chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8 days after vaccination, developed allergy/cold like symptoms with labored breathing. Tested for COVID on 5/28 but continued breathing difficulties have continued. Have had chest X-ray/clear, prednisone with no impact, allergy testing. Urgent care, pediatrician and allergy specialist all agree breathing isn?t related to asthma or allergies. Still continues.
The entire deltoid area is also red in addition; Swelling of right deltoid area; Bruise on his arm; Blood came out of the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 61-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7X7A5, expiry date 01-FEB-2025) and (batch number 95K2R, expiry date 07-FEB-2026) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   On 10-OCT-2023, the patient received Arexvy (intramuscular, right deltoid). On 10-OCT-2023, the patient received Influenza vaccine (left arm) and COVID 19 VACCINE (left arm). On 10-OCT-2023, immediately after receiving Arexvy and not applicable after receiving Influenza vaccine, the patient experienced injection site hemorrhage (Verbatim: Blood came out of the injection site). On 11-OCT-2023, the patient experienced localized erythema (Verbatim: The entire deltoid area is also red in addition), muscle swelling (Verbatim: Swelling of right deltoid area) and bruising of arm (Verbatim: Bruise on his arm). The outcome of the injection site hemorrhage, localized erythema, muscle swelling and bruising of arm were not resolved.   It was unknown if the reporter considered the injection site hemorrhage, localized erythema, muscle swelling and bruising of arm to be related to Arexvy. It was unknown if the reporter considered the localized erythema, muscle swelling and bruising of arm to be related to Influenza vaccine.     It was unknown if the company considered the injection site hemorrhage, localized erythema, muscle swelling and bruising of arm to be related to Arexvy. It was unknown if the company considered the localized erythema, muscle swelling and bruising of arm to be related to Influenza vaccine.  Additional Information: GSK Receipt Date: 16-OCT-2023 The pharmacist reported that a patient received Arexvy vaccine (lyophilized antigen lot number 7X7A5 and  adjuvant lot number 95K2R). The pharmacist stated when he removed the needle after the injection, blood came out of the injection site, and then the following day the patient had a bruise on his arm the size of a tennis ball. The entire deltoid area was also red in addition to swollen. This was still (till the time of reporting) ongoing.  The patient also received influenza and Covid-19 vaccines on the same day, but these were administered in the left arm. Time to onset of localized erythema, muscle swelling and bruising of arm was 1 day with Arexvy, Influenza and Covid-19 vaccines. It was unknown if the company considered the localized erythema, muscle swelling and bruising of arm to be related to Covid-19 vaccine. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sl. red, swollen deltoid where received PENTACEL. Sl. warm to touch, no fever, eating and sleeping well.
Client received Moderna second dose after Pfizer first dose. Client is only 17 years old.
She received the Johnson and Johnson vaccine on Wednesday and died on Sunday 3/14/2021.  Her autopsy is pending.
Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On or about 02-APRI-2015, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On an unknown date, the patient experienced shingles (herpes zoster) and on or about 28-NOV-2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages, as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient had not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Two reactions, one severe, one moderate.  Moderate: My arm  starting hurting three days after the first shot, a dull pain at the site of the jab. The dull pain has not gone away. I can feel it right now as I type  this. Severe: One week after the first shot, my varicose vein  problems re-emerged. I had vein surgery in 2018, and my problems vanished until the first shot. My calf muscle swelled and became very painful; my lower leg was covered with black and blue bruises; my varicose veins reappeared. These problems diminished slowly throughout February. I saw a specialist at the Vein Clinic in March, who determined that I needed additional surgery this summer. My leg has almost returned to normal, but I have intermittent heaviness in the calf muscle and pain in the quads, like a weaker version of what I had before the first vein surgery in 2018.  Additional comments: I had a bout of powerful fatigue following the first shot. I slept 14 hours straight the day after getting it. For the second shot, the fatigue was less severe, coming in waves. However, I felt weak for more than two months, which I noticed since I go to the gum regularly. My strength has still not returned to where it was previously.
One days after vaccine she developed fever and back ache and vomited once. Exam shows pharyngitis.
Red/pink body rash primarily on torso 36 hours after receiving second dose. Spread to arms and back, neck/face as the day went on. Minimally irritable
fever (101 degree F), wheezing, cough, chest hurts when she breathes, chills, body ache.
My period has begun unexpectedly. I should not be getting it for 2 more weeks, but I suddenly started bleeding today.
