chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLACKED OUT; VERTIGO AGGRAVATED; BROKEN NOSE; FALL; BUSTED LIPS; COULD NOT EAT ANYTHING; CHILLS; FEVER; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vertigo, non-alcohol user, and non-smoker. The patient was not pregnant at the time of reporting. The patient had no known drug allergies and no history of drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, 1 total, administered on right arm on 03-APR-2021 13:30 for prophylactic vaccination. Concomitant medications included meclozine hydrochloride for vertigo.  On 03-APR-2021, 15 minutes after vaccination the patient felt dizzy. On the same evening, the patient experienced fever, vomiting, sweating, dizziness and chills. On 04-APR-2021, the patient could not eat anything and experienced black out and fell from which the patient experienced busted lips and broken nose. The patient was taken to the emergency room and was hospitalized on 04-APR-2021. During hospitalization the patient had blood test and chest X-ray which was normal and COVID-19 virus test was negative. At the hospital the patient was diagnosed with aggravated vertigo due to vaccination but according to the patient it was not her vertigo since she did not get her usual vertigo symptoms before blacking out (dizziness, room spinning, or feeling like about to fall). The duration of hospitalization was 1 day. On 07-APR-2021, the patient went back to the hospital to follow-up and the patient's physician ran tests for blood work and computed tomography (CT) scan of her head with no abnormal findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blacked out, vertigo aggravated, broken nose, fall, busted lips, could not eat anything, chills and fever was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210423964-covid-19 vaccine ad26.cov2.s -Vertigo aggravated. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY   VO:20210423964-covid-19 vaccine ad26.cov2.s-broken nose, black out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Employee received Moderna COVID vaccine on 1/8/2021. Employee started having tingling in both hands 2 hours after the vaccine. Employee reports increased pins and needles sensation in left extremity starting evening of 1/13/2021 which continues this afternoon.
The pt received the vaccines and then experienced swelling from the elbow to the shoulder on the left arm. The pt has 7 blisters in the area of swelling. Arm is tender to the touch. Blistering started on 3/15/01 and swelling the same day of vaccines. Instructed to see PMD for treatment. Treated with warm compresses, oral antibiotics (cephalaxin) and silvadine cream. Arm swelling and redness have decreased. Has good ROM in arm.
This spontaneous report was received from a nurse practitioner and refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the reporter stated that 4 doses of improperly GARDASIL 9, lot number L007560, expiration date 15-JUN-2017, (dose, route, anatomical location were not reported) were administered to the patients. Thre was no concomitant medication reported. Additional information has been requested.
About 25 hours after vaccine I started having a few hives. I took Benadryl hives stopped. 4 hours later hives stated again.  I called my doctor and was told to go to ER. Went to ER. They gave me iv solumedrol and iv benadryl. Approximately 20 min later hves were gone. Discharged home on prednisone daily for 6 days.  Completed 6 day course and no other incidents.
Patient stated she had first Moderna vaccine on 5/10, and had sore arm the same day. She stated yesterday she developed a lump at the site, that was about 1/2 inch thick, and 1" long. She stated it does not hurt. She has not tried anything on it. RN suggested she may try cool compress. RN stated to let her provider know. She stated she has a routine appt on Friday with provider. RN suggested calling him/her a heads up before appt. She stated understanding.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a child. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 08-Jan-2012. On 09-Jan-2012, the patient inadvertently received expired FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was received on 26-Mar-2012 and incorporated into the narrative: Expired dose of FLUMIST was not administered to this patient.
Had temp 102.4 evening following vaccine - mother took him to after hours pediatric clinic who told her to watch him - saw his regular MD on Wednesday - only had small at that time on arm.  Mother states told doctor about visit to after hours ped clinic but he did not really address that issue.  Child started according to mom a high pitched scream day after receiving shots and has been having it off and on since.  She states he starts screaming when he awakens from sleep.  She states he stops when you pick him up and rock him.  She states he started having a rash 12-11-08 - red bumps on his face, chest, stomach, and on back.  She states in A.M. rash is really bad but then goes to just being red areas later on in the day.  Informed mom to make an appt with her pediatrician for evaluation.  She voiced understanding of instructions.  Called mom back today at 2:45 PM.  She states child is doing better, redness in face gone - but still has bumps on both arms and his stomach.  States will schedule appt with pediatrician.
TOOK VIVOTIF ON DAY 1, 3, 5, AND 6; This spontaneous case report was received from a pharmacist (PVX2019-612) on 11-Mar-2019. It described a 68-year-old elderly male consumer who "took Vivotif on day 1, 3, 5, and 6". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took Vivotif doses in an inappropriate way. The doses were taken on day 1, 3, 5, and 6.  The action taken with Vivotif with respect to the event "took Vivotif on day 1, 3, 5, and 6" was not applicable.  The clinical outcome of the event "took Vivotif on day 1, 3, 5, and 6" was unknown.  Company's Comment: The causality of the event "took Vivotif on day 1, 3, 5, and 6" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif on day 1, 3, 5, and 6" was considered as not applicable.
