chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented on 4/17 to urgent care afer significant vaginal bleeding (soaking through a pad every 1 hour to 1.5 hours) and petechia on multiple extremeties. She also had a nose bleed and bleeding in mouth earlier in the day that resolved spontaneously. After obtaining CBC, platelets were <1000.  She was on oral contraceptives. She is a non smoker. She received work up for thrombosis, not indication of thrombosis.  She did have some muscle aches and fever and fatigue the day after vaccine. Histroy notable for mild diffuse petechiae on all 4 extremeties. As inpatient received solumedrol 125 mg (then switched to prednisone 80 mg daily),  IVIG 1 g/kg x 2 doses. she was discharged on 4/19 d/t rising platelets, Vaginal bleeding slowing and Petechia much fainter.
Suspected vaccination failure; PT CAME IN TODAY WITH SHINGLES; This case was reported by a nurse via sales rep and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 12th July 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received series of Shingrix in 2018. After receiving Shingrix, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation were not provided.
6/ 09 After vaccination was given, pt started to feel funny and nauseous. She later began to get a headache ( by this time 10-15 later she wasn't nauseous or feeling funny). Pt said she would take Tylenol for headache. After 10 minutes she said she felt better, just a little lingering headache. Today (6/10)  when I followed up with her, She stated that she started to get Chills, minor aches and pains and a headache that was going away with Tylenol.  She has a telemed apt with her Dr and she will let Dr know about lingering head that's not getting better with medication.
About 1Hr after getting shot my ears started ringing.... 36Hrs later they are still ringing.
patient passed out about 10 minutes after receiving vaccine.  She started to feel faint and then passed out completely.  Was out for about a minute.
Janssen COVID-19 Vaccine EUA Nearly two weeks out from the vaccine, I am still experiencing a small lump and noticeable tenderness at the injection site, with referred pain at times to my fingers and/or shoulder. Site is blotchy pink and still itches at times.
Full body hives/Uticaria Treated with benadryl until resolved continues to have small patches 5 days post hive event
Started to feel the tops of his arm and his legs/above his ankles itch / started to come back again; burned a little / burning at the tops of his arms; Had a tingling underneath [the skin]; Has dark spots/ his skin is dark on the top of his arms; His muscles hurt intensely; This case was reported by a consumer via call center representative and described the occurrence of localized itching in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in September 2020, reference case US2021012496) and flu shot with an associated reaction of injection site pain (received every year, reference case US2021AMR013295).   On 8th January 2021, the patient received the 2nd dose of Shingrix. On 13th January 2021, 5 days after receiving Shingrix, the patient experienced localized itching, burning sensation, tingling skin, darkened skin and muscle pain. The patient was treated with benadryl (nos) (Benadryl Spray). On an unknown date, the outcome of the localized itching, burning sensation and darkened skin were not recovered/not resolved and the outcome of the tingling skin was unknown and the outcome of the muscle pain was recovered/resolved.   The reporter considered the localized itching, burning sensation, tingling skin, darkened skin and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for himself. The patient started to feel the tops of his arm and his legs/above his ankles itch after vaccination. The patient sprayed Benadryl spray on there and itching went away. The reporter mentioned that it was burned a little and then itching started to come back again and had a tingling underneath the skin and burning and at the tops of his arms. The ankles/leg area has resolved fully. The area on the arms has not resolved and was continuing and it now looks like he has dark spots/ his skin is dark on the top of his arms. The reporter mentioned that spraying Benadryl helps his symptoms. The patient's muscles hurt intensely after vaccination. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021012496:Same reporter. US-GLAXOSMITHKLINE-US2021AMR013295:Same reporter
Fever of 103.9 ~Chills~ extreme muscle pain~stomach pain~Massive headache ~nausea~extremely tired symptoms stared the morning after and last 4 days started with extreme tiredness ~nausea~ muscle pain~headache progressed to stomach pains and really debiltating muscle pain headache nausea and severe stomach pain fever did not break until day 4 when symptons started to subside.
Red, swollen right thigh area 19.5cm x 11cm. Discoloration around injection site 3cm x 4cm. Warm to touch. Not tender to touch. No fever.
I woke up at 2:45am with chills, a bad headache, sore arm at test site and nausea. I took extra strength Tylenol and went back to sleep. The following day, I continued to have the headache and fatigue. I took Tylenol and/or Advil all day to keep the headache at bay and also needed a nap. Today, I feel much better.
pain at the injection site but not on the muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site but not on the muscle) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site but not on the muscle). At the time of the report, VACCINATION SITE PAIN (pain at the injection site but not on the muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-285693.
Injection site sore and reddened. Swollen and has fluid filled blisters at the site.
