chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After I got my first vaccine I felt horrible after about 6 or 7 days and I felt great before that. I tested positive for covid just a little over a week from getting my first vaccine. I had erection issues right away and flu/sinus infection/respiratory issues for 6 months and my gut/stomach has been affected and impacting my life and happiness. I have been constipated, brain fog, prostatitis symptoms, erectile dysfunction, premature ejaculation, muscle twitching, canker sores often in my mouth, fatigue.
Body temp increased (MEDI0003313 is a serious spontaneous case from a physician whose son required hospitalization for tracheitis. The reporter causality is Not related to FluMist. An 8 year old male received FluMist on 12Feb05 and on 06Mar05 the was hospitalized due to tracheitis. On 05Mar05, the pt complained of not feeling well, tired, and throat hurt. At 1:30AM on 06Mar05, the father noticed pt was awake and afebrile. At 3:30AM, he was unable to breathe and had stridor. The pt was taken to the ER on 06Mar05 and was able to breathe a bit better during the car ride. At the ER he was given breathing treatments which included steroids. A throat x-ray showed very little room to breathe for pt. He was diagnosed with tracheitis and a tracheostomy tube was inserted. Pt was taken to ICU on that Sunday 06Mar05 where he was intubated for five days. After 24 hrs in the ICU, his body temp increased and fluctuated to between 102-103.6 degrees F. His lungs were clear and he was heavily sedated with Propofol (diprivan) and Versed (midazolam). He was treated was clindamycin, to which he had an unspecified reaction and Benadryl (diphenhydramine). Throat culture during the hospital stay was positive for Influenza B. The pt was in the ICU for five days and the tracheostomy tube was removed Friday 11Mar05 after a normal x-ray finding. The pt was discharged on 11Mar05. The pt has recovered and is currently receiving daily Claritin (loratadine), Pepcid (famotidine), and Zantac (ranitidine). The reporter stated the pt is a big boy and could stand to lose some weight. He does not have any allergies nor was taking any medications prior to FluMist vaccination. The reporter does not believe tracheitis was due to FluMist vaccination.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-NOV-2007, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
felt really sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt really sick) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced MALAISE (felt really sick). At the time of the report, MALAISE (felt really sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.   This case was linked to MOD-2021-044386 (Patient Link).
The skin area around the injection (approximately 1 inch in diameter) felt dry and rough; The skin area around the injection (approximately 1 inch in diameter) felt dry and rough; At end of the injection, there was a pop from the needle; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the left arm on 13Feb2021 at 14:45 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included calcium carbonate/colecalciferol (CALCIUM+VIT D), cyanocobalamin (VITAMIN B-12), tocopherol (VITAMIN E), tamsulosin (MANUFACTURER UNKNOWN) and multi vit; all for unknown indications from unknown dates and unknown if ongoing. It was reported that at end of the Pfizer injection, there was a pop from the needle, and the nurse told sorry and startled, then the nurse added a band-aid, then sent the patient and his wife on down the driving line. On 16Feb2021 at 14:00, a few days later after removing the band-aid, the patient noticed that the skin area around the injection (approximately 1 inch in diameter) felt dry and rough. No redness nor swelling or pain was there. On 04Mar2021, the skin still had the same dry, rough texture feeling when the patient rubbed his finger over that area. The patient did not know if the vaccine caused this skin reaction, like when they heard the pop might be some of the vaccine popped and dribbled on his left arm around the injection area. Anyway, the patient would like to know if this was the cause of the dry, rough skin area or any other ideas we might have and how long would this area take to get back to normal. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events the skin area around the injection (approximately 1 inch in diameter) felt dry and rough. The clinical outcome of the events the skin area around the injection (approximately 1 inch in diameter) felt dry and rough was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt given hep A#1, then at 1700 she developed a fever and was seen at ER, fever resolved in 48 hours.
Patient came in 2 days later with bruise and a patch of red rashes below the injection site. It's swollen too.
Fever 104 x 2d now, 11 x 16cm redness, swelling, induration and tenderness contiguous to site of injection.
patient states her arm became sore a couple of days after injection and has gotten worse over the past days to the point she cant even lift it
Right thigh swollen, mild to moderate induration. Benadryl 125mg bid prn prescribed.
