chrisvoncsefalvay/vaers-outcomes huggingface dataset:
seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Seizure since an unknown date. Concomitant products included TOPIRAMATE (TOPAMAX) for Seizure.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      No treatment medication information was provided.
This case was reported by a physician and described the occurrence of unconscious in a 12-year-old female subject who was vaccinated with Havrix, Gardasil for prophylaxis. The subject was reported to be "otherwise healthy". The subject experienced on adverse events following previous vaccinations. There were no concurrent medications. On 13 April 2007 at 11:00, the subject received the 1st dose of Havrix (.5 ml, unknown, left arm). On 13 April 2007 at an unspecified time, the subject received the 1st dose of Gardasil. On 13 April 2007, 2 minutes after vaccination with Havrix and an unspecified time after vaccination with Gardasil, the subject experienced two episodes of dizziness and fainting within five minutes of dosing. The subject was unconscious for a minute or less with each episode. This case was assessed as medically serious by manufacturer. On 13 April 2007, the events were resolved. 06/17/10 Follow-up information was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. It was reported that on 13-Apr-2007 a 12 year old female was vaccinated with the first dose of GARDASIL (lot# 656049/0187U) 0.5 mL, injection. Concomitant therapy included HAVRIX, (Lot # AHAVB148AA). On 13-APR-2007, the patient fainted and had pseudo seizure like symptoms. The patient had dreams about receiving the shot and the physician felt that the reaction was anxiety related. The patient had the following laboratory diagnostic tests performed after the incident: glucose 85, blood pressure 135/75 mm Hg, pulse 85 and one hour later, after the incident the blood pressure was 97/63 mm Hg, pulse 73,  oxygen saturation (pulse oximetry) was 99% and serum glucose was 85. No BENADRYL was given to the patient. Subseqeuntly the patient recovered from the events that same day. Conversion disorder, Nightmare and syncope were considered non-serious. VAERS # 277319. This is a consolidation of two reports concerning the same patient. Additional information has been requested.
Patient brought to EMS room by EMT.  At 1635 patient has c/o itching on back stomach and foot.  Patient denies any allergies to food and medications. No rash, hives, or redness present. Per supervisor, patient has already waited 30 minutes in observation. Patient denies any throat pain or respiratory issues. Patient is stable and has been informed they can leave and should take benadryl when arriving at home. Also was informed of the s/s of anaphylaxis and to report to their PCP about instructions before getting 2nd dose. Patient understands.
Reactivating of herpesvirus; This is a spontaneous report from a contactable pharmacist (patient). This pharmacist reported same events for 2 patients. This is the first of 2 reports. A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249, expiration date unspecified), via an unspecified route of administration on 13Jan2021 17:30 at single dose (left arm) for COVID-19 immunization. The patient had no medical history. The patient was not pregnant and had no known allergies. Concomitant medications included calcium and colecalciferol (VIT D3). On 15Jan2021 05:30, the patient experienced reactivating of herpesvirus. Her colleague had exact reaction as well. The patient had no treatment for the event. The patient had no other vaccine in 4 weeks, no Covid prior vaccination and was not Covid tested post vaccination. Outcome of event was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046529 same report/drug/event, different patient
PT C/O FLUTTERING HEART, HEART BEATING FAST, DRY MOUTH, TINGLING IN CHEEKS. 1140: V/S TAKEN BP:158/100 P: 110 RESP 16 SPO2 99%, ELEVATED BP AND PULSE. 1145: ADMIN OTC BENADRYL x 2 CAP PO. PT TOLERATE WELL. 1148: V/S TAKEN BP:150/96 P: 92 RESP 12 SPO2 99%. 1150: PT STATES THAT HE IS FEELING BETTER. A&Ox4. 1153: V/S TAKEN BP:150/96P: 92RESP 12 SPO2 99%. 1200: V/S TAKEN BP:146/92P: 91RESP 12 SPO2 98%. PT INSTRUCTED NOT TO DRIVE, AND F/U WITH PCM IN REGARDS TO H/O OF TIA WITH TODAYS V/S ELEVATED BP AND PULSE. PT WAS FEELING BETTER AND STABLE.
vomiting; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient) reported for a patient of unspecified age and gender received bnt162b2 (BNT162B2, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced vomiting. The outcome of event was unknown.  Information on the lot/batch number has been requested.
