chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arthus reaction; red rash on both arms(in right arm 14 cm by 10 cm and in left arm 4 cm by 3 cm); Initial information was received on 27-Jul-2020 regarding an unsolicited valid serious case from a health care professional, issued from a literature article.    This case is linked to case 2020SA197750( same literature).  This case involves a 11-year-old female patient who experienced Arthus reaction (type III immune complex mediated reaction) with red rash on both arms (in right arm 14 cm by 10 cm and in left arm 4 cm by 3 cm) (rash erythematous), while she received vaccines MENINGOCOCCAL VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in the left and right arm respectively for prophylactic vaccination.  On an unknown date, the patient developed serious arthus reaction (type III immune complex mediated reaction) with symptoms red rash on both arms (in right arm 14 cm by 10 cm and in left arm 4 cm by 3 cm) (rash erythematous) within 12 hours following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and within 12 hours following the administration of MENINGOCOCCAL VACCINE. These events were  assessed as medically significant.  Details of laboratory data were not reported.  Final diagnosis was type III immune complex mediated reaction.   Patient was treated with antihistamines and steroid creams.  At the time of reporting, outcome of the event was not reported.  There will be no information available on batch number for this case.; Sender's Comments: This case involves a 11 years old female patient who experienced type III immune complex mediated reaction within 12 hours after vaccination with MENINGOCOCCAL VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The time to onset was compatible. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccines cannot be individually assessed.
tingling down arm up neck (left side) pain in left ear then moving accross forehead into head pain extreme headache chills, fever shot up to 102 hands and face freezing for hours while high temp. Up all night in extreme pain and with fever weakness body aches internal pain, migraine. took some oxy and ibuprofen in the early evening when pain got too bad to bear around I think 7pm. That helped, fever went down to 99, then the meds wore off chills and pain returned. Started taking oxy and ibuprofen every hour on the hour from 2am until 2pm following day when I was then able to sort of sleep for 2 hours. Stopped taking meds. Took NAC to protect against all that ibuprofen. Took warm bath with bathsalts. Still feel sick but head pain and muscle aches have receeded.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 24-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Developed strange hive-like rash on injection arm top from about elbow down and top of right hand on same arm.; Incredibly itchy; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 45-years-old non pregnant female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 14Apr2021 14:30 (Batch/Lot number was not reported) (at the age of 45-years-old) as dose 1, single for covid-19 immunisation. Medical history included high blood pressure, obesity, asthma, mitral-valve prolapse, Known allergies:  Polyester allergy, Bee allergy from an unknown date and unknown if ongoing. The patient concomitant medication included VITAMIN D [ERGOCALCIFEROL], zinc, ascorbic acid (VITAMIN C CITRUS); all taken for an unspecified indication, start and stop date were not reported. The patient had known allergies for polyester allergy and bee allergy. The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient diagnosis for COVID-19 prior to vaccination was unknown and had not been tested since the vaccination. On 05May2021 13:00, the patient developed strange hive-like rash on injection arm top from about elbow down and top of right hand on same arm and incredibly itchy. Almost unbearable for patient at times. Cortisone 10 clear salve helped patient eventually. The patient received treatment for itchy and for the remaining event not received. The outcome of the events was not recovered at the time of report.  Follow-up attempts completed. No further information expected.
3" diameter black mark approx. 180 degrees from the vaccination site.  No pain, or swelling experienced.
Pt developed red, raised rash about 24 hours following pneumoccocal vaccine site. Rash was just below the vaccine injection site.
Moderate muscle fatigue during exercise (as the patient had about 50% of leg strength); Muscles in jaw were weaker and it was difficult to chew gum; Muscles in jaw were weaker and it was difficult to chew gum; This is a spontaneous report from a contactable consumer (patient).   A patient of an unspecified age and gender received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. No underlying conditions were reported and no medications have been taken previous month. On an unspecified date, after the vaccination, the patient experienced moderate muscle fatigue during exercise (as the patient had about 50% of leg strength). The patient had noticed that the muscles in jaw were weaker and it was difficult to chew gum. The symptoms only lasted 24 hours after the first dose of the vaccine. Patient's muscle strength return to normal on day two.  The information on the batch number has been requested.
14 hours after injection- fever, chills, fatigue, muscular and joint pain, feeling pain throughout lymph nodes in clavicle, arms, groin, and legs. Swelling in clavicle. Lasting a minimum of 28 hours so far.
