chrisvoncsefalvay/vaers-outcomes huggingface dataset:
moderate ear pain that turned into dull hearing after about 3 weeks. feels like I have water in my ears and cant fully hear.
10/22 Flu shot AFLURIA (lot # T57405). Developed hives, itching UE, lower back, tingling lips, hoarseness, chest tightness, nausea, vomiting, loose stools, extreme fatigue. TX BENADRYL, steroids hydroxyzine - Allergy consult.
This dose was administered 4 days prior to the patient turning 6 months old. No adverse effects noted.
Adult patient accidentally administered pediatric dose of Engerix B; Adult patient accidentally administered pediatric dose of Engerix B; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number yy2r3, expiry date 12-MAY-2024) for prophylaxis.   On 20-JUL-2023, the patient received Engerix B pediatric. On 20-JUL-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: Adult patient accidentally administered pediatric dose of Engerix B) and adult use of a child product (Verbatim: Adult patient accidentally administered pediatric dose of Engerix B). The outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-JUL-2023 The adult patient was accidentally administered a pediatric dose of Engerix B, which led to accidental underdose and adult use of a child product. The reporter did consent to follow up.
During a review of the department of Health internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
pt denied adverse reaction at time of vaccination- she returned to clinic approx 7:35 and was waiting outside clinic, she states that she has severe pain in right deltoid - site without redness or swelling, pt has sensation and mobility right arm, I spoke with Dr. and he advised pt to go to ER pt had pneumovax in the past without reaction. she states vaccination must be given right deltoid due to lymphedema
Initial 36 hours sore at injection site Day #4 pain in hip joints and moderate aching in legs bilaterally Day #5 prickling needles feeling soles of feet bilaterally and palms of hands for short time. Palms have resolved. Soles of feet remain on Day #6.
no adverse events.  This was an administration error.  The patient was supposed to receive the updated Bivalent booster and got the original moderna pediatric dose instead
anaphylactic reaction; difficulty breathing; dizziness; This is a spontaneous report from a contactable physician.  A 69-year-old female patient (age at vaccination: 69-year-old) received bnt162b2 (BNT162B2, lot unknown), via an unspecified route of administration on 10Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunisation. The patient's medical history include scar. Concomitant medications were not reported. The patient previously took Flu vaccine for immunisation; hyaluronic acid and experienced allergic reaction; lidocaine (15Jan2021) for treatment of scar and experienced drained yellow fluid, infection in site, implant site swelling, had pain, felt hard as a rock/cyst like a rock in site, bruising, weight loss, area/site was black; took vaccine for shingles in 2020 for immunisation. On 10Feb2021, the patient received the Pfizer Covid vaccine and immediately had an anaphylactic reaction described as difficulty of breathing and dizziness. The patient was treated with an EpiPen EPINEPHRINE], Benadryl [DIPHENHYDRAMINE HYDROCHLORIDE, and IV steroids. While she was being observed in the ER, the patient requested and was given IV antibiotics for her implant site infection at her scar.  The outcome of events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Anaphylactic reaction, Difficulty breathing and Dizziness.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Pneumonia vaccine in left deltoid 10/14 approx 1 p.m.  During the night of 10/14, I developed pain, swelling and extreme inflammation, which progressed during the following day to involve my arm from shoulder past elbow. On 10/16 I went to my internist who prescribed prednisone (Medrol 4 mg pak)
Moderate Asthmatic cough for about 5 hours. I used my Albuterol inhaler 2 puffs bid. Headache started same day of vaccine. Tylenol was taken 1000 mg every 6 hours. Switched over to Advil 800 mg every 6 hours. I still have a headache now. Nausea and Diarrhea started 02/24/21 @630am. Went to the restroom 5 times within a 4 hour period. Chills started around 10 am 02/24/21. Extremely tired. Fatigue and weak.
Pt received smallpox, anthrax, Hep A, Hep B, meningococcal vaccines on 2/17/03. Became pregnant, estimated 2/17/03.
2:05-67 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine 30 mcg/0.3 mL IM Susp,  on 5/4/2021. 2:15-The patient experienced the following reaction(s) during the immediate   of observation: pt reports having headache on left side of head near the temple. Pt denies any trouble breathing or difficulty swallowing.  Patient was treated/managed as follows:  pt offered water in the treatment area. VS performed: BP-150/87, HR-80, R-18 02-94% RA. Pt laid down for 5-10 minutes. Pt headache still persist at this time, but declines further treatment and is verbalizing wished to go home. Pt advised to call family for a ride home, pt states no one available at this time. Pt escorted out lobby safely at this time by RN.  Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.
