chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unresponsive for 1 minute; Took about 4 steps and passed out; Nauseated/Felt like vomiting; Headache; This spontaneous case was received on 04-Nov-2022 from a pharmacist via Agency (reference number: SEQW22-05419) and concerned a 71-year-old, male patient.  The patient's concurrent conditions included a prostate problem. The patient's health care practician (HCP) was told the patient did not have a medical history and that she had measured his blood pressure and that it was fine. He was healthy, having a heart rate of 60 bpm and a normal blood pressure. The patient's concomitant medications included Cialis (tadalafil) for a prostate problem and Synthroid (levothyroxine sodium) used for an unreported indication.   On 03-Nov-2022, at 3:40 pm, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for active immunization of persons 65 years of age and older against influenza caused by influenza virus subtypes A and B contained in the vaccine. The batch number reported was 346346, and expiration date 21-Apr-2023. It was reported the patient was okay with it and fine on that day.   On 04-Nov-2022, 14 hours after receiving Fluad Quadrivalent, the patient was asleep. The patient felt like vomiting/ nauseated and got up, took about four steps and passed out. The patient called the pharmacy saying he was vomiting and became unresponsive for one minute. In a later call, he denied having actually vomited and added that he had never passed out in his life. The patient reported having suffered a mild headache as well.  On the same day, the patient recovered from the events. The reporter claims that the patient is fine now.    The reporter did not provide causality assessment.  The events of passed out and 'unresponsive to stimuli' were considered to be medically significant by Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 71-year-old, male patient was vaccinated with Fluad Quadrivalent. Fourteen hours following vaccination, the patient felt nauseated and passed out. Reportedly, the patient was unresponsive for one minute and reported headache as well. The patient did not have a medical history, he was healthy, having a heart rate of 60 bpm and a normal blood pressure. Causal role of the suspect vaccine is assessed as possibly related, with the currently available information and plausible temporal relationship.; Sender's Comments: A 71-year-old, male patient was vaccinated with Fluad Quadrivalent. Fourteen hours following vaccination, the patient felt nauseated and passed out. Reportedly, the patient was unresponsive for one minute and reported headache as well. The patient did not have a medical history, he was healthy, having a heart rate of 60 bpm and a normal blood pressure. Causal role of the suspect vaccine is assessed as possibly related, with the currently available information and plausible temporal relationship.
Moderna COVID-19 Vaccine: I experienced chills, whole body fatigue, injection site pain, headache, and elevated temperature (98.8 and 100.0). Symptoms completely resolved on Thursday 1/7/21. I also experienced symptoms of vertigo (dizziness and nausea) beginning Friday 1/8/21 that lasted till 1/10/21 and am not sure if related or not. I do have a history of vertigo and am prescribed meclizine. Meclizine was taken with minor relief.
Pain in arm; Fatigue; General body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), FATIGUE (Fatigue), MYALGIA (General body aches) and HEADACHE (Headaches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), FATIGUE (Fatigue), MYALGIA (General body aches) and HEADACHE (Headaches). At the time of the report, PAIN IN EXTREMITY (Pain in arm), FATIGUE (Fatigue), MYALGIA (General body aches) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on  6/11/21, 7/12/21 and 1/04/22. Presented to the ED via EMS after being found unresponsive in her home, O2 sat of 80% and placed on O2 by EMS.  Intubated in ED, fever 105.8 rectally, cooling was initiated. Leukocytosis, acute kidney injury, lactic acidosis. Admitted for UT, AKI, resp failure, AMS, hyperthermia and severe sepsis. Administered IV fluids and abx, transferred to ICU. Previously elected DNR status. Tx'd with decadron, ampicillin, and cefepime. Expired on 6/24/22.
After 15 minutes of vaccine administration client c/o dizziness, light headiness. Client taken to exam room via w/c, placed in supine positions with cold compresses in back of neck. Blood pressure 129/81, HR 102. Client after 5 minutes had x3 episodes of emesis , and started hyperventilating. Blood pressure  135/76, HR 100.  911 called @ 2: 20 agreed  by mother to be transported for medial eval  to nearest E.R, Client left via stretcher accompany by mother x 2 emt's.
