chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 14-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 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. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
I developed vertigo and it is bad when I lie down.  The room is spinning   It started the night after the vaccine and it has not gone away.  I feel the motion sensation all day.  It feels like I am drunk all the time.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (soreness of left arm), back pain (extending to neck, shoulder blade and shoulder), chills and vaccination site erythema (red circle around shot site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 10, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 10, 2021, patient experienced pain in extremity (soreness of left arm) and chills. On Apr 18, 2021, patient experienced back pain (extending to neck, shoulder blade and shoulder). On Apr 19, 2021, patient experienced vaccination site erythema (red circle around shot site). At the time of the report, pain in extremity (soreness of left arm), back pain (extending to neck, shoulder blade and shoulder), chills and vaccination site erythema (red circle around shot site) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. The patient did not take any treatment to treat the events. The concomitant medications included epilepsy medications. Reporter did not allow further contact.
2 days p/vax a goose egg came up on rt arm it's red, hot & tender to touch;advised to see PMD;
Mild pain at reaction site and mild fever.  Moderate nausea, headache, chills, muscle and body aches
Moderna authorized for age 6 years through 11 years age was given for a 61 year old as a second dose of the primary series.
I woke up one night with a headache with a little bit of dizziness, I don't normally get headaches. It was on on side of my head, I checked my bp and it was high. So I visited the doctor to check on both things and she recommended I take high bp and cholesterol medications and sent me for labs. I also visited a doctor outside of the hospital, and Endocrinologist and they are doing tests.
Low grade temp 20MAR; dad noted enlarged lymph nodes lt groin on 25MAR; seen by MD 26MAR who stated could palpate enlarged nodes rt groin & neck;
I was having a runny nose and congestion. That led to more congestion and some fatigue, but I am not sure that is not related and more to not sleeping will from being ill.  I took three different COVID-19 Home Test's, and they were all negative. I also went into the pharmacy, and they tested me as well and it was negative as long as for influenza those were all negative as well. I did a telehealth anointment with my doctor, and they have me on OTC meds and using a Netti Pot as well.
LT knee pain, Pain in kidney area, Hoarse, dry throat, General malaise. F/Up 5/23/18 Pt reports symptoms are abating. To contact MD.
ongoing bodyache, pain and stiffness involving multiple large joints, fever, chills, fatigue labs noted elevated ESR, CRP, new onset of normocytic anemia. Evaluated by rheumatologist.  Currently taking prednisone for presumed polymyalgia rheumatica which is almost impossible for anyone who is young than 50 y/o.
Patient was given a COVID-19 vaccine not authorized for their age group. Patient was monitored for 15 minutes after the injection and no side effects were observed at that time. To this date, patient and/or guardian have not reported any side effects or symptoms since being vaccinated. Patient has since completed the vaccination series as recommended by the CDC which can be found on the COVID-19 Administration Errors and Deviations document. A discussion has occurred about how the error took place and strategies have been implemented to ensure that the error does not happen again.
Patient called reporting she has pain, swelling, and pressure on right side of body day after flu shot. She described the pain as minor-moderate where she has trouble doing some of her usual jog. Told the patient to monitor symptoms in case of improvement and to seek medical attention if it gets worse the next day. Couldn't reach patient for follow-up.
Information has been received from a medical assistant concerning a 13 weeks old female who on 29-OCT-2008 was vaccinated with the first dose of ROTAEQ. The reporter stated that the patient received the first dose later than recommended. No adverse effect was reported. Follow-up information has been received from a helath professional concerning a 15 week old (previously reported as 13 weeks) white female patient who was orally vaccinated at 3:00 pm on 29-OCT-2008 with ROTATEQ (lot 662732/1100X) at 15 weeks. It was reported that the patient was fine without signs and symptoms. No further information is available.
> 102 degrees temp "all weekend:. Decreased appetite. "Pale and clingy". "Jaundiced". "Both eyes were swollen". Mother did not take child to PCP for evaluation.
