chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site redness; Injection site swelling; Sneezing; Injection site itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SNEEZING (Sneezing), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced SNEEZING (Sneezing), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site swelling). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness). The patient was treated with PREDNISOLONE at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SNEEZING (Sneezing), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.    The patient called her HCP who prescribe prednisolone and asked her not to receive the 2nd dose of the Moderna Covid-19 vaccine.
Right hand, right arm and right leg and right foot is numb. It goes numb and feels cramp or asleep like blood flow is not there.
Patient reported having extreme pain at the site of the injection a "couple days" after receiving his shot.  He said he did not have any redness, heat, or swelling and that the pain didn't start to go away for a "couple weeks".  He said it was now improving.
received expired FLUZONE QIV NP with no reported adverse event; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from other health professional and physician via (Medical Information- 00814531).  This case involves a 13-year old female patient who was vaccinated with expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On 14-Oct-2021, the patient received a first 0.5ml dose of expired suspect INFLUENZA QUADRIVAL A-B VACCINE (FLUZONE QIV) (lot number UT7108MA and expiry date 30-Jun-2022 was reported) via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported "if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine. This information is regarding the fourth of 12 patients that received expired FLUZONE QIV NP."  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  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.
Immediately started feeling hot nose became numb , couldn't swallow , tingling of extremities . 2-3 hours after a fever of 100.5 . Weird sensation in face .
The patient was brought in by his mother to receive a flu shot with the rest of the family. The patient's mother stated that he had received flu shots in the past and had no adverse effects from the shots. The flu shot was administered IM in the patient's right deltoid. After receiving the flu shot the patient sat down in a chair to wait while his family members received flu shots. After approximately one to two minutes of sitting down, the patient lost consciousness and fell to the floor. The patient remained unconscious for approximately five to ten seconds while in a tense posture with his arms pulled tightly to the front of his chest. The patient then quickly regained consciousness and began crying. The patient was initially confused but regained normal mentation almost immediately. 911 was called and a paramedic team arrived on scene to assess the patient.
I experienced extremely severe arm pain both at the inoculation site on my arm and my entire arm was in EXTREME pain. I was unable to move it all for 4 full days and even after the extreme pain subsided, I still had throbbing pain in my arm. Next the pain moved into the shoulder joint of my arm. Now two full weeks after my vaccine, I am still experiencing lingering pain, stiffness and throbbing in my right arm.
Pt was administered Moderna Covid-19 3rd dose 10.22.21. Vial had an expiration date of 10.21.21, which was extended by Moderna to expire on 12.21.21 on 10.22.21 (via e-mail from management). This morning new guidance was received stating only vials that were frozen are to be used with new expiration date. The vial used for patient was previously thawed-out.
Episode of not breathing-brought around by family friend-pt active & alert; emergency room phsician dx is post immun sz;
severe headached, right temporal area, right neck, upper back, right shoulder, right flank pain, tightness of chest, joint pains
This is a 61y.o.female with a history of seizure disorder who presents secondary to altered mental status.  Patient was brought by her family due to being unresponsive.  She was given Narcan by EMS with minimal improvement in mental status.  Per family, they noticed possible seizure-like activity prior to patient becoming unresponsive.  Patient was recently hospitalized 12/26?12/30 for a right axillary wound and was discharged home with antibiotics.  During that hospitalization she also tested positive for Covid 19.  She is fully vaccinated with Pfizer. On arrival she was found to be tachycardic.  CT head with no acute process.  Did show partially calcified lesion adjacent to the posterior left occipital calvarium thought to be related to an underlying meningioma.  Recommending nonemergent MRI of the brain.  Chest x-ray with no acute process.  X-ray showed right shoulder dislocation: Medial dislocation of the humeral head with respect to the glenoid.  X-ray of the left shoulder showed fracture and dislocation.  She underwent reduction of right and left shoulder dislocation by orthopedics. CT of the chest showed a questionable subsegmental pulmonary embolism involving the right lower lung without evidence of right heart strain.  Lower extremity Dopplers are negative for DVT.  She was started on full dose Lovenox. Infectious disease, neurology, neurosurgery, and orthopedics have been consulted.
Cyanotic episode lasting a few seconds associated with edema of the feet and possibly altered level of consciousness. Mother reports the child got quiet during the episode. Lasted a few minutes. Back to baseline by the time paramedics arrived with possibly minimal cyanosis of part of the lip. ? Seizure like event. No treatment needed.
