chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician assistant concerning a 7-year-old patient with no pertinent medical history or allergies who on 14-AUG-2007 was vaccinated subcutaneous with a second dose of varicella virus vaccine live (Oka/Merck) (lot # "0856U"). There was no concomitant medication. On an unspecified date the patient developed a varicella-like rash of 50 lesions or less. The patient sought medical attention via an office exam on 12-SEP-2007. No diagnostic labs were performed. On an unspecified date the patient recovered. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
The day after my left arm started have a lot of swelling and joint pain. After 3 weeks my wrist got to the point where I couldn't hold anything. I started getting trigger finger in my left ring finger. A week later it started on my right side with trigger finger. I had to wear a brace on both hands to keep my fingers from bending. I had to have physical therapy a few times. After receiving the second vaccine all the pain was gone until February 9th and all the pain came back and has not stopped. X-Ray.
Injection given 5/14/15. Patient c/o chills, Lt deltoid pain, heat at injection site. Redness spread to Lt shoulder and to brachial area. Started on Azithromycin 250mg. 2 tabs first day, then one daily for 2-5.
HIVES EXTENDING FROM BEHIND EARS TO LEGS. MORE PROMINENT ON ABDOMEN AND CREASE AREAS INCLUDING BOTH GROINS AND BEHIND KNEES.
UNDER 12 Y/O GOT COVID VACCINE  ~20 minutes before closing, a customer brought her daughter in to get a Pfizer Vaccine as a walk-in. Before I asked her to fill out the consent form, I asked both mom and the child how old was she,  they both answered me that she's 12 & DOB as 07/20/2009, so we went ahead to do the vaccine. While they were waiting for 15 minutes after the vaccine, I batched the vaccine, got a rejection from Organization saying "name not matching". I confirmed with mom the information while she's still waiting in the store. She again stated the same thing.   I later called Organization and they told me that Organization has patient's DOB 08/20/2009, not 07/20/2009 as mom wrote in the form and confirmed it. I then called mom to ask for DOB, again, she told me DOB "07/20/2009". I told her about what Organization told me, she then admitted that she said that so her daughter could get the vaccine before the school starts.
No additional AE reported; administered Pneumovax 23 syringe the needle was faulty and medication leaked out; administered Pneumovax 23 syringe the needle was faulty and medication leaked out; administered Pneumovax 23 syringe the needle was faulty and medication leaked out; administered Pneumovax 23 syringe the needle was faulty and medication leaked out; This spontaneous report was received from a pharmacist, concerning a 69-years-old male patient. The patient's concurrent conditions, concomitant medications, historical conditions and drug allergies or reactions were not reported.   On 16-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), lot number S024808 with expiration date reported and validated as 02-JUN-2021 (strength, dose, route of administration, and anatomical site of injection were not reported) as prophylaxis.   It was stated that during the administration the needle was faulty (syringe issue) and some medication leaked out (product leakage/incorrect dose administrated/poor quality device used). Additionally, it was reported that the needle was attached to the syringe tip before leaking occurred and the syringe was disposed by the pharmacist. No additional adverse event reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S024808; expirationdate: 02-JUN-2021; deviceage and unit: 0 ; operatorofdevice: Pharmacist; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
pt recvd vax & exp a fever of 103 which lasted approx 24 hrs & redness @ inject site; there has been outbreaks of viruses in the area;
cheeks and tongue have bothgone numb; cheeks are both red; Within one minute of receiving the injection, left arm went slightly numb from shoulder to fingertips; This is a spontaneous report received from a contactable consumer (patient). A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 23Mar2021 at 10:30 (at the age of 31-years-old) as dose1, single for Covid-19 immunization. The patient's medical history included bipolar disorder and obesity with a body mass index of 47. Concomitant medications included aripiprazole (ARIPIPRAZOLE), lamotrigine (LAMOTRIGINE) and clonazepam (CLONAZEPAM); all were from an unspecified date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient was not tested for Covid-19. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 23Mar2021 at 10:30, within one minute of receiving the injection, the patient's left arm experienced slightly numb from shoulder to fingertips. On the same day, after one hour and fifteen minutes, at 11:45, the cheeks and tongue of the patient gone numb, and cheeks were both red. It was reported that it was a similar feeling to novocain wearing off after a dental procedure. The patient was feeling ok other than the numbness at the time of the report and was reported that the patient never had a reaction to any medications or vaccines prior to this. The events did not result in doctor or other healthcare professional office/clinic visit, and the emergency room/department or urgent care visit. Patient lab test included BMI: 47 on an unspecified date. Therapeutic measure and treatments were not taken in response to the events. The clinical outcome of the events was not resolved at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Blister of one inch on right leg; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blister of one inch on right leg) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02A34A2) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced BLISTER (Blister of one inch on right leg). The patient was treated with Surgery (Blister was Drained) for Blister. At the time of the report, BLISTER (Blister of one inch on right leg) was resolving.            No concomitant medications were provided by the reporter.   Action taken with mRNA-1273 in response to the events was not applicable.
