chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had her left side of her face paralyzed and she couldn't shut her eye to sleep and she has to tape her eye shut; had her left side of her face paralyzed and she couldn't shut her eye to sleep and she has to tape her eye shut; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FACIAL PARALYSIS (medically significant), EYE DISORDER (non-serious), outcome "unknown" and all described as "had her left side of her face paralyzed and she couldn't shut her eye to sleep and she has to tape her eye shut".  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a pharmacy student refers to a 60 year old female patient with no pertinent medical history or drug reactions/allergies. On 28-OCT-213 (reported as 2 weeks ago) the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, subcutaneously (lot # unspecified). On 11-NOV-2013 the patient came into the pharmacy to report adverse reactions. Patient had pain from the shoulder to her elbow (unspecified which shoulder and which elbow). Pharmacy student stated "the pain was to the point that the patient could not pick up her arm." The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 19-FEB-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Patient received TD on 11/01/2006 and came back to the clinic on 11/03/2006 with hematoma at injection site with bruising and swollen left axial lymph node. Doctor prescribed  Clindamycin to the patient. Follow up 12/05/06 patient recovered.
Hot to the touch at the injection site; Redness at the injection site; This case was reported by a consumer and described the occurrence of injection site warmth in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2019, the patient received Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site warmth and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth and injection site erythema to be related to Shingrix.  Additional details were provided as follows: On friday, the patient received shingles vaccination. The patient took the new 2 shot series. The patient seemed to be experiencing most of the side affects. The patient's main question was should it still be hot to the touch and should the redness at the injection site still be getting bigger at the reporting date.
Information has been received from a health professional concerning a patient who was vaccinated with PROQUAD.  Suspect therapy included hepatitis A virus vaccine (mfr. unknown).  Subsequently the patient experienced seizures.  Upon internal review seizures were determined to be an other important medical event.  Additional information has been requested.
Patient developed a hard bump after vaccination.  About the size of a golf ball.  Patient did have a small dribble of blood after vaccination but nothing more than I have seen prior, but this is the first time that I noticed a large bump afterwards.  Checked with the patient an hour later and bump was still present.  Patient did not complain it hurt but I did mention to him that it will probably be black and blue and sore  eventually.
Throat Pain, Feels like Swallowing Razor Blades; Mild Fever; Body Aches; Throat Pain, Feels like Swallowing Razor Blades was reported as worsened; sore throat; muscle aches; This is a spontaneous report from a contactable consumer (patient). An 18-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0153, Expiry date: unknown), via an unspecified route of administration in arm right on 08Apr2021 at 14:30 (at the age of 18-years-old) as a dose 1, single for COVID-19 immunization. The family medical history relevant to AE(s) was reported as none. The patient's medical history included ongoing Coxsackievirus, clarified that, she has had Coxsackievirus before and that was what it felt like. There were no concomitant medications. The patient did not took other products. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior Vaccinations within 4 weeks was reported as none. AE following prior vaccinations was reported as none. The caller stated that, she had the vaccine about a week ago and she woke up this morning on 12Apr2021, she experienced body aches and on 13Apr2021, she experienced mild fever and on 14Apr2021, she has much throat pain, feels like she was swallowing razor blades, which was reported as worsened on an unspecified date in Apr2021 and she was achy. The caller asked whether this was normal or if she should go get tested. Clarified that, she has had Coxsackievirus before and that was what it felt like. Clarified that, this was after her first dose. Caller called in because she got the 1st dose of the vaccine on 08Apr2021 and 2 nights ago she started experiencing symptoms. On an unspecified date in Apr2021, she currently has a sore throat and muscle aches. Stated that, she wanted to know whether these are normal side effects and if she needs to test for Covid-19. Any unaddressed medical questions referred or forwarded to the Medical Information was reported as yes. The AE(s) did not require a visit to emergency room and physician office. Patient received treatment with Ibuprofen, yesterday for body aches and cough drops. The outcome for the event body aches was recovering and for mild fever was recovered on 13Apr2021 and for throat pain, feels like swallowing razor blades was not recovered and for sore throat, muscle aches was unknown.  No follow-up attempts are possible. No further information is expected.
Initial unsolicited report received from a physician (patient's husband) on 29 September 2016. This case involves a 56-year-old female patient who was vaccinated with a dose of 0.5ml Fluzone QIV (batch number: UI673AB, expiry date of product: 30 June 2017; dose in series, route of administration were not reported) in the arm at around noon on 27 September 2016. Reportedly, she had received Fluzone QIV multiple doses over the years. The patient's medical history and concomitant medications reported as none (any other vaccinations within 4 weeks of vaccinations, Illness at time of vaccination, Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none). On 27 September 2016, few hours after vaccination (at around 6PM) following the vaccination, the patient began to feel dizzy, had a headache and vomited one time, also had neck and upper back pain, and complained of feeling very weak. Laboratory data was reported as none. Corrective treatment included paracetamol and the patient was advised rest. The outcome of the event was unknown. List of documents held by sender: none.
