chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dermatitis; eczema; postherpetic neuralgia; herpes zoster; Information has been received from a lawyer and a consumer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After being vaccinated, the pt suffered dermatitis, eczema, herpes zoster and postherpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of the pt's use of the defective zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations, not present prior to using the company's product. The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of the conditions. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of company's conduct, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the claimed events was not recovered, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  The reporter considered dermatitis, eczema, herpes zoster and postherpetic neuralgia to be disabling events.
Approx a week or so after 2nd shot I noticed My hand (s) were bothering me.  My left hand 1st - it ached and my thumb  joint especially felt stiff.  Then I noticed  numbness  and tingling sensations at times.  My hands would qake me up at night hurting.  I also noticed at times  discomfort  in my elbows,  shoulders etc.  I didnt have a general practitioner to schedule  and appt with.   Once I saw HCP she did blood work and all my numbers were good except Anti nuclear AB Speckled Pattern - it was slightly elevated.
A couple hrs after injection my shoulder became very sore, achy, weak. Hurt inside the joint. After a few days, muscles felt better but joint still hurts. Had steroid injection so far joint feels better, still sore but not as painful as it was.
3wks after vaccine LE weakness 4-6 wks after: tingling in hands/feet w worsening weakness, dx of Gullian Barre
Information has been received from an approximately 73-year-old female who on an unspecified date was vaccinated with a dose of ZOSTAVAX. The patient broke out in shingles five weeks later. Unspecified medical treatment was sought. The outcome in not reported. Additional information has been requested.
Bell's palsy; Parkinson's disease; Multiple sclerosis; secondary Parkinsonism; Aphasia; dysphasia; benign parotid neoplasm; facial nerve disorder; Down syndrome; mosaicism; This case was reported by a lawyer and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), parkinson's disease (serious criteria GSK medically significant), multiple sclerosis (serious criteria GSK medically significant), secondary parkinsonism, aphasia, dysphasia, benign parotid tumor and facial nerve disorder. The action taken with Shingrix was unknown. On an unknown date, the outcome of the bell's palsy, parkinson's disease, multiple sclerosis, secondary parkinsonism, aphasia, dysphasia, benign parotid tumor and facial nerve disorder were unknown.   It was unknown if the reporter considered the bell's palsy, parkinson's disease, multiple sclerosis, secondary parkinsonism, aphasia, dysphasia, benign parotid tumor and facial nerve disorder to be related to Shingrix.  The initial information was received on 24 Feb 2021 via medical record (case is now medically confirmed). On 1 Oct 2015, the patient assessed for Parkinson's disease, secondary Parkinsonism, Multiple sclerosis, Aphasia, dysphasia, Aphonia,Down's syndrome, mosaicism. The patient had benign parotid neoplasm, facial nerve disorder. Therapy for a Dysphagia evaluated. Patient has a past medical history significant for parotid tumor with parotidectomy on June 17, 2014. As per pharmacy record, on 19 August 2020, patient had used Shnigrix vial Kit.
Tight chest; Shortness of breath; Accelerated heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (Lot number: EM9809) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced tight chest, shortness of breath, accelerated heart rate. The patient underwent lab tests and procedures on an unspecified date for Accelerated heart rate. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.  Follow-up (24Nov2021): Follow-up attempts completed. No further information expected.
face was tight; lips are swollen; Rashes that looks like bug bites around her mustache area and her jaw lines (on both side)/The rashes are white circle with red edges.; Injection site red/Injection site had a 6 inches red ring around it; Armpit was swollen (like the size of a golf ball); Injection site tender; Injection site sore; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL DISCOMFORT (face was tight), LIP SWELLING (lips are swollen), VACCINATION SITE PAIN (Injection site tender), VACCINATION SITE PAIN (Injection site sore) and RASH (Rashes that looks like bug bites around her mustache area and her jaw lines (on both side)/The rashes are white circle with red edges.) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 18-Mar-2022, the patient experienced VACCINATION SITE PAIN (Injection site tender), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE ERYTHEMA (Injection site red/Injection site had a 6 inches red ring around it) and LYMPHADENOPATHY (Armpit was swollen (like the size of a golf ball)). On 22-Mar-2022, the patient experienced FACIAL DISCOMFORT (face was tight), LIP SWELLING (lips are swollen) and RASH (Rashes that looks like bug bites around her mustache area and her jaw lines (on both side)/The rashes are white circle with red edges.). On 21-Mar-2022, VACCINATION SITE PAIN (Injection site tender), VACCINATION SITE PAIN (Injection site sore) and VACCINATION SITE ERYTHEMA (Injection site red/Injection site had a 6 inches red ring around it) had resolved. At the time of the report, FACIAL DISCOMFORT (face was tight), LIP SWELLING (lips are swollen) and RASH (Rashes that looks like bug bites around her mustache area and her jaw lines (on both side)/The rashes are white circle with red edges.) had not resolved and LYMPHADENOPATHY (Armpit was swollen (like the size of a golf ball)) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Based on what she looked up online, the injection site reaction can be described as the COVID arm. The injection site reaction went away by itself yesterday morning and the swollen part of her armpit has reduced to half of the size it was when the reaction stared. There has been no changes to her diet or soap. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
While the pneumonia shot was being administered, it hurt extremely much.  I described exactly how it felt as it was moving down my arm. By the time I got home, about 5 minutes later, I could not move my right arm at all.  It felt like I had been hit with a shotgun blast in the upper part of my arm and beat with a lead pipe on my forearm. I called the pharmacy the next morning and was told that the pain and not being able to use my arm was "normal". I said  "it may be common, but it is certainly not normal."  They told me to put ice or heat (I don't remember which) on it.  I called my doctor on Thursday to see what he recommended as treatment and was told either ice or heat, which ever felt better. I had to use 3 sick days at work because I was unable to get out of bed because of the intense pain.  I went to my doctor's office on March 14th because the pain was still unbearable and I had lost most of the movement in my right arm.
