chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date the patient was inadvertently vaccinated with fourth dose of GARDASIL (lot#, expiration date, dose, route not reported). The healthcare professional was not aware that the patient had already completed the three dose series of GARDASIL. The patient did not seek medical attention. No side effects were reported. Additional information has been requested.
Post vaccination- day after vaccination had body aches, low grade fever, nausea, fatigue and migraine headache.  For the entire week following vaccination-  Suffered nausea, migraine headache, and fatigue (3/12/21-3/20/21). I had to take Relpax for migraine headaches and ginger capsules for nausea the entire week until 3/20/21. Finally started to feel some normalcy on 3/20/21. The body aches & low grade fever only lasted for the one day post vaccination.
inadvertently administered FLUZONE QIV NP from last season to a patient with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health care professional.  This case involves an unknown age and unknown gender patient who was inadvertently administered fluzone QIV NP from last season to a patient with no reported adverse event after receiving vaccine influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival A-B vaccine at an unknown dose (lot number: not reported; strength, formulation and expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient was inadvertently administered fluzone QIV NP from last season to a patient with no reported adverse event (Accidental exposure to product) (latency same day) following the administration of influenza quadrival A-B vaccine .  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
fever, cough, headache, congestion, body aches, sob, diarrhea, weakness
Soreness, redness, heat, and swelling at the site injection that was given approximately 24hrs. ago.
This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain and feeling unwell. On an unknown date, the outcome of the pain and feeling unwell were unknown. It was unknown if the reporter considered the pain and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The caller was a consumer who heard from an acquaintance that she received 1st dose of SHINGRIX and experienced feeling very achy and not feeling well. The caller declined to provide address or other identifiers for the patient. No further information was available. The patient had denied permission to contact their physician. This case has been linked with case US2018158685, reported by the same reporter.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 53L2Z, expiry date 31st May 2022) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with Shingrix 2 months ago from reporting day. The patient developed shingles after vaccination. The reported batch number 53L22 did not exist hence was updated to 53L2Z as per sales data sheet. The physician was not clear on whether he would like to be contact for Follow Up, stated he just wants information on how to proceed with this patient. Expiration Date was reported as May 2022, but captured as May 31st 2022 as per SRL Defining the Expiration Date of GlaxoSmithKline Vaccines When Only a Month and Year Appear: The expiration (expiry) date expressed as "month/year" refers to the last day of the stated month in the given year on the labeling and/or packaging of GlaxoSmithKline (GSK) products. The reporter consent to follow up.
Became nauseated approx 4-5 cm after shot and were still feelin nauseated the day after.
Patient received Pneumovax 23 on 6/3/08 with no reaction. Lot # 1541U Merck Route -IM Body Site- LD Thursday had vaccination for pneumovax- 5-21-20 Friday evening had heartburn and hiccups. Heartburn was severe with spasm if eats Saturday had hiccups with heartburn. Sunday red site of injection on arm. Still spasm in esophagus area with hiccups. More hiccups and heartburn yesterday and stated oral anti-acid Hiccups this afternoon minimal. Still some acid. Worsens if eats. Pain in right lowermost rib area if moves around.
Patient was vaccinated with pediatric pfizer dose instead of receiving the adult Pfizer dose. The error at screening when (Pharmacy Clerk) took in the patient for second covid shot but indicated it for Pediatric covid vaccine.
Small Bowel Obstruction, vomiting,distension, pain - 4 hours after shot. 13 days in hospital
This spontaneous report was received from a physician assistant via a social media (unspecified new source) concerning two female patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL (dose and route were not reported). Concomitant medication, medical history, drug allergies and reactions were not reported. The physician assistant reported that a patient brought in a news article that on unknown date, two sisters developed ovarian failure after receiving GARDASIL. The physician assistant is not the healthcare provider for the sisters and did not have any patients who are experiencing ovarian failure after receiving GARDASIL. The outcome of patients developed ovarian failure after receiving GARDASIL was unkonwn. This is an unconfirmed case and one of two reports received from the same reporter MARRS # 1406USA008485. Additional information has been requested.
