chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine and was asked to sit in the pharmacy waiting room for 15 minutes as she has received her first and second dose of the covid vaccine from a different manufacturer (Pfizer). During her fifteen minute wait, her husband came up to the technician and stated that she was finding her throat felt it was giving her the feeling of closing up. She also stated that her arm felt sore. Upon observing the patient, she seemed to be able to breathe and speak with no issues of breathing, rash, or any other symptoms of anaphylaxis however she kept touching at her throat and repeating she felt her throat felt like it was closing up- so I administered her 50mg (10ml) of Children's Benadryl. Upon administration of the Benadryl she stated she immediately felt better and that it was just her arm. She was given a bottle of water by the store manager and I informed they I would like to call for help, the husband felt that she was okay and better enough to go home. I stated that  if they felt like the symptoms were returning and then counseled on the symptoms of itching, rash, trouble breathing, swelling in any arms, throat or any body part they should seek immediate medical help. They said they would and they left the pharmacy. I followed up with the patient to obtain any information regarding the event and they stated they went to the emergency room/urgent care just to make sure she was okay because she felt dizzy on the car ride home.
Pfizer FP7135 dose #4 inadvertently given with no immunocompromised issues.
Reddened - 9 1/2 x 5 1/2cm, warm to touch.
It was reported that a 79 year old male pt received a Fluzone SV '00-'01 vaccination on 10/10/00. Reportedly, the pt developed respiratory distress and congestive heart failure. The pt was hospitalized in ICU on a ventilator and cease to breath on 10/15/00. Interstitial infiltrates notes on chest X-ray by Pulmonologist. Follow-up from 10/24/00, upon further evaluation is was discovered that the pt died on 10/15/00. Follow-up correspondence received on 11/2/00, it was reported that the pt died on 10/16/00 not on 10/15/00 as previously reported. Additional pt and responsible physician information were also provided.
This spontaneous report was received from a nurse referring to one of two 5 months old patients (twins) the gender was unknown. The patient's medical history or concurrent conditions were not reported. On 28-SEP-2016, on 28-OCT-2016 and on 27-MAR-2017, a day before the patient was 6 months old, the patient was vaccinated with the first, second an third respectively doses of RECOMBIVAX HB the route was not reported (which had the lot # M039642, expiration date 03-JUL-2019). On unknown dates, and also on 27-MAR-2017, the patient was vaccinated with the first, second and third doses of ROTATEQ orally (which had the lot # M042822, expiration date 19-JUN-2018 or M039068, expiration date 19-APR-2018) both vaccines for prophylaxis. No adverse effects were reported. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012679:
needle was not on secure enough and the fluid from the vaccine leaked everywhere / no AE; needle was not on secure enough and the fluid from the vaccine leaked everywhere / no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves unknown demographic patient who was vaccinated with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ288AB (Expiry date 02-Jun-2020) via unknown route in unknown administration site.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to vaccine underdose.  It was also a case of syringe leak.  At the time of reporting no adverse reaction was reported.  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.
pt recv vax 30OCT97 mom reported on 5NOV97 that child had chickenpox w/ 15-20 vesicles on trunk, genital area & down legs;reported no fever;seen 5NOV97 no evidence of vesicles noted-no med rx;
At 12:18 Pt complained of dizziness and feeling faint. Patient was laid down, water and orange juice given. At 12:20 patient moved to a stretcher. At 1245 patient report her symptoms have resolved. CG report she had poor sleep last night and had no food prior to getting vaccine.
6 days p/vax, pt found in crib in AM unresponsive & ashen; To ER; complete arrest;
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
Erythema, edema, hyperemia measuring 10 x 12 cm on deltoid area.
Patient reports that the day after receiving the vaccine, she had a reddened area around the site. The following day, she began having blisters and redness, near where the vaccine had been given. She reports she had  taken Benadryl and Aleve, and  the next day the  the redness was  half the size. Today, that area is intact, but shows white scaring.
PATIENT HAD SWOLLEN, SORE ARM, SENSITIVE SKIN AROUND INJECTION SITE. PT ALSO HAD VOMITING AND DIARRHEA THAT MAY HAVE BEEN RELATED TO THE UTI SHE WAS DIAGNOSED WITH AT THE EMERGENCY ROOM VISIT.
