chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Allergic reaction described by the Volunteer: extreme diarrhea, hives in different parts of her body and her face was completely swelled up. "Everything was itchy and feverish and I had a lot of gas and stomach pain". She answered she does not think it is related to food since "I didn't eat anything weird that day". She answered that she treated it with ibuprofen, drank a lot of water and used anti itch cream from the medical kit (Diphenhydramine). She reported she did not have shortness of breath during this episode, neither feel throat tightness or other signs or symptoms that could compromise her breathing. Volunteer did not contact health unit 11/17/2018 to report reaction Sx were resolved at that time.
Patient called today and reported that he went to the ER on 12/2/21. His first Moderna COVID-19 vaccine was on 12/1/2021. He reported vertigo and feeling very dizzy.
I started experiencing symptoms the evening of 1/20/22 and tested positive the next day 1/21/22. I had symptoms of cough, shortness of breathe, chest pain and tightness, fatigue, headache, body aches, and congestion which lasted 10 days. The severe fatigue lingered for weeks and has never fully resolved, have elevated heart rate, and chest pain daily. I was diagnosed with post Covid pericarditis and I'm under the care of a cardiologist at a local facility.
This spontaneous report was received from a medical assistant and unspecified reporter refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 14-AUG-2018, the patient was vaccinated with improperly stored dose of Oka-Merck PROQUAD, lot # N034561, expiration date: 03-JUN-2019, (dose and route of administration were not provided) for prophylaxis (incorrect product storage). The vaccine was reconstituted with sterile diluent which was properly stored. The vaccine underwent a temperature excursion -14 to -10 degrees Celsius for 3 hours and 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006154: US-009507513-1809USA004439: US-009507513-1809USA004440: US-009507513-1809USA004441: US-009507513-1809USA004442: US-009507513-1809USA004443: US-009507513-1809USA004445: US-009507513-1809USA004446: US-009507513-1809USA004447: US-009507513-1809USA004448: US-009507513-1809USA004449.
Fever 102F- lasted 3 hours- treated with nyquil/ibuprofen Nausea/vomiting/diarrhea/ wide spread body ache, muscle cramps, with lower extremity numbness and tingling- lasted - 48 hours- supportive care brain fog- ongoing Wide spread rash- Benadryl, calamine lotion- ongoing
Arm was swollen and all red; Arm was swollen and all red; A big spot and it was sore and now it is itchy; A big spot and it was sore and now it is itchy; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date in an unspecified arm as dose 2, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported that patient had Pfizer Covid Vaccine, the second shot (on Saturday) and on 21Mar2021, patients arm was swollen and all red, a big spot and it was sore and now it was itchy. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4 month old needed DTAP and IPV. MA found combo (KINRIX) that did not explicitly say on box that it was for ages 4-6 years. She did not check expiration date. Gave vaccine to baby. Then she went to enter it into the EHR and noticed that the vaccine was for ages 4-6 years and was expired. It was immediately reported to supervisor/NP. No treatment was needed at the time. Parent/caregiver of child was notified of mistake and asked to return to clinic for correct and not-expired vaccine. Parent refused stating that she would be taking the baby to another clinic due to mistake.
Patient Vomitted and Fainted for couple secs. No signs of distress or SOB observed. Patient stated "that she is ok".  Patient discharged home.
Fever to 102F, Tachycardia, Nausea, Injection site pain and swelling.
Hospital Infection Control/Risk Management Nurse called clinic to advise patient died in ER and parents think the shots were the cause. Body was sent to Medical Examiner.  3/15/07 Received autopsy Report which reveals COD as SIDS while cosleeping w/adults. Manner of death is undetermined.
