chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT 35 y.o. female who began having reaction to tegadum about 3 days post vax. Continued to use tegadum ? at work; arm very irritated. On approx day 10 began with "heat rash" under breasts, behind ? on neck and down - very pruritic. No pustules developed. PT tried Benadryl w/out much relief. PT seen day 13; minimal remains ? but still c/o of itching. PT under significant stress due to family situation - feel this is definitely contribution to the rash. PT started on Atarax 50 - 100 mg prn itching.
After two days, my arm began to swell, itch, turned red and felt hot to the touch.
3RD COVID VACCINE GIVEN 10/16/21, PFIZER, #FF2593; pt to ED with confusion after falling at home and hitting his head; CT of head is negative; found to be positive for COVID in ED with coughing and hypoxia; O2 supplementation; given ABX and Dexamethasone; DNI; pt's condition continued to decline; transitioned to comfort measures and passed away in the hospital
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 89-year-old female patient received BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm and in Feb2022 as dose 2, single (Batch/Lot number: unknown) at the age of 88 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "hypothyroidism" (unspecified if ongoing); "GERD" (unspecified if ongoing); "hypertensive chronic kidney" (unspecified if ongoing), notes: hypertensive chronic kidney, disease. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: Adverse event: After taking first dosage at 2pm, immediately had bitter taste in my mouth. At 4pm, experienced explosive diarrhea that lasted 15 minutes. Green in color, and then black in color next two times.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Swollen lymph nodes in the left neck and left top of shoulder since 3/11/2021.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received SHINGRIX for prophylaxis.  On 3rd October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain, touch sensitivity increased, blotchy, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site pain, touch sensitivity increased and injection site erythema were recovering/resolving and the outcome of the blotchy and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, touch sensitivity increased, blotchy, injection site itching and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: On 3rd October 2018 at approximately 3:00 PM, the patient received SHINGRIX on the outside of her right arm. After vaccination, the patient experienced tremendous pain at the injection site and could not touch that area. It was sensitive to the touch and red for all days. At the time of reporting, the area looked large and red but it was itchy and the redness was faint. Initially the injection site area was a fire red color and had blotches. By the 4th or 5th day after vaccination, the redness became a faint red pink. The patient had denied permission to contact her a physician.
After receiving the vaccine, I had fever chills and body aches that put me down for about a week. In 09/2021, I was having neurological issues and I was referred to a neurologist. It was determined that I have left frontal lobe scarring that was causing me to have seizures. As of today, I am still having seizures.
Information has been received from a health professional concerning a 62 year old female with hypertension and no allergies who on 10-Nov-2005 was vaccinated in the right arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. (lot # 650082/0691P). Concomitant therapy included atorvastatin calcium (Lipitor) and clopidogrel bisulfate (Plavix). On 12-Nov-2005 the patient was seen by a physician and complained of redness and swelling at the site and under the arm. Diagnosis was no cellulitis, adverse reaction to vaccination. No laboratory tests were done and treatment ordered included hydroxyzine hydrochloride (Atarax). At the time of the report the patient was recovering. The patient's experience was considered an other important medical event (OMIC). Additional information has been requested.
Hemorrhagic stroke (HCC) and CVA (cerebral vascular accident) (HCC). ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
I am allergic to bee stings.  After 36 hours of receiving the vaccine, I became itchy and redness occurred at the vaccine spot.  Realizing this was similar to a 'hives' reaction, I took an antihistamine.  The itchiness and redness was reduced considerably very quickly.  Minor itchiness continued for the next 36 hours, but not enough to warrant another antihistamine.  All symptoms disappeared after that time.
Information has been received from a consumer concerning her husband who on 18-JAN-2010 was vaccinated with a dose of ZOSTAVAX (Merck). The consumer stated that on 02-FEB-2010, her husband developed double vision after he received ZOSTAVAX (Merck) and was hospitalized (unspecified where and for how long). A computerized axial tomography, a magnetic resonance imaging and other unspecified diagnostic labs were performed (results not provided). At the time of the report the patient had not recovered. No further information is available.
was fishing outside on the dock with his grandfather. It was about 1130 am. Was clear, sunny and warm. He was standing. Stated his heart felt fast and he felt light headed. Before grandpa could take the fishing pole became unconscious, fell, hit the back left of his head on the dock railing and his glasses fell off. Grandpa stated he was unconscious for only a few moments and then came to, was tearful and scared. While unconscious his eyes were rolled back in his head. He did not have any incontinence. Once wakeful was aware of his surroundings and wanted to come home after he had lunch with grandpa.
