chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter
Patient reports feeling tingling in hands, legs, and head. Felt pressure in chest. Patient reports symptoms resolved after about 10-20 minutes. Cleared by EMS
Passed out/Collapse; Really cold; Clammy; Headache; fall; feeling dizzy; Pale; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 11Dec2021 (Lot number: FE3594) at the age of 16 years as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, dose 1, single), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 11Dec2021, outcome "unknown", described as "booster"; LOSS OF CONSCIOUSNESS (medically significant) with onset 12Dec2021 07:00, outcome "recovered" (12Dec2021), described as "Passed out/Collapse"; NASOPHARYNGITIS (non-serious) with onset 12Dec2021 07:00, outcome "recovered" (12Dec2021), described as "Really cold"; COLD SWEAT (non-serious) with onset 12Dec2021 07:00, outcome "recovered" (12Dec2021), described as "Clammy"; HEADACHE (non-serious) with onset 12Dec2021 07:00, outcome "recovered" (12Dec2021), described as "Headache"; FALL (non-serious) with onset 12Dec2021 07:00, outcome "unknown", described as "fall"; DIZZINESS (non-serious) with onset 12Dec2021 07:00, outcome "unknown", described as "feeling dizzy"; PALLOR (non-serious) with onset 12Dec2021 07:00, outcome "unknown", described as "Pale". Clinical course: There were no prior vaccinations within 4 weeks. The patient did not even get her flu shot yet. The patient received the booster yesterday around noon and this morning, she just, out of the blue, she just collapsed, she passed out and she was really cold and clammy. Also, she had a headache. This has never happened before. The mother made sure that she gets her fluids. She was really cold and clammy. She just had her lie down in bed actually for like half an hour and just monitored her. The patient was cold, clammy and pale and she was dizzy and she has never had that. She passed out. They were upstairs in our bedroom and she hit the floor, we heard her, we heard her fall, it was a big bang and it was her on the ground.; Sender's Comments: Based on known temporal association, there is reasonable possibility of causal association between the event Immunisation, Loss of consciousness, Nasopharyngitis, Cold sweat, Headache, fall, Dizziness, Pallor and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient reported having red, itchy rash 7 days post vaccination. Upon return for 2nd dose, still had rash on chest. Patient reports using OTC cream for itching. Medical Team consult, determined that patient was unable to receive 2nd dose Pfizer today and will wait at least 28 days and until rash is gone. Also referred for possible Jaansen vaccine.
was not feeling well; She stayed in bed for the next day and that was it; She didn't run a high temperature then. Her arm had a rectangle 4" by 6", it was swollen and hard.; This time, her arm didn't get hard but got very swollen and hot; Her arm had a rectangle 4" by 6", it was swollen and hard. The hard area was 3/4 inch thick.; very tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (was not feeling well), MOBILITY DECREASED (She stayed in bed for the next day and that was it), PERIPHERAL SWELLING (She didn't run a high temperature then. Her arm had a rectangle 4" by 6", it was swollen and hard.), FEELING HOT (This time, her arm didn't get hard but got very swollen and hot) and INJECTION SITE INDURATION (Her arm had a rectangle 4" by 6", it was swollen and hard. The hard area was 3/4 inch thick.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A, 025120-2A and 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Drug allergy. Concomitant products included INSULIN, CLOPIDOGREL BISULFATE (PLAVIX), EZETIMIBE (ZETIA) and ATORVASTATIN for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (was not feeling well), MOBILITY DECREASED (She stayed in bed for the next day and that was it), PERIPHERAL SWELLING (She didn't run a high temperature then. Her arm had a rectangle 4" by 6", it was swollen and hard.), FEELING HOT (This time, her arm didn't get hard but got very swollen and hot), INJECTION SITE INDURATION (Her arm had a rectangle 4" by 6", it was swollen and hard. The hard area was 3/4 inch thick.) and FATIGUE (very tired). At the time of the report, MALAISE (was not feeling well), MOBILITY DECREASED (She stayed in bed for the next day and that was it), PERIPHERAL SWELLING (She didn't run a high temperature then. Her arm had a rectangle 4" by 6", it was swollen and hard.), FEELING HOT (This time, her arm didn't get hard but got very swollen and hot), INJECTION SITE INDURATION (Her arm had a rectangle 4" by 6", it was swollen and hard. The hard area was 3/4 inch thick.) and FATIGUE (very tired) outcome was unknown.            No treatment medication was reported.
