chrisvoncsefalvay/vaers-outcomes huggingface dataset:
During a self-breast exam I had something that felt like lumps. It was my right breast at that time. I ended up having my annual within 4 weeks. My doctor also felt that lump in my breast. My lymph nodes were swollen. At that time they sent me for an ultrasound and mammogram for both breasts 4 weeks after that. By that time the swelling had gone away. I just had fatty tissue. Later on it was confirmed by the CDC that those symptoms might be related to the vaccine. I have completely recovered from this adverse event.
Pt recvd 2 doses of Engerix-B & 7 days p/1st & 2nd inject pt exp flu-like sx including nausea/vomiting, diarrhea, & malaise;
Information has been received from a nurse practitioner concerning a 12 month old male with a history of a reaction to Lorabid and occasional otitis media who on 02/20/2001 was vaccinated with the first dose of varicella vaccine IM in the left thigh. Concomitnat vaccinations that same day included the first dose of MMR SC in the left thigh and the second dose of Prevnar in the right thigh. There was no illness at the time of vaccination. On 02/21/2001, the pt developed a fever of 103 deg. F., irritable, nausea, vomiting and diarrhea. On 02/23/2001 the symptoms continued. On 02/24/2001, the pt was noted to be improving. It was also reported that the symptoms resolved within two to three days. On 03/01/2001, the pt developed a fever of 105 deg. F., was seen in the ER and was diagnosed with early pneumonia. In the ER in the pt had a chest x-ray and unspecified blood work. The pt was started on treatment with oral Augmentin. Follow-up on 03/02/2001 noted that the pt was better. The fever resolved by the third day and the pneumonia also resolved. The pneumonia was treated as an outpatient. On 03/13/2001, the pt developed a chicken pox rash with fever. Subsequently, the pt recovered from the chicken pox rash and fever. It was noted that the pt was not seen in te office for this event. The nurse practitioner was concerned that the combination of the vaccines contributed to the pt's experience. The nurse practitioner also stated that the child was a normal host and received the vaccines as recommended on his last "healthy" visit. In conclusion, the nurse practitioner stated that "she did not really feel that the vaccines' caused the child's experience. It was reported that the pt recovered from all of the events. No further info is expected.
also came down with COVID-19 and now the flu; now the flu; Initial information received on 21-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves adult and unknown gender patient who also came down with covid-19 and now the flu after receiving vaccines COVID-19 vaccine and influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.     On an unknown date, the patient received a Booster dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for COVID-19 vaccination (COVID-19 immunisation) and received of suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date the patient also came down with covid-19 and now the flu (covid-19, influenza) (unknown latency) following the administration of INFLUENZA VACCINE and COVID-19 VACCINE.  Relevant laboratory test results included: SARS-CoV-2 test - On an unknown date: [COVID-19]   Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for both the events.
Swelling of throat, fever and chills. 4 hours after injection of FLUZONE HD 2014-2015.  Fever was controlled with acetaminophen.  Throat swelling lasted approximately 4 hours.
FLUBLOK ADMINISTERED , PT IS UNDER AGE OF 18, NO ADVERSE REACTIONS, MOTHER NOTIFIED
Joint pain, rheumatoid arthritis, auto-immune disease. One month after receiving 2nd Lymerix vaccine. Treated with prednisone and Naproxen and advised to take Embril. The annual follow-up states that the pt still is experiencing acute joint pain and currently taking plaquonil, sulfasalzis and zantac.      Pt received vaccination for Lyme disease on April 6 and May 19, 1999. About one month later she began to have hip pain. Then, moving the neck became painful. Next, her shoulders became stiff and painful, particulary at night. The pain is worse in the morning or after sitting, but she has pain and stiffness throughout the day. She thinks that her symptoms are generally getting worse. Because of the pain and stiffness in the hip and shoulders, she was diagnosed with polymyalgia rheumatica. Apparently the sedimentation rate was no t elevated. In the fall of 1999 she was started on prednisone 10mg, which was then increased to 15mg a day. She marked improvement on this medication, but not total relief of symptoms. However, she disliked being on prednisone, and the decision was made to taper it. The medication was stopped two months ago. Subsequently she has taken Naprosyn 375mg twice a day. However, she does not think this medication helps. She tells me that she has had x-rays in the past of her shoulders and knees which show degenerative changes in the shoulders. She had a DEXA scab which was normal. The family history includes a son who has Lyme disease, but she has no family history or arthritis psoriasis, or inflammatory bowel disease. There are no allergies. She currently takes Tylenol PM at night, which helps with sleep. On physical examination, she has squeeze tenderness of the PIP joints bilaterally, a swollen and tender left second MCP joint, pain on forced flexion at both wrists, and pain on shoulder abduction greater than 90 degrees, and on internal and external rotation bilaterally. She also has pain on lateral movement of the neck, and pain over the greater trochanteric bursae. Examination of the heart, lungs, and abdomen is normal, as is the neurologic examination.
