chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report concerning an 11 years old female patient was received from a medical assistant via a company representative. The patient's concurrent conditions and medical history were not provided. On 25-AUG-2016 (reported as a week ago), the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route, lot and expiration date were not provided). and had a fainting episode (syncope). After that, on an unknown date in 2016, the second dose of GARDASIL 9 was given, but when administered, the patient tensed up (tension) and were unable to pull out the needle (needle issue). It was reported that an unspecified treatment was given for the events of syncope and tension. There were no concomitant medications. The patient recovered from the events of syncope and tension on an unknown date in 2016. The reporter did not assessed a causality between the events of syncope and tension, and the therapy with GARDASIL 9. The reporter did not considered the events of syncope and tension as life threatening. Additional information has been requested.
Headache, Myalgia, Arthralgia & Fever Narrative:  flu-like symptoms causing employee to miss 1/2 of work day
Patient called and stated they are having a 2 inch across and 1/4 inch down sized local red spot. Patient states it is slightly raised and itches.
currently on my third go-around\ suspected Vaccination failure; currently on my third go-around; This one Hurts; itched; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 82-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (At age 12) and shingles (at age 62).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, pain and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles at ages 12 and 62. The patient stated he/she Shingles vaccine was hurts, 1st 2 only itched. The patient stated he/she had two different shingles vaccinations and had shingles (currently on third go-around). The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
I started breaking out in hives/rash on January 27th at church. I was itching all over. I took a benadryl to help. Since then I have continued to break out in spurts. The site will start itching on my body and not stop until I itch it, then it goes away and pops up somewhere else. I have not changed laundry detergent, eating habits or environments. The only thing new to me would be the vaccine. with it being almost 8 days onset from vaccine, I didn't think that would be the problem. I can't figure it out though. I spoke with Doctor this morning and she said it was best to report because it could be an adverse reaction.
earache; red rash at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR PAIN (earache) and VACCINATION SITE ERYTHEMA (red rash at injection site) in an 80-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.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced EAR PAIN (earache) and VACCINATION SITE ERYTHEMA (red rash at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EAR PAIN (earache) and VACCINATION SITE ERYTHEMA (red rash at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment details included Tylenol ( paracetamol )
RASH/HIVES ON NECK AND TORSO.  MOM STARTED GIVING DIPHENHYDRAMINE ON 9-15-16.
Vaccine expired (8/26/22) and was administered to the patient. Patient was observed for 20 minutes after administration and no side effects noted. Spoke with the manufacturer of the vaccine. That patient must receive this vaccine again as the expired dose does not count.
Patient stated "I had severe stomach pain". "I went to ER and they gave me a cocktail and made my throat numb." "I stopped the vaccine and all my symptoms went away."
patient was given an expired Daptacel / no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old patient who received 0.5 ml dose of  DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5254aa (Expiry date 18-Sep-2019) via intramuscular route in the right arm on 30-Sep-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to Expired vaccine used.  At a time of reporting 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.  List of documents held by sender: none.
Gastroparesis, illeus secondary to gastroparesis, is an inflammation of the pancreas.
Devel t104.2 R ped Advil given x 2 days w/vomiting; rash started 18SEP (now over entire body) followed by inconsolable crying but temp down to 101 R; Seen by MD dx strep throat & rxn to imms, probably pertussis; suggested DT be given herea;
Aches, chills, then later a headache on the first night; diarrhea the second day; two days later - better
7 days after DTAP vaccination, baby came down with a high fever - 104.5-105 degrees at one point. Fever lasted 5 days and then baby broke out in rash. Urine test and throat culture showed no infection. Pediatrician said it was a viral infection. Baby was not knowingly exposed to anyone else who was sick.  Baby still irritable
gave the adjuvant only of the Shingrix vaccine; gave the adjuvant only of the Shingrix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-OCT-2023, the patient received Shingrix. On 26-OCT-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: gave the adjuvant only of the Shingrix vaccine) and inappropriate dose of vaccine administered (Verbatim: gave the adjuvant only of the Shingrix vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-NOV-2023 The healthcare professional called to report that one of their staff gave the adjuvant only of the Shingrix vaccine to a patient which led to to inappropriate preparation of medication and inappropriate dose of vaccine administered.