? Tested positive for COVID on 11/29/21. Asymptomatic. Current University athlete (baseball) and had to test as part of the athletic program. ? Moderna Covid Booster given 1/2/22. No history of allergy, rash or hives in entire life. Significant fever of 103.5 after booster. ? Itchy arm on evening of 1/11/22 ? 1/12/22 5am ? Woke up with huge hives covering entire stomach, armpits, underarms, and right eye swollen shut and extreme itching. Took Benadryl and itching subsided. ? 1/12/22 6pm- Wrist and ankle joints started swelling and became very painful. Thumb joint swelled a few hours later. Had to hobble to walk and could not even open a water bottle. Again, I am a current college athlete so movement is not a problem. ? 1/12/22 11pm ? Went to University Medical Center ER. In addition to earlier symptoms, throat and chest started feeling tight. Bloodwork showed elevated WBC of 12.5 and C-Reactive Protein of 1.55. Gave Tordal and IV Steroid and joints started feeling better within 15-20 minutes. Tested positive for Covid (although positive on 11/29/21 also). Discharged from ER with thoughts that it was most likely caused by an allergy or a virus. ? 1/13/22 ? doctors reviewed my chart and decided that I was still positive from my November Covid test.  Since it is a month later they think it is MIS. ? 1/13/22 6pm ? Lips started swelling and it was hard to understand me talking. Actual skin on the center of my chest started swelling and it felt like someone was pushing on my chest when I took a breath. ? 1/13/22 11pm ? Went back to University Medical Center ER. The ER said that they don?t agree with the other doctor and it is not MIS. Gave me an oral steroid and a chest X-Ray which was clear. They said my lungs and breathing were fine and sent me home with a 6 day steroid pack. Also told me to take Zyrtec in the morning and Benadryl at night. ? As of today, 1/20/22, the joint pain and swelling is gone. However, I continue to have hives/red splotches pop up several times a day on my body. They are not small ? they cover large areas of my body (6 inch x 6 inch) and last 20-30 minutes before disappearing. They don?t hurt or itch but I notice them because my skin starts to feel hot. This is the 10th day they have been happening.  Heat or a hot shower or friction seems to definitely trigger them. If I run a fingernail over my skin (not hard), the skin that was touched becomes super bright red.  It is like my skin has become super sensitive and reactive to everything. ? I can?t say for sure that this was caused by the booster, but nothing else in my life had changed or was different. In my experience, NO doctor in either of my ER visits at University Medical Center was willing to even consider that my issue was triggered by my covid booster shot.
Pt started having some tingling of lips a few hours later and took an ADVIL pm. Woke the next morning and went to ER for facial drooping. (Mouth mostly it sounds), headache, swelling.
Dizziness; Numbness of her left arm; Blurry vision; Nausea; Chills; Headache; This spontaneous case  was received on 23-Sep-2020, from pharmacist via agency (reference number: SEQW20-02191) and concerned a 49-year-old, female patient.     The patient had no relevant medical history and reported that she was healthy. The patient's concomitant medications included supplements such as calcium.  On 22-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, left arm) for influenza prophylaxis. The batch number reported was 279828, expiry date: 20-Jun-2021.  On the same day, 15 minutes after receiving Flucelvax QIV the patient experienced side effects such as numbness of her left arm, headache, nausea, dizziness, chills, and she was at bed rest. The patient also had blurry vision. The patient was treated with Claritin (loratadine).   On 23-Sep-2020, side effects seemed to get worst.   At the time of initial reporting on 23-Sep-2020, the patient had not recovered from events.  The reporter assessed the events as non-serious.   The reporter did not provide causality assessment.  Company comment: A 49-year-old, female patient was administered Flucelvax QIV vaccine. On the same day, 15 minutes after receiving Flucelvax QIV the patient experienced dizziness, hypoaesthesia, vision blurred, headache, nausea and chills. The patient had no relevant medical history and it was reported that she was healthy. Chronology is plausible. Causality is assessed as possibly related for all events.; Sender's Comments: A 49-year-old, female patient was administered Flucelvax QIV vaccine. On the same day, 15 minutes after receiving Flucelvax QIV the patient experienced dizziness, hypoaesthesia, vision blurred, headache, nausea and chills. The patient had no relevant medical history and it was reported that she was healthy. Chronology is plausible. Causality is assessed as possibly related for all events.