Severe Headache; major fatigue; body ache; stomach pain; This is a spontaneous report from a contactable consumer (patient) via COVID-19 Adverse Event Self Reporting. A 70-years-old non-pregnant female received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration in arm right on 27Feb2021 at 12:00 (Batch/Lot Number: EN6205) (at the age of 70-years-old) as a single dose for COVID-19 immunization. Medical history included thyroid and high cholesterol. Patient was allergic to CAT scan dye. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in arm left on 06Feb2021 at 12:00 (Batch/Lot Number: EL9269) (at the age of 70-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19 and was not tested for COVID post vaccination. The patient took other medications (unspecified) within two weeks near to vaccination date. On 28Feb2021 at 02:00 AM, the patient experienced severe headache, major fatigue, body aches and stomach pain. No treatment was provided for the events. The outcome of the events was unknown.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Information has been received from a certified medical assistant concerning a 24 year old female with a history of abnormal Papanicolaou smear and papilloma viral infection, who on 25-JAN-2007 was vaccinated intramuscularly with the first dose of GARDASIL vaccine (0.5mL) (lot # 654702/0011U), on 02-APR-2007 with the second dose of GARDASIL vaccine (lot # 656051/0244U) and on 10-SEP-2007 with the third dose of GARDASIL vaccine (lot # 658556/1060U) in the left arm IM. Concomitant therapy included SEASONIQUE. In approximately October 2007, following the third vaccination, the patient developed an injection site reaction. The patient called her physician and reported having a sore hard knot/lump at the injection site in the left arm the exact same spot where the patient recevied the vaccination (5 weeks prior). Medical attention was sought. At the time of this report, the patient had not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. The physician advised the patient to alternate area with heat and ice. The patient did well and there were no problems since.  on an unspecified date the patient recovered. Additional information is not expected.
Pt recv vax on 1/25/99; on 2/4/99 pt exp macular papular rash x 2days
Sickness; COVID-19; Laryngitis; Cold; Loss of voice; Hidradenitis suppurativa; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), COVID-19 (COVID-19), LARYNGITIS (Laryngitis), NASOPHARYNGITIS (Cold) and APHONIA (Loss of voice) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK (Citrate free). On an unknown date, the patient experienced ILLNESS (Sickness), COVID-19 (COVID-19), LARYNGITIS (Laryngitis), NASOPHARYNGITIS (Cold), APHONIA (Loss of voice), HIDRADENITIS (Hidradenitis suppurativa), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, ILLNESS (Sickness), COVID-19 (COVID-19) and HIDRADENITIS (Hidradenitis suppurativa) had resolved, LARYNGITIS (Laryngitis), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown and NASOPHARYNGITIS (Cold) and APHONIA (Loss of voice) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Mycobacterium tuberculosis complex test: Result not provided.         No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.    This case was linked to MOD-2022-624365 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Aug-2022: Significant Live follow-up appended included Medical history, Events were added.
Itch all over-but mostly, itch at base of spine where pt previously had shingles.-No treatment
One day after receiving one dose of varicella virus vaccine live the pt developed skin lesions described as spots on body. Eventually 17 lesions developed, mostly on shoulders.
wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) in an infant 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 an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) 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 WRONG PRODUCT ADMINISTERED (wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This case contains information about patient 4th out of 10 infant patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-731451 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731451:master case
diluted with unopened sterile 0.9% sodium chloride that was to be used for irrigation instead of injection.
Moderna Monovalent given instead of Bivalent . No adverse effects or symptoms reported by caregiver
Patient with 4 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note: "Hospital Course: Patient initial admitted due to severe hypokalemia (2.7) which was repleted with KCl infusion and at this time stable at 4.7.  Patient had also been showing signs of cough and feeling severely weak for the prior 7 days, RSV panel positive for COVID-19. CXR without acute abnormalities.  Evaluated by PT: (P) Home with 24 hr supervision and/or assist.  Patient lives alone, we discussed with patient consideration for a nursing facility which she unequivocally refuses to go to.  Also suggested home physical therapy which she also absolutely refuses.  She states she has 2 daughters in the area and they can come to help her at home.  ABG wnl, SpO2 has been stable with ambulatory SpO2 98%. At this time she is afebrile, WBC wnl  and potassium is stable.  She is stable to discharge home. "
An 18 year old female patient with a past medical history of Tourette's Syndrome and facial palsy (which occurred as a result of two unknown medications that were given at an unknown time) received a first dose of MENACTRA (lot number 2558AA, lot number provided invalid) intramuscularly in the right deltoid on 14 July 2008. 15 minutes post vaccination, the patient experienced a worsening of left jaw pain when she opened her mouth to talk or eat. Her pain continued. She does not have any prior history of dental issues. Recovery status was unknown. Follow up information was received on 11 August 2008 from a health care professional. The patient received a first dose of MENACTRA (lot number U2558AA). The patient did not have any prior history of jaw pain. After she received the injection, she began with jaw pain. She needed to get her back, left tooth filled and may need a root canal. The patient's father stated that the patient's pain had lessened but was still present. No further information was provided.
