chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion for vaccines; This spontaneous report was received from a nursing assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 03-AUG-2020, the patient received a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, route of administration and anatomical site of vaccination were not reported; lot number S038698, which has been verified to valid, expiration date reported and validated as 01-DEC-2021) as prophylaxis. The administered dose of vaccine experienced the temperature excursion of -10.2 degrees Celsius (multiple) for 1 hour and 53 minutes (product storage error), as recorded by data logger. No previous temperature excursion was reported. The outcome of product storage error is unknown.; Sender's Comments:  US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA014697: US-009507513-2008USA014767: US-009507513-2009USA000113: US-009507513-2008USA014757: US-009507513-2008USA01425: US-009507513-2008USA014888: US-009507513-2008USA014806: US-009507513-2008USA014798: US-009507513-2009USA000117: US-009507513-2008USA014803: US-009507513-2008USA015035: US-009507513-2008USA014820: US-009507513-2008USA014951: US-009507513-2008USA014705: US-009507513-2008USA014950: US-009507513-2008USA014936: US-009507513-2009USA000112: US-009507513-2008USA014871:
3/19/10 Left arm soreness at site of PNEUMOVAX vaccine unmediated. The next day warmth and redness appeared and lasted 2-3 days. This has resolved.
onset of violent uncontrollable rigors approximately 9 hours past injection. Temperature 98.0F. with multiple continuing episodes. No apparent seizure activity; neurologically intact with no deficits. intermittent irregular heartbeat with ectopiesThe issue is currently unresolved.. No history of anxiety disorder or seizures.
Aches, chills, fever (100.7°) headache. All started approximately 14 hours after injection. Symptoms lasted close to 18 hours.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose number unknown (booster), single (Lot number: GJ6738) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing); "high bp" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 22Aug2023 to 26Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291372 Same reporter/ drug/ event for different patients.;
minor client arrived for a second dose of Moderna, he had erroneously (underage) received the first dose of Moderna from a Health Clinic. Site Lead RN escalated to Clinical Operations Coordinator to confirm that per CDC guidelines we would proceed and complete the COVID vaccination series for this minor 17yo.  Client and his mother confirmed no medical illnesses or allergies and no adverse reactions from the first dose.  Client also had no adverse reactions to the second dose during his 15min observation period. Client and his mother were educated on the CDC's recommendations not to vaccinate minors under 18yo with Moderna, but the CDCs approval to proceed and complete the series.
I initially reported my adverse reactions via the vsafe health check in, but it only allowed me to enter symptoms one day. I had 24 hours of moderate symptoms including fever of 100.1, nausea, headache, chills, heart palpitations, tingling in my extremities. On day 3 after my shot I had super high anxiety and several panic attacks resulting in more heart palpitations and dizziness/vertigo. I slept for 15 hours (interrupted) and am still feeling dizzy on day 4 after my vaccination. I feel slight pressure in my head and I do have allergies, so I'm thinking it is related to those, but I'm no doctor. I will definitely seek help if these symptoms don't subside by day 5.
Dizzy; Arm soreness; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (Dizzy) and VACCINATION SITE PAIN (Arm soreness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In March 2021, the patient experienced DIZZINESS (Dizzy) and VACCINATION SITE PAIN (Arm soreness). In March 2021, VACCINATION SITE PAIN (Arm soreness) had resolved. At the time of the report, DIZZINESS (Dizzy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient experienced the event dizzy two weeks after and arm soreness for several days after Moderna vaccine. No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments:  MOD-2021-086818:Case  MOD-2021-086996:Case  MOD-2021-087217:Case  MOD-2021-087097:Case  MOD-2021-085006:Case
3/7/15 Received Tdap, HPV, MENACTRA. Next day developed urticarial (3/8/16). By 3/9/16, urticarial much improved. Concurrent viral illness. Treated urticarial with BENADRYL.
Received vaccination on 04/20/21 and had a sore stiff arm.  Approx. 72 hours later developed a couple dozen canker sores all over in her mouth and developed several fever blisters around her lips.  She took an antiviral medication and this seemed to help them heal, still currently has some canker sores and blisters.  9 days after the vaccination she reports her whole left arm started throbbing  and developed a large red welt that got very large and was very itchy and warm.  10 days after the vaccination her eyelids started burning, itching, tingling and swelling almost shut.  Now her eyelids are currently very red, raw and sore.  She states she has been taking Benadryl for the welt on her arm and the itching eyelids.