This spontaneous report as received from a registered pharmacist refers to a 68 year old female patient with no pertinent medical history and no drug reactions or allergies. On 30-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot # J001008, expiration date 24-APR-2014 (also reported as 14-APR-2014)) SQ. There were no concomitant medications. The pharmacist reported that on 30-MAY-2013, later that day, the patient experienced red bump around the injection site, fever and itchiness on the whole body. Also the patient was unable to get out for the last 5 days and she could not sit still. The patient did not receive treatment for the adverse events. There were no lab diagnosis or studies performed. At the time of the report, the patient was recovering. Additional information has been requested.
Adverse event: Swollen left lymph node: bigger than golf ball Fever Spotty period Treatment: run warm water on lymph node, lymph nodes would swell before period, not as big reaction after 3 dose of vaccine
Patient reported being nervous about getting her vaccine.  Denied any current medical issues on her pre-vaccination questionnaire. During her observation period. Patient stated that she felt her "throat was closing". Pt assisted supine. Epinephine and Benadryl given IM. Emergency protocol implemented. Dr. present. No hives, wheezing, or swelling noted. After treatment pt stated she is getting worked up for WPW syndrome. VS stable. Pt transferred to ED for monitoring 1040.
BONE PAIN; HARD TO SLEEP; BAD FLU; BOTH SIDES OF THE BACK HURT; SHAKING; HARD TO BREATH IN MIDDLE OF THE NIGHT; BOWL MOVEMENT WAS VERY GROSS AND SMELLY; PAIN IN HIP; MUSCLE SORENESS; SLIGHT HEADACHE; FEVER; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood thinner, and stroke, and concurrent conditions included grass allergy, tree allergy, and yellow paint allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced bone pain. On 08-APR-2021, the subject experienced hard to sleep. On 08-APR-2021, the subject experienced bad flu. On 08-APR-2021, the subject experienced both sides of the back hurt. On 08-APR-2021, the subject experienced shaking. On 08-APR-2021, the subject experienced hard to breath in middle of the night. On 08-APR-2021, the subject experienced bowl movement was very gross and smelly. On 08-APR-2021, the subject experienced pain in hip. On 08-APR-2021, the subject experienced muscle soreness. On 08-APR-2021, the subject experienced slight headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 09-APR-2021, and fever, was recovering from muscle soreness, bone pain, bad flu, both sides of the back hurt, pain in hip, and hard to breath in middle of the night, had not recovered from shaking, and bowl movement was very gross and smelly, and the outcome of hard to sleep was not reported. This report was non-serious.
A very itchy, burning (pins and needles) rash formed in-between my breasts that spread to my upper chest. They did ooze and crystalize when I did itch but tried over the counter itching cream and Benadryl to help with symptoms. Ended up going to the doctor after 7-10 days of the rash but by that time they could not get a culture of the rash.
Information has been received from on 9/30/02 from a consumer concerning a 73 year old female with a morphine allergy and no past medical history who "about one year ago" was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included estrogens, Premarin, vitamins, Fosamax and dapsone. It was reported that on the evening of vaccination she developed a red, hot swollen arm from elbow to shoulder. The symptoms "lasted two days and started to get better." It was also reported that the pt "did not feel well during the first day either." The pt sought unspecified medical condition. Additional info has been requested.
This medically confirmed spontaneous report (initial receipt: 05-Oct-2012) concerns a 52-year-old female patient. On 26-Sep-2012 the patient received flu vaccine (manufacturer, brand name and batch number were not provided). Concomitantly she also received PNEUMOVAX (batch number: H010515) intramuscularly. After vaccinations, the patient developed swelling at the injection site and a fever of 102 F (Fahrenheit), which was not controlled by ADVIL at home. She was evaluated at an Emergency room and 'treated for the swelling'. The event outcome was not reported.
She had a breakthrough of COVID after first dose. She had wheezing, mild fever, very fussy.
