chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rheumatoid arthristris developed; severe pain in her joints; swelling; This case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant), joint pain and swelling. On an unknown date, the outcome of the rheumatoid arthritis, joint pain and swelling were unknown.   The reporter considered the rheumatoid arthritis, joint pain and swelling to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by patient's parent. Age at vaccination was not reported. The patient was always a completely healthy girl. The reporter stated that the patient had severe pain in her joints, swelling and appears to see rheumatoid arthristris developed.  The physician pressured to administer the vaccine because they were in favor of vaccines. These companies should compensate these children for the damages caused by the vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR205371:same reporter
Heart palpitations, Vertigo, extreme headaches, neck/back pain started 1/14, still ongoing  today.
Adverse effects: numbness in bottom of right foot, pain in right buttocks (travels down posterior thigh), cramp in right calf; undergoing physical therapy. Current diagnosis sciatica originating at L5. Started 8-3-18.
A spontaneous report has been received from a Health Professional concerning a male patient of age 20 to 30 years. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient was receiving Nasal FLUMIST QUADRIVALENT started during Aug-2013. Patient received FLUMIST in Aug-2013 and was diagnosed with the flu 01-Jan-2014 and 28-Feb-2014. The patient recovered from the event of diagnosed twice with flu was unknown. The reporter considered the event diagnosed twice with flu as non-serious.
Patient reported chest tightness and dull pain in center of chest that varied in intensity that occurred 3 days after receiving the COVID Pfizer booster vaccine. On 1/24/22, patient thought it was related to heartburn; however, symptoms did not improve with Pepcid. She was seen at urgent care the same day where an EKG was performed and found to have twave abnormalities. She was then transferred to Hospital and given a "GI cocktail" for reflux symptoms with no improvement. She was found to have an elevated troponin of 86 at this time. Patient was initiated on ibuprofen and transferred to larger hospital on evening of 1/24/22. Troponin levels were <6 on 1/25/22. The patient's symptoms were relieved by Ibuprofen 400 mg.
he experienced a 100.1 fever; chills; vomiting; This is a spontaneous report from Pfizer sponsored program. A contactable 77-year-old male consumer (patient) reported that: A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated the night he received his first vaccination, 01Mar2021, he experienced a 100.1 fever, chills, and vomiting. Patient stated his symptoms lasted for 2 days and now he's perfectly fine. Patient stated he is scheduled for his second vaccination on 22Mar2021. Patient stated he has an upcoming surgery scheduled 23Mar2021 and wanted to know if he could receive his second vaccination after his surgery. Patient stated he had a bad reaction to his first vaccination. The outcome of the events was reported as recovered on an unspecified date in Mar2021. The patient underwent lab tests and procedures which included body temperature: 100.1 on an unspecified date experienced a 100.1 fever.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Diaphoresis, petechiae, and tachycardia. onsent post vaccine, Benadryl 25 mg by mouth, 2nd round of sweating onsent: Benadryl 25 mg by mouth.  Lower lip swelling, administered Epi-pen, called rapid response.  Transferred to ED at 09:11am
Injection site raised/red and warm to the touch. Pt appears in pain, crying constantly. Pt is handicap and cannot speak. The patient is a 15 year old male who is brought to the office today by his mother and grandmother. He presents for evaluation for recheck. He was seen on 02/28/14 for received vaccines (MENVEO, Tdap and VARIVAX all in RT arm) and now areas where vaccines were given are raised and warm to the touch. Oral intake of liquids: normal. There are no other symptoms noted. The following symptoms are denied: fever, vomiting, and diarrhea.
Child vaccinated with Varicella vaccine 08/31/1998.  Mother called 12/27/02 to report child has not broken out with full chickenpox case.  States face, scalp, chest and back covered with lesions. Temperature 99-100 degrees F and headache.
on day p/vax pt devel very mild feverish feeling & sl soreness-main sx was cold sweat, weakness, h/a 9 days later
Patient had 102 fever and flu like symptoms that he went to the emergency room due to symptoms.
Cellulitis - 2 days after. BACTRIM DS 800/160 mg oral tab NORCO 5/325.
