chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient began feeling bad around 0935. Patient reported feeling a "heaviness" in her chest with tightness in her throat. She reported that her breathing felt normal except for the tightness. Paramedic began treatment of her with BP/pulse OX. An ambulance was called for an EKG. Patient states she had this reaction the first time, but left after her time and that the heaviness in chest and throat tightness lasted about 36 hours. She also reports that this reaction happens with her Ocravus, and they treat her with benedryl and steroids. She states she premedicated with 25mg of benedryl this am. BP at 0947 was 95/68, 92% O2 on Ra and 71HR. She did not see her Dr. Between doses of vaccine, and states she "thinks I should have against my better judgement". Patient given 25mg Benedryl IM at 1002 via right deltoid. 1000 EKG by ambulance NSR  HR 80. 1011- patients states feeling the same/"slightly better. The pressure is in the center and getting smaller. My breathing feels normal. The throat tightness is not getting worse." 1015- patient reports feeling "hazy", states she thinks because of the benedryl. States she will have someone pick her up. 1032- patient reports "feeling back to normal". VS- 116/74, 90HR, 100% O2 on RA. EMS suggests getting checked out at hospital , but patient is denying transport at this time. Patient able to walk downstairs on own accord to awaiting ride. Patient again instructed that if she changes her mind, or begins to feel worse to call 911. Patient states that she understands.
One week after receiving first dose, developed intense itching and redness at area of and surrounding injection site. First time woke me from sleep around 1 AM(?), so unsure how long it lasted.  I forgot about it until it started again. Intense itching started again around 11 AM lasted about 1-1.5 hours. This was first time I looked at it and the area was blotchy, slightly red (~ 5 cm)and there were some urticaria and an underlying rash. Slight redness remained all day. Itching returned several times that day but did not last as long. Hydrocortisone cream helped. It is still present as of today,  but is resolving with intermittent redness and itching.
itchy red circle around inj site w/small induration;generalized urticaria on face, arms & legs;took DPH 8MAY95 f/u series d/c;all events resolved by 3APR95
9 PM c/o pain; AM 7/27 Redness, swelling, pain, heat and itching upper right arm. Ice packs, Tylenol ,Benedryl 12.5/5 2 tsp Q 6 hr's.
Area swelled up 3"-4" in diameter around injection site with red bump also at injection site. Pt had joint discomfort, bilateral. Symptoms persisted for 4 days with swelling still evident.
the patient received improperly stored vaccine at an unspecified date; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) lot # S003865, expiration date: 08-AUG-2020 (exact dose, injection site and route of administration were not reported) for prophylaxis. Administered dose experienced the temperature excursions of 32.5 degrees Fahrenheit (F) for 8 hours. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred.
This spontaneous report was received from a healthcare worker referring to a 4 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 22-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
I later contracted Covid19, on April 19, 2022.  It was not related or a reaction to the vaccine.
Severe pain and swelling of arm above left elbow. This lasted about 3 days. Lessened general energy, poor appetite, occassional dizziness. This lasted 5 to 6 days. Gradual returned pre- vaccination status in 7 days.
Arm hurt for a few days. Pain is gone but now very itchy, has fever and bumps. It has been 2 weeks since and still having these effects. The injection site is red.
patient was given Adacel who turned 65 years old; Initial information received on 02-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 65 years old female patient who received 0.5 ml vaccine intramuscular dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [Adacel] (lot U5771AA, expiry date: 22-Sep-2019) in the right deltoid On 27-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for Immunization.  It was as an actual medication error case due inappropriate age at vaccine administration.   It was not reported whether the patient had any adverse event or not.  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.  List of documents held by sender: none.
I woke up at 5 am (2/20/20) w/my head  spinning, in a sweat, my eyes unable to focus.  Felt very nauseas w/bad case of vertigo.  I got to the bath threw up & kept dry heaving. Sitting on the floor, I phoned Hospital,  and spoke with an ER nurse.  I reported my vaccine, my symptoms and told her I could not drive the 1 mile to the ER.  She indicated these may be some of the serious side effects of the Moderna Vaccine.  At 6am I crawled back to my bed & woke at 9:30 am.  I called store & spoke to the pharmacist who vaccinated me.  He concurs w/the ER nurse.  I am still very weak, still slightly dizzy, and very concerned.  I am a healthy 67 year old, lives by himself & this episode frightened me.
Localized inflammation, soreness and itching of skin at vaccine site; onset on day 8 following vaccine
Woke and had incapacitating vertigo. I was unable to sit up without assistance and focus.
1 hr. after receiving vaccine, developed itching on left wrist, no hives; developed swelling in left hand that continued to the following day.
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with Gardasil. Subsequently the patient had a "terrible reaction to the vaccine". It was reported that the patient had such a bad reaction that she was not allowed to get the next two vaccines. No further information was provided. Additional information is not expected. This is one of two reports from the same source.
