chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt complained of mild SOB and chest pain within about 10 min post vaccination. Chest pain with breathing, A&Ox3, VS on EMS arrival T-N/A, P- 110-120, R 14-16, BP-157/88. Taken to EMD.
Macular erythematous, blanchable rash on bilateral palms. Non pruritic and non painful.  Patient first noticed the rash ~50 hours post vaccine administration.  Anticipatory guidance and supportive care provided. No further interventions required.
first dose of Pfizer Covid19 vaccination on 09Apr2021, tested positive for COVID-19 on 14Apr2021; This is a spontaneous report received from a contactable reporter (the patient).   A 29-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on 09Apr2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 14Apr2021, the patient tested positive for COVID-19, second dose of the vaccine is scheduled for 30Apr2021. Outcome of event was unknown.   No follow-up attempts are possible. No further information is expected.
patient had a localized reaction at the site of the injection that swelled and was red and warm to touch. The reaction started about 3 hours after the time of injection, the took benadryl and was seeking medical attention from her doctor.
Administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.   This case was linked to MOD-2021-345448, MOD-2021-345472, MOD-2021-345642, MOD-2021-345457, MOD-2021-345456, MOD-2021-345445, MOD-2021-345460, MOD-2021-345565, MOD-2021-345620, MOD-2021-345666, MOD-2021-345833, MOD-2021-345910, MOD-2021-345931 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes on 08-Oct-2021, Follow-up received on 08-oct-2021 updated batch number.
Received shot on Tuesday, Aug 24, 2021.  Noticed an increase in blood pressure in the days following.  On Monday, Aug 30, 2021 at 10:30 PM blood pressure rose to 214/97 (taken at the ER). Some nausea, light headed, mild chest pain.  No other symptoms.  Released after several hours.  Saw PCP next day. She prescribed 50 mg. Losartan to be taken once daily.   I had the second shot on Tuesday, Sept 14, 2021.  No symptoms other than sore shoulder.  Blood Pressure is slightly elevated even with Losartan, but not like Aug 30th.  Highest recorded was 162/92 since 2nd shot.
Flumist given to my husband and child. Within 5 days, I have the flu. Fever 101.7, headache, body ache. I am a family doctor and I have missed 3 days of caring for my patients. I feel Flumist is a dangerous live vaccine that needs further investigation.
Arm pain morning after shot, general fatigue and achiness in joints afternoon after shot (i.e. 24  hrs after vaccine administered). Arm pain lasted a day, fatigue about 12-18 hours.
Pt presented with no significant medical history and epigastric pain. Patient was found to have elevated Troponin level and suspected coronary artery dissection. Pt emergently transported to Cardiology.
Swelling, pain, hot to touch and redness at injection site on the right deltoid. Treated with oral Keflex for 7 days and Hydrocortisone 1% topically. Seen again on 7/25/2015 for a follow up in clinic.  No change in treatment.
pt recv vax 25JUL97 & pt immed exp a red, itchy, pea size raised bump over the inj site;w/in 1wk the bump inc to a half dollar size;tx w/DPH & heat was applied to the site;
hives breaking all over her body; rash; About one and half hour later she started to have symptoms of anaphylactic reactions; some trouble breathing; complained of dry throat; This spontaneous case was reported by a pharmacist and describes the occurrence of ANAPHYLACTIC REACTION (About one and half hour later she started to have symptoms of anaphylactic reactions) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy, Penicillin allergy, Drug hypersensitivity (Morphine), Drug hypersensitivity (Vicodin), Drug hypersensitivity (Oxycodone), Drug hypersensitivity (Azithromycin) and Drug hypersensitivity (Anaphylactic reaction to IV Benadryl).    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced ANAPHYLACTIC REACTION (About one and half hour later she started to have symptoms of anaphylactic reactions) (seriousness criterion medically significant), DYSPNOEA (some trouble breathing) and DRY THROAT (complained of dry throat). On an unknown date, the patient experienced URTICARIA (hives breaking all over her body) and RASH (rash). The patient was treated with ACRIVASTINE (BENADRYL ALLERGY RELIEF) (oral) on 21-May-2021 for Anaphylactic reaction, at a dose of 1 dosage form. At the time of the report, ANAPHYLACTIC REACTION (About one and half hour later she started to have symptoms of anaphylactic reactions), DYSPNOEA (some trouble breathing), DRY THROAT (complained of dry throat) and URTICARIA (hives breaking all over her body) outcome was unknown and RASH (rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided/unknown. Patient was issued a box of Epipen used as needed. Rash on her body took three weeks to clear.  Company Comment : This case concerns a 42-year-old female with a serious unexpected event of anaphylactic reaction, and nonserious dyspnea, dry throat, urticaria, and rash. Event latency 1.5 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 42-year-old female with a serious unexpected event of anaphylactic reaction, and nonserious dyspnea, dry throat, urticaria, and rash. Event latency 1.5 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Client stated that she felt a tingling funny sensation on her left cheek about two hours after the vaccine.She had visible swelling of left cheek and face,also swollen and painful gums on the left side.S
A non-serious spontaneous report of administration of expired product was received from a registered nurse/health professional concerning a 29-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 29-Mar-2010. On 30-Mar-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
No discernable adverse events to report, other than that the patient was 17 years old at the time of the vaccination.