It was on April 6th, my body was very sore, I felt physically exhausted and not quite feverish, but hotter than usual and my arm was sore. The next day I felt fine.
The major issue issue that I have noticed is menstrual cycle was extremely heavy after I took my first vaccine. I took my first vaccine 3/24/21 and my cycle came on 4/3/21 - 4/7/21. Now my menstrual cycle has just started  again on 04/18/21. I have also been off of birth control for over 2 years because my age. I also had some swelling in my arm  where I received my 1st vaccination at during my menstrual cycle.
Per dad suffers from motion sickness and arrived at clinic feeling nauseated from the trip from home. He also reported she was experiencing 'huge anxiety' about the shot. Vomited a few minutes after receiving the vaccine. Reported no longer feeling nauseated afterward. Observed for 30 mins. Drank a juice box. Walked out of clinic with dad.
Patient felt dizzy about 10 minutes after receiving the vaccine. Patient was alert, oriented, and responsive but her skin looked pale in color. Patient was assisted to lay down on the exam table. No fainting or near syncopal episode noted. Vital signs were taken and were stable. Patient was offered a water bottle to drink. Patient laid down on the exam table for a bout 10 minutes and left in a stable condition.
HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210624187.
muscle spasm; noticed a big nodule below the injection arm; severe body ache; chills; on going headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle spasm), SKIN MASS (noticed a big nodule below the injection arm), MYALGIA (severe body ache), CHILLS (chills) and HEADACHE (on going headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced MUSCLE SPASMS (muscle spasm), SKIN MASS (noticed a big nodule below the injection arm), MYALGIA (severe body ache), CHILLS (chills) and HEADACHE (on going headache). At the time of the report, MUSCLE SPASMS (muscle spasm), SKIN MASS (noticed a big nodule below the injection arm), MYALGIA (severe body ache), CHILLS (chills) and HEADACHE (on going headache) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications reported.
Swollen arm at the injection sight. Arm felt hot/warm to touch. After the swelling went down the are became tender and itchy.
HEAVINESS IN HEAD; FELT DISORIENTED; CHILLS; NOT FEELING GOOD; FEVER; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's past medical history included: mild covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: 02-OCT-2021) dose was not reported, administered on 18-AUG-2021 19:00 for prophylactic vaccination. No concomitant medications were reported. On 19-AUG-2021, the patient experienced heaviness in head. On 19-AUG-2021, the patient experienced felt disoriented. On 19-AUG-2021, the patient experienced chills. On 19-AUG-2021, the patient experienced not feeling good. On 19-AUG-2021, the patient experienced fever. On 20-AUG-2021, Laboratory data included: Body temperature (NR: not provided) 100.5 F. Treatment medications included: ibuprofen. On 21-AUG-2021, treatment medications included: paracetamol. On 23-AUG-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 20-AUG-2021, had not recovered from heaviness in head, and felt disoriented, and the outcome of not feeling good was not reported. This report was non-serious.
