chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acute Myopericarditis; headache; myalgias; numbness; tingling; emesis; This is a literature report.  A 15-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "history of fever of 38.8degreeC" (unspecified if ongoing), notes: 1-day history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunisation. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant, life threatening), 3 days after the suspect product(s) administration, outcome "unknown", described as "Acute Myopericarditis"; HEADACHE (non-serious), 3 days after the suspect product(s) administration, outcome "unknown"; MYALGIA (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "myalgias"; HYPOAESTHESIA (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "numbness"; PARAESTHESIA (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "tingling"; VOMITING (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "emesis". The event "acute myopericarditis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase: 399 IU/l; Blood creatine phosphokinase MB: 19 ng/ml; 174 ng/ml; Body temperature: 38.8 Centigrade, notes: history of fever of 38.8degreeC; Brain natriuretic peptide: less than 10; Chest X-ray: normal; Echocardiogram: normal; Electrocardiogram: normal sinus rhythm; All work-up for other potential causes: Negative; returned to baseline normal values; Magnetic resonance imaging heart: acute myopericarditis with a small pericardial, notes: effusion. Mild patchy delayed subepicardial enhancement was also noted in the mid cavity and basal posterolateral wall (suggestive of postinflammatory scarring related to localized myocarditis); Troponin I: 3.18 ng/ml, notes: elevated; 26 ng/ml. Therapeutic measures were taken as a result of myopericarditis.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events MYOPERICARDITIS Cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
150PM mom reported pt leg was swollen & red; also a red line on leg, crying & fussy; advised cold compresses & APAP & notify MD;
Patient under 18 years given Flublok.  Notified parents and they confirmed no adverse events. They will monitor.
Itchy right now / itchy spots on arms and legs; Same rash all over head, to toe, front to back / rash was on trunck and extremitis; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy right now / itchy spots on arms and legs) and RASH (Same rash all over head, to toe, front to back / rash was on trunck and extremitis) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 17-Jul-2018, Thyroid atrophy, Type 2 diabetes mellitus and Hypercholesterolemia. Concomitant products included LEVOTHYROXINE for Atrophy thyroid, AMLODIPINE and LISINOPRIL for Hypertension, METFORMIN for Type 2 diabetes mellitus, VITAMIN B NOS and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced RASH (Same rash all over head, to toe, front to back / rash was on trunck and extremitis). On 28-Apr-2021, the patient experienced PRURITUS (Itchy right now / itchy spots on arms and legs). On 01-May-2021, PRURITUS (Itchy right now / itchy spots on arms and legs) and RASH (Same rash all over head, to toe, front to back / rash was on trunck and extremitis) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided include, patient washed the area and applied disinfectant for relief. The patient was advised to use over the counter cream for pruritus and the therapy is symptomatic relief.   This case was linked to US-MODERNATX, INC.-MOD-2021-097567 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow-up received on 28-Apr-2021: concomitant medications, past medical history, event details and outcome updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-097567:Dose 1
1/8 vaccination Almost 72 hours later, fatigue, itching in a few spots, I saw hives/welts on couple different areas on upper arms, upper thighs. Very big and itchy. I took some Claritin. Those welts continued to grow and spread;  Upper inner arms, flanks, inner thighs.  Continued throughout the night  *took pictures of welts Took some Benadryl at night. Woke up; symptoms still there and extended even more to include hands. I went to work. I wasn't feeling ill but uncomfortable. Took some more antihistamines. It got worse thru the day. No SOB.  1/12 noon Different kind of rash, petechia in appearance.; shins. My knees, ankles, feet were starting to swell.  Hives had gone from the thighs and up, But below, shins to feet, were swelling.  1/13 I woke up to a lacy rash over all extremities. Bruising on shins. Knees, hands and feet still swollen.  Started Oral steroid. By noon that day, pretty much everything had cleared up. Six day course treatment, no symptoms came back. No fever. No SOB. I did miss work the 1/13 as it was at its worse.