This spontaneous report as received from a physician refers to a 31 year old female patient. Medical  history and concurrent conditions were not reported. Approximately in 1988 "around the age of 6 years old", the patient was vaccinated with (Oka/Merck) VARIVAX. Dose, route, lot number and expiration date were not provided. No co-suspect and concomitant therapies were reported. The physician reports that the patient had titers drawn and the result was negative. The patient stated that she was unsure if she received one does or  two doses. She reports that she had titers drawn "around 01-JUN-2014". The outcome of the titers drawn and the result was negative was unknown. No treatment was given for adverse event. The patient did not seek medical attention. Additional information is not expected (no allowed to contact physician).
Case completed 2 shot Covid series in March 2021, then was hospitalized for Covid in December 2021. COVID Developed symptoms starting on 12/27. He is vaccinated. Initially had mild URI symptoms, tongue paresthesias, and dysphagia, as well as weakness and leg cramps. Given casirivimab/imdevimab in the ER. Later became mildly hypoxic and started on remdesivir and steroids. Note only sotrovimab has been shown to have activity against the omicron variant (worth mentioning as theoretically IVIG may scavenge mAb therapies). ID consulted. Treated with remdesivir (got all 5 days) and dexamethasone. Doing well from symptom standpoint at discharge. He was counseled he should continue isolating until 20 days from symptom onset, though this is somewhat of a moving target at present and may be revised downward in the near future, particularly for vaccinated patients.  Hypoxemia Mild hypoxia only in the setting of Covid infection. See related problem. Sats in low-to-mid 90s on room air at time of discharge.  Hospitalized at:  Hospital.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 22-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). On 28-DEC-2018, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, ROTATEQ (lot # R015435, expiration date 17-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
brought mother to get her flu vaccine, asked for High-Dose, and when she looked at the receipt, she had been given Flublok, with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a Pharmacist on 22-Oct-2019.   This case involves an unknown age female patient for whom  it was reported that mother was taken to get her flu vaccine, asked for INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE], and when she looked at the receipt, she had been given  and INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (wrong vaccine administered).  Medical history, concomitant therapies and family history not reported.  It was as a medication error case due to wrong vaccine administered.  At the time of reporting, No adverse event.  Final diagnosis was wrong vaccine administered.  Action taken and outcome was not applicable.  Batch number has been requested.  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.
Immediate pain with injection.  Arm weakness and pain with certain movements ongoing x 3 weeks.
Received vaccine order from provider to give patient DTaP & IPV (KINRIX) due to the patient not being technically due for Hep B at the time. Double checked with another RN and they thought this was okay as well. Administered vaccine as requested. When documenting the vaccine in the computer I realized that this is not recommended for the age group. I immediately went to my Supervisor, and the provider, to tell them this. My supervisor called the Poison Control to find out information and they stated that it was not harmful to the patient. However, it was not effective and will not count. Patient will need to get another vaccination for it to be valid. Provider will contact patient's mother to let her know of this. Unknown if patient has had adverse effect.
Tinnitus in right ear beginning around February 4, 2021.  Has not improved. I received first shot on 12/25/2020 I received 2nd shot on 01/19/2021
Late Friday evening, my upper front gums became extremely sensitive, to the point I could not brush my teeth that night.  Saturday morning, the sensitivity spread to the back side of my upper teeth and it felt like I had small blisters on the roof of my mouth from drinking too hot a beverage.  That evening I developed a deep cough, and I started taking Halls cough drops.  Sunday I started taking a cough syrup and chest expecturant.  Monday I call my dentist but his office was closed.  My temperature was in 100.1 range.  On Tuesday I saw my dentist and he was somewhat taken back.  My temperature was in the 99.5 range.  He mentioned COVID Tongue issues but had no data, and he put me on a fungal mouthwash.
Swelling-pain-redness-lt arm from elbow to shoulder. Radiate to LT chest.
Information has been received from a nurse concerning a female patient who experienced pelvic pain after receiving the first dose of GARDASIL. The outcome of the event was unknown. The reporter indicated that the patient's whole cheerleading squad also experienced the events after receiving the first dose of dose of GARDASIL. This is one of the several reports received from the same source. Additional information has been requested.
