chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Posterior vitelline detachment - Right eye; Eye floaters in right eye; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VITREOUS DETACHMENT (Posterior vitelline detachment - Right eye) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included INDOMETHACIN [INDOMETACIN], VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.   On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021, the patient experienced VITREOUS DETACHMENT (Posterior vitelline detachment - Right eye) (seriousness criterion medically significant). In August 2021, the patient experienced VITREOUS FLOATERS (Eye floaters in right eye). At the time of the report, VITREOUS DETACHMENT (Posterior vitelline detachment - Right eye) and VITREOUS FLOATERS (Eye floaters in right eye) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications provided by the reporter.   Patient reports Posterior Vitelline Detachment 4 days later (after second dose). Symptoms included eye floaters in right eye. Ophthalmologist diagnosed condition on 08-Sep-t2021.  Company Comment - This case concerns a 60 year old male with no relevant medical history who experienced serious unexpected event of vitreous detachment 4 days after receiving the first dose of Moderna Covid 19 vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns a 60 year old male with no relevant medical history who experienced serious unexpected event of vitreous detachment 4 days after receiving the first dose of Moderna Covid 19 vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.
Pt described slight cough and headache 2 days after receiving Tdap. Lasting for 3-4 Days.
Medical Assistant reported an expired dose of PROQUAD was administered to a patient.; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 22-APR-2022, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) 1 dose, 0.5 ml, administered subcutaneously, lot # T032148, expiration date 20-MAR-2022 (anatomical location was not provided) for prophylaxis (expired product administered).
Report A0360710A describes headache in a female in her late 30s who received hep A inactivated and hep B rcombinant vaccine (Twinrix). The medical history included allergy to yeast. Concurrent conditions and medications were not known to the reporter. The vaccinee received her first injection of Twinrix on 02/14/02. On 02/15/02, one day post-immunization, she experienced "severe" headache, nausea, vomiting, yellowish diarrhea, and bruising over the breast area. The vaccinee was seen by a physician. These events resolved on 02/16/02. The Twinrix immunization series was discontinued.
Seizure episodes one day after the vaccination, similar to his regular seizures episodes. Pt noted to have 1-2 baseline seizures from his underlying chronic medical conditions.
This is a 62y.o. male who is a current smoker with a 20 pack-year history with medical history significant for hypertension, hyperlipidemia, type 2 diabetes mellitus ("borderline" per patient), coronary artery disease with myocardial infarction in 2005 with stents, and obstructive sleep apnea who presents with shortness of breath and cough. His dyspnea was initially worse with exertion and now occurring at rest and associated with wheezing. His cough is productive of yellow/brown sputum and he admits to sinus congestion and nasal drainage. The patient states his symptoms began last week on Wednesday. He says he knows to get in to see his primary care physician as soon as possible, so he was seen in his office the following day and provided with a prescription for a Z-pak and Symbicort. He was using these medications as prescribed, but wasn't getting any relief. In fact, he states he stood up from his bed yesterday and woke up on the floor. He denies any obvious head trauma or other pain. He states a co-worker was on antibiotics last week for a cough. He denies any other known exposures, such as influenza. He did receive his influenza vaccination this year.    He denies any fevers, chills, sweats, chest pain or pressure, lower extremity swelling, calf pain, or recent travel. No history of congestive heart failure or blood clots. He reports that he was hospitalized several years ago for pneumonia and referred to see pulmonology as an outpatient upon discharge. He says he went through formal lung function testing at that time and was told he did not have chronic obstructive pulmonary disease or asthma. He does admit to 3 weeks of direct exposure to asbestos dust 30 years ago.   Upon arrival to the emergency department, he has labored respirations and conversational dyspnea and is hypoxic requiring 3 liters of supplemental oxygen. He is afebrile. Chest x-ray is negative for any acute infectious process. He has diffuse coarse wheezes and was started on IV Solu-Medrol. He reports he has been getting significant relief from nebulizer treatments, as well.
pt recv vax 10AUG95 & lab eval revealed that pt failed to seroconvert;
C/O CHEST PAIN AFTER VACCINE, ALSO GIVEN TO MUCH DILUENT C VACCINE
day following vax pt exp redness, swelling, soreness lt upper arm. referred to PMD.