Persistent tinnitus and sensitivity to loud sounds had started about a week after vaccination. I had received two doses with the first being in march and the other being in may. Over 7 months later I still have symptoms of tinnitus and sensitivity to loud sounds.
Chills, severe body ache head to toe, feel like I've been run over by a truck
Patient is here today with left shoulder pain. She had an influenza vaccination into the left deltoid on 10/5/23; the next day she noted more pain than usual, then some pain with reaching across her torso or reaching behind her.  She did initially have pain with abduction but this has improved.  No swelling or bruising noted. No history of left shoulder problems/injury in the past.  She is right hand dominant.  Left shoulder medial pain along bicipital tendons to anterior AC joint area. Difficult to reach across torso without pain over AC joint. Unable to reach behind Has good abduction of shoulder No swelling or bruising is noted   1. Shoulder injury related to vaccine administration (SIRVA)   After influenza vaccination on 10/5/23 Mostly pain over AC joint/medial anterior shoulder PLAN: 1. Sulindac 200 mg po BID with food 2. Pt will use her ATC on staff at college for shoulder exercises; avoid heavy weight lifting 3. Consult to Orthopaedic Surgery to consider steroid injection unless pain resolves by then (not an urgent consult)
Developed wheezing, throat congestion, vomitings around 1.30 pm, fever around 4.15 pm, swelling of lips around 9.30 pm. Symptoms subsided after taking Benadryl tablet. Symptoms subsided next day.
Pfizer BioNTech COVID-19 Vaccine EUA:  Patient with office visit for follow up s/p heart transplant received entire multi-dose 1.8mL vial of Pfizer BioNTech Bivalent vaccine on 10/17/2022. Pt has no reported significant reactions. No harm came to patient.
pt recv vax & devel inj site rxn characterized by ecchymosis & itching;pt was treated w/DPH  w/some relief of itching;
Excruciating headache, nausea, dry cough - entered emergency room around 11:00am driven by my husband treatment at nearest Emergency Room, Fluids given to me intraveniously mixed  with pain meds and nausea meds mixed in with, vitals taken, blood taken, urine specimen - headache was a #10 on pain chart 4 hrs later around 4pm, headache was about a 3-4 pain chart, i left hospital given pain meds, nausea meds, cough meds, antibiotics
Approximately 30mins post vaccination patient stated that she "felt funny" and reported that she was dizzy. Instructed patient to sit down, patient reported that she was hot so she then took of her coat. She then reported that her throat "felt weird" water was provided to patient as she stated that it didn't feel itchy or swollen but it felt "thick" NP asked to come examine patient. Patient stated that she did not want to take IM Benadryl at this time but was willing to take PO Benadryl. 25mg PO Benadryl administered to patient at 12:12pm. Symptoms persisted without changes until approximately 12:19pm when patient said she felt like her throat was getting worse, nose felt congested and stuffy and her voice started to change; flushing noted to chest as well; 0.3mg Epi Pen administered to Left thigh and 911 called at this time.  Patient was sitting upright in a chair during this event and said she felt faint and was lowered to the ground and placed on left side. O2 Sat 98-99%, HR after Epi 118-122, BP 153/66, Resp rate 22-24/min.  EMS arrived at this time and took over care of patient.
Received1st dose of Moderna on 12/30/2020 and was in the hospital on 1/19/21-1/25/21 for a neck mass.
I had no reaction to the vaccine. I began not feeling well on 12/15/2022 with a cough. I tested for COVID-19, and it was negative. On 12/16/2022, I was feeling better. On 12/17/2022, I had the cough and a fever, so I tested again for COVID-19, and it was positive. I contacted my doctor and received the prescription for PAXLOVID. As of today, I still have a cough.
Approximately 3 weeks after the 2nd Moderna vaccine above had been administered, I went to bend over to pick up my dog's dish, and almost fell over from the pain in my hips.  I experienced extreme joint pain in my shoulders, hips, knees, elbows, wrists and more extreme across my collarbone/neck.  This pain and reduced mobility caused me to visit my primary caretaker. I did explain that I felt it was a reaction to the vaccine because I had no previous joint issues whatsoever other than periodically overworked muscles.  He did some examination and told me he felt I had frozen shoulder syndrome, but stated that usually is associated with post-surgery lack of physical use of the shoulder - my right shoulder was where I was experiencing the most discomfort.  He prescribed a regimen of steroids to knock down the immediate pain, as well as muscle relaxants.  As soon as the steroid regimen was complete, the pain returned with a vengeance and persisted for several months, finally starting to diminish in approximately November 2021.  I took one of the muscle relaxants one time after the steroid regimen, but it did not help.  I did not return to the doctor as I felt it wouldn't help since there seemed to be no agreement that the vaccine could have caused the issue.  There were days when it was very painful to move at all and this persisted with severe discomfort for 5-6 months.  At about 6 months, it was feeling like it was beginning to dissipate and the pain was less severe.  I have now returned to mostly normal, joint-pain free function after a year.
My husband suffered a cardiac arrest and died at home 19 hrs after receiving the COVID bvaettbtr
This spontaneous report as received from a pharmacist refers to a 64 year old female patient. Medical history and concurrent conditions were not reported. In 2011, the patient was vaccinated with ZOSTAVAX lot # J016258, expiration date 26-FEB-2015, 0.65 ml, subcutaneous in the left arm. The pharmacist reported that the patient was inadvertently vaccinated with a second dose of ZOSTAVAX on 08-SEP-2014. No adverse effects reported. Additional information is not expected. No allowed to contact physician.
Itchy bumps (hives?) on toes and feet, spreading to ankles and legs.
Myopericarditis after COVID-19 Vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "Myopericarditis after COVID-19 Vaccination". The patient underwent the following laboratory tests and procedures: Echocardiogram: unknown results; Imaging procedure: unknown results; Magnetic resonance imaging: unknown results.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200057449 Same article/ drug/event and different patient.;
Positive COVID test; Positive COVID test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 17Apr2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single and intramuscular, administration date 27Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No covid prior vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022, outcome "not recovered" and all described as "Positive COVID test". The event "positive covid test" and "positive covid test" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
vaccination site swelling; feverish; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (vaccination site swelling) and PYREXIA (feverish) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-May-2021, the patient experienced VACCINATION SITE SWELLING (vaccination site swelling) and PYREXIA (feverish). At the time of the report, VACCINATION SITE SWELLING (vaccination site swelling) and PYREXIA (feverish) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up appended to AER
March 10th, I had fatigue and I was very thirsty the day of shot. About ten days after is when my arm was very sore, and a red puffy hard circle formed. I also had fever, chills, and body aches 10-12 days afterwards the red circle grew larger and covered most of my left upper arm. The doctor measured redness at injection site and below 11x12 it did go beyond elbow.  I do have pictures. I went to the emergency room where it was thought to be Cellulitis, I was treated with antibiotics. I think it was Cephalexin. I was sent home March 21 with some cephalexin as well. I also self-treated with Ice, Tylenol, and Ibuprofen for pain. The rash and swelling cleared up in about a week.
Headache.  Hot flashes.  Cold flashes.  Body aches.  Dizzy
Got shingles vaccine and got shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles vaccine and got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he or she know the patients who received Shingles vaccine and still experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sore arm; back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) and PAIN IN EXTREMITY (Sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event (No relevant medical history provided.).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced BACK PAIN (back pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with METHOCARBAMOL ongoing since an unknown date for Muscle pain, at a dose of 2 tablets four times daily as needed She is taking every 6-7 hours half a tablet. At the time of the report, BACK PAIN (back pain) had not resolved and PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-073898 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073898:Dose 2 of vaccine
Severe headache, all over severe pain, bones ache, weakness, flu like symptoms, fever, extreme fatigue
Local Rxn. 2 Red papules L thigh, surrounding redness, one with pustule no streaks.
second dose on 02/11/2020 / experienced a sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 12th December 2019, refer linked case US2020AMR248211).   On 11th February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. The patient experienced a sore arm. The reporter consented to follow up. For further tolerance after 3rd dose of Shingrix refer linked cases US2020247551.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR248211:1st dose US-GLAXOSMITHKLINE-US2020247551:3rd dose