24 hrs post vax pt experienced an inject site rxn which included pain, swelling, erythema & hot to touch; Rxn is still present & getting worse @ time of this report; Tx ice packs only;
As last vaccine (varicella) was admin., patient said "not feeling well". Her face lost color, eyes rolled up, & she slumped back from a sitting position. I laid her head down, feet up on table. Right arm was twitching for 2-3 seconds. Lab tech called for N.P. Patient's eyes opened. She started talking lucidly, then her eyes rolled back again. She began twitching & was unresponsive for 15-20 seconds. She also wet her pants during this episode.
High fever; Pain and soreness near the injection site; Headache; Sleepy; A spontaneous report was received from a caregiver, concerning his 19-year-old son, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced high fever 102 Fahrenheit (F), pain and soreness near the injection site, headache and sleepy.  The patient's medical history included COVID-19. Concomitant medications were not reported.  On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 01EJ20A) in his left shoulder area for the prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient experienced high fever of 102 F, pain and soreness near the injection site, headache and was sleepy. The caregiver stated that patient had COVID-19 earlier this year.  Treatment for the events was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, high fever, pain, soreness near the injection site, headache and sleepy, were considered not resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Inappropriate Reconstitution Technique (Non-Approved Diluent); patient was given a Menveo vaccine reconstituted with an unapproved diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Inappropriate Reconstitution Technique (Non-Approved Diluent)) and inappropriate dose of vaccine administered (Verbatim: patient was given a Menveo vaccine reconstituted with an unapproved diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 09-JUN-2023 Nurse did not want to give information as she stated it was a violation of law. The reporter did not consent to follow up. The patient was administered with Menveo vaccine reconstituted with an unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
The rash first started on her hands on 4/2 and was originally attributed to powdered gloves she used during her job at a restaurant. She had her wisdom teeth out on 3/24 and started amoxicillin and steroids for the wisdom teeth on 3/25. She had her first COVID vaccine on 3/30 with arm pain only on 3/31.  She was seen in the urgent care on 4/4 . Rash felt to be due to amoxicillin or contact dermatitis (gloves). She stopped amoxicillin. The rash has continued to evolve. Originally maculopapular and only on hands, nby 4/13  there was both a maculopapular rash in addition to urticarial lesions primarily on her lower extremities, but also present on her trunk and in her groin. It is intensely pruritic. It seems to change over time, though the family is not entirely sure about that. Certainly, they describe confluent erythema and swelling over her right ankle the morning  of 4/13 which was not present by the time she saw me that afternoon. She has had ankle arthralgias as well.    as of 4/16, rash is gone other than feet.
Erythema multiforme. Treated with Benadryl, topical steroids.
Confirmed DVT in right calf behind the knee that started on 7/9/21, 2 days after the 2nd vaccine injection.
dose administered following potential temperature excursion; expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (dose administered following potential temperature excursion) and EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (dose administered following potential temperature excursion) and EXPIRED PRODUCT ADMINISTERED (expired vaccine used). At the time of the report, PRODUCT STORAGE ERROR (dose administered following potential temperature excursion) and EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist calls to report they have some Moderna vaccines that went out of range on 01DEC2021. Pharmacist says he did administer 3 doses to 3 patients from the vials but was not sure if it was at the time of the excursion. Pharmacist was not at the pharmacy at the time of their call and did not have details to provide at the time of the call for a temperature excursion escalation. Pharmacist took case number and temperature excursion tool and depending on the response from the tool will collect additional information
Received 2 rabies vaccine in clinic at 9:30AM 8/4/05. Pt reported she became nauseous, dizzy, and had abd cramping at wk and 3 hrs later. She became pale and weak. Rescue squad was called and pt was taken to ER. Received fluids, fully recovered, discharged at 4PM.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JUL-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB injection (lot # J004700, exp 26-NOV-2015, strength, dose and route unspecified). The reporter did not state if the administered RECOMBIVAX HB was the first dose in the series. No concomitant meddication was reported. No adverse symptoms reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Aditional information has been requested.
I received my vaccine at 6 PM sometime during the course of the night I became very restless and my arm begin to hurt. If few hours after waking up I developed the chills, body aches, headaches, and nausea.
