chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Laryngeal swelling with laryngitis; extreme fatigue; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of LARYNGITIS (Laryngeal swelling with laryngitis), FATIGUE (extreme fatigue) and PYREXIA (fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Milk allergy, Fruit allergy (Allergic to pineapple) and Seasonal allergy.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced LARYNGITIS (Laryngeal swelling with laryngitis) (seriousness criterion medically significant), FATIGUE (extreme fatigue) (seriousness criterion medically significant) and PYREXIA (fever) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, LARYNGITIS (Laryngeal swelling with laryngitis), FATIGUE (extreme fatigue) and PYREXIA (fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported by reporter.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded The case was reported as serious but on an event level described as non-serious for each criterion.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded  The case was reported as serious but on an event level described as non-serious for each criterion.
The initial symptoms were a strange feeling in several places in the upper left arm, but not at the injection site.  Not exactly itchy, but just  slightly sore.  Was intermittent.  This was first noticed about 12 days after the first COVID-19 shot.  It was noticed several times over the next two days or so.  Around midnight on the 15th day after the shot I noticed a red rash developing on my chest.  Just a few red blotches, flat and not itchy or sore.  On the 16th day I noticed a marked decrease in energy and some general soreness in the body, similar to a fluish feel.  These symptoms increased on days 17 and 18 and the rash got progressively worse, getting much redder and becoming raised.  It developed over the left side of my upper chest, starting just outside the left armpit and spreading over to mid-chest, but not past.  The lowest part is on the left nipple.  On the back the rash is slight on the back of the upper left arm, and starts on the upper back just outside the left armpit and spreads over almost to the mid-back, maybe 5 inches from top of rash to bottom.
Patient received J&J vaccine 5/8, developed SOB 2 days ago, came to hospital last night and found to have pulmonary embolism and thrombocytopenia
Four days after receiving my second dose, I started to experience tightness in my chest. It was very hard for me to breathe and there would be a sharp pain that would take my breath away. I went to the hospital ER and was diagnosed with pneumonia. I was given steroids and sent home. About two weeks later, I started to have red streaks down my arm. I went to see my doctor and they told me to try ice packs and heating pads on them and to monitor them. I started to have complications breathing again and I went to a local medical center. There, they found I had a blood clot in my liver and kidney. I was admitted for a few days. They were trying blood thinners, but they were not working. I was eventually given a medication that I have to inject myself with every 12 hours. I will, more than likely, be doing this for the rest of my life. As of now, I am being monitored and following up with a Hematologist, monthly. They are making sure that the injections are working for the blood thinner. They also noticed that my platelets were dropping so I am taking injections to increase them now too. I am now diagnosed with antiphospholipid and thrombocytopenia. I was hospitalized another time, at the hospital, because I couldn't breathe. They found that I had a blood clot in my lung. I was in the ER for 7 days. I am still being tested on and having my blood checked. They also think, about 95% sure, I have lupus and I do have lupus anticoagulant.
GETTING SORES; PAINS IN LEGS; HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced getting sores, pains in legs, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pains in legs, headaches and getting sores was not reported. This report was non-serious.
On 08/27/2021, my left lower eye lid became quite red and painful, a lot of weeping from the eye or tearing. On 08/31/2021, I went to see my doctor. She wondered if I didn't have an allergic reaction. She wanted me to call her the next day, 09/01/2021 and it wasn't getting better. I went to the vision care clinic, she prescribed the antibiotics, Keflex, the pharmacy gave me cephalexin. I got 5 doses in and it wasn't getting better. On 09/02/2021 I saw her partner and it was worse I had a large bump and it was painful. He examined my eye and gave me a steroid drops and told me to continue the prescription plan. He told me to continue with the antibiotics and icing. I am not totally recovered from the AE, but it has improved, you can still see there is a little growth or lump there, about a 1/4 of an inch. It's small and not painful today and I think I am on the road to recovery.
