chrisvoncsefalvay/vaers-outcomes huggingface dataset:
following 3rd dose of Engerix-B vax pt devel water retention of the arms, legs & ankles; liver was swollen & tender to touch; liver enzymes were elevated; exp diarrhea of clay-like stools; constipation; chest pain, bradycardia, cant sleep;
dose administered to patient after more than 1 temperature excursion; dose administered to patient 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 (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:17 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:17 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient 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.   On 03-APR-2021, Excursion time was reported at 9:00 A.M AM with  temperature as 34 degrees Fahrenheit, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-MAR-2021, vial was moved to clinic on 03-APR-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-APR-2021.  Vial was stored on cooler 1, on 03-APR-2021, Excursion duration At 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, PM: 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM : 41.  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 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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half 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).
Erythema Multiforme Minor by macular papular rash over entire body developing 5-6 days after vaccination
This spontaneous report as received from a nurse refers to a 17 year old patient of an unknown gender. On 03-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
cheek bones hurt underneath her eyes.; Experienced chest pain; Experienced arm soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (cheek bones hurt underneath her eyes.), CHEST PAIN (Experienced chest pain) and VACCINATION SITE PAIN (Experienced arm soreness at the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement, Stent placement (Kidney stent.), Hysterectomy and Diverticulitis (Diverticulitis surgery(bagged then reversal).). Concurrent medical conditions included Aching in knees, Bladder discomfort, Migraine, Back pain, Sciatic nerve injury (Sciatic nerve pain.), Blood pressure inadequately controlled (High Blood pressure), Acid reflux (esophageal), Penicillin allergy, Allergy (Sulfa allergy.), Allergy (Codeine allergy.), Iodine allergy, Allergy (Morphine allergy.), Allergy (Patient reported: NSAID's (can't take due to bad kidneys).), Allergy (Ultram allergy.), Allergy (Cymbalta allergy.) and Allergy (Requip allergy. Reporter mentioned:Requip (hallucinated).). Concomitant products included ZOLMITRIPTAN (ZOMIG) for Migraine, HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for Pain, CLOPIDOGREL BISULFATE (PLAVIX), MIRABEGRON (MYRBETRIQ), FESOTERODINE FUMARATE (TOVIAZ), FAMOTIDINE, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D3), DOCUSATE (Col-rite), GABAPENTIN (NEURONTIN), LUTEIN [XANTOFYL], ROSUVASTATIN CALCIUM (CRESTOR) and OLMESARTAN MEDOXOMIL (BENICAR) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced FACIAL PAIN (cheek bones hurt underneath her eyes.), CHEST PAIN (Experienced chest pain) and VACCINATION SITE PAIN (Experienced arm soreness at the injection site). On 20-Jan-2021, FACIAL PAIN (cheek bones hurt underneath her eyes.) and CHEST PAIN (Experienced chest pain) had resolved. At the time of the report, VACCINATION SITE PAIN (Experienced arm soreness at the injection site) had not resolved. The consumer reported that on 20JAN2021, her cheek bones hurt underneath her eyes, and she experienced chest pain. Both events lasted 20 minutes and resolved. She reported that she pushed on her face to help with the pain and held her chest. No treatment medication reported. That same night, she again experienced and reported that her cheek bones hurt underneath her eyes and she experienced chest pain. This time, these same events lasted 30 minutes and resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
Uncontrollable  shaking, chills, hyperventilating, diarrhea
Patient had vaccine moderna fisrt dose at 237pm, in right arm. Pt. sittngn inobservation area aat 3pm, c/o of headache sharp, adn SOB, vitalas take at 3pm, BP 142/94, pulse 106. Temp 98.9F Right arm 154/95  pulse 112   SAT O2 100%... pulse 116 Pt anxious as well. Wheeled via wheeklchair to ER, for evaluation in satble condition Alertt adn oriented to arrvial ER; lot # 0011A21A   exp 8/16/2021 moderna  first dose
After patient received his shot, while sitting during the 15 min waiting period. The patient began getting lightheaded and hot, his color went out of him and his eyes began rolling back in his head.  His eyelids turned a purple color and he appeared to momentarily stop breathing.  Myself and another pharmacist got him on the ground and supported his head with a coat.  When he "came to" and was talking to us.  He described feeling better on the cold floor and his color began coming back.   I was speaking with him the entire time.  While we were out with his 9-1-1 was called and paramedics arrived 15 min later.  by the time paramedics had arrived the patient had gotten up and back into the chair himself, was lucid and had color back in his face.  Paramedics arrived and took over.  He was given the green light from them and remained in the pharmacy area for a total of about 30 minutes before heading home. The patient was admittedly nervous for the shot and had not eaten or had anything to drink the whole day to that point. I believe he passed out from a variety of factors not related to the actual ingredients in the vaccine but cannot confirm this.
