chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pre-medicated with 25mgs Benadryl at time of vaccination 10:00am. At 6pm,  started with feelings of being flushed all over body with tingling in extremities to include face, tongue, throat felt like it began to swell with voice beginning to get raspy. Begininng of chest tightness. By 7pm  marked shortness of breath with increased chest tightness, more difficulty swallowing , raspy voice and oxygen saturations dropped to low 90's . Complete activity intolerance. Injection site had rash extending over entire upper arm and  forearm that was hot, raised and painful.  Took 50mgs Benadryl, multiple doses of rescue inhaler (albuterol) due to difficulty breathing following by steroid based inhaler (3 doses).  Sx continued through night and slowly improved. At 5 am took another 25mgs of Benadryl and took repeated doses of albuterol and steroid inhaler for 48 hours. (normally don't use at all). Oxygen saturation level returned to normal within 8 hours. Rash resolved with persistent Benadryl use x 2 days.  Due to lack of insurance coverage did not go to ER for Tx as recommended. I am a front line nurse so monitored at home.  Contacted MD via messaging system  MD has stated I cannot receive vaccine number 2 due to risk for complete anaphylaxis.   Was notified my Lot was same lot OHA put notice out as having higher incident of vaccine reaction.
This spontaneous report was received from other health professional refers to an unspecified patients of unknown age and gender. On an unknown date, an unspecified number of unspecified patients received improperly stored GARDASIL (lot # K007264 and expiration date 02-MAR-2017 and lot# K007828 and expiration date 02-MAR-2017) (dose and route were not reported). No adverse effect reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Headache 1/13 sweats, left sided pressure headache, neck stiffening, tingling and cold left side of body Narrative:  1/13 2:45 pm vaccinated 5 hrs later sweats, left sided pressure headache and down to neck stiffening up, 15 minutes later tingling and cold left side of body. Check VS, given Tylenol. Resolved. 1/14 called out, took Tylenol resolved, pt reports will be back tomorrow. No PMH. Came in person occupational health seen by NP.
A pediatrician practicing at clinic did not follow the Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger, 2017 for my son. He was expected to receive the 3rd dose of HepB but instead, the pediatrician gave him the 1st dose of Hep A. A board certified pediatrician gave a 10-month-old Hep A instead of the expected Hep B!
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (expired vaccine administered to 155 patients) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 026L21B) for COVID-19 immunization. No medical history reported. On Apr 4, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; .25 milliliter. On Apr 4, 2022, patient administered expired product (expired vaccine administered to 155 patients). At the time of the report, administered expired product (expired vaccine administered to 155 patients) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The pharmacist called to verify an expiration date for batch/lot# 026L21B. The pharmacist said he thought the vaccine expired in June 2022, however the vaccine expired on Apr 1, 2022. 80 patients received the expired vaccine. Vial initially stored in refrigerator on Apr 4, 2022. No temperature excursions.
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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 9:00 AM, 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, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 36.79. Concomitant products were not provided. On 13-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 152 condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021. 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.   This case was linked to MOD-2022-566976 (Patient Link).
about 15 minutes after receiving the vaccine, the person that accompanied the patient yelled for help. She states his eyes rolled back and then slumped over and arms flailed a few times. The patient didn't know it had happened. He stated he felt dizzy and looked pale. We gave him a water bottle and after a few minutes he felt better.
Left anterior thigh with 4cm erythematous wheal developed within 5 minutes of vaccine administration. No systemic symptoms. Benadryl 12.5mg given p.o. with resolution of rash within 20 minutes.
Approximately 12 hours after receiving the vaccine I began to run a fever, extreme headache, extreme joint pain that was constant but would have what felt like a "stabbing" pain through my joints, extreme muscle aches, nausea, no appetite which lasted 48 hours
Body aches, loss of appetite, chills, headache, rhinorrhea, cough.
Swelling around the left eye. Eye was almost shut from the swelling.. Started during the night. Lasted a full day.
Stomach Bloating; Headache; All over body pain; Muscle Weakness; Fatigue/Tiredness; Diarrhea; This is a spontaneous report from a contactable consumer (patient).   A 60-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration, administered in left arm on 24Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient previously administered with first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) administration date on 01Feb2021 at 9:15 AM on left arm for COVID-19 immunization and Shingrix vaccine dose first dose administered on 16Nov2020 and second dose on 23Jan2021 both in in right arm. The patient had no known allergies or other medical history. The patient did not have covid prior to vaccination. Concomitant medication included loratadine, pseudoephedrine sulfate (CLARITIN-D), ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE), colecalciferol (50m D3) and apple cider vinegar (600m Apple Cider Vine). On an unspecified date in 2021 at 08:00 AM, the patient experienced headache (lasted 2 days), all over body pain, muscle weakness, fatigue/tiredness, stomach bloating and diarrhea. The patient did not receive treatment for the events. The patient did not test for covid post vaccination. The outcome of headache was resolved and for other events it was recovering.  Information about lot/batch number has been requested.
Lg raised > 10 cm erythematous warmth to palpation tender area.
day 10 post vaccine: elevated temperature, swollen lymph nodes and infection of skin from tape burn at reaction site.