Received her second dose Pfizer vaccine (LOT#: EW0179 EXP: 8/2021) at 1108 on 5/07/21. Patient had completed her observation time. Patient returned to vaccination site after getting to her car due to experiencing tingling in her throat and pain in her stomach. Patient stated that these symptoms started when she was walking to her car with her daughter. Patient alerted EMT. EMT alerted PHN. PHN  gave patient water. Patient did not have any difficulty swallowing. PHN recommended that patient take Diphenhydramine. Patient agreed. PHN gave patient adult dose of DIphenhydramine . EMT  took patients vital signs. BP: 140/80. PHN asked patient to stay an extra 30 minutes for further observation. PHN educated patient on worsening signs and symptoms of side effects from vaccine and when to seek help from EMS. Patient agreed and verbalized understanding. EMT reassessed patient. Patient stated she was feeling a lot better. EMT took blood pressure. BP: 120/90. Patient completed observation time. Patient left vaccination site unassisted with a steady gait with her daughter. Daughter stated that she would be driving her mom home.
vision blurr; Tired; colour blindness; This spontaneous case was reported by a nurse and describes the occurrence of VISION BLURRED (vision blurr), COLOUR BLINDNESS (colour blindness) and FATIGUE (Tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020 and Fever (Patient had high fever.). Concurrent medical conditions included Multiple sclerosis.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced COLOUR BLINDNESS (colour blindness). On an unknown date, the patient experienced VISION BLURRED (vision blurr) and FATIGUE (Tired). At the time of the report, VISION BLURRED (vision blurr), COLOUR BLINDNESS (colour blindness) and FATIGUE (Tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.     This case was linked to MOD-2021-003907 (Patient Link).
Within 2 weeks of getting  my second dose of the Maderna vaccine, I started getting bad dizzy spells and diarrhea which caused me to go to Urgentcare and the ER numerous times and to miss a week of work. I am still dealing with both. None of the doctors could figure out what was the cause. I mentioned my thoughts about possible adverse affects from the Maderna vaccines and that almost everyone I mentioned it to, said they had been having the same symptoms since getting the COVID vaccines.
Patient was administered a dose of HAVRIX that expired (06/07/15) on 6/17/15.
Box 17 - HepA, MMR, PCV13, Hib, Polio  Within the hour whelps appeared near injection site, then started to spread. He was given Tylenol. Approximately 7-8 hours later, whelps spread all over body. He was then taken to ER, where he was given Benadryl and steroids. Next day (7/7) he was warm to touch with a fever. Given Tylenol. Currently experiencing fever since 11am, going down but still feels warm.
Patient presented to the ED on 5/1/2021 with subarachnoid hemorrhage and was subsequently hospitalized. This was within 6 weeks of receiving COVID vaccination.
I was in the shower and had my eyes closed for a couple minutes.  I could see the red of my eyelids.  Suddenly, I thought the power/lights suddenly went out because everything became pitch black vs the light red you normally see from the eyelids.  However, when I opened my eyes, everything was lit.  When I close my eyes again, it goes pitch black, as if I have some cover over my eyelids.
Pt states she gets nervous and breaks out into hives after shots, pt did not have hives but an itchy rash after a meningococcal vaccine.  Benadryl 25 mg po given and it resolved.
SLEEPY; SHOULDER FRACTURE (LEFT); PAINFUL JOINTS (KNEE AND SHOULDER); PAIN IN ARM; BROKEN KNEE CAP (RIGHT); FALL; This spontaneous report received from a patient concerned a 66 year old female of unspecified race and ethnicity.  The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient was previously treated with covid-19 vaccine ad26. cov2. S (dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on 02-MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received non-company suspect drug included: Rinvoq (upadacitinib) (form of admin unknown, oral, batch number was not reported) dose and frequency were not reported from an unspecified date to 02-MAR-2021 for moderate to severe rheumatoid arthritis.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on 01-DEC-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 66 years old. No concomitant medications were reported. On an unspecified date in JAN-2022, the patient experienced fell and broke right knee cap (dose number in series 2). On an unspecified date, the patient experienced sleepy, shoulder fracture (left), painful joints (knee and shoulder), and pain in arm. Patient stated that she got really sleepy and joint pain for four days after covid-19 vaccination. The patient reported going to physical therapy for knee pain and shoulder pain (dose number in series 2). The patient received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of admin unknown, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAR-2022 for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination Moderna covid-19 vaccine (elasomeran) (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable; and treatment with upadacitinib was withdrawn on 02-MAR-2021. The patient recovered from painful joints (knee and shoulder), was recovering from fall, shoulder fracture (left), and broken knee cap (right), and had not recovered from pain in arm, and sleepy. This report was non-serious.
received a pediatric vaccine with no reported adverse event; Initial information received on 13-Jul-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 25 years old female patient who received a pediatric vaccine with no reported adverse event , and it involved vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 01-Jun-2022, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE, once, ( lot: UJ581AAA ; expiry date: 17-Sep-2022)  via intramuscular route in unknown administration site for immunization. It was reported that patient was supposed to receive TD from Sanofi but her medical record stated that she received Tetanus IG TG. However, doctor office stated that they had no Tetanus IGTG and the patient received pediatric vaccine instead (wrong product administered) (onset date: 01-Jun-022; latency: same day).  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Started with a fever - that began about 6 hrs after the injection.  That lasted a little more than 24 hours, then went away.  Last night - about 55 hrs after that vaccine, I have developed an itching rash over most of my body - I still have it as of this morning.  Also, slight swelling of my lips
Patient called to report developed area of redness about 4/5 inches wide, slightly itchy and warm to touch.  Advised patient to take Tylenol for warmth or Benadryl if itchiness continues and continue to monitor for spread
Injection site is red, warm, swollen and tender to touch.  Mild headache.