Tested positive for COVID-19 with home test on 06-May-2022.; Tested positive for COVID-19 with home test on 06-May-2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58-year-old patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EP6955), on 10Apr2021 as dose 2, single (Lot number: EP6955), on 08Dec2021 as dose 3 (booster), single (Lot number: FJ8762) and on 11Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 58 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Vit D deficiency" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing), notes: Osteoarthritis (knee) all controlled with meds/supplements; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ATORVASTATIN; CALCIUM VIT D; VITAMIN D [COLECALCIFEROL]. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: VACCINATION FAILURE (medically significant) with onset 06May2022, outcome "unknown", COVID-19 (medically significant) with onset 06May2022, outcome "not recovered" and all described as "Tested positive for COVID-19 with home test on 06-May-2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: No other vaccine in four weeks. Tested positive for COVID-19 with home test on 06May2022. Symptom of runny nose began 05May2022. Additional symptoms experienced beginning 06May2022: cough, congestion, loss of sense of taste, headache, low grade fever.  treatment ae include Phenylephrine, Benzonatate, Diphenhydramine, Luden's cough drops. No covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Patient experienced acute cellular rejection ater Moderna vaccine; This literature-non-study case was reported in a literature article and describes the occurrence of TRANSPLANT REJECTION (Patient experienced acute cellular rejection ater Moderna vaccine) in a 71-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     The patient's past medical history included Liver transplant.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSPLANT REJECTION (Patient experienced acute cellular rejection ater Moderna vaccine) (seriousness criterion medically significant). At the time of the report, TRANSPLANT REJECTION (Patient experienced acute cellular rejection ater Moderna vaccine) outcome was unknown. Related      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered TRANSPLANT REJECTION (Patient experienced acute cellular rejection ater Moderna vaccine) to be related.    Company comment: This is a literature-non-study case concerning a 71-year-old male patient with medical history of liver transplant, who experienced the serious (medically significant) unexpected event transplant rejection, after receiving an unspecified dose of mRNA-1273.  Very limited information has been received: Clinical course, diagnostic tests and treatment details were not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.   No concomitant and treatment medications were reported.   This case was linked to MOD-2022-621477, MOD-2022-621478 (E2B Linked Report).; Sender's Comments: Company comment: This is a literature-non-study case concerning a 71-year-old male patient with medical history of liver transplant, who experienced the serious (medically significant) unexpected event transplant rejection, after receiving an unspecified dose of mRNA-1273.  Very limited information has been received: Clinical course, diagnostic tests and treatment details were not available. The benefit-risk relationship of mRNA-1273 is not affected by this report. MOD-2022-621477:Patient 2: 50 years male MOD-2022-621478:Patient 3: 61 years female
Case reference number 19990153791, is a spontaneous report from a RN referring to a 33 year old female. Allergies, and Medical history are not specified. On06/03/99, the pt received an unspecified dose of tetanus diphterhia. On 06/03/99, the pt received the first dose of Havriix for prophalaxis of hepatitis A. Subsequently in the evening and on 06/03/1999, the pt experienced, vomiting, achiness, and fatigue. As of 06/04/1999 the pt is queasy. The most recent information received 06/04/99, reports the condition of the pt is ongoing
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 3/31/2023 AORTIC ANEURYSM, UNSPECIFIED SITE
Site: Pain at Injection Site-Mild, Systemic: Dizziness/Lightheadedness-Severe, Systemic: Exhaustion/Lethargy-Severe, Systemic: Fainting/Unresponsive-Medium, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Weakness-Severe.
Dizzy and nauseated when standing, Shivering beginning two hours after symptom start, Headache, Muscular pain at site of injection, mental inhebriation (brain felt drunk)  getting increasingly worse. Three hours after symptom start unable to keep balance while standing, shaking in blankets. Next day, fever of 100.4 at 9am down to 99 by 12pm (after nsaid at 10am), fatigue,  trembling, stiff neck
Acute swelling at inject site. Swelling of hands and feet w/ maculopap rash. Serum sickness appearance to rash.
