chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vx diluted with sterile water; Received vx diluted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 7h9ch, expiry date 8th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 11th April 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 11th April 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine 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: 13-APR-2022 Reporter's Comments: The patient received Rotarix diluted with sterile water instead of the correspondent diluent. The reporter did not consent to follow-up. Additional Supportive Information: The patient received Rotarix diluted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case has been linked with case US2022064751 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022064751:Same reporter.
Patient began feeling pain in her legs that woke her up several times at night and into the morning.  Walking helped to prevent serious pain.  Offered that she get electrolytes and magnesium and contact her doctor.
1340 - As patient left shot table, she became faint and eased to floor by assist of staff at shot table. Patient panicked stating she needs air. Patient instructed to remove mask and deep breath. Assisted x 2 into w/c and taken to private observation area. EMT on site in attendance.  1349 - c/o inability to catch breath, opened back doors and sat partially outside. Mask off, on room air. BP 135/103; HR 85. Offered water, patient declined.  1356 - BP 129/95; HR 73 1405 - BP 135/111; Recheck of BP with another cuff and is 144/96; O2 sat 98% on r/a. HR 79 then 71. Denies SOB, or difficulty breathing. Talking and explaining medical history. States she feels a lot better. Patient denies injuries from being assisted to the floor.  EMT does not indicate need for ambulance for further eval or for transport. Patient declines EMS for further eval.  1417 BP 118/89; HR 72 Patient states she feels fine. States she has had this vagal reaction before but not with an injection. Discussed with patient to attempt to obtain dose #2 in a private setting, however to notify wherever second dose is taken to notify staff so she can be placed in a w/c from beginning through observation. Pt. laughed, stating she will be fine. Re-stressed the need to avoid fainting and should either recline or be in a w/c for dose #2. Patient agreed. Patient stood and re-assessed. No dizziness noted. Patient ambulated to parking lot independently, accompanied by nurse. Gait steady. No SOB noted.
Mother states infant was hosp 2-2-91.  At 0600, infant let out strange high pitched cry, was listless, unresponsive, and cold to touch.  To ER, body T = 91.  Adm X 4 days.  MD said HIB rxn.
pt recv vax 8APR98 & 19APR98 pt devel swollen posterior cervical lymph nodes described as active pharyngeal lymph tissue ecchymosis in the rt ankle;painful swollen ankles & wrists;
This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a medical assistant concerning a 16 year old female patient with no medical history or allergies who on 26-JUN-2007, was vaccinated IM into the left deltoid with a third dose of GARDASIL (Lot# 657868/0523U). On 27-JUN-2007 at 10:17, the patient experienced migraine, fever and a whole body ached and was sore. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. It was reported that the patient was having flu like symptoms and it was not a reaction to the vaccine as her first and second injection were without adverse effects. It was reported that the patient was fine after receiving the first two doses. No product quality complaint was involved. Additional information is not expected.
local rxn consisting of edema & redness @ site in rt deltoid;redness migrated almost down to pt rt elbow;exp no SOB;pulse rate 85;did have hives;ice applied & epi given;
The patient received a fifth dose of Gardasil 9; The patient received a fourth dose of Gardasil 9; The patient received a total of 5 doses of Gardasil 9 on 7/16/2015, 11/19/2015, 1/18/2016, 8/23/2019 and 12/30/2019; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies.  On 16-JUL-2015, 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), 1 dose, lot number L001312, expiration date 24-FEB-2017 for prophylaxis (anatomical location and route of administration were not reported).  On 19-NOV-2015, the patient was vaccinated with the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 1 dose, lot number L000610, expiration date 31-JAN-2017 for prophylaxis (anatomical location and route of administration were not reported) (inappropriate schedule of product administration).  On 18-JAN-2016, the patient was vaccinated with the third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 1 dose, lot number L000610, expiration date 31-JAN-2017 for prophylaxis (anatomical location and route of administration were not reported).  On 23-AUG-2019, the patient received the fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) respectively, 1 dose, lot number 1621929, expiration date 06-DEC-2021 for prophylaxis (anatomical location and route of administration were not reported) (overdose).  On 30-DEC-2019, the patient received the fifth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) respectively, 1 dose, lot number R028386, expiration date 27-APR-2021 for prophylaxis (anatomical location and route of administration were not reported) (overdose).
Vomiting, diarrhea 4:30 am on 2/8/2006, rash 2/10/2006.
