chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nurse reports that they administered an expired ACT-HIB today with no reported adverse event; Initial information received on 14-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient who was administered an expired HIB (PRP/T) vaccine [ACT-HIB] today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for prophylactic vaccination (Immunisation).  On 14-Aug-2023, the patient received a dose of 0.5 ml (dose 4) once total of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (strength: standard) (lot: UJ803AA; expiry adte : unknown) via intramuscular route in left leg for Immunisation.  On 14-Aug-2023 the patient was administered an expired act-hib today with no reported adverse event (expired product administered) (latency: same day).  It was reported, "Nurse declined to provide email. Nurse asks for information regarding the expired dose; asks if there are any recommendations about how to document the expired dose on the patient's vaccine record."  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.
Saw on 10/08/08 with swelling, redness and induration to injection site. Placed on AUGMENTIN 875 mg p-o BID
THE PATIENT STARTED SWEATING WITH SHAKES FOR A FEW MINUTES THEN STARTED FILLING COLD HE STATED IT FELT LIKE SEIZURE NOT SURE IF THAT'S WHAT  HE HAD. HE STATED HIS CHEST FELT TIGHT.  HIS EYE MAY HAVE ROLLED BACK NOT SURE  AFTER A FEW MINUTES(5-10 MINUTES) HE STARTED FILLING BETTER  WE CALLED 911 AND THEY CAME WITHIN 5-10 MINUTES HE WAS OBSERVED FOR A WHILE HE SAT ON THE CHAIR TILL BETTER AND WENT TO ER  FOR FURTHER OBSERVATION
Fever; shivers; severe headache; This case was reported by a consumer via call center representative and described the occurrence of shivers in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th March 2020, the patient received Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced shivers and headache. On 16th March 2020, the patient experienced fever. On an unknown date, the outcome of the shivers, headache and fever were not recovered/not resolved.   It was unknown if the reporter considered the shivers, headache and fever to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and had the shivers and a severe headache. On 16th March 2020 had a fever.  Patient enquired for can the reaction to it last this long?
woke up from nap and felt hot all over, her face was hot as could be; temperature of 101 degree Fahrenheit.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (woke up from nap and felt hot all over, her face was hot as could be) and PYREXIA (temperature of 101 degree Fahrenheit.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced FEELING HOT (woke up from nap and felt hot all over, her face was hot as could be) and PYREXIA (temperature of 101 degree Fahrenheit.). The patient was treated with ACETAMINOPHEN on 18-Mar-2021 for Fever and Feeling hot, at a dose of 250 mg. On 18-Mar-2021, FEELING HOT (woke up from nap and felt hot all over, her face was hot as could be) and PYREXIA (temperature of 101 degree Fahrenheit.) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 101 degree fahrenheit (High) 101 degree Fahrenheit.
12 x 13 cm area around injection site of swelling, redness & warmth. Pt. was instructed to use BENADRYL & ice. Symptoms were resolved by 7/24/12.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 11:10 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 11:10 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was reported as 20.07. No concomitant medications were reported. On 27-Apr-2021, 8 vials were moved to clinic.   The vial was initially moved to the fridge on 19-Apr-2021 and proposed beyond use date was 19-May-2021. On the date of administration, at 09:00 A.M., the temperature recorded was 35 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 27-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided. The occupation of reporter was reported as clinic manager.   This case was linked to MOD-2022-566976 (Patient Link).
menstrual cycle issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "menstrual cycle issues".  Additional Details: She was experienced menstrual cycle issues after the COVID vaccine and would like to talk to someone.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID vaccine inadvertently given to a 16 year old patient.  No adverse reaction up to time of report.
Patient developed a red pin point rash all over her body. Dx: Urticaria. Tx: Prednisone 20mg  qd x4days. Patient currently BID for strep throat.
child recv vax & father who slept w/child devel varicella lesions about a wk p/the child did;father was given acylovir & is fine;2 possibilities seem likely, wild type virus transmission w/coincidental vaccination or poss vax rxn
Fever, pain stiffness.. Treated both and no noticeable swelling until forty-eight hrs later..Large area swollen and very red. Acetaminophen and ice/heat admin. Taken to Emergency room. Thurs A.M.
Administered FLUMIST, VARIVAX #2. Patient vomited, hives, tired, dizzy. Administered Xyzal to patient. Hives disappeared and felt better. Nausea stopped. Observed patient then went home.
This spontaneous report as received from a consumer, as part of a marketing research study program concerning to refers to the consumer's 13 year old daughter. On an unknown date in July 2012 the patient was vaccinated with the first dose of GARDASIL (dose, frequency, route and lot # not reported). On an unknown date in July 2012 the patient had an allergic condition to her first shot of GARDASIL ("broke out"). The patient was hospitalized to be worked up and monitored for flare-ups. The patient's outcome was reported as recovered but sequelae was unknown. The stop date of event was reported as unknown date prior to September 2012. No further incidents were monitored. Therapy of GARDASIL was reported as interrupted as the vaccines series delayed until workup. She received her second and third doses after the workup as normal. The stop date of GARDASIL was reported as January 2013. The adverse event did not re-appear after these two doses. The reporter considered the event to be related to GARDASIL. Additional information is not expected.
