chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a herpes rash on nose; This case was reported by a physician via sales rep and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, 4 days 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 age at administration was not reported. The patient recived shingrix and after 4 days presented to physician's office with a herpes zoster rash on nose.  There was no PCR confirmation. Patient was not immunocompromised or receiving any immunocompromising treatments. Doctor shared that he would be referring the patient to the eye doctor since the herpes zoster rash is on her nose.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient indicated to having had previous fainting episodes. Had a bruise around the right eye after fainting.
The day following the shot I had a very sore arm (which was to be expected) this went away in a day or two and felt completely fine after. On day 9/10 following the vaccine, I woke up with severe pain in the same arm at the injection point and pain with mobility of the same shoulder. Later the same day I unexpectedly began my menstrual cycle. It was 7 days early. It's never early, ever. My cycle is down to the day and regular, always. No usual menstrual cycle indicators/symptoms prior to it beginning either. The day after my cycle started, I noticed my heartbeat was pounding very loudly at night in bed, this lasted for 3 days with moments of minor chest tightness in the center of the chest, which was concerning, I almost opted to go to ER. this sensation subsided on the 4th day and has not returned.
patient was administered an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 21-Aug-2021 from a Pharmacist via Medical Information (Reference number- 00734255) and transmitted to Sanofi on 23-Aug-2021.  This case involves a patient (unknown age and gender) who administered an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] with no adverse event (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.    On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6521AB, expiry date 26-Jan-2021] via unknown route in unknown administration site for prophylactic vaccination.  It was reported, "A patient was given an expired dose of Menactra".  It was a case of actual medication error due to expired vaccine used (latency was on the same day).  At the time of reporting, patient had no adverse 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 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.
Leg weakness, Numbness in hands and feet, weight loss, Jaw soreness, Muscle loss, Headache, Loss of mobility, Drop foot, Double Vision, In a wheelchair,  Diagnosed with CIPD after 72 days, in Intensive care at local Hospital 10days, On IVIG drips every 3 weeks, on Predisone, Gabipentan, Norco and Physical Therapy  . Outcome is he will never be the same there is no cure and his life is forever changed he can not dress himself, open a bottle, eat with fork or spoon, brush his teeth, walk without assistants, do any physical work or even take a walk.
Sudden face flushing with elevated blood pressure and HR.  Gave 50mg diphenhydramine capsule by mouth.  Initial vital signs at 2:20pm. BP: 155/102,  HR: 87, RR: 24,  Pulse ox: 98% on room air.   Discharge vitas signs at 2:40: BP: 120/92, HR: 72, RR: 16, Pulse Ox: 97% on room air.  All complaints resolved, flushing resolved, no other symptoms.
On 12/12/15 developed fever- CBC and UA reassuring. By 12/14/15 fever persisted and had increasing fussiness- CSF showed over 500 WBCs.  Baby was admitted to hospital and treated with antibiotics and antivirals for meningitis.
This spontaneous report as received from a pharmacy technician refers to a 20 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 19-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
About 12 hours after shot experienced fever and chills,  that subsided after 24 hours after the shot,  about 40 hours after the shot had sudden onset of blurred vision in right eye.    Received shot on 09/21/2021 at 4:30 pm,   blurred vison started on 09/23/2021.     Went to eye doctor on 09/27/2021 at 10:00am,   Did eye exam and tests and showed atypical spots on the cornea of right eye.  Started lubercated eye drops and Doctor sent pics of cornea to a cornea specialist.   Had follow up appointment on 09/29/2021,  Shows some slight change. Cornea specialist said that it looked like cells in cornea had burst.   No change in blurred vision yet but continuing eye drops every two hours and added gel eye drops at night.  Unable to drive due to extreme blurred vision in right eye.  Have a follow up appointment scheduled for 10/08/2021 with eye doctor
It?s been a week after my second dose. I?m having an extended menstrual cycle since the 12th of April. After the second dose it?s extended my period and made it extremely heavy, having lots of clots in my cycle,  still having tingling and numbness in my right forearm, tingling/ itching in my ears, very tired all day. The main concern is that with the vaccine I?m of day 17 of my period and it doesn?t seem to be slowing down just getting heavier.
pt devel fever on day of immun; fever went to 105 & remained there intermittently for next 5 days; pt seemed to have soreness & tenderness @ site & would cry w/local touch or movement; no abn high pitched, or inconsolable crying;
Days 5, 6, and 7 I broke out in hives and itches from head to toe.  This is also when I noticed I started getting "warm" sensations in my left leg.  These random warm sensations lasted for 2 weeks.