Vaccination site pain; bruising of the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and CONTUSION (bruising of the arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RIVAROXABAN (XARELTO), CARVEDILOL, DILTIAZEM and ESTRADIOL, NORETHISTERONE ACETATE (ACTIVELLA) for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and CONTUSION (bruising of the arm). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and CONTUSION (bruising of the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Administration of only the liquid component; Administration of only the liquid component; 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 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA910a, expiry date 28-FEB-2025) for prophylaxis.   On 18-JUL-2023, the patient received Menveo. On 18-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Administration of only the liquid component) and inappropriate dose of vaccine administered (Verbatim: Administration of only the liquid component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-AUG-2023 The healthcare professional asked when they could administer a proper reconstituted dose to this patient. The reported did not provide patient initials. The reporter consented to follow up. The reporter called to report the administration of only the liquid component of Menveo to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
FELT BAD THE DAY; This spontaneous report received from patient via other manufacturer (Company) concerned a 70 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included: idiopathic pulmonary fibrosis. The patient received covid-19 vaccine ad26.cov2.s  (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, for covid-19 prophylaxis.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin was not reported, and batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date of APR-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested.  Non-company suspect drugs included: nintedanib esilate (capsule, oral, batch number was not reported) 150 mg, 1 time every 12 hours, from 24-MAY-2021 for idiopathic pulmonary fibrosis.  Concomitant medications included loperamide for drug used for unknown indication.  On an unspecified date (around Christmas, also reported as was diagnosed in JAN), the patient experienced A fib (atrial fibrillation)(Dose number in series 1).  The patient received company suspect Xarelto (rivaroxaban) (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for atrial fibrillation.  On an unspecified date, the patient experienced gas, abdominal pain, stomach problems, constipation, and diarrhea (Dose number in series 1). The patient had emergency room (ER) visit for pain 2 days ago and she was diagnosed of gas pocket. The patient stated that he had been experiencing stomach problems . He mentioned that he went to the emergency room Saturday Night and they told him that it was gas, but he don't think that was the problem. He stated that he thought he needed to try different foods with the medication. On APR-2022, the patient experienced felt bad the day (dose number in series 2). In MAR-2022, the patient experienced surgery for watchman device (Dose number in series 1).   The action taken with covid-19 vaccine ad26.cov2.s was not applicable; action taken with rivaroxaban was not reported; and dose of nintedanib esilate was not changed. The outcome of felt bad the day was not reported. This report was non-serious. This case, involving the same patient is linked to 20220864773.
Blood pressure dropped significantly the day after and felt weak. Got to 88/55 then for the next 3 days was high. As a parent this made me entirely uncomfortable wondering what is happening in his body to cause fluctuations with blood pressure since this can be related to your heart.
I have been having heart palpations and some slight chest pains for a couple weeks.  I was not sure if caused by stress, but it has gone on for some time and really started a few weeks after my second dose.
Chills, fever, headache, fatigue. Lasted the good part of a day (<24 hrs)
Patient began filling flushed after receiving  vaccine. patient began feeling nauseous and having diarrhea. she reported she ate something earlier and did not have an empty stomach. pt hands began to cramp as she felt the urge to use the restroom.  pt began to actively vomit en route to restroom. after using restroom(diarrhea) and vomiting pt reported she felt better. her color began to return, BP was WNL and pt reported feeling better.
Patient denoted that he had not yet had the COVID vaccine. Vaccination itself went without issue. Upon attempting to bill for the administration, a third party rejection indicated he got the J&J vaccine already. I confirmed this using the immunization registry that she received this on 3/13/21. Patient has been notified she is not to receive another dose.
In late May 2022, I developed pain in my left foot with certain movements (not walking). I presented at my PCP's office and saw a ARNP who referred me to an orthopedic specialist. In August 2022, I saw the orthopedic doctor, who diagnosed it as a nerve issue (neuropathy). I've never experienced that before this year.
This case was reported by a nurse and described a 56 year old female subject who did not respond to immunization with Hepatitis B vaccine recombinant.  The subject's medical history included no known allergies.  On an unspecified date in December 2004, the subject received the third dose of Engerix-B.  At an unspecified time following the administration of the third dose of Engerix-B, on or after December 2004 and on or before 06/27/2005, a hepatitis B surface antibody test revealed a titer of less than five.
Dizzy ness, body aches, head ache, really sore inj site. And knot on left side of my neck. Lymph node swelled I assume
Information has been received on 08-OCT-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 21-JAN-2010, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical center as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 19-SEP-2016, the patient was treated at an urgent care for the onset of a severe vesicular rash, which was diagnosed as severe shingles. The patient was prescribed VALTREX for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Guillen Barre Syndrome,  received IVIG.  Transferred to rehab after 13 days in hospital.
Information was received from a nurse practitioner concerning a 7 year old female with no known drug allergies who on 14 OCT 1998 was vaccinated SC with a dose of Varicella virus vaccine live.  The week of 14 FEB 2005 the patient developed a "moderate case of break through greater than 50 lesions".  It was reported that the patient was "still breaking out".  Unspecified medical attention was sought.  There was no product quality complaint involved.  Follow-up information from the nurse practitioner indicated that on 07 FEB 2005 patient noticed blister-like lesions on abdomen, back, neckline, and arms.  On 08 FEB 2005 the patient "presented and was diagnosed with chickenpox".  The patient was "told to stay out of school until all lesions were crusted over".  On 15 FEB 2005 the patient recovered.  Additional information is not expected.
Noticed it was a little warm to the tough, swollen and itchy. NO FEVER. next day Noticed it was a bright red. very itchy. really big and swollen. it looked like the inside of a watermelon. from the shot location almost to my elbow.
