chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 24-JUL-2018, the patient was vaccinated with improperly stored doses of Oka-Merck PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. DILUENT MRK INJ was properly stored. No adverse effects were reported. No product quality complaint was involved. The Oka-Merck PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381:Original Case : 1808USA001261 US-009507513-1808USA004382:Original Case : 1808USA001261 US-009507513-1808USA004383:Original Case : 1808USA001261 US-009507513-1808USA004384:Original Case : 1808USA001261 US-009507513-1808USA004385:Original Case : 1808USA001261 US-009507513-1808USA004380:Original Case : 1808USA001261 US-009507513-1808USA004379:Original Case : 1808USA001261 US-009507513 1808USA004376:Original Case : 1808USA001261 US-009507513-1808USA004377:Original Case : 1808USA001261 US-009507513-1808USA004378:Original Case : 1808USA001261 US-009507513-1808USA004386:Original Case : 1808USA001261 US-009507513-1808USA004387:Original Case : 1808USA001261 US-009507513-1808USA004388:Original Case : 1808USA001261 US-009507513-1808USA004362:Original Case : 1808USA001261 US-009507513-1808USA004363:Original Case : 1808USA001261 US-009507513-1808USA004364:Original Case : 1808USA001261 US-009507513-1808USA004389:Original Case : 1808USA001261 US-009507513-1808USA004390:Original Case : 1808USA001261 US-009507513-1808USA004392:Original Case : 1808USA001261 US-009507513-1808USA004393:Original Case : 1808USA001261 US-009507513-1808USA004394:Original Case : 1808USA001261 US-009507513-1808USA004395:Original Case : 1808USA001261 US-009507513-1808USA004396:Original Case : 1808USA001261 US-009507513-1808USA004365:Original Case : 1808USA001261 US-009507513-1808USA004366:Original Case : 1808USA001261 US-009507513-1808USA004367:Original Case : 1808USA001261 US-009507513-1808USA004397:Original Case : 1808USA001261 US-009507513-1808USA004398:Original Case : 1808USA001261 US-009507513-1808USA004399:Original Case : 1808USA001261 US-009507513-1808USA004368:Original Case : 1808USA001261 US-009507513-1808USA004369:Original Case : 1808USA001261 US-009507513-1808USA004400:Original Case : 1808USA001261 US-009507513-1808USA004401:Original Case : 1808USA001261 US-009507513-1808USA004370:Original Case : 1808USA00126.
This spontaneous report as received from a other health professional refers to unspecified multiple patients of unknown age. On an unknown date the patients were vaccinated with PEDVAXHIB lot # N007751 for prophylaxis.  On an unknown date the patient experienced incorrect product storage and no adverse event.  The reporter considered incorrect product storage and no adverse event to be not related to PEDVAXHIB. Sender's Comments: US-009507513-1709USA000333.
10 x 7 cm erythemia and swelling mild discomfort,  TReatment was ibuprofen and benadryl
Pt developed signifgant edema around injection site with itching - no systemic s/s.
Pt recvd vax & devel rash @ inj site & fever recurred;no further details were provided;
My daughter got HPV, DTap and MMr vaccines for middle school all in same evening. Arms were sore but otherwise was fine till next morning. Around 6:00am the next morning my daughter crawled up to my bedroom and was pale as a ghost and complained of feeling like she was going to pass out. This has never happened before and has no medical issues. I stayed with her and got her something to eat. About 30 min later started to feel better. Unsure if due to vaccine or not but hasn't happened again since. Unsure rather to do 2nd vaccine?  Sorry concerned mom.
Large red extremely painful swollen knot at the site of injection. Looks like a poisonous spider bite.
