chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anaphylaxis; Based on the current case data, this case has been classified as invalid. This literature-study case was reported in a literature article and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaxis) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylaxis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (anaphylaxis) to be possibly related.    Treatment and concomitant medications not reported.  Patient desensitized and no adverse events occurred after second dose.  Patient developed hives, flushing, shortness of breath, and feeling of impending doom within 30 minutes.  Company Comment: This literature non-study case concerns a patient of unknown gender and age with no details on relevant medical history, who experienced the expected serious (medically significant) event of Anaphylactic reaction after mRNA- 1273 Moderna vaccine. The event occurred within 30 minutes after the first dose of mRNA- 1273 vaccine. Clinical manifestations included hives, flushing, shortness of breath, and feeling of impending doom. Information regarding treatment is not available. The rechallenge was negative, since patient desensitized and no adverse events occurred after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report   This case was linked to MOD-2021-396936, MOD-2021-396937, MOD-2021-396938, MOD-2021-396939, MOD-2021-396940 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up received by safety on 25-Nov-2021 included an Email team and contains significant information.; Sender's Comments: This literature non-study case concerns a patient of unknown gender and age with no details on relevant medical history, who experienced the expected serious (medically significant) event of Anaphylactic reaction after mRNA- 1273 Moderna vaccine. The event occurred within 30 minutes after the first dose of mRNA- 1273 vaccine. Clinical manifestations included hives, flushing, shortness of breath, and feeling of impending doom. Information regarding treatment is not available. The rechallenge was negative, since patient desensitized and no adverse events occurred after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (route of administration, dose, lot number and expiry date were not reported) for prevention of shingles. On an unknown date, a couple of days after the vaccination, a couple of months ago, the patient experienced redness, bruising and a lump at the injection site. The patient sought medical attention. No rash was reported. No rash was reported. No treatment was given for the adverse events and no lab diagnostic test was performed. The pharmacist reported that the patient was seen in the pharmacy about a week later and the symptoms had completely gone away (recovered on an unknown date). The relatedness between the vaccination and the adverse events was not reported. Additional information has been requested.
Throwing up; body ache; feeling feverish; sweating; chills; headache; This is a spontaneous report from a contactable other Healthcare Professional (HCP, patient).   This 24-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot # EK4176), intramuscular, on 12Jan2021 at 05:45 PM at single dose for COVID-19 immunisation. Vaccine location was right arm. No other vaccine was received in four weeks. Medical history included anemia, possible COVID in Mar2020, obgyn related health conditions. Historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot # EL1284), intramuscular left arm, on 22Dec2020 at single dose for COVID-19 immunisation. Age at vaccination was 24 years old for both doses. Concomitant medications were unknown. On 13Jan2021 at 04:00 AM, the patient experienced throwing up, body ache, feeling feverish, sweating, chills, headache. No treatment was received for the event. Outcome was recovering.
Severe cough, lost voice, difficulty swallowing, tightness in neck, shoulders, and head all for 2-1/2 weeks duration.  Pt bedridden for 4 days.
I had my vaccination on 09/21/2022. In 12/22/2022 I started to get a surface clot in upper thigh and my leg ached. I went to my doctor for wellness check in 12/28/2022 and I was referred for an ultrasound. There was no specialty care as it was a benign deep vein and I was instructed to increase my walking. I had a follow up on 01/05/2023 to monitor the deep vein thrombosis.
Started out just feeling tired, a little chilled the first day. Woke up the next morning and my skin hurt to touch. This isn't unusual for me, as it usually happens when I'm very sick, like with the flu. But then the oddest thing started happening. I became increasingly sensitive to sound! Every loud or even vaguely loud noise sent a wave of... Like nausea through me. Reminded me of just getting motion sickness after riding a ride at the fair. It became worse and worse to the point that it was maddening! Even the sound of my own chewing would hurt. This lasted almost exactly a week. I believe it was the next Saturday I woke up mostly ok, and the next day felt normal again.
DX COVID-19 pneumonia (covid + 10/12/2021).  Admitted with Hypoxia, acute respiratory failure  and non-ST elevated mycoardial infarction. D-Dimer 539.   He completed course of medical therapy as recommended by ID and pulmonary. Decadron, supplemental O2, remdesivir with heparin.  He was discharged to long term facility to continue high flow oxygen and further management
pt brought to ED with respiratory distress; placed on O2 supplementation; tested positive for COVID 2 wks ago and is testing positive in ED as well; pt in A Fib with RVR; DNR; COVID pneumonia with severe sepsis; pt had a rapid decline and passed away 1 hour after being transferred to in-hospital hospice care
periodic rashes over body and all over itchy starting on day 4. also there has been sore joints and muscles and random fatigue.
Large rash starting at injection site and extending down to elbow. Rash wrapped around my entire arm.
