chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling achy; got the worst chills; high fever; chest pain; diagnosed with ST depression; Initial information received on 31-Oct-2022 regarding an unsolicited valid serious case received from a nurse(patient).  This case involves a 71 years old female patient who experienced diagnosed with ST depression, got the worst chills, high fever, chest pain and feeling achy while receiving vaccine influenza quadrival A-B high dose hv vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. The patient had ongoing allergy to Halibut(fish allergy).   On 26-Oct-2022, the patient received suspect vaccine influenza quadrival A-B high dose hv vaccine at a unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for immunization.  On 26-Oct-2022 the patient developed a serious got the worst chills (chills), high fever (pyrexia), chest pain, feeling achy (pain) same day latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. The patient was hospitalized for this event. In Oct-2022 the patient developed a serious diagnosed with ST depression (electrocardiogram ST segment depression) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event. Product composition confirmed no fish was in the product.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.; Sender's Comments: Sanofi company comment dated 03-Nov-2022: This case involves a 71 years old female patient who experienced diagnosed with ST depression, got the worst chills, high fever, chest pain and feeling achy while receiving vaccine influenza quadrival A-B high dose hv vaccine [Fluzone High-Dose Quadrivalent]. The patient was allergic to Halibut. Additional information regarding condition at the time of vaccination, risk factor excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
red area at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red area at the site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red area at the site of injection). At the time of the report, VACCINATION SITE ERYTHEMA (red area at the site of injection) had not resolved.            Concomitant medications were not reported. Treatment information was not reported.   This case was linked to MOD-2021-048244 (Patient Link).
Patient passed away unrelated to covid vaccination Narrative:  The patient had rectal cancer with metastases and stage 4 chronic kidney disease. Has been placed on palliative care. Patient received his first dose of Pfizer vaccine on 12/22 and second dose of Pfizer on 1/12. No adverse reaction related to vaccination was reported. Patient passed away on 1/17. Patient's daughter had concern that his rapid decline over the past few days may have been related to COVID vaccine. Attending explained that patient's clinical changes are more consistent with decline due to an end of life status. No indication that death was related to COVID 19 vaccination.
Fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved and FATIGUE (Fatigue) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient was concerned that vaccination may not be properly completed.  Treatment medication information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-075471 (Patient Link).
Information has been received from a Medical Assistant concerning an old male patient in his 80s who was vaccinated with PNEUMOVAX 23. The patient experienced a cellulitis reaction after being administered PNEUMOVAX 23. Therapy was discontinued. The patient did not seek medical attention. Follow up information was received concerning the patient with no illness at time of vaccination and pre-existing allergies, birth defects, medical conditions unknown who vaccinated with PNEUMOVAX 23 (exp. 03-JAN-2012) IM on deltoid. The patient experienced edema and redness to the arm below the injection site which cleared within 1 week. No further information is available. This is one of several reports received from the same source.
vaccine expired 7/13/2022 used 7/15/2022 for clinic no adverse reaction reported as of 7/27/2022
Diffuse maculo-papular rash at the site of injection, enlarged lymph nodes in the neck, left axillary pain about 5-6 days after the vaccination.
Pt developed massive swelling in left arm - it appeared to be somewhat edematous. It appeared in one day. The swelling extended from mid upper arm to mid forearm. Treated with Keflex, however I believe it was a local noninfectious reaction.
Seasonal Flu Vaccine, but type unknown to me. I'm in constant pain in left shoulder, feels tired. I cannot sleep on that side and need to be mindful when using my left arm. My should is also constantly popping. I cannot swim or workout without causing pain to my shoulder. I saw my PCP who was unable to help/offer assistance beyond referring me to an orthopedic doctor. I've tried massage and have an acupuncture appointment. Ive tried heat and ice and rest, nothing seems to help. Daily activities have become hard and it's taken an toll on my mental health.
On Thursday, November 4th a little before 3pm she went to get her booster shot following another appointment.  Patient stating tingling in legs and unsteady gait  the evening after receiving their Pfizer Booster on 11/4/21.  On Friday patient woke up with extreme weakness, headache, incontinence of urine and overall unwell feeling.  Had fever, chills, fatigue for 2 days and symptoms all resolved.