Information has been received from a licensed practical nurse, for the Pregnancy Registry for GARDASIL, concerning a 24 year old female with no drug reactions/allergies who was trying to get pregnant. The patient was vaccinated intramuscularly with three doses of GARDASIL (0.5 ml): 1st dose (lot # 663451/0216Y) on 30-JUL-2009, 2nd dose (lot # 663433/0249Z) on 30-SEP-2009 and 3rd dose 663454/0672Y on an unspecified date. Concomitant therapy included prenatal vitamins (unspecified). The patient was given a pregnancy test at the office prior to vaccination of the 3rd dose and it was negative. On 05-FEB-2010 the patient had a positive home pregnancy test. At the time of the report, the outcome was unknown. Follow-up information has been received from the licensed practical nurse and a registered nurse who reported that the female patient was vaccinated intramuscularly with the third dose of GARDASIL at right deltoid on 01-FEB-2010 at 16:38. The patient had three previous pregnancies, one was full term delivered from LMP of 39 weeks, and another one was spontaneously aborted from LMP of 12 weeks, and the third one was electively terminated at unknown weeks from LMP. There were no birth defects in previous pregnancies and infant complications. The current pregnancy's LMP was 05-JAN-2010 and EDD was 16-OCT-2010, conception date was approximately on 19-JAN-2010. On 15-FEB-2010, an ultrasound was tested for early pregnancy and pelvic pain; it revealed that patient had a 4 cm right ovarian cyst, normal yolk SAC. Maternal Serum Alpha-Fetoprotein Screening performed on 30-APR-2010 was negative. On an unspecified date, quad screen was negative. During pregnancy, the patient was placed on therapy with unspecified prenatal vitamins, omeprazole (manufacturer unknown) for gastrooesophageal reflux disease (GERD) and TYLENOL EXTRA STRENTH for discomfort. On 09-OCT-2010, 39 weeks from her LMP, the patient delivered a normal, healthy male baby weighing 7 pounds 14 ounces, length 22 inch, apgar score 9/9 and head circumference 35.5 cm. At the time of this report, the outcomes of GERD, pelvic pain, 4 cm right ovarian cyst and discomfort were unknown. Follow up information was received which indicated that the patient was not the physician's. Additional information is not expected.
back pain; eye pain; sensitive to lights and sounds; sensitive to lights and sound; aches; Chills; excruciating headache; diarrhea; nausea; This is a spontaneous report from a contactable Other HCP. This 50-year-old female Other HCP (patient) reported that: A 50-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201), via unspecified route of administration in left arm on 12Feb2021 at 16:00 (at the age of 50-years old) as dose 2, single for COVID-19 immunization. The patient medical history included Epstein bar virus (at 18 years old), pneumonia and disc herniations. The patient had known allergy to Sulfa. The patient did not receive other vaccine in four weeks of vaccination. The patient had not had COVID-19 prior to vaccination. Concomitant medications received within two weeks included xantofyl (LUTEIN), xanthine, Multivitamin and nortriptyline. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249), via unspecified route of administration in left arm on 22Jan2021 at 16:00 as dose 1, single for COVID-19 immunization. On 13Feb2021 at 02:00 AM, the patient experienced chills, aches, back pain, excruciating headache, eye pain, sensitive to light and sounds, nausea and diarrhea. The patient had not been tested for COVID-19 post vaccination. The patient did not receive treatment for the events. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Had a pulling in his right shoulder and numbness and tingling down his right arm whenever he moved neck up/down to the left side.
ACUTE EMBOLISM AND THROMBOSIS OF LEFT FEMORAL VEIN  Orders from PAC received as resident has partial thrombus distal superficial femoral vein, nonocclusive. Start Eliquis for DVT. Stop Naproxen and Pepto-bismal d/t possible interaction with Eliquis. Resident weight has been increasing and legs are significantly edematous. Increase Lasix to 40 mg daily and f/u in 1 week for recheck.
first day of adverse effects: palpable swelling of left axillary lymph nodes with slight discomfort of area  second day of adverse effects: increased palpable swelling of left axillary lymph nodes with heightened discomfort of area; swelling and redness of area 3 inches in diameter on left arm where injection was administered
One hour after administration of PPD and flu shot, pt "felt dizzy". Stated his skin feels hot but he is cold. No complaints of shortness of breath. Has had no new foods or detergents. Mild urticaria noted on both forearms and hands. No "itching". No treatment given. Pt just wanted it documented.