This spontaneous report as received from a healthcare worker (medical assistant, M.A.) refers to a patient of unknown age and gender. Pertinent medical history and drug reactions or allergies were not specified. On 09-MAY-2014, the patient was vaccinated with a dose of GARDASIL (dose number, dose, frequency, route and lot number were not specified), 1 vial, which was stored outside the temperature ranges specified in the product information (PI) (exact temperatures and dates not specified). Concomitant medications were not specified. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received Moderna COVID vaccine on 1/6/21. On 1/7/21 stated that her right upper arm was red, swollen and warm to touch from injection site into axilla.
This spontaneous report was received from a nurse, via consumer reporting on male patients of unknown age, as part of a market research program. On an unknown date the patients were vaccinated with a dose of GARDASIL (dose, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse noticed a trend of large number of boys experiencing syncope under her care, also reported as she had experienced a huge increase of males with syncope. The nurse reported all patients had syncope never had it before GARDASIL but did after. Had never had large number of boys with syncope in the past. Only common factor with all boys was GARDASIL. At the time of the report the outcome was unknown. This is one of three reports from the same source (1409USA010733, 1409USA011219 and 1409USA009660). Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. The patient's current conditions included diabetes, hypertension. On 18-NOV-2013, the patient was vaccinated with ZOSTAVAX (lot # J000427, expiry: 10-APR-2014) (0.65 ml, subcutaneous). Concomitant therapies included FLUZONE received on 18-NOV-2013 and unspecified oral medications for hypertension and diabetes. On an unknown date in September 2014 (reported as early September 2014), the patient experienced shingles. Patient received treatment with unspecified antiviral medication. No product quality complaint was involved. The outcome of shingles was unknown. The relatedness of the event shingles with the therapy ZOSTAVAX was not provided. Additional information has been requested.
I had some arm pain; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A female patient in her 80's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I had some arm pain".  Additional information: It was reported that, after the patient got her Pfizer one, she had some arm pain and stuff and stated that, they felt a little, patient's were well and they were like really. The causality of the event was reported as related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3 hrs after shot I had the shakes, very cold, bloodshot eyes, low grade fever and sweating. Lasted all night. I fell asleep at 9:30.
Pfizer-BioNTech COVID 19 Vaccine EUA.  I had chills, fever of 101.7, headache, stomach upset which started on 2/10 at 5 pm and lasted for several hours.  The chills came and went for about a week,  the headache lasted for several days and the stomach upset for a week.    I had my second shot, lot number EN6203, on February 22, had the chills and headache about 5 pm on Monday, March 1st that lasted about 5 hours.  Then on Friday, March 5th at 11:30 pm, I woke up with the chills, headache and fever of 101.5.  The chills last for 4 hours, headache the next day until noon and fever broke about 7 am.
Stopped Breathing - turned Blue - started having Seizures. Transferred to a Hospital - had uncontrollable seizures and apnea for 20 days.  Was put on two anti seizure meds.
Patient reports experiencing intense pruritis at injection site, around eyes, in ears within a few hours after receiving the vaccine. The next day a rash developed on her face along with pruritis over her entire body. Pt self-treated with diphenydramine for several days, while itching continued and rash came and went daily. Called PCP on 10/31/12 and was started on methylprednisolone taper. Pt reports that symptoms improved initially, but did not completely resolve by the end of the steroid taper. Is still experiencing minor itching.
fever of 103.8; headache; Chills; achy muscles; nausea; weak; dizzy; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9267; expiry date: unknown), via an unspecified route of administration on 18Feb2021 at 15:15 (at the age of 67-years-old) on Right arm at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No Allergies to medications, food, or other products. The patient previously took first dose of BNT162B2 (lot number: EL0142) on 28Jan2021 at 03:45 PM (at the age of 67-years-old) on Right arm for COVID-19 immunisation. It was reported that the patient had experienced chills, fever of 103.8, headache, nausea, achy muscles, dizzy weak on 20Feb2021 at 07:00. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. Outcome of all the events was recovering.
Patient reports rash on hands in creases, on legs, center of back and on waist.