1st dose of moderna covid vaccine on 19Jan2021 at a hospital. The patient came to the pharmacy yesterday, 11Aug2021 for their second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of moderna covid vaccine on 19Jan2021 at a hospital. The patient came to the pharmacy yesterday, 11Aug2021 for their second dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E121A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included BUDESONIDE for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 19-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of moderna covid vaccine on 19Jan2021 at a hospital. The patient came to the pharmacy yesterday, 11Aug2021 for their second dose). On 11-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of moderna covid vaccine on 19Jan2021 at a hospital. The patient came to the pharmacy yesterday, 11Aug2021 for their second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter.
shingles; Information has been received regarding a case in litigation, concerning a patient of unknow age and gender. The patient's concurrent condtions, mediacal history and concomitant therapy were not reported. In 2012, patient was inoculated with a dose of zoster vaccine live (ZOSTAVAX) (dose, unit, route of administration, lot # and expiration date were not reported), as prescribed and/or dministered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by a physician for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not reported.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 2017 the patient was vaccinated with ROTATEQ lot # M031651, oral for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. Additional information is not expected. Sender's Comments: US-009507513-1706USA004143.
very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS. At the time of the report, ILLNESS had resolved. Not Provided          No concomitant medication provided. No treatment medication provided.  Patient's age reported by the reporter was around late 20s or early 30s   This case was linked to MOD-2021-372525 (Patient Link).
Severe allergic reaction - swollen face, neck, nose, throat.  Had trouble breathing around 1 am. She felt like her nose was stuffy. She developed chills and started gasping for breath. Patient waited until 4 am and contact daughter. Daughter took her to emergency room at 4 am and she was sent home at 8:30am. She was treated for an allergic reaction in the emergency room with IV benadryl, epinephrine, and prednisone.
<24 hr after admin. -vesicular rash and (R) red-unilateral site to vaccine administration
Patient is complaining of pain in her elbow crease since receiving the Shingrix vaccine.  No sign of redness, swelling or infection.  She reported it to the pharmacy 11 days after receiving the vaccine.
About 4 hrs after shot (5PM) my arm ached a little. By 6PM (5 hrs after) my arm was painful especially when I moved it. This continued all night.  But by 9 am (17hrs after shot) a only had (have) a mild ache.  No other side effects.
A non-serious spontaneous case of blurred vision, muscle aches, headache, sore throat, cough, and a runny nose was received from a registered nurse concerning a 15-year-old female. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 12-Oct-2009. On 14-Oct-2009, the patient experienced blurred vision, muscle aches, headache, sore throat, cough, and a runny nose. On 15-Oct-2009, the blurred vision resolved. The muscle aches, head, sore throat, cough, and a runny nose were ongoing at the time of the report.
After receiving his vaccination. pt went up to front to make a purchase and lost consciousness for less than a minute. pt recovered quickly and waited at the pharmacy for 15 minutes with no reactions.
18 yo female previously not vaccinated, needed immuniz. for college, came into office and had Tdap, Hep B, MENACTRA and MMR administered (6/29/11). A few days later developed body aches and a fever at aprox 10d. after immunizations developed a head to toe rash which is itchy. No tongue/lip swelling, no wheezing/anaphylaxis symptoms.
Flu symptoms - fever 99.9, aches in joints and muscles, sensitive skin on back, backache, headache, chills, stomach ache, weakness these symptoms lasted 1 day, 2nd day mainly weakness.
Pt called and reported swelling at right deltoid, nausea, vomiting (x5) and malaise after receiving PNEUMOVAX vaccine at appt today. Vaccine given 8/9/12 at 2:30. Pt reported this happened 3 hrs after.
I threw up last night and nausea and exhaustion have continued all day today. I slept 12 hours last night.
Patient received second dose of Moderna 14 days after first dose. Patient will  need to repeat second dose after 28 days of incorrect dose.