Red, swollen, bump on (L)-(R) leg 2 cm around inj site bil.
FiFive (5) seizures over the course of two (2) weeks. The seizures consisted of all of my muscles tensing up and my entire body twitching/ shaking for 1-2 minutes.
Pt recvd vax 31AUG92 & approx MN pt had fever of 105 & rx w/APAP; following morning,fever down to 101; several; hrs later temp nl; also c/o h/a; recovered; pt recvd Dt only for @ least 3 immun-reason unk;
The patient noticed last night around 10 PM, his arm was very sore and itching. The patient pulled up his sleeve, there was a huge red circular swelling, and the area was very hot. At 2 PM the following day and it was still red, hot, and swollen.
Spot that looks like a ring higher up from where the vaccine was given; Swollen at injection site; Itchy rash; Arm was sore; Arm was hot to touch on the site of injection; Arm was very painful; A spontaneous report was received from 31 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced burning sensation all over the arm, itchy rash, arm was very painful and sore, she was not able to lift anything, arm was hot to touch on the site of the injection, a little swollen, rash bigger, and a spot that looks like a ring higher up from where the vaccine was given.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly (lot number 011L220A) on her left arm for prophylaxis of COVID-19 infection.    On 31 Dec 2020, the day of administration, the patient started to experience burning sensation all over the arm. She stated that it turned into an itchy rash at night. On an unknown date, her arm was very painful and sore, she was not able to lift anything. Her arm was hot to touch on the site of the injection and a little swollen. On an unknown date, she stated that the soreness is no longer there, but the pain is. She mentions that the rash bigger, and a spot that looks like a ring higher up from where the vaccine was given. Treatment include cetirizine hydrochloride, which helped ease the effects a little.   Action taken with mRNA-1273 vaccine is not applicable.  The outcome of the events, soreness, was resolved. The outcome of events, burning sensation all over the arm, itchy rash, arm was very painful, she was not able to lift anything, arm was hot to touch on the site of the injection, a little swollen, rash bigger, and a spot that looks like a ring higher up from where the vaccine was given, were unknown. .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Within ten hours of the second Pfizer COVID19 vaccine the patient became severely dizzy. The dizziness continues to date 9-13-22 on an intermittent basis.
Extra dose/both flulaval administered on the same day; administered intradermally in the forearm; administered intradermally in the forearm; This case was reported by a physician via call center representative and described the occurrence of accidental overdose in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis and flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season (intradermal) .1 ml, Flulaval Tetra Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season (intramuscular) .5 ml and Flulaval Tetra Pre-Filled Syringe Device. On 10th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced accidental overdose, intramuscular formulation administered by other route and vaccine administered at inappropriate site. On an unknown date, the outcome of the accidental overdose, intramuscular formulation administered by other route and vaccine administered at inappropriate site 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: 11-OCT-2022 Reporter's Comment: The reporter reported that, a patient received an extra dose of Flulaval. One Flulaval 0.5 cc dose administered intramuscularly and then another Flulaval 0.1cc dose intradermally in the forearm both administered on same day.  The reporter stated that, the nurse accidentally administered the extra 0.1cc dose but was trying to give a TB test but withdrew the Flulaval instead.  No other details were provided.  MD was unable to provide vaccine and patient details.  The reporter did not consent to follow-up Additional Supportive Information: The patient received one Flulaval 0.5 cc dose administered intramuscularly and then another Flulaval 0.1cc dose intradermally in the forearm both administered on same day, which led to accidental overdose, intramuscular formulation administered by other route and vaccine administered at inappropriate site.
I had the 2nd moderna shot on May 5 the following Monday I had pain right below my chest left side bottom of rib cage Monday May 10th then developed a rash around Wednesday May 12th, this was a couple a bumps on skin left side front bottom of rib cage.  Other than pain, I generally feel fine.  Pain is severe at times but not consistent.   Gradually the rash spread from a coupe of spot into a line of spots from the original point to sternum and then around the back to the spine.  Gradually the pain became more consistent and more.  I did an E-visit with APNP at 5/16/2021  8:37 AM.