Information has been received from a pharmacist concerning a female patient who on 11-MAY-2007 was vaccinated with a dose of Zostavax. On 14-MAY-2007, the patient developed an injection site rash. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA: After receiving dose 1 on 5/19/21 & 2nd dose on 6/9/21, I noticed daily, low-grade headache and continued muscle soreness in my left arm at the injection site that was used for both vaccines. I had frequent flushing/burning in my cheeks. As of 7/1/21, these symptoms linger but are becoming lesser. I treat the headache as needed with OTC ibuprofen. Note: When I contracted & was treated for Lyme's disease in or @ 2010, I had severe daily headaches for 1 year & then they went away. The covid vaccine side effects seem to be similar to the Lyme disease side effects.
Initial affects of the shot (first 2 days): Cascading joint pain which started at the injection site. An elliptical bruise approximately 4 square inches in size formed around the injection site. Lone term: Intense pain in left shoulder, similar to a football injury from throwing a football all day with an injury. I am right handed and I have not thrown a football within the last few months. I was unable to light my arm up in a chicken wing motion without immense pain. No medication was taken for the pain. Motion was restricted/limited for for duration of pain (up to 2 weeks after shot). No sleeping position or other situation can be connected to the random intense pain. At the 2 week point: Bruise is indistinguishable but injection point is still able to be found due to the lingering light red dot. Shoulder mobility has been restored to normal range of motion and I am working on exercising the shoulder to strengthen the socket once again.
Very sore injection site. Fatigue, Flu Like Symptoms, "Pins ands Needles" feeling. Needed to leave work to rest on day following injection.
Patient developed an itchy rash on his back on Thursday evening to Friday. He is currently treating it with hydrocortisone cream. I advised him to monitor the rash and also take benadryl to reduce inflammation. Will follow up with patient.
tested positive for Covid 19; cold; little fever; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 27Mar2021 at 23:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Patient did not receive other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 16:00 the patient experienced getting cold and little fever. Tested positive for covid 19 on 06Apr2021. Patient did not receive treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient questioned, whether she should take the second shot. On 06Apr2021, the patient underwent a COVID-19 test: Nasal Swab, and the result was Positive COVID-19 test. The clinical outcome of events cold, fever and tested positive for covid 19 was unknown at the time of reporting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt had hives that started 2 weeks after shot. lasted over a month. went to Dr on 12-14-20 to get prednisone 20mg for hives.
Received a phone call from patient on 04/30/2021 at 0745 am and stated she woke up the day after her shot with a few bumps at the injection site.  She stated "thought I just had a bug bite". went to work and asked the nurses to look at her arms and hands. Stated she had hives and took Benadryl and placed cortisone cream at the site on both arms. Stated she did not have to go to the Emergency Room and the hives and itching was the only Signs and symptoms she has had.  Patient Stated' the nurses at the facility she works at are keeping a close eye on it and other than that she feels fine." I did reiterate the importance of seeking medical  treatment if symptom continue or worsen.  She replied with an understanding.
Information has been received from a registered nurse concerning a male who on 08-OCT-2007 was vaccinated intramuscularly in the left deltoid with a 0.5 ml dose of Gardasil (Lot #604595/1062V).  The family was receiving flu shots and the daughter was receiving Gardasil.  The wrong syringe was picked up and administered to the patient's father by the licensed practical nurse.  No adverse experience was related to the event.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Received pneumonia shot 4/18/17. Diagnosed with pneumonia in May 2017. Vaccine was pneumococcal polysaccharide PPS V23 manufacturer Lot no. MO 2324, expiry 10 June 2018, VIS version date April 24, 2015. Given at hospital. About May 2, 2017, developed sore throat, cough, difficulty breathing. X-ray May 4 showed patchy right infrahilar...treated with antibiotics for pneumonia. Improved after 2 weeks.