After vaccine patient went to the observation area.  After a minute she began to feel lightheaded and waved to alert us.  I went out to check on her and she began unresponsive and limp.  I helped her to the floor and began check for a pulse, at which point she opened her eyes and began talking.  EMS was already on the way so came and check her vitals.  Patient had no other issues and was allowed to leave
Driving home and hit several trees; Van was totaled; Patient mentioned that patient could not stay awake after the dose/could not stay awake/3-4 hours nap; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Patient mentioned that patient could not stay awake after the dose/could not stay awake/3-4 hours nap), DISTURBANCE IN ATTENTION (Driving home and hit several trees) and ACCIDENT (Van was totaled) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 200GC21A) for COVID-19 vaccination.     The patient's past medical history included Loss of consciousness. Concurrent medical conditions included Seizure. Concomitant products included LEVETIRACETAM for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced SOMNOLENCE (Patient mentioned that patient could not stay awake after the dose/could not stay awake/3-4 hours nap). On 24-Apr-2021, the patient experienced DISTURBANCE IN ATTENTION (Driving home and hit several trees) and ACCIDENT (Van was totaled). At the time of the report, SOMNOLENCE (Patient mentioned that patient could not stay awake after the dose/could not stay awake/3-4 hours nap), DISTURBANCE IN ATTENTION (Driving home and hit several trees) and ACCIDENT (Van was totaled) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Blood test: normal normal (normal) normal. On 21-Apr-2021, Sleep study: normal normal (normal) normal.         This case was linked to MOD-2021-095406 (Patient Link).
Had generalized mandrual seizure one hr after 3rd dose of hep B injection. Had 4 episodes of seizures in 24 hrs. H/O seizures-had seizure 2 years ago. Was on Depakob until a year ago.
13:40 dizziness/vertigo feeling.  14:25 nausea, headache, dizziness.  Went to Emergency room in our hospital to get checked out.  My blood pressure was severely elevated, felt unwell, headache increased in  intensity, nausea worsened & dizziness.
Congestion; Cough; Few pains in body; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion), COUGH (Cough) and PAIN (Few pains in body) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 026D21A, 029K20A and 039K20A) for COVID-19 vaccination.    Co-suspect product included non-company product PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for an unknown indication.    Concurrent medical conditions included Atrial fibrillation (Patient has A-fib but it fairly healthy). Concomitant products included WARFARIN SODIUM (JANTOVEN) for Atrial fibrillation.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) (unknown route) 1 dosage form. In April 2022, the patient experienced NASAL CONGESTION (Congestion), COUGH (Cough) and PAIN (Few pains in body). At the time of the report, NASAL CONGESTION (Congestion), COUGH (Cough) and PAIN (Few pains in body) outcome was unknown.            It mentioned that according to patient history patient is eligible to receive two of the Pneumonia vaccines.  Patient got the 2nd booster and Pneumovax in different arms but couldn't remember which arm for which vaccine. Patient stated that patient never had any of these events from other vaccines.  Patient didn't taken any medications for adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Non significant follow up received.
New onset generalized tonic-clonic seizures the next day. Had full workup, including CBC, electrolytes, lumbar puncture, head CT, EEG, all negative. Treated with antiseizure medications and hospitalized for 3 days. 9/24/09 Discharge summary received for date of service 8/15/09. Assessment seen in ER for generalized seizures x3. One at home and 2 at ER.
6/3/15 Reported fine rash all over body and pain in fingers and right shoulder. Fingers are also swollen. 6/9/15 Rash and pain/swelling in fingers has resolved. Pain continues in right shoulder.
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: open sores near arm pit areas-Medium, Additional Details: pt reported having open sores near armpit area since receiving the second vaccine. he has tried benadryl which hasnt helped, was advised to seek a doctor as he described it as painful.
dizziness; brain fog; vision issues; balance issues; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 10Mar2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included migraine from an unknown date and unknown if ongoing, kidney stones from an unknown date and unknown if ongoing. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included tizanidine hydrochloride (ZANAFLEX); amitriptilina [amitriptyline] (AMITRIPTILINA); and topiramate (TOPAMAX), all taken for an unspecified indication, start and stop date were not reported. Tizanidine, amitriptyline, and topiramate were taken within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient previously received the first dose of BNT162b2 on 10Feb2021 at 12:00 (at the age of 42-years-old) for COVID-19 immunisation. On an unknown date after the second vaccination, the patient experienced dizziness, brain fog, vision issues, balance issues. Therapeutic measures were taken as a result of dizziness, brain fog, vision issues, balance issues included anti-inflammatory steroid. Clinical outcome of the events dizziness, brain fog, vision issues, balance issues was not recovered.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021284020 same reporter/ patient, different drug dose/ AE.
