chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 week after receiving the first dose, in the afternoon i had loose stool followed by some mild abdominal cramping for the rest of the day. I took some ibuprofen. The following morning (Wednesday), the pain was on my right abdomen and right flank area only.  It was persistent, achy, soreness.  My insides felt very tender to put any pressure on my right abdomen or flank. The pain on the right side of my back became more intense as the day went on. I had sharp right flank pain when lifting my right leg after showering to get dressing and use lotion. When I was walking up the stairs I turned to the left and had a sharp pain in the right flank again, taking my breath away for a moment.  Around 4pm I took ibuprofen.  About an hour later my eyes felt hot and tired. My cheeks were pink.  My temp was 99.2.  I generally just didn't feel good from this achiness. I took Benadryl and went to bed at 7pm, and slept for about 12 hours, waking once at midnight. The following day (Thursday) I felt 99% better and contacted my doctors office.  When putting pressure on the same areas I could feel very slight tenderness if I pushed hard. That evening and into the next morning (Friday) I was mildly achy on my right side but barely at all. I didn't feel any more discomfort until this past week on the 22nd or 23rd.  During sexual intercourse I felt that same mild internal tenderness on my right side. At this time, I don't believe I have any pain. My urine seems unusually clear, light colored, and smaller volume but this is very subjective. I have some abdominal swelling but this has been present since my breast reconstruction in January of 2020 and seems to get worse or better depending on the days activities or meals so it's hard to know what causes what.  Labs were done on 1/22 showing decreased kidney fuction. Pending tests include an ultrasound of the Right Ovary that remains after the hysterectomy, bladder, and kidney. In addition to a 24 hour urine and some other urine studies.
Case was vaccinated in April 2021 for Covid, then was hospitalized for Covid in January 2022.  Hospitalized at: a local health care facility.  * Acute respiratory failure due to COVID-19 (HCC) Presented with 6 days of URI symptoms, cough was so severe it was hard for her to eat. She tested positive for covid 1/10/22, was mildly hypoxic, and had bilateral patchy infiltrates on CXR on admission. She received one dose of J&J vaccine in April 2021. She has no history of heart or lung disease but has been on an extended prednisone taper for PMR which may increase risk of severe illness. She was treated with dexamethasone and remdesivir. She received 3 doses of remdesivir before she discharged. She will complete a 10 day course of dexamethasone as an outpatient because she was still requiring supplemental O2 at the time of discharge.
Unusually thirsty; Trouble clrearing throat; Became hoarse; Extremely achy; Many Symptoms of a very bad cold; Cough lingered for 2 weeks; Inflammatory reaction to Vaccine; Missed three days of work; Never tested for COVID, but was sick with similar symptoms for five days; Fatigued; Bad chills; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (Unusually thirsty), OROPHARYNGEAL DISCOMFORT (Trouble clrearing throat), DYSPHONIA (Became hoarse), PAIN (Extremely achy) and NASOPHARYNGITIS (Many Symptoms of a very bad cold) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (Flu shot has never bothered her). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Allergy to nuts.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced THIRST (Unusually thirsty), OROPHARYNGEAL DISCOMFORT (Trouble clrearing throat), DYSPHONIA (Became hoarse), PAIN (Extremely achy), NASOPHARYNGITIS (Many Symptoms of a very bad cold), COUGH (Cough lingered for 2 weeks), INFLAMMATION (Inflammatory reaction to Vaccine), IMPAIRED WORK ABILITY (Missed three days of work), ILLNESS (Never tested for COVID, but was sick with similar symptoms for five days), FATIGUE (Fatigued) and CHILLS (Bad chills). At the time of the report, THIRST (Unusually thirsty), OROPHARYNGEAL DISCOMFORT (Trouble clrearing throat), DYSPHONIA (Became hoarse), PAIN (Extremely achy), NASOPHARYNGITIS (Many Symptoms of a very bad cold), COUGH (Cough lingered for 2 weeks), INFLAMMATION (Inflammatory reaction to Vaccine), FATIGUE (Fatigued) and CHILLS (Bad chills) outcome was unknown and IMPAIRED WORK ABILITY (Missed three days of work) and ILLNESS (Never tested for COVID, but was sick with similar symptoms for five days) had resolved.            No concomitant medications were provided.  It was reported that within a few hours of having shot, patient was unusually thirsty and had trouble clearing her throat and became hoarse. Within 12 hours of the booster, patient had bad chills, was extremely achy, fatigued and had many symptoms of a very bad cold. Patient had contacted her doctor and he told her she had an inflammatory reaction to a vaccine.  No treatment medications were provided.   This case was linked to MOD-2022-484093 (Patient Link).
A report has been received from a Health Professional concerning a 16 year old female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 03-OCT-2014. The patient experienced tested positive for influenza A which started on 24-NOV-2014. The outcome of the event of tested positive for influenza A is unknown. The report was considered to be non-serious.