Nausea, very fatigued and slight fever, some swelling at injection site and soreness at injection site
Breakthrough case admission after 3 vaccines MOderna 7/30/21 Lot# 050C21A;  Moderna 8/29/21 Lot# 017E21A;  Moderna 6/28/22 Lot# 014B228
MD has noticed an inc incidence of hematomas @ the injec site following immun w/Tetramune; 1 of 5 pts (out of 10 pts immunized) who exp hematomas, approx 1 inch in diameter; treated w/massage;
Received vaccine 11/6/02. Saw physician 11/8/02 with localized pain. Large area of erythema, warmth, tenderness and edema affecting the upper extremity. Pt states symptoms have slightly improved over last 12-24 hrs. Pt noticed tingling in arm on evening 1/6/02 felt like "a warm fluid." Symptoms stayed constant 2 days going away on 3rd day. Now arm really really tender. Has hot flashes of arm being hot. Always tingly. The information entered in box #13 is from the documentation in the pt's medical record. However, the pt insists he was given the pneumonia shot in the right arm and that is what he reacted to. He stated the nurse told him which arm each was injected into-states he remembers his left arm bled after the flu shot and he didn't bleed after the pneumonia shot. Per 60 day follow up: It is unknown if the patient has recovered. The patient has not been seen at clinic since 11/08/2002.  Pt. returned for an influenza vaccination 11/20/03. He had no other physician visits since 11-08-02.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 39-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in May2021 as dose 2, single (Batch/Lot number: unknown), in right arm and in Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reportedly the patient was taking paxlovid and noted that he had a very bad taste in his mouth. He described it as metallic and felt most prominent on roof of mouth.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Janssen COVID-19 Vaccine EUA Strong headache,  strong pulsating (debilitating) pain in the neck area, 100ºF fever. Lower back pain.  9am one 500mg Tylenol pill. 3pm three 200mg Ibuprofen. Pain subsided and is under control with medicine. I did not report this to my doctor.
The evening after she received the vaccine, she had a HA and stomach distress.  She reports waking up frequently due to sweating.  On 12/22/20, her symptoms continued and got a bit worse - including soreness at the injection site with continued stomach distress and HA.  She took ibuprofen 400 mg PO TID.  Was unable to eat food, only drank Sprite. During the early morning hours of 12/23, was unable to sleep due to severe pain in right upper arm.  She felt a "pulling sensation" and felt an enlarged lymph node under her arm. It was very "tight" - she was able to come to work - sent to the ED for evaluation - found to have BP slightly above her normal range, mild tachycardia.  Was released and told to continue symptomatic treatment and to call or come in if symptoms worsened.
mom states pt had elevated temp 102 for 7-10 days p/vax;pt would not use arm unless forced to for 7-10days p/vax;mom took pt to ER 29APR96 d/t cont limited use of rt arm & fever;had x-ray of rt shoulder which was neg;
Patient received SHINGRIX (herpes zoster) vaccine on 4/24/18. On 4/26/18 patient developed cold-like symptoms - stuffy nose, sore throat, cough, etc. During the cold the patient could not smell or taste. Nasal symptoms ceased on 5/10/18, but taste and small sensations have still not returned. Patient also still has persistent productive cough.
A patient received a dose of Engerix-B that had expired on 11 Aug 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HBV (Engerix B) (batch number 4345R, expiry date 11-AUG-2023) for prophylaxis.   On 23-AUG-2023, the patient received Engerix B. On 23-AUG-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: A patient received a dose of Engerix-B that had expired on 11 Aug 2023).  The outcome of the expired vaccine used was 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: 24-AUG-2023. On 24-Aug-2023, a pharmacist called to inform that, a patient received a dose of Engerix-B which was expired, which led to expired vaccine used. The reporter consented to follow-up. The Vaccine Administration Facility was the same as Primary Reporter.
p/vax pt devel a papular rash on inside of rt thigh;over the next 24-36hr pt devel progressive rash;pt devel SOB w/wheezing;tx w/medrol dosepak;pt had dramatic improvement w/in 48hr of initiating steroid therapy;lymerix d/c;
DEMAND ISCHEMIA 3/25/2021 CKD STAGE 3 (GFR 30-59), UNSPECIFIED.  ACUTE RESPIRATORY FAILURE 3/30/2021 CKD STAGE 3 (GFR 30-59), UNSPECIFIED.  ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/25/2021 CKD STAGE 3 (GFR 30-59), UNSPECIFIED.