Discharge Provider: Primary Care Physician at Discharge: Admission Date: 4/19/2023 PRESENTING PROBLEM: Acute respiratory failure with hypoxemia [J96.01] COVID-19 virus infection [U07.1] Acute on chronic respiratory failure with hypoxia [J96.21]   HOSPITAL COURSE: Patient is a 65 yr old M with PMHx of recently diagnosed metastatic right lung adenocarcinoma (3/2023), CAD s/p CABG in 2021 with post-operative atrial fibrillation (no longer on anticoagulation), HTN, 40 pack year smoking hx, chronic right shoulder pain 2/2 rotator cuff tear and cancer pain who presented to the ED in respiratory distress. At baseline, he is on 3L nasal cannula at home and dyspneic on exertion but noticed worsening shortness of breath and profound fatigue Visiting palliative care home nurse found the patient to be hypoxic to 70% on room air and hypotensive, thus EMS was called.   On admission he was placed on a non-rebreather mask then BIPAP.  He was found to be tachycardic in the 130s to 140s with EKG showing atrial flutter.  CT angiogram thorax with contrast was negative for PE but showed extensive mixed consolidation and ground-glass opacities of bilateral lungs as well as interval enlargement of the metastatic disease.    In the intensive care unit, he was found to have COVID 19 and treated with tocilizumab, remdemisvir, steroids, and broad-spectrum antibiotics.  His work of breathing improved and was subsequently moved off of BiPAP and transitioned to high-flow nasal cannula.    He remained on high-flow nasal cannula with slow titration.  Pulmonology consulted and he completed 10 days of remdesivir and 10 days of Decadron.  A tapering dose of prednisone was planned after.  He was started on IV Lasix to facility the negative fluid balance.  SLP consulted recommended general nectar thick liquids.  He was initially placed on Rocephin and azithromycin then cefepime.  With negative cultures, antibiotics were discontinued.   Regarding his atrial flutter and RVR he was placed on amiodarone metoprolol increased to 50 mg 2 times a day and Cardizem.  Heparin drip transition to oral Eliquis. Seen by pulmonology, concern for lymphangitic spread of lung cancer, recommended hospice.  Continued to require 100% FiO2 via high-flow nasal cannula, due to overall poor prognosis, patient and family agreed for hospice. Patient continued to decline and was made comfort care before passing on 5/10/23.  Date of Death: 5/10/23 Time of Death:  1:17 AM Preliminary Cause of Death: Hypoxia       Discharge Disposition: Deceased
No additional AE reported; ROTATEQ were administered after a temperature excursion; This spontaneous report has been received from a health care professional (HCP) concerning a 6-month-old female patient. Her concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unknown date in 2022, the patient was vaccinated with the first and second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered as prophylaxis, taken orally (dosage regimen, lot number and expiration date were not provided). On 01-DEC-2022, the several vaccines underwent a temperature excursion of 47.9 F for 47 minutes. On 27-DEC-2022, the patient was vaccinated with an improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered as prophylaxis, taken orally, lot number 1892784 with expiration date 03-DEC-2023 (dosage regimen was not provided) (Product storage error). No previous temperature excursions were reported. No additional adverse event was reported (No adverse event).    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175:
About 6 hrs after I got it I started having a severe headache (the worst I ever had) and I laid down and went to sleep. Woke up in the middle of the night with chills, severe arm pain and my temp was 100.1F, I went back to bed and next day no energy, I stayed in bed most of the day. A shower would take all my energy. No taste I had appetite though. The only thing I could taste was salt, no flavor. Nauseous for the next few days, general malaise. 3/4 days I could only stand crackers and ginger ale. Thursday night I started having taste again. I went to the Drive Thru clinic and they tested me for Flu strand A and B and covid and all negative. The following week I got tested again and it came back negative as well.
Vaccines given, within 1 minute after administration RA site became inflamed, swollen. Within 2 minutes swelling and redness diminished. No f/u treatment.
Caller states that on 1/17/2007 complained of hip pain.  On 1/19 2007  states that he has not slept for 2 nights because of back and hip pain. States this is different then when he had sciatica before Limping. Leg going numb.  Advised he needs to see his private medical physician.  On 1/12/2007 states MRI showed a back problem. States problems were probably not caused by the yellow fever shot but it may have irritated it.
Patient has to take (Propranolol ER) 60 mg 2x's daily (TOPAMAX) 100 mg 2x's daily has headaches, stomach issues, anxiety, jerking spells. Did EEG showed underlying seizure disorder all issues started after taking first shot. She hasn't and can't get driver's license due to this issue.
Pain in arm immediately after injection. more than anticipated. Pain continuing and shooting down patient's arm with movement. Difficulty lifting arm and moving over head.
