chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 08Nov02, concerning a male vaccinee who inadvertently received Fluvirin SC on 07Nov02. On 07Nov02 the vaccinee received 0.5ml Fluvirin SC. No adverse reaction was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP-2002-00728, PJP200200690, PJP200200729, PJP200200793, PJP200200792, PJP200200791, PJP200200720, PJP200200745, PJP200200743.
4 hours post injection.  Severe pain at site of injection.  5 hours post injection Nausea with 3x occurrence of vomiting.  5.5 hours post injection chills and extremely diaphoretic with nausea continuing.  Chills/Fever 101.1 tympanic.  Diaphoresis lasted for 30 hours with associated dehydration known by darker urine.  6 hours post injection mild to moderate headache along with moderate body aches lasting for 24 hours.  36 hours after injection symptoms subside with only mild pain at site of injection.
Woke up  early (around 2-3 am )  Friday, January 22 feeling muscle and joint pain . Nausea and vomiting followed at 4: am.  Severe fatigue, weakness and upper back and shoulder aches, with a  fever of 99.7. which climbed to 100.  On Friday evening  @ 11:00 pm nausea subsided  somewhat but other symptoms mentioned continued along with a fever of 100 F.   On Saturday @ noon January 23, 2021, Fever reduced to normal. (97.7), But still very fatigued and week.
Itching around injection site within 5 minutes of administration. Did not progress over next 15 minutes. Patient took 1 dose of Benadryl and reported being "fine" at call at 6pm 1-26-08
First shot on 4/13/2021- instant reaction -tingling in legs and hands, rapid heart rate, swollen throat. EMT monitored me for 1 hr. Symptoms went away after 1 hr. No medicine was given. Advised to still get second shot. Second shot on 5/15/2021- instant reaction- tingling in legs, rapid heart rate, swollen throat. Went to hospital. Given a 25mg shot of Benadryl. Symptoms went away after 1 hr. Given a 10 day steroid and 10 day antihistamine. Released from hospital same day. Day 2 - 5/16/2021- New symptoms. Tightness in chest, shortness of breathe, inflamed  hemorrhoids, muscle pain, fatigue.
Patient reports soreness in the arm. Manifested at approximately 11:00 pm on 09/24/2018 and was still present at 10:00 am on 09/25/2018.
Blurred vision; Nausea; Headache; Rash; Dose 1 on 28Apr2021 and Dose 2 on 16May2021; This is a spontaneous report received from a contactable consumer or other non health care professional, the patient.  A 50-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/ Lot number: not reported) via an unspecified route of administration in the right arm on 16May2021 at 16:45 (at the age of 50-year-old) as dose 2, single for COVID-19 immunization. Medical history included hypothyroidism and rheumatoid arthritis (RA) on an unknown date and unknown if ongoing. The patient had no known allergies. Historical vaccine included as the patient previously received the first dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/ Lot number: unknown) via an unspecified route of administration in the right arm on 28Apr2021 at 14:30 (at the age of 50-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021, the patient experienced blurred vision, nausea, headache and rash. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events blurred vision, nausea, headache and rash was not recovered at the time of this report.  Information about lot/ batch have been requested.
Headache, Muscle Aches, Nausea, Dizziness, Fatigue
right lower quadrant pain - started about 1:30a, no nausea, no diarrhea, no fever or chills, but some generalized muscle aches.  Took 650mg of tylenol.  All symptoms gone when I woke up about 5:30a on 1/10/2021
104.2 fever 2am-5am Fever 1am -8am  Skin felt like it had paper cuts all over  Nauseas  Headache  Ear pain  Chills
Information has been received from a physician concerning a 10 week old male, with no allergies, who on 10-OCT-2006 was vaccinated with a first 2 ml oral dose of rotavirus GI G2 G3 G4 P1 reassortment vaccine live (human-bovine) (Lot# 654794/0776F). Concomitant therapy included ranitidine HCl for reflux and amoxicillin for an ear infection. It was reported that the patient was experiencing cold symptoms at the time of vaccination. On 11-OCT-2006 the patient experienced vomiting and diarrhea. It was reported that the physician was unsure if vomiting and diarrhea were definitely related to the vaccination with rotavirus reassortment vaccine live and indicated that it could have also been viral. It was reported that the patient's diarrhea stopped "6 days later", on 17-OCT-2006 the patient was vaccinated with a second dose of rotavirus reassortment vaccine live. Concomitant vaccinations administered on 04-DEC-2006 included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, HIB conj-hepatitis B vaccine (MSD), a dose of poliovirus vaccine inactivated, and a dose of pneumococcal A vaccine. On 04-DEC-2006 the patient had cold symptoms and a fever of 100.4 during the evening. It was noted that there was no vomiting or diarrhea following the second dose of rotavirus reassortment vaccine live. At the time of the report the patient was still experiencing fever. Unspecified medical attention was sought. No product quality complaint was involved.  Additional information has been requested.
