chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was diagnosed with herpes zoster; Patient was diagnosed with post herpetic neuralgia; Information has been received from a lawyer and the patient regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-SEP-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles.   Shortly after vaccination, the patient suffered a painful rash in her right upper back, chest and underarm, she also experienced abdominal pain and malaise, therefore the patient was diagnosed with herpes zoster and post herpetic neuralgia. As a direct and proximate result of these malfunctions, the patient's symptoms had resulted  in physical limitations not present prior vaccination of zoster vaccine live (ZOSTAVAX). Additionally, the patient sustained severe, permanent, serious, progressive and incurable injuries. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The outcome of the events was not recovered. The reporter considered the events to be disabling.
Case completed 2 series of Moderna vaccine in March 2021, then was hospitalized in March of 2022. Hospitalized at:   Hospital.  She was admitted on the date noted above with hypercapnic respiratory failure requiring BiPAP. She had severe CO2 narcosis and was very obtunded. When she started becoming more awake she removed her BiPAP and promptly went into cardiac arrest. She was resuscitated and placed on mechanical ventilation. Further evaluation found her to have a severe left-sided pneumonia, probably on the basis of an aspiration event. She required high levels of PEEP and FiO2 for oxygenation. Discussions with the family ensued as she had failed multiple spontaneous breathing trials. Tracheostomy was suggested due to her body size and habitus. The family realized that she would never want to be placed on artificial life support for prolonged amount of time nor go to a nursing home. They opted for comfort care. She was given morphine infusion, extubated and then passed away with family at her side. WHILE CASE WAS HOSPITALIZED FOR COVID CARE, AND SUBSEQUENTLY DIED DURING THIS HOSPITALIZATION, COVID WAS NOT NOTED ON HER DEATH CERTIFICATE AS CONTRIBUTING TO HER DEATH. SHE HAD MULTIPLE COMORBIDITIES, AND COVID DID NOT MAKE THE LIST ON HER DEATH CERTIFICATE.
Headache, Myalgia, Fever, ElevatedLiverEnzymes, on 12/31/20,10 days after 1st dose, had fever (up to 101.8), chills, headach, back/neck pain. bad taste, insomnia, anorixia and severe malaise. stated he could not get out of bed. NO sob or cough. Neg. COVID test x3.noted elevated liver enzymes Hepatotoxi Narrative:  Physician employee reported to OHS on 1/21/21 the adverse events: Initially sore site/arm and mild " constitutional" symptom. Seen by PCP for hepatotoxicity, fever, malaise, headache, back/neck pain, bad taste, insomnia, anorexia and severe malaise. 2nd dose refused for time being. Livener enzymes are improving.
Rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 15-year-old female patient received BNT162b2 (BNT162B2), on 14Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 14 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 24Jul2021, when the patient was 14-year-old, for COVID-19 immunisation. The following information was reported: RASH (non-serious) with onset 15Dec2021, outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300151562 Same patient, same product, different events (dose 4);
received first dose of the covid-19 vaccine on 27Jan2021, he tested positive for covid-19 on 05Feb2021; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program.  This male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 27Jan2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that received first dose of the covid-19 vaccine on 27Jan2021, he tested positive for covid-19 on 05Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Feb2021, sars-cov-2 test: positive on 11Feb2021 (He went again yesterday to be tested and tested  positive).  He asked if he should receive the second dose of the vaccine next Wednesday.  Information on the Batch/Lot number has been requested.
HAS BEEN EXPERIENCING TRIGGER FINGER IN LEFT HAND AFTER COVID VACCINATIONS. MOST OFFTENC OCCURING AFTER HOLDING FORKS AND KNIFFS (FINE MOTOR ACTIVITIES) HAS HAPPENED UP TO 4 TIMES DURING ONE MEAL. OCCASIONALLY RIGHT HAND HAS SIMILAR ISSUES AND PAIN. PATIENT HAS BEEN USING A BRACE AS WELL. HAS HAD SOME UPPER ARM PAIN AS WELL, MORE IN THE LEFT ARM THAN IN THE RIGHT.  Had a friend report similar events after the vaccines prompting her to come in for the same.