6/5/19 c/o indigestion; mintox administered and effective 6/7/19 c/o abd pain, diarrhea and emesis, v/s T 98.9, HR 91, RR 18, BP 124/71; transferred to hospital for eval
Flushing on both the hands.(Palms turned red )Lasted for 20 minutes,subsided after 20 minutes.
SICKNESS; PAIN UNDERNEATH ARM LIKE IN LYMPH NODES; LOW ENERGY; LEG PAIN; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a 5 decade old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced sickness. On APR-2021, the subject experienced pain underneath arm like in lymph nodes. On APR-2021, the subject experienced low energy. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sickness, low energy, tiredness, leg pain, and pain underneath arm like in lymph nodes. This report was non-serious.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number N2E73, expiry date 31st March 2022) and (batch number A55XP, expiry date 22nd March 2022) for prophylaxis.   On 12th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, couple of months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows:  The pharmacist reported a patient experienced shingles after dose one of Shingrix.  HCP reports the patient experienced shingles a couple months after receiving dose one, no exact date provides.  HCP reports shingles symptoms resolved as of a week ago.  No exact symptoms reported.  No exact date of resolution provided.  batch and expiration date, one was for powder portion of Shingrix.  Batch and expiration date two are for diluent portion of Shingrix. The reported batch number N2E74 for Shingrix did not exist and was updated to N2E73 as per the sales database.
MODERNA COVID-19 VACCINE EUA CHILLS, WEAKNESS, DIZZINESS, MUSCLE PAIN IN LOVER LEGS
I experienced fluttering in my chest woke me up in the middle of that Friday night. On that Monday contacted my doctor went was given a monitor to wear for 3 days. After the results was referred to a Cardiologist diagnosed with Supraventricular tachycardia (SVT). i was advised to continue to monitor as of right now there short can be long. I'm keeping a diary of the episodes last recorded was on February 17, 2022.
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 18-SEP-2017, the patient was administered 1 dose of expired RECOMBIVAX HB (expiration date 15-SEP-2017, lot number M013639). No adverse effects reported.
Admission Date: 5/6/2022 Discharge Date: 5/8/2022  PRESENTING PROBLEM: COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 49 y.o. female who presented to the emergency department with complaints of shortness of breath.  Patient has a past medical history of OSA, depression with anxiety, ADHD, GERD, fibromyalgia, history of DVT, atrial fibrillation, chronic low back pain, and ADHD. Patient states that on Tuesday, 05/03/2022 she started developing cold-like symptoms.  She states that over the past week, her symptoms have worsened and she became increasingly short of breath with wheezes which prompted her to seek further evaluation in the emergency department.  In the emergency department, patient was tachycardic, tachypneic, but did not require supplemental oxygen at rest.  With ambulation, patient's oxygen saturation decreased to 88% without supplemental oxygen.  Complete blood count and BMP were unremarkable.  D-dimer was 270. EKG shows normal sinus rhythm.  Chest x-ray showed no acute cardiopulmonary disease.  Patient has been admitted for further evaluation and management of COVID-19. She has received 3 doses of Covid vaccine.   The patient was quickly weaned from oxygen on 5/6. She remained in the hospital for feelings of palpitations and chest tightness on 5/7. Telemetry monitoring showed no signs of arrhythmia. Vital signs were stable on room air. Lab work showed normal d-dimer and CRP and the patient is anticoagulated on Eliquis for a-fib. She was hesitant to discharge on 5/8 but by the afternoon she was agreeable as she had been stable on room air without any further chest pain or palpitations. It was explained that it would be normal for her to continue to have fatigue, slight shortness of breath, decreased appetite, cough and other symptoms of covid, but that she should continue improve. She was discharged home in stable condition with tessalon and mucinex prescribed to help with symptom management.  Follow up with her PCP is recommended to ensure full recovery.
Alopecia Areata first developed about 2-3 weeks after 2nd dose of the vaccination on the left side of the head about 1.5 inches in radius.   The affected area increased after 1 month of the vaccination. The second affected area was noticed on the top right corner of the forehead after 1.5 months of receiving the vaccination.
Fever 101 with swelling/pain at injection site, cellulitis. Pt is on KEFLEX & TYLENOL.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Patient administered with the vaccine that underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered with the vaccine that underwent temperature excursion) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021 at 3:51 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Nov-2021 at 3:51 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered with the vaccine that underwent temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered with the vaccine that underwent temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature.  The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.  No treatment medications were provided.
