chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2022 14:45 (Lot number: FK9895) at the age of 60 years as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (previous dose product: COVID 19, previous  dose brand: Pfizer, previous  dose lot number: EW0176, previous  dose lot unknown: False, previous  dose administration date: 09May2021 previous  dose dose number: 2, previous  dose vaccine location: Left arm), administration date: 09May2021, when the patient was 59 years old, for Covid-19 immunization; Bnt162b2 (previous dose product: COVID 19, previous  dose brand: Pfizer, previous  dose lot number: EW0162, previous  dose lot unknown: False, previous  dose administration date: 18Apr2021 previous  dose dose number: 1, previous  dose vaccine location: Left arm), administration date: 18Apr2021, when the patient was 59 years old, for Covid-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 03Mar2022 08:45, outcome "not recovered", described as "Felt strange morning after vaccine"; CHEST DISCOMFORT (non-serious) with onset 03Mar2022 08:45, outcome "not recovered", described as "heavy chest"; DIZZINESS (non-serious) with onset 03Mar2022 08:45, outcome "not recovered", described as "bit light headed / definitely feel light headed"; HEART RATE INCREASED (non-serious) with onset 03Mar2022 08:45, outcome "not recovered", described as "rate shot from 147 which is standard if not working too hard to 208 / heart rate jumps to 105 without much effort". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, chest discomfort, dizziness, heart rate increased. Additional information: The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient was not tested Covid-19 positive post vaccination. The patient had no known allergies. Follow-up attempts are completed. No further information is expected.
Swelling noted below the injection site, then six (6) days later a burning/itching sensation was noted below injection site and found a bright pink rash - size of lid of Dannon yogurt. Treated 2xs/day with betamethasone DP 0.05% cream x 7 days (5/11), whereby rash gradually faded - resolved 5/15.
PRESYNCOPAL SYMPTOMS/ALMOST FAINTED; LEFT ARM RADIANT PAIN; HEART PALPITATIONS; ABDOMINAL PAIN; SEVERE ENOUGH THAT SHE COULD NOT EAT; BURNING SENSATION OF STOMACH; TENDER/SORE SUBMANDIBULAR LYMPH NODE; LEFT JAW SWOLLEN; INFLAMMATION ON LEFT JAW; CHEST PAIN; TINGLING LEFT ARM; NUMBING OF LEFT ARM; DIZZINESS; LEFT ARM TENDERNESS AT INJECTION SITE; NAUSEA; HEADACHE; NECK LEFT LYMPH NODE INFLAMED; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain injury, and concurrent conditions included hypothyroidism, asthma, food allergies, latex allergy, nsaids (ibuprofen and aspirin) allergy, erythromycin allergy, betadine allergy, ct scan iodine allergy, dizziness, nausea, intermittent headache, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included fluticasone propionate for asthma, midodrine for brain injury, and levothyroxine for hypothyroidism. On MAR-2021, the subject experienced neck left lymph node inflamed. On 24-MAR-2021, the subject experienced dizziness. On 24-MAR-2021, the subject experienced left arm tenderness at injection site. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced numbing of left arm. On 25-MAR-2021 01:30, the subject experienced chest pain. On 25-MAR-2021 01:30, the subject experienced tingling left arm. On 31-MAR-2021, the subject experienced tender/sore submandibular lymph node. On 31-MAR-2021, the subject experienced left jaw swollen. On 31-MAR-2021, the subject experienced inflammation on left jaw. On 07-APR-2021, the subject experienced abdominal pain. On 07-APR-2021, the subject experienced severe enough that she could not eat. On 07-APR-2021, the subject experienced burning sensation of stomach. Laboratory data included: CT scan (NR: not provided) came out clear. On 13-APR-2021, Laboratory data included: Endoscopy (NR: not provided) came out clear. On 26-APR-2021, the subject experienced presyncopal symptoms/almost fainted. On 26-APR-2021, the subject experienced left arm radiant pain. On 26-APR-2021, the subject experienced heart palpitations. Laboratory data included: Diagnostic ultrasound (NR: not provided) came out clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, and tingling left arm on 25-MAR-2021, recovered with sequelae from numbing of left arm on 25-MAR-2021, had not recovered from dizziness, nausea, headache, and left arm tenderness at injection site, and the outcome of tender/sore submandibular lymph node, left jaw swollen, abdominal pain, burning sensation of stomach, presyncopal symptoms/almost fainted, left arm radiant pain, heart palpitations, severe enough that she could not eat, inflammation on left jaw and neck left lymph node inflamed was not reported. This report was non-serious.