COUGH, SORE THROAT, FEVER, FATIGUE FOR 2 DAYS
p/vax pt devel chickenpox that started w/6 vesicles on abd;pt had 20-40 vesicles on back & buttocks;
pt recvd vax & had stiffness & swelling in LA from deltoid area to elbow; pt feb w/ t 102;
Immediate muscle soreness mid-back within 15 minutes of the vaccination, lasting over 12 hours.  Muscle weakness was noted for 4 hours within 5 hours of the vaccination.
COVID vaccine was not diluted. Pt received full strength dose of vaccine. pt did not exhibit any s/s. No treatment required.
Symptoms began 9-13-06 am, soreness, redness, swelling- noticed redness 9-13-06 pm.  No treatment prior to today's visit.
Initially there was swelling, redness, itching and a hive at the site. Ice was applied and took 50mg Benadryl. The hive disappeared however the redness, swelling and temperature at the site increased. The next day the swelling was about 10cm diameter with heat to touch and pain radiating into shoulder joint and neck area.
Hearing loss both ears.   They tried antibiotics then 10 days steroids, nasal sprays.   Seen by Eye and Ear, Dr. In April 2023.  She pull in ear tubes through the eardrum Both ears in May 2023.   Follow up in November 2023.   Hearing returned with the tubes in place.   Buzzing in both ears still present.
Child started walking on tiptoes for a few minutes, then started crying in pain and showed stiff legs. Refused to have legs touched. Cried "boo boo" for a half hour or more. Relaxed after being rocked and held. Could not stand. I called the Dr's after hours service and said that my  child had received 6 (!!!!) vaccines that day (they said he needed to catch up because he missed appointments when our insurance changed and we had to change dr's) and her response to that was "oh g-d!". She suggested liquid ibuprofen 1.5 teasp and liquid Tylenol alternating every 3 hours and we were able to administer about half teasp at 9:45pm. Child finally fell asleep. Woke up 2 hours later crying. I took the opportunity to administer another half teasp of ibuprof. Presently, child's legs are stiff when I try to bend them in his sleep. Ankles and knees showing resistence. If child was up and he tried to walk, he would not be able to. He can not roll over in bed.
Crepitations; Shingles; Foot callus; Ear pain; Neck pain; Neck injury; Pain; Muscle injury; Foot pain; Localized muscle pain; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of CREPITATIONS (Crepitations), HERPES ZOSTER (Shingles), HYPERKERATOSIS (Foot callus), EAR PAIN (Ear pain) and NECK PAIN (Neck pain) in an 84-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate free. On an unknown date, the patient experienced CREPITATIONS (Crepitations), HERPES ZOSTER (Shingles), HYPERKERATOSIS (Foot callus), EAR PAIN (Ear pain), NECK PAIN (Neck pain), NECK INJURY (Neck injury), PAIN (Pain), MUSCLE INJURY (Muscle injury), PAIN IN EXTREMITY (Foot pain), MYALGIA (Localized muscle pain) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, CREPITATIONS (Crepitations), HERPES ZOSTER (Shingles), HYPERKERATOSIS (Foot callus), EAR PAIN (Ear pain), NECK PAIN (Neck pain), NECK INJURY (Neck injury), PAIN (Pain), MUSCLE INJURY (Muscle injury), PAIN IN EXTREMITY (Foot pain), MYALGIA (Localized muscle pain) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On unknown date, the patient experienced shoulder muscle pain/hurt shoulder muscle while pulling herself up/left side popped, foot pain, shingles, callus on the bottom left foot, covid-19 vaccinations caused soreness at the injection sites, ear pain from waiting hearing aids, pain/hurt neck while pulling herself up and therapy made patient sore. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 6/27/2022, 12/14/2022, 2/2/2023,  /3/2023 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This patient had bad swelling of her cheeks and lips. She received a shot on 01/05/01 at 12 noon. On 01/06/01 in the AM Benadryl every 6 hors 01/06/01 - 01/07/01.
As documented by Dr. the supervising provider present, the patient had a total of 4 episodes over 50 minutes; these episodes consisted of palpitations, being "shakey", and "feeling weird".   She stated she has a hx of anxiety.  Pt declined ER visit; left with friend.  Before departure, she was provided with precautions.  Patient stated she would follow up with her PCP.
Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine, Loratadine and Diphenhydramine allergy) and HIV infection. Concomitant products included AMLODIPINE BESILATE (NORVASC), COBICISTAT, DARUNAVIR ETHANOLATE, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (SYMTUZA), SERTRALINE HYDROCHLORIDE (ZOLOFT) and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). On 07-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that the patient had a clinical history of HIV, and was under treatment for this illness.   No treatment drug details was reported.  Reporter stated that the vials had been moved to the fridge on 28-DEC-2021 and did not undergo temperature excursions..   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow up received on 08-FEB-2022 contains significant information: Added patient demographics, patient medical history, suspect drug information, concomitant medications added.