swelling at the site of injection; injection site pain; nausea; vomiting; headache; fever; This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix (intramuscular). In February 2019, 1 day after receiving Shingrix, the patient experienced injection site swelling, injection site pain, nausea, vomiting, headache and fever. On an unknown date, the outcome of the injection site swelling, injection site pain, nausea, vomiting, headache and fever were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, nausea, vomiting, headache and fever to be related to Shingrix.  Additional details were provided as follows: In February 2019, the patient in her late 50's received her first dose of Shingrix. The patient experienced injection site swelling, injection site pain, nausea, vomiting, headache and fever. The patient has declined the second dose of Shingrix.
Vaccine administrated beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administrated beyond use date after the thaw process) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 prophylaxis.     Unknown if patient has ever been diagnosed with or tested positive for COVID-19.  Unknown if patient had acute illness at the time of vaccination and up to one month before.  Unknown if patient had any chronic or long-standing health conditions.   On 07-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administrated beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administrated beyond use date after the thaw process) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported vaccine administrated beyond use date after the thaw process. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  Treatment information was not provided.  Vaccine 1 Ndc Code was reported as 80777-0273-99.   This case was linked to MOD-2022-542869 (Patient Link).
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 21-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX vial 19400 PFU (lot #, dose, dose  number, frequency and route unspecified). Beginning on 22-OCT-2014, the patient experienced injection site reaction in her arm. Site was warm to touch and tender. The outcome of the event was unknown. Additional information has been requested.
temperature excursion for MMR II; No additional AEs; This spontaneous report was received from a medical assistant referring to patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication were not provided.  On unknown dates, these patients received improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, route, vaccination scheme and anatomical sites of vaccination were not reported, lot # S015284, expiration date 19-MAY-2021) for prophylaxis. The vaccine administered experienced a temperature excursion of 52.3 degrees Fahrenheit, for a time frame of 1 hour and 45 minutes. There were no previous temperature excursions. The call was not due to digital data logger. Due to Coronavirus (COVID-19), no one could monitor the data logger information. No additional adverse events reported.  This case has been considered non-valid due to the lack of patients' identifiers.
PPV vacine shot on 4/13, 99.4 fever on 4/14, fever of 102 4/15, Stuffed up nose, cough, breathing impacted.  Muscle ache, sever are pain after shot for more than24 hours.  Head ache.
Patient reported itchy rash from shoulder to clavicle area on the side the immunization was given.
This spontaneous report as received from a healthcare worker refers to approximately 15 to 20 patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiry date were not reported). On unknown dates ,the patients were vaccinated with an additional dose of GARDASIL 9 (dose, route, lot # and expiry date were not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No adverse effects were reported. The outcome of interchange of vaccine products was unknown. The relatedness between interchange of vaccine products and GARDASIL and GARDASIL 9 was not reported. Additional information has been requested.
Within ten minutes of receiving her COVID 19 vaccine the patient experienced tingling in her lips.  She received 10 mg of Zyrtec and ten minutes following medication administration her symptoms progressed to tingling in her throat and lip swelling.  Epi-Pen was administered with good effect with ACC provider at bedside.  911 was called to transfer patient to nearest ED for observation and her care team was contacted to manage 2nd dose of vaccine when needed. VSS remained stable through event and patient remained alert and oriented with stable VS and airway.