Dizzy; Disorientated; Can't balance, fell several times; fell several times; A spontaneous report was received from a consumer and confirmed by a healthcare provided concerning a 73-year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness, disorientation and balance issues falling several times.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 03-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly on unknown arm for prophylaxis of COVID-19 infection.  On 16-FEB-2021, it was reported that the patient was dizzy, disorientated, couldn't balance and fell several times. On 17-FEB-2021, the patient was admitted to the hospital.    Laboratory reports were not provided. Treatment information was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Started feeling tired and weak. Began to get the chills, shaking vigorously. Felt nauseous. As the rest of the day progressed and into the night I developed a fever. The fever did break by the next afternoon. For the next few days I had body ache particularly in  my joints. Especially on Friday Saturday and Sunday I was sleeping a lot!  After four days the fatigue and body ache eased.  I had lost my appetite and was basically eating just once a day. I?m just now regaining my appetite. On Sunday I corresponded with my doctor and he felt it was just a reaction from the tetanus shot.
The adverse event was not related to the vaccines.  I tested positive for Covid-19 on April 26, 4 months after getting the Pfizer vaccine booster and flu shots.  Symptoms, including sore throat,  chest congestion and cough, started on April 22.  I had no fever or other symptoms.
was diagnosed with severe reaction to the2nd vaccine; chest pains; itching on my hands; my arms with welts; my neck turned extremely red and whole body became red; my head felt like fleas were in my head,; threw up twice; This is a spontaneous report from a contactable consumer (patent). A 70-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: en6201) via an unspecified route of administration in left arm on 01Mar2021 13:00 (at age of 70-year-old) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus. Patient had no allergy. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: el9262) via an unspecified route of administration in left arm on 08Feb2021 at 01:00 PM as single dose for COVID-19 immunisation. Concomitant medication was not reported. Patient not had Covid prior vaccination. Patient was not tested for Covid post vaccination. It was reported that on 03Mar2021, 2nd Day after 2nd dose of vaccination, patient starting with itching on her hands, then up arms with welts, her neck turned extremely red, and whole body became red, and her head felt like fleas were in her head, threw up twice before going to the doctor. Patient went to her family doctor and was diagnosed with severe reaction to the 2nd vaccine. Patient's doctor stated 1 percent of patients will have this severe reaction. She was having chest pains which started while she was waiting for her appointment. The doctor prescribed a treatment of prednisone and advised her if she had trouble breathing to go to the emergency room. After taking the medication on 3/3 the itching has stopped, but still had some red marks on her skin. Hopefully the medication treatment (9 days) would clear up skin marks. The outcome of the events was recovering.
This spontaneous report as received from a nurse practitioner via company representative refers to a 64 year old patient of unknown gender. On 10-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (route, lot # and expiration date were not provided). On 11-SEP-2014, the patient developed redness and tenderness at the injection site. The patient called the office and was advised to take BENADRYL. On 12-SEP-2014, the patient went to the office and was diagnosed with an abscess at the injection site. On approximately 12-SEP-2014, the area of the abscess had a line of blisters. The patient was prescribed an unspecified antibiotic medication. At the time of the report, the patient's status was unknown. Additional information has been requested.
Felt fine day 1, 2nd day i started having seizures off and on for 1 week. For 2 days after initial dose constant twitch of lower right lip for 2 days. Still having off and on numbness in right arm. Se; Felt fine day 1, 2nd day i started having seizures off and on for 1 week. For 2 days after initial dose constant twitch of lower right lip for 2 days. Still having off and on numbness in right arm. Se; Felt fine day 1, 2nd day i started having seizures off and on for 1 week. For 2 days after initial dose constant twitch of lower right lip for 2 days. Still having off and on numbness in right arm. Se; Felt fine day 1, 2nd day i started having seizures off and on for 1 week. For 2 days after initial dose constant twitch of lower right lip for 2 days. Still having off and on numbness in right arm. Se; This is a spontaneous report from a contactable Nurse (patient).   A 41-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number FC3181), via an unspecified route of administration in Arm Right on 08Aug2021 at 16:00 (at 41 years) as single dose for covid-19 immunisation. Medical history included Epilepsy, Hashimoto,lupus, Inflammatory bowel disease (IBD) , autoimmune liver hepatitis and seizure (seizure norm was one or two a month). No Covid prior vaccination, nor Covid tested post vaccination. The patient had known allergies to Penicillin (Pcn), duloxetine hydrochloride (CYMBALTA), pseudoephedrine and azithromycin (ZITHROMAX Z-PACK).Concomitant medications included levetiracetam (KEPPRA), hydroxychloroquine (HYDROXYCHLOROQUIN), levothyroxine, vitamin D all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. Patient felt fine on day 1 (08Aug2021); on the 2nd day (09Aug2021) she started having seizures off and on for 1 week and for 2 days after initial dose, constant twitch of lower right lip. Patient still having off and on numbness in right arm since 09Aug2021. Seizures seem to be slowing. Her seizure norm was one or two a month. After vaccine it was multiple seizure in one day. Headache started on 09Aug2021 barely relieved by TYLENOL.No treatment given for the other events. Events resulted all in Doctor or other healthcare professional office/clinic visit. The final outcome of all the events was reported as  recovering.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Seizures  . The case will be reassessed once new information is available   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.