This spontaneous report was received from a healthcare worker also reported as a nurse assistant and refers to an unspecified number of patients of unknown age and gender. Information about patients' medical histories was not provided. On 09-FEB-2015, the patients were vaccinated with VARIVAX (Merck) (dose, frequency, lot number and expiry date were not reported) which was improperly stored. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
high pitched scream x 3 1/2 hrs & fever 103.2; given APAP; mom took pt to ER on 25MAY93;
Patient is a 56 y.o. male patient of MD with a history of Obesity, OSA, Asthma, Vocal cord dysfunction, Hypertension, Hyperlipidemia, Hypothyroidism, Diverticulitis, IBS, Complex regional pain syndrome, Chronic pain, Anxiety, PTSD, presented with left shoulder pain, abdominal pain, and diarrhea.   AKI, nonoliguric Suspect prerenal etiology secondary to diarrhea and poor oral intake due to COVID infection.  Baseline Cr ~1 with known right nephrectomy for unclear reasons Creatinine 1.02 (9/11/2022) -- > 4.93 on admission > 3.5 > 2.41> 1.56. CT ab/pelvis without contrast negative for obstructive uropathy. Improved with IV hydration Held lisinopril and hydrochlorothiazide. At discharge advised to hold lisinopril and HCTZ.  Patient will have BMP on 10/27/2022.  Advised to call PCPs office about restarting lisinopril and hydrochlorothiazide.  Verbalized understanding   Abdominal pain Diarrhea CT abdomen/pelvis without contrast negative for bowel obstruction Resolved, likely due to COVID Tolerating regular diet, DC PPI Continue chronic oxycodone    Covid-19 Virus Infection Date of onset of symptoms: 10/14/22 Symptoms present on admission: diarrhea Date of covid positive test: 10/21/22 Vaccination status: vaccinated, no boosters Imaging: CTAP nonacute Oxygen requirements on admission: none Current oxygen requirements: none (wears nightly when cannot tolerate CPAP) Medical therapy: not indicated Consultants following: none Anticipated special isolation end date: 10/24/22   Obstructive sleep apnea Continue CPAP nightly, add afrin to decrease nasal congestion   Asthma Albuterol PRN   Essential hypertension -Held Lisinopril and hydrochlorothiazide as above secondary to AKI Continue Coreg and nifedipine -See above about resuming lisinopril and hydrochlorothiazide -Advised patient to monitor BP closely as outpatient and contact PCPs office as needed   Hyperlipidemia Continue simvastatin  Hypothyroidism Continue Synthroid   Prediabetes Hemoglobin A1c from 4/24/2022--- 6.5% Advise outpatient follow-up
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received SHINGRIX (batch number G2ZF2, expiry date 22nd March 2021) for prophylaxis. On 8th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site blisters, injection site pain and fever. On an unknown date, the outcome of the injection site erythema, injection site blisters and injection site pain were recovered/resolved and the outcome of the fever was unknown. It was unknown if the reporter considered the injection site erythema, injection site blisters, injection site pain and fever to be related to SHINGRIX. Additional details were provided as follows: The pharmacist stated the redness and blisters at the injection site were 3 inches by 5 inches in size in the shape of a band around the arm. The pain level was seven out of ten on a pain scale. This lasted for four weeks. Did not consent to follow up. The dose of the injection was what the pharmacist stated when the question was asked. The pharmacist did provide the name and address of the patient.
Case number PHHY2011US49509 is an initial spontaneous report received from a nurse on 06 Jun 2011 with a combined follow-up received from the nurse on 05 Jul 2011 and 19 Jul 2011. This report refers to an adolescent female patient. She was given only the MenA lyophilized component of MENVEO (batch number M10049) intramuscularly at a dose of 0.5 ml into the left deltoid on 06 Jun 2011. The lyophilized powder was mixed with a regular sterile diluent instead of MenCYW liquid component of the vaccine. No other adverse reaction was reported. Combined follow-up received from the nurse on 05 Jul 2011 and 19 Jul 2011: Updated information about patient's demographics, site of administration and dose.
DTaP/IPV and VARIVAX given at 14:30 on 2/7/11 as health care maintenance. Patient found unresponsive with vomit in bed around 6 am on 2/8/11. Pronounced deceased on arrival to the ED on 2/8/11. Presumed cause of death is status epilepticus in this patient with known and worsening epilepsy. Medical Examiner involved, and no autopsy performed.
A few days after receiving the second Pfizer vaccine, I was driving and my heart began pounding rapidly. I experienced extreme tiredness, loss of vision and headache. I had to pull over on the side of the road and call my husband to come get me. When he arrived, he took me to the emergency room. Since this experience, I have continued headaches. I would like someone to understand that this experience has left me in an unhealthy state and I would like someone to take this seriously and help me with this.
Vaccine administered was outside of approved storage and handling  instructions...Pfizer manufacturer recommended revaccination because it does not have data to support vaccine stability.
pt recvd vax & exp bruise & dent; some discoloration & sl induration on the rt arm; pt denied pain or discomfort; full ROM; poss pt allergic to vax;
Patient did not receive second dose of the Moderna COVID-19 vaccine (first dose 19FEB2021).; This spontaneous case was reported by a pharmacist and describes the occurrence of INCOMPLETE COURSE OF VACCINATION (Patient did not receive second dose of the Moderna COVID-19 vaccine (first dose 19FEB2021).) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Patient did not receive second dose of the Moderna COVID-19 vaccine (first dose 19FEB2021).). At the time of the report, INCOMPLETE COURSE OF VACCINATION (Patient did not receive second dose of the Moderna COVID-19 vaccine (first dose 19FEB2021).) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
COVID-19 Vaccine, First dose of 2   Normal symptoms: fever, fatigue, malaise, sore arm  Adverse event: Chest tightness, difficulty breathing (approximately ~30 hours beginning on Sunday the 11th the morning of Tuesday the 13th, elevated heart rate. Similar feeling to pericarditis - positions such as leaning forward and lying down on stomach relieved some difficulty breathing.