Patient received J&J vaccine in May. Returned from tour of duty with the army sometime in July. Became ill on 7/22 with URI symptoms. Tested Covid Positive on 7/23. Rapidly deteriorated and developed fulminant myocarditis requiring mechanical ventilation and VA ECMO. Also with failing kidneys and liver.
Dose administered post the expiration or beyond use date; Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022) in a 34-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 022C21A and 032H20A) for COVID-19 prophylaxis.     Allergies to medication, food and other products were unknown. It was unknown if the patient had ever been diagnosed or tested positive for COVID-19. Chronic and acute illness at the time of vaccination and one month prior was unknown.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. On 13-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .5 milliliter. On 19-May-2022 at 10:18 AM, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .25 milliliter. In May 2022, the patient experienced PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022). On 19-May-2022 at 10:18 AM,  after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022).    Prescriptions, over the counter medications, dietary supplements or herbal medicines being taken at the time of vaccination and or at the time of adverse event was unknown. The event did not cause the patient to seek medical care. It was unknown if the patient had experienced any similar event in the past. Treatment information was not provided.   This case was linked to MOD-2022-585601 (E2B Linked Report).; Sender's Comments:  MOD-2022-585601:Master case
I experienced swelling in my armpits and that has been persistent since I've first noticed it in October.
Hypoglycemia and seizure activity. For approximately 1 minute, patient stared off, non-responsive, both arms shaking.
This spontaneous report as received from a consumer refers to her daughter with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with MMR II (lot#, route and dose were unspecified) on approximately August-1974, "15 months old" and for 5 years didn't walk. No concomitant medications were reported. On approximately 1974, "the next day" after given MMR II the patient was shaking and then 3 days later stopped walking. The patient couldn't sit up and lost motor control. The consumer stated her daughter was a perfectly healthy child until the MMR II was given. Consumer states her daughter couldn't read for a long time and when her daughter started school, she was 3 years behind. Consumer stated treatment with "ACTH shots" for 3 months then her daughter would start walking again but if her daughter had a fever, her daughter would stop walking and needed "ACTH shots". This occurred for 5 years. Consumer states to this day, her daughter's fine motor skills were not 100%. Consumer mentioned her daughter would run high fevers with most vaccines but not with MMR II. Consumer could only remember DTAP (manufacturer unknown). The patient sought medical attention via office visits, and was hospitalized every 3 to 4 years. Lab diagnostic studies included brain scans and kidney tests. Lab diagnostics results were not reported. Additional information is not expected.
Client had received her second Hepatitis B on 9/30/11. Had reaction 15 min. after shot - headache that immediately made her sick - blurred vision. Felt "ill" for 2-3 days.
After the vaccine, my daughter platelet dropped. First we could not figure out what caused it. Then we looked into the symptoms of the vaccine. She started getting rash and bruises. She is now diagnosed with ITP.
A report has been received from a Physician concerting a 43 year old, male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent was started on 16-DEC-2014. The reporter stated that the patient experienced expired FLUMIST administration  on 16-DEC-2014. The outcome of the event of expired FLUMIST administration is unknown. The report was considered to be non-serious.
1.  Almost unbearable neuroapathy developed in both feet 2 months after the shot.   Had slight numbness in feet before shot but never this kind of burning pain.  Still have it and it's getting worse as time passes.    2.  Tremors in both hands.   Not excessive or debilitating but didn't exist before shot. 3.  AFIB/Atrial flutter no longer controlled by meds.   I had 2 ablations to control my AFIB and combined with daily meds it was under control for over 3 years.  Minimal events per year.   I have been in constant atrial flutter now for over over two months with occasional AFIB lasting days. 4.  Migraine/Ocular and standard.   Multiple times a month.   This was never an issue prior to the shot.
on 3/2/2021 immediately after receiving moderna 2nd dose vaccine pt experienced rash to right arm and torso. Benadryl was administered and pt states rash began to look better. pt denies other s/sx experienced. pt has allergy to pcn- caused rash.  on 3/3/2021 phoned pt for f/u. Pt states he is doing fine following event. States rash has resolved, no additional s/sx.