Upset stomach, headache, fever, aching of arm where injection was given and soreness to the touch of injection site.  Have been getting flu shots for years.  This is the first time I have had any reaction at all.
Initial and swelling followed by persistent pain at injection site. Pain with movement beyond typical 24-72 hours. Has not returned to work. Immunized due to worker's compensation injury/exposure to raw sewage.
Within 10 min. of having the shot, the right side of my face started to go numb.  I first noticed my right ear and then it moved toward the center of my face, and even the right edge of my tongue (from back to tip).  Over the following days, I did notice that my right arm felt more numb as well.  Now after 1.5 weeks after vaccination, the right side of my face continues to be number than the left.   I have some non-length dependent small fiber neuropathy anyway, but my left has always been more affected than my right.  After my shot, I saw a dramatic exacerbation of numbness on my right side.
TOOK 2 DOSES OF CRUSHED VIVOTIF; A spontaneous case report was received from a pharmacist on 16-Jul-2019 for three consumers.  Based on the information obtained from a pharmacist, three individual case safety reports PVX201907-000597 (PVX2019-1841; first consumer), PVX201907-000598 (PVX2019-1842; second consumer), and PVX201907-000605 (PVX2019-1864; third consumer) were created and cross-linked in the database.  This case describes a female consumer who "took 2 doses of crushed Vivotif" (PT: Wrong technique in product usage process). The consumer was receiving oral Vivotif capsule (one dose every other day) for typhoid fever prophylaxis.  Case report: It was reported that the caregiver crushed first two capsules of Vivotif and gave it to the consumer. However, the consumer took the rest two doses normally.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took 2 doses of crushed Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 2 doses of crushed Vivotif" was considered as not applicable. US-PaxVax Berna GmbH-PVX201907-000597: US-PaxVax Berna GmbH-PVX201907-000605:
Client became near syncopal complained of "not feeling good" and "headache" 2-5 minutes post vaccination. According to mother, client had not eaten yet that morning. Gave candy cane and water and carried to exam room and layed flat on exam table. applied cold/cool compress to neck and forehead. Client recovered within 15 minutes but still complained of headache. Was able to leave ambulatory with parent. Advised parent to make sure child ate as soon as possible. Called parent 3:50pm same date child ate and had no further incident up to that time. Advised parent to follow up with physician especially if episodes recurred.
At 8pm same day of vaccination client began to have severe chilling. At 1am felt hot, temp 103 severe headache. By the next morning temp 100. Severe headache continued through the next day. On the following day client went to see his doctor and was given an Rx for codeine and ibuprofen. Client took both as prescribed x1 and the severe headache subsided.
Acute pancreatitis Hospitalized for 2 days  Abdominal pain - worsened upon eating   Chronic Pancreatitis May 2022
Red, swelling at vaccine site, then hot on arm next 3 days. Two weeks later itchy red rash on chest. Starting third week red itchy rash on neck creeping toward face.
Mother states child started having what looked like flea bites on her legs appoximatly 2 weeks ago they progressed to back and head over this past weekend and sites on legs are now crusted over.  States child had fever several times over the weekend.
soreness of arm; Fever; Chills; Body ache; Nausea; Vomiting; Throat pain; Ear pain; Headache; This is a spontaneous report from a non-contactable consumer (reported for herself). A 32-years-old female non-pregnant patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on an unspecified date in Feb2021 at 09:15 (at the age of 32-years-old) as dose 2, single for covid-19 immunisation at Workplace clinic. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE) at a dose of 75 mg taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the 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 has no reported allergies. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on an unspecified date in Jan2021 at 13:00 as dose 1, single for covid-19 immunisation at Workplace clinic. On 19Feb2021 at 18:00, the patient experienced soreness of arm, fever, chills, body ache, nausea, vomiting, throat pain, ear pain and headache. No treatment was given for the events. The outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
This spontaneous report as received from a female consumer of unknown age refers to himself. No medical history or drug reactions/allergies were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (Lot # and dose not provided) one time vaccine injection. On an unknown date, 12 hrs after receiving ZOSTAVAX the patient developed carpal tunnel syndrome in her right hand. The outcome of developed carpal tunnel syndrome in her right hand was unknown. Additional information is not expected.