Within a minute or two of vaccination I felt my eyes bulge or feel pressure and my vision start having flashes of light and dark.  When I went back to Pharmacy for my second shot said these are called auras.  I  agreed except mine were black and white instead of color that the examples I saw there showed. I didn't have a migraine or headache.   Back to the day of the reaction. I hurried home because I was afraid I wouldn't be able to drive. By mid afternoon next day still bothering me so I went to Eye Specialists and he checked my eyes but said there wasn't excess pressure.  The vision problem went away when he  dilated my eyes.
Pt received 1 month immunizations (DtaP, IPV, HBV and Rotavirus) on 12/5/06 (6 weeks of age). Pt presented on 12/8/06 with green, foul-smelling stools and temperature 38.8. Otherwise well-appearing. Work-up for full rule-out sepsis (blood, urine & CSF) negative. Received Ceftriaxone and hospitalization for 48 hours.  1/9/07 Received medical records from hospital which reveal patient admitted 12/8/06-12/11/06 with emesis, foul smelling diarrhea, fever 101.8 & decreased oral intake for 3 days following multi vax including Rotateq.  Treated with IV antibiotics empirically & IVF for hydration.  Improved during hospital stay with good oral intake, no further fever & formed stools. FINAL DX: R/O sepsis; diarrhea; & fever.
pt to hospital with mental status and behavior changes, confusion, disorientation, weakness; positive for COVID; not hypoxic, therefore, no COVID treatment; stroke, not a tPA candidate; stayed in hosp x 4 days;  dc'd to home with home health (the name of the agency is not in the medical records; pt brought back to hospital on 10/11/22 where pt passed away
Radiating pain at the injection site. Intermittent dizziness and chills. Malaise, joint pain, body aches, sleepiness..
Pt states felt chills and under the weather, soreness higher on arm so not shingles which was on same arm subq.
Swelling, redness (increasing in size), itching, increased warmth at site of redness
Received vaccine 8/11/05. 8/12/05 pt awoke with 12.5x14cm induration around injection site.
Information has been received from a physician concerning a male with a history of vaccination adverse reaction who "about three weeks ago" on approximately 28-SEP-2006 was vaccinated with a SC dose of MUMPSVAX. There was no concomitant medication. Three weeks after the vaccination, on approximately 19-OCT-2006, the patient developed a wheal and flare at the injection site. He was treated with antihistamines and the symptoms resolved. There was no product quality complaint involved. Additional information has been requested.
Patient received flu vaccine on Fri. Injection was uneventful. The following day his upper arm was swollen. By the evening, the swelling progressed to mid-forearm. The following morning his hand was also swollen. He was taken for evaluation and given oral steroids. Swelling improved the following day.
Information has been received from a physician concerning a 37 year old male  pt who on 05/06/04 was vaccinated with a 1st dose of varicella virus vaccine, live. Approximately 2 weeks later, the pt developed a vesicular rash of approximately 15 lesions spread over his body. Unspecified medical attention was sought, but treatment was not required. A product quality complaint was not involved. Additional information has been requested.