Consumer states that she may have gotten COVID after getting the 1st dose of the Pfizer COVID vaccine.; Consumer states that she may have gotten COVID after getting the 1st dose of the Pfizer COVID vaccine.; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced consumer states that she may have gotten covid after getting the 1st dose of the pfizer covid vaccine on an unspecified date in  2021. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown on an unspecified date in 2021. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Flare up of acute uveitis in left eye only. Redness, discomfort, sensitivity to light. First flare up in 6 months. First noticed two mornings (42+ hours after day of vaccine dose. First day after dose included general body inflammation, which I suspected might trigger uveitis, now knowing my HLA B-27.  Currently self-treating with leftover Durezol steroid drops from my previous case. I am now realizing that while that previous case came before my first dose in the Pfizer vaccine series (May 2021), my uveitis symptoms did persist for 2-3 weeks after that first vaccine dose, which may have prolonged the inflammation. No signs of uveitis during my second Pfizer dose in June 2021. Current uveitis case still ongoing.
Patient says he experienced his hands shaking uncontrollably to the point he could not hold anything with liquid. He also experienced chills the night of the injection.
This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Idiopathic Intercranial Hypertension" (unspecified if ongoing); "Factor V Leiden mutation" (unspecified if ongoing), notes: other medical history: Factor 5 Leiden. Known allergies: No. Other medication in 2weeks product concomitant medication(s) included: VIT D [COLECALCIFEROL]; CETRIZINE; FLONASE ALLERGY RELIEF. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 20Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 20Apr2022, outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: Test: (Apr2022) high viral load; SARS-CoV-2 test: (12Apr2022) Negative, notes: Tested negative, 12Apr & 16Apr on at home test; (Apr2022) Positive, notes: Symptoms started back up 20Apr2022 and then tested positive on at home test; (16Apr2022) Negative, notes: Tested negative. April 12Apr & 16Apr on at home test. Therapeutic measures were taken as a result of covid-19. It was reported that, Anti viral details: product=COVID-19 Treatment, Brand= Paxlovid, Treatment start date=06Apr2022,, Treatment stop date=11Apr2022, Indication=Treatment of COVID-19. Patient Had a reinfection 8 days after ending treatment of Paxlovid. Tested negative 12Apr & 16Apr on at home test. Symptoms started back up 20Apr and then tested positive on at home test. Local Hospital did a test and found high viral load, said more than likely was infected. Adverse event start date: 20Apr2022. Patient recovered: Recovered. Treatment ae: No. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
He came home and went to bed, had a fever for 5 days.  Shaking, rigid, unable to communicate.  Was transferred to the hospital on 12-16-21.  He was released home but returned 12-25-21 and was there until released on hospice on 1-1-22.
Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates in 2015 ("after 17-NOV-2015"), the patients were vaccinated with doses of improper stored PEDVAXHIB (lot # K026533, expiration date 07-AUG-2017; lot # L012838, expiration date 10-MAR-2018; lot # L012837, expiration date 11-MAR-2018)(dose and  route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
first dose on May 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-JUL-2022 Reporter's Comments:  The pharmacist reported that, the patient was not immunocompromised that received Shingrix. During the call, reporter was not asked if he wanted the information stored in GlaxoSmithKline database, but he agreed a follow up with Safety. The reporter consented to follow-up by email.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
2-4 HOURS AFTER THE SHOT, PT DEVELOPED FEVER TO 102, NECK PAIN STARTED TO HURT SEVERELY, MIGRAINE CAME BACK, ARM STARTED TO HURT SEVERELY; SYMPTOMS LASTED FOR 2 DAYS.  PATIENT'S PRIMARY DOCTOR CALLED IN TAMIFLU WHICH SHE STARTED ON 1/25/14, AND PT TOOK 3 DOSES BUT STOPPED B/C BROKE OUT IN A RASH (RED DOTS) ON ARMS, LEGS, TORSO, AND ANKLES, SLIGHTLY ITCHY WHICH LASTED ABOUT 5 DAYS AND SLOWLY STARTED TO GO AWAY.  ARM CONTINUED TO BE SORE, BUT 3 DAYS LATER THE PAIN ALL OF A SUDDEN GOT EXCRUCIATINGLY WORSE; MUSCLE STARTED CRAMPING AND RADIATING TOWARD ELBOW.  THIS PAIN CAME ON OVER A PERIOD OF 2-3 HOURS.  PT COULD NOT SLEEP SECONDARY TO THE PAIN.  NECK PAIN WAS WORSE.  BY THE NEXT MORNING, ALL THE JOINTS WERE PAINFUL: ELBOWS, WRISTS, SHOULDER WHERE SHE GOT SHOT, NECK, KNEES, ANKLES (NOT HIPS).  UPPER BACK PAINFUL.  WAS SLIGHTLY BETTER THEN NEXT DAY, BUT IN THE MIDDLE OF THE NIGHT, THE PAIN WAS MUCH WORSE.  WENT TO FACILITY ON 1/29/14 AND 2/1/14.  WAS PRESCRIBED PREDNISONE (WHICH THE PATIENT DID NOT TAKE) AND PAIN MEDICATION.  WENT TO E.R. ON 2/2/14 AND GOT A SHOT OF STEROIDS AND WAS PLACED ON ORAL STEROIDS; XRAY WAS DONE.  WAS BETTER WITH STEROIDS AND SHOT, BUT WHEN OFF STEROIDS THE PAIN CAME BACK; YESTERDAY PAIN GOT WORSE WITH ACTIVITY.  TODAY HER DOCTOR CALLED IN MORE STEROIDS BUT DID NOT SEE HER.  HAS APPT TOMORROW.
