chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Area approximately 30mm in size - red and warm to touch. Area has 4-5 raised areas approximately 5mm in size. Complained of tenderness and itching. Seen by MD and placed on ACYCLOVIR 800mg 5x/d x 7d.
Atrial fibrillation with rapid ventricular response; Felt loopy; 64 percentage Left ventricular hypertrophy; Hepatomegaly; BNP 137 slightly high; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 1 day after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: Atrial fibrillation with rapid ventricular response) (serious criteria hospitalization and GSK medically significant), feeling drunk (Verbatim: Felt loopy) (serious criteria hospitalization), left ventricular hypertrophy (Verbatim: 64 percentage Left ventricular hypertrophy) (serious criteria hospitalization), hepatomegaly (Verbatim: Hepatomegaly) (serious criteria hospitalization) and brain natriuretic peptide increased (Verbatim: BNP 137 slightly high) (serious criteria hospitalization). The patient was treated with diltiazem. The outcome of the atrial fibrillation was not resolved and the outcome of the feeling drunk, left ventricular hypertrophy, hepatomegaly and brain natriuretic peptide increased were not reported.   It was unknown if the reporter considered the atrial fibrillation, feeling drunk, left ventricular hypertrophy, hepatomegaly and brain natriuretic peptide increased to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation, feeling drunk, left ventricular hypertrophy, hepatomegaly and brain natriuretic peptide increased to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-Nov-2023 The reporter reported that atrial fibrillation with rapid ventricular response new onset rate now controlled on Diltiazem however A fib persists.  Only symptoms felt loopy Wife was a physician and heard A fib upon auscultation hospitalized for 2 days at hospital. Follow-up would not possible as no contact details were available.
Both arms are swollen and red feeling fatigue and hasn't been feeling well since the vaccines were administered.
During sleep our 4 month old had a seizure. Eyes rolling back, foaming mouth, body twitching and jerking. We then went to the ER and they sent us home. Once home at 11:15 pm she had another seizure. We were then admitted to another hospital.
Next day she had severe fatigue, hot flashes, headaches, body aches, and 3 diarrhea stools. Denies ever having a fever. (However she takes meloxicam daily due to residual dyspnea and pleuritic pain s/p covid infection )
I was vaccinated on Friday morning. Everything seemed OK. On the next day Saturday, I felt some numbness on me left upper lip and right tooth. The numbness increased and changed to my left face paralysis. I could not chew or close my left eye totally. My husband brought me to the ER on Tuesday morning. They diagnosed that I had peripheral Bell's palsy and gave prescription to me with antivirus medicine, prednison, eye oilment and eye drops, and shield to cover my left eye while I go to sleep. Today is Friday, one week after I got vaccinated. I also go to get acupuncture.
Itchy rash; Pressure on her chest; Very pale; Joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Itchy rash), CHEST PAIN (Pressure on her chest), PALLOR (Very pale) and ARTHRALGIA (Joint pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Non-Hodgkin's lymphoma and Drug allergy (Allergic to a certain chemotherapy during treatment).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced RASH PRURITIC (Itchy rash), CHEST PAIN (Pressure on her chest), PALLOR (Very pale) and ARTHRALGIA (Joint pain). On 25-Feb-2021, CHEST PAIN (Pressure on her chest) and PALLOR (Very pale) had resolved. At the time of the report, RASH PRURITIC (Itchy rash) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include chemotherapy Treatment medications included loratadine, diphenhydramine and calamine lotion
This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via unspecified route of administration on 17Apr2021 as single dose for COVID-19 immunization. Medical history, concomitant medication or past drug history of the patient were not reported. On 17Apr2021, 17 minutes after receiving first dose of vaccination, patient had a severe reaction and developed dry throat, swelling of the lips, hands, mouth, and tongue. She also experienced numbness of her tongue as well. Patient was initially given benadryl, steroids, and currently taking Zyrtec 30mg, and Pepcid 40mg. On an unspecified date in 2021, patient had nine "flare-ups" since first dose, her flare-ups has "itchy skin", skin redness and "feels like a sunburn", inside of her mouth feels tingling and numb, cheek numbness, and her lips swell. Patient had total of 9 reactions and 6 rounds of steroids since. HCP said that she may be reacting to the polyethylene glycol (PEG). She did see an allergist. PEG seems to be in her life a lot, deodorant, hairspray, toothpaste, etc., so she stated that she had been exposed to it a lot and had since removed it as much as possible. Reports that she went to a 2nd allergist to figure out what it was. Therapeutic measures taken in response to the event included benadryl, steroids, Zyrtec 30mg, and Pepcid 40mg. Outcome of the events were unknown. Follow-up attempts are needed. Information on Lot/Batch number can be requested.
Myalgia, Fever, low grade fever, sore throat, aches, fatigue Narrative:  Other Relevant History:
Right deltoid red, warm. Patient w/nausea, weakness, chills. Was seen 72 hrs later. Given Rx for ZOFRAN and Ibuprofen.
severe nausea for 7 days, vomited 3 times, extreme arm pain.