Rash both times; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash both times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash both times). At the time of the report, RASH (Rash both times) outcome was unknown.            No concomitant medication was provided by reporter. No treatment medication was provided by reporter.    This case was linked to MOD-2021-386112 (Patient Link).
stomach ache; headache; vomiting; This case was reported by a pharmacist via call center representative and described the occurrence of stomach pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, 24 hrs after receiving Shingrix, the patient experienced stomach pain, headache and vomiting. On an unknown date, the outcome of the stomach pain, headache and vomiting were recovered/resolved.   It was unknown if the reporter considered the stomach pain, headache and vomiting to be related to Shingrix.  Additional details were provided as follows: The patient experienced stomach ache, headache, and vomiting after receiving 1st dose of Shingrix. The symptoms lasted for approximately 3-4 days. Consent to follow up was provided. This case has been linked to US2020005575, reported by the same reporter.
7/6/16 Patient in for nurse visit to receive MMR vaccine. (MMR titer was neg) MMR Vaccine given. When charting MMR - I noted patient received on 6/29/16 VARICELLA vaccine - (MMR given to soon) MD aware and follow up with Primary MD.
Week later - redness, swelling, rash, tenderness, knot at and around injection site on left arm.
diarrhea; Fever; nausea; vomiting; This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included diarrhea ('sensitivity reaction (diarrhea, nausea and vomiting) from eating red meats'), nausea ('sensitivity reaction (diarrhea, nausea and vomiting) from eating red meats') and vomiting ('sensitivity reaction (diarrhea, nausea and vomiting) from eating red meats').   On 18th August 2021, the patient received the 1st dose of Shingrix. On 18th August 2021, less than a day after receiving Shingrix, the patient experienced fever, nausea and vomiting. On an unknown date, the patient experienced diarrhea. On an unknown date, the outcome of the fever, nausea and vomiting were recovered/resolved and the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the fever, nausea, vomiting and diarrhea to be related to Shingrix.     Linked case(s) involving the same patient: US2022AMR063926   Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's comment: The reporter was the patient, who called in regarding adverse reactions she had to Shingrix. The patient reported she received first dose of Shingrix and the same evening after taking vaccine she developed a fever and nausea/ vomiting which lasted 3-5 days after and had since resolved.  The patient also mentioned that since receiving Shingrix, she had an increased sensitivity reaction (diarrhea, nausea and vomiting) from eating red meats.  The patient reported that this had been an issue for her since before taking the vaccine but had become markedly worse since Shingrix. She had been evaluated for a possible alpha gal allergy and did not have a diagnosis as of the reporting time.  The reporter consented to follow up. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022AMR063926.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR063926:Same patient/reporter
Significant pain in the injected arm; muscle ache; general malaise; Fatigue; flu/cold like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 38-year old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 18Mar2021 at 10:45 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported and the patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 23Feb2021 at 10:00 (at the age of 38-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 at 08:00, patient experienced significant pain in the injected arm, muscle aches, general malaise, fatigue, and flu/cold like symptoms. No drugs were taken for the treatment of significant pain in the injected arm, muscle aches, general malaise, fatigue, and flu/cold like symptoms. The clinical outcome of pain in arm, muscle aches, general malaise, fatigue, and flu like symptoms was recovering at time of this report.   No follow-up attempts are needed. No further information is expected.