This medically confirmed report (initial receipt 31-Dec-2014) concerns a 79 year old male patient, who had a medical history of stroke in 2009. The subject had a recent history of atrial fibrillation (see 2014045133). At the time of the event the subject concomitantly suffered from hypertension since 2009, acid reflux since 2012, erectile dysfunction since 2007, depression since 2004, benign prostate hyperplasia since 2008 and osteoarthritis in the left knee since 2000. Concomitant medications included oral silodosin (8mg daily) since 27-Aug-2014 for benign prostatic hyperplasia, oral clopidogrel (75mg daily) since 2009 for stroke which was ceased on 10-Sep-2014, oral tramadol (50mg as needed) since 2010 for osteoarthritis of the left knee, oral celecoxib (200mg twice daily) since 2012 for osteoarthritis of the left knee which was ceased on 10-Sep-2014, oral finasteride (5mg daily) since 2009 for benign prostatic hyperplasia, oral lisinopril (20mg twice daily) since 2008 for hypertension, oral hydrochlorothiazide (25mg daily) since 2008 for hypertension which was ceased on 12-Sep-2014, oral alprazolam (0.5mg as needed) since 2004 for depression, oral lansoprazole (30mg daily) since 2012 for acid reflux, oral tadalafil (20mg daily) since 2007 for erectile dysfunction, oral diltiazem (240mg daily) since 2010 for hypertension which was ceased on 11-Sep-2014 and re-commenced on 360mg daily on 12-Sep-2014, oral amiodarone (200mg twice daily) for the treatment of atrial fibrillation (see 2014045133) and a cortisone injection (one injection in both knees) via the intra-articular route once for osteoarthritis of the right and left knee. The patient had last received the influenza vaccine in Oct-2013. On the 29-Aug-2014 at 16:30, the patient received an influenza vaccine (trivalent or quadrivalent) in the left deltoid via the intramuscular route as part of clinical trial. On the 30-Aug-2014, the subject commenced oral loratadine (20mg twice daily) and was ceased on 01-Sep-2014 for the treatment of a runny nose. On the 25-Sep-2014, the patient received seasonal flu vaccine (manufacturer and batch number not specified) 0.5mL via the intramuscular route. On the 06-Oct-2014, the subject received oral celecoxib (200mg twice daily) for osteoarthritis of the right and left knee. On the 09-Oct-2014, the subject commenced oral clopidogrel (75mg daily) for the treatment of the past medical history of stroke. On the 14-Dec-2014, the subject developed a severe stroke. Medical advice was sought and concomitant medications were taken. On the 14-Dec-2014, the subject was admitted to hospital for an evaluation of a three week history of dizziness and falls. An MRI (Magnetic Resonance Imaging) and CT (Computed Tomogram) scan of the brain showed a chronic infarct of the cerebellum without acute change. The MRI also showed non-specific white matter changes that were felt to be chronic and microvascular in nature. Carotid ultrasounds showed no significant lesions. On the 17-Dec-2014, the subject was discharged from hospital. Outcome was recovering. Case linked to 2014045133, 2014045164 and 2015047684.
patient had received the second dose of Pfizer vaccine and he did not wait the 15 minutes as suggested ( but he did have nurse with him) and as he was in front of store he almost passed out, he was given a seat, he was shaking, disoriented, and kept trying to pass out .  we called 911 and they determined he needed to go to hospital
This case was reported by a consumer via call center representative and described the occurrence of chills in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 25th September 2018, 10 hrs 30 min after receiving SHINGRIX, the patient experienced chills. On 26th September 2018, the patient experienced fever. On 26th September 2018, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the chills and fever to be related to SHINGRIX. Additional details were provided as follows: On 25th September 2018 at 10:30 am, the patient received SHINGRIX on left deltoid. On the day of vaccination in evening at 9 pm, the patient developed chills. The next morning, the chills had resolved, but her temperature was 101 degrees F. The reporter gave permission for her physician to be contacted.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The nurse reported that the patient was vaccinated with a dose of GARDASIL (doses, route and lot # not provided) on 14-APR-2009 and on 29-OCT-2009. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. No other information provided. No treatment information was reported. Additional information has been requested.
One week after shot experienced left sided chest pain2/10 progressed to burning in left axils. Fatigue  heaviness in bilateral arms and legs. Cold feet. Persistent dull left temporal headache. Felt dizzy and lightheaded in addition on 4/7 went to ER
Adverse reaction reported on 8/8/12 after receiving note from FNP requesting follow up. ZOSTAVAX vaccine administered on 6/22/12 without incidence. Client stated approximately ten days later small rash on her right arm near injection site the size of pinky tip. Warm to touch. On 7/24/12 "pinky tip" size rash on right ear lobe, both rashes "itchy". Additional rash on right eyebrow "pinky tip" size again. On 7/28/12 right ear swollen and patch/rash on right arm above elbow gradually spread to hand same side. Administered BENADRYL topically to affected areas. Rash currently on right waist size of 2 half dollars. Saw PCP on 8/7/12 and was given "cortisone type" shot for allergic reaction and prescription for VALTREX. No further symptoms, no fever, no malaise, no pain experienced. Only complaint, pruritus at rash sites.