8JUN92 temp low grade x 3 days; n&v, lethargy, knots on each side of throat, rt ear draining; 9JUN92 seen by MD dx vax induced mumps; tx meds;
ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE PERIPHERAL NEUROPATHY
Small, slightly red, bumps on abdominals and back. Suspected non-viral pustulosis.
Edema of the tongue and throat. No acute respiratory distress. complained of mild itching around eyes and forehead. No erythema or rash noted in this area. Claritin 1 PO given.  Monitored for 1 hour.  Symptoms did not worsen. Discharged with two claritin tabs and instructed to take one on Thurs and Fri. AM.  Instructed to go to nearest ER if symptoms worsen.
Mother states that patient had uncontrollable muscle spasms, constant tremoring and that when the patient is trying to sleep she is woken up by the muscle spasms.  Mother reports that patient was taken to her primary care doctor and was given an IM dose of steroids to help alleviate symptoms.
pt. recvd vax & developed measles rash,cough,coryza,conjunctivitis, & Koplik spots.
Original pfizer was given instead of bivalent. CDC recommended no course of action needed may receive bivalent in 2 months.
PATIENT NOTICED REDNESS AND A LUMP OVER THE INJECTION SITE, EXPERIENCED SOME PAIN IN UPPER ARM THAT IS IMPROVING, MAIN COMPLAINT IS ITCHINESS. USED NSAID, COLD COMPRESS AND BENDADRYL WITH EFFECTIVENESS IN DECREASING SYMTPOMS. REDNESS BORDERS MARKED ON 1/13/2021, TODAY REDNESS IS SIGNIFICANTLY DECREASED AND PT REPORTS A DECREASE IN ITCHING AND PAIN. PATIENT WAS ADVISED TO CALL HER PHYSICIAN FOR ANY FURTHER INSTRUCTIONS TO WHICH SHE DID, AT THIS TIME WILL CONTINUE TO MONITOR AND WILL CALL PHYSICIAN BACK IF SYMPTOMS GET WORSE.
This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and current conditions were reported. The nurse reported that on an unknown date unknown number of patients were vaccinated with that doses of GARDASIL (unspecified dose and route) lot K008931 expiry date 04-MAR-2017. On an unspecified date the vaccine had been improperly stored. The outcome of event was unknown. No adverse effects reported. Product quality complaint (PQC) was not reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
I was vaccinated on 01/07/2021.  I did have some significant side effects including fever, headache, extremely painful left arm at injection site, hives that the injection site that lasted approximately 4 hours and were resolved with Benadryl and ibuprofen., nausea and significant fatigue.  The pain in the arm after injection was not at the injection site but several inches below the injection site.  On 01/13/21 I developed a raised, red, painful rash below the injection site on the left arm but at the site where the severe pain was.  This is also being investigated by Infectious Disease.
About 15 minutes later felt throat closing and feeling went away after 5 min. About 2 days later redness at site appeared and small knot, no itching.
This spontaneous report as received from a nurse refers to a unknown number of patients of unknown age and gender. The patient's current conditions and medical history were not reported. Since unspecified dates in October 2014, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (unknown strength and route) (incorrect product storage). Concomitant medications were not reported. No adverse effect was reported. The outcome of the events were unknown. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Achy; Nausea; Slight  fever (barely 99); Chills; Exhaustion; swollen lymph nodes of neck; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER 8730) via an unspecified route of administration in the left arm on 25March2021 at 13:45 as a single dose for COVID-19 immunisation. Patient medical history was kidney stones, long COVID-19 infection. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN), mirtazapine (MANUFACTURER UNKNOWN), vitamins and aluminium hydroxide, magnesium trisilicate, sodium alginate (PEPCID) received within 2 weeks of vaccination. The patient was allergic to dairy and sulfa based antibiotics. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, it was unknown whether patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27March2021, the patient experienced nausea, slight fever of 99 degree Celsius, chills, exhaustion, swollen lymph nodes in neck, ache. No therapeutic measures were taken for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events nausea, fever, chills, exhaustion, swollen lymph nodes in neck, ache were unknown at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Adult dose given to pediatric patient; Adult dose given to pediatric patient; This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 19-year-old female patient who received HBV (Engerix B) for prophylaxis.   On 25th October 2021, the patient received the 1st dose of Engerix B. On 25th October 2021, unknown after receiving Engerix B, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional details were provided as follows: The patient received 1st dose of adult Engerix B at the age of 19 years which led to adult product administered to child and overdose. The 2nd dose of Engerix B was administered on 26th November 2021, batch number 722KC and expiry date 06th April 2022 but it was a pediatric one. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
I had my 2nd Pfizer vaccine at 8:15am yesterday....felt fine all day...toward the end of the day the right upper arm was sore, but had no other symptoms. I woke suddenly at 12;45am....the middle of the night....feeling ill....slightly nauseous and as if I needed to get to the bathroom and my chest hurt on the left side....immediately I felt that my hands and feet had no feeling....told my husband I needed some help....and lost consciousness. He said my eyes rolled back in my head and my throat made gurgling noises. He talked to me until I came to....according to him. Then we put a cold damp cloth of my neck and forehead. No fever or other symptoms.