Have a lump there now, over from the injection site, it's really itching; Have a lump there now, over from the injection site, it's really itching; it was a little sore/ sort of sore; left side was really itchy; had a small lump; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Apr2021 14:00 at the age of 67-years-old (Lot Number: EN6204) as single dose for covid-19 immunisation. Medical history included ongoing inactive thyroid. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for thyroid disorder from an unspecified start date in 2001 (20 years before 15Apr2021) and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated she was just having a lump there now, its not at the injection site, its over from it and its really itching. She stated the lump started on 13Apr2021. The patient received her shot on 08Apr2021 and it was a little sore from 13Apr2021. Her left side was really itchy, had a small lump, and was sort of sore, but is unsure if it's from her laying on that side. She did not know if it's one of the side effects. No treatment was received for the adverse events. The outcome of events sore, left side was really itchy, had a small lump was not recovered, of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
I have a fever of 40 degrees C after second dose of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (I have a fever of 40 degrees C after second dose of Moderna) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (I have a fever of 40 degrees C after second dose of Moderna). At the time of the report, PYREXIA (I have a fever of 40 degrees C after second dose of Moderna) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 40 (High) 40 degrees C.         Concomitant medications were not provided by the reporter. Treatment medications were not provided by reporter.
Patient developed hives about 22 hours after receiving 4yr boosters- DTap, IPV, MMR and VZV. No previous reaction, no respiratory or GI symptoms. Hives were treated with BENADRYL in the beginning. Hives started to subside 5/25, but are still present today.
OPEN IPOL was exposed to 82.62 F for 15 minutes believes the door was left open with no reported adverse event; Open IPOL was administered to patient after excursion with no reported adverse event; Initial information received   on 16-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA235228.  This case involves a 18 months old male patient open IPV (VERO) [IPOL] was administered to patient after excursion with no reported adverse event and open ipol was exposed to 82.62 f for 15 minutes believes the door was left open with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, It was reported that open ipol was exposed to 82.62 f for 15 minutes believes the door was left open with no reported adverse event (product storage error).  On 23-Feb-2022, the patient received suspect Ipol vaccine (lot T1871M, expiry date: 10-Oct-2022) at dose 0.5 ml via unknown route in unknown administration site for immunization after excursion with no reported adverse event (poor quality product administered, latency same day).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for both events.   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 guidelines. 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.
Beginning approx. 2 weeks after first injection my body has developed daily hives that itch intensely. So far after seeing an allergy specialist we are able to suppress them by taking a daily Zyrtec. As of 08-28-21 the hives return once antihistamine has stopped being taken.
has rash over chest, back & legs;body felt warmer than usual but mom did not take temp;
Client presented for 2nd dose in Moderna monovalent primary series and received expired vaccine. After administration of vaccine client sat 15 mins. in waiting area for observation of side effects. None noted. Expiration of the vaccine was not noted until 2:00 pm after clinic closed. Vaccine expired 04/01/2023. Client was contacted and informed of this incident, denied any side effects and potential for revaccination. Moderna was contacted to check viability of expired vaccine. See below #19. Based on response from Moderna's analysis  revaccination is not needed. Clients made aware.
Initial information received on 05 FEBRUARY 2013 from a consumer who is the patient's parent.  A male child, age at time of event not reported received DTAP on an unknown date, (manufacturer, route, dose and site of administration were not reported). Six months after vaccination, the parent was notified from the hospital that the patient had received an "extra shot of DTAP", details not reported. Around the time of the child's vaccinations, the patient "got real sick for a few days". The parent reported that she thinks he had an allergic reaction to the shot. The patient's concomitant medications and medical history were not reported. The patient outcome was not reported. No further details were available at the tine of this report.
Pt recvd 1st dose of vax 28OCT92 & 4 hrs following vax exp fatigue & could not drive; 3 hrs later exp a cold feeling in hands & feet; also exp fatigue, nausea, vomiting, h/a & dizzines; 29OCT92 exp sl nausea, dull frontal-parietal h/a;
balance problems; post herpetic neuralgia; herpes zoster; Information was received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information regarding the pt's current condition, historical condition and concomitant medication was unknown. On or about 20-APR-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster, post herpetic neuralgia, balance problems. As a result of these symptoms, the pt was seen and treated by her medical providers and was still under their care. As a direct and proximate result zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presented prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the company's conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).     The events of herpes zoster, post herpetic neuralgia, balance problems were considered as disabling.
This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age (reported as 65 unknown units) and ethnicity started to receive PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced rash developed over neck and chest, further spreading to other parts of body. Rash started several days after patient received the vaccine. Initial visit to the nurse practitioner resulted in the thought that the rash was due to some form of external factor (i.e. plants in yard). However rash continued to develop and did not have classic symptoms of such a rash. The action taken in response to the event for 13-valent conjugate vaccine (diphtheria crm197 protein) was not applicable. Therapeutic measures were taken as a result of rash developed over neck and chest, further spreading to other parts of body and included treatment with an unspecified cortisone shot and a biopsy was taken on an unknown date. The clinical outcome for the event was unknown. It was reported that the patient visited dermatology clinic today and their assessment was it is likely related to the PREVENAR 13 vaccine.