A improperly stored vaccine (VARIVAX) was administered to a 22 year old, female patient.; No adverse effects reported.; This spontaneous report has been received from a medical assistant concerning to a 22-years-old female.  The patient's medical history, current conditions, previous drug reactions or allergies, were not reported.   On an unknown date, the patient was  vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered subcutaneousl, as prophylaxis (dose, route, anatomical site of administration, and vaccine scheme were not provided, lot number T029533 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported and upon internal validation established as 01-SEP-2022) (product storage error). It was reported that the sterile diluent was used as concomitant therapy to reconstitute the vaccine (lot number and expiration date was not provided) but it was not reported at what temperature it was stored.  The vaccine was stored at a temperature of 19.2 degrees Fahrenheit (F) for a timeframe of 3 hour and 15 minutes. There was no previous temperature excursion. No PQC (product quality complaint) was reported.  No adverse events were reported.
Symptoms of swollen, sore, and red throat. Body aches, arm soreness,  fever.
Information has been received from a health professional concerning an 11 year old male who a few years ago, in approximately 2002, was vaccinated with a dose of varicella virus vaccine live. It was reported that the child now has a mild outbreak of chicken pox. Unspecified medical attention was sought, but no treatment was provided. No product quality complaint was involved. It was reported that there were many cases, possibly 50 in the area. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not specified. On an unknown date, the patient was vaccinated with a properly stored PNEUMOVAX 23 lot # N013521, expiration date 23-JAN-2019, one dose (route of administration not specified) for prophylaxis. The patient was administered FLUZONE HIGH-DOSE (dose, route of administration, lot # and expiry date were not reported) on the same day. The reporter was unable to specify if it was administered in the same arm as PNEUMOVAX 23. On an unknown date, the patient had a local injection site reaction described as itchiness, swelling, redness and welt around injection site. The patient sought medical attention from primary care physician and was prescribed hydroxyzine 25 mg for itchiness. The outcome of the events was reported as recovered on an unknown date. The relatedness between the treatment with PNEUMOVAX 23, FLUZONE HIGH-DOSE and the events was not specified. The reporter requested the lot check for PNEUMOVAX 23 with lot # N013521. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA005621: Original Case: 1710USA005621.
Report A0364078A describes fever in a 4 week old male who received hepatitis B vaccine recombinant (Engerix B). The treating physician submitted this report directly to VAERS. Medical history, concurrent conditions, and concurrent medications were not specified. On 3/19/02, the vaccinee received his first injection of Engerix B (lot ENG5217A2). On 3/21/02, the vaccinee experienced a fever of 38.5 degrees C. On that date, he was admitted to the hospital to investigate the cause of his fever. The treating physician considered the fever to be possibly related to Engerix B administration. As of 3/22/02, the fever was ongoing.
died from cancer; kidneys shut down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (death), outcome "fatal", described as "died from cancer"; ACUTE KIDNEY INJURY (death), outcome "fatal", described as "kidneys shut down". The patient date of death was unknown. Reported cause of death: "died from cancer", "kidneys shut down". It was not reported if an autopsy was performed. Clinical course: As per reporter, he had lost 3 friends in the last 45 days, kidneys shut down. All 3 of them died from cancer.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200354728 Same reporter, different patient/drug/event;; Reported Cause(s) of Death: died from cancer; kidneys shut down
Myalgia redness, swelling at injection site Narrative:  #2 covid vaccination on 3/12. Over weekend pain to injection site redness swelling radiating into l neck. Called off work on 3/15 and seeing pmd.
Narrative:  Employee tested positive for Covid-19 and was hospitalized despite full vaccination of Pfizer 1 and 2 plus two boosters (booster 1 on 8/8/2021 and booster 2 on 3/11/2022).
Pt reported usual mild left arm pain after IM injection in left deltoid first few days, then pain in same area worsened approximately day 5-7, and the pain persists still when she attempts to use the arm, she complains of reduced range of motion and strength interfering with usual activities of daily living, reaching, dressing, etc., still. She also complained of unusual, increased fatigue and lack of her usual energy, requiring her to take mid-day naps daily, which she states she never needed before her 2nd shot.
The site of injection became a bump and turned red. I didn't think much about it. Months went by and the place never changed. I visited a dermatologist to have the spot removed. He suggested having a biopsy. I did and it came back a little strange. I was sent to an oncologist. He quickly ordered a PET scan and then scheduled surgery to have the "tumor" removed.
Information has been received from a health professional concerning a 71 year old male who on 30-JAN-2008, was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 646313/0065R) instead of zoster vaccine live (Oka/Merck). The patient sought medical attention at the physician's office. Current patient status was not reported. The reporter indicated that the event was staff error only. A product quality complaint was not reported. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 10:13 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 10:13 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was reported as 68.04.  No concomitant medications were reported.  On 20-Mar-2021, 19 vials were moved to clinic.  The vial was initially moved to the fridge on 09-Mar-2021 and proposed beyond use date was 08-Apr-2021. On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and at 10:00 AM, the temperature recorded was 37 degree Fahrenheit that has been reached by the vial. The vial was moved to clinic on 20-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.  The occupation of reporter was reported as clinic manager.   This case was linked to MOD-2022-566976 (Patient Link).