Muscle ache Fever Sore throat Postnasal drip From initial information on 11/04/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 55 year old female patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1135FA, administrated in the left deltoid on 10/16/2003. The reporter stated that the vaccine was administered with a 5/8 inch needle and may have been given subcutaneously. The following day, the patient developed a sore throat and muscle aches in her shoulder and neck. She also experienced a temperature of 99.1 degrees fahrenheit which lasted for three days, as well as postnasal drip. The patient self-medicated with Ibuprofen and Tylenol and visited a chiropractor for the muscle aches. Reportedly, the symptoms resolved and returned on 10/30/2003. It was not reported whether the patient recovered. From information received on 04/23/2004 from a health care professional, it was reported that the information has been reviewed and no additional information is available. The recovery status was erroneously checked as yes in version 0 but was corrected in version 1. No further information is anticipated, this case is considered closed.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Graves' disease" (unspecified if ongoing); "endometriosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Effexor, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Additional information: Possible rebound. Only took 3 of 5 days. Pt reported helped reduce fever and symptoms significantly. Then tested neg. Then left for vacation 2 weeks later and had similar symptoms for 10 days while there.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events Drug ineffective, COVID-19 and the suspect drug cannot be excluded.
This spontaneous report was received from a other health professional referring to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with VAQT, intramuscular after being improperly stored at 33F. No other concomitant therapies reported. No adverse effects reported. The outcome of the event was unknown. Additional information is not expected.
p/recv vax pt exp severe pain on arm. MD hypothesized vax given on deltoid close to the joint. pt referred to orthopedic MD
Day one: Chills, Nausea, Weakness, and achiness; Day two: Fever, chills and tiredness; Day three: Fever, heart palpitations; Day four: No Fever, chills and body aches along with heart pale;  Day five: extreme fatigue and sleepy ness with increase appetite; Day six: sleepiness; Day seven: Throat pain and aches.
Approx 10-11 days after shot developed systemic hives. Itchy spots develop sequentially all over body lasting approximately 5 minutes in each location before migrating. Occur in both spots with and without hair. Have used Benadryl to reduce symptoms.
I have had migraines every day since 3-4 days after vaccine... I get nausea, feel motion sickness. This has altered my life. I struggle to do daily activities.  as of today 10/20/21 I have tried 2 different prescription medications.
Second vaccine yesterday, began vomiting last night, temp to 101., weakness bilateral lower extremities. To emergency department 11:00 am 6/10/21.
Localized reaction, RUE (deltoid) at the site of injection. Elliptical redness (80x60 mm) with central area of induration (35x25 mm). (-) Vesicles, (-) Lymphangitis. No distal involvement.
My mouth is mildly numb.  No paralysis, just a somewhat numb tongue, chin, cheek (jawline).  It is not completely numb.
Raised red bump increasing in size over time and developed red bumps/vesicles. Site is itchy and the size of a baseball in circumference as described by the patient. Advised to see a doctor.
ITCHING ON STOMACH, BACK AND BACK OF THE NECK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient had previously received covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin, batch number, and expiry not reported) dose was not reported (dose number in series was 1), 1 total, administered for prophylactic vaccination.  It was unknown whether patient had any adverse events (dose series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 182281 expiry: UNKNOWN) dose was not reported (dose number in series was 2),1 total, administered on 22-NOV-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 24-NOV-2021, two days after booster shot, the patient experienced itching on stomach, back and back of the neck. It started at the same time in the all of the above mentioned areas (dose series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching on stomach, back and back of the neck. This report was non-serious. This case, involving the same patient is linked to 20050503613.
C/O fever, body aches x 6 days and child will not move RUE. Ofc visit 3/1/10.
PATIENT RECEIVED VACCINATION AND LATER THAT EVENING HE STARTED ITCHING AND NOTICED HE HAD HIVES UNDER HIS ARMS, WHICH SPREAD TO BACK. THE HIVES SPREAD TO TRUNK, GROIN, AND BUTTOCKS. PATIENT ENDED UP GOING TO EMERGENCY ROOM AND RECEIVED  A STEROID INJECTION AND PREDNISONE DOSEPACK TO TREAT REACTION. PATIENT HAS RECEIVED FLU VACCINATIONS ANNUALLY AND HAS NEVER HAD A REACTION. UPON SPEAKING WITH THE PATIENT, HE DID TELL US THAT HE HAD BEEN STUNG 3 DAYS PRIOR TO RECEIVING THE VACCINE AND IS ALLERGIC. WHEN PATIENT CAME INTO PHARMACY TO SHOW US REACTION AND PICK UP PRESCRIPTION AFTER ER VISIT, I NOTICED THERE WAS NO REACTION AT THE INJECTION SITE.