HEAD TO TOE RASH, REDNESS IN RIGHT ARM, BACK PAIN, GENERALIZED ACHES AND PAINS, FEVER.
On 08/23/2000 the patient developed "itchy" spots around her waist. It was noted that it was an itchy rash of papules 2mm-5mm that was on the waist circumferentially and on the right thigh and left neck. The physician stated the lesions go completely around the patient's waist and she does not fell they are herpes zoster. It was noted that the patient had 50 lesions and a temperature of 98.6F. It was also noted that the worst symptoms were on day 2. Over the past several days, the patient has continued to develop additional lesions around her waist, on her right leg and on her left neck; however, she has not developed and vesicular lesions. On 08/29/2000 the physician saw the patient and she just has "large erythematous and hyperpigmented" areas, but no vesicles. the patient reports the lesions are very itchy, but otherwise she feels fine. She has no reported fever or any other symptoms. Of interest is that the patient may have had a possible exposure to varicella prior to developing her rash. The patient's coworker who had never been immunized, also developed a rash on the same day, and very similar to the patient's. The coworker was diagnosed with chickenpox. On an unspecified date the patient recovered. Additional information has been requested.
Information has been received from a registered nurse concerning a 39 month old male with no known medical history of allergies who on 24-MAY-2006 was vaccinated with a dose of Varivax (Oka/Merck). concomitant therapy included BENADRYL. On 10-JUL-2006 at 9:10 am the patient presented with breakthrough rash that began on 08-JUL-2006. There were 60-75 spots with diffused fluid filled vesicles. it appeared on the torso, groin and extremities. The patient did not have a fever but experienced itching. There were no additional problems. BENADRYL was used for itching relief. medical attention was sought. No laboratory diagnostic test were performed. The patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested.
Severe pain behind left scapula; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Severe pain behind left scapula) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Severe pain behind left scapula). At the time of the report, ARTHRALGIA (Severe pain behind left scapula) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: CT scan was normal with no evidence of metastatic disease..         Treatment includes lidocaine patches
A couple days after receiving vaccine began experiencing breast pain, tenderness, sensitivity, and lumpy feeling. Symptoms have mostly resolved but still present. Had mammogram and ultrasound on October 10th and both returned as stable. Also I began my October 5th period and it lasted until October 25th. This is very atypical for me, as my cycles usually are very predictable and last 5 days. I went to OB/GYN on 10/19/2022 for yearly physical and she noted a mass on cervix. It was ultrasound on 10/26/2022 but I have not gotten results. It was not present during my last yearly OB/GYN visit about a year ago. For the past year my cycle has consistently ran 27 days. My period prediction app is currently predicting a 40 day cycle.
Pt received vaccine at 17:00.  Around 02:00, pt experienced possible emesis. Following AM, approximately 06:00-07:00 emesis and several times.  Pt experienced emesis again1 time 2 days later.  No fever, aches, headache, or any other symptoms apart from anorexia and emesis.
Extreme muscle aches, cold and shivering, upset stomach and pain on right side. Could be related to muscle aches.
arrived to home from doctors appt. sat down to get ready to eat breakfast at breakfast table and patient just vomited up everywhere.