Fever; Chills; Fatigue; This is a spontaneous report from a contactable consumer. A 15-years-old female consumer (patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history included type 1 diabetes mellitus and she was on insulin pump. The patient's concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for COVID-19 immunization. As per the description it was reported that two sisters experienced similar symptoms. 15 years old with type 1 diabetes mellitus experienced fever, chills and fatigue on an unspecified date. The outcome of all the events was recovered in 48 hours (for 15 years old).  Follow-up activities closed: as reporter denied for further contact. No further information expected.
swollen face around the left side of her lip; This spontaneous case was reported by a pharmacist and describes the occurrence of SWELLING FACE (swollen face around the left side of her lip) in a 59-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (swollen face around the left side of her lip).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
ON 9/30/2021, PATIENT PRESENTED TO THE PHARMACY WITH REDNESS, SWELLING, AND A KNOT AROUND THE ADMINSTRATION AREA ON THE LEFT ARM. PATIENT ALSO REPORTED REDNESS/RASH UNDER THE BREAST AND VAGINAL AREA POST-VACCINATION. PATIENT REPORTED NO TREATMENT. PATIENT WILL CONTINUE TO MONITOR THE ADVERSE REACTION AND CONTACT MEDICAL ASSISTANCE IF THE SIGNS AND SYMPTOMS WORSEN.
At 6am I had a fever, body ache, chills. Then at 3pm I had very sharp chest pains and shortness of breath. They would not go away so I went to the ER
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2007, a healthcare provider at the office of a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 05-JAN-2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 including care for hospitalization (dates unknown), 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
dose 1 of vaccine at 11am 12/24/20, after vaccination I noticed some pain and burning that radiated down arm, lasted for seconds and resolved. This pain came and went throughout afternoon of 12/24. Upon waking around 730am on 12/25/20 I noticed slightly red erythematous ovoid rash that measured approx 3 in x 1 in in size, was exquisitely tender to touch, but smooth, without vesicles, pustules, non-fluctuant. Took tylenol and applied heat to area without relief of pain. Pain is burning in nature, with a soreness that radiates down the back of my upper arm. Pain worse with raising or using arm. Also have aching in neck and upper back. Also having increased fatigue and slight headache all of 12/25, worst at night and located on right side of head, throbbing. On 12.26.20 I woke and noticed rash has slightly increased from markings made on 12/25/20. I continue to feel tired, achy, with slight headache. Arm very sore and upper back very sore.
Information has been received from a pharmacist and a RN concerning a 68 year old male with no known allergies who during a vaccination clinic at a pharmacy on 10/5/03 between 1400 and 1500 was vaccinated IM in the right arm with a dose of pneumococcal 23v polysaccharide vaccine (644219/1079M). On 10/8/03 the pt was also vaccinated in the left arm with a dose of influenza virus split virion 3v vaccine inactivated (Fluzone). Concomitant therapy included Flovent and Serevent. The pt's wife reported to the pharmacist that on 10/8/03, about 6 hrs after administration, the pt developed a lump at the site of injection in the right arm. It continued to get worse and worse. On the morning of 10/9/03 the pt went to the ER because the arm had become so swollen and painful and he was unable to move it. A venous ultrasound revealed a hematoma at the injection site. The pt was diagnosed with cellulitis and treated with Rocephin and Keflex. On the afternoon of 10/9/03 the pt was seen by his primary care physician and started on Keflex, Vicodin, and ibuprofen. As of 10/10/03, the pt was doing better. It was also reported that the wife had indicated that her husband developed a 'bad reaction" in the arm to the pneumococcal 23v polysaccharide vaccine because the product was "contaminated." On 10/10/03 the pt's wife called the pharmacist to obtain the lot number for the pneumococcal 23v polysaccharide vaccine and that the pt was going for a second visit to his PCP. On 10/11/03 the pt was again seen in the physician's office and was considered to be much improved. It was also reported that this pt lives about an hour away from the pharmacy and is not a regular customer of this pharmacy. A product quality complaint is involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards and was released. Upon internal review, cellulitis and hematoma at the injection site were determined to be other important medical event (OMIC). Additional info has been requested.  Follow up on 11/26/2003: "No futher information is expected."
became flushed and nauseated. dry heaves w/out emesis.denies cp/diff. breathing and pain.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Apr2021 as dose 1, single (Lot number: ER836), in right arm, on 22May2021 as dose 2, single (Lot number: EW0177), in right arm and on 07Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 28 years, in right arm for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Positive; (17May2022) Negative; (20May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not receive other medication in 2weeks. The started taking Paxlovid on 11May (1 day after testing positive). Patient finished the dose on 15May and tested negative on 17May. On 20May, patient started feeling sick again and tested positive for Covid again. Patient wanted to report since these rebounds are rare and in case it is helpful. The patient received Treatment, Brand: Paxlovid, (Treatment start date: 11May2022, Treatment stop date: 15May2022). The patient known allergies was none. The patient other medical history was asthma.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to a 14 year old patient. The patient's medical history was not reported. On an unknown date in 2005, the patient was vaccinated with first dose of RECOMBIVAX HB. Concomitant medications were not reported. On an unknown date in 2009, the patient was vaccinated with second dose of RECOBIVAX HB. On 04-JUN-2014 the patient was vaccinated with third dose of RECOMBIVAX HB. No adverse effect reported. The outcome of inappropriate schedule of drug administration was unknown. Additional information has been requested.