Lt arm was sore & at the injection site discoloration of skin & a spot at the injection site pt visited MD after 2 weeks of pain. MD. diagnosis inflammation of soft tissue on upper Lt arm (shoulder) treatment with MEDROL.
On 1/12/20 resident woke up and was not able to stand in the E-Z stand. E-Z lift was needed. In addition he needed assistance with eating. At that time VS were stable, equal hand grasp noted, and no further concerns. Around 3pm resident became flaccid on the left side of his face and speech became mumbled. Hand grasp was equal at that time and VS were stable, but B/P was elevated compared to previous recordings earlier in the day. Family did not want him sent to the hospital and asked for comfort cares. Hospice referral obtained and he will be admitted to hospice in the near future. Resident's left side of face has improved within the last 48 hours. He remains total assist with all cares.
by injection site a Red slightly swollen 3 inches by 1.5 inch area  has developed. First noticed just over a week after injection.  I have outlined the area with a pen and will monitor to see if it gets larger.
covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), on 23Mar2021 as dose 2, single (Batch/Lot number: unknown), on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 28Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Breast Cancer" (unspecified if ongoing); "BMI" (unspecified if ongoing), notes: BMI 27-28. Concomitant medication(s) included: METOPROLOL TARTRATE, start date: 14Mar2013. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) 27-28, notes: BMI 27-28; SARS-CoV-2 test: (unspecified date) Unknown results; (13Jun2022) Negative, notes: after testing negative for 3 day, 13Jun-15Jun; (14Jun2022) Negative, notes: after testing negative for 3 day, 13Jun-15Jun; (15Jun2022) Negative, notes: after testing negative for 3 day, 13Jun-15Jun; (22Jun2022) Positive, notes: positive test. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient was treated with Paxlovid for covid-19 from 13Jun2022 to 17Jun2022. Rebound 5 days after treatment completed, mild symptoms plus positive test on 22Jun2022, after testing negative for 3 days, 13Jun2022 to 15Jun2022. Event was not recovered and no treatment received.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial and follow up information have been received from a registered nurse concerning female patient of unknown age. On 07-FEB-2012, the patient's mother was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (lot number not reported). There was no concomitant medication. The registered nurse reported that on 29-FEB-202 a urine pregnancy test was performed and the patient's mother tested positive. The estimated last menstrual period was on 06-FEB-2012 and the estimated due date (EDD) was on 05-NOV-2012. The patient's mother sought unspecified medical attention. No treatment given for the event. On 02-NOV-2012, the patient's mother delivered a full term baby girl at 39 weeks vaginally. The patient's Apgar scores were 9 and 9. Jaundice was mentioned in a hospital note but otherwise the patient seemed normal and healthy. The physician looked through all routine follow up visits from last year and reported that there was no mention of congenital anomalies. Baby seemed totally healthy. This is one of several reports received from same source, the mother report captured in 1203USA00152. Additional information is not expected.
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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cardiovascular disease" (unspecified if ongoing), notes: cardiovascular disease. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive; (Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient received Paxlovid as an antiviral treatment from 03Sep2022 to 07Sep2022. Patient had no known allergies. This case assessed as non-serious by the reporter.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
G4 P2 32 wk pregnant female received a pertussis immunization on 19Apr2018 at 1440 as part of a routine medical examination. At 0600 the next morning she starting having localized swelling, erythema and itching at the site of injection.
This spontaneous report was received from a nurse, and refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 13-DEC-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose: 0.5 milliliter, lot # S039311, expiration date: 04-DEC-2021 as prophylaxis (route of administration and anatomical location were not provided) (expired product administered).  No temperature excursion and no additional information was provided.
Mom called to report infant still running 99.2 rectal temp. after 6 days as well as spitting up more all week & never had done this before.  Also increased irritability reported.  On day 3 mom noted small raised bumps on infants lower legs & under chin-not red or itching.  Reports decreased appetite with normal urine output & bowel movements.
This spontaneous report was received from a physician refers to a 62 year old female patient. The patient did not specify her medical history or her medical profile. On 13-OCT-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous. On 13-OCT-2014 patient reported she has an injection-site adverse experience that her physician told her is an allergic reaction to ZOSTAVAX. In October 2014, the patient sought medical attention. The patient did not provide further description of the symptoms of her injection-site adverse experience. The patient did not specify the injection-site adverse experience time of onset, nor did she specify which treatment, if any, as prescribed. Reporting physician stated the adverse event as not serious because the patient was speaking freely, while at home, and denied being in any other distress. The outcome of adverse event is unknown. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Tachypnea, Tachycardia edema Narrative: hospitalized due to tachypnea, tachycardia, fluid retention and found to have pneumonia and pericardial fluid
Pt is a 12 y.o. male accompanied with mother. Mother states that pt. received vaccines on Monday 9/23/13 and since then pt has been nauseated and lethargic. Mother also states that (L) arm where pt received vaccine is red and swollen. Upon examination (L) arm very erythematous and warm to touch. Diagnosed with Cellulitis. Tx: KEFLEX 500mg.