PATIENT WAS GIVEN THE MMR SHOT ON DECEMBER 10, 2007. SHE WOKE UP ON DECEMBER 21, 2007 WITH A SEVERE RASH AND A SWOLLEN FACE.  SHE ALSO WAS SUFFERING FROM SEVERE RESPIRATORY SYMPTOMS AS WELL AS PINK EYE AND EAR INFECTION.  I TOOK HER BACK TO THE PEDIATRICIAN AND SHE TOLD ME THAT IT WILL NEED TO RUN ITS COURSE.  SHE GAVE ME 3 DIFFERENT PRESCRIPTIONS AND SAID THAT IF IT IS NOT LOOKING ANY BETTER WITHIN 24-48 HRS TO CALL HER BACK.  I WENT TO MY PARENTS HOUSE FOR CHRISTMAS AND CALLED DR ON THE 23RD BECAUSE THE RASH HAD APPEARED TO SPREAD.  I ENDED UP TAKING HER TO THE EMERGENCY ROOM ON THE 23RD. THE ATTENDING PEDIATRIC DOCTOR TOLD ME THAT IT WAS JUST A RASH... NOT TO WORRY.  HE ALSO CHANGED ALL OF HER MEDICATION THAT I HAD GOTTEN FROM HER DOCTOR.  ABOUT 4 DAYS LATER THE RASH HAD GONE AWAY BUT SHE WAS STILL SUFFEREING FROM THE RESPIRATORY SYMPTOMS.  I TOOK HER BACK TO THE DOCTOR ON JANUARY 7 FOR A RE-CHECK, SHE WAS THEN ADMITTED INTO THE HOSPITAL ON JANUARY 8TH AND STAYED UNTIL THE 12TH.  SHE HAD RSV AND PNEUMONIA.  BEFORE SHE HAD THE MMR SHOT SHE WAS VERY HEALTHY.  AFTER SHE GOT THE SHOT SHE WAS SICK CONSTANTLY FOR A MONTH.  03/19/2008 MR received for ID and Pulmonary consults 2/5/08 with Impression:  Post RSV Asthma. Pt presented for eval of multiple episodes of upper and middle airway infections, conjunctivitis, and otitis media since December 2007. Pt developed a respiratory infection which was txd with amoxicillin, and subsequently developed a erythroderma-like rash with facial swelling.  It was initially thought to be an allergic rxn to abx, but also was 1 week following MMR. Pt was hospitalized for RSV Bronchiolitis x5days and subsequently developed pneumonia. 04/21/2008 MR received for DOS 1/8-12/2008 with DX: RSV infection and pneumonia. Sent for admission by PMD for URI sx of intermittant fever, nasal congestion, cough.  PE (+) for grunting respirations. Tx with nebs and Zithromax.
2- quarter-sized hives left lower arm 1- 3in erythematous, swollen, warm to touch circle at injection site
By this time, my child has usually moved her bowels at least once. At this time (11:54 PM), she has not. She woke up crying at approximately 10:00 PM after sleeping for nearly 5 hours and would not eat. She was also not easily consoled and has experienced worse gas than usual and seems to be painfully constipated.
A lump devel @ the inj site;14DEC98 it was painful & drained cloudy fluid;office visit 15DEC98, 21JAN98 pt seen by surgeon for recurrent pain & inflammation @ site;tx w/ATB;surgical excision cult positive for mycobacterium avium. 60 day follow-up dated 09/28/00 states still has scarring at the injection site.
severe Dizziness beginning 45 minutes after  injection, could not walk without holding on to walls, chairs etc for 2 days.  Left upper arm swollen
Treatment of COVID-19; Treatment of COVID-19; Pfizer BioNtech dose number 4; Pfizer BioNtech dose number 4; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 15May2022 as dose 4 (booster), single (Lot number: fj4989) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing), notes: hypothyroid; "Known allergies: peanuts" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHROID. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 15May2022, outcome "unknown" and all described as "Pfizer BioNtech dose number 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive, notes: 19May2022 positive home test; (24May2022) Negative, notes: 24May2022 Negative home test (Binax); (25May2022) Negative, notes: 25May2022 Negative home test (Binax); (29May2022) Positive, notes: 29May2022 same symptoms continuing - Positive home test (Quidel). Therapeutic measures were taken as a result of drug ineffective, covid-19, off label use, immunisation.  Clinical course information: Covid rebound after Paxlovid and on 18May2022, Covid symptoms started. On 19May2022, Positive home test (Binax), started Paxlovid. On 24May2022, Negative home test (Binax), still had runny nose, sore throat, diarrhea. On 25May2022, Negative home test (Binax) and on 29May2022, same symptoms continuing Positive home test (Quidel).  No follow-up attempts are possible. No further information is expected.
03/01/2021 Hair starting falling out and had to seek care from a dermatologist. 08/05/2021 Starting having extreme bleeding.