PT HAD A VERY SERIOUS REACTION TO THIS - LARGE SWELLING REDNESS, TERRIBLY SORE ARM, BUBBLING SKIN NEAR THE SITE OF ADMINISTRATION. AFTER 5 DAYS IT IS NOW LOOKING LIKE A SMALL SPIDER BITE... SHE SHOWED ME A PICTURE OF IT FROM 1/3 AND EVEN 4 DAYS AFTER THE VACCINE I CAN AGREE SHE SHOULD NOT RECEIVE THE SECOND DOSE AT THIS POINT. NAUSEA AND MUSCLE ACHES (WITH THE ACHES SPREADING TO HER THIGHS) WERE THE MOST SEVERE SHE HAD NOTICE WITH ANY VACCINE
suspected vaccination failure; got it; debilitating pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got the shingle shot and got shingles.  The reporter stated they were painful and over two months of debilitating pain. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case is one of the 8 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178234:Same reporter US-GLAXOSMITHKLINE-US2021AMR178222:Same reporter US-GLAXOSMITHKLINE-US2021AMR178106:Same reporter US-GLAXOSMITHKLINE-US2021AMR178101:Same reporter US-GLAXOSMITHKLINE-US2021AMR138446:Same reporter US-GLAXOSMITHKLINE-US2021AMR179367:Same reporter US-GLAXOSMITHKLINE-US2021AMR179366:Same reporter
35 + 3 G4/P2 with 2 prior vaginal deliveries, EDD 10/01/2021, reaction fine rash over abdomen starting next day, lightheadedness after vaccine. Tachycardia being observed after first vaccination with cardiology and OBGYN.
injection area itching; injection arm hurt a little/injection arm tender; injection area swollen; injection area red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection area itching), VACCINATION SITE PAIN (injection arm hurt a little/injection arm tender), VACCINATION SITE SWELLING (injection area swollen) and VACCINATION SITE ERYTHEMA (injection area red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was given.     On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (injection area itching), VACCINATION SITE PAIN (injection arm hurt a little/injection arm tender), VACCINATION SITE SWELLING (injection area swollen) and VACCINATION SITE ERYTHEMA (injection area red). At the time of the report, VACCINATION SITE PRURITUS (injection area itching), VACCINATION SITE PAIN (injection arm hurt a little/injection arm tender), VACCINATION SITE SWELLING (injection area swollen) and VACCINATION SITE ERYTHEMA (injection area red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants were not provided. Treatment was not given.
no additional AE's were reported; that the patient was given her second dose of GARDSIL 9 one month after her first dose instead of two months after the first dose; This spontaneous report was received from a medical assistant and refers to a female of unknown age.  The pertinent medical history, concomitant medications or drug reactions and allergies were not reported.  On an unknown date in January 2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis. On 25-FEB-2023, she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, injection, 0.5 milliliter, lot #U031056, expiration date 16-JUN-2024, administered intramuscularly (injection site was not provided)f or prophylaxis. The patient was given her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) one month after her first dose instead of two months after the first dose (inappropriate schedule of product administration). No additional adverse event was reported.
Approximately 1 week after my 3rd dose I experienced the following symptoms: Left upper arm pain and as of today 04/19/2022 I have difficulty moving my left arm and shoulder. I saw my doctor and had a steroid injection, it helped ease the pain but I can still feel it until now.
Kinrix and Pediarix administered same day; 4YO received 1st Pediarix after 1st Kinrix; 1st Kinrix 07Dec2022, 2nd 16Jan2023; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number TS425, expiry date 21st October 2024) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + POLIO VACCINE + TETANUS VACCINE TOXOID (KINRIX).   On 16th January 2023, the patient received the 2nd dose of Kinrix, Kinrix Pre-Filled Syringe Device, the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 16th January 2023, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose, inappropriate schedule of vaccine administered and extra dose administered. On an unknown date, the outcome of the overdose, inappropriate schedule of vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 17-JAN-2023 Reporter comment: Assistant manager/medical assistant inquired that, how to proceed with patient receiving two DTaP-IPV. The assistant manager reported a 4 year old patient received both Kinrix and Pediarix on 16th January 2023. The assistant manager mentioned this was the patient's second dose of Kinrix, the first dose was administered on 7th December 2022. This was only the first dose of Pediarix patient received. The patient was playing catch up on vaccines. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Kinrix and 1st dose of Pediarix on same day, which led to overdose, extra dose administered and inappropriate schedule of vaccine administered.
Information has been received from a 61 year old female patient concerning herself with allergic to sulfa. No pertinent medical history was reported. On 07-MAY-2015 the patient was vaccinated with ZOSTAVAX (lot # K010969, expire date unspecified). Concomitant therapies include Loratadine and Triamterene. On 09-MAY-2015, the patient experienced redness, itching, swelling, tenderness and "an area about the size of a large egg" at the injection site after receiving ZOSTAVAX. The patient sought medication attention. Ice, hydrocortisone treatments were given to the patient via contacting pharmacist. At the time of reporting, the patient was not recovered form the adverse events. Additional information has been requested.
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history.). On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. No concomitant information provided. No treatment information provided.