Approx. 1 hr. after vaccination this pt. presented to employee health RN with complaint of severe rash and itching on throat and chin. Dr. examined pt. at that time. Patient was given diphenhydramine 50 mg PO at that time and was sent home with diphenxydramine for prn use and instructed to go to ER if any breathing or swallowing problems developed.
Pt recv vax on 2/26/98; approx 6-8 hr post vax pt exp urticaria rash & redness x 48 hr
21OCT93 extreme fatigue leftside of neck swollen; 23OCT93 same sx plus lt ear blocked; 26OCT93 sx subside; 29OCT93 pt reocvered;
Vommiting and watery diarrhea. Temp 100.4 Supportive Care.
Night of vaccine there was mild pain in arm, the following day severe pain and not wanting to lift arm from said pain. Joint pain, aches and headache at the same time. Next day sore arm.
Pt recv vax on 10/24/98; on 10/25/98 pt exp aches, pains, congestion w/ productivity.
Soon after injection I developed ringing in both ears, high pitched and constant, slightly worse in my left ear. I had something similar for one or two days after the second injection. It has now been almost 10 days and there has been no change in the symptoms.
My daughter went from having no fear of loud noises, no issues with being wet or feeling textures, confident away from her mom, always happy.   The day of her vaccine it was like flipping a switch.   She was immediately fussier, afraid of loud noises, aggravated by wet clothing, and clingy with her mom.   This was not just a few days after her MMR shot.  It has changed her and she is only slowly getting back to her normal personality.    I am not reporting this because I want compensation.   I am reporting this because you need data.    I am pro public health and have both of my children fully vaccinated.   I am not imagining this.  It was not coincidental.   Her nervous system was adversely impacted by the MMR shot.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CIALIS, start date: Jan2018; FAMOTIDINE, start date: Jan2021; FEXOFENADINE, start date: Jan2020; FINASTERIDE, start date: Jan2011; FLUTICASONE, start date: Jan2021; SIMVASTATIN, start date: Jan2005; TEMAZEPAM, start date: Jan2020; AZELASTINE nasal, start date: Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (13May2022) Negative; (15May2022) Positive. Therapeutic measures were taken as a result of covid-19.  Additional information: If vaccine received: Yes; Other medication in 2weeks: Yes; Known allergies: No. Adverse event: 3 days after completing 5-day treatment of Paxlovid tested negative for Covid without any symptoms. 5 days after completing treatment of Paxlovid rebounded with a sinus congestion and sore throat and tested positive for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Caller reports she gave a patient the adjuvant ONLY of the Shingrix vaccine; Caller reports she gave a patient the adjuvant ONLY of the Shingrix vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number AT772, expiry date 5th October 2023) for prophylaxis.   On 13th September 2022, the patient received the 1st dose of Shingrix (intramuscular). On 13th September 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-Sep-2022 Reporter's comment: The caller was the pharmacist to report a Shingrix vaccine adverse event.  The patient received Shingrix vaccine in left arm. The caller reported that she gave a patient the adjuvant only of the Shingrix vaccine (Inappropriate Reconstitution Technique).  The call was transferred to medical information for further instructions. The caller would call the patient with follow-up steps after talking to medical information. The consent to follow up was granted. Additional Supportive Information: The caller reported that she gave a patient the adjuvant only of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
p/vax pt devel numerous lesions on truck, arms, legs, & genitalia;the lesions did not resolve;
Pt experienced swelling of thigh and advised to treat with Tylenol, Benadryl and ice.
Heavy vomiting, diarrhea, severe dehydration, muscle pain, persistent fatigue
Hiccups; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HICCUPS (Hiccups) in an 88-year-old male patient 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) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced HICCUPS (Hiccups). On 13-Feb-2021, HICCUPS (Hiccups) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided/unknown by the reporter.   Treatment: Not given.
Atrial fibrillation episode lasting 22 hours then converted to sinus rhythm . Heart rate during episode 100- 124
This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. On unknown dates, the patients received ROTATEQ, oral, that had been improperly stored (lot #, expiration date, dose and frequency not provided). No adverse experience was reported. A telephone attempt to obtain follow-up information on 23-MAR-2015 was unsuccessful. The nurse could not supply the information regarding lot numbers, expiration dates and patient identification information at the time of the call. The reporter confirmed that there had been no reports of adverse events following administration of the vaccinations. This is one of several reports received from the same reporter. Additional information has been requested.