It was reported that an 18 year old female pt received a Menomune on 5/29/03. Five hrs later, the pt experienced chest tightness, an asthma-like reaction and malaise. The pt used an inhaler, and was reported as "doing fine" at the time of this report. It was reported that the pt recovered from these events.
pt vax w/1 dose of varicella on unspecified date, pt exposed to sibling w/varicella, 2/21/98 pt exp breakthrough varicella.
pt recv vax 23MAY97 & 31MAY97 pt devel a fever of 101 to 104 & diarrhea;
Patient developed a red, round, slightly raised bump/spot on right arm where varicella vaccine was administered.  It lasted for about 4-5 days.  Bump/spot was approximately 30mm x 30mm.
No adverse event. 3rd dose of MENACTRA given. 1st dose 03/22/07, 2nd dose 09/28/09, 3rd dose 11/09/11.
Pneumovax admin right deltoid.  Had redness and swelling entire upper arm to elbow.  Painful.
Fluzone High Dose which was administered to a 15 year old male/ with no AE; Fluzone High Dose which was administered to a 15 year old male/ with no AE; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 years old male patient who experienced vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ290AB via intramuscular route in the left deltoid on 08-Nov-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error Inappropriate age at vaccine administration and overdose.    It was reported that the patient had no AE symptoms   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This is a spontaneous report from a contactable nurse (physician assistant). A patient of unspecified age, ethnicity and gender started to receive PREVNAR 13, (lot number: S70879, expiration date: Oct2019) via an unspecified route of administration on 19Feb2018 at 0.5 ml, single for routine vaccination. The patient's medical history included hemangioma from an unknown date. The patient's concomitant medications were not reported. On 19Feb2018, it was reported that one of the staff gave pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) but did not notice there was a hemangioma in the spot where the staff gave the injection. The reporter stated that injection site started to bleed and pressure was applied and the bleeding stopped. The reporter wanted to know if there are any side effects and what should they look for. The patient recovered from the injection site bleeding on an unspecified date.
Possibly aggravated underlying autoimmune condition.  I am not sure.  Developed ?tight? throat within shot time of vaccine (not sure as I may have ignored it as it was mild).  Progressed to ?flare? of underlying autoimmune condition.  Tight throat, Asthma, severe nasal polyps. Parasthesias, raised LFT?s. I can?t be sure if the vaccine aggregated underlying condition but it most definitely paralleled it
Information has been received from a physician assistant health care student regarding to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies were not provided. On an unknown date, the patient was inadvertently vaccinated with a dose of VARIVAX (merck) (dose, route and lot number were not provided) instead of ZOSTAVAX. Staff error only. No adverse effects reported. Additional information has been requested.
vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022; Vaccine was expired on 01 Apr 2022 and was administered on 12 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 12 Apr 2022) and PRODUCT STORAGE ERROR (vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 12 Apr 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 12 Apr 2022) and PRODUCT STORAGE ERROR (vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The vials were initially stored in refrigerator on 04-Apr-2022. The vial has not undergone any temperature excursion. 155 patients where vaccinated with expired doses.  No treatment medication was provided.
extreme dizzy spells; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizzy spells) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (extreme dizzy spells). At the time of the report, DIZZINESS (extreme dizzy spells) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Copious bleeding from left nostril, running down throat to the point patient was choking on it. Clott-like material in the sputum.  Copiuus bleeding lasted for fat least 1.5 to 2 hours, slowed down only when treeated an packed in the hospital ED. Chemical cauterization with Silver Nitrate at approximately 10:30 PM. ENT follow up scheduled for April 1.
Severe chills and fever, bad dizziness, headache, joint pain, inability to focus
Arm soreness, achy body, lightheaded, drowsy, high fever, chills, nausea, increased sensitivity to touch, rash at injection site
vaccine given and was not correctly reconstituted.  administered grey top liquid portion of vaccine without mixing with dry powder component.  Patient notified of incomplete vaccine given and advised to return to the clinic for re-vaccination. Patient plans to call our office back to schedule an appointment.  The patient also received a COVID 19 booster and HPV vaccines on the same day.  She reports she did have a fever the day after the vaccines but this has resolved.