Influenza vaccine administered in right deltoid. 2 days later, patient's arm became black and blue and sore, unable to lift over head. Visit to MD office - reported that his MD speculated that an artery had been hit during adminstration. No blood was in syringe when plunger withdrawn during adminstation.
states 30mins p/vax felt stiffness & pain lt arm,couldn't lift it,it was red from deltoid to mid brachial area;t99 & felt flushed through noc of 5JAN96;worked used arm a lot 6JAN96 & it was real heavy to lift & pain begin in neck;t1100-101
Patient experienced self-limited angioedema of the lips resulting in perioral numbness that persisted for 2 weeks before resolving.  Errythematous papulovesicular rash on dorsum of both great toes. Thrombocytopenia with platelet count of 129,000.
it was an infection, it was celulitis; felt bruised; it was red; it was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (it was an infection, it was celulitis) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) 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 medical history reported).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced CONTUSION (felt bruised), VACCINATION SITE ERYTHEMA (it was red) and VACCINATION SITE PAIN (it was sore). On 02-Apr-2021, the patient experienced CELLULITIS (it was an infection, it was celulitis) (seriousness criterion medically significant). On 25-Mar-2021, CONTUSION (felt bruised), VACCINATION SITE ERYTHEMA (it was red) and VACCINATION SITE PAIN (it was sore) had resolved. At the time of the report, CELLULITIS (it was an infection, it was celulitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Description: The patient in the first couple of days felt bruised, like a normal shot, it was sore and red. Then it was red and had a red area, probably it happened during the first week and second week it got worse, got swollen, it was hot. On 02 Apr 2021, the patient  went to the urgent care and they said it was an infection, it was cellulitis (medically significant) and she stayed there for a couple of hours.  The patient was treated with two intravenous (IVs): antibiotic (piperacillin/tazobactam) intravenous and a steroid (dexamethasone) intravenous. They gave her three pills to take: clindamycin, methylprednisolone pack and ibuprofen, both oral (did not take the latter).   Subsuming events swelling, skin warm and erythema under cellulitis.  Company Comment - 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.; 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.
Having trouble getting getting second vaccine; More than 36 days have passed since first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT AVAILABILITY ISSUE (Having trouble getting getting second vaccine) and PRODUCT ADMINISTRATION INTERRUPTED (More than 36 days have passed since first shot) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PRODUCT AVAILABILITY ISSUE (Having trouble getting getting second vaccine) and PRODUCT ADMINISTRATION INTERRUPTED (More than 36 days have passed since first shot). At the time of the report, PRODUCT AVAILABILITY ISSUE (Having trouble getting getting second vaccine) and PRODUCT ADMINISTRATION INTERRUPTED (More than 36 days have passed since first shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient is having trouble getting their second dose of vaccine because  decided to vaccinate more people and did not have enough vaccine for second inoculations.; Sender's Comments: This report refers to a case of Product dose omission issue and product administration interrupted, for mRNA-1273, lot # unknown,  with no associated AEs.
It eventually was an earache on right ear and it was outside the ear, not deep inside. Used hydrogen peroxide and used homeopathic Earache drops. That relieved it a little bit. 01/01/2022 it hurt unbearably bad. Went to Urgent care and he said that I packed it all in with the stuff I was using and he prescribed me an antibiotic and steroid. Neomycin and polymyxin B sulfate and hydrocortisone optic solution, USP. To this day, still have an earache, pain is not as bad. It wasn't just an earache, there was also tinnitus. ringing and pulsing in ear.
Tinnitus of varying volumes. It seems to be improving over time. It could be due to earwax buildup, as earwax removers have caused the weight in the ears to shift.