This spontaneous report as received from a healthcare worker refers to two patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX batch/lot number, expiration date not provided, 0.5 ml, subcutaneous, exposed to -14 degrees Celsius for 731 hours. No adverse events were reported. Additional information has been requested.
Patient fainted a few minutes after administration of Pfizer COVID Vaccine (1st dose), regain consciousness  within 30 seconds, looks pale, strange feelings, "in a dream", a few minutes later, she fainted again, but regain consciousness within 10 seconds, talking, feeling tongue tingling, warms on the head and back, applied Cold pack to the forehead, then she felt cold.  Ambulance was called.  She looks pale but talking, as we wait for the EMS to arrive, she seemed to getting better, able to drink small cup of water, pulse normal, breathing normal.  When EMS arrived, suggested to be taken to hospital for observation, agreed by the father, needed assistance to stand up from seating on chair.
PATIENT IS 17 YRS OLD AND RECIEVED MODERNA VACCINE INSTEAD OF PFIZER. HE STAYED WITH PARENT IN CLINIC FOR 20 MINS WITHOUT INCIDENT
Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Medium
Starting after second vaccine developed POTS, persistent sinus tachycardia, SOB (dyspenea), ovaries started functioning again with cyclical menses and removed and stopped HRT (and ruled out PMP bleeding), syncopal episodes resulting in injuries, Myalgic encephaitis, CFS/fibromyalgia, MCA-S, TIA's, IBS,  Loop recorder inserted.  Numerous EKG's.  Injuries from new onset of syncopal epidsodes
Swollen right neck Lymph node- CT Scan shows neck mass and thyroid obliterated.  biopsied 6 days after dose #2 and diagnosed with Thyroid cancer!  This is the 3rd case of thyroid cancer I've heard of that starts b/w doses 1 and 2 of moderna!!!
1-2 hrs p/DTP/HIB pt was noticed by mom to become limp & blue while pt was sitting on a walker; pt was not breathing & not responsive to calling or shaking; up-rolling eyes were noted but no tonic jerky movements of limbs; pt cried;
Onset of tachycardia 5 minutes after injection which lasted 10-15 minutes. Resolved by itself.
Mother indicated that client sat down and requested water to drink. Mother began to look for water and noticed client begin to slump in chair. Staff assisted in easing client to the ground. Feet were elevated. EMS and NP paged. VS #1 BP: 106/57, HR: 49, O2: 98%. Gatorade and water provided along with snacks. Client assisted into sitting position, VS #2 BP: 129/62, HR: 66, O2: 98%. Observed pale lips, cold and clammy. Mother offered hx of fainting after blood draw at a young age. VS #3 BP: 119/64, HR: 74, O2: 98%. Client c/o dizziness, feeling cold and was clammy. Client assisted onto back and feet elevated. At 0923, 911 called. VS #4 BP: 128/55, HR: 51, O2: 99%. EKG strip read by NP - normal sinus. VS# 5 BP: 114/63, HR: 63, O2: 99%. Ambulance arrived on location at 0927. VS #6 BP: 114/73, HR: 75, O2: 98%. Client transported to ambulance at 0930 for assessment. At 0946, EMS released client into the care of his mother and client exited the location in their vehicle. Client admitted he had not consumed any alcohol or drugs.
Patient was nervous/agitated prior to shot. Patient told  vaccinator that is was all psychosematic and to not to worry. About 3 minutes after injection, patient stated he felt faint. Another staff member noticed he was bobbing his head around. Patient got up from chair and laid on the floor. Staff raised his feet. Once patient was feeling more stable, we moved him to a lift chair in the flat position. Patient stated he gets faint with other vaccines.
Dizziness, fatigue, fever, aches around the injection, weakness. Cough, headache, hoarseness. Resulted in me leaving work 4 hours early, due to not being able to stand up.
Seizure lasting about 1 1/2 minutes with vomiting afterwards off and on for 30 minutes. He was very tired on the 24th.
Left deltoid area red hot to touch, has had some fever the first day only.  Mother seems to think this was normal for him.  Child has been itching, scratching area.  DTAP 5th.  Child eating and sleeping, playing around normal.
was sleepy; around noon pain in chest, goes away and then starts again, hurts me a lot; experienced arm sore and a lot of pain; was not feeling very well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (experienced arm sore and a lot of pain), MALAISE (was not feeling very well), SOMNOLENCE (was sleepy) and CHEST PAIN (around noon pain in chest, goes away and then starts again, hurts me a lot) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Colitis and Thyroiditis, unspecified.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (experienced arm sore and a lot of pain) and MALAISE (was not feeling very well). On 19-Mar-2021, the patient experienced SOMNOLENCE (was sleepy) and CHEST PAIN (around noon pain in chest, goes away and then starts again, hurts me a lot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (experienced arm sore and a lot of pain), MALAISE (was not feeling very well), SOMNOLENCE (was sleepy) and CHEST PAIN (around noon pain in chest, goes away and then starts again, hurts me a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included deep breaths. Patient reported that she takes lots of medications.