Received Flu shot 10/14/08 Fry's. That nigh had hallucinations + feet extremely sweaty - wringing wet- 2nd night same thing hallucinations not feeling well. 3 days ago had muscle twitching in a leg he had injected a couple weeks ago. Not fully recovered but is better. (Had a previous injury to hip area + that's where the pain+ twitching starts)
Dizziness  Dehydration  Nausea and vomiting, intractability of vomiting not specified, unspecified vomiting type  Dyspnea, unspecified type
Immediate tingling in throat, metallic taste, red streak appeared from injection site to elbow. within 3 hours developed headache, jaw\neck pain,  fever to 102.7 F, severe joint pain, nausea, cough  I took Benadryl on 7/30/21, Advil q 8 hours  8/02 tongue remains slightly numb, headache and jaw pain persist
Approximately 4.5 hours after 2nd dose, toes started to horribly and painfully contract with twisting, unable to resolve for approximately one hour. I attempted to stretch toes, feet, legs, lie down on bed, lie down on floor. 10 year old grandson attempted to comfort me as I was going thru this and my granddaughter watching, I was excessively irritable due to pain and inability to standstill. I was crying and grunting from the pain and event which I have never experienced in my life.  24 hours after this event, my lower legs started to burn fro  Knee to lower calf with any activity and non activity. This burning a week later went to my hips, shoulders, spine and pelvis, anterior and posterior. This pain would linger on and off for approx 3 months.  After booster on 12/10/21 my right foot cramped very mildly after 16 hours (730am) Pain to hips, legs and pelvis, shoulders and now wrists feel like electric shocks that come and go starting at  10 hours post booster vaccine.  Body aches all over and painful to get up out of bed, toilet.
Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium
Narrative:  Patient received two doses of covid vaccine. Passed one day after second dose. PMH includes dementia, cad, chf c/b severe aortic stenosis, htn, depression. No further documentation of cause of death or complications of receiving the vaccine.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 09Apr2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient immediately began feeling hot in body and had a seizure.. patient regained consciousness and was taken by EMS to emergency room for evaluation.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 02-FEB-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (dose, route, lot number and expiration date were not provided). Concomitant medication was not provided. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of nine reports from the same reporter. Additional information has been requested.
60-year-old female with a PMH significant for multiple sclerosis,Hashimoto's disease, sarcoidosis, rheumatoid arthritis and hypertension who came to ER with C/O of shortness of breath. Was found to be COVID 19 positive. No chest pain, shortness of breath. No CP,N/V/D.
Eczema rash, breathing issues, thick sputum that will not stop production, blacking out spells, eye infections that keep coming back, swollen veins under eye lids. As of 02/04/2021 I cannot taste certain foods. I can taste spicy and salty at random.
Woke up from nap feeling nauseous, faint, cheeks and jaw tight and throat uncomfortable.  Presented to ER around 2 PM and was given Benadryl, Zofran and an IV.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA284721, 2018SA284755, 2018SA284751, 2018SA284752, 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284753, 2018SA284754, 2018SA284750, 2018SA284707, 2018SA284709, 2018SA284711 (same reporter). This case involves a two year old patient (gender not reported) who received vaccine FLUZONE QUADRIVALENT that was outside of the recommended temp range below 32 Fahrenheit. The patient's past medical history and concomitant medication were not provided. On 03-Oct-2018, the patient received a dose of suspect QUADRIVALENT INFLUENZA VACCINE (lot number UT6262MA and expiry date 30-Jun-2019) via intramuscular route in the right thigh. It was a case of actual medication error due to product storage error. It was not known whether patient had any adverse event. 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 Directive 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. List of documents held by sender: none
CAN NOT MOVE ARM AFTER GETTING COVID-19 VACCINE; This spontaneous report received from a consumer concerned a female of unspecified age. 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced can not move arm after getting covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of can not move arm after getting covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211043237.
Pt vaccinated with DTP/OPV later that day had fever to 103.6 lasting 18hrs, vomiting for 12 hrs & diarrhea. Fever & vomiting subsided but diarrhea persists. Child doing well otherwise.
Information has been received from a licensed practical nurse referring to multiple patients of unknown ages and genders. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates in 2016 (reported as "between 01-MAR-2016 and 14-JUL-2016"), 3 doses of improperly stored LIQUID PEDVAXHIB (lot# L042835, expiration ate 19-AUG-2018, route not reported) were inadvertently administered to the patients. No adverse effect was reported. This is one of several reports received from same reporter. Additional information has been requested.
Patient stated that she felt muscle aches and fatigue lasting a week on the side of the body that she received the flu shot on. She said that her leg swelled and she had shortness of breath "reduced lung capacity" so that she could not walk on her treadmill
Chest tightness, shortness of breath, tight jaw, tingling left foot, racing heart rate/arrhythmia, irritability, inability to sleep more than 1 hour a night, excessive thirst? still waiting on treatment
Information has been received from a physician concerning a female patient who was vaccinated IM with Gardasil (date unknown). Three weeks after the patient received her second dose of Gardasil, she experienced numbness in her arms and legs and went to the hospital. It was not clear if the patient was admitted or not. However, at the hospital, the patient underwent testing. One test was described as a "drop test." During this test, the patient's arms were released from above her head and "it dropped on her face." Subsequently, the patient recovered from the numbness in her arms and legs. The physician noted that the patient was fine after she received her first dose of Gardasil. Additional information has been requested.