11 days post vaccination a red rash started to appear, day 12 and 13 size and brightness of rash increased, day 14 post vaccination size of rash had not changed, but was itchy and little brighter red
First shot in Sep-2020; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in September 2020).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not applicable. The patient recently found out that, he/she supposed to have a second shingles shot.  At the time of first shot, the patient was not informed that he/she would need another one.  Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The patient asked could he/she still get the second shot. The follow-up would not possible as no contact details were available.
using an alternate diluent from an MMR vaccine that had been kept at room temperature with no reported adverse event; using an alternate diluent from an MMR vaccine with no reported adverse event; Initial information received on 30-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old female patient who received HIB (PRP/T) Vaccine [ACT-HIB] using an alternate diluent from an mmr vaccine that had been kept at room temperature with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine (Hepatitis B [Hepatitis B Vaccine]) for Prophylactic vaccination.  On 27-Jan-2023, the patient received a dose of 0.5 ml Total dose 1 of suspect HIB (PRP/T) Vaccine using an alternate diluent from an mmr vaccine that had been kept at room temperature with no reported adverse event (product storage error), (product preparation error) Powder and solvent for solution for injection: form (lot: UJ679AAA) via intramuscular route in the left thigh for immunization with expiry date: 07-Apr-2023 with unknown strength.  Action taken: not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient was mistakenly given a shot of air instead of the vaccine. Patient had no issues after the shot and the correct vaccine was administered afterwards. Patient was monitored for 15 minutes afterwards without any issues.
At 2:00 pm, the patient had fainted 2-3 minutes after receiving the Janssen covid 19 vaccination.   She regained consciousness about 1 minute later.  The patient was sitting down, and collapsed over and hit her head on the table.  The patient had answered "no" on the VARs consent form that she didn't have a history of dizziness or fainting after vaccinations.  She also verbally answered "no" as well when she was asked if she had a history of dizziness/fainting.  It was only AFTER the patient had received the vaccination and fainted that her mother mentioned that her daughter "often faints or gets lightheaded" after receiving vaccinations.
Axilla pain and swelling (lymph node), L arm/shoulder reaction at site and below with redness, itching and swelling. Present for 1 week after initiation of symptoms with 2-3 days of pain and swelling and then improved over 3-4 days after that.
Patient felt lightheaded after flu shot leaving store. She sat down in aisle and used inhaler she carries. Sat for 10 minutes. Said she was okay - did not need assistance. She waited further about 20 min. She said she was okay and left. Called when she got home.
Pt completed COVID 19 vaccine on 12/14/21. According to documentation in EMR vaccine was administered into left deltoid. However, Pt reports vaccine was administered into right arm. On 12/29/21 Pt contacted PCP c/o increased right arm, shoulder and neck pain. Pt denied history of similar S/S and reported S/S started and worsened following vaccine   Of note Pt also received TDap Vaccine in LEFT arm on 12/21/21- pt verified that this vaccine was administered into left arm
8 days after receiving first dose woke to red swollen arm, pain at injection site, headache, nausea, diarrhea, fatigue. These symptoms lasted for 3 days. Symptoms were the worst on the second day and prevented me from doing my normal daily activities for the first two days.
Itchiness all over body especially arms and torso/bumps which cause itching; hives all over body, especially arms and torso; rash, different parts of body/fine rash; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2022, the patient received the 1st dose of Shingrix. On 3rd March 2022, 3 days after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the patient experienced generalized pruritus and hives. The patient was treated with loratadine (Claritine). On an unknown date, the outcome of the generalized rash and generalized pruritus were not recovered/not resolved and the outcome of the hives was unknown.   It was unknown if the reporter considered the generalized rash, generalized pruritus and hives to be related to Shingrix.     Additional Information: GSK Receipt date: 28-APR-2022 Reporters comment: The patient self-reported the case. After receiving Shingrix, the patient broke out in a fine rash. Less than 3 months after receiving Shingrix, the patient experienced hives and itchiness all over her body especially arms and torso. There was reportedly always a bump which caused the itching. Healthcare professional initially did not consent to follow-up, according to the caller but upon follow up the reporter consented to follow up.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the unknown number of patients were vaccinated with GARDASIL (lot# and expiration date not provided) (dose not reported). It was reported that GARDASIL and ROTATEQ were exposed to 34F for 48 hours and VARIVAX was exposed to 32F for 48 hours. The reporter stated that she did not have access to specific patient or vaccine information but she was able to state that all products had been administered post excursion. No adverse effects have been reported by any patient. It was reported that the unknown number of patient did not seek medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021 at 1:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021 at 1:24 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 65.18. Concomitant products were not provided.  On 02-Mar-2021, excursion time was 09 AM, 10 AM and 11 AM, temperature was 27, 29 and 32 respectively and excursion time was 12 PM, 02 PM and 03 PM, temperature was 33, 35 and 36 respectively, total doses given for the day was 177, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 02-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 29, 11 AM: 32, 12 AM: 33, 1PM: 36, 2 PM: 35, 3 PM: 36, 4 PM: 37 and 5 PM: 37.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Information has been received from a registered nurse concerning a college-aged female who was vaccinated with Gardasil in the past in the gluteal area from another provider and there was less pain.  The patient also experienced burning pain after vaccination.  This is one of several reports received from the same source.  Additional information has been requested.
