chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inappropriate route at vaccination; localized reactions; This case was reported by a nurse via call center representative and described the occurrence of local reaction in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th June 2019, the patient received the 2nd dose of Shingrix (subcutaneous). On 6th June 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In June 2019, the patient experienced local reaction. On an unknown date, the outcome of the local reaction and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the local reaction to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix via subcutaneous route instead of receiving intramuscularly, which led to intramuscular formulation administered by other route. The patient had also experienced localized reactions.  The nurse proceeded to call GSK medical information for directions on next steps. The reporter did not consent to follow-up.
08/26/22 I felt like I had the flu, was exhausted, for the first 24 hours. The next day I was 50% better and within 5-6 days I was fine. My morning glucose and A1C has risen each month to being dangerously out of range. There is a possible LADA diagnosis which will happen on December 5, 2022.
8/8/22 EMS transported pt to hospital with SOB and tachycardia; given medications without changes to heart rate; cardioverted without changes; septic shock; right sided pneumonia; generalized weakness, cough, poor oral intake due to mouth ulcers from chemotherapy treatment; had a positive COVID test on 7/14/22 and given Paxlovid; 8/8/22 continued to show positive COVID test; CCU; ABX; pt's condition worsened; hypoxia requiring intubation with mechanical ventilation; pt's condition continued to deteriorate; transitioned to comfort care measures; pt passed away in the hospital
pt exp bilat hearing loss;pt devel an infect w/in 1wk of getting shot which thought was a rash rxn to the vax;pt underwent various audiological testing which suggested pt had a moderate to severe bilat sensorineural hearing loss; Annual follow-up dated 11/27/00 provided no additional data.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as yes.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report has been received from a medical assistant referring to a 8 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010748.
Pfizer Covid Vaccine treatment under Emergency Use Authorization(EUA): Patient left the vaccine clinic and needed help in the hallway of the building. When staff arrived, the patient was AAO x 3. Patient was pale and stated she was walking to her car when she suddenly felt her heart racing. She was sat on a bench and vitals assessed ( BP 190/100, HR 92, pulse ox 98% room air). She stated she had received her second dose of the covid vaccine ( Lot # EL9265, Exp. 05/31/2021). She stated she had a reaction after her first dose in which she had a red rash 45 minutes after her injection. No rash was noted. She denied any shortness of breath or chest pain. After 5 minutes, vitals were reassessed (BP 180/98, HR 75, pulse ox 98% room air). Patient stated she felt better. Patient refused to have EMS called.
Vaccine given at 545 PM, pt left the clinic and came back at 623 with complaints of shortness of breath and facial numbness. Vitals were 150/80 97% on RA HR 80 and RR 18. At 630 PM vitals were 115/65 HR 92 100% on RA and RR 18. Pt reported all symptoms had resolved by that time and left the clinic.
patient was administered the dose while the temperature excursion assessment was ongoing; patient was administered the dose while the temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered the dose while the temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered the dose while the temperature excursion assessment was ongoing) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered the dose while the temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered the dose while the temperature excursion assessment was ongoing). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered the dose while the temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered the dose while the temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Pt presented to the office today to receive a booster vaccine. Pt scheduled himself through system for a Moderna Booster. We currently do not have Moderna Boosters in our office as they have not been FDA or CDC approved/recommended. This is an issue with the system scheduling process.  I forgot to confirm with the pt before administering the vaccine if Pfizer was correct, this then would have prompted me not to administer the Pfizer Booster. It was not until after the vaccine was administered and the new lot number stickers were placed on the vaccine record card was it noticed the wrong vaccine booster was given.  Documentation of the vaccine administration was done at the time of vaccine administration.
The patient came into the pharmacy as a walk-in for a COVID vaccination with a prefilled informed consent form. The technician asked the patient if this was his first vaccination shot and he answered yes. She proceeded to take a copy of his ID and insurance card. The technician then gave the prefilled form to the intern. Following usual procedures for vaccinations, the intern asked the patient if this was the patient's first vaccination/Pfizer vaccination and talked to him about the side effects of the vaccine. Later on that afternoon, the technician was batch processing the Pfizer vaccines and noticed that the patient noted on the consent form that he had received a J&J vaccination on 03/30/2021. The pharmacist on duty called the patient to verify, and the patient stated "he got the J&J on 03/30/21. He did a blood test at the doctor's office and the doctor told him that he does not have antibodies. The doctor recommended that he get revaccinated." The patient states that he will ask the doctor for the recommendation in writing and will bring it to the pharmacy once he gets the written note.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. Pertinent medical histories and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored PROQUAD lot # M006104 and expiry date 01-AUG-2017 for prophylaxis (incorrect product storage) which was reconstituted with sterile diluent (manufacturer unknown). No adverse effects reported (no adverse event). This is one of the two case from the same reported. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014690: Original Case : 1704USA014450.
pt recvd vax & exp redness, irritation, itchiness, sl swelling & minimal tenderness; pt was examined by ER dx as having localized react to hepatitis vax; tx DPH, Advil or Nuprin; sl discoloration @ inject site;
Patient became nauseous, lightheaded within 5 minutes, heart rate rose and patient mentioned difficulty breathing and pharmacist called 911.