Mom called office saying pt having redness and is small reaction. No itchiness or pain as per patient.
Tingling in left hand, specifically thumb and index finger.  Not fully numb.  Hasn't gotten better or worse since 10 min after injection.  Time is now 8:35 pm
Within 30 seconds: Dry Throat, patient requested water, request was denied. 1 minute after vaccination: Coughing and difficulty breathing  2 minutes after vaccination: Patient refuses EpiPen administration stating she will not go to the hospital and not to call 911. 3 minutes after vaccination: Patient attempts to leave observation area to go use her own EpiPen in her apartment. 4 minutes after vaccination: Patient agrees to EpiPen administration into left leg and 911 is called. 5 minutes after vaccination: Patient continues to cough and clear throat. Patient throws herself out of her chair onto the floor while coughing. 6 minutes after vaccination: Patient hoarsely requests a second administration of EpiPen.  EpiPen is administered into right leg. 7-10 minutes after vaccination: Patient is breathing easier however is forcing herself cough. 11 minutes after vaccination: EMTs arrive. Patient's HR: 141 bpm, SpO2: 96% 13 minutes after vaccination: Patient's SpO2: 99% 18 minutes after vaccination: Patient goes outside with EMTs 20 minutes after vaccination: Patient signs "Against Medical Advice" form - refusing to go to the hospital 22 minutes after vaccination: Patient is walked by to her apartment by EMTs.
12 hours after vaccine, fever and chills began (peaked at 103.2 degrees), unable to move from bed. Fever broke around 12 hours after beginning. 24 hours after vaccine, bruising below injection site and swollen lymph node under arm (still persisting 3 days later). Continued headache and tiredness.
This was my booster.  Unbearable increase in tinnitus, swollen arm, armpit and left breast.  Headache and dizziness.
Approximately 4 hours after receiving the vaccines pt. projectile vomited. Then she started to look really pale and started breathing really shallowly. Her lips turned blue so mother gave her a couple of rescue breaths. She would cry for a little bit then go unresponsive. Mother would then give her a few more rescue breaths and this happened a few times. Mother then called our office and since we couldn't get her in right away instructed her to go to the emergency room. Mother opted to take her to urgent care. Urgent care monitored her for a little while but couldn't tell family if this was a reaction to the vaccine or may just to vomiting. They sent her home to be observed carefully. Since then she has not had any further problems/adverse effects.
Less than 24 hours: Sever fatigue Moderate body aches, chills, headache, fever, cough
This spontaneous report as received from a nurse refers to a female patient of unknown age. On 24-APR-2014 the patient was vaccinated orally with ROTATEQ (lot# reported as H020311) 2 ml expired on 16-APR-2014. No adverse effects. Additional information has been requested.
This is a spontaneous report obtained from a contactable pharmacist. A 71-year-old female patient of an unspecified race and ethnicity received the first dose of PREVNAR 13 on an unspecified date, in 2016, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. It was reported that the patient received only a quarter of the vaccine. On an unspecified date, in 2016, after the vaccination, the patient developed pneumonia. The vaccine was not injected properly (no possible immunity obtained). Clinical outcome was unknown at time of this report. The information on the lot number has been requested.; Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.