Several weeks (end of November) after getting flu vaccine, client began experiencing weakness in legs with numbness in feet and toes.  He began walking with a cane and 2 days later he was in a wheelchair.  Family took client to the ER when he couldn't swallow.  Admitted to hospital on December 3rd, 2007, and diagnosed with Guillian-Barre Syndrome.  He was on life support X 17 days and in ICU X 1 month.  Transferred to rehab center. 5/27/09-records submitted with report-Presented on 12/2/08 with 10 day history of increasing weakness and numbness of feet which made an ascending pattern up entire body. 4 days prior began with feelings of breathlessness and day before presenting to ED C/O trouble with swallowing and muffled speech. Elevated BP on admission 148/99 and subsequent transient increase in BP. Treated with IVIG. Mechanical ventilation required with intubation and subsequent extubation. NG feedings. DX: Guillain-Barre syndrome.  One month hospitalization. Office visit follow up 1/23/09 residual weakness on both sides of face, CN VII focally affected R>L.   6/26/09 Hospital records and DC summary recieved. DOS 12/02/07 to 01/04/08. Assessment: Ascending paralysis, probable Guillain-Barre. Patient presented with ascending numbness and weakness. Nausea and vomitjng. Numbness in feet. Difficulty swallowing liquids. Unable to walk or sit up on his own. DTR's absent. Stregnth diminished upper and lower extremities. Fever, headache. Sedation/Analgesia dependence. Agitation with respiratory distress. Hypertension. IVIG administered. Transferred to rehabilitation facility.  ICD-9 Codes: 357.0, 518.81, V46.11, 707.03, 292.0, 304.01, 112.0, 401.9, 075, 726.87, 041.5, 564.00, 110.5
flea like bites on feet, legs, back arms with rash on back that is starting to go away after use of cortisone creams
Sore arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment reported.  Upon internal review on 21-May-2021, the age was corrected to unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-036127 (E2B Linked Report). This case was linked to MOD-2021-036029 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-036127:
1 day after: pain around injection site 2 days after: low energy, sleepy 3 days after: slight pink mark around injection site 4 days after: began getting joint pain in knees and legs, more severe at night. started to get incredibly itchy all over including arm and legs. no pain in arm, pink mark fading around injection site. 5 days after: still have joint pain, at night had increased heart rate, still very itchy everywhere, no mark around injection site 6 days after: some joint pain, increased heart rate is gone and itchiness is down 7 days: little joint pain, no increased heart rate, only arm is itchy. Have now developed an approximately 2 inch raised, red, hot bump around injection site. Note: this is much redder, warmer and raised as compared to earlier when it was just a small pink circle.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021 at 11:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 11:59 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 22.43.  Concomitant medication of the patient was not reported.  Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature of 35 degrees Fahrenheit at 09:00 AM and 35 degrees Fahrenheit at 10:00 AM. These vials were moved to fridge on 23-Mar-2021 and beyond use date for the vials was reported as 22-Apr-2021. The vaccines moved to clinic on 27-Mar-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 10:00 (Lot number: FA7484) at the age of 55 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "ME/CFS" (unspecified if ongoing); "ME/CFS" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Vitamin D Deficiency" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "allergy: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 23Jul2021, outcome "recovering" and all described as "arm soreness & swelling"; HEADACHE (non-serious) with onset 23Jul2021, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 23Jul2021, outcome "recovering", described as "fatigue"; MALAISE (non-serious) with onset 24Jul2021, outcome "recovering", described as "malaise"; PAIN (non-serious) with onset 24Jul2021, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 24Jul2021, outcome "recovering", described as "chills"; DECREASED APPETITE (non-serious) with onset 24Jul2021, outcome "recovering", described as "loss of appetite"; SOMNOLENCE (non-serious) with onset 25Jul2021, outcome "recovering", described as "sleepiness/I have slept approximately 55# hours plus since Friday"; FRUSTRATION TOLERANCE DECREASED (non-serious) with onset 26Jul2021, outcome "recovering", described as "frustration"; WEIGHT DECREASED (non-serious) with onset Jul2021, outcome "unknown", described as "losing 4 lbs.". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pain in extremity, peripheral swelling, headache, fatigue, malaise, pain, chills, decreased appetite, somnolence, frustration tolerance decreased, weight decreased. Additional Information: facility type vaccine was Pharmacy or Drug Store. if other vaccine in four weeks was no. Day 1 - arm soreness & swelling; headache & fatigue. Day 2 - malaise; arm soreness & swelling, in addition to, body aches & chills, loss of appetite. Day 3 - continued fatigue & sleepiness; loss of appetite; Day 4- continued fatigue & sleepiness; loss of appetite & frustration; Day 5 - continued fatigue & sleepiness; frustrated. I have slept approximately 55# hours plus since Friday, 23Jul2021, in addition to losing 4 lbs., since my first vaccination. if Covid-19 prior vaccination and If Covid-19 tested post vaccination was no. Follow-up attempts are completed. No further information is expected.
PATIENT COMPLAINED OF REDNESS, FEVER OF 104, SWELLING, AND DIAGNOSIS OF CELLULITIS WHEN SHE REPORTED TO URGENT CARE.
Information has been received from a registered nurse concerning a 36 year-old female employee with no allergies who on 29-AUG-2006 was vaccinated intramuscularly in the left deltoid with a 1.0 ml first dose of Recombivax HB. "A few days later", the patient experienced tenderness and soreness of the left elbow. The patient mentioned that she rides a bicycle long distance every day with significant weight-bearing on her arms. No medical attention was sought, no laboratory or diagnostic tests were performed. At the time of this report, the patient has not recovered. No product quality complaint was involved. No further information is available.
Left shoulder pain with injection. 4th day after injection difficulty raising arm. Pain x 3 months. Saw PCP. Dx of rotator cuff tendonitis. Started PT 12/23/13.