15 year old male with a passed medical history significant for Marfan syndrome, aortic root dilation, and ADHS transferred to our facility for further evaluation and management of chest pain with elevated troponin. Father reports patient recieved the first dose of the COVID-19 Pfizer vaccine on 5/21/2021. On 5/22 patient developed a mild headache as per father that self resolved with rest. On 5/23 as per patient he was feeling back to baseline with some mild body aches. On the night of 5/23 patient felt some mild chest pain prior to going to bed that had self resolved.  This morning patient refused to eat breakfast, and complained of stomach pain.  Patient took Tylenol, however began to complain of severe chest pain and asked father to take him to the hospital.  Patient was taken to his Doctor where his labs were significant for a WBC of 6.6, creatinine of 0.62, normal LFTs, troponin of 7.26, CPK of 312, D-dimer less than 0.19.  EKG at Doctor was significant for normal sinus rhythm with an ST elevation, and chest x-ray was negative for cardiopulmonary disease.  Patient had an episode of emesis at Doctor. A troponin was repeated prior to transferring to our facility and it had increased to 11.8.  Father/patient denies chills, fever, diarrhea, sore throat, nasal congestion, and cough. ID consulted for further recommendations on management of myocarditis in the setting of recent Pfizer COVID-19 vaccination.  Troponin repeated upon arrival to our facility, and has improved with no interventions.  Interval History 5/27/21 No acute events overnight. Denies chest pain, SOB, cough, or palpitations. Cardiac MRI yesterday describing inflammation related to possible myocarditis, along with stable findings of MVP and aortic root dilation. Troponin this morning dowtrending to 0.28. No fever. He received a Mg Sulfate bolus yesterday due to low Mag on BMP
after 10 minutes developed sensation of throat swelling, tongue tingling and facial flushing: transferred to ED: no intervention, observed for 3 hrs & d/cd
No adverse events noted at this time. Boostrix vaccine was given instead if infanrix. CDC was called for recommendation and information.
Vial initially stored in refrigerator on 04-Jun-2022 and adminstered on 15-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and adminstered on 15-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and adminstered on 15-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and adminstered on 15-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and adminstered on 15-Jul-2022).    Concomitant medication information was not provided by the reporter.  Vial was initially stored in the refrigerator on 04-Jun-2022.  Vaccine administered to 346 patients after the 30 day by used involved 35 vials. Vial did not undergone any temperature excursions.  Treatment information was not provided by the reporter.
Less than 24 hours-pain in left arm pit.  Lymphnode palpable and enlarged
ONE OF FIVE PATIENTS WHO EXPERIENCED SWELLING OF INJECTION SITE AND FEVER (1-3 DAYS) AFTER IMMUNIZATION.
parent got the flu shot and they got sick; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via social media.  This case is linked to cases 2020SA305859 and 2020SA305873 (same reporter).  This case involves a patient of unknown age who got the flu shot and they got sick (illness), while patient was treated with Influenza Vaccine.  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got the flu shot and they got sick (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Chest pain and shortness of breath following cross country practice.  Developed myalgias, headache and hyperventilation.  Subjective fever and chills.  Seen ED,  Afebrile, SaO2 100% on room air.
Patient develops  a moderate to severe dizziness after five minutes receiving the shot for 15 minutes
The vaccine was administered on Friday March 4 and on Saturday I was very fatigued, felt feaverish with chills, and I started experiencing pain in my left armpit.  The shot was given into my left arm.  It?s now Sunday night and my armpit is still very swollen and painful.  The fever and chills have mostly subsided
Adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ADVERSE EVENT (Adverse event) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event). At the time of the report, ADVERSE EVENT (Adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug information provided. No concomitant drug information provided.
DVT; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2, via an unspecified route of administration on 09Mar2021 10:00 at a single dose for Covid-19 immunization. The patient had no relevant medical history. No allergies to medications, food, or other products. No COVID prior to vaccination, he was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included evolocumab (REPATHA), levothyroxine, and unspecified vitamins. No other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar2021 03:00 PM (as reported), DVT occurred after receiving the first dose. Treatment received for the adverse event was blood thinner. The event resulted to doctor or other healthcare professional office/clinic visit. The event was reported as non-serious (did not result to death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, and not congenital anomaly/birth defect). No COVID test post vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Approximately 3 weeks post second dose, injection site would start to present with pain at the injection site. Pain would radiate down the arm. In the elbow region, the patient would begin to develop a rash that would itch. The itching would spread from the elbow region to the wrist. The rash was localized to just the elbow region. The patient reports this would flare about twice weekly and it recurred for 2 months post the second vaccine. Patient would use topical hydrocortisone cream to treat the itching and rash. This relieved the discomfort and reportedly the pain associated with the reaction. Days before the rash presenting, the entire left arm would begin to start itching, but no inflammation or rash was present.
he had injection site reaction like redness; rash; sore for 2-3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (he had injection site reaction like redness), RASH (rash) and MYALGIA (sore for 2-3 weeks) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (he had injection site reaction like redness), RASH (rash) and MYALGIA (sore for 2-3 weeks). At the time of the report, VACCINATION SITE ERYTHEMA (he had injection site reaction like redness), RASH (rash) and MYALGIA (sore for 2-3 weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product known safety profile.