Headache, chills, fever,( pain ,tenderness , edema, redness & hot to the touch of injection site), fatigue, dizziness, muscle & joint pain, restlessness. Increased fluid intake & took Tylenol ES every 6 hours, rested as much as possible.
This spontaneous report as received from a medical assistant refers to a 6 month old patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 11-JAN-2018 the patient was vaccinated with dose one of VARIVAX from lot N022978 expiration date 23-AUG-2019 (Inappropriate age at vaccine administration) and dose one of M-M-R II from lot N020925 expiration date 01-AUG-2019; both for prophylaxis. No adverse effects reported. No further information provided.
Pt experienced tingling sensation and arm felt like it was asleep in R/arm where the injection was given.
Episodes of dizziness began day 5 following vaccine accompanied by nausea.  Have not yet sought treatment from my regular doctor, but plan to contact her today to discuss whether to proceed with second dose of vaccine.  I was sitting down during the episodes, so did not sustain other injury.  Had I been standing, the dizziness was severe enough that I may have fallen.
Within the first 1/2 hour around 10 AM my tongue started to feel thick and I felt woozy. They monitored me at the clinic (where vaccine was received) for over an hour and then suggested to take Benadryl so I waited until I got home to take that. The doctor suggested I stay there. Over the next few days my arm got red, swollen, and hot. I also had a variety of other expected side effects such as headache, covid-like symptoms, night sweats a day or two later, upper stomach pain around the top of my stomach, my hands and feet were cold, I had a weird knot at my injection site, fatigue. The symptoms lasted around 7 days after the shot
3 days p/vax pt devel swelling/knot @ site, some redness;now dec redness, swelling to site 2x2cm , ecchymosis;pt mom advised warm compress to area;
painful injection site; swelling muscle at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling muscle at the injection site) and VACCINATION SITE PAIN (painful injection site) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling muscle at the injection site). On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (painful injection site). At the time of the report, VACCINATION SITE SWELLING (swelling muscle at the injection site) and VACCINATION SITE PAIN (painful injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.    Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: No new information.; Sender'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.
Twelve yr. old female given Moderna as first COVID vaccine dose.  No adverse reactions reported.  When returned for second dose 10/11/21 found was given Moderna.  Reviewed with Pt. and  adult male with her that per COVID-19 Vaccine Administration Errors and Deviations from CDC dated 5/28/2021 the your could receive another Moderna (off label use).   Adult male refused .
Swelling immediately, vaccine "travelled" lower in arm. Probably Not IM but SQ Treated for infection & allergic RXN for 3cm erythemous swelling which began quickly
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender (Encounter key #414478). The patient's concurrent conditions and medical history were not provided. On 07-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 72 hours, the lowest recorded temperature was 28F (-2.222 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
"Flu"; Arm pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA ("Flu"), PAIN IN EXTREMITY (Arm pain) and FATIGUE (Fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported ).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA ("Flu"), PAIN IN EXTREMITY (Arm pain) and FATIGUE (Fatigue). At the time of the report, INFLUENZA ("Flu"), PAIN IN EXTREMITY (Arm pain) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient is concerned about the administration of 2nd dose of vaccine No concomitant medication reported  Treatment using  acetaminophen was reported
A non-serious spontaneous report of nose bleed has been received from a healthcare professional concerning a 41-month-old male, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history and concomitant medications were not reported. The patient received FLUMIST on 13-Sep-2010. The reporter stated that later in the evening after receipt of FLUMIST the patient began to experience nose bleeds. The nose bleeds have since stopped per the reporter.
Within 4 hrs arm began to ache, sore. Redness appeared 2 inches around injection within 6 hrs. 10 hrs - after shot had chills and fever. Took ALEVE and that took care of fever, soreness and redness lasted 3 cays. Very painful to lay on the arm where injection was.
