chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 69 yo F with PMH OSA, HTN, HLD, hypothyroidism, and depression who presents as an Outside facility information: I do not have phone number of hospital or a list of providers who cared for the patient at facility transfer for acute hypoxic respiratory failure due to COVID pneumonia requiring intubation. Patient is intubated / sedated with no family at bedside. History was obtained via chart review.    Patient had about 1 week of dyspnea, headache, fevers, cough, and nausea and was found to be COVID-19 positive on 12/8. Of note, patient was vaccinated with one dose of J&J vaccine. She was prescribed Decadron 4 mg daily, doxycycline, and an albuterol inhaler but failed to improve. She presented to Hospital on 12/12 and was found to be hypoxic with SaO2 76%. On admission, WBC 13K, CRP 17. CXR with b/l airspace disease. Her TTE showed EF 60%, mild LVH, normal left and right ventricular function. She was admitted to the Hospital ICU and started on remdesivir and continued on decadron. She was initially on 100% HFNC with ABG 7.43/46/81.   She clinically worsened on 12/12 with increased O2 requirements and received one dose of Amcetra 8 mg/kg. She was also started on ceftriaxone and azithromycin on 12/12. She continued to worsen and antibiotics were broadened to Levaquin and meropenem on 12/21. She was also started on therapeutic lovenox for suspected PE. She did not undergo a CT PE due to clinical instability. She was transitioned to BiPAP and then intubated on 12/22 for worsening hypoxia. She developed hypotension on propofol and was switched to versed and fentanyl drips for sedation and analgesia. She was also given midodrine for the hypotension.   On arrival to Higher Level of Care Facility, patient was on FiO2 100% and PEEP 10 with SaO2 in mid 90s. She was normotensive on fentanyl and versed drips.  Patient is a 69 y.o. female presenting from facility with AHRF on MV (Intubated 12/22) d/t COVID-19 PNA/ARDS (+12/8). Extubated on 1/5. Required reintubation 1/7 for respiratory distress. Course complicated by MRSA bacteremia, MRSA PNA, and right sided pneumothorax requiring chest tube 1/17.   Dexamethasone (10 IV daily, day 15 on transfer), Remdesivir (s/p 10d), Toci (x1 dose), Rocephin/Zitro for CAP coverage -> decompensated on 12/21, ABX broadened to Levaquin/Merrem (day 15 total of ABX on transfer), empirically treated for PE w/ tLov -> intubated 12/22, developed sedation-related hypotension and started on Midorine   Patient's clinical course continued to worsen. She required CRRT and continued to required pressors and high ventilator settings. Patient's family made the decision to make patient DNR and transition to comfort care. She passed away with family at her bedside.
Mom called to report fever of 104F, vomiting large amt x 2, limp & crying, call received 2AUG91 @ 1150AM; @ 2PM 102 per mom referred to PMD;
This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported. It was unspecified whether the patient had sought any medical attention. There was no product quality complaint involved. Follow up information has been received from office manager, who stated she may call back or fax information as it becomes available. Also, reported that MMR II was not mentioned in the original call, but did experience a temperature excursion. No further information was available at that time. Follow-up information as received from office manager refers to a 2 years old patient. On 02-JUN-2014 the patient was vaccinated with a dose of improperly stored MMR II (lot # reported as J013315, expiration date 18-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of several reports from the same source. Additional information has been requested.
pt recv vax & following each of 5 vax exp arthralgia, fatigue, flushing & gen malaise;pt switched to Rabies vax adsorbed;w/in 12 hr again exp arthralgia, fatigue, flushing & gen malaise;seen by MD 29SEP95 given Relafen & Toradol for relief
Shoulder swelling and severe pain. Diffuse fever/sweats and joint pains, racing heartbeat.
rash to face, petechia to face, flushed, vomiting, headache
First dose of vaccine was moderna and the second dose taken 28 days later was pfizer.; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (First dose of vaccine was moderna and the second dose taken 28 days later was pfizer.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (First dose of vaccine was moderna and the second dose taken 28 days later was pfizer.). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (First dose of vaccine was moderna and the second dose taken 28 days later was pfizer.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt recvd 3 doses of Engerix-B & 10MAR92 titer checked neg for antibodies; may be given additional doses;
Subdermal nodule, pain L axilla x 3-4 days. 7/30 no edema, no redness, slight tender when palpated.
pt recv vax; fever to 103.8 starting > 24 hr<48 hr; sluggish;
Patient received second smallpox 6 days ago and came into clinic today to have checked. Smallpox took on arm and patient also brought up a bump that came up on his left cheek after administration of smallpox.
About 23 hours after my second vaccine I developed "normal" side effects (fever, achy, tired, headache), which lasted about 12 hours, with the exception of the headache, which I still have a week later. I rarely get headaches, and when I do they're mild and always respond to ibuprofen or acetaminophen. This one fluctuates in intensity but not in response to painkillers. Sometimes I also feel lightheaded and my head throbs intensely and I have to put my head between my legs to keep from passing out (I have low blood pressure and this happens occasionally when I stand too fast, but now it's happening frequently, and the throbbing headache lasts for hours/up to a day).
