chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccinated with expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-JUN-2022 Reporter's Comments: The medical assistant reported that a dose of Havrix was given to the patient and it was already expired. HCP (health care professional) requested to remain anonymous.  The reporter only provided lot# and expiration date for Havrix.  The reporter consented to follow up by fax. Additional Supportive Information: The use of Havrix dose which was already expired on 22nd May 2022, which led to expired vaccine used.
I usually have mild arthritis symptoms when the weather changes including sometimes knee, hip and lower back pain especially at night, however on November 1st, I developed severe joint and muscle aches throughout my body that continued for two and 1/2 weeks with gradual improvement.  I alternately took Advil and Extra Strength Tylenol to deal with the pain (my physicians prefer that I do NOT take Advil because of my transplant so I withheld it as much as possible).  The pain exceptionally intense for my shoulders and thighs which I don't remember having before.  I had no fever but felt "feverish" - my temp was always around 98.5 or so.  I always felt cold and a hot bath always relieved the symptoms momentarily.  I also had a Sinus Infection during this period and was put on Doxyclycline on 11/17 for it.  I took 2 home Covid tests on Wednesday - both negative.  I am feeling better now but not 100% yet.
Urticaria noted at 11:05. 25mg Benadryl PO given. 11:20 patient reported decreased itching and redness . Patient left facility recovered per Nurse.
Office would draw up all COVID booster vaccines at the beginning of the day and discard vial. They kept a sticky note with bivalent  NDC, lot and expiration date and used that data to enter into the record. At some point the realized that on some days they had pulled and administered monovalent instead of the bivalent booster as intended. Office is unable to say with certainty who received monovalent or bivalent.
Patient by mistake was given 3rd dose of COVID 19 SHOT, though at this moment after checking with long-term facility patient was not having any adverse effects
Shortness of breath, hives, nausea, vomiting, swelling of injection site, fever, chills, fatigue.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 08-NOV-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (dose, frequency and route of administration were not reported) lot # M036544 and expiration date: 15-AUG-2018. The vaccine was reconstituted with an improperly stored sterile diluent (manufacturer unknown) (lot # M023895 and expiration date: 18-JAN-2019). No adverse effects were reported. On 08-NOV-2017, the M-M-R II and sterile diluent (manufacturer unknown) were stored in between 47 Fahrenheit degrees to 77 Fahrenheit degrees for 45 minutes. There was no previous temperature excursions. The digital data logger was involved in recording the temperature excursion. This is one of five reports received from the same reporter. Sender's Comments: US-009507513-1711USA006684: US-009507513-1711USA006683: US-009507513-1711USA006682: US-009507513-1711USA006685.
Vaccine sprayed in Nurse's eye; Vaccine sprayed in Nurse's eye; Vaccine sprayed in Nurse's eye; This spontaneous report was received from a medical assistant regarding a female nurse of unknown age. Information on pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On 23-AUG-2019, the nurse vaccinated a patient with varicella virus vaccine live (Oka/Merck) (VARIVAX), lot# R035223 with expiry date of 04-DEC-2020 for prophylaxis. During vaccination a minute amount of reconstituted vaccine sprayed in her eye (Accidental exposure to product, Occupational exposure to product and Exposure via eye contact). The nurse flushed her eye. The nurse sought medical attention by consulting a MD in office. Medical assistant reported that the patient had received full dose. No product quality complaint (PQC) was identified.
Mild fever, chills, body aches, joint pain, nausea, headache.
Swollen lymph nodes:1) Axillary (mild/moderate) 2)Supraclavicular (severe); This is a spontaneous report from a contactable other health care professional (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200), via an unspecified route of administration, administered in arm left on 24Feb2021 at 16:45 as 1st dose, single dose for COVID-19 immunization. The patient's medical history included thoracic outlet syndrome and Lyme disease. The patient's concomitant medications were not reported. The patient did not had COVID-19 prior to vaccination. The patient did not test for COVID post vaccination. On 01Mar2021, the patient experienced swollen lymph nodes: axillary (mild/moderate) and supraclavicular (severe). No treatment was received with regards to the events. The outcome for the event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This spontaneous report received from a patient concerned a 53 year old female. Initial information was processed along with additional information received on 10-FEB-2022. The patient's height and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, 1 total, administered on 01-MAY-2021 for prophylactic vaccination and also received additional dose of Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered (dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On an unspecified date in DEC-2021, the patient experienced COVID-19 and was hospitalized for six days due to being sick with COVID, low oxygen levels (oxygen saturation low), double pneumonia (bilateral pneumonia, coded as Covid-19 pneumonia), difficulty in walking and breathing and was prescribed steroids. On an unspecified date, the patient experienced asthma, ongoing heart condition (heart disorder) and tachycardia. The date of hospitalization was not reported. The patient had occasional pain, muscle aches, headaches and tiredness and was prescribed amitriptyline (dose number in series 1). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn. The patient was recovering from Covid-19 pneumonia, had not recovered from asthma, heart disorder, and tachycardia, and the outcome of difficulty in walking, inappropriate schedule of vaccine administered and off label use was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000217009. This case, involving the same patient is linked to 20220225398 and 20220235226. Sender's Comments: V0:20220222411-COVID-19 VACCINE AD26.COV2.S- Covid-19 pneumonia, difficulty in walking, asthma, heart disorder, tachycardia. 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). Therefore, this event(s) is considered unassessable.
shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The healthcare professional did not have the date of vaccination or the vaccine lot number and expiry date. The patient received the 1st dose of Shingrix and developed shingles a few days later. The vaccine was not administered with this healthcare professional. The reporter consent to follow up.
Fever, shaking, extreme pain in joints and large muscle groups, extreme fatigue, unable to stand alone, unable to complete adls alone, unable to feed self.
Later that day of the vaccine I woke up about 11pm with a fever, all joints hurting, my eyes were hurting and flu like symptoms which continued throughout the night.  I was extremely thirsty which caused me to consume over 60 ounces of water overnight.  Woke up about 7am and went to prepare coffee and blacked out.  When I woke up I was on the floor and had a bursted nose and EMT was called.  I was transported to the ER where I was administered IV fluids, EKG and CBC were done but clear and I was diagnosed as severly dehydrated.  I was released about 5hrs later but the consistant feeling of constant thirst has remained even still today.  I have also had a lingering headache also.
I had a headache just after my shot. Two hours later my lips turn red and swell up. Also, my face was burning. Then the next day ever since I felt lightheaded, nauseous, weak, and tired since 2/24. Lips are fine.
(L) deltoid. Red area with edema 3" x 2 1/2". Warm to touch. Raised area the diameter of red area. Pain, 1/1-10. When pressure applied.
w/in 15-20 minutes of inject, pt devel a metal taste in mouth, nausea, sl dizziness & some gastric upset; seen in ER & sent home; sx resolved over the remainder of the day & was able to report to work next day;
A nurse reported that a 4 year old female received a first dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on 9/27/02. Medical history included congenital cytomegalovirus and cochlear implants in 11/00. On 10/4/02, the child developed hives. The child has recovered.
chills; terrible aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 2023, outcome "unknown"; PAIN (non-serious) with onset 2023, outcome "unknown", described as "terrible aches and pains".  Additional information: Reporter stated that she never took her temperature but had chills, but she had terrible aches and pains, but they all vanished. Reporter mentioned "Two other people that had very similar side effects just like herself". Reporter stated that two friends of her reported the same thing and they never had the same response like this before.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX, (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning his daughter, an approximately 19 year old female patient who on 31-MAY-2007 was vaccinated with the first dose of GARDASIL in deltoid. The patient received the second dose on 20-MAR-2008, the third dose on 23-MAY-2008 and the fourth dose on 14-OCT-2008. The patient experienced pain and redness at injection site post vaccination. The patient sought unspecified medical attention. At the time of report, the patient had recovered. This is one of several reports received from the same source. Additional information has been requested.
The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 25-MAR-2021, the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis. The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:
Informed Consent for immunization with inactivated vaccine from originally filled out for Insurance card provided was a copy of the primary card holders. Patient added into the pharmacy system as a  new patient after confirming this was there first time to the pharmacy.  Vaccine provided to the patient. When attempting to resolve the insurance rejecting we called the insurance company and found that the date of birth and name would need to be confirmed and verified by the parents because there was not a matching dependent on the plan. When we called to update the family the parents updated the provided name and DOB to. Patient just bellow the age to receive the vaccine.
Severe chest pain 3 weeks, 1 day after 2nd COVID-19 vaccine. 911 called and patient needed Fentanyl, morphine and Toradol for pain. ECG w ST segment elevation in inferolateral leads and troponin-I 12,726 ng/L (normal < 45 ng/L). Patient admitted to cardiac telemetry floor. Ibuprofen given and troponin-I trended down to 3,600 upon D/C 7/4/21 repeat troponin-I sent today 7/21/21.