This spontaneous report as received from a pharmacist who received a call from another patient refers to 6 patients of unknown age and gender. On 09-SEP-2014 the patients were respectively vaccinated with a dose of PNEUMOVAX 23 (strength, dosage and route unknown) lot # K004184, expiration date: 10-MAY-2014. On unknown date in September 2014, the patients had unspecified injection site reactions. The outcome of the event was unknown. Pharmacist was requesting a lot check on lot#K004148 exp. 10-MAY-2014. This is one of several reports received from the same reporter. Additional information has been requested.
Received 1st time seasonal flu shot at 1330. Remained in room x 15 minutes and left without any problems. Returned at 1430 with c/o itching on both arms and on neck. No rash/hives. No respiratory problems. Offered epinephrine and/or BENADRYL per anaphylaxis protocol. Pt declined. Returned to work and did not return with further problem.
pain on the shot area (Left deltoid)down to the lower arm and slightly up to the shoulder and side of neck, tenderness, redness, swelling from a size of a dollar coin, warm to touch,
Pt afraid of needles. Identified prior to shot. Pt fainted 30 sec. after receiving shot and when EMT administered IV at site.
lt arm red, swollen, puffy;red @ inj site 19MAR96; like big whelp, site is hot to touch, burns, & itches;t98.0 by mouth;raised;21MAR95 arm pink in color as apposed to red on 19MAR96;warm to touch-was hot;
Vaccine 1: 1/29/21. Vaccine 2: 2/26/21. Found out I was pregnant: 3/25/21. Miscarriage: 5/10/21. First OBGYN appointment baby was smaller than expected and had to get vaginal ultrasound. Baby was measuring at 6 weeks with no heartbeat. 10 days later repeated ultrasound and baby had not grown and still no heart beat. Baby never developed longer than 6 weeks. Adverse event: miscarriage.
12 hr after receiving the vaccine-baby found dead in hotel bed next to his mother Autopsy Dx: SIDS.  8/31/07 Received vax record from pcp which confirm dose & lot as reported.  1/15/08 Reviewed autopsy report which states COD as Undetermined.  Found dead in bed.  Findings at autopsy included: SIDS; petechial hemorrhages of thymus & pleura; pulmonary edema & congestion; cerebral edema; & patent ductus arteriosus.
Pt C/O red, swelling at site and hot to the touch, itchy, soarness.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. The patient was vaccinated with GARDASIL (dose, route, lot # and expiration date were not reported) on 21-JUL-2015 and GARDASIL 9 (dose, route, lot # and expiration date were not reported) on 22-SEP-2015. (interchange of vaccine products) Concomitant drug was not reported. No adverse symptoms were reported. Outcome of the events and the causality were not reported. Additional information has been requested.
pt 11 should have had peds dose, got adult dose (error thinking pt was 12)
I had severe stomach pain and was later diagnosed with Gastroenteritis (swollen of the stomach lining). Symptoms keeps coming back. Was prescribed Omeprazole 40mg.
This spontaneous report as received from a registered nurse refers to an unknown number of patient who on an unknown date were vaccinated with (Merck) VARIVAX injection (strength, dose, route and frequency unspecified) (lot# and exp date were unspecified). The reported stated that on an unknown date, an unknown number of patients may have received improperly stored (Merck) VARIVAX. The doses of (Merck) VARIVAX were stored an average of -14C instead of -15C. Additional information has been requested.
Immunocompromised; Low grade fever; received the booster covid-19 vaccine; received the booster covid-19 vaccine; This is a spontaneous report from a contactable consumer (patient), based on information received by Pfizer (manufacturer control number: 21K-163-4051970-00). Spontaneous report received by by a consumer with events of non-serious. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 3 intramuscular in 2021 (Batch/Lot number was not reported) as single dose for COVID-19 Vaccination; and started to receive adalimumab (HUMIRA, strength 40 mg, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 40 mg for Psoriatic Arthritis. The patient's medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a covid-19 vaccine trial. Historical vaccine included bnt162b2, dose 1 intramuscular and dose 2 via an unspecified route of administration, both in 2021 for COVID-19 Vaccination. In 2021, patient received the booster covid-19 vaccine manufactured by Pfizer. On an unknown date, the patient experienced immunocompromised. In 2021, the patient experienced low grade fever. The action taken in response to the events for adalimumab was unknown. The outcome of the events was unknown. The reporter's causality for the events of adalimumab was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sick; positive Covid test; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (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: ILLNESS (non-serious), outcome "unknown", described as "sick"; COVID-19 (non-serious) with onset 27Apr2021, outcome "unknown", described as "positive Covid test". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient is young and healthy but after getting the vaccination developed Covid. No underlying health issues in perfect health but the shot must've Given him Covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.