Moderna vaccine given to 14 yo old patient per parent request.  The RN mistakenly administered the Moderna vaccine to the pediatric patient.  Per CDC hotline, submit VAERS report and schedule patient for 2nd Moderna vaccine and document as "off label" administration given that the EUA does not include less than 18 yo for Moderna. Patient observed for 30 minutes and did not have a reaction to Moderna.
Local reaction of redness, itching, and swelling of left lateral shoulder at site of injection about one week after injection.  Progressed to discomfort of injection site with radiation of discomfort down into arm and up into neck 9-10 days after injection.  Then nonspecific urticarial rash in bilateral brachial fossa and left chest along with swelling of the left cheek on 1/29/2021 which was 12 days after injection.
This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 58-year-old female patient who received Shingrix (batch number D294J, expiry date 22nd March 2021) for prophylaxis. On 9th October 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In October 2018, less than a week after receiving Shingrix, the patient experienced tiredness and erythema. On an unknown date, the outcome of the tiredness was unknown and the outcome of the erythema was not recovered/not resolved. It was unknown if the reporter considered the tiredness and erythema to be related to Shingrix. Additional details were reported as follows: After vaccination, the patient experienced redness 4 inches below the injection site. The reported lot number (D2945) for Shingrix did not exist and was updated to D294J, according to sales datasheet.
36 hours later, (approximately), I woke up with a rash. Under the both arms it looked like a sunburn. Across the chest an sides, it was spotty. The right side had more rash than the right, and both sides wrapped around to the back, about 2 inches, on both sides. Less going down the rest of the torso. Took Benadryl, 2-25 mg, 4 hours apart, for a total of 100 mg. 1:00PM, Feb. 26, rash faded significantly.  Also had a dry mouth and a bit of a racing heart, right after being given the vaccination & again when the rashes appeared. However, this could have been anxiety. Both times it went away after walking & deep breathing. Lasted for about 15 minutes each time.
no appetite for 2 weeks; extreme itching in hands, feet, scalp; Severe fatigue; This is a spontaneous report from a contactable other hcp (reporting for herself) A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose left arm on 18Jan2021 for covid-19 immunisation. First dose was administered intramuscular on left arm on 28Dec2020 17:15. Medical history was none. The patient's concomitant medications were not reported. The patient experienced severe fatigue on 25Jan2021, no appetite for 2 weeks on an unspecified date, extreme itching in hands, feet, scalp on an unspecified date. It was reported to be unbearable, and she was treated with Medrol dose pack, now Atarax, and prednisone (higher dose) and still have uncontrollable itching with only relief at night. The events outcome was not recovered.  Information on the lot/batch number has been requested.
Information has been received from a pharmacist concerning an adult female resident in a long term care facility who was "recently" vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #650087/0815P). Approximately one week after vaccination, the pt developed an URI and was hospitalized. Subsequently, the pt died. Details of the pt's death were not available. Additional information has been requested. No product quality complaint was involved. 4/29/05 Received Death Certificate which revealed COD as CAD & COPD complicated by IDDM, type 2.
Six hours post vax, the pt developed rash/hives. The most recent information received reports the outcome of the event as resolved.
Chills; Severe headache; Really bad tinnitus; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in left arm on 16Apr2021 15:00 (at the age of 65 years old) as dose 1, single for COVID-19 immunization. Medical history included mildly high blood pressure, and Sulfa-based drugs allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included acetylsalicylic acid (ASPIRIN 81); hydrochlorothiazide; and losartan, all taken for an unspecified indication. The patient previously took aspartame and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. After vaccination, on 17Apr2021, the patient woke up at 01:30 AM with chills and a severe headache. The symptoms disappeared the next day, but still have mild headaches and noticed really bad tinnitus several days later on an unspecified date in 2021. No treatment was received for the events. The outcome of the event really bad tinnitus was unknown, and for other events was recovered with sequel. The patient received the second dose of BNT162B2 on 07May2021 15:00, for COVID-19 immunization.
doses administered after more than 1 temperature excursion; doses 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 (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 10:33 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 10:33 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses 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 65.99.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 9 AM, temp was 34 and at 10 AM temp was 37; total doses given for the day was 184, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vial was moved to clinic. Vaccine BUD date was 08-Apr-2021.  Vial was stored on cooler 1, on 20-Mar-2021, Excursion duration At 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM : 44, 2 PM : 44, 3 PM: 44, 4 PM: 44 and 5 PM : 43  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a physician assistant concerning several patients (age and gender not reported) who on an unspecified date were vaccinated intramuscularly with the first dose of Pneumovax 23. Subsequently, the patients developed redness all over their arms at the injection site. The physician assistant demonstrated that the redness went "from the top of their shoulders, almost down to their elbows." The physician assistant had "recently seen patients with this same reaction for the first time and never before with Pneumovax 23." It was reported that the patients received the vaccine outside of the physician assistant's office, most likely in a clinic. The patients sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Lt arm very swollen & tender, red & hot to touch x 3 days; Taken to ER 2 days p/DT given; Tx APAP & ice packs; c/o nausea;
shingles on her hip; Caller mentioned that she had shingles on her hip and wants to cancel; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she and husband were due tomorrow morning (04May2021) to get their second dose. The caller mentioned that she had shingles on her hip on an unknown date and wanted to cancel their appointment tomorrow. Outcome of the events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an female patient (age was not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT on an unknown date. It was reported that the patient received vaccination by her employer. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Details of concomitant medication was not provided. It was a case of actual medication error due to incorrect product storage. It was unknown whether the patient experienced any adverse events. The patient enquired whether she can be revaccinated or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
After the first shot, my throat got tight and I had to take benadryl. I also had night sweats and hot flashes. After the second shot, the pain in my arm started immediately. It felt like fire spreading to my fingers. About an hour later, swelling started in my left shoulder, arm, and hand. The next day the swelling and pain spread to my collar bone and neck. Collar bone felt bruised. Neck muscles became tight and painful. Each day this fire and pain and tight muscles spread further down the left side of my body. It became difficult to move my left arm and shoulder. Some chest pain, left side, left breast as well. Nauseous and dizzy often. Extreme fatigue. I saw the Nurse on 11/12/2021 for these issues. She gave me Prednisose and Gabepentin. She listed Hyporeflexia, Neuropathic pain, and racing heart. I am still undergoing treatment for these symptoms.
Since receiving the COVID 19 vaccine, I often, randomly receive severe joint pain/aches.  The joints most affected are bilateral knees, hands, and lower back. It often restricts me from doing physical activity with my children, and each episode basically does not resolve until I take over the counter pain relief medication.
shortness of breath/ Problems breathing; forearm aching; body was aching; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath/ Problems breathing), PAIN IN EXTREMITY (forearm aching) and MYALGIA (body was aching) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath/ Problems breathing), PAIN IN EXTREMITY (forearm aching) and MYALGIA (body was aching). At the time of the report, DYSPNOEA (shortness of breath/ Problems breathing), PAIN IN EXTREMITY (forearm aching) and MYALGIA (body was aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.
1/12-N/V was vomiting every 15 mins. Started about 1300 after getting the vax. by 1430 starting vomiting uncontrollably. HA. Sx worsened through the night. Felt extremely dehydrated and dizzy. Went to ER on 1/13 in the AM, got IVF, Zofran IV, Phenergan IV, Benadryl, Toradol, Dilaudid. D/C'd home  1/13 Thurs-no nausea, felt achey 1/14 Friday (today)-sore. Feels ok, working from hom.e
autoimmune hypothyroidism/extreme fatigue/cold hands and feet/lethargy; polycystic ovarian sydnrome (PCOS)/missed menstrual cycles; brain cavernoma/trouble focusing/brain fog/dizziness/imbalance issues/headaches/falls with seizure-like symptoms upon standing too quickly; irritable bowel syndrome (IBS)/abdominal symptoms/indigestion/constipation; Information has been received from a lawyer regadring a case in litigation, concerning a female patient (patient) of unknown age. P t's medical history, concurrent conditions, and concomitant medications were not reported. Pt's mother and father agreed to their daughter receiving Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) after being exposed to marketing that GARDASIL is very safe, prevents cancer, and that teenagers must get the GARDASIL vaccine. On 25-AUG-2017, pt's health care provider (HCP) recommended the pt to received GARDASIL vaccine, which was touted as a safe and effective vaccine for preventing cervical cancer. Therefore on 25-AUG-2017, at 17 years old, pt received her first dosage of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, units, route of administration, lot#, and expiration date were not reported). On 13-APR-2018, she received her second dosage of GARDASIL and on 06-AUG-2018, pt received her third dosage of GARDASIL (doses, units, route of administration, lot#, and expiration dates were not reported). Following her third GARDASIL vaccine, pt began experiencing abdominal symptoms, including indigestion and constipation, trouble focusing, brain fog, extreme fatigue, dizziness, imbalance issues, missed menstrual cycles, cold hands and feet, and headaches. As the months progressed, so did pt's symptoms. She was seen by multiple physicians and specialists for her complaints which now included: brain fog, trouble focusing, lethargy, indigestion, constipation, headaches, dizziness, imbalance, falls with seizure-like symptoms upon standing too quickly, missed menstrual cycles, and cold hands and feet. As a result of her post-GARDASIL symptoms, pt has been unable to engage in activities that a normal young person would enjoy. Her academic performance and social and extracurricular activities have been adversely affected by her post-GARDASIL symptoms. Based upon her chronic and severe post-GARDASIL symptoms, pt has been diagnosed with various medical conditions, including but not limited to, autoimmune hypothyroidism, polycystic ovarian syndrome (PCOS), brain cavernoma, and irritable bowel syndrome (IBS). Pt contended that her GARDASIL injections caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to autoimmune hypothyroidism, PCOS, brain cavernoma, and IBS, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by GARDASIL or otherwise linked to her GARDASIL-induced autoimmune disorder. The outcome of all events was considered to be not recovered.  Upon internal review, all events were considered disabling.
Pt recv vax on 2/11/99; on 2/13/99 pt exp jerky movements of extremities, drowsy, fever & cough