THe flu shot was given high into my shoulder and it has caused ongoing pain and loss of movement in my left arm due to pain at injection site.  I have subsequent neck and shoulder/arm pain going on 6 weeks.  It wakes me in the night and causes loss of movement so that easy tasks like getting dressed are difficult and painful.
Site: Redness at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: cellulitis-Medium, Additional Details: pt ended getting keflex
This spontaneous social media report was received via "Question From MerckVaccines.com Technical Assistance" web page, from a 64 year old female patient in relative good health, who was reporting on herself. No medical history, current conditions and concomitant therapies were reported. On an unknown date, the patient was vaccinated with two doses of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) one in each arm (lot #, expiration date, vaccination route and dose were not reported). Additional information has been requested.
Information has been received form a nurse practitioner concerning a 28 year old female patient who on 15MAY2003 was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). About 6 days later, on approximately 21MAY2003, the patient developed joint pain in her knees and ankles. No additional information was provided.
high pitched, unconsolable screaming @ RANDOM when awake; projectile vomiting; sleepiness; szs (infantile spasms); constipation; staring; deep, motionless sleep;
MEDI-003806 is not a serious spontaneous case from a consumer in the USA  involving sore throat. The reporter causality is not provided to FLUMIST. An office manager in a physician's office reported that a 33 year old female and 3 other staff experienced headache and sore throat 2 days after receiving FLUMIST vaccine on 26Oct05. After taking Tylenol Ibuprofen, she completely recovered. The reporter causality is not provided.
arm tenderness; difficulty walking to bathroom; Pale; profuse sweating/soaking wet; Lethargy; upset stomach; confusion; dark urnine that was brown; This case was reported by a consumer and described the occurrence of pain in arm in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Heart attack and shingrix with an associated reaction of pain in extremity (received 1st dose on 10th August 2020, refer case US2020AMR244097). Concurrent medical conditions included diabetes.   On 9th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, 24 hrs after receiving Shingrix, the patient experienced pain in arm, walking difficulty, pallor, sweating, lethargy, upset stomach, confusion and brown urine. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, walking difficulty, pallor, sweating, lethargy, upset stomach and brown urine were recovered/resolved and the outcome of the confusion was unknown.   It was unknown if the reporter considered the pain in arm, walking difficulty, pallor, sweating, lethargy, upset stomach, confusion and brown urine to be related to Shingrix.  Additional details were reported as follows: The reporter was patient's wife. The patient received Shingrix and 24 hours later developed arm tenderness, difficulty walking to bathroom, pale, profuse sweating, lethargy, upset stomach, and confusion.  The reporter was scared and unsure of what was occurring with patient. The reporter asked if the patient was had chest pain due to history of heart attack, but due to confusion patient did not provide a response to reporter.  The reporter checked patients' blood pressure, pulse, and glucose which were all within normal limits.  After lunch, the patient's upset stomach went away and looked better and moved around better.  At bedtime, patient used bathroom and stated observing dark urine that was brown.  During the middle of that night the patient woke up soaking wet.  The reporter stated that the patient woke up like normal as if nothing happened the day and night before.  All symptoms reportedly resolved.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR244097:same reporter
Information has been received from a nurse practitioner concerning a 37 year old female patient, with no past medical history and no concomitant medications, who on 4/15/03 was vaccinated with a dose of MMR (second generation) (lot # 643715/0838M). It was noted that the patient was not ill at the time of vaccination. It was reported that the patient received tuberculin purified protein derivative (reported as a tuberculin skin test) on 3/31/03 (results not provided). On 4/17/03 the patient presented to employee health with a complaint of just not feeling right and whole body shakes. The patient was referred to her primary care physician. It was reported that the patient did not have insurance or a primary care physician so she had not been seen. The patient returned to employee health on 4/30/03 stating that the shakes (also reported as intermittent tremors) were continuing in the legs and hands to the point where she can not work and had to sit down and she also complained of tachycardia, palpitations, and weight gain. The reporter indicated that as far as she knew the patient was not treated with anything nor was she diagnosed with anything. It was unknown if the patient recovered. The patient had not been seen in employee health since 4/30/03. it was noted that no work up was done except for the physical exam. Upon internal review, body shakes to the point where she can not work was considered to be an important medical event (OMIC). Additional information has been requested. It was noted that the reporter had two other patient's had experiences after receiving a dose of MMR (second generation). This is a consolidation of two reports concerning the same patient.
5:12p: PT complained of tightness in chest after vaccinated (vaccine administered at 4:55p; timed out at 5:10p) Water was given on vaccination floor. PT was brought back to Med Ops1 for vitals & observation. PT was given another bottle of water & apple juice. PT states she just came from the gym. PT states she was anxious about getting vaccine, but her chest tightness was not anxiety. PT's husband did bring her inhaler - staff brought it back to Med Ops1. PT administered inhaler at 5:30p & 5:33p - no change. PTs vitals were within normal range, no other symptoms. PT was visibly anxious. PT was on her phone most the observation with her husband & mother. PT refused to go to hospital by EMS. PT was released at 5:40p but stated she was driving herself to an urgent care for further evaluation.