Weakness; Loss of appetite; Sweating through the night; Chills; Not feeling well; Thumb, index finger, little bit of other finger tips and entire left hand was numb; This is a spontaneous case from  initially received from other non-health professional on 31-Oct-2018, concerning a 58-year-old, adult, female patient.   The patient's concomitant medications included Zocor (simvastatin), lisinopril and levothyroxine (levothyroxine sodium) for unknown indications.  On 25-Oct-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, batch number: 02844611A, expiry date: 25-Jun-2019, dose, route of administration, anatomical location: not reported] for unknown indication. It was reported that, the patient received the vaccine through in-house at her job.   On 27-Oct-2018 (reported as Saturday), 2 days after vaccination, the patient was not feeling well.   On 28-Oct-2018 (reported as Sunday), at the night, she started having chills, weakness, loss of appetite, sweating through the night. On 29-Oct-2018, the patient woke up feeling better.   On an unspecified, the patient reported that her thumb, index finger, little bit of other finger tips and entire left hand was numb. It was reported that the patient tried to get blood circulation, but the numbness persisted. Also, the patient reported that she hasn't had any excursing and thought it was because of new bra but realized it was not.   At the time of this report, the patient was recovering from the event (weakness, sweating, chills, loss of appetite and not feeling well) and had recovered from the event numbness in hand.  The reporter assessed the case as non-serious.  Significant case amendment (31-Oct-2018): The lowest level term (LLT) for the event 'sweating through the night' was changed from 'sweating' to 'night sweat' in the event tab. No changes were made in narrative.  Follow up received from reporter on 15-Jan-2019: It was reported that, one attempt had been made on 12-Dec-2018 in order to obtain additional information regarding this case, with no success. Hence this case was considered as lost to follow up. Med Info number (SEQ18-07356) was added in the additional information tab. Hence, no changes were made in the narrative.; Reporter's Comments: A 58-year-old, female patient experienced malaise two days after and weakness, loss of appetite, night sweat, chills three days after and numbness in hand on an unspecified date, after vaccination with Afluria quadrivalent. The company assessed the causality of the events as related to the suspect vaccine due to the plausible temporal relationship between events and suspect vaccine.
*sypmtoms could be unrelated to shot and caused by a dive trip I went on but I was told to report anyway b/c it's within the 3 week window of 2nd vaccine*  (Vaccine on 5/5, fever started 12 hours after vaccine and lasted for 20 hours. Peaked at 102. Flew on a plane 5/7 and dived to 10m (33') on 5/8 and 5/9. Syptoms below were noticeable on 5/10 at noon.) -tightness in chest, shortness of breath, lightheaded
Rsh began at injection site afternoon after receiving second vaccine dose. Scattered wheals, and site tenderness that evening. Fever, restless sleep during night. Joint aches, tender lymph nodes in neck next am, rash decreased. Rash returned evening after vaccine given; rash on chest, L arm, scrotum, bilateral legs/feet with itching, wheals. Possible low grade temp. Rash much improved following day. Some muscle aches, tender enlarged lymph nodes in neck, groin (bilaterally), not axillary. Given Motrin 600mg to take q 6-8 hrs for next 2-3 days with food. reported to HC 1-25-08 lip swelling and lip numbness on 1-21-2008 evening, denied other symptoms, took Claritin, resolved in am. Recalled at that point similar episode of lip swelling 1/13/08 after vaccine dose on 1/9/2008. Referred to allergist prior to giving 3rd dose. Employee (who is intern/guest researcher) decided to decline 3rd dose at this point as vaccine is not essential to job. Advised to discuss with chief of rabies branch/supervisor and would follow up with allergist for possible pre-treatment prior to 3rd vaccine dose.
Developed chest tightness, runny nose and sneezing and fever on 7/22.  Tested positive that day.  Spoke to doctor on 7/23 and received Paxlovid which I am currently taking.
This spontaneous report as received from a medical assistant via a company representative and refers to a 8 year old patient of unknown gender. On an unknown dates the patient was vaccinated with a first and second dose of VARIVAX (Merck) (doses, units, routes of administration, anatomical locations, lot numbers were not reported). On 22-JUL-2014 the symptoms of chickenpox occurred (described as spots and no fever) and was diagnosed with chickenpox. The outcome of event was reported as not recovered. The relatedness between event and VARIVAX (Merck) was not reported. Follow-up information has been received from a medical assistant. The reporter stated a VAERS (Vaccine Adverse Event Reporting System) report has been filled and additional information regarding patient was available at that time. The reporter also stated if any additional information becomes available she may fax that information. This is one of several reports from the same reporter. Additional information is not expected because address was correctly entered but the correspondence was returned.
2nd dose on 2/26/2021. Then admitted to hospital on 7/31/2021. Currently still  in hospital in regular nursing floor. Unable to reach family for status update
10 mins post, severe syncope, and headache, severe ringing in ears * Severe headaches every morning * continued moderate ringing ears *  Severe dehydration every morning *  Frequent heartburn  * lungs tight, a bit shallower breathing * Vertigo all day and night *  Chills and hot flashes but no fever *  Nausea every morning until I eat; have to eat every few hours to avoid nausea * random dry raspy cough * 100+oz. H20 daily+powerade(S/F)p * urine near clear by afternoon * using RR 3x/night, but avg 5a wake-up with severe headache & PARCHED with very dry mouth
I woke up feeling nausea Saturday morning around 6:30 am. I had the shot Friday afternoon. I also had the chills. Soon I had a headache. I went back to sleep from 9:30 am till 2:00 pm. Throughout the day I had chills, aches, fever, and exhaustion.  I had a headache all day long.  Late afternoon, I began to have some chest pains and a burning throat.  I also notice thru my fitness device that my heart rate was elevated all day long.  I still felt awful when I went to bed. On Sunday, I still had a headache and no energy.  I also had no appetite and my heart rate was still elevated.  Throughout the weekend my left arm really hurt. I was taking Tylenol throughout the weekend to feel better but it didn't seem to help much. I felt pretty terrible.. Today is Monday and i feel slightly better. I am able to get up and eat alittle.