Eryth pap lesions with hint of vesicular appearance on abd. Scattered almost confluently in center abd, then thickly on trunk, forehead, sparsly on scalp and extremities.
An MMR vaccine was given after the expiration date of 7/3/14. Patient's parents will be called and an additional MMR will be given when appropriate.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Headache; Chills; Fever; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2021, the patient received the 1st dose of Shingrix. In June 2021, less than a day after receiving Shingrix, the patient experienced headache, chills, fever and fatigue. On an unknown date, the outcome of the headache, chills, fever and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache, chills, fever and fatigue to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received Shingrix and experienced headache, chills, fever, and fatigue approximately 6-8 hours after she received the dose.  The patient stated that symptoms were at their worst 24-48 hours after onset.  All symptoms were resolved after approximately 3-4 days.  The patient had not yet received second dose. The reporter did not consent to follow-up.
Covid-19 vaccine in March, then got Covid; Covid-19 vaccine in March, then got Covid; This is a spontaneous report from a contactable pharmacist. A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on Mar2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient got COVID-19 vaccine in March, then got COVID. The outcome of events was unknown.  No follow-up attempts are possible. No further information was expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the event of drug ineffective and COVID-19 cannot be ruled out.
Heart racing, shaking, light headed, and nauseated it started right away pretty much and lasted about 30min.
Mild fever beginning 12hrs after injection improved over the next 12hrs.  At time of this submission 40hrs out with very mild to nil fatigue.
Day following shot, injection site got hot and swollen. There was and still is a lump in my arm. Although the size has gone down, there still is a lump. I had a large red ring around injection site. Very painful. ER said to treat with warm compresses.
Arm is warm to the touch; Itchy; Redness in her injection site arm that's about 6 inches by 3 inches in size; Raised just a little; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm is warm to the touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Redness in her injection site arm that's about 6 inches by 3 inches in size) and VACCINATION SITE SWELLING (Raised just a little) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Arm is warm to the touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Redness in her injection site arm that's about 6 inches by 3 inches in size) and VACCINATION SITE SWELLING (Raised just a little). At the time of the report, VACCINATION SITE WARMTH (Arm is warm to the touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Redness in her injection site arm that's about 6 inches by 3 inches in size) and VACCINATION SITE SWELLING (Raised just a little) 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.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: No new information On 02-Jun-2021: MOD21-074967 added during MI recon- email address added.
26Apr91 pt vax; 28Apr exp stiffness in joints, eye swelling, flushed feeling, fever, & vomited once.  CBC & UA ordered.  Events persisting slightly.
Had a rash on the upper secotion of his arm. Not itchy or hot to the touch.
Initially after the vaccination Jasmyne felt hot and passed out.  She was woozy and we waited until she was more stable so we could take her home.  Within a week roughly she started to have random fainting spells which she had never experienced before.  Additionally, she has numbness/tingling in arms and legs and intermittent chest pains.  She is constantly fatigued and because we never know when she will have a fainting episode she is homeschooled.  She tends to be very weak and dizzy after she faints and it can take a hour or so for her to regain any strength.  Many times her legs give out when she is walking and she falls down.  She has seen multiple doctors and specialists.  We just monitor her condition and make sure stay hydrated and we also increased her sodium to try and combat the fainting which has been slightly effective.  The biggest issue now is the constant fatigue and pain she experiences regularly.  11/16/09 Medical records received fro DOS 1/27/09. PCP notes documents vaccine dates and h/o beast pain, redness, swelling. ABx therapy.
Patient developed 2 DVT in right leg on 4/5/2021. Patient was seen at  Hospital for event, but was not hospitalized. Patient was placed on Eliquis for DVT and sent home. Patient states that he continues on Eliquis and that the swelling in his right leg is going down. Patient noted that he did take a long drive the day before, but has done this many times and never had this problem before. Patient received both Moderna vaccines listed. Dose 1, 2/21/2021 and Dose 2, 3/24/2021. Stated that he has not had any other vaccines in the past several months.
"Bronchitis" on 7/19/07:  fever, cough/congested.  8/3/07:  coughing only.  knees & ankles painful, swollen 7/31/07.  Hands swollen - onset 7/30:  Left hand more swollen.  8/7/07:  Pt continues to cough (productive).  Fingers swollen.  Wrist better. Left hand better.  Did not see MD for evaluation.  (Patient also received PPD - left forearm - at the time of vaccination.)
Tuesday, the day after the shot body was aching, I had chills, no fever, I was exhausted.  I took an ibuprofen that afternoon and went home to bed. I felt much better the next morning. Wednesday after the shot I noticed my arm that got  the shot had a large area down my arm that was red and a little discoloured, a little itchy, warm to the touch and still a little sore.
Severe Pain in arm around 1 hour following vaccination. 10 hours after vaccination experienced fatigue followed by chills, fever, muscle and joint pain and nausea, and vomiting. Symptoms resolved at 5:30pm on 4/14/21.