Lethargic  Weak Nauseated  Malaise  Stomach ache Bruised arm Tired
approx 3mos p/vax pt exp a case of breakthrough chickenpox w/less than 50 lesions. no further info avail
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 02Dec2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1. single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Stem cell recepient ALL leukemia" (unspecified if ongoing), notes: Stem cell recepient ALL leukemia; "Allogenic Transplant patient 2014", start date: 2014 (unspecified if ongoing), notes: Allogenic Transplant patient 2014; "Butter" (unspecified if ongoing); "dairy" (unspecified if ongoing); "soy oil" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Coediene, reaction(s): "allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID-19, which is considered as ineffectiveness of the vaccine BNT162B2, and the administration of BNT162B2, as the efficacy of a vaccine varies individually and may be affected by different factors including drug potency.
Pulmonary Embolism resulted in emergency care and 4 days in hospital with blood thinners and eventually sent home with having to give self infections and oral blood thinners. All blood tests do not show that it came from a DVT or or that it was inherited therefore, can not show where the clot came from. It is unknown or considered "Unprovoked" due to unknown cause. This causes a concern for an adverse reaction from the vaccine
Pt received vaccine on 9/24/16 and developed persistent soreness in deltoid area of arm, especially when lifting arm. Her arm is still sore at time of reporting 19 days after administration.
This spontaneous consumer report (initial receipt- 30-Jun-2014) concerns a 57-year-old female patient. The patient had a medical history of anxiety and penicillin allergy. She received gabapentin (300 mg three times daily) concomitantly. On 07-Nov-2013, the patient received influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date in Nov-2013, after vaccination, the patient experienced hives, cataracts and was diagnosed with neuropathy. The patient underwent neuropathy and lupus tests. The outcome was reported as not recovered.
SYMPTOMS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210666990.
Information has been received from a physician concerning a 60 year old female who was vaccinated with a dose of Zostavax. The patient experienced very mild local rash around the injection site. No further information is available.
48 hours - high fever 102F for 2 days; 48 hours ore - swollen lymph node in neck; 24 hours more - shooting pain starting in neck, going over head to front of scalp. Given antiviral for shingles. MD changed mind and said it wasn't shingles. - 74 hours more and arm cannot be raised (vaccine arm).
Runny nose; feeling unwell; muscle & joint aches; muscle & joint aches; chills; tired; stomach cramps; acid reflux; vomiting; This is a spontaneous report from a contactable consumer, reporting for herself.  A 66-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK9231, via an unspecified route of administration on 20Jan2021 at 09:15 (at the age of 66 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included obese from an unspecified date, and cancer in 1998 & 2015. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included letrozole, vitamin (unspecified), Omega, 'TransResve', calcium, 'eld'. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 12:00PM, the patient experienced runny nose, feeling unwell, muscle & joint aches, chills, tired, stomach cramps, acid reflux, and vomiting. The patient did not receive treatment for the events. The clinical outcome of runny nose, feeling unwell, muscle & joint aches, chills, tired, stomach cramps, acid reflux, and vomiting was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Enlarged lymph nodes on left side of neck. Pain in left side of face and neck, two weeks post vax.
Chief complaint was SOB, Patient was diagnosed COVID positive on 9/19/21.  He has been having a cough, but tonight developed chest pain. Hurts to cough and take a deep breath. No past history of CAD or lung disease.  He stated that his pulse ox at home was 92%.  At bedside it is 96%. Patient had monoclonal antibody infusion.Stable, discharged with instructions. Has pulse ox device at home, advised to return to ER if oxygen saturation drops below 90%, or difficulty breathing.
The day after the vaccine I felt very weak and fatigued on April 7th. A couple days later on April 9th I developed a fever. A few days after that my muscles started twitching and haven't stopped. I feel like something is crawling under my skin and the vaccine is extremely affecting my nervous system. I did not have this problem before I had the vaccine. It has not gone away and it is now April 23rd I still feel weak, not the same as I used to feel before having the vaccine, and my muscles are twitching all over my body. My face is twitching and my eye and there is nothing I can do to make it stop. I am so young and I thought the vaccine was safe but I am suffering from it. Especially in my feet I feel like they are tingling and vibrating and my calves are convulsing too. Meanwhile, my heart is fluttering and I feel like it is very hard for me to focus and I feel things crawling under my skin in my brain.  The muscle convulsions are happening everywhere.
Mom found child approx 3.5 hrs p/vax, groaning in crib but not really breathing; Face blue & holding arms rather stiffly - mom encouraged to take breath but wouldn't; took out in cold air & started breathing. Occurred over 60 sec. Pale
This spontaneous report as received from a female consumer of unknown age referring to herself. Pertinent medical history, drug reactions or allergies were unspecified. The patient reported having had shingles. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. On an unknown date the patient experienced mild recurrence of shingles and post herpetic neuralgia (reported as PHN). The patient also reported that she had temporary relief after the vaccination with ZOSTAVAX. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected because no reporter details were provided.
On 03/19/2021 She felt dizzy and went to sit down. She ended up passing out and fainting. Now her platelets have dropped 120 points.
Lt arm swollen and purple an hour after the vaccine. BENADRYL 25-50 mg q6 hr PRN.