I have a swollen large red lump at injection site. It feels like a softball under my skin. Painful and warm to touch. Also have had side effects fever, chills, body aches, headache, nausea.
Around of the middle of June 2021,  I started having trouble breathing, coughing a lot and coughing phlegm.  No fever.   These symptoms did not go away so I went to see a doctor.  I was prescribed Albuterol inhaler which did not seem to help.  I also tested negative for Covid. I did go see a pulmonlogist who could not find anything wrong.  The symptoms took about a month to resolve.
This case was reported by a healthcare professional sales representative and described the occurrence of anaphylactic reaction in a 19-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline), FLUVARIX, THYPOID (unspecified non-GSK manufacturer) and Yellow fever (unspecified non-GSK manufacturer). The subject's medical history concurrent conditions, and concurrent medications were not reported. On the afternoon of 1 November 2007 the subject received 1st dose of HAVRIX (unknown, adult dose), 1st dose of FLUARIX (unknown), unspecified dose of Typhoid vaccine (unknown), and unspecified dose of Yellow fever (unknown). The sites of administration of the vaccines were not provided. On 1 November 2007, less than one day after vaccination with FLUVARIX, HAVRIX, Typhoid vaccine and Yellow fever, the subject experienced anaphylactic reaction. The subject was treated in an emergency room. The exact time to the onset of the event, after vaccination was not known.  The vaccination course with HAVRIX was discontinued. At the time of initial reporting, 02 November 2007, the event was resolved. The healthcare professional reported to the sales representative that she did not know which of the vaccines may have cause the event. Note: Anaphylactic reaction was assessed as medically serious by GSK.
Pt developed hives within 30-60 minutes of her vaccines. She received her 3rd Pediarix, Rotateq, PCV13, Hib and her first Influenza vaccine. She still had hives when I saw her the next day.
My reaction was within 15mins with hives , itching  and redness over my body. And tongue swelling. I took Benadryl as soon as I started itching  do to I was familiar of my reactions  of latex and keFlix. Then I follow up with my primary doctor  as well as the Pharmacy.
Discharge Provider:  Primary Care Provider:  DO Admission Date: 12/20/2022 Discharge Date: Dec 27, 2022 COVID positive 12/20/2022 PRESENTING PROBLEM: COPD exacerbation Respiratory tract infection due to COVID-19 virus   HOSPITAL COURSE: Patient is a 59 y.o. female with PMHx of RA on humira and prednisone, chronic respiratory failure on 2L with ILD and pulmonary fibrosis, COPD, emphysema, HLD, migraine, NASH, DM who presented with COVID-19 pneumonia.   Patient's symptoms started on 12/17/22 with dyspnea, non-productive cough, aches, and fatigue. She took a home COVID test which returned positive. She was referred to COVID clinic and they met with her remotely. They had concerns about her respiratory status and referred her to the ER for further evaluation.    In the ER, her COVID test was positive. CXR showed left basilar discoid atelectasis. She did not get a CTA due to contrast allergy, though she is open to it. CBC and CMP largely unremarkable. LA was 0.9. Procal was 0.14. She attempted to ambulate and her symptoms were significantly worse. Her HR elevated to 130's-140's. Given her progressive symptoms, and unstable vitals with minimal ambulation, she was admitted to medicine for further management of COVID.   Patient was initially is based on dexamethasone and remdesivir for COVID infection.  Due to presence of interstitial lung disease and immunosuppression pulmonology was consulted.  Patient was transitioned to aggressive IV steroid regimen.  With improvement in respiratory status patient was transitioned to steroid taper.  Patient on baseline steroid use of 10 mg daily.  CellCept was held during this admission and can be resumed after holding it for total 2 weeks.  Patient's oxygen saturations improved to baseline 2 L per nasal cannula.   Patient had elevated blood sugars in the presence of aggressive steroid regimen.  As steroids are being weaned on blood sugar should improve.   Patient was cleared for discharge..
