chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient notes that she received the COVID vaccine around 1800 today. After receiving the vaccine she notes she had developed a headache. She was otherwise doing fine until around 2000-2100 when she noticed her left arm become numb with paresthesias from her left bicep to her hand with whole arm localization. She felt her hands and wrists were puffy at this time and somewhat swollen. She reports feeling "floaty"/Dizzy at this time, and at least once had to sit down due to this. She started feeling her heart race and some associated SOB, this has since resolved. She notes that she had two loose stools around this time as well.   This progressed to develop into right numbness/paresthesias from her mid right forearm down to her hands. As the evening progressed she developed itchiness of her bilateral arms and torso. She notes that she has had a waxing/waning reddish rash on her arms that has been pruritic. She has since developed intermittent nausea, and still endorses feeling some "skipped beats."   While in the ED from Triage to repeat evaluations her lips began having progressive swelling. She had been given Benadryl 50mg, Zofran 4mg, 1L IVF. Given ongoing tachycardia and lip swelling she was given Prednisone 40mg and Epinephrine for allergic reaction and concern for anaphylaxis.
had a reaction; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INJECTION SITE REACTION (had a reaction) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALIROCUMAB (PRALUENT) for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE REACTION (had a reaction). At the time of the report, INJECTION SITE REACTION (had a reaction) outcome was unknown.        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.   Reporter did not allow further contact
Information has been received from a consumer who saw a report on the internet concerning two patients (unspecified ages) who were vaccinated with 3 doses of GARDASIL (dates were not reported). Subsequently the patients died, the cause of death was unknown. This is one of several reports received from the same source. This is a hearsay report, attempts are being made to obtain identifying information to distinguish individual patients. Additional information has been requested.
tenderness; soreness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness) and MYALGIA (soreness ) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 2003. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MULTIVITAMIN [VITAMINS NOS] for Supplementation therapy, ASCORBIC ACID (VIT C) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced TENDERNESS (tenderness) and MYALGIA (soreness ). On 15-Apr-2021, TENDERNESS (tenderness) had resolved. At the time of the report, MYALGIA (soreness ) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-077660 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow- up received on 30 JUNE 2021, contains no new information.
Systemic: Vomiting-Medium, Additional Details: patient fainted while in triage...woke up and vomited. 911 called, emt's responded. unknown if patient was brought to hospital..
pt recvd vax; returned to ofc w/ inject site rxn of erythema, tenderness, swelling 3-4 " in diam; apap & ice packs used
After 30 minutes receiving the vaccine pt felt itching of the tongue, feeling flushed & itching of both cheeks,  after an hour, slight difficulty swallowing & talking, tongue felt thick & funny, also itching of whole body no rashes, Took liquid Benadryl & Liquid Zyrtec per instructions of immunologist with some relief.
Palpitations and shortness of breath. They're constant throughout the day. No medication has been used to allievate these symptoms.
Developed stomach pains, constipation, vomiting, joint pain. Went to the ER at hospital, he was admitted and after two days diagnosed with HSP,  henoch Schlonlein purpura. Was in hospital three days then discharged. Condition worsened at home, went back to emergency room at hospital. More ultrasounds and CT scans found nothing. Went back hole where condition has worsened. In immense pain if not on Motrin ibuprofen. Intestines are incredibly swollen, joint inflammation, cannot walk. Cannot keep food or fluids down.  His body is still attacking itself.
Headache, sore throat, dry mouth, thirsty, low grade fever, swelling and red at injection site.
This case was received by a nurse via call center representative and described the occurrence of induration in a patient who received FLUARIX QUADRIVALENT (batch number 5C2L4, expiry date 18th June 2016). On an unknown date, the patent received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced induration, injection site induration and neck swelling. On an unknown date, the outcome of the induration, injection site induration and neck swelling were unknown. It was unknown  if the reporter considered the induration, injections site induration and neck swelling to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: The reporter stated that, 70 patients received FLUARIX QUADRIVALENT and 5 patients developed localized reaction. The patients experienced quarter sized induration to a full arm and neck swelling. The reported batch number (5C2LA) for FLUARIX QIV did not exist and was updated to be 5C2L4 as per sales database. No patient information available at the time of reporting. This case was one of the 5 cases reported by same reporter.