Pt received fist dose of Moderna vaccine. Within 5 minutes patient started exemplifying signs of syncope and began falling to the floor while seated. Another patient that happened to be near caught him from falling face to the floor and managed to set him upright against the wall. Patient regained consciousness within a few minutes and stated he may have had a panic attack while being told to wait 15 minutes for post observation period. He was able to stand himself up and sit in a chair to wait out the remainder of the 15 minutes. Patient decline any type of medical emergency services.
Chief complaint of tightness in chest lasting for approximately 8 minutes. No SOB noted. BP 141/68, P 74, R 16. Patient remain under observation for 30 minutes. Released at 11:45AM, patient denies any chest tightness, pain or distress. She stated that after Dose #1 she experienced similar symptoms as well as lymph nodes swelling.
Travelled over Labor Day Weekend.  On September 4th a member of our party began to experience chills at the wedding reception.  On September 5th on the flight home I was starting to feel a little weak.  On September 6th started to experience a persistent cough.  On September 7th I took an at-home COVID test which was negative, but was experiencing diarrhea, and the beginnings of a head cold.  On September 8th I again tested negative but was having the same symptoms.  On September 9th I tested positive and was too weak to work so had to take a sick day.  I took OTC Flu-type medications and called my Doctor for a telehealth call.  She later prescribed benzonatate for my cough and encouraged me to take flonase on a regular basis to try and get rid of my nasal congestion.  I did feel like I had reduced lung capacity through the entire ordeal and once I started to feel better, despite having a persistent dry cough, I eventually got over it within about a week and without having to take the benzonatate.
Patient states she experienced redness, tenderness and hotness on her right deltoid almost after the vaccination, with noticeable symptoms about 2 hours after. The patch of redness on her right upper arm grew larger over the next 8 days until she seen the doctor yesterday 10/29/20. Patient has received antibiotics, Keflex, Bactrim DS and Fluconazole for her condition. Today she states the redness is lighter.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 41-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download for the months of DEC2021, JAN2022, and FEB2022. Reporter said that they are filling out a temperature excursion assessment with the local Health Authority at this time and she was calling in to report the same to Moderna. Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing.  It was reported that no adverse reactions were reported by any patients.
Information has been received from a MA concerning a 59 year old female who on 11/04/03 was vaccinated IM in the left arm with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647634/0863N). On 11/05/03 the pt presented to the physician's office with swelling of the left arm, erythema and tenderness. The pt was treated with a Medrol pack and ice. Subsequently, the pt recovered. No product quality complaint was involved. Additional information has been requested. It was also reported that 2 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed adverse reactions (WAES # 0405USA01451 & 0405USA02065).
Patient had cancer but nurse could not confirm whether cancer began before or after receiving previous doses of DTaP and IPV; Kinrix was given to a 7 year old patient; Patient was late for last dose of DTaP and IPV because had cancer; This case was reported by a nurse via call center representative and described the occurrence of cancer in a 7-year-old female patient who received DTPa (DTaP vaccine) for prophylaxis.   Co-suspect products included POLIOMYELITIS VACCINE INACTIVATED (IPV VACCINE) for prophylaxis, DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received DTaP vaccine and IPV VACCINE. On 21st January 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 21st January 2021, not applicable after receiving DTaP vaccine and unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   It was unknown if the reporter considered the cancer to be related to DTaP vaccine.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was late for their last dose of DTaP and IPV (5th and 4th respectively) because patient had cancer but nurse could not confirm whether cancer began before or after receiving previous doses of DTaP and IPV because they were new practice. The patient was administered Kinrix at the age of 7 years, which led to inappropriate age at vaccine administration. The reporter was inquiring about incident of Kinrix and wanted to make sure of what was the best method to continue with it. The reporter consented to follow-up.
pt recv vax 31JAN97 10AM pt remained @ school but c/o arm hurting all day;pt went babysitting in the evening: around 9PM face & eyes very swollen;skin bright red;w/in a few min neck starting to swell & breathing labored;taken to hosp ER;
when nursing and almost asleep, patient's head, arms and trunk started shaking king of like someone who has Parkinsons Disease . He had no fever, no stiffness. He shook for a few seconds, stopped for about 10 seconds and shook again for 3-5 seconds. He has continued to do this 2-4 times per week since Sept 17th . Sometimes it happens in the ARM, sometimes in PM. Sometimes just his head shakes. No treatment except lab tests listed.