This spontaneous prospective pregnancy report was received from a 29 year old female patient regarding herself. No medical history was reported. On 08-MAR-2013, the patient was vaccinated with (merck) VARIVAX (lot #,dose not reported) and the patient is currently pregnant. Other suspect therapies included rubella virus vaccine live (Manufacturer unknown), tetanus toxoid(Manufacturer unknown) and hepatitis b vaccine (recombinant) (Manufacturer unknown). The LMP and EDD is not known. The pregnancy outcome was pending. On 10-MAR-2013, the patient experienced red itchy bumps on her legs, arms and neck. Blood work was done last week(results not reported). The outcome of red itchy bumps on her legs, arms and neck was unknown. Additional information has been requested.
Information has been received from a reporter via social media concerning eight patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the patients received HPV vaccine (manufacturer unknown) (lot#, expire date, dose and route unknown). On unknown dates, the patients died. It was unknown if autopsy was done. The relationship between the events and vaccine was not confirmed. Upon internal review, death was determined to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected because of lack of privately contactable information for the reporter. This is a new safety report and has been created due to safety report "US-009507513-1610JPN011009" having been created with the incorrect primary source country code. Unfortunately our system is not fully ICH-E2B (R2) compliant, so US-009507513-1610JPN011009 is being nullified and we have created this new safety report ID to reflect the correct country code. US-009507513-1610JPN011009 is now listed as an E2B Report Duplicate.
This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown. On 05-FEB-2019, the patient was vaccinated with an expired dose of ZOSTAVAX for prophylaxis, lot # N023002 and expiration date 20-NOV-2018 (dose, strength, frequency and route of administration were unknown). No adverse symptoms were reported.
A few days after the first vaccine my lips became very large, swollen, and I developed a very bad rash-like chapping around the outer edge of my lips.  My lips were very sore and peeled and peeled. This lasted at least a month, and just started to go away when I received the second vaccine on 4/7/2021. The rash-like chapping has continued to a lesser degree until now, off and on for months after receiving the vaccine. My lips still also get slightly swollen as well. Not quite as bad as right after the first shot, but slightly swollen. The chapping peels off, and then the cycle starts all over again.  My lips are swollen today, and beginning to chap again.
hours after first vaccine administered patient reported hive like lesions on the abdomen with pruritus, continued to be present x several days, denied initial SOB, wheezing, diarrhea, fatigue; after several days on the 18th of Sept patient noted sudden increase in symptoms, spreading to abdomen, flanks  then on the 20th had some mild SOB, was seen in the ER and likely given dexamethasone tabs, no response, evaluated by myself (Dermatologist), reaction c/w morbilliform drug eruption, treated with prednisone taper, topical steroids and atarax and avoidance of second pfizer vaccine recommended
Initial report received from a consumer who is also the patient on 25 October 2012 and follow up information received on 26 October 2012. A female patient, whose age, medical history and concomitant medications were not reported, received a dose of flu vaccine manufacturer unknown (lot number, route and site of vaccination not reported) on 18 October 2012. On an unspecified date, after vaccination the patient developed laryngitis and flu symptoms. Corrective medications and laboratory investigations were not reported. The patient's outcome was not recovered. List of documents held by sender: None. Follow-up information received from a healthcare professional on 21 February 2013. A 68-year-old patient received 11th dose of FLUZONE with lot number: UH729AB in right deltoid. At the time of this report, the outcome of the patient was not reported.
9.5 x 10.5 cm local reaction to Tdap 2 days after administered to (L) deltoid. Rx BENADRYL, ice, Ibuprofen. Improved 10/2/14.
Pt c/o IM site became very hot flush to face rash and redness at IM site size of baseball pt describes rush feeling not feeling well sl blurred vision denied SOB B/P 120/80 HR 78 remains talking no SE of anaphylaxis applied cool compress to site IM inc increased fluids observed 15 min symptoms slowly dissipated.