chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reports llllspecified patients were inadvertently administered doses of Rotateq that had been improperly stored; No additional adverse event; This non-valid spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information was provided regarding the patients' historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.     On unknown date, the patients was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, (lot #1660947 and expiration date:16-FEB-2021 has been verifed to be valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ)) (dose, dose number and anatomical location were not reported) for prophylaxis. No adverse symptoms were reported. The dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was exposed to a temperature of 48 degrees of Fahrenheit (F) during a time frame of 1 hour. No previous temperature excursions. A data logger was involved.  This case was considered to be non-valid due to unspecified patients with no identifiers.
Given expired Daptacel to patient by mistake, No AE; Initial information received on 11-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 18 months old male patient who was vaccinated with an expired 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (fourth dose in series, lot number: C5367AA and expiry date: 30-Jan-2020) via intramuscular route in the thigh NOS on 11-Feb-2020.   Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Shingles on the right side of face: Forehead, eye, nose. Date Shingles appeared: 03/26/2011. Was misdiagnosed by pediatrician as a simple rash. Visited Urgent Care after symptoms got worse, affecting eye: 03/29/2011. Properly diagnosed and sent to hospital. Hospitalized same day: 03/29/2011. Advised shingles were the result of the varicella vaccine. Discharged: 03/31/2011. High Fever (104): 04/01/2011 - 04/04/2011. Finished antibiotic: 04/06/2011. 04/13/2011: Shingles still visible, but showing improvement.
Patient received a dose more than 12 hours after vial puncture.; wouldn't take it to room temperature, just take it out of the refrigerator, drag a dose, and back; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose more than 12 hours after vial puncture.) and PRODUCT STORAGE ERROR (wouldn't take it to room temperature, just take it out of the refrigerator, drag a dose, and back) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose more than 12 hours after vial puncture.) and PRODUCT STORAGE ERROR (wouldn't take it to room temperature, just take it out of the refrigerator, drag a dose, and back). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose more than 12 hours after vial puncture.) and PRODUCT STORAGE ERROR (wouldn't take it to room temperature, just take it out of the refrigerator, drag a dose, and back) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Systemic: Shakiness-Medium. Additional Details: Patient received the vaccine on 06/28/2021. Two days later, she developed what she described as a nervous tic, which is still manifests even after 7 days. The patient received the vaccination on the same arm she has a Nexplanon implant.
2hrs p/vax malaise,myalgias,nausea,h/a,shaking,t99.8;IV Nacl,APAP,heparin lock
Patient experienced chest tightness and pain 4 days post vaccination. Parents had the patient evaluated at local emergency department for endocarditis/pericarditis and they determined that he had an abnormal EKG finding but could not diagnose endocarditis without additional testing.
Pt received expired dose of bivalent vaccine. Pt reports having cold chills, body aches, and a low grade fever for 24 hours post vaccine dose. Reports no vaccine site reaction. Pt also received flublok vaccine at the same visit.
myalgia, facial  and hand swelling, body aches requiring more than Tylenol/ibuprofen.
1a-3a Sweats and difficulty sleeping,  sore arm 7a-9p body aches and lethargy, sore arm, low fever likely (at work and unable to test) 10p-11p fever (too uncomfortable to test), chills, difficulty sleeping, sore arm 3/18/21 12a-12p low fever (untested), headache, sore arm, fatigue, missed day of work
RED BLOTCHY, HOT, SWOLLEN, SORE & TENDER TO THE TOUCH
Immunized Friday 3/23/07-returned Monday 3/26/07 about 3cm diameter local erythematous duration with slight swelling.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 21-FEB-2018 the second patient was vaccinated with 2 doses of expired PNEUMOVAX 23 (dose, frequency, lot # and route were not reported) (expiry date: 04-FEB-2018) for prophylaxis. No adverse event reported. Product quality issue was not involved. The outcome of events was not provided. The relationship between the events and PNEUMOVAX 23 was not provided.
3 to 5 days: intense pain in the back of the head and headache, esp when bending down as if to pick up a ball (head dips toward knees) within 14 days - intense vertigo for 12 hours, residual dizziness and unsteadiness has lasted several weeks, higher level of ringing in the ears is first noticed 21- 40 days - tinnitus is more apparent to me (bothers me sleeping and going to see an ENT about it), occasional wooziness in the head, full pressure feeling around the ears
Extreme pain and bruising in the left arm which lasted for 4 days, decreasing pain each day.    I couldn't sleep lying on my left side.   Very restless the first night with little sleep.  Small bruise is still showing  7 days later.  Mild headache, nausea, and dizziness for 4 days.