On 2/24/03 service member received AVA 1 she denies a significant local reaction to vaccine site. She recalls feeling nauseated for a few hours right after vaccine receipt, but denies any unusual or prolonged systemic symptoms. This was the only vaccine received on 2/24/03. On 3/8/03 service member received AVA 2 this was the only vaccination received on this date. Service member dose no recall specific details regarding this vaccination because she was getting ready to deploy. (Deployment was later postponed to Dec 2003. She does not recall any local reactions, but knows that this was the time of onset of her first break out, which she thought might be an allergic reaction to food or something. She had never previously experienced similar symptoms. Her reaction started with her eyes becoming swollen and then hives appeared under her arms and later, on her hips and on her neck and back. The affected areas were pruritic, raised and red. Lesions began as individual welts, but on hips, the welts coalesced. She did not seek evaluation and the hives resolved within 24-48 hours after vaccine receipt. She had no other reactions until after she received her next anthrax vaccine. On 11/13/03 service member received AVA 3 she also received Hep A, Hep B Typhoid and Influenza vaccination on this date. Service member does no recall any unusual local reactions at her vaccination sites. She denies any unusual or prolonged systemic symptoms except for recurrence of urticaria. Her records show lab results CBC from 11/24/03 from an ER visit for evaluation of this reaction had she also had photos of this reaction dated 11/24/03. This was about 11 days following vaccine receipt. AT the ER she was treated with 1-2 week course of prednisone, with complete resolution of hives but residual hyperpigmentation. For the next year, she continued to experience similar episodes of urticaria about once every 2-3 weeks. She was seen by a civilian dermatologist prior to deployment, she recalls the dermatologist performing a number of tests including a biopsy. During her deployment, she was evaluated and treated at troop medical clinics multiple times and and she was evaluated by an allergist. During the time she was treated with Prednisone, Zyrtec, Allegra and Zantac, as well Claritin, Between episodes, the areas remained discolored, and then with recurrent episodes, the discoloration was replaced with hives. Service member denies associated signs and symptoms such as rhinorrhea, wheezing or breathing difficulties, angioedema, metallic taste, diarrhea or vomiting, hoarseness, cough or tightness of or itchy throat. Last episode of urticaria was in November 2004.
I noticed the bottoms of my feet were turning purple, there was no pain involved. I thought it was odd and maybe a circulatory issue. I had ultrasounds done, went to the dermatologist. It doesn't last long, but doesn't go away. Usually first thing in the morning the bottoms of my feet are purple. My dermatologist wasn't able to determine what is was. To this day I still have purple feet every day.
On 12/26/13 I administered 0.5mL of FLUVIRIN to patient, approximately 5 minutes later a customer ran up to the pharmacy and reported a man down in the store. I responded and found patient laying on the floor. He was sweating and looked pale. I removed his jacket and fanned him for a bit. Checked his BP = 88/55.
SHE HAD EKG ORDERED IN EARLY NOVEMBER FOR TACHYPNEA AND TACCHYCARDIA AND WAS DX WITH NEW ONSET A-FIB. PALLIATIVE CARE MEASURES IN PLACE AND FAMILY/ADPOA DECLINED FOLLOW-UP WITH CARDIOLOGY. 11/5 FOUND TO HAVE ELEVATED WBC AND UA C&S SENT. >100,000 E.COLI CULTURED. TREATED WITH CIPRO BEGINNING 11/9. 11/15 STARTED ON LEVAQUIN FOR LEFT BASILAR ATELECTASIS, ELEVATED WBC AND RESPIRATORY SYMPTOMS. SHE WAS TESTED AND NEGATIVE FOR COVID. PASSED AWAY AT 1620 ON 11/17/21
Vaccine stored in refrigerator on 03-Nov-2021, product expired on 3-Oct-2021, product administered on 09-Nov-2021.; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 03-Nov-2021, product expired on 3-Oct-2021, product administered on 09-Nov-2021.) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 03-Nov-2021, product expired on 3-Oct-2021, product administered on 09-Nov-2021.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 03-Nov-2021, product expired on 3-Oct-2021, product administered on 09-Nov-2021.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No temperature excursion of the product reported, Patient experienced no adverse event.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-491837 (Patient Link).