Chills, myalgia,fatigue, headache.   Taking Tylenol.
Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Mild, Additional Details: Patient stated he suffered from vasovagal syndrome but had not had an episode in 6 years.  He felt  that it was more anxiety over the shot. He did not experience any difficulty breathing. passed out for about 15 to 20 seconds, regained conciousness, sat on the ground upright, then laid down. monitored for an hour.
pt recv perceived that smell like wet chicken feathers p/recv vax;according to reporter no one else was aware of any odor emanating from pt;19JAN98 pt no longer perceives an odor;
COVID-19; Cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and NASOPHARYNGITIS (Cold symptoms) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included HIV disease (HIV Positive).   On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 03-Sep-2021, the patient experienced COVID-19 (COVID-19) and NASOPHARYNGITIS (Cold symptoms). On 18-Sep-2021, COVID-19 (COVID-19) and NASOPHARYNGITIS (Cold symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2021, SARS-CoV-2 test: (Positive) Positive.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.
Symptoms reported: tingling tongue around perimeter, on second day on right side predominately; right side of face warm as if "hives" though no hives, no raised skin; itchy around mouth past lip area, below lower lip. Client reports taking benadryl, relief for 2 hours then symptoms presented again and were constant throughout day (day after receiving vaccine).
Fever of 104.7 Chills,  Shivering all night, Sick to stomach and soreness at site
Broke out on arms; Arms were red; itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Broke out on arms), ERYTHEMA (Arms were red) and PRURITUS (itching) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced RASH (Broke out on arms), ERYTHEMA (Arms were red) and PRURITUS (itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form twice a day. At the time of the report, RASH (Broke out on arms), ERYTHEMA (Arms were red) and PRURITUS (itching) outcome was unknown.
Within 5 to 15 minutes after getting the vaccine I began to experience severe itching in bilateral arms starting above the elbow. The pharmacist asked me to stay another 10 to 15 mins at which time a started to get a tingling sensation in my tongue the Pharmacist advised that I go home and take some Benadryl. After getting home I take two 25mg pills and notice a RED RASH burning and itching comeing on my neck and face. I called my doctors office and had to leave a message I then called and spoke to the Pharmacist who stated I should go to the ER.  My doctors called also and stated the same thing to go to the ER. I also called the number on the paper work give at time of injection but was talk they can't give medical advice. I hurried and drove myself to hospital While waiting I started to have a very bad headache my BP was 202/107 when taken by the intake nurse
stumbling, sleepy, cold & hot feeling, jerking of extremities, pupils dilated, loss of memory;
10 days post vax pt was seen for the treatment of tracheopharyngitis and sinusitis and complained of pain and swelling at the injection site. Physical examination revealed that the pt was afebrile and developed swelling in his axillary nodes. Follow up information received 04/11/2000 indicated patient recovered.
Projectile vomiting and diarrhea from 11:00 PM ? 4:00 AM, fever through late afternoon on Tuesday.
Nausea and vomiting beginning 12 hours after injection, headache, muscle weakness, painful injection site
This spontaneous report was received from a health care worker refers to a patient of unknown demographics. On 24-OCT-2013, the patient was vaccinated with unsupported dose of MMR II (lot number J000202 and expiry date 09-JAN-2015). No concomitant therapy was administered. No adverse effects reported. This report is one of the four patients reported from same source. This case is linked to 1311USA008915, 1311USA008916 and 1311USA008744 (same reporter link). Additional information has been requested.
lt deltoid warm & tender to touch read area 4" x 3" tx cold compresses, DPH-return if worse onset 16APR96 seen 17APR96
low fever at around 100F; This is a spontaneous report from a non-contactable consumer or other non hcp. This consumer (patient) reported that a 34-year-old non pregnant female patient received bnt162b2 (COMIRNATY; Formulation, solution for injection, Batch/Lot Number: EW0173), dose 2 via an unspecified route of administration on left arm on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unknown route of administration on an unknown date as dose 1, single for covid-19 immunisation and experienced left arm was swollen and pain. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. On 15May2021 23:00, the patient experienced low fever at around 100f. The patient underwent lab tests and procedures which included body temperature: 100 Fahrenheit on 15May2021. The clinical outcome of event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Patient inadvertently received  Covid19  Vaccine  Moderna primary series second dose   Lot # AS1412B with NDC # 8077-279-05  with an expiration date of 03/13/2022.  This  Moderna  Covid19  Vaccine was expired by one day.