Ear ringing, sore arm, went to the emergency room on 2-11-17 because her neck was sore and ear ringing got louder.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received HAV (Havrix pediatric) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2023, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 7th February 2023, unknown after receiving Havrix pediatric and Havrix 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: 07-FEB-2023 Reporter's Comment: The reporter reported that a pediatric patient was administered with a one day expired dose of Havrix. The reporter consented to follow up. Additional Supportive Information: The reporter reported that a pediatric patient was administered with a one day expired dose of Havrix, which led to expired vaccine used.
Pt given Hep B MMR, Tdap at 930am. (NKDA) (No meds). No hx medical problems 950 am. Pt c/o red swollen area RA, throat itchy, c/o stuffiness, itchy eyes. BP 136/84 P-60 R-16 911 called 953 ambulance arrived. Pt transported.
This spontaneous report as received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with improperly stored M-M-R II injection (lot # M008588, expiration date 16-FEB-2018, lot # L040960, expiration date 16-OCT-2017 and lot # reported as L027432, expiration date 22-JUL-2017) for prophylaxis (strength, dose and route were unknown). On unknown dates, the following temperature excursions were registered: between 46 Fahrenheit degrees and 77 Fahrenheit degrees for 20 minutes and between 46 Fahrenheit degrees and 77 Fahrenheit degrees for 10 minutes. There were no previous temperature excursions. Digital Data Logger was involved. No adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA002579: US-009507513-1701USA008577: US-009507513-1701USA008576: US-009507513-1701USA008575: US-009507513-1701USA008579.
This spontaneous report as received from a physician via a company representative refers to an infant patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with ROTATEQ dose, lot#, expiry date were not reported. It was unspecified which of the series of 3 ROTATEQ this one was. On 14-SEP-2015, after the patient received ROTATEQ, the patient aspirated and was taken by squad to an unspecified hospital and admitted. Within the same day, the patient was discharged from the hospital. Later within the same day, the patient began to have trouble breathing and was taken back to the hospital. Unspecified treatment was given for adverse events. The outcome of the events was unknown. The patient sought medical attention-was already in the office at the time of the report. The relatedness between the events and ROTATEQ was not reported. The reporter considered the events to be life threatening. This is one of several reports received from the same reporter. Additional information has been requested.
24 hrs post administration, developed 5cm round hard subcutaneous nodule.  Warm and tender to touch. Started self treatment with Benadryl 50mg HS, used "anti-itch" cream (Benadryl generic) to 5cm area, and ice packs. 48 hrs post administration, developed erythema from anterior right shoulder to elbow, posterior shoulder, right chest.  Had severe itching. but avoided scratching.  Developed two 1-2cm vesicles.  Continued Benadryl 50 mg HS, topical Benadryl cream, ice packs. 72 hrs post administration erythema decreased slightly. 96 hrs post administration erythema markedly decreased, itching decreased, injection site measures 15cm.
0.1 mL of Jynneos administered intradermally; 17 year old patient received Jynneos vaccine; Case reference number US-BN-2022-004544 is a spontaneous case report initially received on 04-Nov-2022 from other health professional via Communication (reference number: USBAV22-1862) and concerns a 17-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 24-Sep-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00003), at dose reported as 0,1 mL administered intradermally at an unknown site, for monkeypox prophylaxis. As reported, the patient was vaccinated with an adult dosage but since the patient was a minor, the smaller dose of vaccine 0,1 mL instead of 0,5 mL was administered intradermally (explicitly coded as 'intradermal injection' and 'inappropriate age at vaccine administration').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  This case is linked with case US-BN-2022-004542 (same reporter).  Non-significant case correction received on 11-Nov-2022 from included local case ID.; Reporter's Comments: A 17-year-old female patient was vaccinated with the first dose of Jynneos, at dose reported as 0,1 mL administered intradermally at an unknown site, for monkeypox prophylaxis. Reportedly, the patient was vaccinated with an adult dosage but since the patient was a minor, the smaller dose of vaccine 0,1 mL instead of 0,5 mL was administered intradermally (considered as intradermal injection and inappropriate age at vaccine administration). Injection and product administered to patient of inappropriate age are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Injection and product administered to patient of inappropriate age are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 17-year-old female patient was vaccinated with the first dose of Jynneos, at dose reported as 0,1 mL administered intradermally at an unknown site, for monkeypox prophylaxis. Reportedly, the patient was vaccinated with an adult dosage but since the patient was a minor, the smaller dose of vaccine 0,1 mL instead of 0,5 mL was administered intradermally (considered as intradermal injection and inappropriate age at vaccine administration). Injection and product administered to patient of inappropriate age are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Injection and product administered to patient of inappropriate age are both assessed as not related to suspect product but to human factor. The case is non-serious.