I developed a sharp, shooting pain on the right side of my face on 11/12/21 (day after my Covid booster). I felt the pain inside my mouth, on my cheek, up the side of my face, and into my jaw. It felt like an intense electric shock that would come and go throughout the day and night. Chewing, talking, and drinking hot and cold liquids made it worse. I tried heat packs, ice packs, ibuprofen, and Tylenol. The pain was so bad that I had to cut back on my work hours and couldn't sleep through the night.  I sought treatment through multiple visits to urgent care, my dentist,  a dental specialist (who suspected it might be Trigeminal Neuralgia), and my PCP over the next few weeks. My PCP prescribed Gabapentin and referred me to a neurologist. I saw a neurologist on 12/16/21 and he confirmed a diagnosis of Trigeminal Neuralgia.  Between 12/16/21 and 4/27/22, I have continued to suffer from Trigeminal Neuralgia. Gabapentin provided some relief from nerve pain but caused me to have a side effect of intense cold sores and mouth sores. My neurologist switched me to Carbamazepine, which had the same effect (despite being prescribed Valtrex to counteract this side effect of cold sores). I am currently prescribed Baclofen and Topamax, which are not as effective against the pain and cause me to be extremely tired during the day. I am still not able to work full time.
4i inch roundish red, swollen and prickly at injection site. Tender- aka covid arm?
Patient briefly lost consciousness (~15-30 seconds), hypotension, weak pulse, sweating and nausea.
Primary scab came off 3/23/03. Second scab formed 3/25 (small amount drainage). Noted flat, red rash on neck and face first on 3/28, all over body by 3/30. Feels feverish and hot but temp 98 degrees F. Denies exposure to anyone with rash illness. Pt still has symptoms.
Two days after my second dose, I noticed a grey blind spot in the center of vision in my right eye (the left eye is unaffected).  It lasted for few minutes and happened 2-3 times a day. I sent to see an eye doctor the following week on 5/18/2021. The doctor saw my eye and examined the retina, vision was normal. But the retina was not scanned or pictured. However, the following weeks, the vision started to become blurry and became sensitive to bright light. I saw another eye doctor on 7/30/2021. I was diagnosed with CENTRAL RETINAL VEIN OCCLUSION  in the right eye. The doctor referred me to eye surgeon and also asked me to see primary care doctor and ordered blood tests.  The following week I saw the eye surgeon, where I was further thoroughly checked and retina was scanned and pictured. I was treated with Avastin injection in right eye and was told to visit back every 30 days for the next one year for repeat treatment. I was also advised to see the primary care doctor and undergo blood tests.  I then went to see my primary care doctor on 8/10/2021 for annual physical and blood tests. The tests were ordered for number of blood tests. My BP, BMI was all normal
Starting the day after the vaccine, severe left shoulder pain and left leg pain. The left knee joint was especially painful. The night of January 21, 2021, the patient could hardly walk the pain was so bad. January 22, 2021 the pain subsided considerably in the shoulder. The leg pain is improved and the knee joint pain has subsided, although the knee joint still hurts more than the shoulder or leg. This was all reported to the patient's primary care physician.
within 4 hours, feeling of disorientation,  Feverish, temp slight elevation, behavior change, memory loss, lasting at least 24 hours.  Lack of energy, strength, pain in joints, tendons
Pt showed no adverse side effects. Was administered to a patient under the age of 18 years old.
Patient described burning and itching of the esophagus as well as chest pain. She was given 20 mL of bendaryl and watched for over an hour. I followed up with the patient at 6pm (6 hours post vaccination) and she still reported chest pain. I advised that she go to the ER.
Chills, Red around arm, joint pain, headache. Muscle pain, decreased appetite.
Shingles; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 05Mar2021 at 10:15 (at the age of 75-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, obesity, thyroid nodules and seasonal allergies. Concomitant medications included acetylsalicylic acid (ASPIRIN) 325mg daily, insulin (MANUFACTURER UNKNOWN) and salbutamol (ALBUTEROL) prn; all for unspecified indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 12Feb2021 at 09:45 (at the age of 75-years-old), as a single dose for COVID-19 immunisation. The patient previously took cefixime (SUPRAX), clarithromycin (BIAXIN), lisinopril (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and fluticasone propionate;salmeterol xinafoate (ADVAIR DISCUS) for unspecified indication from unknown date and experienced drug allergy to cefixime (SUPRAX), clarithromycin (BIAXIN), lisinopril (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and fluticasone propionate;salmeterol xinafoate (ADVAIR DISCUS) on unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09May2021, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with valacyclovir & gabapentin. The clinical outcome of the event shingles was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.