AREA OF ERYTHEMA ON UPPER LEFT ARM APPROX. 3 CM IN DIAMETER WITH MILD INDURATION. NO PUSTULE.  MOM NOTICED AREA OF REDNESS 9/2/09 IN THE MORNING.  OBSERVATION RECOMMENDED AND PATIENT TO POLLOW UP IF SYMPTOMS PERSIST OR WORSEN.
nasal congestion; temperature of 100.1°F; achiness over sides; headache; she felt really bad; in bed early/sleeping on and off/did not get up till 1; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (she felt really bad), SOMNOLENCE (in bed early/sleeping on and off/did not get up till 1), NASAL CONGESTION (nasal congestion), PYREXIA (temperature of 100.1°F) and MYALGIA (achiness over sides) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 939906, 028L20A and 013L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (three times a day). Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jun-2022, the patient experienced SOMNOLENCE (in bed early/sleeping on and off/did not get up till 1). On 26-Jun-2022, the patient experienced FEELING ABNORMAL (she felt really bad), NASAL CONGESTION (nasal congestion), PYREXIA (temperature of 100.1°F), MYALGIA (achiness over sides) and HEADACHE (headache). On 26-Jun-2022, FEELING ABNORMAL (she felt really bad), SOMNOLENCE (in bed early/sleeping on and off/did not get up till 1), NASAL CONGESTION (nasal congestion), PYREXIA (temperature of 100.1°F), MYALGIA (achiness over sides) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jun-2022, Body temperature: 100.1°f 100.1°F (Oral).         The first two dose did not effect hardly at all.  No treatment medications were reported.   This case was linked to MOD-2021-369076 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2022: Added the concomitant medication.
at approximately the 17  hour mark, began to feel aches that escalated and expanded out from hip area to a general body ache. headache began at the 23 hour mark. both conditions existed through approximately the 36 hour mark.
This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 27-MAR-2015, the patient was vaccinated with an improperly stored dose of VAQTA (Lot No. K001792 Expiration date: 22-OCT-2015) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patients mother states no adverse reaction and has been given flu shots previously with no reactions. Patients Pediatrician was notified through Voicemail.
episcleritis/Left eye became inflamed and red; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW6208) via an unspecified route of administration in the left arm on 10Mar2021 at 12:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and elevated cholesterol levels. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient received the second dose of Shingles vaccine (MANUFACTURER UNKNOWN) in the right arm on 15Jan2021. Concomitant medications included montelukast (MANUFACTURER UNKNOWN) 10 mg, losartan (MANUFACTURER UNKNOWN) 100 mg and simvastatin (MANUFACTURER UNKNOWN) 20 mg, Hepatitis A vaccine (MANUFACTURER UNKNOWN) on 15Feb2021, all for unspecified indications. Since the vaccination, the patient was not tested for COVID-19. On 11Mar2021 at 21:00, the patient's left eye became inflamed and red. On 12Mar2021, the patient visited the ophthalmologist and was diagnosed with episcleritis. The patient was treated with prednisone acetate (MANUFACTURER UNKNOWN) 4 times per day. On an unspecified date in Mar2021, the patient's condition worsened and on 15Mar2021, the doctor had increased the frequency of prednisone acetate to 6 times a day following which the patient's condition had improved. On 17Mar2021, the left eye was slightly inflamed. The clinical outcome of the event episcleritis was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pain at injection site x24 hours with radiation down arm 2-3 days later.  Pain worse at night- awakens her from sleep.  Injection given high in deltoid.