I have on and off fever, vomiting, nausea, chilling. The problem is I am currently spending tourist visa-May 9 to May 16- with my mom and my 3 kids and they trace my 40.3 fever, that time only small cold I have when I enter, I inform them of my hpv vaccine and show when the pack indicating the shot given May 7 night time by my auntie doctor, I trust my doctor auntie because she take also same brand, she is working in dept. of health - CERVARIX by glaxo smith kline-, I am now starting cough -May 10- and continuos on and off chilling 4 to 5 times a days. Now I am depressed, there is no way that I can accompany my kids, this is 1st time for them to go outside the country and happiness experiencing disneyland, I am new and I don't know where to ask help beside my fund is enough for our trip. Until now may days the side effect I dont know. The happiness with kids is really cannot paid by money, the sadness of them without me is a lifetime bear in their mind that their mom is not with them only their grandmom that also suffers pelvic muscle pain due to aging. Please tell me that what are the medicines I need to take ...I have paracetamol, vit.c. multivitamins and b1-6-12. . .my location is in hotel I am here until May 11, 2011 and will move - I need your urgent reply, I am really afraid. I tick all the box in "B" because I cannot pursue if I will not put a tick. This is bias, only adverse effect supposed to be.
Routine mammogram showed a lump. There was a biopsy on February 9th that came out atypical ductal lobular hyperplasia, pre-cancerous, we ended up doing a lumpectomy for it on March 22nd and that was at hospital. Pathology showed the same thing on multiple spots. They did put me on chemo prevention which is an oral medication that is a five-year course. Surgeon also saw: Nurse Practitioner at the clinic.
Fever of 103 F, took two 500 mg Acetaminophen. Fever NOT reduced by 1:00 P.M.
Temporary paralysis in limbs and trouble breathing.  Started as tingling and numbness in body. Both lasted for 5-10 minutes and then went away
CLIENT BROKE OUT IN SMALL RED PAPULES ALL OVER BODY, FIRST NOTED IN EARLY AM HOURS OF 11-06-2008.  CLIENT HAD ALSO RUN LOW-GRADE TEMPERATURE THROUGHOUT NIGHT.  IMMIS WERE GIVEN ON 11-05-2008.  MOM GAVE BENADRYL EVERY 6 HOURS, STARTING ON 11-06-2008 UNTIL 11-07-2008.  STATES RASH RESOLVING BY 11-07-2008 AM.  CLIENT WAS ALSO RX PREDNISONE 5MG-5ML 2CC BID FOR 7 DAYS.  UNSURE HOW LONG MOM GAVE THE MEDICINES.
@ 9PM evening of the day vax was given, pt vomited once & had a fever according to parents up to 104.8 R; cont w/APAP; temp nl next day;
Vaccination around noon. Around 6 pm patient had chest pain not relieved by antacids. Went to emergency room for cardiac event and had an myocardial infarction with 3 stents placed. No prior history of heart problems.
HOT FLASHES, TINGLING IN HANDS AND FACE, FACIAL FLUSHING, DIZZINESS. PATIENT STAYED SEATED AND MONITORED FOR 20 + MINS BEFORE PARAMEDICS WERE CALLED. VITALS WERE CHECKED BY EMS, ELEVATED HEART RATE AND BLOOD PRESSURE. BLOOD SUGAR NORMAL. SYMPTOMS LASTED FOR ABOUT 40 MINS THEN PATIENT LEFT FOR HOSPITAL. DECLINED AMBULANCE TO HOSPITAL.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up. This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    60 doses was received to several patient from Lot AS7148B. Concomitant medications were not reported.  No treatment information was provided   This case was linked (Patient Link).
Dizziness, sudden onset 6-26-10, seen in emergency room at Medical Center treated with ZOFRAN, meclizine, IF fluid, discharged to home.