Patient was vaccinated on 2/05/2021 with 2nd Pfizer vaccine and was hospitalized for Guillain Barre On 03/11. Has been In hospital since.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6202), in right arm, on 23Mar2021 as dose 2, single (Lot number: EP6955), in right arm and on 06Jan2022 as dose 3 (booster), single (Lot number: TL3197) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Nerve pain treatment" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: GABAPENTIN taken for neuralgia, start date: May2022. Past drug history included: Metformin, start date: Aug2016, for Diabetes Treatment, notes: medical history: Type 2 Diabetes; Glyburide, start date: Aug2016, for Diabetes Treatment, notes: medical history: Type 2 Diabetes. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I tested myself, and resulted Positive; (05Jul2022) positive, notes: On 05Jul2022, I tested positive for COVID; (16Jul2022) negative, notes: 3 days after finishing Paxlovid, I tested negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid from 07Jul2021 to 11Jul2021 for COVID 19 treatment. On 05Jul2022, patient tested positive for COVID. Received the Paxlovid medication on 08Jul, and immediately took the medicine for 5 days. 3 days after finishing Paxlovid, tested negative. However, as of that morning (22Jul2022), felt a light cough, runny nose and weakness. Tested myself and resulted Positive. Called the COVID nurse [address withheld], and the nurse described his condition as paxlovid covid rebound. He was told to quarantine for five more days without another Paxlovid prescription.
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced a cold sore outbreak appeared on their upper lip. The patient notified the pharmacist about her event. There was no treatment given for the adverse event. The outcome of the event was not reported. The relatedness between vaccination with ZOSTAVAX and the event was not reported. Additional information has been requested.
My eyelids were itching and became swollen and red then it went all around my eyes, I used cream to try and help and CERAVE to help or moisturize plus some steroid ointment about a month later. Most recently or back in November I got alclometasone dipropionate it helped some. In January my entire face was swollen red and itchy and I was prescribed DUPIXENT on 13FEB2023, I had an initial dose but still had problems all over my face, on 20FEB2023 fluconazole was prescribed. On 23FEB2023 I quit taking the niacin I had been taking for years. 27FEB2023 I saw my Dermatologist again and she asked me to stop DUPIXENT and prescribed SOTYKTU tablets and the redness is gone and rash is very minimal.
Patient had MMR #1, Varicella #1 and Hepatitis A #1 vaccines on 9/15/2011. He was seen on 9/23 and 9/24/2011 for fever for three days which father claimed persisted on and off for 8-9 days. Blood and urine cx were negative. Fever went up to 103.5 F. Since then noted by parents with delayed receptive and expressive speech. Today at 4 yo check up MMR declined because of lasting of high fever. His speech is now markedly improved.
HEADACHE; This spontaneous report received from a consumer concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seafood allergy, and shellfish allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 12-APR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Fever, chills, muscle and joint aches, elevated heart rate (85-100bpm at rest), and fatigue from 9pm to about 2am
Menses began 1 week early than normal and was accompanied by significantly more painful cramping than usual. Increased pain and more frequent cramping was present during next pre-menstruatal and menses time. Prior to receiving second vaccine.
Shot administered left arm. About 3 inches below puncture marks, I developed a giant itchy hive measuring about 4"x6". Contacted my doctor who advised using hot compresses and topical cream.
received a dose of the Moderna COVID-19 Vaccine that expired on July 25th; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided.  No treatment medications provided.
Migraine, facial numbness,  dizziness,  ear pain,  chest pain, panic attach
Patient received vaccine and several minutes later, while shopping in store, had ringing in ears and had trouble walking. The mother caught her as she passed out, she did not hit her head. She regained consciousness a couple seconds later and felt very dizzy, nauseous and still had ringing in the ears. She also stated that the light was very bright and that she had a headache. Emergency Services was called and paramedics checked her vitals after escorting  her off the premises.
No other issues or concerns noted; Varivax had a temperature excursion and had been administered; This spontaneous report was received from an office manager, referring to a patient of4 year old of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 07-APR-2022, a temperature excursion was of -6.9 Centigrade degrees (°C), during 9 minutes occurred. A previous temperature excursion was not reported.   On 11-APR-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot# U022320, expiration date 15-JUL-2023, for prophylaxis (strength, dose, route and frequency were not reported). No other issues or concerns noted.  This is one of 4 reports received from the same reporter.
15 min. after shot, nausea, dizziness, 20 min. after, hoarseness, hard to swallow. Emergency room. Epi shot, several medicines. Released after 5 hrs. had hoarseness for next three days.