Janssen COVID-19 Vaccine EUA 12:15pm (3/10/21)- initial injection 12:20pm- excessive bleeding from arm 6:45pm- chills, inability to get warm, headache 7:45pm- low grade fever (100.3F), took Tylenol Overnight- inability to sleep, constant chills and sweating, muscle aches, felt very horrible 2:30pm (3/11/21)- fever breaks, only arm is still sore
Pt was here for follow up with PCP, MD ordered a flu vaccine for pt. This nurse administered the vaccine and shortly after the pt. c/o itching at the injection site. MD was notified and gave verbal order to administer 25mg tablet of BENADRYL, PO to pt. Pt received medication orally, and was monitored after. Pt was then given the okay to leave after the nurse witnessed that the allergic reaction had substituted.
Patient received a monoclonal antibody treatment on 4/24/21, received the first dose of Pfizer on 5/21 and answered "no" to the question "have you had the monoclonal antibody treatment" so the shot was given. She returned today to get the second dose and then told us she had the treatment.
Pt recv vax on 10/9/95; on 5/6/99 pt exp outbreak of lesions
While the patient was waiting, seated for 5 of the 15 minutes, post-vaccination she began to feel light headed. The patient shortly after expressing this concern slumped over in the chair, shaking and twitching, for a few moments (likely 60 seconds or less) before regaining normal stature and attention. The patient expressed some changes in her field of vision, a continuation of feeling light-headed, and a ringing in her ears.  EMS was called to evaluate the patient, concerned that the patient had experienced seizure activity. EMS arrived shortly after, evaluating the patient's current state and vitals. After assessment, EMS determined this was a syncopal episode related to the patient's anxiety around the vaccination and cleared the patient to drive themselves home after resting on-site. Patient rested and recovered in pharmacy vaccination room for an additional 20 minutes before leaving.
Patient was given the shot and was telling the immunizer that this was his first time getting a shot when he suddenly stopped and said he was feeling light headed and then passed out. The immunizer came and got me and when I entered the room the patient was bent forward and slightly swaying and unresponsive. I was about to call 911 when the patient finally came to. He said he was still a little dizzy so I had him continue to sit in the chair. upon talking to the patient I found out that he had not eaten yet and was outside painting in the hot weather. When I checked on him a little bit later he said he was feeling much better. I called him a little later to check on him and he told me he had eaten and was doing much better.
red spot was warm to touchred spot was 41/2 inch in width by 31/2 inches in size; red spot was itchy in nature; red spot was warm to touch; sever muscle pain on both legs; both ankles were swollen.; red spot persisting; little red spot; red spot started to increase in size; injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (injection arm soreness), ERYTHEMA (little red spot), RASH MACULAR (red spot started to increase in size), JOINT SWELLING (red spot was warm to touchred spot was 41/2 inch in width by 31/2 inches in size) and RASH MACULAR (red spot was itchy in nature) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (injection arm soreness). On 16-Apr-2021, the patient experienced ERYTHEMA (little red spot), RASH MACULAR (red spot started to increase in size), RASH MACULAR (red spot was itchy in nature), VACCINATION SITE ERYTHEMA (red spot was warm to touch), PAIN IN EXTREMITY (sever muscle pain on both legs), JOINT SWELLING (both ankles were swollen.) and RASH MACULAR (red spot persisting). On an unknown date, the patient experienced JOINT SWELLING (red spot was warm to touchred spot was 41/2 inch in width by 31/2 inches in size). At the time of the report, PAIN IN EXTREMITY (injection arm soreness), ERYTHEMA (little red spot), RASH MACULAR (red spot started to increase in size), JOINT SWELLING (red spot was warm to touchred spot was 41/2 inch in width by 31/2 inches in size), RASH MACULAR (red spot was itchy in nature), VACCINATION SITE ERYTHEMA (red spot was warm to touch), PAIN IN EXTREMITY (sever muscle pain on both legs), JOINT SWELLING (both ankles were swollen.) and RASH MACULAR (red spot persisting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Severe light-headedness and feeling like going to pass out. Headache, body aches - patient rested.
large redden raised area at injection site.  It began to subside then reappeared.  Lasting atleast 7 days.