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-May-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The index number was reported as m6976676.  No concomitant medication information was reported. No treatment medication information was reported.
Member received Typhoid shot around 10:30 5/14/05. Then she became , mouth itchy, general vesicular rash to extremities around 1300.
TOOK DOSES EVERYDAY INSTEAD OF EVERY OTHER DAY; This spontaneous case report (PVX2019-2461) received from a pharmacist on 30-Sep-2019. It described a female consumer who "took doses everyday instead of every other day" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took doses of Vivotif every day instead of every other day.   Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took doses everyday instead of every other day" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took doses everyday instead of every other day" was considered as not applicable.
24 hours after vaccines had temp of 103.2 degrees. Gave Tylenol. On Tues., lack of appetite. On Wed, blotchy rash on face & body. On Thurs, rash lessened. On Fri, no rash. Fever lasted about 24 hours. Has had cold for approx. 3 weeks/runny nose, occasional fever). Directed to inform physician of vaccines and events.
12 hrs p/vax pt devel severe cramping in both legs;was able to work for 2 or 3 days; CPK 12,700;serum myoglobin 1700;
I had severe pain in abdomen and stomach. I called an ambulance because the pain was very severe and I didn't think I was going to make it. I went to the ER on 26 Mar. I have now a tumor in right colon with colitis. They did a CT and blood work. I was there 12 hours because they could get their stuff together. They prescribed two antibiotic (ciprofloxacin HCI and Metronidazole). Then they sent me home.
Initial misuse report was received from a health care professional on 29 OCT 2013. Cases were received on 21 March 2014 at GPV. A patient whose demographic details, medical history and concomitant medication were not reported received a dose of FLUZONE intradermal on an unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received a vaccine of incorrect age. Laboratory investigation were not reported No adverse event was reported. List od documents held by sender: none
Very itchy, rash over entire body, starting the afternoon after getting flu shot. Lasted more than 1 week.
I just got tired; Headache; I just slept a lot; Stomach was feeling kind of weird; looks like I pooped out tomato soup; looks like I pooped out tomato soup; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05May2021 (Batch/Lot number: unknown) as dose number unknown, 0.3ml, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "I just got tired"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; SOMNOLENCE (non-serious), outcome "unknown", described as "I just slept a lot"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Stomach was feeling kind of weird; looks like I pooped out tomato soup"; FAECES DISCOLOURED (non-serious), outcome "unknown", described as "looks like I pooped out tomato soup".  Additional Information: Patient had got the vaccination yesterday and (confirmed as 05May2021) and Patient stated I just got tired, I got a headache and I just slept a lot, I woke up this morning, I went to work and my stomach was feeling kind of weird and I got home and you know I really describe it that looks like I pooped out tomato soup and I am just trying to figure it out.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt stated she had body aches and bad headache later in the day after her vax.  When she work up next day she had 101 fever w/ chills, body ache, headache and fatigue.  she has been alternating Motrin and Tylenol  but has not contacted her PCP at this time.
I recently received the second Moderna vaccine, April 20. The next day I experienced severe body aches and extreme tenderness to the skin of the arms and upper torso, followed by 1-2 days of malaise. Then, on 29-30 April, I began having extreme pain in the lower back, migrating up the thoracic spine and around the left to the mid-chest area. I took one 500mg Naproxen 3x/day which helped mitigate the pain temporarily. I then discovered a red blister on my side 1 May. Since then my symptoms have been painful back/chest and stabbing pain at the site of the blisters which followed the path of the pain described above. I was diagnosed with Shingles yesterday, 3 May. I have been prescribed 1000mg of Valacyclovir
DTaP site, Large red swelling from injection site down arm- warm to touch- given 2/3/04, seen 2/5/04 - diagnosed with cellulitis, placed on Augmentin for ten days.