Tolerated first and second doses just fine without issue. After booster, began having severe nausea and vomiting overnight 12/12/2021 into 12/13/2021 - was unable to stand, profuse nausea and vomiting. Taken to ER and given fluids, meclizine and Reglan. Discharged home same day with supply of medications. Continued to have intermittent nausea and dizziness.
Pt spiked fever @ 3PM of 105F APAP given & cooled in tub; temp now 104F;
Patient received Tdap & Pneumonia vacc. in (L) arm. Now having redness, swelling, pain which is now traveling down arm. Patient started on cefdinir 300mg x 7 days.
Client came in to clinic for vaccines and blood work and to see the doctor.  When asked if he had any chronic medical problems, client said no.  Nurse went over vaccines (Tdap and MMR).  After vaccine administration, as blood was about to be drawn, client disclosed that he is a patient at a local HIV clinic.  Nurse unsure of HIV status.  Client signed medical release form.  Letter sent to client's doctor at HIV clinic informing doctor of vaccines administered.    No adverse events.
little arm pain which she figured was normal side effects; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A female patient of an unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: unknown, expiration date: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced little arm pain which she figured was normal side effects. Therapeutic measures were not taken as a result of the events. The outcome of the events was unknown.  Information about Lot/Batch has been requested. Follow-up attempts are completed. No further information is expected.
Blood leakage; Trouble breathing; Shot when right through her body like a wave; Black and blue bruise mark on her arm; Heartburn; Feeling sick; Felt so tired; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Blood leakage) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 36A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No historical condition reported.). Concomitant products included LEVOTHYROXINE, METOPROLOL, LOSARTAN and ROSUVASTATIN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HAEMORRHAGE (Blood leakage) (seriousness criterion medically significant), DYSPNOEA (Trouble breathing), FEELING ABNORMAL (Shot when right through her body like a wave), VACCINATION SITE DISCOLOURATION (Black and blue bruise mark on her arm), DYSPEPSIA (Heartburn), MALAISE (Feeling sick) and FATIGUE (Felt so tired). At the time of the report, HAEMORRHAGE (Blood leakage), DYSPNOEA (Trouble breathing), FEELING ABNORMAL (Shot when right through her body like a wave), VACCINATION SITE DISCOLOURATION (Black and blue bruise mark on her arm), DYSPEPSIA (Heartburn), MALAISE (Feeling sick) and FATIGUE (Felt so tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was treated with Vicks and paracetamol. Reporter's causality was not reported.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the has been provided at this time for the event (hemorrhage). Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the has been provided at this time for the event (hemorrhage). Further information has been requested.
This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. The reporter considered the vaccination failure and influenza to be unrelated to Influenza vaccine Quadrivalent. Additional details were provided as follows: This case was reported by a receptionist from physician's office. The age at vaccination was not reported. The receptionist advised that, the patient got the flu even though she had received the flu vaccine, inferring the flu vaccine (brand unknown) the patient received was ineffective. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule and lab test confirmation for targeted disease was unknown. No other details were available at the time of call. The sales representative did not know the reporter's contact information. This case is 2 of the 3 cases reported by the same reporter.
Blood clot (DVT) in right leg followed by pulmonary embolism (several blood clots in lungs).  Hospitalized for 1 day and put on blood thinners. Subsequently diagnosed with pulmonary hypertension.
From initial information received on 6/17/04 from a registered nurse, regarding an adverse event occurring in the USA, it was reported that a 19 year old female patient received her fourth dose of IMOVAX RABIES, lot number X0581, administered in the left deltoid on 6/15/04 in the afternoon. The route of administration was not reported. It was not reported whether the patient received the vaccine as part of a pre- or post-exposure series. That same day, the patient developed soreness and swelling at the site of injection. That evening, she also experienced chills, shaking, and temperatures ranging from 97.8 to 99.0 degrees F. She also complained of a lump in her throat, but no difficulty in breathing was reported. The patient was instructed by the director of nursing at the reporting facility to apply a cold pack to the site of injection. She did not go to the emergency room. The patient's recovery status was not reported.
vaccine administered 10/24/22 expired 10/15/22, notified provider, will reach out to oncologist to determine need to revaccinate
On March 29, 2022 at 11:30PM, I started to have chills, fevers, and my whole body started to hurt. I took some Tylenol that night and stayed in bed because I was shaking so bad. The next day I took an at home test and tested positive. I then, called Dr.'s office the next morning and spoke with her nurse who related all of my symptoms to Dr. I was told to stay in the house for 5 days until my fever broke. I wasn't offered any medicine.
Patient received Janssen vaccination on his right deltoid via intramuscular injection at 16:40. At 16:41 while sitting outside under shade, patient experienced an episode of delayed awareness that lasted about 5 seconds. Patients vital signs were monitored and patient mental status was accessed. Patient regained awareness of person, tome, place, and event however stated that he often had syncope episodes after stressful experiences. Patient denied ambulance services called in his behalf and family members proceeded to take patient home under watch for any continued or worsening conditions. Patient and family were educated to contact emergency services if condition did not improve.