Per parents pt. began experiencing the below symptoms 2-3 days after her MMR and Varicella vaccines. In addition to the list they described below, she was seen in the ED   a few days after her vaccines for fussiness and a headache, and subsequently diagnosed with an ear infection. However, they felt her symptoms did not improve much with antibiotic treatment. At about 10-14 days she developed the typical measles like rash that I saw in pictures and her vaccine site was quite itchy. See below.  Symptoms:  "Strange movement with her head  Body twitching   Rash all over her body  Itchy  Mouth sores  Swollen bottom lip  Keeps putting fingers in mouth.  Hoarse throat  Tantrums   Sensitive to light, wants to wear sunglasses all the time.  Holding her head and screaming I don?t want this.  Difficulty concentrating   Hitting the wall in the corner and crying she wants it to leave.  Lack of appetite   Easily annoyed   Lots of crying and screaming  No interest in playing  Lack of sleep  Crying during sleep   Sleeping in our bed again. She hasn?t done that since she was 3 months old."  The above symptoms did resolve after about 3 months.
Patient had neck pain and facial swelling hours after first dose of COVID moderna. Went to hospital for treatment. He came in for his second and told us what happened. We refused the second dose.
This case was reported by a nurse via call center representative and described the occurrence of back pain in a 17-year-old female patient who received BEXSERO (batch number 156801A, expiry date 31st August 2017. Concomitant products included FLUZONE. On 20th September 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 20th September 2016, less than a day after receiving BEXSERO, the patient experienced back pain, pain in arm and sweating. In September 2016, the outcome of the back pain, pain in arm and sweating were recovered/resolved. The reporter considered the back pain, pain in arm and sweating to be possibly related to BEXSERO. Additional details were provided as follows: On 20th September 2017, the patient received FLUZONE as a concomitant medication in right deltoid (batch number: UT5673KA, expiry date: 30th June 2017). The patient received BEXSERO in left deltoid and experienced severe back pain, sweating and arm pain. The events lasted for 24 hours.
Several minutes after vaccine administration, patient was in monitoring area and reported to EMS staff having a scratchy throat and a rash. Pt was scratching chest, redness present.  No facial swelling noted, no signs of respiratory distress. An IV was started by EMS, and IV Benadryl was administered. Pt was monitored by EMS, symptoms improved. Patient denied wanting transport to the hospital for further monitoring and had a friend give her a ride home. She was informed to not receive the second dose.
Breakthrough positive COVID test (9/24/2021); symptomatic on 9/24, likely exposed in-transit from travel. Negative at-home nasal rapid test on 9/23 post-travel for surveillance, but became symptomatic on 9/24 and worsened by the hour. Began quarantine on 9/25 for ten days; tested negative via PCR test on day 11. Started steroids as Rx?d by Urgent Care facility on 10/13/2021. Completed on 10/22.   Symptoms included (9/24-9/28): fever, chills, coughing, body aches, productive sputum cough, loss of sense of smell/taste, sneezing, nausea, diarrhea, and severe head/sinus congestion. Symptoms (9/29-10/8): persistent moderate cough and congestion, elevated heart rate with minimal exercise, and sneezing. Sense of taste and smell mostly returned to normal. Symptoms (10/9-present):  sense of taste and smell mostly normal, elevated heart rate with moderate exercise, normal oxygen levels, began steroids (20mg prednisone 10 days), improved significantly, diminished cough, but dry.
Unused pre-filled syringe was found to be empty upon use. No sign of leakage in the packaging. Syringe was disposed but still have packaging.
Patient was a patient with long time diabetes and hypertension. She received the Moderna vaccine last Thursday.  She had some nausea and vomiting and later some diarrhea. Unfortunately, she continued to take her diabetic meds and antihypertensives. Her CT abdomen showed duodenitis.    She presented with multisystem organ failure and severe lactic acidosis.  Despite aggressive treatment, she died less than 24 hours after admission. She was a complex patient and the renal failure and metformin toxicity seemed to be the terminal event, the vaccine may have started the process with some dehydration from nausea and vomiting.
No additional AE reported; Physician reports that a patient was inadvertently administered both VARIVAX and PROQUAD; This spontaneous report has been received from a physician, regarding a 4-year-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 13-SEP-2022, the patient was inadvertently administered both varicella virus vaccine live (Oka/Merck) (VARIVAX) frequency reported as once (lot number: W011622, which was determined to be valid, with an expiration date of 06-APR-2024) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) once (lot number: W017573, which was determined to be valid, with an expiration date on 29-NOV-2023), both as prophylaxis (doses, route and anatomical location of administration were not provided) (accidental overdose) (accidental exposure to product). No additional adverse event was reported.
Loose stool on 12/20/20, post nasal drip 12/21/20, nasal and chest congestion, fever of 100.7 on 12/22/20.
SYNCOPE SHORTLY AFTER DOSE. FALL WITH NO INJURY. KEPT SITTING AND SIPPED WATER. FULL RECOVERY WITHIN 15 MINUTES.
"Started about midnight, used Ibuprofen then itching and hives showed up - I took BENADRYL. That cleared it by Friday night or Sat. morning" so lasted from 5-29 to 5-30-14. Red raised welts with itching. States completely resolved. No further symptoms.
This is a spontaneous report from a contactable other health professional (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via intramuscular route of administration on 25Jan2021 at 14:30 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was reported as none. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), intramuscular on 04Jan2021 at 11:30 am (age: 54-years) on the left arm for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 02Feb2021, the patient experienced numbness in arms, hands, legs and feet. The patient did not receive any treatment for the reported event. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event was not recovered.