12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.
Pt felt faint, sat in chair & apparently fainted; BP 86/50; Sat w/head down; Seen by MD 30min later BP 90/50;  Talking & taking H20;
Severe pain in upper-right arm.  Sought medical help and was given several rounds of oral steroids. Severe pain lasted several months and then led to muscle atrophy.  Began physical therapy to regain use of right arm.
Pain in the muscle from just above the elbow to the back of the shoulder. Redness and swelling increased over time. Visited an ER on 9/12/21 for redness, swelling, pain, and hot to the touch. Diagnosed with cellulitis and treated with antibiotics.
This spontaneous report was received from a patient's sister and refers to a 12-year-old non-pregnant female patient. There was no concurrent conditions, medical history and concomitant medications were not reported. On unspecified date in 2012 (reported as ''at the age of 12''), the patient was vaccinated with a first dose of GARDASIL to prevent human papillomavirus (HPV) (lot #, expiration date, dose, site and route of administration were not reported). On unspecified dates reported as ''within a couple of weeks after her first dose'', the patient experienced several adverse events; she had gastroparesis, a feeding tube, brain lesions near her pituitary gland, plummeting blood pressure, connective tissue problems, scars as well as continuous "flair ups". Since unspecified date in 2012 (reported as ''at the age of 12''), the patient had a gastric pacemaker implant inserted and as a result could not have children (significant disability or incapacity). In approximately 2014, (reported as ''over the past four and a half years''), the patient had numerous hospitalization at a number of unspecified hospitals due to unspecified reasons. The patient sought medical attention and treatment for adverse event was given. The outcome of the events was reported as not recovered. The causality assessment between the events and GARDASIL was not provided. Upon internal review, the events of gastroparesis and gastrointestinal tube insertion were determined to be medically significant.
Chills and shaking 05/27/2021 Cough, fatigue, pain in legs 05/27/2021-05/30/21 I slept nearly all day 05/31/21- 06/02/21 Difficulty breathing + coughing 06/05/21-06/07/21 Fever, pounding headache, Shortness of breath, pain in arms 06/08/2021 Shortness of breath, pain in abdomen, headache, nose feels like it?s underwater, nauseous 06/09/2021
devel about 40 lesions, afebrile, pleasant lesions scabbed over in 5 days;
About  between 2 and 3 minutes after vaccination patient felt nausea, blurred vision followed by fall. Patient was in standing position at the vaccination table and just finished taking a picture of the vaccination record with the phone. Nausea, blurred vision and loss of consciousness happened quickly in a 3 seconds interval so patient did not get time to react or inform the parent and medical personnel which was sitting within 2 feet. Patient lost consciousness and fall hitting the head on concrete.
No adverse reactions per pt. legal guardian. Event - received duplicate varicella dose on same day.
I arrived at my mother's home to find her unconscious in bed.  She had vomitted, non-responsive.  Once the paramedics arrived and got her in the stretcher, she started convulsing. The paramedics took her to the hospital.  Upon arrival the gave her a covid test and after an hour they discovered that she had a massive brain hemorrhage and she needed to be airlifted to a hospital that had specialists that could treat her. Dr. put in two wire coils to stop the bleeding. After her surgery, she had Bells Palsy, no short-term memory, could not walk or eat and had no sensation that she had to use the bathroom.  She couldn't feed herself and couldn't stay awake.  The fluid from her brain would not drain properly and they had to put in a drain in her head.
I had diarrhea on the 14th. On Saturday fever body aches migraine cough stuffy nose, running nose. I tested positive for COVID-19 on the 16th. On Monday I went to the doctor and gave me PAXLOVID. Then I lost sense of smell and taste on Wednesday for about 10 days. I started to test negative on 25th but I still had a cough and fatigue for 4-5 weeks. I still get shortness of breath and I had to use my inhaler again. I haven't had to use my inhaler for almost 2 years until I got COVID-19.
Expired vaccine received; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Sep-2021 at 12:52 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that on 24-Sep-2021, patient received the Moderna vaccine which expired on 22-Sep-2021. The patient did not have any adverse events and did not require any medical attention. No problems were reported from the patient.  No concomitant medication was reported. No treatment information was reported.
Patient passed out around 5 minutes after receiving the second dose of the Moderna vaccine. He hit his head hard on the ground and felt dizzy and lightheaded for about 15 minutes after the fall.