Pt exp a very sore arm, large swollen, hot to the touch, red circular area @ the inject site & a burning, aching (painful) shoulder p/receiving Inluenza vax;
pt recv vax 7MAY97-spoke to school nurse 9MAY97 stated fine the day of vax played basketball that evening;pain in arm shoulder & underarm the next morning 8MAY97;went to baseball practice p/practice went home;head very hot body chills;tired
Vaccines given 29JUL2009. Mom reported swelling/redness at bilateral deltoid areas AM of 31JUL09. Rt deltoid area worse. Pt. evaluated by Dr. and prescribed MOTRIN, TYLENOL and BENADRYL.
30 minutes after vaccine, experienced coughing, tightness in throat, itchy throat. I was advised to take an antihistamine which seemed to help the itchiness. 8 hours later, my arm was not mobile and in extreme pain. The shot was administered in my left upper arm, but the pain radiated down my arm into my hand and up across my clavicle. I have a dilated cardiomyopathy and had palpitations. My arm hurt so bad that I could not sleep that night.  My arm is much better after 24 hours. Also, I'm allergic to soy.
t101, large area erythema, induration, hypereuria w/6cm swelling arm; pt had tetanus booster 6 yrs ago w/o problems;
Patient received a Pfizer Monovalent booster instead of a bivalent booster. Patient's mom has been contacted and informed of the vaccine administration error.  Reports no adverse reactions.
Adverse events occurred both during 4 month administration and 6 month administration. Patient experienced severe vomiting and diarrhea during 4 month administration and was hospitalized for 2 days for dehydration.  I was told by the physician that it was not the vaccine, however patient experienced the exact same symptoms after ther 6 month administration.  She has experienced severe vomiting, diarrhea, fever, stomach pain, coughing, and congestion.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unspecified dates,the patients were vaccinated with improperly stored VAQTA (strength, dose and route of administration were not reported) of lot # N008823, expiration date 26-MAY-2018, for prophylaxis. The vaccine was exposed to 32 degree Fahrenheit to 35 degree Fahrenheit for 40 minutes. There was a previous temperature excursion at 32 degree Fahrenheit to 35 degree Fahrenheit for 3 hours 10 minutes. Digital data logger was involved. No adverse effects were reported. There was no product quality complaint(PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1708USA005415: US-009507513-1708USA005626: US-009507513-1708USA005628:
pt recv vax 6NOV97 by the PM had a bruise the size of a quarter, a bump & it was sore;the bruise seemed to go sl bigger & stayed blue w/red in it until Sunday, Saturday noc arm hurt so much couldn't sleep;cranky & achy;T100.8, nausea, hurt;
After receiving the Pfizer COVID-19 booster, I experienced soreness of the vax site. After one day I began to have soreness in my back and knees, which at this writing is ongoing.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 at 15:15 as dose 5 (booster), single (Lot number: GJ5342) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin Allergy" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for immunisation, on 07Nov2022 as dose 1, single. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot No: EN6205; Anatomical location: Arm Right; Administration Time: 12:00 PM), administration date: 09Mar2021, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot No: ER8727; Anatomical location: Arm Left; Administration Time: 12:00 PM), administration date: 31Jul2021, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot No: 330308D; Anatomical location: Arm Left; Administration Time: 12:00 PM), administration date: 02Dec2021, for Covid-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE; Lot No: FJ4991; Anatomical location: Arm Left; Administration Time: 03:45 PM), administration date: 12Jul2022, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 29Nov2022 at 16:00, outcome "not recovered", described as "Very dizzy"; VERTIGO (non-serious) with onset 29Nov2022 at 16:00, outcome "not recovered", described as "horrible vertigo"; BALANCE DISORDER (non-serious) with onset 29Nov2022 at 16:00, outcome "not recovered", described as "unsteady". Therapeutic measures were taken as a result of vertigo, dizziness, balance disorder.  Additional information: Within 1 hours of vaccination the patient started suffering from horrible vertigo. Never experienced anything like this. The patient was wondering if had been drugged with some sort of narcotic. Almost 24 hours later still had it. Very dizzy and unsteady. The patient had no adverse reactions to previous COVID vaccinations. The patient didn't experienced covid prior vaccination. The patient was not tested for covid post vaccination. The Other medical history was reported as none (as reported).