Bloody diarrhea 7-14 days after each Rotateq. No fever or other ill SX cultures negative. Immune W/U revealed low levels of IgG. Further eval is pending.
No adverse effects reported; a 32 year old patient, received one dose of PROQUAD/Adult patient received PROQUAD; This spontaneous report was received from a medical assistant referring to a 32 years old patient of unknown gender. Information of concomitant medication, concurrent condition, pertinent medical history and drug reaction/allergy was not provided.  On 22-AUG-2019, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S006830 with expiration date 02-SEP-2020; strength and dose detail were not reported) subcutaneously for prophylaxis(adult use of a child product). Other suspect therapy included sterile diluent (lot # S013899 with expiration date 07-MAR-2022; strength, dose, route and indication were not reported). No adverse effects were reported. The outcome of the event was unknown.
Received small pox vaccine on 01/28/2002. On 02/04/2002 developed arm swelling, warmth, redness at site, tender, cellulitis left arm. On 02/05/2002 drainage, lymphadenopathy. and went to ER. 02/08/2002 cellulitis resolved. Augmentin was prescribed.
an expired PROQUAD was administered to a patient; This spontaneous report was received from a registered nurse (RN) referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.       On 12-AUG-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (1 dosage form, lot # S003862 with expiration date 08-AUG-2020; dose detail, frequency and route were not reported) for prophylaxis (expired product administered).
Numbness in left ear, side of face, and tongue Severe dizziness Pain in injection site, left arm, and shoulder Severe headache I took Benadryl and Ibuprofen and stayed in bed for two days. Symptoms lasted for 4 days.  Extreme fatigue lasted for 10 days
I tested positive for Covid 19 on October 26, 2022 I experienced sneezing, coughing, runny nose, tighten of the chest, chills no fever. I was taking SUDAFED and TYLENOL.
Patient lives with family in private residence with parents and 2 siblings. Spends most of time in own room. First family member diagnosed with COVID-19 on 12/21 2020,  the other 3 family members diagnosed with symptomatic mild COVID on 12/26/2020. Parents are healthcare providers and used specific informed diligent protective strategies to prevent infection in patient with minimal close contact and gloves, masks. Patient never had symptoms and was not tested for COVID.. Had first vaccine dose on 1/16. On 1/17 had shaking chills with temp to 101.3F, gone on 1/18.. No other overt reactions. Subsequently in usual state of health.  On 2/15 he developed vomiting and fever with progressive abdominal pain and transient wheezing.  Outpatient testing for SARS-CoV2 was negative and full respiratory pathogen panel (including SARS-CoV2) also negative. With worsening fever to 40.2C and abdominal pain, was admitted on  2/18.  Found to have high leukocyte count, low lymphocyte count and transaminitis.  CT imaging with terminal ileitis, thought possibly infectious but extended GI pathogen panel negative. Experienced persisting daily high grade fevers to up to 39.1.C. Developed transaminitis and  hypotension and was transferred to intensive care unit on 2/21. Was intubated for hypoxia, agitation, required levophed, large volume resuscitation and empiric antimicrobials. Had transient AKI. Antimicrobials stopped on 2/22  with negative cultures. Colonoscopy performed with leal biopsy of identified ulcerative disease with focal active enteritis without specific etiology identified by stains.  Ferritin rose to 24,000 with hypertriglyceridemia and  thought to have possible HLH and underwent bone marrow biopsy which showed leukocytosis and lymphopenia, and rare hemophagocytosis.  Dobutamine was started for low LVEF and levophed weaned. High dose dexamethasone started on 2/23 and pressor further reduced, dobutamine weaned to off on 2/25. Extubated on 2/24.  Febrile still to 39 on 2/24 and with leukocytosis but transaminases, ferritin and triglycerides improving. Discussion ongoing about HLH vs macrophage activation syndrome. Currently meets 4 criteria for HLH with soluble IL-2R and NK activity pending.
Both leg muscles were extremely tight, it was hard to walk. I felt like a Charley horse that wouldn't give. The muscles would loosen up. It lasted 3 days.