Information has been received from a physician concerning a 71 year old female who on 24-FEB-2009, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, dose and route not reported). On 25-FEB-2009, the patient experienced itching around the injection site. The physician reported that the patient put ice on the site and she had recovered on an unknown date. The patient sought medical attention by calling the physician. Additional information has been requested. Follow up Information has been received from a physician concerning a 71 year old female with hypertension, gastrooesophageal reflux disease, fibrocystic breast and allergy to codeine, allergy to NAPROSYN, allergy to NSAIDS, allergy to PREVACID, allergy to CLARINEX and allergy to EVISTA, with no illness at the time of vaccination, who on 24-FEB-2009 was vaccinated with first dose of ZOSTAVAX (Merck) (dose and route not reported) (lot number 663174/1552X) after 1:00 PM. The physician reported on the day of vaccination, the patient tensed up because she was afraid of needles. The physician also reported that the patient did not remove the bandage until the following day (25-FEB-2009) during lunch as her arm of injection site started itching. Then she realized that bandage was still there and she noticed a "50 cent coin" size red bump (an array of small red bumps forming a "50 cent coin"). The was a raised bump. Patient applied an ice pack to stop the itching; then she put BENADRYL cream on the area on 25-FEB-2009. Patient called the physician to inform her. No vesicles, bumps and redness went away after one week. Recovery date reported as 04-MAR-2009. No further information is available.
I am in a wheelchair. The needled was inserted at shoulder joint and was more upright instead of top of arm as all my other vaccines are given in the muscle. About two hours after injection, I started having severe arm pain to fingers. I used ice, heating pad, Tylenol. I have pain to touch at the bone joint at shoulder.  No problem with any other reaction to vaccine. The pain continues today as bad as yesterday.
I woke from a full deep sleep with stomach nausea that lasted through to the early morning. I spent the day extremely lethargic on the couch with no energy for even low-level activity.  I fell asleep early in the evening, but then woke up around 2 am and could not fall back to sleep so despite feeling 80% better the next day, I was still tired.     Also, I had the tell-tale sore arm.  Obviously, the protection of the Moderna Covid vaccine far outweighs any passing discomfort or lack of sleep and I would absolutely do it again!
It started with an irritated throat on 3/8/2023. As it progressed, I had chills, rigors, sinus drainage, achy muscles, and primarily a sore throat. I probably also had a fever, but I didn't take it, because I just felt bad. On 3/9/2023, I took a home antigen test and got a positive result. On 3/10/2023, I was prescribed PAXLOVID. Within a couple of days, I noticed a marked improvement. I had no more chills or aches, but the sore throat persisted until 3/15/2023. I finished the last dose of PAXLOVID on 3/15/2023. By 3/18/2023, I felt sick again. I had throat irritation. I had severe sinus congestion, chills, and general malaise on 3/19/2023. At the time of this writing, I feel a little better than I did 3/19/2023. I have been taking SUDAFED, TYLENOL, and ADVIL intermittently to manage the symptoms, and they help make it more tolerable.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 12-year-old female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 15-Dec-2010. On 20-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Complain of metallic taste and oral parathesia immediately following vaccination administration. No shortness of breath or swelling.
27 year old female, post injection with Hepatitis A+B, TD + Typhoid pt became stiff, face and extremities turned bright red and then appeared to have seizures with tremors and shaking of all extremities which lasted approximately 6 sec Pt not responsive at this time, after 15-20 sec pt responsive to verbal stimuli. B/P 90/60. Pulse 64. Pale and diaphoretic
Fatigue, headache, chills, and bodily achiness for 2 days following receipt of 2nd dose of Moderna Covid vaccine.
Palpitations No hx of headache, dizziness nor nausea/vomiting Observed patient, patient felt better, symptoms resolved Discharged to home
BELLS PALSY; This spontaneous report received from a patient concerned an adult male of an unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered, start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date (3 days after vaccination), the patient experienced bells palsy (left side of the face and eye were drooping). Patient visited ED (emergency department) and was receiving physical therapy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bells palsy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220849826- covid-19 vaccine ad26.cov2.s -Bell's palsy. This event(s) is labeled per Agency and is therefore considered potentially related.
This spontaneous report was received from a medical assistant and refers to a 18 month old (reported also as 2 year-old), black, female patient who did not have any known drug reactions or allergies. There was no information about the patient's concomitant therapy or medical history provided. The patient did not have any illnesses at the time of vaccination. On 23-OCT-2015 at 14:30 (reported also as 2:30 pm), the patient was vaccinated with improperly stored dose of VARIVAX lot # L013068 in the right thigh for prophylaxis (dose, route of administration, and expiration date were not reported). The vaccination was in privates doctor's office/ hospital and administered VARIVAX was purchase with public funds. No adverse event was reported. Previous temperature excursions, the range and time of temperature excursion the administered VARIVAX experienced were not reported. It was unspecified if a digital data logger was involved. A signed informed consent form was not obtained. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1611USA014213: US-009507513-1702USA004104: US-009507513-1702USA004102: US-009507513-1702USA004103: US-009507513-1702USA004110: US-009507513-1702USA004109: US-009507513-1702USA004108: US-009507513-1702USA004107: US-009507513-1611USA008278: US-009507513-1702USA004105:
My arm turned all red as wide as my arm and I had a bump the size of an half dollar. It was also warm to the touch.
Sudden onset of extreme fatigue, brain fog, headaches, then vision loss in left eye including double vision in only that eye
Varicella vaccine 05/05, Shingles diagnosed 10/11/2005.