Patient reports to feeling like heart was racing 5 minutes after shot that resolved shortly after.  She reports that symptoms resolved after a few minutes and since then has no tachycardiac complaints.  Reports to feeling fatigues x 24 hours after vaccine.  She is comfortable getting second vaccine which is scheduled for 05/07/2021
12/11/21 presents as transfer "to WBH-RO from Hospital" for "a right pathologic periprosthetic femur fracture and multiple bony lytic lesions". PMHx of "Chron's disease on Imuran and depression"
This spontaneous report as received from a Medical assistant referring to a patient of unknown age.  On 14-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA dose 1, lot # N003194, expiration date 28-OCT-2017, for prophylaxis. No adverse event reported.  The vaccines were exposed at a temperature of 33.6 °F, during a time frame of 21 hours 40 minutes. There was no previous temperature excursion.
After flu shot administered to right upper arm, upper arm, neck and face on right is numb.  Still has not gone away but has subsided some.  Did not seek treatment.
severe tinnitus, inflammation and reduced hearing in both ears, left ear worse than right. received vaccine in left arm
Fever; headache; body aches; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL8983) intramuscular on the left arm on 27Jan2021 08:30 at a single dose for Covid-19 immunization. Medical history included allergies, sinus (disorder), hearing loss and allergies: shellfish and sulfa. The patient previously received first dose of BNT162B2 on 04Jan2021 for COVID-19 immunization (first dose, 04:00 PM Intramuscular on the left arm lot number: EL 0142). Concomitant medication included nigella sativa (black seed oil), turmeric [curcuma longa rhizome] and multivitamins. On 28Jan2021 05:00 AM, the patient experienced fever, headache and body aches. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Patient was not pregnant. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was unknown.
Patient stated that he has a sharp pain in his arm that he has had since he taken the vaccine. The pain in his left shoulder is very severe. Her can not rest. He stated that he has also lost his ability to concentrate. Patient was at the hospital in the ER when he called to make report. 08/20/21.
Client received second dose of Pfizer Covid 19 vaccine and went to observation area for the 15 minute monitoring. Shortly after arriving,  the client felt dizzy. Neighboring clients alerted EMS and client was lowered to floor just before an estimated 30 second loss of consciousness. Client regained consciousness and was found to be alert and oriented. Vital Signs were stable and within normal limits. Client declined follow up monitoring.
I have began to have severe pain at the injection site in my left arm. The pain is extended into my elbow. I have tried muscle creams and hot and cold packs. Nothing is working. I can't lift anything more than a few pounds. And I can't extend my arm out completely without severe arm and elbow pain.
Had arm soreness on the day of the vaccine. The following day continues to have soreness of the arm but noticed a firm hard small lump in her left neck. Left neck lump persists. Non painful
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: EMS WERE CALLED. PATIENT WAS GIVEN CLARTIN 10MG  AS SHE REFUSED DOSE OF BENADRYL
Crying, itching, Rash all over body (pubic area and up stomach and back, face/forehead), fever of 101.