approximately 12 hours post vaccine patient experienced swelling of her left eye in conjunction with flu-like symptoms. This eye swelling has persisted and is still present today (04/16/2021). It has not affected her vision, and she reports there has been no drainage. She describes the swelling and discoloration as if she "has a black eye" although she denies any incident that would have caused an injury to the affected eye.  She also reports that the edema has been shifting and changing color.
none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, and refers to a 49 years old male patient with chronic lymphocytic leukaemia. He received 2 courses of antibiotics in the year before enrollment. Prior to ibrutinib, the patient was on therapy with rituxinib.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 5. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 5. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The authors considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of ten reports derived from the same literature article (cross referenced with MARRS# US-009507513-2103USA003406).  Literature report:  Sender's Comments:  US-009507513-2103USA003406:
Injection occurred at approximately 1015am local on 12/28. Extreme lethargy began at approximately 8pm. At 2am following morning (12/29), I woke and was unable to return to sleep. I had extreme back and muscle main, as well as pain at injection site. I had a low grade fever. I took ibuprofen and/or acetaminophen every 4-6 hours. Low grade fever subsided by mid-day, however muscle pain and injection site pain continues at time of this report (12/30 at 0730). I am applying topical pain relievers to assist with muscle pain.
14 year old given vaccine ~ 6 months ago; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old given vaccine ~ 6 months ago) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE. In 2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old given vaccine had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.
severe leg cramps; light fatigue; pain in the injection site; Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), MUSCLE SPASMS (severe leg cramps), FATIGUE (light fatigue) and VACCINATION SITE PAIN (pain in the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (Light headedness), FATIGUE (light fatigue) and VACCINATION SITE PAIN (pain in the injection site). On an unknown date, the patient experienced MUSCLE SPASMS (severe leg cramps). The patient was treated with FOLIC ACID for Folic acid supplementation, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Light headedness), MUSCLE SPASMS (severe leg cramps), FATIGUE (light fatigue) and VACCINATION SITE PAIN (pain in the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood folate: low (Low) low folic acid test.         Concomitant medication was not reported. Other treatment information included something cold on the cramps.   This case was linked to MOD-2021-255303 (Patient Link).
Left arm 2 inches below injection site to the elbow  became red and swollen, warm to touch and itchy . Started swelling with redness a few hours after injection and continued to swell and expand in redness the next day
pt cried p/vax then 3-4min later became pale;no apnea;responded immediately to touch & voice stimuli then became pale;no tx given;
very labored breathing i used albuterol nebulizer for breathing treatments to relieve symptoms. symptoms lasted for 2 days.
Per patient, he developed chills, subjective fevers, body aches few hours after the vaccine  on 04/15.  Also developed chest discomfort that progressively got worse over the next 1-2 days which prompted him to visit the ED   on 04/18.   He was found to have troponin elevation  with diffuse J-point elevation.    He received aspirin and was started on heparin drip.   Chest pain completely resolved by the next day. Coronary angiogram was negative. Cardiology attributed stroke elevation and chest pain to myocarditis secondary to vaccine.  Echo was normal with no evidence of pericardial effusion.
3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022; No adverse event; 3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022).    Concomitant medications were not reported.   The patient received Monovalent primary dose.  The excursion occurred in the refrigerator on 03-Oct-2022 and involved 1 unpunctured red cap vial and 3 unpunctured Bivalent Booster vials.Temperature was reported as Minimum 1.76 Celsius and Maximum 1.97Celsius. Temperature excursion duration was reported as 1 Hour and 40 Minutes. On 03-Oct-2022 it was reported that 11 adult patients had received booster doses from the Bivalent vials on 03-Oct-2022  and 05-Oct-2022.                              No treatment information was provided by the reporter.  This case contains information for one of three adult patients who received primary monovalent doses described by the reporter.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 29-MAY-2014, the patient was vaccinated with an improperly stored dose of GARDASIL 5 mg/0.5 ml injection, lot # J013777, expiration date 11-AUG-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to four separate temperature excursions (dates unspecified): the first lasting for 32 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.555555556 degrees Celsius), the second lasting for 260 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius), the third lasting for 152 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius) and the fourth lasting for 492 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.555555556 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt went pale and started seizing up for about 20 secs. Time was around 1120 am 11 July 2011. Pt given oxygen and laid down. Pt returned to normal after doctor cleared.
Patient was given the first dose of Pfizer vaccine in left deltoid.  Approximately 10 minutes into his observation period he started complaining of pain in his ribs, head, chest and back.  Vitals were checked by on site nurse and EMS was called.  EMS arrived and upon their examination they found he had hives on his back.  EMS transported to  Hospital
Pt received ZOSTAVAX Monday 12-30-13, started feeling malaise and "achy" Wed 1-1-14 and started noticing rash by Saturday 1-4-14 rash spread from lower back all the way around on left side only and down to groin. Went to walk in clinic Sunday 1-5-14 and was prescribed VALTREX 1 gram 1 tablet by mouth every 8 hours. Has not seen improvement as of today 1-8-14 will follow-up with Dr in a weeks time. Pt diagnose with shingles.