Patient given Hep A and VARIVAX vaccine in right deltoid approx 5 mins after injection child c/o itching and redness at site approx 2.5 cm diameter. BENADRYL was given to patient and he improved in approx 30mins and was sent home.
Info has been received from a physician and a school nurse concerning an 8 year old male who on 11/6/97 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy that day included a dose of MMRII. It was also noted that the pt was vaccinated with a dose of MMRII on 11/28/00. A school nurse reported to the physician that between 3/24/05 and 5/9/05, the child developed a mild case of breakthrough varicella with less than 50 lesions. Unspecified medical attention was sought. The outcome was recovered. A product quality complaint was not involved. It was also noted that the pt's brother was vaccinated with varicella virus vaccine live and developed chickenpox. No additional info is expected.
Superficial erythema on right arm approx. 2cm in diameter with mild swelling. Treated with Zyrtec for 1 week or until it clears.
administered with the vaccine which has been stored in the refrigerator for 34 days; administered with the vaccine which has been stored in the refrigerator for 34 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for 34 days) and EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for 34 days) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for 34 days) and EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for 34 days). At the time of the report, PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for 34 days) and EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for 34 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported.
No additional AE's/PQC's reported; temperature excursion for VARlVAX / have been administered to the patients; This spontaneous report was received from a registered nurse and refers to a 6-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 17-SEP-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot# U015682 verified as valid, with expiration date:18-MAY-2023) in dose: 1 (units not provided) for prophylaxis (exact dose, dose number, route of administration and anatomical location were not reported).  The temperature to which the vaccine was exposed was -10C to 8C (4 degrees of Celsius (C)) for 20 minutes on 07-SEP-2021 during the transport, and -10C to 8C (4 degrees of Celsius (C)) for 20 minutes on 09-SEP-2021 also during the transport. The vaccine underwent previous temperature excursion of temperature -10C to 8C ( 4C) for 7 hours and 30 minutes.   It was unknown if a digital data logger was involved. No adverse symptoms were reported. The outcome of product storage error was unknown.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA005628:
Swelling of arm. Was referred to ED due to reduced range of motion of LUE. X-ray-> Supracondylar FX - ON 12/18/2020 Child received 2nd dose of Influenza on Left arm on 12/16/2020. Develped swelling of arm with pain and unable to lift left extrimity on 12/16/2020. Was advised Tylenol and check in office on 12/17/2020. Was seen in office on 12/18/2020 and was noted to have diffuse swelling of left arm and left proximal forearm with no evidence of cellulitis. Was referred to ED for testing. In ED, X-ray revealed Supra Condylar FX of Left Humerus. No H/O fall.  Child never had fever/breathing difficulty/ d/c from injection site.
Redness, swelling and itching at injection site occurred after injection. As of 2/19/14, there is still some redness, a slightly raised area and occasional itching at the injection site.
Patient received Hep A vaccine #2 and Hep B vaccine #3 on 12/8/22.  Patient then received another Hep A and Hep B vaccine on 12/13/22 by a different nurse.  No report signs or symptoms.
Pt was given MMR II one day after expiration date of 05/01/2018. Manufacturer was contacted and stated dose was still viable and patient can continue on second dose when the time comes. Incident report was documented. No treatment or repeat dose necessary. Good outcome. No further action necessary.
No additional AE information provided; HCP states that VARIVAX was administered to a patient on 12/19/2022 after a supported temperature excursion that took place on 12/1/2022. No additional AE information provided. No PQC.         ?    Names of vaccines involved (including lot/exp) VAR; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 19-DEC-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot number W021741 verified as valid, expiration date reported and upon internal review stablished as 10-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided) after supported temperature excursion that happened on 01-DEC-2022 at a temperature of 19.4 Fahrenheit degrees (F) for 50 minutes (product storage error). No additional adverse event information provided.
After 2nd shot, extreme arm pain. Numbness, pins and needles, nerve issues, in shoulder, down arm, and into hand. Severe pain in neck and shoulder. Symptoms have been non stop, and worse now that even at beginning.