Presents to the ED for evaluation of acute bronchospasm, dry non-productive cough, and wheezing.  Symptoms developed last Friday.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 16-SEP-2011, the patient was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly, on 13-MAR-2012, the patient was vaccinated with the second 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly and on 26-DEC-2012, the patient received the third 0.5 ml dose of GARDASIL (Lot # not reported). No adverse effects were reported. Additional information has been requested.
Received pediatric dose instead of adult; Rceived pediatric dose instead of adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 52-year-old male patient who received HBV (Engerix B pediatric) (batch number 5DN72, expiry date 27th December 2022) for prophylaxis.   On 28th June 2022, the patient received Engerix B pediatric. On 28th June 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Linked case(s) involving the same patient:  US2022103250   Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comments: The patient received a pediatric dose of the Engerix-B vaccine instead of the adult dose of the Engerix-B vaccine. The reporter was consented to follow up. Additional supportive information: The patient received pediatric dose of the Engerix-B vaccine instead of the adult dose of the Engerix-B vaccine which led to underdose and adult use of child product.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022103250:FU1
Swelling/discomfort in under arm (armpit, potentially lymph node); Discomfort; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration on 09Apr2021 as a single dose for COVID-19 immunisation. Medical history of the patient was reported as none. Concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration on 15Mar2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, the patient experienced swelling/discomfort in under arm that is the armpit, potentially lymph node. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. The clinical outcome of the events swelling, discomfort in under arm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
SUSPECTED CLINICAL VACCINATION FAILURE; LIVER FUNCTION TEST ABNORMAL; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 50 year old female of an unspecified race and ethnicity. Initial information processed with additional information received from the department on 17-MAY-2022. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 (recovered). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, first dose (1 in 1 once) administered on JUN-2021 (date unspecified) for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient received non-company suspect drugs included: Upadacitinib (Rinvoq) (form of admin unknown, oral, batch number: Unknown and expiry: Unknown) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On 23-AUG-2021, the patient experienced covid-19 (suspected covid-19 infection and suspected clinical vaccination failure). On 30-NOV-2021 and 01-FEB-2022, the patient experienced covid-19. On an unspecified date, the patient experienced liver function test abnormal. Laboratory data (dates unspecified) included: Liver function test / liver levels (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient recovered from suspected covid-19 infection on 2022, and the outcome of liver function test abnormal and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint (PQC): 90000230989. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220526854 -Covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
pt recv vax 2APR99 & that evening very sore am & couldn't lift rt arm or lay on that side;sharp chest pain which resolved w/o any other sx;also c/o joint pain & insomnia;3APR99 joint pain, also assoc w/abd pain;fatigue, weakness, body aches
Within 48 hours of vaccination, patient developed nasal congestion, ear fullness, and left sensorineural hearing loss. This progressed over the next several weeks to persistent, transient urticaria, small-fiber neuropathy, and autonomic dysfunction.
Non-approved diluent Menveo/normal saline was used to reconstitute Menveo and it was administered to a patient; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number VA9024A) for prophylaxis.   On 08-MAY-2023, the patient received Menveo. On 08-MAY-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Non-approved diluent Menveo/normal saline was used to reconstitute Menveo and it was administered to a patient) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-MAY-2023 The reporter called to report normal saline was used to reconstitute Menveo and it was administered to a patient, which lead to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The vaccine administration facility is the same as primary reporter.  No expiration date was reported. The reporter consented to follow up via email.
This spontaneous report has been from a medical assistant concerning to an "unspecified number of unspecified patients" of unknown age and gender. Current conditions, medical history and drug reactions/allergies were not reported. In 2013, the group of patients were vaccinated with VARIVAX lot # H018456, expiration date: 09-OCT-2013, (dose, frequency and route not reported). Concomitant medication was not reported. Since March 2013, a physician's office had numerous temperature excursions involving VARIVAX that were administered to an unspecified number of unspecified patients. The reported stated that the vaccine had multiple excursions between 6F and 14F totaling 248 hours between March-2013 and September-2013. The reporter also stated that the vaccine had multiple excursions between the range of 15F to 35F with a total of hours of 140 hours at refrigerator temperature: from March 2013 to July 2013 with the last excursion occurring on 16-JUL-2013. The stability data showed that VARIVAX was supported for one month. The reported stated that the vaccine had not been administered to any patients since 16-AUG-2013, so no adverse event occurred. No adverse effect reported. Additional information has been requested.