PT WAS ASKED TO VERIFY AGE- PT STATED HE WAS 18- PT INFORMED THE MODERNA VACCINE IS APPROVED FOR 18 YEARS OF AGE AND OLDER.  VACCINE ADMINISTERED.  AFTER VACCINE CLINIC DURING DATA ENTRY IT WAS DISCOVERED THAT THE PT. WAS ACTUALLY 17.
Cellulitis of Right deltoid. Rx - Prednisone x 4 d. Will see her again in 3 days pro.
received the first Moderna shot on 03/17/2021 @approximately 6pm. waited the required 15 minutes and drove home.  on the way home, face started getting numb on the right side. right eyelid, right nostril, right side of lips, right cheek and right ear.  this lasted for approximately 2 and a half days.  received the second Moderna shot on 04/14/2021 @ approximately 6pm. asked pharmacist about reaction from the first shot. she suggested i wait in the store for 30 minutes. my face started getting numb on the right side before I left the store, but not as much as it did with the first shot. my right outer eyelid, right outer lips, and right cheek felt numb. it is approx 2pm on 04/15/2021 and my face still feels slightly numb.  sore arm at the injection sight with both shots but seemingly no other reaction.
Pt. passed out at home in the afternoon after receiving HD Flu vaccine around 9:15 AM. Pt. reported having chills. Advised husband to call physician.
Heart rate 100bpm for 14  hours continuous,  103 degree fever, Chills, sweats, balance problems, vision extremely blurry, shoulders weak enough to make my hands shake when lifting an 8 oz. glass of water, non stop headache, lost control of my bladder several times, spent nearly 36 hours in bed
Patient states that about 8 hours after getting vaccine, she was extremely sick and could not get out of bed for 4 days afterward. She stated she felt lethargic, "sick", and overall ill. She was not specific about what types of symptoms she had or anything else.
The patient was administered the wrong vaccination. She was administered with the pediatric dose of Pfizer instead of the normal Pfizer booster dose. The physician and head pharmacist was informed. We administered another pediatric dose as per physician and pharmacist orders and monitored the patient for 30 minutes.
Joint Pain; Chills; Fever; Tiredness; Feeling Unwell; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration on 16May2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Other vaccines within four weeks prior to the vaccination was not reported. On 16May2021, the patient experienced joint pain, chills, fever, tiredness, feeling unwell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events joint pain, chills, fever, tiredness, feeling unwell was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
no aditional AE; patient ws vaccinated with VARIVAX that experienced a temperature excursion; This spontaneous report was received from medical assistant and refers to a 1 year-old female patient.  The patient's medical history, concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 18-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX)  lot #W003819 expiration date reported as 24-FEB-2022 but upon internal validation was set as 02-FEB-2022, administered subcutaneously on the left thigh as prophylaxis (strength was not provided) following a temperature excursion of  14 degrees Fahrenheit (F) up to 46 F for 1 hour 30 minutes data logger involved (product storage error), it was mentioned that no previous temperature excursion occurred. No additional adverse event was reported.; Sender's Comments:  US-009507513-2208USA008462: US-009507513-2209USA008834: US-009507513-2209USA008720: US-009507513-2209USA008835:
Approximate 2 inch circle of rash/hives at sight of injection; skin was hard to the touch; moderately itchy.  Applied Benadryl ointment twice per day.  Circle grew larger on next couple of days.  Then started to go away in center portion with noticeable red ring at outer edge of circle remaining.  It was gone in 5 days.
Redness and warmth to Rt deltoid area slight itching 2-4 welts near area of injection site. Apply ice pack as needed Benadryl tablets for itching as needed
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: experienced mild nausea/sweating/dizziness- monitor blood pressure- over the course of 30 mins- felt better after 45 mins- gave water- asked to sit for 10 more minutes
I began feeling weak and fluey around 8:30 or 9:00 pm. I decided to go to sleep around 10, noticed my fingers had turned yellow and lost all circulation. I went downstairs to ask my dad what to do, and immediately felt like I was going to faint. Sat down on a chair and put my head between my legs, but passed out as I was doing so, and fell on the floor. According to onlookers (brother and sister, who is an EMT) I was convulsing and stopped breathing for about thirty seconds, and my eyes were glassy and rolling. I woke up to my sister telling me to breathe. There was blood on the floor (I had hit my face on the way down) and I was trembling uncontrollably and had wet myself. I was awake and aware of my surroundings, and remembered everything up to and including sitting sitting on the chair before I passed out. My brother had called 911 while I was out and an ambulance came within five minutes. The paramedics put me in the ambulance and took me to the hospital (they would have taken me to local except there was risk that it was a seizure, which I guess local isn't equipped to handle). They measured my vital signs, made IV ports in my arms and drew some blood. My blood pressure was super low and my heart rate was super high,  and I had a temperature of 102. When I got to the hospital they put two liters of saline drip into me to rehydrate me, did a CAT scan, and some bloodwork. They discharged me around 3:30 AM on Monday morning, told me to stay hydrated and get a lot of rest. I slept all day yesterday (Monday) and was feverish and weak. By today (Tuesday) I think I have mostly recovered.