additional information has been requested.
Information has been received from a female physician assistant with no known allergies, who was vaccinated SC with four doses of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) in the last ten years. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently the pt never seroconverted to measles but has seroconverted to mumps and rubella. No lot numbers were available. No other information was provided. Unspecified medical attention was sought. Additional information has been requested.
On 10/26/2005 patient has febrile sensation, multiple joint pain and generalized muscle pain were noticed. Everyday about 3 pm, patient felt febrile sensation. Patient still having the same chief complaints on 11/02/2005.
Shortness of breath or difficulty breathing     Chest pain     Fatigue or tiredness  Hospitalization and death
Pimple-like rash with extreme itching, resolved next day, reappeared after next dose, extending to chest, back.
This retrospective pregnancy case was reported by a consumer and described the occurrence of sore arm (injection site) in a 29-year-old female subject who was vaccinated with influenza vaccine (manufacturer unspecified) and influenza vaccine. A physician or other health care professional has not verified this report. Concurrent medical conditions included gestational diabetes. The pregnancy was by normal conception and the mother was not using contraception. The mother had the Kell antibody in her blood (Kell antibody transfusion) and gestational diabetes and the father had the Kell antigen in his blood. In 2011 the subject received a dose of influenza vaccine (unknown, unknown arm) and in 2010, 2009, 2008, 2007 and October 2006 the subject received a dose of influenza vaccine (unknown arm for 2007-2011, left arm for October 2006). In October 2006, less than one month after vaccination with influenza vaccine, the subject experienced sore arm (injection site). The subject experienced vaccine exposure during the second trimester of pregnancy. The date of the last menstrual period was June 2006 and the estimated date of delivery was 13 March 2007. Approximately 5 months after the influenza vaccine, the subject gave birth to a live infant with no apparent congential anomaly due to the influenza vaccine. The mother's pregnancy was full term and the baby was hospitalized with jaundice for first 8 days due to the Kell antibody. The baby was bilaterally deaf due to a genetic reason. This was reported as medical history by the mother and was not reported as due to the vaccine. The mother was aware of the Kell antibody issues, gestational diabetes and genetic link prior to the influenza vaccination. Less than one year after vaccination with influenza vaccine, the subject experienced sore arm (injection site). The subject was vaccinated in 2006, 2007, 2008, 2009, 2010 and 2011 and experienced sore arm (injection site) after each vaccination. The subject was pregnant at the time of this report and planned to get the influenza vaccine for 2012-13, but had not received it yet. At the time of reporting the outcome of sore arm (injection site) was resolved. For details regarding the baby see case A0995817B. 11 December 2012 - No further information provided; patient lost to follow-up.
12/23/2020 - VACCINATION 12/24/2020 - WOKE UP AT 6AM WITH HEADACHE. LASTED 12 HOURS; NO RELIEF WITH TYLENOL (TOOK 2 BRANDS); NAUSEOUS. 'WAS NOT THE NORM'. FELT BETTER AFTER THE 12 HOURS.  PREGNANCY HISTORY; 12 WEEKS,; DUE DATE JULY 11/12TH 2021.
Vaccine Monday. Thursday felt SOB. Ran during fitness assessment Friday and was seen in the clinic for O2 sat 89%, wheezing. Improved with steroids and beta agonist.
Tongue numbness on left side, sometimes hard to speak properly. Intermittent facial numbness around mouth.
Patient came to get second dose of Moderna vaccine and reported with the first one she had lots of itching and redness from the top of her arm down to her elbow. She reported that the itching and redness took about a month to go away. Per Health Department MD patient advised to see PCP to be referred to allergist before receiving 2nd dose.