After my booster on 12/22/21, I started having moderate itch on scalp on 1/2/22. Overnight into the morning of 1/3/22, I woke up from a severe itch in the scalp. By the evening my scalp, neck and behind ears were inflamed, hot, burning, swollen and severe itch. After a 5 day tx of prednisone, the symptoms were gone but then I started receiving hives and itchy feet. I still get them to this day. Chronic spontaneous urticaria continues. Benadryl helps lessen the itch and hives.
12/7/2022 Tested positive on a PCR COVID-19 Test.  Televisit with Doctor, who proscribed Paxlovid, and to treat symptomatically.  I had runny nose, sore throat, and Fever peaking at 101.7.  These lasted about 3 days.  By 12/11 I was feeling better.  Sore throat lingered but diminished until being gone 12/13.  I recovered on 12/13.
p/vax pt running  a lo grade temp, was limp, out of it, couldn't sleep but wanted to;taken to MD;mom called illnes a moderate rxn to vax recv that day;MD stated rt leg was warmer than other;
patient had dizziness,nausea, and low blood pressure after injection. took about 5 min.s to occur. pharmacists at clinic monitored blood pressure and breathing. gave pt water and called ems. pt stated he felt like he may pass out. ems monitored pt and took pt to hospital pt call store aprox. 4 hrs letter. pt stated he was released from hospital and was ok. wanted us to know that he was ok
11/11/22 had bad sinus attack which I normally have during hurricanes, so I did not think anything about it because it is common. The next morning, I woke up and had cold symptoms and thought I had a cold. I had sneezing so hard it made my throat hurt, nose running like a faucet, a little bit of coughing, exhaustion, sleeping a lot and a lot of head congestion. I tried to manage the symptoms. On 11/14/22 I lost my sense of taste and smell. I tested positive with a home COVID test. I had a telehealth with my doctor. I had a PCR test that was positive. Later that day I was prescribed PAXLOVID and began taking it that night. I feel like I am better today. I have no way near the congestion, it is mild. I only sneeze and cough every once in a while. I do not feel as exhausted, just dragging a little. I feel a lot more alert.
onset of n,v,d, & poss a fever beginning Friday lasting thru Saturday noc; site of inject moderately sore;
Pt returned to ER 3 days later w/reddened rash on rt upper arm @ site of inject; no fever, no trauma;
Spoke to mom. She is calling to report patient has severe reaction to flu vaccine. Vaccine administered on 12/24 at approx 9:00am. At noon started feeling ill. Mom gave TYLENOL. Approx 4 hrs later patient started shaking, couldn't put words together, didn't know who mom was, increased HR, vomiting. Fever 100.2. Taken to ER and advised likely reaction to flu vaccine. Symptoms of confusion, increased HR and tingling feet continued intermittently for next two days. Currently patient is doing well and back to baseline with exception of mild cold symptoms. He does not remember details of reaction. Activity is good, eating and drinking fluids. Mom and patient are both very anxious about symptoms. Patient will not leave her side for very long. Mom states last year patient vomited after flu vaccine. She is angry that she agreed to vaccine this year.
Presented with recurrent chest pain.  Tropnin neg and EKG non acute.  Echo was done and did not show significant abnormalities.  Chest pain continued so a stress test was done which did not reveal any evidence of ischemia.  She did continue to have some chest pain which improved with ibuprofen and oxycodone.  She was tender on exam and it was felt the pain was most likely muskuloskeletal and possibly related to some component of anxiety.  She will be discharged nd follow up with her PCP and cardiology. Admission within 6 weeks of receiving the COVID vaccine.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Patient received its 30-days Expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received its 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2022 at 9:01 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Mar-2022 at 9:01 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received its 30-days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received its 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  A Series of patients approx. 540 patients received lot number 066H71A past its 30 days expired date. Vaccines went into 2-8 degree Celsius thaw state on or above 24-Dec-2021. This vaccine was administered up until its Mfg Exp date of 04-Apr-2022.  Patient received booster dose on 18 Mar 2022.  Treatment information was not provided.   This case was linked to MOD-2022-542869 (Patient Link).
