chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse event; dose administered from vial that underwent a temperature excursion; dose administered from vial that underwent a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered from vial that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Sep-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered from vial that underwent a temperature excursion). On 09-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered from vial that underwent a temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered from vial that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (dose administered from vial that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered from vial that underwent a temperature excursion).    No concomitant medications were reported. It was reported that there was an temperature excursion on the 02-Sep-2022 for one hour and there were no remaining doses. The vials were under frozen condition at the time of the excursion and individual vials were in the box of vial size 2.5ml. The maximum temperatures reached was -12.5°C, the vials had not moved from freezer to refrigerator and there was no any vaccine state change found by visual inspection. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654338, US-MODERNATX, INC.-MOD-2022-654336, US-MODERNATX, INC.-MOD-2022-654306 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654338:same reporter US-MODERNATX, INC.-MOD-2022-654336:same reporter US-MODERNATX, INC.-MOD-2022-654306:same reporter
This spontaneous report has been received from a a nurse who was also the patient's mother and refers to a 2 month old female patient. The patient's concurrent conditions included dysphagia diagnosed at birth. The patient had no concomitant medications nor drug reactions or allergies. On an unknown date in 2017 (at 2 months old), the patient was vaccinated with the first dose of ROTATEQ orally (dose, lot # and expiration date were not reported) and on 02-JUN-2017 (at 4 months old), the patient received the second dose of ROTATEQ orally (dose, lot # and expiration date were not reported). The patient began choking on the vaccine when she received it at 2 months old on an unknown date in 2017 and when she received it at 4 months old on 02-JUN-2017. No treatment was given for the adverse events. There were no lab diagnostic studies performed. The patient sought medical attention as the events occurred in physician office. No product quality complaint was involved. The outcome of the events of choking was recovered on unknown date in 2017 and on an unknown date in June 2017. The relatedness between the events and ROTATEQ was not reported. Upon internal review, the events of choking were considered to be medically significant. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 16-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012710 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Pt received Boostrix, Pneumovax, (right arm)  and Shingrix (left arm) yesterday 07/24/2019.  Patient called our pharmacy at approximately 5:20pm today 07/25/2019 expressing concern that her arm is swollen.  Her son got on the phone and explained that her arm is swollen from elbow to shoulder, is slightly pink from outside of arm to inside.  Patient was advised to seek medical care.  In meantime, patient was advised to apply cool compresses eveyr 15 minutes careful not to burn the skin, and to take acetaminophen or nonsteriodal pain reliever.
nausea, lump/swelling under left arm/breast, headache severe, body aches at the slightest touch, painful eyes from 1/15-1/17 w/ headache severe, loss of appetite, nausea lasting from 1/15-present day.
Vasovagal response, no lose of consciousness with dizziness and lightheaded immediately after injection.  Patient brought to observation via wheelchair, placed in supine position with legs elevated, blood pressure assessed within normal range. No additional treatment given.  Declined further medical transport or medical treatment.  Left in stable condition, alert, awake and orientated.
frequent urination during the night once every hour for five hours starting at1:30am thru 5:30am ; frequent urination has stopped
This spontaneous report has been received from a nurse prescriber referring to a 18 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 19-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 by intramuscular route, (strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was reported that on 21-JUL-2017, the patient was given the second dose of GARDASIL 9 (inappropriate schedule of drug administration). No adverse effects were reported.
PATIENT CALLED TODAY 11/5/21 TO SAY THAT SHE HAD A RASH ON HER FACE.  IT STARTED IN THE MORNING OF 11/4/21 BUT SEEMS TO BE WORSE TODAY.  SAID ITS JUST THAT HER FACE IS RED AND BUMPY. NO SWELLING OR TROUBLE BREATHING.  THE ONLY ISSUE SHE HAD WITH EITHER OF THE FRIST TWO DOSES WAS A DELAYED RASH ON HER ARM WITH THE SECOND DOSE.  SHE SAID IT WAS SMALL AND JUST AROUND THE AREA, MUCH LIKE THE KNOWN REACTION CALLED "MODERNA ARM".
pt recv vax; died later on same day; autopsy report and investigation pending; COD: smothering due to obstruction of face by plastic bag;
Newly diagnosed with hyperthyroidism now; Increased heart rate; Period issues irregularity now; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 24Sep2021 14:30 (Lot number: FC3184) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). No covid prior vaccination. No known allergies. There were no concomitant medications. No other vaccine in four weeks, no other medications in two weeks. Vaccination history included: Bnt162b2 (Dose 1, Pfizer, lot number= FC3184, Intramuscular in Right arm, at 01:15 PM), administration date: 30Aug2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: HYPERTHYROIDISM (medically significant) with onset 01Oct2021, outcome "recovering", described as "Newly diagnosed with hyperthyroidism now"; HEART RATE INCREASED (non-serious) with onset 01Oct2021, outcome "recovering", described as "Increased heart rate"; MENSTRUATION IRREGULAR (non-serious) with onset 01Oct2021, outcome "recovering", described as "Period issues irregularity now". The events "newly diagnosed with hyperthyroidism now", "increased heart rate" and "period issues irregularity now" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: heart rate: (01Oct2021) increased; sars-cov-2 test: (08Dec2021) negative. Therapeutic measures were taken as a result of hyperthyroidism, heart rate increased, menstruation irregular.; Sender's Comments: Based on the known drug temporal relationship and Limited information in the case report a casual association between reported event Hyperthyroidism with the suspect product BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
"I don't know if this is related to the vaccine from this morning or not, but I started having a HA around 8:30 am or so. No other symptoms." "I do get HAs, but typically it is behind my left eye. I would rate it a 3-4 at this time and I have not had a chance to take any ibuprofen for it, but I will. It started about 8:30 and has continued and gradually worsened."