An Adult patient was scheduled to have Covi-19 Booster vaccine administered at Clinic with as precaution due to previous reaction.   As per normal routine, the site leader, picked up the pre-drawn syringe from the Covid vaccine team prepared a Pediatric 10mCg (low) dose for the pick-up. The patient needed the adult 30mCg (12y+) dose.  Incorrect low dose was administered to the patient by the allergy team.  The error was not recognized until well after the patient had received the incorrect dose and left the office. notified the patient.  Covid will coordinate a Full dose administration ASAP as recommended by Pharmacist. 1. Future clinics will not allow mixing of adult and peds during the same time. 2. Allergy will be required to learn all vaccine protocols to continue providing vaccine.  A vaccine handoff protocol will be created.
severe swelling of the face and lips, benadryl did not relieve symptoms, saw almost immediate relief with prednisone taken the following morning with minor symptoms still present 8 hours later
No adverse event; patient was given a dose of Moderna that has been expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was given a dose of Moderna that has been expired) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was given a dose of Moderna that has been expired). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was given a dose of Moderna that has been expired) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient was given a dose of Moderna that has been expired).    No concomitant medication was reported. Suspect product dosage text was reported as unknown. The expiry date was reported as 24-May-2023. The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 22-Jun-2023 and was administered on the same day. The vial did not undergo any temperature excursions.  No treatment medication was reported.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting,  fatigue Narrative:  Other Relevant History:
Vaccination failure; Suspected COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL3302), in left arm, on 10Feb2021 as dose 2, single (Lot number: EM9809), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 52 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing), notes: Hashimoto's; "arthritis" (unspecified if ongoing); "migraine" (unspecified if ongoing). Patient had unspecified known allergies. Concomitant medication(s) included: GABAPENTIN, start date: 15Oct2021, also reported as other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19 included anti viral Paxlovid (brand=Pfizer) started on 21Apr2022 to 25Apr2022. Patient had Rebound of COVID symptoms Sore throat, head congestion, cough, exhaustion on 30Apr2022 at 18:15, and was not recovered from symptoms. Reported that, the patient previously received a COVID-19 Vaccine.
headache, fatigue, elavated  temp 99.1, dizziness, nausea  vomitting, headache & fever
Expired vaccine used/19 patients received an expired booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/19 patients received an expired booster) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/19 patients received an expired booster). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/19 patients received an expired booster) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  HCP states that they had two lots from the Moderna vaccine in the freezer. They pulled one or two vials for a clinic yesterday, 30Nov2021, and administered 19 doses (all boosters).   17 patient identifiers and all  were monitored for at least 15 minutes after the injection with no adverse events reported.  Also stated that vial does not undergo any temperature excursions.
Body ache; This is a spontaneous report from a contactable nurse (patient) via Pfizer sponsored program. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EJ1686, via an unspecified route of administration on 05Jan2021 at a single dose to prevent getting Covid. The patient's medical history and concomitant medications were not reported. The patient received the covid vaccine about 24 hours ago and was now having a body ache (unknown date in Jan2021) with outcome of unknown. She was wondering if she can take Tylenol or Advil or something to help that. The patient did not receive any treatment for the event.
Redness, swelling, and minimal pain to the left, upper arm, skin induration.
9:30 AM Flu vac L-59YY4 Ex. 6/30/13 Rt deltoid c/o at 10AM. Headache - VS taken 10 AM 200/120 P170. 911 called - pt responsive, lethargic, vomited. 10:10 - VS 200/170 P170 - 10:15 180/100; P100; 10:20 Rescue came.
Sore arm; Myalgia; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Myalgia), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Myalgia), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Myalgia), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Additional information received on 30 Aug 2021 contains non-significant information.
14-year-old patient received the Moderna COVID-19 vaccine as the first dose in the primary series of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14-year-old patient received the Moderna COVID-19 vaccine as the first dose in the primary series of the vaccine) in a 14-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.  No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14-year-old patient received the Moderna COVID-19 vaccine as the first dose in the primary series of the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14-year-old patient received the Moderna COVID-19 vaccine as the first dose in the primary series of the vaccine) outcome was unknown.  For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.  The reporter worked as a clinical consultant at an urgent care center.  Concomitant medication of the patient was not reported.  The error was discovered when the patient returned for the second dose of Moderna COVID-19 vaccine. The reporter also mentioned that following vaccination no reaction was reported regarding the patient.  No treatment information was provided by the reporter.  Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2022: Upon follow-up non-significant information was received and reporter email address was added.