confusion, tired, exhaustion, shortness of breath, fever (99.5), dizziness
84-year-old male with multiple comorbidities in ED after referral from  cardiology office.  on previous hospitalization, patient was noted to have an apparent 10-second pause during hospitalization and was discharged home with a Holter monitor.  11/16/2021  cardiology office and company monitoring machine called him and advised him of a 14-second pause overnight and advised him to come to the ED.  He reports he felt near syncope and SOB with pause and has been significanlty more weak and fatigued 11/16/2021 with dyspnea that worsens with exertion. He denies any associated chest pain, orthopnea, PND, nausea, or diaphoresis. At present time he reports feeling fatigued but no other acute concerns.   He received COVID Moderna vaccine x 3 with booster given last week.  He denies any recent illness, exposure to illness, or travel. Pacemaker implanted 11/18/2021. Patient still hospitalized at home of this report. Event seems unrelated to COVID 19 vaccination. Patient has long standing history of cardiovascular disease. Report submitted as required per EUA.
Around 7p 2/2 felt a little different. I went to bed awoke at 3am to such terrible body aches, left arm felt like it weighed 100 lbs,and it hurt to walk and my head fell forward. i experienced these symptoms severe till about 2pm 2/3 felt alot better. i returned to work on 2/4 still experiencing symptoms in left arm and shoulder back of neck area. I also had a lilttle bleeding at the site and bruising. with all this being said i would do it again. Thank You doctor
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Patient reports that they did not eat or drink anything all day prior to receiving vaccination in the early afternoon. Suspect that  dehydration or low blood sugars may have contributed to syncope event. Patient become unresponsive for about 60 seconds with pulse. Patient had returned to stable vitals within 10 minutes of event.
Hospitalization: 9/30/2022 - 10/15/2022 Presentation to the ED: Acute respiratory failure with hypoxia, SEPSIS AND PNEUMONIA. CHEST TUBE PLACED, THORACOTOMY PERFORMED. COVID + date: 10/15/22 Treatment: NO SPECIFIC TREATMENT. PATIENT TESTED POSITIVE FOR COVID-19 UPON DISCHARGE.  Discharge to: SNF.
Heart pain, trouble breathing, chills, heart palpitations, panic attack, additional heartbeats
This spontaneous report was received from a registered nurse referring to a 12 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 12-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
broke out; This case was reported by a consumer via interactive digital media and described the occurrence of skin breakout in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced skin breakout. On an unknown date, the outcome of the skin breakout was unknown.   It was unknown if the reporter considered the skin breakout to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient had shingrix vaccine and broke out 2 days later. The follow-up would not possible as no contact details were available.
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of oral ROTATEQ lot # K022995, 22-JUL-2015, L009119, 17-DEC-2016, L006184 13-DEC-2016, L013203 28-JAN-2017. No adverse effects were reported. This is one of the 4 reports received from the same reporter. Additional information has been requested.
Nurse is reporting that an adult patient came to the office with low titer for varicella and measles, mumps, and rubella.  The patient possibly received MMR II and VARIVAX in the past.    No additional AEs were reported. No further information provid; This spontaneous report was received from a nurse refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. The patient's concomitant therapies included ADIPEX.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for vaccination.  On an unknown date, the patient experienced antibody test negative. On unknown date, the titer test was performed and showed low title. The outcome of antibody test negative was unknown.  The causality assessment was not provided.
Broke out in a rash that at first resembled shingles and appeared to run straight in a nerve path. Within 24 hours the rash moved from back flank to entire s chest and back wall with several sores being on legs and under arm pits. These sores looked like large pimples with yellow centers until they broke and scanned over
No adverse event; The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023).    No concomitant medications were reported.     The patients did not report any adverse event.  No treatment medications were reported.  This case contains information for the 4th of 6th patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-719555 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719555:Master case