A spontaneous report has been received from Health Professional reporting for 5 patients and this report is concerning a 07 years old male patient. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient was receiving Nasal FLUMIST started on 27-Aug-2013. The patient received FLUMIST of lot BH2174. He tested positive on Flu A on 19-Dec-2013, he was not hospitalized but was treated with TAMIFLU. The action taken with FLUMIST was not applicable. The outcome of the event of Flu A was unknown. The reporter considered the event of Flu A to be non-serious.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT; Initial report was received 05 September 2008 from health care professional. A male patient (age not reported) developed body aches, chills, fever, fatigue and shortness of breath within 12-18 hours after he had received an intramuscular (site not reported) injection of ADACEL, lot number C2997AA. The symptom of shortness of breath resolved while the patient was on the way to the hospital, he then went home. The reporter stated the event lasted between three and 12 hours, and the patient recovered from the event. The reporter for this case is the same as for case 2008-02813 which involved a cluster of two additional patients whom ADACEL, lot number C2997AA.
was hospitalized with multiple blood clots; This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS (was hospitalized with multiple blood clots) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (on his shoulder.) on 12-Mar-2021.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced THROMBOSIS (was hospitalized with multiple blood clots) (seriousness criterion hospitalization). At the time of the report, THROMBOSIS (was hospitalized with multiple blood clots) had not resolved.        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.   Concomitant drugs were not reported.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of thrombosis, a causal relationship cannot be excluded.
Both Ears Plugged, clogged. Noise Sensitivity. Whooshing / Ringing Noise. Consistent vibration in right ear. Inability to clear ears plugged. Ear issues leading to dizziness and nausea, headache. Inability to relax or concentrate because of ear issues.
2 SISTERS WERE IN FOR THEIR WELL CHILD EXAMS AND VACCINES. THEY BOTH REQUIRED THE TDAP AND MCV VACCINES. WERE SEEN IN THE SAME EXAM ROOM TOGETHER. A MEDICAL ASSISTANT DREW UP THE 2 TDAPS AND MCV INJECTIONS AND BROUGHT THEM ALL TO THE ROOM AT THE SAME TIME. SHE THEN GROUPED THEM SEPERATELY ON THE COUNTER AS VACCINE TYPE INSTEAD OF PT. I CAME IN THE ROOM TO ASSIST. WE WERE GOING TO GIVE THE VACCINES SIMULTANEOUSLY TO MINIMIZE DISCOMFORT TO THE PT. THE MEDICAL ASSISTANT TOOK A VACCINE AND I THEN TOOK THE REMAINING VACCINE FROM THE GROUP WHICH WAS MARKED "RIGHT" IN MARKER ON THE NEEDLE COVER. WE PROCEEDED TO GIVE THE VACCINE, ME TO THE RIGHT DELYOID AND HER TO THE LEFT AND I IMMEDIATELY SAW THAT WE EACH HAD GIVEN THE TDAP B/C OF THE PRE DRAWN SYRINGE. I IMMEDIATELY REPORTED TO THE PROVIDER. PT WAS EXAMINED. I ADMINISTERED THE MCV IN THE RIGHT DELTOID AND PT WAS RELEASED WITH NO ADVERSE SYMPTOMS.
WEIGHT GAINED BY 20 POUNDS; COVID-19 RECURRENT; This spontaneous report received from a patient concerned a 55 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on unspecified date for covid-19 vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The patient received Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. On an unspecified date, the patient experienced weight gained by 20 pounds, and got covid twice before and after getting vaccination (covid-19 recurrent) (Dose number in series 1). Laboratory data (dates unspecified) included: Weight (NR: not provided) Not Reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the weight gained by 20 pounds and covid-19 recurrent was not reported. The patient received additional booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, and batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2). This report was non-serious.
Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General aches; fatigue; This is a spontaneous report from a contactable healthcare profess. A 41-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899), intramuscular on 29Dec2020 14:45 at a single dose for Covid-19 immunization. Medical history included colitis ulcerative. Concomitant medications included infliximab (REMICADE), calcium D, sertraline hydrochloride (ZOLOFT), and probiotics. The patient previously took ampicillin sodium (OMNIPEN) and BACTRIM DS and experienced allergies. On 30Dec2020, at 04:45 PM, the patient experienced abdominal cramping and diarrhea on pm overnight, injection site soreness/arm pain, general aches and fatigue. The patient did not receive any treatment for the events. The patient has no Covid prior to vaccination and did not take Covid test post vaccination. The outcome of the events was recovering.