pt recv vax;erythematous area on lt leg;painful & pruritic esp when walking;erythematous area w/ small area of blue black discoloration;warm, tender,modular area of 4 cm below puncture site;
vertigo; fatigue; off balance; heaviness in my head; my head feels like it has a fog feeling; nausea feeling; my blood pressure goes up too; pain under my right breast by the rib cage like a stabbing feeling; This is a spontaneous report from a contactable consumer (patient herself). An 88-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date were unknown), via an unspecified route of administration in right arm on 09Feb2021 at 13:30 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller states that the 3rd day, yesterday (13Feb2021), she started getting vertigo, fatigue, off balance, heaviness in my head, my head feels like it has a fog feeling, nausea feeling. The episodes last about 15 min. They started in the front of my forehead/eyes. These episodes come and go, and my blood pressure goes up too on 13Feb2021. Patient get this pain under my right breast by the rib cage like a stabbing feeling on 13Feb2021. It happen 3 times yesterday. Enquired was this normal to have these symptoms after the vaccine. Enquired that patient taking Aspirin for peripheral arterial disease was that okay to take with the vaccine or not. Enquired Pfizer vaccine was not approved or not. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Limping and dragging left leg, started right after vaccine given on 12/29/2000. No swelling noted. Admitted to orthopedics. Informed that dx: fluid in hip ; dx was septic arthritis L hip. On 1/14/2001, arthrotomy and drainage done. Per F/U 3/27/01: treated with cephalexin and ASA.
Information has been received from a Registered Nurse referring to a 7 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 23-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K025004, dose 0.5 (unit not provided)). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received the COVID vaccine for the 6 month-4 yr age group instead of the 5-11 yr age group dose. He had mild soreness of arm muscles, arm pit and low grade temp =100 the day after the vaccine given.
No additional AE information provided; HCP states that ROTATEQ vaccine, that underwent a supported temperature excursion, was administered to a patient on Dec 27, 2022; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-DEC-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), route of administration was defaulted to oral, lot #W010331 was valid, expiration date was 01-NOV-2023, for prophylaxis. The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent a supported temperature excursion. Temperature was 8.9 Celsius degrees and time frame of excursion was 1 hour 49 minutes (product storage error). There was no previous temperature excursion.
pt recvd shot (NOV & 11NOV face became swollen, eye hurt & 14NOV mouth crooked, eye closed & drooping & difficult to eat; & seen @ urgent care; dx bell's palsey; recvd prescription; 22NOV sx resolved;
Notes ongoing cough since COVID-19 in February 2022 but not worsening. continues to test positive for SARS-CoV-2 (active infection versus persistent shedding).  In the past day or so, he has had fluctuation in his respiratory status, with increased oxygen requirement.  Chest CT scan yesterday showed increase right lower lobe consolidation and increasing consolidative and ground-glass opacities in the right mid lung.
No sickness prior. At 6 PM chest congestion. At 9 PM felt like I had the flu. Got up at 3 AM to get med to help, felt very nauseated and flushed. I fainted resulting in a broken ankle needing surgery with plate and 6 screws.
This spontaneous case reported by a consumer, describes the occurrence of in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 039K202A) for COVID-19 immunization. The patient's medical history included hemodialysis since an unknown date. Concurrent medical conditions included diabetes. Concomitant medication included Plavix (clopidogrel bisulfate). On Dec 28, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): intramuscular: unknown. The reporter did not provide any causality assessments. Sender's comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient's medical history of  being on hemodialysis and taking clopidogrel bisulfate remains a confounder for the event of blood thinning.
Pt states she had her flu shot by the county health dept nurse in late January or early February before going on a cruise. She saw her MD 1-2 weeks after the flu shot for a check up and mentioned her bones aching but it was very mild and she was told to take Motrin. Presented to our office on 03/24/05. C/o pain and weakness proximal posterior thighs. Has trouble getting out of chair. Is ok once she starts walking. She feels problem started after she got her flu shot. 04/13/05- Talked to pt per telephone and she states her symptoms are a little bit better. All information given via telephone 04/11/05.