Incredible red site at injection part; Severe nausea; soreness at injection side; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Incredible red site at injection part), NAUSEA (Severe nausea), VACCINATION SITE PAIN (soreness at injection side) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E219) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Asthma, Drug allergy (Allergic to Sulfa) and Drug allergy (Allergic to Cephalosporins).    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Incredible red site at injection part), NAUSEA (Severe nausea), VACCINATION SITE PAIN (soreness at injection side) and HEADACHE (Headache). At the time of the report, VACCINATION SITE ERYTHEMA (Incredible red site at injection part) and NAUSEA (Severe nausea) had not resolved and VACCINATION SITE PAIN (soreness at injection side) and HEADACHE (Headache) was resolving.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Patient confirmed the correct spelling of their email address since previously documented was incorrect. Patient would like a follow up from Safety.   This case was linked to MOD-2021-364875 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Follow-up document received on NOV-1,contains non significant information -Contact info updated
pt recv vax 7NOV97 &  10min p/vax devel a sudden onset of welts around face & neck area;also exp lightheadedness, pounding in chest, palpitations (102-120), inc heart rate (120), feeling hot, elevated BP 140/80 & had obvious rash;to ER
I received my second dose of the Moderna vaccine in my right deltoid in 1 May 2021. All my joints were very painful and sore for about two weeks. I took acetaminophen at least once a day during this period, I cannot take NSAIDs,  After this, I notices my right pinkie tingled. My assumption was that this was the beginning of a repetitive stress injury and I wore a wrist braces. Over the next month, my ring and middle finger became numb as well and I could not control these three fingers at all,. I had minor pain in the location I received the injection if I touched or engaged the muscle.  I made a video appointment on 24 June with the earliest available doctor. She is not my regular primary care doctor, so I made a second in person appointment with another doctor for 2 July. The first doctor also thought this was probably an RSI and recommended I keep the arm straight with a brace or towel wrapped around it, The second doctor had the advantage of seeing me in person. I did not present with any typical RSI symptom. She consulted with someone out of the exam room and returned to refer me to a neurologist. I met with a third doctor on 6 August where he and his staff did several tests ordered labs and MRIs for further work up and followed up with me on 23 August after the blood tests returned. I will still have an MRI in September.  The diagnosis is:  (D89.89,  G63) Immune-mediated neuropathy (MA-HCC)  (primary encounter diagnosis) (G54.0) Brachial plexopathy without trauma   Positive asialo-GM1 and GD1a antibodies supporting immune-mediated neuropathy in the form of Parsonage-Turner  syndrome (idiopathic brachial plexitis).  It is likely a variant of Guillian-Barre syndrome (AIDP, Acute Inflammatory  Demyelinating Polyradiculoneuropathy), and may be triggered by Covid-19 vaccination.  I have not had a COVID test, but I have not been ill at all since early 2020. I work at home and my family and I rarely go inside public places beyond the doctor's office. l. I always wear a mask even after restrictions were lifted.
About two weeks after receiving the Moderna shot my upper right arm got red and itchy. It also felt warm to the touch.
Moderate to severe burning affect on left side on tongue. started almost day after or so still having it as of now 4/9 but little better than before.
Fever   Fatigue, possible Celulitis  Narrative:  Vaccinated on 12/29. Developed symptoms on 12/30. Arm became Red, tiredness, fatigue, Temp 99.9, Arm became sensitive to touch. Felt arm was getting better over the holiday. Called clinic on 01/06/2021 to report arm still sore, sensitive with redness. Advised to seek care from PCP.
Information has been received from a health professional concerning a 18 month old female patient, who on 01-JUN-2012 was vaccinated with a dose of VARIVAX (Merck) (lot number 670992/0822AA, expiration date June 2013) (dose and route and not reported). It was reported that on 12-JUN-2012, the patient experienced swelling on the leg, fever, leg became itchy, leg became red and leg became warm to the touch. At the time of the report, the patient had recovered (date not provided). It was unspecified if the patient sought medical attention. This is one of several reports from the same source. Additional information is not expected.
Pt received inj 12/18/09. Mom states he had pain and swelling at inj site. Fever lip swelled with blisters. Mom states she talked doctor 12/20/09. She states BENADRYL has helped feeling better today 12/21/09,but arm right is still tender.
Narrative:  COVID infection following COVID vaccine series 03/09, Pfizer, dose #1 04/02, Pfizer, dose #2 08/03 pt cc: cough, diarrhea, cold like symptoms , headache exposure: "patient claims a lot of people from her work were positive for COVID19" 08/04 COVID swab, result: detected 08/05 pt cc: cough, diarrhea, fatigue, fever, headache, myalgias, sore throat 08/06 pt cc: cough, fever, myalgias 08/07 pt cc: cough, fatigue, loss of taste or smell symptoms are improving 08/08 pt cc: cough, fatigue symptoms are improving 08/11 pt cc: bilateral leg numbness 08/11 ED admission with cc: tingling in her extremities and face, fatigue, malaise 08/12 SARS COV-2 LINEAGE result: AY.4 08/12 SARS-COV-2 CLADE result: 21A Delta
Headache,  Chills,  Fatigue,  sore joints, nausea
-pt fainted outside the store in parking lot - called 911 . pt was conscious and breathing . 911 advised to see primary care doctor
6 cm in diameter to left and right deltoid area where shots were given. Erythema and induration.