Mild Asthma; 3 patients received Pfizer covid 19 vaccine orange cap past the expiration date.; Additional Vaccines Administered on Same Date of the Pfizer Suspect: T-DAP -Sanofi, HPV - Merck, Influenza -Sanofi; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team, Program ID.  An 11-year-old female patient received BNT162b2 (BNT162B2), on 05Oct2022 at 16:30 as dose 1 (orange cap), 0.2 ml single (Lot number: FL8095, Expiration Date: 31Aug2022) at the age of 11 years intramuscular, in left deltoid for covid-19 immunisation; influenza vaccine (INFLUENZA), on 05Oct2022 as dose 7, single (Lot number: UT7701KA, Expiration Date: 30Jun2023) intramuscular, in right deltoid for immunisation; hpv vaccine (HPV VACCINE), on 05Oct2022 as dose 1, single (Lot number: 1780878, Expiration Date: 02Dec2023) intramuscular, in right deltoid for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), on 05Oct2022 as dose 1, single (Lot number: U7461AA, Expiration Date: 12Jul2024) intramuscular, in left deltoid for immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing), notes: She takes allergy meds but that was about it. The patient took concomitant medications. Vaccination history included: Influenza vaccine (Dose Number: 01, Sanofi), for Immunization; Influenza vaccine (Dose Number: 02, Sanofi), for Immunization; Influenza vaccine (Dose Number: 03, Sanofi), for Immunization; Influenza vaccine (Dose Number: 04, Sanofi), for Immunization; Influenza vaccine (Dose Number: 05, Sanofi), for Immunization; Influenza vaccine (Dose Number: 06, Sanofi), for Immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 05Oct2022 at 16:30, outcome "unknown", described as "3 patients received Pfizer covid 19 vaccine orange cap past the expiration date."; PRODUCT USE ISSUE (non-serious) with onset 05Oct2022 at 16:30, outcome "unknown", described as "Additional Vaccines Administered on Same Date of the Pfizer Suspect: T-DAP -Sanofi, HPV - Merck, Influenza -Sanofi"; ASTHMA (non-serious), outcome "unknown", described as "Mild Asthma". Therapeutic measures were not taken as a result of asthma.  Additional information: The patient did not administer any other vaccinations within four weeks prior to the first administration date of the suspect vaccine and no AE(s) following prior vaccinations.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201223008 same reporter/drug/event, different patient;US-PFIZER INC-202201223295 same reporter/drug/event, different patient;
Patient fainted after waiting in the for 10 to 15 minutes, reported by the store supervisor patient left the store to the parking lot and fainted in between the entrance door while coming back from outside. Patient was found conscious on the floor and answering all questions asked to verify consciousness. Given bottle of cold water to drink and ice bag treatment at the place of hit. Patient's mom declined our offer to call the EMS and said, "He is fine and he had this fainting history in the past". Then in 10 or so minutes they left while patient was completely observed awake and conscious.
Very dizzy, pale, temp at school, tired acting 5-9-11 through 5-11-11. Pain at injection site.
pt received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 68-year-old male patient who received HAB (Twinrix) (batch number 75C72, expiry date 13th June 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd June 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 23rd June 2022, unknown after receiving Twinrix and Twinrix 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: 23-JUN-2022 Reporter's Comment: The public health nurse reported that on day of reporting, a patient received an expired dose of Twinrix. The vaccine was expired on 13th June 2022. The reporter consented to follow-up. Additional Supportive Information: The patient received a dose of Twinrix vaccine which was already expired, which led to expired vaccine used.