Flu-like symptoms, aching all over, chills, nausea, diarrhea, tiredness, low grade fever, headache, head congestion. Had taken MOTRIN the day of immunization at suggestion of the Pharmacist.  Symptoms started when I woke up the next day (10/21/18). Continued to take MOTRIN, slept, rested. It's now the 2nd day after the immunization (Monday, 10/22/18) and I'm feeling much better but still not back to normal.
pt reported shortness of breath on 12/30 in the ED and was sent home, returned 1/10 w/angioedema and increase in shortness of breath, CTA PE completed w/e/o pulmonary emboli (mostly segmental and subsegmental). pt was admitted and started on anticoagulation
Developed SARS COV-19; tested positive via nasopharyngeal swab PCR 7 JUL 2021.
Information has been received from a consumer who is a 43 year old female licensed visiting nurse with a concurrent condition of diabetes who on July 06 2004 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). Concomitant medication included insulin. It was noted that the patient received the first vaccination about five years ago. On Jul 06 2004, the patient developed a large welt at the injection site that was painful and lasted for two days. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mention a few calls from other patients who have had similar reactions after receiving pneumococcal 23v polysaccharide vaccine (WAES0407USA02583). Additional information has been requested.
A 17 YEAR OLD MALE PATIENT PRESENTED TO THE CLINIC ON 07/26/2021 FOR COVID VACCINE. ACCOMPANIED BY FATHER. MODERNA 0.5 ML ( A SINGLE DOSE)  WAS GIVEN VIA IM ROUTE TO THE RT DELTOID BY THE LPN ON DUTY. THE PATIENT WAITED FOR 30 MINS. LEFT THE CLINIC WITH NO ADVERSE S/S.
9/24/00- 10:30 PM- chills, body aches, soreness at site injection 9/25/11 - 09:00 AM - fever 99.6, chills, body ache, redness, swelling at site injection, Aleve 200mg 3:00pm- 101.1 fever, body aches, fatigue, stomach upset 5pm: 600mg Motrin 9pm: mild fever, 99.4  9/26- 9/29: no fever, chills, ache, continued swelling, redness at site. site hot to touch. 2 inches in diameter
Information has been received from a health professional concerning a 55 year old white female laboratory director with no relevant medical history or illness at the time of vaccination who on Sept 21 2004 was vaccinated intramuscularly in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 647028/0564N). It was reported that the patient received a first dose of pneumococcal 23v polysaccharide vaccine on Mar 02 2004. On Sept 21 2004, the patient developed swelling, redness, and pain at the injection site. the patient had swelling from clavicle and shoulder blade to elbow. She could not move her arm. She was seen by a physician on Sept 22 2004, and was treated with unspecified steroids and and allergy type medicine. The patient gradually got better and could use her arm normally by Sept 25 2004. The patient recovered on Sept 25 2004. No additional information is expected.
RUNNY NOSE; MILD SHORTNESS OF BREATH; CHILLS; SHOULDER PAIN; HEADACHE; MILD FEVER; LOCAL ARM PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced shoulder pain. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced mild fever. On 10-MAR-2021, the subject experienced local arm pain. Laboratory data included: Body temperature (NR: not provided) 99.0 UNITS UNSPECIFIED, Oxygen saturation (NR: not provided) Normal, and Pulse rate (NR: not provided) Normal. On 11-MAR-2021, the subject experienced runny nose. On 11-MAR-2021, the subject experienced mild shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, shoulder pain, headache, and local arm pain on 10-MAR-2021, was recovering from mild fever, and had not recovered from runny nose, and mild shortness of breath. This report was non-serious.