Had IPV vaccination that evening patient had a fever 104 deg per mom at 6pm 1 episode of sweats at midnight. temperature increased to 101 deg had decreased appetite. Given Tylenol the next am-patient feel better.
(6:55 pm) feels nauseated.  Dizzy 15 minutes after.  Also took a WAL-ZYR (5 minutes after the flu shot).  BP went down from 150/80 at 6:45 pm to 130/80 (7:25 pm) after 30 minutes. Pt seemed normal after that.
Nausea; Stomach Cramps; Chills; Itching; Initial Report Received 30-Jan-2020 and 31-Jan-2020  A physician reported a 42-year-old female employee received her first injection of HEPLISAV-B (Lot #933621) in Jan-2020. No concomitant vaccinations were administered. Two to three hours after injection, the employee experienced nausea, stomach cramps, chills, and itching. No treatment was administered, and all events resolved within a day.     None of the events were reported as serious.    Company comment. The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
The patient is HIV positive. The prescriber sent in an RX for Prevnar 13 but Prevnar 20 was administered instead. Patient has not reported any effects post vaccination, but Prevnar 20 does not have evidence based recommendations for HIV positive patients.
On 12/9/22, I had Flu like symptoms and that lasted for a couple days. I tested for COVID-19, and it was negative. I had a friend call me and tell me she tested positive on 12/14/22. I took another test and was positive. I had no symptoms at all, but I was testing positive. On 12/26/22, I came down with a bad cold that kept getting worse, so I went in to see urgent care. They prescribed azithromycin and benzonatate. I did not take the benzonatate because I wanted to cough up all the Phlegm. I was still not better, so I called my PCP, and they renewed my montelukast and albuterol. I still wasn't getting better, so I had to go back to urgent care on 3/15/23. They said because of all the respiratory issues I was having, that I was having a hyperactive Immune response. I was prescribed a nebulizer and prednisone. They also did a chest x-ray and it showed Minimal Bibasilar Atelectasis Changes.
Information has been received from a nurse concerning a 16 month old male patient who on 12-FEB-2009 was vaccinated with the first dose of ROTATEQ (lot # 662825/1168X). On 15-APR-2009 the patient was vaccinated with the second dose of ROTATEQ (lot # 663396/1724X). On 15-JUN-2009 the patient was vaccinated with the third dose of ROTATEQ (lot # 663842/0068Y). On 29-MAR-2010 the patient tested positive for rotavirus after being fully vaccinated with ROTATEQ. The patient went to doctor's office for medical attention. The patient was treated with diet and fluids and was improving. This is one of several reports from the same source. Additional information has been requested.
arm swollen; arthritis; wrist carpel tunnel flares up; Arm is hurting especially under her armpit; 2 fingers same arm are hurting; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), PERIPHERAL SWELLING (arm swollen), ARTHRITIS (arthritis), WRIST DEFORMITY (wrist carpel tunnel flares up) and PAIN IN EXTREMITY (Arm is hurting especially under her armpit) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included SIMVASTATIN, LISINOPRIL, LEVOTHYROXINE SODIUM (LEVOTHROID), AMLODIPINE and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.  Treatment medication includes Tylenol for arthritis.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 24-Feb-2021, the patient experienced PERIPHERAL SWELLING (arm swollen), ARTHRITIS (arthritis), WRIST DEFORMITY (wrist carpel tunnel flares up), PAIN IN EXTREMITY (Arm is hurting especially under her armpit) and PAIN IN EXTREMITY (2 fingers same arm are hurting). The patient was treated with PARACETAMOL (TYLENOL) for Arthritis, at an unspecified dose and frequency. On 29-Jan-2021, PAIN IN EXTREMITY (arm was sore) had resolved. At the time of the report, PERIPHERAL SWELLING (arm swollen), ARTHRITIS (arthritis), WRIST DEFORMITY (wrist carpel tunnel flares up), PAIN IN EXTREMITY (Arm is hurting especially under her armpit) and PAIN IN EXTREMITY (2 fingers same arm are hurting) outcome was unknown.          This case was linked to MOD-2021-044410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: declined further follow-up