The patient described his symptoms to pharmacist on duty on 11/18/2019.  He stated at the time of injection, he "felt it all the way down to fingertips." He has had pain since the injection in the left shoulder. It hurts to lift his arm.  He has applied rub on it. He believes the injection was administered too far up his arm, too close to the shoulder joint.  Pharmacist recommended that the patient be evaluated either by his PCP or at a Clinic to decide the next course of action for his treatment.
Very heavy period at unusual timing for 7 days as of time of reporting, never experienced an irregular or heavy flow period in previous years.
Initial information received on 05-Jun-2018 regarding an unsolicited valid non-serious case received from other health professional (medical assistant). This case involves an 18 years old female patient who experienced fever of 101.2 and headache, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Jun-2018, the patient received a single dose of suspect MENACTRA (Lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious fever of 101.2 (pyrexia), following the administration of MENACTRA. On an unknown date, the patient developed a non-serious headache following the administration of MENACTRA. Final diagnosis was headache and fever of 101.2. The patient was treated with IBUPROFEN. The patient outcome is reported as unknown for fever of 101.2 and as unknown for headache. List of documents held by sender: none.
On date of 3rd anthrax vaccination (6 mo.), about 10 hours post vaccine, he was at work (not exerting himself) and presented with outbreak of tachycardia (140 bpm) and bilateral facial flushing. Treated and released from ER with BENADRYL. Symptoms are episodic now every 3-4 days; treatments ongoing.
Localized erythema surrounding injection site covering the whole of her tricep of her right arm, warm to the touch with a small nodule at the injection site.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 77-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing), notes: heart disease. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Paxlovid as Covid-19 treatment from 16Jun2022 to 21Jun2022. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event, Drug ineffective and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Patient  was admitted to hospital for underlying health condition. Tested positive for Covid during stay and passed away.; Patient  was admitted to hospital for underlying health condition. Tested positive for Covid during stay and passed away.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Feb2021 (Lot number: EL3247) at the age of 49 years as dose 2, single and intramuscular, administered in arm right, administration date Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic health condition" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, hospitalization, medically significant), COVID-19 (death, hospitalization, medically significant) all with onset 26Nov2021, outcome "fatal" and all described as "Patient  was admitted to hospital for underlying health condition. Tested positive for Covid during stay and passed away.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Nov2021) positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. The patient date of death was 05Dec2021. The reported cause of death was covid-19. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.; Reported Cause(s) of Death: Patient  was admitted to hospital for underlying health condition. Tested positive for Covid during stay and passed away.
Pt. stated symptoms started 3/6/2022, very weak and tired. Brain fog, extreme diarrhea. Stayed in bed for 3 days, and then went to urgent care. 5 days later went to ER, was told she had pneumonia. Brain is still very slow. Pt. also stated she had a rash for about 3 weeks and was given steroids and antibiotics.
pediatric /patient had received an adult dose; pediatric / patient had received an adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 12-year-old female patient who received HAV (Havrix adult) (batch number F4EL2, expiry date 9th November 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2021, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Pharmacist reported that a pediatric patient had received an adult dose of HAVRIX which led to adult product administered to child and overdose. No further details were reported at the time of the call. The reporter consented to follow up by phone. The case had been linked with U2021174388 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-U2021174388:Same rSeporter
This spontaneous report was received from a medical assistant concerning to a 12 month old patient, gender unknown. Patient's information as concomitant medication, concurrent condition and medical history was not provided. On 09-JAN-2019 the patient was vaccinated with an unspecified dose of PROQUAD for prophylaxis (strength, dose, route of administration, lot # and expiration date was not provided) and on the same date, the patient was vaccinated with a dose of  M-M-R II for prophylaxis (strength, dose, route of administration, lot # and expiration date was not provided) and sterile diluent (route of administration, lot # and expiration date were not provided).No adverse effects was reported.
I experienced a breakthrough case of COVID-19 with a sore throat, extreme fatigue and diarrhea.
I experienced numbness of my chin and lips. Also, I had stiffness of my jaws. I was given a Zetec (allergy Tablet PO) and monitored for 1 hour, with vital signs being taken.
VERTIGO; NAUSEA; FREEZING/CHILLS; This spontaneous report received from a patient concerned a 30 year old white male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced freezing/chills. On 15-MAR-2021, the subject experienced vertigo. On 15-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from freezing/chills on 13-MAR-2021, and was recovering from vertigo, and nausea. This report was non-serious.
Information has been received from a registered nurse referring to a patient of unknown age and gender on 20-OCT-2017. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 15-SEP-2017, the patient was vaccinated with improperly stored VARIVAX lot # N012131 and expiration date of 17-APR-2019, (route of administration and anatomical location were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (MERCK) (lot # unknown). The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees for 3 hours and 40 minutes. No previous temperature excursion was reported. The patient did not experience any adverse events. Digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007342: US-009507513-1710USA014743: US-009507513-1710USA014749: US-009507513-1710USA014745: US-009507513-1710USA014746: US-009507513-1710USA014747: US-009507513-1710USA014748.