Macular, maculopapular rash all over.  Started on face and went down intermittently.  Started 24 hours after flu shot.  Also flushing of face noted along with it.
Patient has exhibited small bumps, pimple like in appearance, on shoulders and collar bone area.  She states that there is itching with the rash and that diphenhydramine does not calm the itching.  She did experience a previous rash with the first dose of the vaccine which was given 09/02/2021, but to a lesser degree.  She has not experienced any swelling of the mouth or tongue, and no difficulty in breathing with first or second vaccine.  She stated the rash/bumps/itching lasted about 7-10 days with the first vaccine on 09/02/2021, and was expecting for the rash to last about the same length of time for the second vaccination.
Cellulitis at injection site 24 hours after vaccination (left leg). Treated with Keflex oral antibiotic and cool compresses. Cellulitis improved 24 hours after initial antibiotic dose.
9/14/21 SEEN AT URGENT CARE. COVID TESTED.  REFERRED TO MEDICAL CENTER ER:  PATIENT PRESENTED WITH DIFFICULTY BREATHING AND COUGH. ONSET 10 DAYS PRIOR. ALSO NOTED WITH FEVER, CHILLS, NAUSEA. PATIENT REPORTS SHE IS A PULMONARY MD. REPORTS SHORTNESS OF BREATH X 4 DAYS.  HS BILAT PNEUMONIA BUT NO EFFUSION. HER EKG  SHOWS ST ELEVATION IN MULTIPLE LEADS.  TROPONIN IS NEGATIVE.  ADMITTED TO HOSPITAL. HYPOXIA WITH O2 SATS = 83% ON ROOM AIR IMPROVED TO 99% ON 2 LO2. DECLINED REMDESIVIR AT THIS TIME, STARTED ON DEXAMETHASONE, ROCEPHIN AND IV FLUIDS. .  9/16/21 DISHCARGED FROM HOSPITAL TO HOME. DISCHARGE DIAGNOSIS: PNEUMONIA DUE TO COVID 19, ACUTE PARICARDITIS.
pt recvd vax 8NOV95 & stated was fine afterwards for about 36hrs;then began having diarrhea on the 9th;11NOV & 12NOV was nauseated & vomitted several times;also had cough, h/a, shest ached & lower back pain;has an elevated temp;chills w/fer
This patient was mistakenly given Dtap (pediatric) instead of Tdap (Adacel). No symptoms were identified at time. Given approx. 4:45 pm 3/27/07.
Seen in ER on 5/17/00 with increasing swelling at injection site. Seen in MD office on 5/18/00 wih swelling about 8cm X 18cm, no fever.
This spontaneous report as received from a medical assistant refers to unspecified number of patients. No medical history, concurrent conditions, concomitant medications and drug allergies or reactions were reported. On unknown dates, between 03-MAR-2015 and 20-MAR-2015, the unspecified patients were vaccinated with improperly stored GARDASIL, dose 0.5 ml, intramuscular, (lot#, expiration date and administration site were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Visit ED with c/o chest discomfort, nausea, shortness of breath and diaphoresis lasting 2-3 hours.  Temp 100.8, P-71, RR 16 and BP 130/68, SaO2 99%. EKG showed acute anterior T-wave flattening. 10/10 Temp 98, P 64, BP 115/71, SaO2 93% on room air. Due to EKG changes, treadmill nuclear stress test performed.  Within 3 minutes of walking, developed sx of chest tightness, 6/110 with dizziness and SOB.  After 5th minute chest discomfort returned, tightness 6-7/10 with SOB, lightheadedness and marked ST depression on lead V3-V6 with up to 6 mm depression noted on V4 and V5.  Stress test stopped at 6 minutes. Nuclear scan revealed left ventricular size and wall motion WNL.  Coronoary angiography performed which was normal.  Provider determined sx due to "reaction to flu vaccine".
Swelling, pain, redness that resembles cellulitis measuring 11cm x 23 cm.
pt recv 1st dose of vax on 15sep98 & approx 15 minutes later the pt devel a ``quarter sz reddened, raised area'' at inject site. pt sought medical attention & cold compresses were applied, given benadryl. pt recovered same day