Dermatographia appearing about 1.5 weeks out from receiving the Moderna booster shot. Symptoms continue without improvement through today
This spontaneous report as received from a medical assistant refers to a 24 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 05-FEB-2018 and 12-FEB-2018, the patient was vaccinated with first and second dose of GARDASIL 9 (dose was not reported) (Lot # N013698, Expiry date :19-DEC-2019) for prophylaxis (inappropriate schedule of drug administration). There was no adverse effect reported. There was no product quality complaint reported.
Moderna COVID-19 Vaccine EUA: Vaccine recipient reported chest pain (7/10) 10 minutes after receiving the vaccine. They were sent to the emergency room. The chest pain lasted 1 hour. The EKG and cardiac labs were normal. The patient was discharged to home.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       The concomitant medication was not reported by reporter It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  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.
feeling warm; itching at injection site, injection site more itchy; Red mark on left arm, injection site redder; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (feeling warm), INJECTION SITE PRURITUS (itching at injection site, injection site more itchy), VACCINATION SITE ERYTHEMA (Red mark on left arm, injection site redder) and PRURITUS (itchy) in a 67-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 CETIRIZINE HYDROCHLORIDE (ALLERGY RELIEF [CETIRIZINE HYDROCHLORIDE]) for Allergy, PANTOPRAZOLE, HYDROCHLOROTHIAZIDE and Artorvastatin for an unknown indication.  On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 22-Jan-2021, the patient experienced VACCINATION SITE WARMTH (feeling warm), INJECTION SITE PRURITUS (itching at injection site, injection site more itchy), VACCINATION SITE ERYTHEMA (Red mark on left arm, injection site redder) and PRURITUS (itchy).    On 22-Jan-2021, VACCINATION SITE WARMTH (feeling warm) had resolved.   On 28-Jan-2021, INJECTION SITE PRURITUS (itching at injection site, injection site more itchy), VACCINATION SITE ERYTHEMA (Red mark on left arm, injection site redder) and PRURITUS (itchy) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Mild headache, fatigue, sore throat, white patches and red streaks in throat, body aches, swollen mouth, bright pink spot on the back of leg.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # L008057 and expiration date 01-DEC-2016, 2 ml administered orally. No adverse effects were reported. The vaccine had six temperature excursions one of 24 hours with a lowest recorded temperature of 8.5 Fahrenheit (F) (8.5 Celsius (C)), the second one of 24 hours with a lowest recorded temperature of 8.3 F (8.3 C), the third one of 24 hours with a lowest recorded temperature of 8.1 F (8.1 C), the other one of 24 hours with a lowest recorded temperature of 8.4 F (8.4 C), other one of 24 hours with a lowest recorded temperature of 9 F (9 C) and the last one of 24 hours with a lowest recorded temperature of 8.7 F (8.7 C). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
administered expired vaccine to patient. Vaccine rep notified, parents notified. no adverse reaction noted by parents. 09/30/2022 parents do not express any concerns at this time. plan to revaccinate in 28 days.
My menstrual cycle started a few days after and wasn't supposed to start for a few weeks. It lasted almost 3 weeks instead of the usual 5 days and in the months since has nearly ceased completely being very light and and weeks late
Acute respiratory failure with hypoxia - Cardiology was brought on board and patient was started on diuresis and planned for cardiomyopathy work-up. RHC and LHC were scheduled for 01/24 after patient was adequately diuresed. He had resolution of his bilateral leg swelling, abdominal and scrotal swellings. GI was consulted and EGD was doneHemoglobin remained stable and patient continued to improve and was weaned off O2 supplementation  He completed IV Zosyn for scrotal cellulitis.  ID involvement well appreciated. Per GI recommendation, he is to continue pantoprazole 40 mg twice daily for 3 months. He will follow-up with cardiology outpatient for evaluation for LHC.  In the meantime he will continue on 2 mg Bumex p.o. daily  Due to HbA1c of 12.3 (greater than 10) he will be discharged on insulin Lantus.  He will continue on his home dose of Metformin. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
A nurse reported that an 18 month old female received Acel-Imune, Hib-Titer, and IPV vaccines on 01/11/2001. On 01/13/2001, the child developed a rash on both arms, which became itchy and spread to her back. The rash was described as being superimposed on an "eczemoid type" rash. These symptoms were treated with Benadryl, with no responses. On 01/18/2001, the rash was treated with Elocon ointment. On 01/19/2001, the child develped a cough and nasal congestion which was treated with Pediacare Cough/Cold Formula. On 01/25/2001, the rash was no longer raised or itchy. The reporter noted that the child was being referred to a pediatric allergist. Follow up info received from pediatric allergist on 03/06/2001, stated that the child recovered.
Swelling, redness and warmth of injection site went to ER on 03/20/12 then f/u with PMD on 03/21/12.
pain & redness @ inject site w/fever of 100.8 reported by mom; pt was originally seen for a routine well visit & immun catch-up on 28JUL93; seen again on 29JUL93 & started on Vantin 100mg BID x 7 days; seen on 2AUG sx resolved;