Patient presented at 5:05 with complaints of burning sensation in chest, tachycardia, throat irritation and itching, mild cough, flushing of chest and face.  No SOB.  Pulse 120.  O2 sat 99%.  BP 110/70. She had a history of serious allergic reactions to foods in the past, and was familiar with the symptoms.  She was provided a 25mg dose of diphenhydramine  (she had previously taken 25mg prior to her vaccine, in addition to her daily allergy medication in the morning) and she was observed.  over a 30 min observation period her pulse came down to under 100, her flushing and throat irritation resolved.  She was feeling back to baseline and she was allowed to leave.
This is a spontaneous report from a contactable office manager communicated to a Pfizer sales representative. A female patient of unknown age and race received PREVNAR 13 for immunization in Feb2017 via an unspecified route in the arm at single dose. The patient experienced an allergic reaction on the same day as the injection, swelling, breakout, and rash, all occurred at the injection site. The patient placed ice and all events resolved.
Pt received vaccination on 5/1, but the BUD was 4/27/23. Expiration is 6/15/23. Moderna has been contacted to do a lot assessment and will return with results in 3-5 business days. Patient is aware.
Started itching, but the itching could have been due to something else. Got bad chills, high fever. Took tylonol. Fever went down. Still has fever. Took tylonol again this morning. Has aches and pain. Hard to get around.
This spontaneous prospective pregnancy report as received from a nurse refers to a 17 year old female patient. The patient had no pertinent medical history, drug reactions or allergies nor concomitant medications. On 24-MAR-2011, the patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL lot # 0786Z and expiration date 18-OCT-2012 as her physician recommended. Then on 18-MAR-2014, she received the second intramuscular 0.5 ml dose of GARDASIL lot # J011272 and expiration date 21-APR-2016 as her physician recommended. The patient became pregnant with estimated last menstrual period (LMP) of 19-MAR-2015 (based on number of weeks of the pregnancy) and estimated delivery date (EDD) of 24-DEC-2015 (based on LMP). The patient finished the series of vaccinations on 21-JUL-2015 with the third 0.5 ml dose of GARDASIL 9 lot #K026246, expiration date 21-JAN-2017 administered intramuscularly per the physician's recommendation. Other suspect therapies included MENACTRA administered on the same day (dose, frequency, lot #, expiration date, route of administration not reported). On unspecified date in 2015, the patient experienced rash on her torso and both arms. The nurse stated the rash was present for over a month and it was raised, red, very itchy and painful after scratching. The patient was prescribed with prednisone (manufacturer unknown) but the rash got worse after she took the medication. The nurse stated the patient was seen at an unspecified clinic on 27-JUL-2015 (reported as 2 weeks ago) due to the rash. The patient was seen at an unspecified women's clinic on 06-AUG-2015 and had an ultrasound performed, which showed she was 20 weeks pregnant. The nurse stated the patient was also seen in their office on 06-AUG-2015 due to the rash. The nurse stated the patient was prescribed WESTCORT cream for the rash. The outcome of the event was unknown. The pregnancy outcome was pending and fetal outcome was unknown. The relatedness between the event and GARDASIL, GARDASIL 9 and MENACTRA was unknown. Additional information has been requested.
Had blurry vision after her first vaccination (onset the evening after the vaccination with Moderna). She washed her face, eyes and applied OTC hydrating drops without relief. The following day, she continued to have blurry vision in the left eye. The left eye felt like she was seeing only gray. The right eye was only hazy. Eventually her vision returned that day. Also had itching and redness, which also resolved.
I did not vaccinate this patient, but I went out to the parking lot when a customer said someone fainted outside.  The patient was asked to wait 15 minutes in the store.  However his mom was with him and stated that he always faints after injections, so she wanted to put him in the car to lie down.  When I arrived the patient was awake and feeling warm. Sitting up
The pt experienced a sore neck, achy joints. The pt states that she is tired all of the time. Always complaining she feels so old.