4 yo with L arm redness swelling and pain. She had vaccines 2 days ago.  It was a little itchy. Acting well. No fever, no vomiting, no diarrhea, no sick contacts reported. Mom is not too worried but just wanted to make sure child was ok because this has not happened to her before. She tried a compress as advised by the nurse.  Likely a localized reaction at the injection site. May get a little worse before it gets better. Can use a cool compress. Can give motrin and benadryl for symptomatic relief. Advised mom to outline the area so she can tell if there are significant changes. Follow up for worsening or concerns such as worsening pain, streaking, swelling, fever.
Received Covid vaccine and 1 month later patient with ramsay hunt and residual facial palsy. Complicated by concurrent left T12 or L1 dermatomal VZV suggesting a disseminated presentation. No known immunosuppressive disorder. She was evaluated with lymphocyte enumeration and all cell types were WNL and CD4 WNL. HIV was negative and IgG subgroups were WNL Originally placed on a high dose regimen of valacyclovir that has been tapered down to 1g. Now initiating off label use of shingrix vaccine series.
Shortness of breath started on 3/13/21 with failure to thrive. Oxygen saturation as low as 55% on 3L NC. Oxygen was increased to meet comfort. Cephalexin and doxy were given.  Chest xray showed cardiomegaly, furosemide was given with the antibiotics.
After the MMR booster (I had 2 MMR vaccines as a child) my neck, jaw, and left side of my body started aching badly. Later that afternoon my chest tightened and I had a pain under my left shoulderblade. At 7pm I went to the ER because I was afraid I was having symptoms of a heart attack. They did blood tests, an EKG, and chest xray and everything came back normal. I was released at 10pm.
I got COVID-19 at the end of February 2023. I went to see my PCP about my A-Fib that I was having while having COVID-19. She sent me to the emergency to get my heart checked, I had multiple tests ran, EKG. echocardiogram, they were able to get me stable and sent me home. I went back to my PCP to get a follow up visit, my heart again showed I was in A-Fib, I was again sent to the emergency room. This time every thing they tried the last time did not work to stabilize me, I had to have a cardiac ablation.
left arm swelled up and was very tender at DTaP site. Swelling was very large.
Information has been received from a licensed practical nurse concerning an approximately 50 year old female with drug hypersensitivity to thimerosal and a history of Graves' disease who on 21-NOV-2008 was vaccinated IM with PNEUMOVAX 0.5ml (LOT# not reported). Concomitant therapy included atenolol, LEVOXYL, FIORICET with Codeine and desipramine. Subsequently, the patient experienced painful, red, and swollen from deltoid to elbow after administration of PNEUMOVAX. The patient experienced fever and chills. The patient was recovering from the adverse events. No lab or diagnosis studies were performed. It was reported that the patient sought medical attention: office visit. Additional information has been requested.
Patient's arm was swollen at the site of the injection and warm at the site. There was pain at the site on 10/15/2017. Patient will see a healthcare provider today (10/17/2017).
experiencing pain when lifting his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "experiencing pain when lifting his arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician assistant concerning and 18 month old patient with no allergies and no pertinent medical history who on 14-Aug-2007, was vaccinated with a subcutaneous dose of PROQUAD (lot #0194U).  On 12-Sep-2007, the patient was seen in the office after developing a varicella-like rash of 50 lesions or less.  Specific treatment was not reported and the patient recovered.  No product quality complaint was reported.  No further information was available.  Additional information has been requested.
Pt recv vax on 7/21/98; approx 4 hr post vax pt exp crying, swelling of right thigh to knee
Approximately 10 days after injection the injection site had a nearly circular red hive; only periphery, not complete to center. It also appeared to have a slight hardness at the center of hive and although it was hard it was not very painful/sensitive to the touch.  The entire hive area, approximately 2 inches in diameter, was itchy.