Chills (1 day); Headache(still going on); Fatigue (3 days); Herpes outbreak (1 spot)
A shingles rash developed after a day and a half later.  The rash is on the back of both legs. Largest area and breakout I've ever had. Right leg is ankle to upper thigh. Left leg rash is behind knee.  Extremely sore arm.
pt recv vax 23OCT97 & 14NOV (22 days post vax) pt exp lt eye pain, dec visual acuity of the lt eye, h/a & dizziness;
Periorbital edema, facial swelling, joint pain and flare of eczema on upper and lower eye lids. Over the counter Zyrtec, cool compress.
Patient began having excessive yawning day after vaccination. No prior history of motor tics. Yawning as often as once a minute when not talking. Persisted over the weekend. Evaluated in clinic on 11/23/21 with normal neurologic exam. When patient talking, no yawning. When not talking, yawning once a minute at rest. He has no other motor tics observed by parents or this physician
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date in approximately August 2003 (reported as on an unspecified date 10 years) the patient was vaccinated with the first dose of VARIVAX (Merck). The patient would not like to receive his second dose. No adverse symptoms was reported. It was unknown if the patient sought medical attention or not. At the time of report, the status of patient was unknown. Additional information has been requested.
patient was admitted on 08/03/2023 due to acute on chronic respiratory failure with hypoxia secondary to COVID-19 infection.
Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 23 year old female who was vaccinated with the first or second dose of GARDASIL 0.5ml (Lot# not reported). Couple days later, the patient called the office and informed that she think she was pregnant. The patient had a home pregnancy test, the result was not reported. The outcome of adverse event was unknown. It was reported that the patient sought unspecified medical attention. Follow-up information was received from the registered nurse who reported that the patient on 26-NOV-2008 was vaccinated with the first dose of GARDASIL (Lot# not reported), on 26-JAN-2009 was vaccinated with the second dose of GARDASIL (Lot# not reported) 0.5ml. The registered nurse reported the patient was not pregnant when she received GARDASIL. The patient's LMP Was unknown. On an unspecified date, the patient miscarried. An ultrasound on 16-MAR-2009 showed "blighted ovum and no gestational sack". Upon internal review, the miscarried and blighted ovum were determined to be an other important medical event. Additional information is not expected.
I had vaccination on 05/31/2022. I started to have a bad headache on 09/24/2022 with a cough a low grade temperature achiness and feeling fatigued. I could hardly get out of bed. I tested COVID-19 positive on 09/26/2022. I started PAXLOVID on 09/26/2022 after conferring with my doctor. The medication made me nauseous and could only take for 2 days. I am currently feeling on 11/30/2022 much better.
Narrative: 68 yo white male reported dizziness 6/10 after receiving first dose of COVID PFIZER vaccine during the observation period (15 minutes). Patient denied any other symptoms besides the dizziness. Prior to receiving the vaccine, patient denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy. At time of complaint BP 155/82, HR 64, temp 98.3, RR 18. Prior to leaving, BP was 135/83, HR 62, RR 16 and dizziness also improved 3/10.
Positive redness and swelling began on the morning of 2/27/2003 at the immunization sites X 2 over the lt bicep 5 1/2 cm diameter. No fever or difficulty breathing per patient and patient's mother. Advised to apply warm compress at home prn. Gave Orapred 15mg/5ml one teaspoon by mouth in office and Atarax 10mg/5ml one teaspoon in office.
26FEB h/a, dizziness, joint achness 10PM 27FEB AM fever, chills, joint soreness, joint hurt, hard to walk, rash began on chest area; seen in ER, t101.4, rash over all of body, pain in wrist, hands, knees-pleuritic lt chest pain;
large area of red raised rash localized to site area of lt leg vax given; sl warm to touch;
Swelling at injection site after patient was fiven the Fluzone Quad injection. Swelling was immediate and about a quarter in size.  Cold compress was applied at the injection site for about 15 minutes and patient was advised to take acetaminophen or a non-steroidal anti-inflammatory drug if swelling persisted or pain began. Patient said he had no pain at all at injection site.  Also advised patient that he could apply a cold compress at home if needed.