Presented on 8/13 with worsening  severe abdominal pain, peritoneal signs, CT concerning for perforated bowel. Taken for exploratory lap which showed walled off abscess with perforated sigmoid colon and necrotic small bowel. Performed partial small bowel resection and end colostomy.  The next day the patient had an aspiration event leading to desaturations to the mid 70s. Proceeded with increasing oxygen requirements requiring intubation. Became increasingly hypotensive and started on levophed, vasopressin and epinephrine. COVID test returned +. Pulmonary consulted and started patient on dexamethsone, remdesivir and flolan.  Improved some with respiratory status but unable to be extubated with inability to follow commands. On 8/24 patient remained stable and scheduled for trach and PEG, however became increasingly tachycardic and hypotensive requiring increased pressors. CT of chest negative for PE but showed moderate pneumoperitoneum with pneumatosis and gas suggesting bowel perforation and ischemia/necrosis. Due to instability preventing further surgery family requested comfort care.
About 4h after the shot I ate a piece of Pecorino Cheese and I immediately had an allergic reaction in my mouth, more specifically  in the internal part of my lower lip I started to feel a grown swollen and  vesicles. I want to be clear that I often had eaten cheese in My life and I have never had an allergic reaction.
This spontaneous report as received from a consumer refers to a female patient (her daughter) of unknown age with penicillin allergy and sensory issues/problems such as not eating. On 03-OCT-2011 the patient was vaccinated with the first dose of M-M-R II, lot# reported as 10582, dose and route not reported, in the left arm. On an unknown date, the patient was vaccinated with VAQTA in right arm, (dose, route and lot# not reported). The reporter questioned if M-M-R II in 2011, or currently, had any thimerosal in it. The reporter stated her daughter was vaccinated with M-M-R II on 03-OCT-2011 and post vaccination had fever of 102F and rash from head to toe on an unknown date. Rash and fever resolved on an unknown date. The reporter stated her daughter had sensory issues such as not eating, etc., prior to M-M-R II vaccination, but her daughter's sensory issues seemed to increase post vaccination with M-M-R II. Her daughter had a psychological evaluation and was determined to be autistic at 2 years of age. The reporter stated her daughter was due for a second dose of M-M-R II and she wanted to make sure there was no mercury in the product. The outcome of sensory issues seemed to increase and autistic at 2 years of age was unknown. No further details was provided. Additional information has been requested.
Swelling and redness a little larger than the size of a quarter on left deltoid X 7 days.
patient devoloped shortness of breath one week post vax, 3 weeks post vax developed chest pain, upon admission to ED found to be having and N-Stemi (heart attack), acute cholecystitis, and pancreatitis as well as ground glass opacities on Xray.
Along with the 3 vaccines listed, patient also had his cholesterol checked via a finger prick. Younger sibling got shots right after him, when patient's mother and I turned around, patient was pale in color, lips were blue and unresponsive. Patient also was very clammy. LPN was able to get him on the table right away after provider was called back into the room and cold wash cloths were applied to his forehead and neck. Pillow was placed under his feet and small bottle of apple juice given. Color returned soon after patient regained consciousness.
Information has been received from a physician concerning a "16-17 year old" female who was vaccinated on an unspecified date with a first dose of GARDASIL (lot # not reported).  Subsequently, on an unspecified date, the patient experienced upper right quadrant pain.  The patient sought unspecified medical attention.  "She was referred to see a gastroenterologist and found out she had raised liver enzymes."  Therapy with GARDASIL was discontinued.  Subsequently, the patient recovered from upper right quadrant pain and raised liver enzymes, "after stopping therapy with GARDASIL."  No product quality complaint was involved.  Additional information has been requested.
Itchy eyes. Skin around both eyes turned red and puffy.  Lasted about 24 hours.  Stinging sensation in both eyes.
Patient diagnosed with shingles on 1/31/2021 at an urgent care facility out of state.  Patient was treated with acyclivir 800mg PO 5x/day.  Patient later followed up with her PCP