After initial dose of vaccine, eczema patch begun spreading up my arms (had only previously had it on my hands).  Some mild lymph node swelling and general fatigue between the first and second vaccine dose. After the second dose I had severe lymph node swelling (up to a baseball size lump under my arm). Within a week of the second dose, I was treated for a sinus infection (though had no symptoms such as congestion) with antibiotics and steroids. After going off steroids, the eczema rash that had occurred after the first shot cropped up again and spread from my scalp to my knees and was extremely itchy. I also had painful, swollen lymph nodes from my ears to collar bone. I was not wheezy, but was coughing and had a tight feeling in my chest frequently. I had to do 2 rounds of steroids, increase antihistamine doseage, and begin a steroid cream (topical). I also had to decrease my immunotherapy doseage significantly because I had more severe responses to my injections. My skin finally cleared after about 4 months though I am still having to take increased medication dosages and decreased immunotherapy doseages.
covid vaccine injection site turned pink and felt hot; covid vaccine injection site turned pink and felt hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) based on information received by Pfizer. (manufacturer control number: US-AMGEN-USASP2021072816.  A 73-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for covid-19 immunisation. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "covid vaccine injection site turned pink and felt hot".  No follow-up attempts possible. No further information expected.
Fell asleep for over 4 hours and could not wake up; Crushing headache; Bad fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Fell asleep for over 4 hours and could not wake up), HEADACHE (Crushing headache) and FATIGUE (Bad fatigue) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Fell asleep for over 4 hours and could not wake up). an unknown date, the patient experienced HEADACHE (Crushing headache) and FATIGUE (Bad fatigue). At the time of the report, SOMNOLENCE (Fell asleep for over 4 hours and could not wake up), HEADACHE (Crushing headache) and FATIGUE (Bad fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
TOOK SECOND DOSE ON DAY 4; TOOK UNREFRIGERATED VIVOTIF DOSE; A spontaneous case report was received from a caregiver on 17-Jun-2019 for four consumers.  Based on the information obtained from the caregiver, four individual case safety reports PVX201906-000505 (PVX2019-1565; 14-year-old male consumer), PVX201906-000506 (PVX2019-1566, 10-year-old female consumer), PVX201906-000507 (PVX2019-1567; 13-year-old female consumer), and PVX201906-000508 (PVX2019-1568; 16-year-old female consumer) were created and cross-linked in the database.  This case describes a 16-year-old adolescent female consumer who "took second dose on day 4" and "took unrefrigerated Vivotif dose". The consumer was receiving oral Vivotif (one capsule every other day) (lot number: 3003277) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 14-Jun-2019 and took the second unrefrigerated dose a day late that was on 17-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the events was unknown.  Company's Comment: The causality of the events "took second dose on day 4" and "took unrefrigerated Vivotif dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the events "took second dose on day 4" and "took unrefrigerated Vivotif dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201906-000505:
Dizziness, Headache, Myalgia, Arthralgia, Fever, ErythemaMultiform, NauseaVomiting, Tachycardia,  Chills, Dyspnea, Fatigue, Injection site pain, Rigors, Swelling at injection site Narrative:  with in 15 min rapid heart beat, baseball size swelling, and itched after 48hrs red hot; weak after the ED visit as my muscles had spasms, felt chest tightness till 02/06/21  Other Relevant History:
This spontaneous report was received from a nurse practitioner via a company representative and refers to a 13 year old non-pregnant female patient. There was no information regarding the patient's pertinent medical history, drug reactions or allergies provided. The patient did not take any concomitant medications. On 16-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # reported as K010215 (verified to be invalid), expiration date 05-MAY-2017; exact dose was not reported), frequency reported as 0, 2 and 6 months, intramuscularly. On the same day, when the patient was at the provider's office she felt hot and lightheaded. Subsequently, she passed out and began shaking. The patient received an unspecified treatment for the events, but she did not seek any medical attention. The outcome of the events was reported as recovered on an unspecified date in August 2016. The relatedness between the events and the GARDASIL 9 was not reported. Additional information has been requested.