Breakthrough case: I contracted COVID-19. My symptoms included a bad headache, sinus congestion, loss of taste & smell, coughing, and throat pain. I went to the doctor. I later took a COVID-19 test at a drive-thru. I received the monoclonal antibodies treatment on 08/07/2021.
It was not just a "sore arm" it felt like I was stabbed with a knife through my arm into my armpit Swollen/painful lymph nodes under left arm which have decreased gradually over the week but still present Rapid resting heart rate between 90-100bmp Fatigue-needing a nap daily persists a week later Vivid dreams
This spontaneous report was received from a registered nurse, referring to unspecified number of patients of unknown ages and genders. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (which had the lot number of L040419, expiration date 14-OCT-2017) (dose, strength and anatomical site of vaccination were not reported). Information regarding concomitant medications were not reported. Therefore, no adverse effect was reported. Additionally it was also mentioned that the vaccines experienced a temperature of -4.1C, in a time frame of 13 hours, 15 minutes, there was not previous temperature excursion, and call was because of a "data logger". There was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
pt recvd vax 18JAN95 & cried steadily for approx 5 hrs; mom states there wasn't a period of even 30 seconds where pt didn't cry through the rest of the noc; pt irritable;
TOOK VIVOTIF ON CONSECUTIVE DAYS INSTEAD OF EVERY OTHER DAY; This spontaneous case report (PVX2019-1881) was received from a pharmacist on 22-Jul-2019. It describes a 31-year-old female consumer who "took Vivotif on consecutive days instead of every other day" (PT: Inappropriate schedule of product administration), while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took doses of Vivotif on consecutive days instead of every other day. She completed Vivotif course a couple of weeks ago.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vivotif on consecutive days instead of every other day" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif on consecutive days instead of every other day" was considered as not applicable.
after the 1st dose he has a sore arm; after the 1st dose he has a headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (after the 1st dose he has a sore arm) and HEADACHE (after the 1st dose he has a headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 036A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), NIACIN, Citadel and VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (after the 1st dose he has a sore arm) and HEADACHE (after the 1st dose he has a headache). On 07-Feb-2021, PAIN IN EXTREMITY (after the 1st dose he has a sore arm) and HEADACHE (after the 1st dose he has a headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test: ALT 79, AST 49..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided by the reporter.
Patient is experiencing strong muscle and body aches all over for 8 weeks so far starting 3 days after shot was administered.
Date for the next shot: 22Jan2021; I broke out in hives all over; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on 04Jan2021 at single dose for covid-19 immunisation. The patient's medical history was not reported.   The patient's concomitant medication included montelukast sodium for Allergy and simvastatin for Cholesterol. 06Jan2021, the patient stated that "I called my doctor yesterday and said that I had an reaction from the shot, the first one. And they told me at my doctor's office to call this number to let you know that I had a reaction from it." The patient stated experienced "I broke out in hives all over." The patient took the first one on 04Jan2021 and date for the next shot was 22Jan2021. The patient was treated with Prednisone. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Erythema, color to area from high upper thigh to above the knee, anterior & medial thigh. Small papule on anterior thigh did not appear to be at injection site.
First Dose: 02/07/2021 I have lymphedema in my legs and 4 hours after the injections my legs got very painful. I also had a bad headache. Second Dose: 03/16/2021 2 hours later I had severe vomiting and diarrhea and cramping in my stomach. feels like labor pains
Heart palpitations at 2:am and then again at about 9: am the next day after the vaccination
body aches; dizziness; pain at injection site; nausea; exhaustion; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 41-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; ER2613), via an unspecified route of administration in Left arm on 25Mar2021 at 13:30 (at the age of 41 years) as single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; EN6203), via an unspecified route of administration in Left arm on 04Mar2021 at 13:00 (at the age of 41 years) as single dose for COVID-19 immunisation Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. On 26Mar2021 at 01:00, patient experienced body aches, pain at injection site, nausea, dizziness and exhaustion. Therapeutic measures were taken as a result of adverse event included ibuprophen. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event body aches, pain at injection site, nausea, dizziness and exhaustion was recovered on an unknown date at the time of report.   No follow-up attempts are needed. No further information is expected.
two days father receiving a flu shot patient complain of sorness and could not move arm.   talk with Rph an he said that it never happens.  Patient comes in today 3/15/21 still complain that he can not move his arm but is getting better.  patient thinks it was SIRVA?