Increasing headache; A spontaneous report was received from consumer concerning a female patient, of unknown age, who was administered Moderna COVID-19 vaccine and experienced increasing headache (headache).  The patient's medical history was not reported. No relevant concomitant medications were reported.  The patient received her first of two planned doses of mRNA-1273 (Batch number: 025L20A) through intramuscular route in her left arm for prophylaxis of COVID-19 infection on 07 Jan 2021. The patient experienced increasing headache on 08 Jan 2021.  The patient received pain reliever for headache.   The action taken for Moderna COVID-19 vaccine was unknown.   The outcome of the event which was increasing headache was unknown.; Reporter's Comments: Based on the established safety profile and a temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded.  The Headache is consistent with the known safety profile of the vaccine.
5 minutes post vaccine, while sitting  in the socially distanced observation area the patient felt dizzy.  While getting a gurney to the area, she had a syncopal episode.  We moved her to the gurney and elevated her legs.  She  regained consciousness promptly.  She told us she was diabetic and her glucose was 101 that morning.  We gave her juice and observed her for 30 minutes more.  She had no focal symptoms and felt well at discharge.  No previous history of vagal episodes, hadn't eaten before the  vaccine.  The patient is an RN.
Itching, rash on hands, abdomen pt given BENADRYL capsules and hydrocortisone 1% crm.
injection site irritation, redness, bleeding.  Seen by EMT on site and released  134/95  88  100%
Tested positive for Covid; sore arm; congestion; A spontaneous report was received from a consumer concerning a 51-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for covid, sore arm, congestion.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011A21A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Tested positive for Covid, sore arm, congestion.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), tested positive for covid, sore arm, congestion was unknown.
p/vax pt devel an inj site rxn characterized by pain, swelling, warmth & redness;pt recovered;
Patient complained of lightheadedness and upset stomach. Patient was instructed to lay down on the floor, and patient recovered within 5 minutes. After standing back up, his nose and upper lip were slightly swollen. No signs of airway obstruction or difficulty breathing, but patient was given a dose of diphenhydramine oral liquid and was urged to seek medical care. Patient's mom brought patient to his school and had him checked out by the school nurse, before returning to classes for the rest of the day.
Information has been received from a medical assistant concerning a female with vaccinated with Gardasil. Subsequently the patient developed a rash on her arm and part of the face. The rash spread to the rest of the body. The patient was diagnosed with allergic dermatitis and pityriasis rosea. Patient outcome was unknown. Additional information has been requested.
moderate or severe primary immunodeficiency; Fibromyalgia; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 14May2021 as DOSE 2, SINGLE (at the age of: 69-year-old) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date, the patient experienced fibromyalgia and moderate or severe primary immunodeficiency. The outcome of all events was unknown.   Follow-up activities closed. Batch/lot number not available for vaccine/BNT162B2.
1st dose one year ago, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose about one year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 21-Dec-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix yet, which led to incomplete course of vaccination.
5 minutes after shots complained of pruritus all over body-received Benadryl 25 mg-complained of increased itching 45 min later
PATIENT WAS GIVEN PFIZER VACCINE ON 2ND DOSE INSTEAD OF MODERNA AND IT WAS AFTER 28 DAYS.
This spontaneous report was received from a consumer refers to his father of unknown age. On an unspecified date, the patient received a dose of ZOSTAVAX (lot# unspecified), (dose, route and location unspecified). The son reported that his father developed vertigo and uneasy feelings after being administered ZOSTAVAX. At the time of report, the outcome of vertigo and uneasy was unknown. Additional information is not expected.