Pt received varicella vaccine 08/17/09 to RPUA SQ.  Pt presents to PCHD today with 25w X 30l erthythematous raised area to site of vaccination states headache today Mom states low grade temp 99.4, temp taken at PCHD is WNL at 97.6 child and Mom state no other symptoms, site is not tender no warmth noted to touch.  Child and Mother referred to family physician.
Pain in (R) shoulder beginning 3-4 wks post vaccination in same arm. Dx by orthopedist that "capsule is freezing up" from the immunization. Improving with exercise, local therapy but not back to baseline.
Redness, with rash formation in area of pressure persisting for about >2 months after vaccine; muscle aches and weakness.
sloughing in her mucosa; immune systen going haywire/feeling pretty bad; Tachycardia; received 5cc or 33cc of Moderna COVID-19 vaccine; Dizzy; muscle aches; Injection site hard; Injection site is swollen; feet and hands were white and cold; Nasal drainage; fingers turned blue; A spontaneous report was received from a physician concerning a 60-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced tachycardia, immune system going haywire, felt pretty bad, dizziness, muscle pain, nasal drainage, feet and hands white/blue, heart rate 100 bpm and 5cc or 33cc of Moderna COVID-19 vaccine.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 16 Jan 2021, approximately 6 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 025L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 16 Jan 2021, patient Patient states having tachycardia and felt "pretty bad" about 12 hours later, which she knows is normal after immunization. Continued to have tachycardia, and yesterday began to feel incredibly dizzy and like every single muscle was aching. Reports the injection site is hard and swollen but not red. States she could hardly see because of the dizziness and tachycardia. Also reports experiencing sloughing in her mucosa similar to when she was on chemotherapy for lymphoma. Reports no cough, no fever. Patient states that on Saturday which had tachycardia, her feet and hand were white and cold and temp was 95 degrees F. Her fingers turned blue and were white, but she had no shivers, no fevers. Also reports nasal drainage every time she gets an episode of the tachycardia. Physician state she was able to control tachycardia by drinking an enormous amount of fluid. Her heart rate was about 100 bpm, normal average is 65 bpm.  Treatment for the event included Tylenol 500mg x 2 and OTC Advil.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events tachycardia, immune system going haywire, felt pretty bad, dizziness, muscle pain, nasal drainage, feet and hands white/blue, heart rate 100 bpm and 5cc or 33cc of Moderna COVID-19 vaccine was not reported.; Reporter's Comments: This refers to a case of product administration error for mRNA-1273 (Lot number 025L20A), where 5cc or 3cc of the vaccine was administered to the patient. The adverse events of tachycardia, feeling abnormal, dizziness, myalgia, peripheral coldness, cyanosis, rhinorrhea, mucosal exfoliation, vaccination site swelling and vaccination site induration were reported associated with this case of incorrect dose of vaccine administered.
I woke up around 2:30am with chills, fever, body aches and  had a hard time moving my left arm. I took 100mg of acetaminophen and felt some relief, but after 3hrs the symptoms came back. I continued to take 1000mg of acetaminophen and  800mg ibuprofen alternately every 4hrs with a little relief but the chills and body aches continued for 24hrs with intermittent nausea and diarrhea.  The second day I woke up with a migraine that lasted around 24hrs with no relief from symptoms even when taking  OTC migraine relief medications. On the third day post vaccine I woke up feeling  completely fine and have not had any lingering symptoms.
1/8/21 (evening): Feeling weakness and tiredness 1/9/21: Itching and redness around the injection site, all joints aching badly (8/10 pain scale) 1/10/21: White ring around injection site; Itching continued 1/11/21: White ring around injection site; Itching continued *Itching continued through 1/15/21. * White ring around injection site currently still visible on 1/29/21. No treaments given; advise by clinic to report via V-Safe.
History of anaphylaxis after flu vaccine. Twenty minutes after vaccine, itching, hives along left arm and neck. Received Benadryl 50mg po at 11:30am. Symptoms worsened and client stated these were the same symptoms she had prior to previous anaphylaxis so EpiPen 0.3mg administered in left thigh. Sent to ED for follow-up.