This spontaneous report was received from a physician refers to a 14 year old male patient. No medical history or drug allergies were reported. On 29-JUL-2013, the patient was vaccinated with a dose of GARDASIL (lot # J003727, expiry: 07-NOV-2015), 0.5 ml, intramuscular. No concomitant medications were reported. On 29-JUL-2013, the patient's mother reported to the physician that the patient experienced numbness and tingling of his entire tongue immediately after receiving GARDASIL. The patient's tongue was getting better. However, there was still numbness and tingling on the tip of the patient's tongue. The outcome of numbness and tingling of his entire tongue was reported as recovering. Additional information has been requested.
After about an hour after shot, light headed.  12 hours later, dizziness, rapid heartbeat and pain or ache in isolated spot in upper left thigh.  Discovered 2 days later, a red spotty area on upper left thigh where the ache was.
9/26/23 1933: chills, body aches, headache. Temperature 99.1. PRN Tylenol given at 1940. Temperature recheck at 2215 98.9. 9/27/23 at 1004 resident was found deceased.
A report has been received from a Health Professional concerning a 7 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The reporter stated that the patient experienced half of vaccine dose sprayed on face which started on 10-DEC-2014. The outcome of the event of half of vaccine dose sprayed on face is unknown. The report was considered to be non-serious.
@15 hrs after injection I experienced a fever of 101.4 for a five hours. I experienced discomfort at the injection site greater than any previous injection over the years In the morning after my fever had subsided I noticed lower back pain and some cramping in my hips, buttocks and thighs, the right side a bit more so. I have not had any injury involving my back. The stiffness pain and cramping have continued. I walk almost daily comfortably after ibuprofen and Tylenol, which I take at the max dosage now since the end of April. I did speak with my doctor who prescribed methocarbinol and as per realm. The practice was trying to get me a referral to my neurosurgeon but this has not happened. I only recently started to question things. I feel only as an informed person this may be a mild Guillan  Barre syndrome. The symptoms have not declined or worsened.
5th day p/vax devel frontal/temporal h/a, T103.9, n/v;presented to ER, blood cult,;T103;devel spinal h/a;
I started having elevating heart rate and chest pain. It was ongoing as I was sitting still, sleep, and walking. My heart will rise to 158 beats per minute. I seen a doctor but no medicine was giving. I started taking herbal medication and did not have any more problem.
0600 - Flu vaccine IM. 0630 - Lip swelling, tight throat - admitted to ED for treatment. Symptoms resolved with IV BENADRYL and "one other med". Discharged from ED at 0740.
Immediately upon administering the influenza vaccine, the patient reported having a headache and feeling tingling on the right side of her face. She later reported that it moved down to her arm and she was having difficulty breathing. I asked her to take a few breaths and she was able to take full breaths and her breathing was not debilitated. I took the patient's blood pressure and it was 114/80. I called the patient's physician and spoke with a Midwife Nurse Practitioner that was on duty that recommended Benadryl 50mg if necessary and to follow-up in a few days. I continued to monitor the patient and gave her a cold compress, water, and elevated her feet. The patient remained seated the entire time. Upon further monitoring the symptoms continued and the patient reported they were getting worse. I called 911 and an emergency response team took her to the hospital.
Information has been received from a physician concerning a 5 yr old female who on 15Sep05 was vaccinated IM in the left arm with a second, pediatric dose of hep A virus vaccine inactivated (lot649459/0287R). On 26Sep05 the pt was hospitalized in the ICU and initially diagnosed with Guillain Barre syndrome. The symptoms included ptosis of the left eye, acute cough, respiratory failure, dysphasia, altered mental status, and an inability to control secretions. She was on a ventilator with left lower lobe atelectasis. Treatment included plasma phoresis. A pediatric intesivist overseeing the pt's care reported that the pt did not have Guillain Barre syndrome, but was diagnosed with polyneuropathy. Protein in her CSF fluid was negative. At the time of report, the pt remained hospitalized and was making some recovery, but it was very slow. No product quality complaint was involved.  Additional information has been requested.
First few hours felt warm... started to feel dizzy and sore... by evening had a fever and aching... the next day could barely move... high temperature... very sore all over body. Symptoms had subsided by the third day.
Patient's mom said that the injection site had a knot where the vaccine was administered and the patient was taking ibuprofen for the pain and inflammation
6:30 am 1/13/21: swelling in right axilla, headache, body aches, soreness at injection site 4:pm 1/13/21:  temp 99.8, chills, selling and redness in right axilla extending to right breast, body aches, severe headache 6:30 am 1/14/21: afebrile,  moderate body aches and headache, increased swelling and redness in right axilla extending to right breast Called PCP office.  Told to continue Tylenol and use ice packs
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 9-year-old daughter who developed the flu. At 9 years of age, the patient received a dose on 11-Dec-2003. Medical History: The patient had no relevant medical history. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 11-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: A mother reported that on 13-Dec-2003, 2 days post-immunization, her daughter developed the flu. the child developed "a wicked headache", muscle aches, clear runny nose, sneezing and a fever of 102.5 deg. F. On 14-Dec-2003, her temperature increase to 103.5 deg F. The headache resolved with Tylenol (acetaminophen) and cool packs, but the other symptoms continued. Later on 14-Dec-2003, her fever was 101.7 and the runny nose continued. No additional information was available at the date of this report.