Flu- like symptoms including  nausea, aches, pains, dizziness but no fever.  Red patch 1"x1&1/2" in size below injection site
pt recvd vax approx 3PM 29AUG94; called MD 9PM that noc saying pt cried since inject & still crying @ 9PM; no fever or sx;
8:45am pt. c/o dizziness while under observation. He was diaphoretic,pale and hyperventilating. Helped him to the floor in a supine position with legs elevated. Encouraged slow deep breaths, applied ice pack behind his neck. Vitals were, BP=133/88, RR=24, HR=60. At 9:00 BP=120/86, RR=20 , with pink skin color. pt. Reported feeling stable/better with no dizziness. Pt was offered a bottle of water at room temperature. At 9:15am pt left the clinic in a stable condition with no ambulation difficulties. Pt. did not incur any falls, injuries or trauma while at the clinic.   F.T. RN-BSN
24 year old male who had his COVID vaccination 08:00 yesterday. By last night about 22:00, he start an upset stomach. He has thrown up twice. 4-5 episodes diarrhea. Body aches. No fever. Little bit of scratchy throat but no itching or difficulty swallowing. No skin rash. Left arm where he got shot is sore but is not red or swollen. He has not taken anything for this. He is concerned he is reacting to the COVID vaccination. Patient describes symptom is mild-to-moderate. But just concerned so he came in. No known infectious exposure.  He is active duty and works as security at the front gate. Air Force is vaccinating all their essential personnel.  Allergies/ Adverse Reactions:  No Known Drug Allergies Allergy (Verified 01/15/21 03:38)
Swelling and pain in arm extending distal to elbow, started within 12 hours of injection
Severe joint pain (can no longer walk without assistance / device); neurological issues (tremor, polyneuropathy, hypersensitivity to touch, neck and chest pain, central sensitization, shooting pain, tingling, numbness); severe fatigue and brainfog; insomnia / difficulty sleeping; severe anxiety, depression, and panic attacks; nightmares; severe muscle weakness and difficulty gripping; swollen and painful lymphnodes in my neck
It wouldn't let me add this, but it was my first Pfizer shot. I started feeling dizzy within the first 30 minutes, and didn't think much of it. Went home and just under 3 hours later, started to feel strange. I felt almost drunk, like my brain was fuzzy. Even more dizzy. Then my tongue swelled. I then had palpitations and felt my heart jump.  The palpitations came and went a few times through the night. I couldn't sleep and experienced some slurring. I then took aspirin and tried to drink a lot of water. I felt scared so asked my parents to call every hour to make sure i was alive. I didn't think to call 911 because I felt so out of it. I had a mild headache that went from my forehead to the back, but it felt more strange than anytthing. The next morning my tongue had several bites all along the edges and top of the edges.  I then got hives on my face, on Sunday, April 11. I took benadryl and put cortizone cream on. I took benadryl again on 4/12. I'm still dizzy and slightly short of breath. i have an appointment with an immunologist for thursday.
vaccinated with expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old male patient who received HAV (Havrix) (batch number Y29KL, expiry date 21st February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 26th October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's comment: Nurse reported that the patient was vaccinated with expired dose of Havrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. Additional Supportive Information:  The patient received a dose of Havrix which was already expired, which led to expired vaccine used.
Got a red rash at the injection site a week after my first moderna vaccine started going away a couple days after now its coming back
Felt a strong heat from the waist down / felt that heat all over her body from her head; Very cold; Pain; Tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt a strong heat from the waist down / felt that heat all over her body from her head), NASOPHARYNGITIS (Very cold), PAIN (Pain) and FATIGUE (Tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced FEELING HOT (Felt a strong heat from the waist down / felt that heat all over her body from her head), NASOPHARYNGITIS (Very cold), PAIN (Pain) and FATIGUE (Tired). At the time of the report, FEELING HOT (Felt a strong heat from the waist down / felt that heat all over her body from her head), NASOPHARYNGITIS (Very cold), PAIN (Pain) and FATIGUE (Tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Heart rate: low (Low) Very low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Same day of vacc. - pain in left arm, difficultyifting left arm, numbness in face and right arm, nausea, fatigue, weakness in limbs, joint pain in right hip, shoulders, legs, arms.  Day after vacc. - migraine, right hip joint pain, weakness in right leg, numbness in face and right arm, nausea, left arm pain, difficulty lifting arm, fatigue, general weakness.
Body Rash and continues to have it since vaccine.  Covers trunk, legs, and every body part intermittently.  Only goes away with treatment and then comes back.
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis and Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease) and Ulcerative colitis (Moderate to severe ulcerative colitis).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was unknown whether patient was enrolled in clinical trial  Co-suspect Humira solution for injection in prefilled pen was taken on an unknown date.  No concomitant medication was reported by reporter.  On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  No treatment medication was reported by reporter.  Causality for the co-suspect Humira was not related.   This case was linked to MOD-2022-580239 (Patient Link).
itching; a rash type thing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old male patient received bnt162b2 (BNT162B2), administration date 20Jan2021 (Lot number: EL3302) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itching"; RASH (non-serious), outcome "unknown", described as "a rash type thing". The events "itching" and "a rash type thing" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pruritus, rash.  Additional information: It was reported that, this report is not related to study or program. Information about other conditions and investigations not provided. Patient is the reporter. He had a lot of itching and a rash type thing going on for quite a while. He said he had shown allergists and dermatologists and they can't seem to find any solutions. He said he had steroid shots, so he wanted to know if the people who manufactured the vaccine have come up with any solutions for this. He said he has heard of other people who have the same thing, he has been on the internet, and everything has side effects.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200503395 same reporter/drug/AE with different patient
Case number PHEH2011US06738 is an initial spontaneous report received from a healthcare professional (pharmacy intern) on 12 Oct 2011 with the follow-up received on 12 Oct 2011. This case refers to a 33-year-old male patient. He was vaccinated with expired MENVEO (batch number: 1000, expiry date: Aug 2011) intramuscularly on 11 Oct 2011. No additional details were reported at the time of this report. Follow up received on 12 Oct 2011: Batch number and expiry date were updated.
This spontaneous report as received from a nurse referring to unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patients received improperly stored doses of VARIVAX lot #, expiration date unknown by reporter (dose, route and frequency unknown) for prophylaxis. The temperature and time frame was reported as 6 degree Fahrenheit) (F) to 14 (F) for 1 hour. There was no previous temperature excursion and data logger was involved.; Sender's Comments: US-009507513-1708USA010747:
Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Headache-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe