chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I know someone who received one and can no longer walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I know someone who received one and can no longer walk".  Additional information: I would never consider a COVID vaccine. I know someone who received one and can no longer walk.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2nd dose in 2017, now wants to complete full schedule; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 39-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   Previously administered products included Engerix B (received 2nd dsoe on 13th January 2017) and Engerix B (received 1st dose on 12th December 2016).   On an unknown date, the patient received the 3rd dose of Engerix B and hepatitis B vaccine pre-filled syringe device. On an unknown date, unknown after receiving Engerix B and hepatitis B vaccine pre-filled syringe device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 age at vaccination wasnot applicable for this report. The pharmacist reported that a patient wanted to complete the full schedule of EngerixB. Till the time of reporting, the patient did not receive 3rd dose of Engerix B, which led to incomplete course of vaccination. The reporter consented to follow up.
Hearing tones and roaring in the right ear starting 2 days ago, 1 day after receiving both the bivalent COVID (local Health Dept) and the Flu shot from alternate location.  Please note that the flu vaccine manufacturer is unknown, but I had to pick one.  Some intermittent hearing loss as well.   Pt was referred to ENT specialist for further evaluation. Appt on 10/19/22
Extreme redness, swelling and pain in (L) arm, extending from shoulder to below elbow. Required E.R. visit. Mom described it as "looked like his arm would explode."
Around 11PM on 4/12/21 fever started; spiking at 101.1. Vomited at 1AM on 4/13/21. Intense headache lasting from 4AM 4/13/21 until 6PM 4/13/21. Fever reduced with 500mg Acetaminophen every 6 hours but returned at hour five spiking at 101.8. Fever abated only after 36 hours.  Swelling and tenderness of injected arm began evening of 4/13 lasting persistently through writing of this form. Pink coloration of skin at injection site, rash and itching at injection site and across upper arm began 4/16/21.   Patient previously tested positive for COVID on 2/09/21 and experienced similar symptoms throughout illness, only fully recovering by 3/5/21.
Sore throat; Hives; Itches; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), URTICARIA (Hives) and PRURITUS (Itches) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), URTICARIA (Hives) and PRURITUS (Itches). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), URTICARIA (Hives) and PRURITUS (Itches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Heart rate: unknown (High) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Information has been received from a nurse referring to a male patient of unknown age. Medical history and current condition of the patient was not reported. On an unknown date, the patient was administered improperly stored dose of GARDASIL (lot# K001631, expiry date: 06-NOV-2016) dose, route unspecified. Other suspect and concomitant therapies were not reported. No adverse events were reported. No further information was provided. The nurse provided that there have been no need for revaccination and provided patient names and dates of birth who had received the vaccination (other patients were captured in MARRS# 1412USA002140, 1502USA006588, 1502USA006589, 1502USA006590). This is one of several reports from the same source. Additional information has been requested.
3yo with isolated IgA deficiency, administered pneumococcal vaccine. 4 days before admit she developed swelling, redness & fever within 24 hrs of injection. Swelling increased, cellulitis. Admitted for IV ABX, prednisone.6/8/09-records received for DOS 4/24-4/26/09 DC DX:Cellulitis of Buttock at site of pneumoccoal immunization. Admitted because of painful red swelling and fever follow vaccine four days ago. Fever within 24 hours of injection with increased swelling.  6/25/09 Hospital records DC summary DOS 4/24/09 to 4/26/09. Includes medical records DOS 4/30/09. Assessment: Cellulitis of buttock at site of pneumococcal immunization. Patient presents with fever, cough, redness of injection site, cries if leg is touched. Violatious/red/purple area sligh above injection site extending onto thigh and posterior to buttock. Prednisone and IV antibiotics administered.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live.  Recently, in approximately March 2006, the patient was seen by the physician and determined to have developed mumps/  The patient was getting better and was doing fine without treatment and was at home.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/19/2006.  No further information is available.
Received FLUZONE HIGH-DOSE 0.5 ML syr on 9/17/16. Could not sleep all night because of muscle and bone aches. At 6:00am on 6/18 woke up and vomited. Experienced no appetite entire day along with muscle and bone aches. At approx. 8:30pm on 6/18 it all went away. I have never had a reaction to the flu vaccine in the past.
broke out in petechiae in shins/ petechiae again, on shins on her skin, not in the upper thigh, just the lower legs, both legs; purpura on left knee; This spontaneous case was reported by a consumer and describes the occurrence of PETECHIAE (broke out in petechiae in shins/ petechiae again, on shins on her skin, not in the upper thigh, just the lower legs, both legs) and PURPURA (purpura on left knee) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046821A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PETECHIAE (broke out in petechiae in shins/ petechiae again, on shins on her skin, not in the upper thigh, just the lower legs, both legs) and PURPURA (purpura on left knee). In May 2021, PURPURA (purpura on left knee) had resolved. At the time of the report, PETECHIAE (broke out in petechiae in shins/ petechiae again, on shins on her skin, not in the upper thigh, just the lower legs, both legs) had not resolved.            Concomitant medications were not provided.  Patient reported that no treatments  was tried. Patient's dermatologist did not prescribe anything.  Patient went to see a dermatologist. It did not go away for a while.  Company Comment: This case concerns a 49-year-old female patient, with no medical history reported, who experienced the unexpected AESI events of Petechiae and Purpura. The events occurred on the same month after the second dose of mRNA-1273 Vaccine. At the time of the report, after at least 2 months, the outcome of the events was resolved. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-407959 (Patient Link).; Sender's Comments: This case concerns a 49-year-old female patient, with no medical history reported, who experienced the unexpected AESI events of Petechiae and Purpura. The events occurred on the same month after the second dose of mRNA-1273 Vaccine. At the time of the report, after at least 2 months, the outcome of the events was resolved. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
DISCHARGE DIAGNOSES: DKA, mild Type 2 diabetes mellitus on insulin AKI, resolved Hypokalemia, improving. COVID-19 infection, incidental finding HTN Asthma HOSPITAL COURSE: Patient is a 55 y.o. male with a past medical history of Type 2 Diabetes mellitus on insulin, hypertension and asthma who presented to the ED on 1/10/22 for evaluation of hyperglycemia. Admit BG 376. Corrected anion gap of 18. Beta hydroxybutyrate elevated at 3.09. Likely, hyperglycemia and DKA precipitated by acute COVID infection. Also found to be hypokalemic with an AKI likely secondary to lack of PO intake and hyperglycemia. Patient was hydrated with NS + KCL with improvement in his AKI and improvement in his hypokalemia. His Lantus was increased from 23 units q noon to 30 U at noon with improvement in his BG. Stressed the importance of close PCP follow up regarding his diabetes as his HgbA1c came back at >15.9. Patient will be given 5 days of 20 mEq KChloride to take daily with instructions to get a BMP repeat in 2 days when he follows up with his PCP. Patient and his wife understand and are in agreement with this plan. Reviewed COVID quarantine guidelines.    PCP Recommendations: - repeat BMP in 2 days - f/u on COVID recovery, Potassium  - Adjust DM regimen, Lantus increased this admission   HOSPITAL COURSE BY PROBLEM:   DKA, mild, resolved Type 2 diabetes mellitus on insulin Admit BG 376. Corrected anion gap of 18. Beta hydroxybutyrate elevated at 3.09. Likely, hyperglycemia and DKA precipitated by acute COVID infection. PTA Metformin, Glargine 23 U at lunch, Humalog with meals sliding scale. VBG with pH WNL. Lantus increased this admission from 23 U to 30 U daily. HgbA1c came back >15.9.  - continue PTA SSI - Continue 30 U Lantus q noon - counseled on importance of follow up with PCP for DM management given A1c   AKI, resolved Hypokalemia, improving Admit Creat 1.91, baseline Creat ~1.2. K 2.4. Received NS IVF since admission, will switch to NS + KCL. Improved K on day of discharge.  - BMP in 2 days - PCP f/u in 2 days - 5 day rx of Potassium chloride 20 mEq daily given   COVID-19 infection, incidental finding Patient tested positive in ED. Currently asymptomatic and on room air. D-dimer elevated at 11.83. initially placed on 40 MG Lovenox but changed to therapeutic. Remained on room air throughout this admission.  - COVID quarantine guidelines reviewed with patient   HTN PTA Amlodipine 10 MG daily, triamterene/HCTZ 37.5-25 MG daily, hydralazine 25 MG TID, ASA  and Metoprolol 100 MG daily. Bps on the soft side here. Triamterene/HCTZ held in setting of AKI, will resume at d/c - continue Amlodipine, Hydralazine, Metoprolol, ASA - Resume Triamterene/HCTZ in setting of AKI   Asthma PTA fluticasone noted, however, patient states he does not take this.  - hold PTA Fluticasone
A non-serious, spontaneous report of administration of expired product was received from a nurse concerning a ten year-old female subsequent to FLUMIST. There was no adverse event 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 for the medication errors were caused by 1) customers not discarding product form the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 09-Apr-2009: product complaint investigation results.
4th day after injection moderate deep joint pain in shoulder and decreased range of motion unable to lift arm greater then 15 degrees from trunk of body. Also unable to reach behind body.
This is a breakthrough covid case. this patient had second dose 1/15/21 and became positive 5/14/21 after community exposure
Large knot on arm for approximately 3 weeks; This case was reported by a nurse via sales rep and described the occurrence of local swelling in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was recovered/resolved.   It was unknown if the reporter considered the local swelling to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The reporter reported that the patient had large knot on arm  after  the administration of first dose of Shingrix which lasted for approximately 3 weeks. The reporter consented to follow up.
Injection-site redness; Injection-site soreness; Injection-site swelling; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm right on 27Apr2021 at 14:15 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity. Concomitant medications included loratadine (CLARITIN) and bismuth subsalicylate (PEPTO BISMOL) for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm right on 06Apr2021 at 14:15 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 08:30, the patient experienced injection-site redness, injection-site soreness and injection-site swelling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event injection-site redness, injection-site soreness and injection-site swelling was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
During the night following my second dose of the Pfizer COVID-19 vaccination, I experienced a severe, debilitating headache that left me bed-bound and unable to get up for the entire night. I had never experienced a headache so severe in my life. In the months that followed, I continued to experience recurrent headaches (albeit more mild) which had not occurred in my life prior to vaccination, though by now these have largely subsided. However, following vaccination (and beginning essentially following the severe headache I experienced after my second dose) I also developed prolonged short term and working memory deficits, reduced problem solving ability, and concentration deficits which I had also not experienced prior to vaccination, and which now remain incompletely recovered and effect my quality of life.  I have not yet seen a healthcare professional regarding this issue, as I had held hope that I would recover fully, though now that it has persisted I will be doing so.
This case was was reported by an attorney and described the occurrence of autism spectrum disorder in a female patient who received hepatitis B vaccine recombinant for prophylaxis. This report was received via the litigation process and a physician or health care professional has not verified the report. At an unknown time after receiving Engerix-B vaccine, the patient developed autism spectrum disorder. The event was attributed to exposure to thimerosal from the vaccine. This case was assessed as medically serious by manufacturer (OMIC).
Patient suffered bruising, excessive swelling of the upper left arm, and hot/pink-red patch near immunization/shot site on arm. Patient went to Immunization clinic then to Emergency Room and was diagnosed with cellulitis and prescribed with Clindamycin 300mg x 10 days, VICODIN 5mg, and MOTRIN 800mg.
Fever FEVER 101.4 YESTERDAY, THEN AT NIGHT 99.7, TOOK MOTRIN, BODY ACHE, NAUSEAS. ARM SORE. Narrative:
Injection site pain began approximately 2 hours following injection and continued to intensify and spread down the arm and up the neck and upper back over the next hour. A headache and intense fatigue began and I took 500mg Tylenol at that time. Approximately 30 minutes later I unintentionally lost consciousness and awoke several hours later confused and disorientated. I arose to get a drink of water and was unable to walk, falling twice within approximately 10 feet. I noticed my vision was affected as the entire room appeared to be rocking left to right even though I was holding myself still in an attempt to steady my sight and balance. I immediately went to bed and have no memories until I awoke the next morning. At that time, my vision and balance had returned to normal though the aches and pain in my arm, neck and back persisted. This pain slowly dissipated over the next 3 days.
Patient reported on 11/16/2017 that she has had and has a hard bump at the immunization site since 10/2/2017. Patient was not able to pull up sleeve to show me. Patient stated it was and is not hot, is not itchy and is not swollen. Just a hard bump. A friend told her to put heat instead of ice so she was putting heat on it.
This spontaneous report as received from a pharmacist refers to a currently 23-year-old male patient, who was a pharmacist's nephew. The patient's current conditions included asthma. No information on the patient's concomitant medications, drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with VARIVAX injection (dose, route of administration, lot # and expiry date were not reported) for routine. On an unknown date, after receiving VARIVAX, the patient was in contact with the reporter's father, who had shingles. It was confirmed that the reporter's father did not receive ZOSTAVAX. An unspecified time after the patient had contact with the reporter's father, he developed chickenpox. The outcome of chickenpox was reported as recovered on an unknown date. The relatedness between the event of chickenpox and VARIVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA011679.
Extreme fatigue. At onset felt like a giant tractor ran over me. Could barely move, could not get off sofa. Very heavy sleeping at tonight, wake up at 60%, then crash again (unable to sit up) about 12-1pm. Often nap for 2 hours and ever so slightly more energy from 6-8pm. Each day is the same, no change.  NOw on day 10.
No additional AEs; patient received an expired PNEUMOVAX 23; This spontaneous report was received from a Doctor of Pharmacy and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 06-OCT-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) 1 dose, lot # S012244, expiration date 09-FEB-2021 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse events were reported.
Pt exp inject site pain, blotching, redness p/recvd 1st dose of Engerix-B; these have been resolved @ the time of this report;
Case number PHEH2014US022750, is an initial spontaneous report from a health care professional (clinic coordinator) received on 11 Nov 2014. This report refers to a 2 years old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUVIRIN (batch number: 1413901) intramuscularly on 10 Nov 2014. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).
Patient received his Moderna vaccination, and while waiting in the observation area, the patient slumped over in his chair unconscious.  The pharmacist tried to revive the patient - when he became alert his pupils were dilated.  A nearby customer called 911 at 5:58 pm and EMTs arrived at 6:06 pm.  Before their arrival, his blood pressure was checked at 160/40, pulse 60.  EMTs rechecked vitals and they were the same - they wanted a glucose reading but the patient refused. Patient contacted parents and refused any additional treatment from EMTs or to be transported to the hospital. EMTs left at 6:28pm. Dad took patient home. Patient did make pharmacist aware that this has happened on multiple occasions prior to his vaccination.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 02-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 576 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Mild erythema, mild swelling on (R) deltoid. Advised ice, BENADRYL r/o ibuprofen.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (strength, dose, frequency and route were not reported) lot # K016131 and lot # K007781, expiry dates not reported. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the two reports from the same reporter. Additional information has been requested.