Patient experienced chest pain, tachycardia, and dizziness around 1 and 1/2 hours after vaccine, she was transported to hospital where she was diagnosed as heart attack and under went procedure.
diarrhea ever since; This case was reported by a consumer via interactive digital media and described the occurrence of diarrhea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving 2nd dose of Shingrix, the patient experienced diarrhea. The reporter did not consent to follow up.
it made me very ill; they had me dizzy and weak; a fast heartbeat; Problem with breathing; Face was swollen; they had me dizzy; My arm sore; Broke my face out/Broke my arm out; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (it made me very ill), ASTHENIA (they had me dizzy and weak), TACHYCARDIA (a fast heartbeat), DYSPNOEA (Problem with breathing) and SWELLING FACE (Face was swollen) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (it made me very ill), ASTHENIA (they had me dizzy and weak), TACHYCARDIA (a fast heartbeat), DYSPNOEA (Problem with breathing), SWELLING FACE (Face was swollen), DIZZINESS (they had me dizzy), PAIN IN EXTREMITY (My arm sore) and RASH (Broke my face out/Broke my arm out). At the time of the report, ILLNESS (it made me very ill), ASTHENIA (they had me dizzy and weak), TACHYCARDIA (a fast heartbeat), DYSPNOEA (Problem with breathing), SWELLING FACE (Face was swollen), DIZZINESS (they had me dizzy), PAIN IN EXTREMITY (My arm sore) and RASH (Broke my face out/Broke my arm out) outcome was unknown.     No concomitant medications reported. Treatment included pain medications given at the hospital.
Raising blood pressure after getting every shot of the Moderna COVID-19 vaccine (second dose); This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Raising blood pressure after getting every shot of the Moderna COVID-19 vaccine (second dose)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027K20A and 025L20A) for COVID-19 vaccination.     The patient had never been tested positive or diagnosed with COVID-19. The patient did not take any other vaccine within 1 month prior to Moderna COVID-19 vaccination. The patient did not have a medical history of high blood pressure.  Concurrent medical conditions included Immunocompromised, Diabetic (The diabetic condition goes up an down, 8.3 in the last one, and last year she did not have any 8.3) since 2002, Drug allergy (Allergy to Epinephrine) and Thyroid disorder (patient takes thyroid medication). Concomitant products included INSULIN, METFORMIN, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), LEVOTHYROXINE, INSULIN DETEMIR (LEVEMIR), INSULIN ASPART (NOVOLOG), ZOLPIDEM and ALPRAZOLAM for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HYPERTENSION (Raising blood pressure after getting every shot of the Moderna COVID-19 vaccine (second dose)). At the time of the report, HYPERTENSION (Raising blood pressure after getting every shot of the Moderna COVID-19 vaccine (second dose)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: high (High) Raising blood pressure after getting every shot of Moderna vaccine.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication also included unspecified thyroid medication.  The patient was suggested by the physician to take a tranquilizer, a beta blocker, Atenolol at a dose of 25 mg and call, whenever the blood pressure rises.   This case was linked to MOD-2022-543448, MOD-2021-021010 (Patient Link).
Two days after the vaccine when patient came back to work, he stated that he started having sharp shooting pain from top of shoulder down to his fingers and also shooting pain from shoulders down to his lower back
Intermittent hives and flat red rash of backs and palms of hands, neck, arms, trunk,  back, and lips. Much worse after second dose.   Gastritis
received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th September 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201274:Same Reporter
Balance was off/balance problems; This spontaneous case from was received on 27-Oct-2021 from other non-healthcare professional (consumer) via Communications (reference number: SEQW21-04665) and concerned a 73-year-old, female patient.  The patient's concurrent condition included high blood pressure and cellulitis. The patient's concomitant medications included unspecified blood pressure medicine, COVID-19-vaccine (brand not specified) and unspecified eye drops, both used for unreported indication.   On 21-Oct-2021, at 10:15 a.m., the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 312869 and expiry date: 30-Jun-2022.  On the same day, after receiving Fluad Quadrivalent, at 06:00 p.m., the patient noticed she was having balance problems/balance was off, had to hold on to things when she got up to walk in her apartment and that lasted through the night. The patient did not receive any treatment measures.  On 22-Oct-2021 (reported also as '25-Oct-2021' as discrepant information), about 24 hours after, the patient's symptom disappeared.  The reporter did not provide a causality assessment. The patient was taking eye drops at the time and thought maybe it could be them.  Company comment: A 73-year-old, female patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient developed a balance disorder. No alternative aetiology was provided. Based on plausible time relationship, causality is assessed as possibly related.; Reporter's Comments: The patient was taking eye drops at the time and thought maybe it could be them.; Sender's Comments: A 73-year-old, female patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient developed a balance disorder. No alternative aetiology was provided. Based on plausible time relationship, causality is assessed as possibly related.