2:15 pm Tdap given 1st in (L) arm. Then MENVEO in (R) arm. Immediately after giving MENVEO, the child became rigid, stiffened up, LOC for 3 seconds. Had the child lay down for 15 mins, V/S P.66, RR 20 BP 100/56 O2 sat 97% RA; Child's color came back, after 30 min was able to go home.
Headaches, body aches, fatigue, irritability, depression, pain behind the eyes, numbness in the limbs.
Patient called and stated she was having an asthma attack. She was advised to go to the emergency room. She went to a walk in clinic 7 days later.
Headache, Diarrhea, NauseaVomiting,  Ocular Pressure and Neck pain Narrative:
Large 3" x 3.5" area of erythema, indurated, which resolved after 5 d without any treatment.
3JUN96 swollen w/a hard area for 1 wk;pain in shoulder lasting till 18JUL96;shot given on the lt shoulder;12JUL96 pt reports pain behind shoulder blade & trouble inhaling;this lasted until 18JUL96;as of 20JUL96 shoulder is still painful;
debilitating weakness, zero strength, barely unable to walk, diarrhea, faint, dizzy, exhausted, sweating, headache, fever, chills, knife-like arm pain - all lasting four days
The injection didn't hurt at first when being injected. But about 2 hours after I have extreme pain in arm. I can't sleep my movement is slim. I try meds for inflammation to try to help with pain an nothing is working. I can't lay certain ways or my arm goes numb. I am wanting it to go away. I have never had pain like this before. I can only lift my shoulder mid way an that is it without pain after that it shocks me with allot of pain.
very lifeless, no pain, chills, appetite good;couldn't get warm;no nausea;
Sudden allergy to mosquito bites. Mosquito bites sites became swollen, bigger than a quarter.
Patient presented requesting second dose of Pfizer vaccine, Pfizer vaccine was  given. Previous dose of Pfizer was given 07/01/2022. Upon reviewing chart patient had 2nd dose on 07/01/22 and 1st dose of Pfizer vaccine, last year. Making the Pfizer vaccine given the 3rd dose (booster); therefore making the 3rd (a booster) dose given to soon.
Patient began feeling nauseous and light-headed post-vacccination. EMS evaluated her and determined that her blood pressure was low. Patient was given water, snacks, and a cold compress.  6/1/21: 11:47am - TC to parent. No answer. left message to call back. 6/4/21: 2:23pm - TC to parent. No answer. Left message to call back  6/7/21: No call back from parent. Record closed.
received 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 06-MAY-2022 Reporters comment: The patient received 3rd dose of Shingrix. Healthcare professional was unable to provide any adverse event details.  The reporter consented to follow up. Additional supportive information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Injection site soreness/pain set in 5 hours after vaccination, much faster than with first dose. Woke up at 2:00am with headache and severe fever chills. Took 2 standard size tablets of acetaminophen at 3:30am and went to sleep.  Woke up again at 5:00am with  no headache or fever chills but feeling very hot and sweaty.
Within 2 minutes of receiving the vaccine, my heart started racing and was fluttering. Within an hour, my heart would not stop racing (HR 115-120) and my blood pressure was increasing. It reached 184/121 with a HR of 130 and I took an additional 5 mg of Lisinopril. I developed a severe headache and mild nausea. 6 hours after the vaccine I went to urgent care because my BP would not not go down lower than approximately 180/100. Once the diastolic got under 100 at urgent care facility, they sent me home. My BP and heart rate were elevated for 3 days while I continued to take extra Lisinopril each day. I feel that I am having a lasting affect as I continue to take an additional 2.5 mg of lisinopril to keep my BP down, and it is still a little higher than usual. On March 15th I returned for 2nd dose and was refused due to adverse affect. I went to cardiologist that day and she felt it was an allergic reaction. My allergist does not view it as an allergic reaction, just an adverse affect.
Left posterior shoulder skin lesion (fixed drug eruption) began post-vaccination day 4 and grew on day 5. No treatment indicated.
Presented w/ worsening confusion, poor oral intake, steady deterioration in health. Covid +, tx w/ dexamethasone
Itchiness, swelling, hives within 12 hours of receiving vaccine - treated with ibuprofen, BENADRYL and prednisone.
On 7/21/19 pt had leg sensitivity & tingling. On 8/5 pt had: Fever, chills, shaking & needed electric blanket. After 1 day, all symptoms resolved.
Patient describes red, rash, swelling in her vaccine arm and will be following up with her doctor.