G62.9 PERIPHERAL NEUROPATHY 4/18/2023 BACTERIAL ARTHRITIS OF LEFT KNEE G62.9 PERIPHERAL NEUROPATHY 4/18/2023 BACTERIAL ARTHRITIS OF LEFT KNEE G62.9 PERIPHERAL NEUROPATHY 4/18/2023 BACTERIAL ARTHRITIS OF LEFT KNEE
over 24hr, devel pain, erythema, swelling on rt deltoid;no fever;
HPV vaccine given 10/11/2011 at 10 AM. C/o rash over chest, neck, abdomen and legs. Started 10/13/2011 at 1am, c/o itching rtc for phn to eval. or seek md for eval. of rash. Denied meds, lotions, detergents, soaps.
Pt experience metallic taste fairly soon after injection and called me 4 hours later concerned about the taste in her mouth.
Chills, fever, throwing up, no appetite or energy for a day and a half now.  Horrible pain.
Patient felt dizzy approximately 5 minutes after vaccine and came close to passing out, patient laid on ground and ice packs given, patient recovered within 15 minutes on own
Menveo was diluted with sterile diluent instead of the MenCYW Liquid Conjugate Component and then administered. Denies any symptoms/side effects from administration.
pt reports 4 hrs p/immun feeling tired & taking temp which was 100 that time;  took ASA that time & called in ill @ work; pt states had noc sweats; had 48 hrs flu;
Dec 14-injection, Dec 16 severe pain knees, hips, shoulders - 2 weeks pain gone from knees and 1 hip. Feb 4-pain in hands, shoulders and 1 hip. Progressed. No difficult to use hands. Pain continue in hands, wrists, arms and shoulders.
Patient died in hospital on 12/24/21. She developed cardiopulmonary arrest and was resuscitated but developed severe anoxic encephalopathy and was unresponsive. Family withdrew life support.
pt died @ approx 3AM 14JUN94 coroners report COD-SIDS recvd DTP/HIB & OPV on 13JUN94;
COVID arm.  Itchy, red welts in an area 7cm x 5 cm occurred 8 days post first immunization at injection site.  Treated with hydrocortisone cream to relieve the itch.
Initial report was received on 11 January 2012 from a health care professional. A five year-old male patient who had no illness at the time vaccination had received on 23 September 2011 an intramuscular left deltoid injection of FLUZONE, lot number UH478AA and on 29 September 2011, experienced a widespread rash over the body and was itchy. The patient had no breathing difficulties. The patient was evaluated in the ER (emergency room) and treated with prednisone and hydroxizine. The patient was referred to an allergist. No further information was available at the time of the report. The patient's outcome was recovered (date not reported). Documents held by sender: none.
The pt received the first and second dose in June and July, 1999. After the 2nd dose the pt experienced achiness all over. A Lyme test on 11/9/99 was positive.  The most recent information received on 11/12/1999 reported the condition of the pt is ongoing.
On 12/11/2021 at 03:00 AM I woke up with a bad headache, blurry vision, sore, felt really bad, It went on for 3 or 4 days. 12/19/2021 I went to the urgent care- they prescribed me: ibuprofen 800 mg, and tested me for COVID-19- negative. The symptoms resolved after about 2 or 3 days.
1/7/22 Telephone call from PCP office, positive for COVID OB-GYN visit 1/27/22 She is currently 15 weeks EGA Patient's last menstrual period was 06/10/2021 (exact date). of which patient is Sure:  Yes.  COVID at 11 wks - minimal sx - vaccinated and boosted REVIEW OF SYSTEMS:  Constitutional: Oriented, no unexpected weight loss/gain, or fatigue  Gastrointestinal: No nausea, vomiting, constipation, diarrhea, bloody stool  Genitourinary: No pelvic pain or incontinence, no vaginal bleeding Psychiatric: No depression or anxiety
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 29-JUN-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23 0.5 ml, which had a lot # L003188 and an expiration date of 06-JUL-2016 (route and anatomical location of administration were not reported). The sum of hours in excursion was 64 hours and the lowest recorded temperature reported was 34 Fahrenheit (F) (1.111111111 Celsius (C)).. The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.