10 mins p/vax pt felt nauseated, lightheaded, & dizzy; this lasted several hrs & DPh relieved sx; later @ noc devel rash in extremities & tingling in lips;
Day after extreme fatigue and joint pain, chills for 5 days. It has been over a month and have continued joint pain and bouts of exhaustion. I had covid and this is worse than having it.
1/20/21 CVS administered the vaccine at the center. 1/21/21 Employee called out for her shift, reporting left face drooping and has reached out to her PCP.  Diagnosed by urgent care doctor with Bell's Palsy, taken out of work 1/21 through 1/24.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "bronchiectesis" (unspecified if ongoing); "long COVID" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "osteoporosisis" (unspecified if ongoing); "Biaxin/Bactrim/Cipro/Levaquin/Sulfa" (unspecified if ongoing). Concomitant medication(s) included: NITROFURANTOIN, start date: Oct2023, stop date: 14Oct2023. Vaccination history included: bnt162b2, bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), administration date: 19Oct2022, for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 17Oct2023 to 22Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350930 same patient, different drug and AE;
Rib pain; Cold; Headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Rib pain), NASOPHARYNGITIS (Cold), HEADACHE (Headache) and CHILLS (chills ) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Rib pain), NASOPHARYNGITIS (Cold), HEADACHE (Headache) and CHILLS (chills ). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Rib pain), NASOPHARYNGITIS (Cold), HEADACHE (Headache) and CHILLS (chills ) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines were reported. No treatment information were reported.
received an expired 4th dose of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old male patient who received DTPa (Infanrix) (batch number D2KX9, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd December 2021, the patient received the 4th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 2nd December 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient's date of birth was not provided. The reporter reported that patient received an expired dose of Infanrix, which led to expired vaccine used. The reporter did not consent to follow-up.
MEDI-0003807 is a not serious spontaneous case from a consumer involving sore throat. The reporter causality is not provided to FluMist. An office manager in a physician's office reported that a 35 year old male and 3 other office staff experienced headache and sore throat 2 days after receiving FluMist vaccine on 26Oct05. This patient completely recovered. The reporter causality is not provided.
EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED FROM TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: 21-SEP-2021) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, the patient experienced expired vaccine administered from the vial affected from temperature excursion. On 07-JUL-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered from the vial affected from temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916300, 20210916228, 20210916520, 20210915646, 20210915852, 20210916312, 20210916401, 20210916415, 20210915731, 20210916553, 20210915661, 20210915623, 20210916455, 20210916910, 20210915719, 20210916129, 20210916465, 20210915748, 20210916584, 20210916658, 20210916768, 20210916811, 20210916849, 20210916959, 20210916498, 20210913164, 20210916715, 20210916808, 20210917160, 20210917163, 20210916965, 20210917226, 20210916907, 20210917515, 20210917603, 20210917074 and 20210917500.
Client was given a pediatric dose of Hepatitis A instead of adult dose and was given a Tdap that was not yet due.
Pt vaccinated with DTP/OPV developed high & prolonged crying & possible cyanosis; Hospitalized x 24 hours. A pneuocardiogram was done.
Approximately 10 days following vaccination patient began to have nerve and mobility issues. Per the patient she was eventually diagnosis with Guillian-Barre syndrome.
Severe chills and fever of 102.   Fever would not respond to ibuprofen or tylenol.   Headache and injection site itching.
Since about 10 minutes following the shot, I began having tingling in my feet that has continued.  I also have tingling in my hands.  Additionally, initially, I had a scratchy throat and itched, but that lasted less than 5 minutes.  However, the foot and hand tingling, which is bilateral on both but worse on the right of each, has continued and it is now about 9 hours since the vaccine shot.  I did not report this to the pharmacy as I thought it would stop.  I did call back a few hours later asking if I could take Benedryl in case I was having an allergic reaction.  I was told I could but I have not taken anything as the tingling is not severe at this moment, just present.  It was NOT present prior to getting the shot.