Patient and father stated that date of birth was 08/27/2004 when making an appointment for COVID 19 vaccine. Pharmacy discovered on entering in WIR that patient had DOB listed as 08/27/2005, making him ineligible for vaccination at the time of the vaccine. WIR contacted pharmacy to verify DOB of patient. Confirmed with healthcare system he uses that the DOB given at the time of vaccination was not correct.
8/24/23 Received a call from client. Client states at approx 2 am on 8/23/23 she experienced fever, body aches, chills and a headache that lasted until approx 5 pm on 8/23/23. Client states at approx 1 am on 8/24/23 she experienced severe back pain that ran up and down her spine and was "almost unbearable". Client reports no other sx but reports she has had this pain for 12 hours and continues to have this severe back pain. Client states she has not taken any medication for relief. Advised client to seek medical evaluation from a provider. Client states she is on her way to a walk in clinic for an evaluation of her back pain sx. Will contact client in a few days to assess her health status. See continuation page
Patient with 3 Pfizer COVID vaccinations who admitted to hospital with COVID detected test.  Provider D/C note below:  "71-year-old male with a past medical history of ulcerative colitis and BPH.  He presented to the emergency department on 07/18/2022 with a chief complaint of fatigue.  He was diagnosed with COVID but did not require any oxygen supplementation and had minimal symptoms except for dry cough.  He was admitted to the hospital due to notable hyponatremia at 118. The patient does have a history of chronic hyponatremia of unclear etiology.  He was originally given fluids due to some poor oral intake at home but sodium actually decreased so further workup was performed.  Workup revealed SIADH so patient was placed on a fluid restriction and sodium tablets.  Nephrology was also consulted for further recommendations.  Labs were not revealing of an etiology of the SIADH, but COVID could have been a contributing factor.  Patient was also on Wellbutrin at home which was held due to the possibility that this could be contributing, states he has been on this for years but does not think it is helping him anymore so we discussed stopping and discussing with his PCP alternative treatment.  His sodium was very slow to improve, on day of discharge was 132 which is close to his baseline.  He was discharged home with instructions per Nephrology for continued fluid restriction given his chronic hyponatremia.  Labs are ordered for later this week to recheck.  He will follow-up with his PCP.  All questions were answered at time of discharge and patient was given strict return precautions to which he verbalized understanding."
pt devel hives under lt armpit & across chest the noc received Td inj;
Vaccine was initially stored in the refrigerator on 07-Feb-2022 and administered on 11-Mar-2022; Expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 07-Feb-2022 and administered on 11-Mar-2022) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 07-Feb-2022 and administered on 11-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 07-Feb-2022 and administered on 11-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that, the vaccine was administered beyond the beyond use date. The vial was initially stored in the refrigerator on 07-Feb-2022. The vial did not undergo any temperature excursions. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2022: Live Follow-up received contain Non significant information.
c/o numbness over lt face on 24JUN95 4AM which last through the whole day until 6PM;no other discomfort or problems;no more numbness since then;not seen by MD;desired not to get 2nd & 3rd dose to complete series;
approx 24 hrs p/vax pt broke out in a rash w/some whelps mostly on torso; a few on extremities & 1 spot on face;
Bell Palsy, still healing, pain behind right ear, sensitivity to sound, impaired speech, and currently facial muscle control.
On 2/18/21 I awoke with sharp transient chest pain. It awoke me at 2:00AM an subsided around 2:10AM and I went back to sleep.  I was then awoken 2 additional times with chest pain that subsided in about 10 minutes after sitting up.  I experienced chest pain every evening thereafter which awoke me and finally on 02/21/21 I went to the emergency department where the physician performed an EKG, Chest Xray, CBC, BMP, BNP and Troponin levels.  All of the tests were normal and the physician did not determine a diagnosis for my chest pain.  I felt as if the symptoms were similar to pericarditis and after my trip to the ED I experienced transient chest pain during the day along with at night.  I took ibuprofen 800mg TID, which helped to alleviate the chest pain for most of the evening and day.  The chest pain ceased on 2/26/21 and I have not experienced it since.  I have never experienced this type of chest pain in the past and do not have any chronic cardiac conditions.
This spontaneous report was received from a healthcare worker concerning an 80 year old female patient with no known allergies. Current condition of the patient included hypertension. On 19-FEB-2013, the patient was vaccinated with 0.5 milliliter (ml) of PNEUMOVAX23 (lot number and expiry date reported as H01547 and 08-JUN-2014 respectively, route unspecified). No concomitant medications were reported. On 19-FEB-2013, the patient experienced redness, swelling and possible cellulitis at the injection site after being administered with PNEUMOVAX23. On 22-FEB-2013, the patient sought medical attention (visited the office). The physician prescribed an unspecified antibiotic and to apply ice to the injection site to bring down the swelling. It was unspecified if any lab tests were performed. The outcome of redness, swelling and possible cellulitis at the injection site was unknown. The relatedness for redness, swelling and possible cellulitis at the injection site was unknown for PNEUMOVAX23. Additional information has been requested.
Mom stated 'my child had a head to toe rash, and high fever after receiving MMR and VZV on 6-22-15.' This child was vaccinated at another facility.