Spots on right thigh at site of varicella vaccine. Continued to get new lesions, 3/6/06 on face. Spots continued. Vomiting day before onset of rash only occurred for 7 days. Unsteady gait, freg falling for 10 days, from 12 days after shot given.
Information has been received from a Pharm. D. student concerning a 66 year old male patient with hypertension, gout, arthritis and prostate cancer, who on 24-JUN-2008 was vaccinated  with a dose of ZOSTAVAX (Merck) (lot# not provided) 0.65ml subcutaneously.  Concomitant therapy included LABETALOL HCL, MSD, NORVASC, NEXIUM, MONOPRIL, CELEBREX, COLCHICINE injection, ULTRAM and LOMOTIL.  In September 2008, the patient experienced post herpetic neuralgia.  At the time of the report the patient had not recovered.  Additional information has been requested.
Patient called 2 days after receiving the vaccine and stated both the injection site and the other arm had a rash. He had no difficulty breathing. He used Benadryl to help with the rash. Advised him to notify his Dr. about the reaction in case they want to see him or provide another treatment.
Pt thought Shingrix was to be given YEARLY. After telling her we'd see in in 2-6  months for second shot she said she got it previous year x2. Patient not claiming any injury or no adverse reaction. Filling out form due to third dose being given (corporate recommendation)
Starting 04/29/2022, I developed intermittent shock sensations similar to physical therapy STIM from my left ear to my jaw and down into my clavicle. They last from 8 - 30 seconds and they can happen multiple times an hour or be several hours apart. There is no other co-existing symptoms. There are no precipitating actions that cause it.
pain in legs; stomach burn; severe sweating and ringing in her ears; severe sweating and ringing in her ears; swelling on the arm and a rash on the injection site; dizziness; swelling on the arm and a rash on the injection site; nausea; Soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (severe sweating and ringing in her ears), PAIN IN EXTREMITY (Soreness on her arm), PAIN IN EXTREMITY (pain in legs), PERIPHERAL SWELLING (swelling on the arm and a rash on the injection site) and DIZZINESS (dizziness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT), CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), VITAMIN B NOS and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness on her arm). On 01-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling on the arm and a rash on the injection site), DIZZINESS (dizziness), INJECTION SITE RASH (swelling on the arm and a rash on the injection site) and NAUSEA (nausea). On 02-Apr-2021, the patient experienced HYPERHIDROSIS (severe sweating and ringing in her ears). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in legs), DYSPEPSIA (stomach burn) and TINNITUS (severe sweating and ringing in her ears). At the time of the report, HYPERHIDROSIS (severe sweating and ringing in her ears), PAIN IN EXTREMITY (pain in legs), PERIPHERAL SWELLING (swelling on the arm and a rash on the injection site), DYSPEPSIA (stomach burn), TINNITUS (severe sweating and ringing in her ears) and INJECTION SITE RASH (swelling on the arm and a rash on the injection site) outcome was unknown, PAIN IN EXTREMITY (Soreness on her arm) had resolved and DIZZINESS (dizziness) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment medication include Hydrocortisone cream, Claritin, Dramamine and Pepto Bismol.   Reporter did not allow further contact
got very ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MALAISE (non-serious), outcome "unknown", described as "got very ill".  Clinical course: It was reported that the patient took the covid and flu shot together and got very ill.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This client received a Pfizer COVID-19 dose on 2/6/2021. She returned to receive her 2nd dose of Pfizer COVID-19 vaccine and was give Moderna vaccine by mistake. The client is aware and had no adverse reaction while at the vaccination site. She was advised to notify her MD of the vaccine error.
Swelling in left armpit. Hard nodule approximately golf ball sized. Constant dull pain in area.