Hospitalized (12.23.21 - 12.30.21); COVID-19 positive (12.22.21); fully vaccinated Admission Date: 12/23/2021 Discharge Date: Dec 30, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19  HOSPITAL COURSE: 74 y.o. female history significant for nonischemic cardiomyopathy, chronic systolic and diastolic heart failure, history of PE on Xarelto, weighs vaccinated for COVID but not received booster presents today with complaints of shortness of breath, cough, fever, generalized weakness and loose stools going on for past 3-4 days.  Vitals were stable apart from hypoxia when presented to the emergency department, requiring 5 L oxygen via nasal cannula.  Significant labs showed creatinine 1.28, AST 46, COVID-19 PCR positive, chest x-ray showing cardiomegaly, increased pulmonary vascular congestion with prominent interstitial opacities.  Received dose of dexamethasone in the emergency department, for further evaluation and management transferred to Hospital and admitted under hospitalist service. Patient treated for COVID with dexamethasone and remdesivir.  This was completed.  Cardilogy saw patient and diuresed her and placed her back on oral diuretics for maintenance as she has progressed to no longer need supplemental O2.  Home dosage Lasix was increased to 40 mg daily. She was dealing with new nausea on 12/28.  She had reported not had a bowel movement in many days and had some abdominal distension.  Her bowel regimen was intensified.  She had an episode of lightheadedness in the bathroom with low BP which then quickly returned to normal once back in bed.  Suspect hypovolemia due to diuresis in the setting of poor PO intake due to nausea.  Gave her 500 mL fluid back and continued PO maintenance diuretics for 12/29.  Patient was able to discharge home on 12/30.
Developed red, pruritic rash at injection site one week after administration.  Lasting several days, denies swelling.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Itching/tingling in facial area. The same happened during first dose.-Mild, Additional Details: Post vaccine, patient experienced itching in facial area/tongue. No difficulty breathing. Diphenhydramine 25 mg x1 given with patient's consent. She was observed for approximately 45 minutes post-vaccine, and was walked to her car after. She feels comfortable to drive home, as she lives 10 minutes away and was feeling better. She was counseled and given instructions for appropriate measures (911) if necessary.
This case was reported by a healthcare professional (nurse) and described the occurrence of double vision in a 33-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 17 October 2012 at 13:00 the subject received 1st dose of ENGERIX B (unknown route, right deltoid). On 17 October 2012, 15 minutes after vaccination with ENGERIX B, the subject experienced double vision, flu-like symptoms (diagnosis unknown) ("flu to the 10th power"), feels like a stomach virus, fever, and chills. The nurse reported that the subject fell "asleep and woke up five hours later, her temperature was better but still shaking and felt nauseous." Relevant test results included elevated body temperature of 103 degrees Fahrenheit. On 18 October 2012, the events were resolved. "The patient went to work the next day [18 October 2012]." Per the nurse, "the second dose in the series was scheduled to be administered"; however, "due to the patient's response" the nurse was debating on continuation of the series. Follow-up information was received on 18 December 2012 via healthcare professional who reported that subject received 20mcg of ENGERIX B intramuscularly on 17 October 2012. The subject was diagnosed with an allergic/adverse reaction. The onset date was 17 October 2012 and resolved on 18 October 2012. The immunization series with ENGERIX B was discontinued until the subject could follow-up with their primary care physician for instructions. The events were not associated with lack of efficacy, erroneous administration or suspect transmission of the infectious agent via medicinal product. Medical history / concurrent illness were not known. The reporting healthcare professional considered the events probably related to vaccination with ENGERIX B. The reporting healthcare professional did not consider the events serious.
Missed period with negative pregnancy tests 15+ days past expected period date. Rash at injection site 12 days after covid vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 97-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 at 14:30 as dose 5 (booster), single (Lot number: GJ2524) at the age of 97 years, in right arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 17Jan2021 at 14:15 as dose 1, single (Lot number: EK4176), in left arm, on 07Feb2021 at 13:45 as dose 2, single (Lot number: EL9263), in right arm, on 02Nov2021 at 13:45 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 18Apr2022 at 14:30 as dose 4 (booster), single (Lot number: FK9729), in left arm for COVID-19 immunization. The patient's relevant medical history included: "dementia" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "CHF" (unspecified if ongoing), notes: CHF; "BPH" (unspecified if ongoing); "major depressive disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, COVID-19.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine products BNT162B2 to the reported events Vaccination failure and COVID-19 cannot be ruled out.