Patient got really hot, blurred vision, dizzy and threw up once. Gave her water and a fan. Offered her crackers, but didn't want to eat anything. Symptoms lasted for about 5 to 10 minutes. Observed her for 50 minutes after and felt fine. Her aunt came to pick her up. Patient stated she has a history of adverse effects such as this with vaccines.
itchy arm -26 Feb 2021; swollen arm- -26 Feb 2021; hard at injection site -26 Feb 2021; warm at injection site -26 Feb 2021; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy arm -26 Feb 2021), PERIPHERAL SWELLING (swollen arm- -26 Feb 2021), VACCINATION SITE INDURATION (hard at injection site -26 Feb 2021) and VACCINATION SITE WARMTH (warm at injection site -26 Feb 2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy arm -26 Feb 2021), PERIPHERAL SWELLING (swollen arm- -26 Feb 2021), VACCINATION SITE INDURATION (hard at injection site -26 Feb 2021) and VACCINATION SITE WARMTH (warm at injection site -26 Feb 2021). At the time of the report, PRURITUS (itchy arm -26 Feb 2021), PERIPHERAL SWELLING (swollen arm- -26 Feb 2021), VACCINATION SITE INDURATION (hard at injection site -26 Feb 2021) and VACCINATION SITE WARMTH (warm at injection site -26 Feb 2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
5/9/07 16:30 Pain at the injection site. 5/9/07 22:00 Headache, fatigue 5/10/07 15:00 Body aches, fever, chills,    headache, tiredness, mild nausea, joint pain 5/10/07 19:00 Severe muscle pain (all over body), migraine 5/10/07 20:30 Fever over 102 F, severe nausea/nearly vomiting, difficulty breathing, wheezing, violent muscle pain, weakness (could barely stand up), dizziness, rapid heart beat, redness and significant swelling at injection site 5/11/07 11:00 Symptoms had subsided over night, but worsened again 5/12/07 17:30 Rash around injection site with about 4 inch radius (might have been there previously, but didn't notice it before.)  Still experiencing muscle aches, fatigue, persistent headache  5/16/07--Injection site still sore, red, swollen, warm, and hard.
pt devel a fever of 104.5 F exp a febrile sz (this was considered to be an other medical event);pt recovered;
One day after vaccine fever to 102, severe vomiting, diarrhea.   All lasted three days.
fatigue, diarrhea, body aches, nausea, injection site tenderness Narrative:    Other Relevant History:
pt presents to ED with acute right sided weakness, slurred speech, right mouth droop; CVA; admitted to hosp; pt treated for CVA; went into cardiac arrest after coughing up blood ; intubated, with large clot of blood removed from the mouth; transferred to ICU; renal function worsened; hemodialysis; tested positive during hospitalization (1/5/22) for COVID; treatment initiated; suffered cardiac arrest again with ROSC achieved; arrested again; family made pt DNR, comfort measures; pt died in the hospital
On 03/21/19, 73 yo F presented to clinic for scheduled visit. During this visit, pt was ordered and administered Pneumococcal polysaccharide vaccine 23-valent greater than or equal to 2yo SQ/IM (PNEUMOVAX-23). At 1548, 0.5 mL was injected in left deltoid (NDC: 0006-4837-01, Lot #R033342, Exp: 8/3/2020). Pt was then discharged with no noted adverse effects. On 03/22, pt presented to Urgent Care reporting that ~2 hours after injection she developed left shoulder pain "not so much at the vaccination site" which worsened to become 9/10 pain overnight. Pt self-medicated with diphenhydramine 50 mg PO on 03/21 at 2200, ibuprofen 600 mg PO on 03/21 at 2200 and 03/22 at 0800 and a "muscle relaxant" on 03/21 at 2300. Pt denied any numbness or tingling in the area or distally to left forearm /hands/fingers, but endorsed vomiting and feeling light headed around 0100 and again around 0300. Due to continued pain, pt came to urgent care on 03/22. Physical exam found no skin irritation at injection site. MD concluded "the pain/reaction appears to be deeper inside the shoulder than at the injection site per se. Since this requires services beyond what is available in current UC setting, advised patient to transfer care to ED. Patient agrees and opts to go to [ED]". On presentation to ED, pt had no fever or chills, but left deltoid was "tender on examination". MD documented "no redness or other sig changes on exam. MD diagnosed "Degenerative changes at the shoulder and Small calcific or ossific focus associated with the inferior aspect of the glenohumeral joint". Pt was discharged home with warm compresses. On 03/27, pt returned to clinic with continued c/o 5/10 pain . Pt reported use of acetaminophen extra strength 2 tabs TID and topical lidocaine with some relief. MD diagnosed Impingement syndrome of left shoulder with no evidence of frozen shoulder. Pt provided with prescriptions for methylprednisolone Dosepak, hydrocodone/acetaminophen 5-325 mg Q6H PRN for pain and Ambulatory Referral to Physical Therapy. No resolution at this time.