Chills.                                 Used Tylenol. Lasted  Body aches.                     Approximately 36 hours.  Headache Extreme lethargy Slight nausea
Arm pain immediately after injection, fever (~100 degrees). 3 hours after injection, left shoulder, neck and throat pain ~ 5days after with progression until seen by doctor on 11-2-09. Doctor diagnosed thyroiditis. Prednisone prescribed on 11-4-09.
Pt recieved all 3 vaccines on 03/06/2022. Her daughter came in to fill her Rx on 3/09/2022 and informed us she had rx from getting all 3 vaccines and she was seen by Dr at Hospital.
took both vaccines at once. side effects were minor injection site pain (both sides), then fever, chills, body weakness, aches and pains, nausea, headache, lethargy, disorientation. I have never had side effects from a vaccine before, and the side effects may have come from combining the flu one
Immediately felt flush, recovered. 4 hours later felt chilled, was shaking, and weak. Unable to walk with out assistance, no memory of episode. Experienced syncope, nausea and vomiting. Temp of 100 for a couple days. Continues to feel weak.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 15-JUN-2009, the patient was vaccinated with ZOSTAVAX, (lot # and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-APR-2016, the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-APR-2016 the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed prednisone, BACTROBAN and acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Increased redness, slight swelling to right thigh. Area tender to touch x 4 days. Skin intact. Treatment ice applied to affected area. Ibuprofen prescribed for pain.
Redness and erythema at the injection site and a separate area 3 inches below. Dr. diagnosed localized reaction, not cellulitis. The patient also claimed generalized aches and joint pain.
Site: Swelling at Injection Site-Mild, Systemic: Dizziness/Lightheadedness-Mild, Systemic: Shakiness-Mild.
27APR93 severe back-leg aches-low energy level-low appetite; low grade fever 100-101; APAP given; spasms in arms & legs-crying because of pain w/spasms; 29APR 93 feeling better w/ sl abd pain;
MD has seen an unusually high incidence of reacts following immu w/Td; 1 of 3 w/in 1 wk who exp extreme swelling (size of small grapefruit) of inject site, fever to 103, & nausea;
Administered 7 booster doses of the Moderna COVID-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022 & had been initially refrigerated on 11Mar2022; Administered 7 booster doses of the Moderna COVID-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 7 booster doses of the Moderna COVID-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022) and PRODUCT STORAGE ERROR (Administered 7 booster doses of the Moderna COVID-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022 & had been initially refrigerated on 11Mar2022) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 7 booster doses of the Moderna COVID-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered 7 booster doses of the Moderna COVID-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022 & had been initially refrigerated on 11Mar2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 7 booster doses of the Moderna COVID-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022) and PRODUCT STORAGE ERROR (Administered 7 booster doses of the Moderna COVID-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022 & had been initially refrigerated on 11Mar2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided.  Date the vial was initially stored in the refrigerator on  11-Mar-2022. The vial did not undergo any temperature excursions.
8/10 sharp pain in left shoulder. Persistent for >3 weeks, c/w bursitis
The following early morning hours, right eye was swollen and throat was incredibly itchy. Took Benadryl throughout day and monitored symptoms while at work and contacted my family doctor to notify.  Around 4pm on 3/23/21, the itchy throat sensation had subsided and the right eye was less swollen. By the next day, 3/24/21, my right eye returned to normal.
Regular aches and pains; Nausea; Stomach issues; Diarrhea and stuff like that; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach issues), DIARRHOEA (Diarrhea and stuff like that), MYALGIA (Regular aches and pains) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach issues), DIARRHOEA (Diarrhea and stuff like that) and NAUSEA (Nausea). On an unknown date, the patient experienced MYALGIA (Regular aches and pains). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Stomach issues), DIARRHOEA (Diarrhea and stuff like that), MYALGIA (Regular aches and pains) and NAUSEA (Nausea) had not resolved.            No concomitant medication was mentioned.   This case was linked to MOD-2021-339316, MOD-2021-339288 (Patient Link).