the plunger was more difficult than usual, sprayed some of the injection out upon removing the needle from the consumer arm/No AE; the plunger was more difficult than usual, sprayed some of the injection out upon removing the needle from the consumer arm/No AE; the plunger was more difficult than usual, sprayed some of the injection out upon removing the needle from the consumer arm/No AE; Initial information received on 11-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of an unknown demographics who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ221AB via unknown route in unknown administration site on 10-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to vaccine underdose and Exposure via skin contact. It was also the case of syringe issue. A pharmacist reporting having difficulty while pressing down the plunger of 1-Fluzone High-Dose. The caller reported that the consumer had her injection on 10Sep2019; that the plunger was more difficult than usual; that she has given this injection many times without an issue; that she is down to the last syringe from this LOT; that she may have sprayed some of the injection out upon removing the needle from the consumer arm; that the syringe was empty upon observation; that she does not recall any visible defect in the syringe, plunger, or needle; that she does not look too close to the needle prior to injection; that at the injection site there was not seen any liquid; that it is unknown to the caller where the consumer felt the wetness; that the syringe has been disposed of; and that the medication was not exposed to anything in the environment out of the ordinary storage.  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.  Documents held by sender: none.
Vertigo and tingling in hands. Patient had to lie down for approximately 10 minutes.
17 year old patient with no known allergies who was given 1st dose of Pfizer vaccine at 1655. At 1700 during observation patient mentioned to the mother that she was not feeling well, was slumped over. The RN on observation noticed that she was apneic, whole body  was rigid. Vital signs at 1701: BP 153/88, HR: 64. Oxygen saturation 99%. After 5 minutes a recheck of the vital signs: BP 115/74, HR: 64. Oxygen 97%. Patient did state that she gets anxious when she gets shots.The paramedics were called. Vital signs on arrival: 117/83, HR: 58, Oxygen saturation 100%. Blood sugar 70. After a few minutes patient stated that she was feeling a little better. Patient was able to walk to the ambulance for them to perform an EKG: Results were  normal sinus bradycardia.(Patient is an athlete). Patient's mother declined further treated and signed AMA form.
On the evening of 7 days post vaccine through day 9 post vaccine I developed a red raised, hot, and slightly itchy rash (about the size of a deck of cards) on the arm that I received the vaccine and right around the injection site. This did not require any medication and resolved on its own within a few days.
I woke up Sunday morning with sores on both my elbows. I cleaned them and put antibiotic cream on them. Monday they were very tender to the touch. Monday evening they were both warm to the touch. I messaged my primary care physician photos and asked if there's anything else I should do if they don't clear up.
This spontaneous report was received from an office manager and refers to a 4-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 07-DEC-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Patient started running fever of 102 degrees that lasted about 30 hours. Her Right upper arm became swollen, hot and has a knot. She stayed in bed all day Saturday and her face turned very red. She also had muscle and joint pain. She is better now but still has a knot where shot was given.
EXTREMELY BLOOD SHOT EYES, EXTREMELY SORE THROAT, CONGESTED CHEST AND COUGH, CHILLS, HEADACHE. SYMPTOMS LASTED 8HR - 24 HRS.  TOOK BENADRYL AND IBRUPROFEN.
Severe pain at injection site. Severe chills. Fatigue. Mild nausea.
pt to ED with dyspnea, productive cough, fever, chills; admitted to hosp; positive for COVID; treated with ABX, steroids, O2 supplementation, dexamethasone; HFNC with overlying NRB; experienced A Fib with RVR; pt's condition declined; transitioned to hospice care and died in the hospital
Pt recvd 3 doses of Engerix-B & following 3rd dose exp hives @ inject sit; no known tx;
No additional AE details were provided; patient was administered a dose of PNEUMOVAX 23 after it expired.; This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-FEB-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliter, lot #U026796, expiration date: 28-JAN-2023 (strength, anatomical location, and route of administration were not provided) administered as prophylaxis (Expired product administered). No adverse events were reported.
The inj site is really red about the size of a tangerine, round shape,  Itchy comes and goes.  The circle were there 12/31-1/2, Gone 1/4-1/6, The 1/7-1/8 it came back. Gone 1/10 and returned 1/11/21. Some days it looks red purple, raised some times.