ARM GOT VERY SWOLLEN AND ITCHY, ARM SWELLED AT INJECTION SITE AND THEN SWELLED FROM ELBOW DOWN.  SITE WAS WARM, ITCHY AND PAINFUL.
vial was initially stored in the refrigerator on 29-May-2022, administration of vaccine was on 5-Jul-2022; Booster dose administered after 30 day use-by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose administered after 30 day use-by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 29-May-2022, administration of vaccine was on 5-Jul-2022) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose administered after 30 day use-by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 29-May-2022, administration of vaccine was on 5-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose administered after 30 day use-by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 29-May-2022, administration of vaccine was on 5-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that vial did not undergo any temperature excursions. It was reported that one dose was administered. No treatment drug was reported.
Hospitalized 1/24/22-1/28/22 dizziness, neck pain, fatigue, cough, headache, weakness, hypoxia, dyspnea , respiratory failure, PNA,
shingles; Information has been received on 04-MAR-2020 from a lawyer regarding a case in litigation. This case refers to a male patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On or about 08-AUG-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) by a pharmacist for the long-term prevention of shingles and zoster-related conditions. Subsequent to inoculation, pt was treated by a healthcare provider at the medical office of a doctor for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications and supplies: diminished capacity for the enjoyment of life; diminished capacity of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses and damages in the future. At the reporting time, the patient was not recovered from shingles and it was considered to be related to zoster vaccine live (ZOSTAVAX).
Chemical and metal taste in mouth; Affected smell to where some things smell terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Apr2021 08:00 (Lot number: ER8735) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Dec2020 (unspecified if ongoing), notes: He got COVID back  around Dec 2020, which was 5 months ago.; "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism; MULTIVITAMINS [VITAMINS NOS].  The following information was reported: DYSGEUSIA (non-serious) with onset 23Apr2021, outcome "not recovered", described as "Chemical and metal taste in mouth"; PAROSMIA (non-serious) with onset 23Apr2021, outcome "not recovered", described as "Affected smell to where some things smell terrible". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: it was reported that patient did not get sick, but thinks it affected his taste and smell.  He had a very odd taste and smell.  He doesn't know how to describe other than saying it was a  chemical, metal taste and certain things just smell awful.  Coffee, when brewing, smells terrible.  He believes it has been going on around 4 weeks now. Patient took Synthroid at least 10 years. He got COVID back  around Dec 2020, which was 5 months ago. He also take a multivitamin and is pretty healthy. He does not know if it ever returned to normal.  He did not think about it though.  After vaccine, it just got really bad.   No follow-up attempts are possible. No further information is expected.
Fever; Cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and NASOPHARYNGITIS (Cold symptoms) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and NASOPHARYNGITIS (Cold symptoms). At the time of the report, PYREXIA (Fever) and NASOPHARYNGITIS (Cold symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information were not reported.
Vomiting and diarrhea for approximately 3 hours, then nausea and headache for another 24 hrs.  Stayed in bed, slept, took ibuprofen.
5 minutes post injection patient  got very dizzy and couldn't stand. Her dad propped her up until I got a chair for her. She sat for 15 minutes and her dad applied a cool compress to her forehead, as she was hot. I gave her cups of water and her dad got her a nutrition bar which she ate.  She hadn't had lunch yet according to her dad. She felt better after 15 minutes and then walked with her dad to the front of the store. I called her at 4:50PM today and she is fine now.
Pt. has experienced itching all over his body, starting 2-3 days after receiving Shingrix. Still going on curently
*runny nose/nasal congestion *no fever but mild case of the chills *tiredness, weakness, fatigue The live intranasal virus was administered on  12/12/03 at 8:30 a.m., and I was symptom-free until app. 8:30 a.m. of 12/16/03 when I lay down for a nap and slept for three hours. I needed to rest in bed for all of Tuesday and Wednesday. By Thursday, I could summon the energy to walk for two miles on my treadmill. By Friday, I felt well enough to go for a long walk and then see The Lord of the Rings with my family that night. in bed