Cramps, diarrhea and headache 2 hours after 3rd dose of Oral typhoid vaccine.
Large indurated warm tender swelling on left thigh with large area of erythema at injection site, normal gait. Febrile with papular rash on both UE's, non pruritic, patchy erythema on face.
Transient global amnesia,  lost approx 15 minutes.  In Hosp for 3 days, extensive tests.
Patient reported localized redness and warmth to right deltoid area where 2nd Anthrax vaccination was administered.
Employee received H1N1 vaccine on 10/21/09. On Sunday, 10/25/09, employee had an onset of HA, mild fever, and some orbital swelling. Orbital swelling decreased on Monday 10/26/09. HA continues currently. Fever lasted about 12 hrs.
ADVERSE SIDE EFFECTS; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (ADVERSE SIDE EFFECTS) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (ADVERSE SIDE EFFECTS). At the time of the report, ADVERSE EVENT (ADVERSE SIDE EFFECTS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Mother reported redness and discomfort to right shoulder 1 day following PROQUAD.  She marked limits of the wheal of redness.  Overnight it has grown or expanded 1 cm further.  Child complains of pain however has no constitutional symptoms.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient had vasovagal response after injection, became lightheaded and pale. Recovered fully after 5-10 minutes lying supine with cold compress.
Initial and follow-up information has been received from a physician concerning a 30 year old, male, system analyst with no drug reactions or allergies, with no illness at the time of vaccination, whose reported weight was 285 pounds and whose reported height was 72 inches who on 11-APR-2007, at 7:30 a.m., was vaccinated subcutaneously, into the left arm with the first 0.5 mL dose of Pneumovax 23 vaccine, reportedly for recurrent sinusitis, "low titers and to assess immune infection" and decreased "pneumoniae AB titers", (Lot # 655290/0959F). Concomitant therapy included omeprazole (MSD), lisinopril (manufacturer unknown) and Sudafed. The physician was seen in the emergency room (ER) about 24 hours after vaccination. The patient's symptoms included a fever of 102 degrees, Fahrenheit and a small amount of redness at the injection site. The patient was ordered antibiotics (unspecified brand). The next day, the patient complained of more pain and redness. He was admitted to the hospital on intravenous (IV) antibiotics (unspecified brand) for cellulitis. The physician mentioned that the hospital will keep the patient for one week. At the time of the report, the patient had not recovered. In follow-up it was reported by the physician that the patient was put on clindamycin and had a negative test for the cellulitis. The patient recovered and had been sent home from the hospital. The physician considered the patient's fever of 102 degrees, Fahrenheit, pain and redness at the injection site to be disabling and other important medical events. In follow-up it was reported by the physician that on 13-APR-2007 the patient developed a fever of 102 degrees. On 14-APR-2007 the patient developed cellulitis of the left arm and was hospitalized. A surgeon was "consulted". At the time of the report, it was unknown if the patient recovered. Follow-up information via Medical Records included laboratory evaluation of streptococcus pneumoniae IGG AB (12 serotypes) which revealed serotype 3 (3) 0.6 ug/mL, serotypes 12 (12F) 1.0 ug/mL, serotype 23 (23F), 1.5 ug/mL and serotype 51 (7F) 0.6 ug/mL. Additional information has been requested.
1st dose 2021, didn't require 2nd; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA728A, expiry date 20th September 2023) for prophylaxis.   Previously administered products included Menveo (1st dose received in 2021).   On 27th October 2022, the patient received the 2nd dose of Menveo. On 27th October 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comments: The health care professional reported that a patient received a Menveo dose on 2022, but this patient was already administered with the vaccine on 2021, so the patient did not require a second dose of Menveo. The reporter consent to follow up. Additional Supportive Information: The patient received extra Menveo dose, which led to extra dose administered.
A few days after the Moderna COVID19 vaccine she started having a metalliac taste to her mouth, sensation of rotten smells in her nose and down her throat. Causing her to have nausea and vomiting, decreased appetite and malaise. Lack of food from taste is causing headaches, fatigue, malaise as well.
Upon receiving vaccination, patient already felt her arm was sore.  She tried rubbing the site to soothe it and self treated with Tylenol 500mg 2 tabs 2-3 times per day (that day and almost every day thereafter).  The patient was vaccinated almost three weeks ago but still feels muscle pain and soreness/achiness.  Achiness is only around injection site.  No sharp, shooting pain or tingling.  No burning sensations.