chrisvoncsefalvay/vaers-outcomes huggingface dataset:
brain felt swollen; glands were also swollen; bad headache; minimal arm pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. Medical history included lupus-like history and chronic Lyme disease. The patient's concomitant medications were not reported. The patient stated she received the first vaccine dose on 30Dec2020 and had minimal arm pain, fatigue that went to a very bad headache on Thursday (31Dec2020). By Friday headache and fatigue were terrible until this morning. Her brain felt swollen and her glands were also swollen on 03Jan2021. The patient stated that she called healthcare professional (HCP) and was told that her body was "having an auto immune response", "due to a lupus like history and a history of chronic Lyme disease and to hydrate well". It was so hard to talk, she was so fatigued. Her doctor compared it to like an encephalopathy. The patient was feeling better today but was concerned about taking the second dose. She works in a facility with a lot of Covid-19 patients. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product to the development of event brain felt swollen cannot be totally excluded.  Medical history of lupus-like history and chronic Lyme disease may provide plausible alternative explanations for the event. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Information has been received from a Registered Nurse concerning a male between the ages of 60 and 70 who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient had a sore arm and discomfort after receiving zoster vaccine live (Oka/Merck). Additional information has been requested. This is one of several reports from the same source.
I administered a Pfizer Bival Ped ages 5-11 dose in error as patient is 12 years old.  I should have administered Pfizer Bival 12 and up dose.  Vaccine coordinator notified at clinic.  Clinic manager notified at clinic. MD notified who was the provider seeing the patient today.  Informed mother in person that an error happened.  She asked if she needed to do anything further for the patient. Vaccine coordinator informed me that he could get the correct dose today (patient had left) or in 8 weeks.  I sent Mother a message informing her of getting the 12 and up dose in 8 weeks if interested.
I experienced a breakthrough case of COVID-19 with fatigue, sore throat and headaches.
I get raised skin kind of textured, its red and goes in straight lines. It appears on mostly my arms and hands but has been on my back and face. Most of the time Benadryl helps it go away.
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Pfizer-BioNTech on 7/1/21 and 7/22/21. Presented to ED 8/29/22 c/o generalized weakness, fatigue, N/V/D, confusion, decreased appetite. Other household members Covid +. BP 99/72, HR 83, RR 25, afebrile. Not hypoxic. Labs significant for BUN 117, Cr 15.06, Na 140, K5.5. Trop 1.32. LA 4.3. Covid+. BCX's sent. CT imaging shows ground-glass RUL, and possible colitis. Hospitalization c/b aspiration PNA, bacteremia & septic shock w/acute hypoxic respiratory failure. Cont'd to decline, transitioned to comfort care. EX'd 9/15/22. TX'd w/Zosyn and decadron.
pt recv vax & exp upper quad soreness, nausea & fatigue, & devel a swollen face, neck & arm on one side; pt recovered;
was injecting the shot and it started to leak between the plastic collar and the syringe. He was not able to tell how much dripped out but it was enough that it was on her arm / no AE; vaccine dripped out on her arm / no AE; it started to leak between the plastic collar and the syringe / no AE; Initial information regarding an unsolicited valid non-serious case received from a pharmacist on 25-Oct-2019.  This case involves an unknown age female patient for whom it was reported that he was injecting the shot and it started to leak between the plastic collar and the syringe. He was not able to tell how much dripped out but it was enough that it was on her arm (syringe issue, exposure via skin contact, underdose), while she received vaccine influenza usp trival a-b subvirion no preservative vaccine [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a single Dose (dose unknown) of suspect influenza usp trival a-b subvirion no preservative vaccine lot UJ292AB via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to (exposure via skin contact and underdose). It was also a case of syringe issue.  case details: Pharmacist states that he was administering a Fluzone HD injection and he was injecting the shot and it started to leak between the plastic collar and the syringe. He was not able to tell how much dripped out but it was enough that it was on her arm  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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 interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Diarrhea, hot flashes, left upper arm pain, left neck pain, nausea, sore throat, swollen throat, swollen tongue, sores on tongue. First two days altered Tylenol and IBP. Third night Benadryl Allergy. Forth night Benadryl allergy. On day 5 my symptoms had resolved other than sore throat and sores on tongue. Gargle with warm salt water for 2 nights at bed time before symptoms resolved completely.
This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown ages and genders. The patient's medical history or concurrent conditions were not reported. On unknown dates since 01-NOV-2016 (reported as "excursion started on 01-NOV-2016 and vaccinations may have occurred since then"), the patients were vaccinated with unspecified doses in series of improperly stored doses of PEDVAXHIB (which had the lot # M001813, expiration date 14-OCT-2018) (dose, route and vaccination site were not informed). Information regarding concomitant medication was not provided. No adverse effects were reported. It was also reported that the temperature was 12.6 C. The time frame was 168 hours. There was not previous temperature excursion. The call was not because of a "data logger". And there was not product quality complaint involved. A list of patients and actual dates of administration was not available. Additional information has been requested.
Right arm rash (pink, lacy rash over right anterior lateral and posterior upper arm).  No warmth, no induration.
Itchiness, growing red rash Benedryl, Ice compress rash  continues to cover more of left arm
Since 29 January he has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body, especially at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affected his palms and soles, and resolve without post-inflammatory changes. He reports facial swelling and transient globus sensation but denies difficulty swallowing. He denies pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 20 January, 9 days prior to onset of symptoms. He has used oral antihistamines with benefit. He denies constitutional symptoms. UCT score today is 4 (0, 2, 0, 0, 0 2, 0, 0). No history of adverse reactions to prior vaccines.
passed out for a few sec.;  hot & dehydrated;   patient given water and snack-  feel better.
GARDASIL given, pt has headaches and nausea that lasted 5-10 min. Pt give BENADRYL 25 mg in office. BP was nl.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M024677, expiry date 18-MAY-2018; dose and route were not reported). The dose was stored under temperature of -11 Celsius degrees for 8 hours and 30 minutes. The previous temperature excursion was -9.3 Celsius degrees for 8 hours and 30 minutes and -10.6 Celsius degrees for 4 hours. The call was because of a data logger. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA001139:
10 days after injection, my arm began to itch at the injection site and a red circle on the skin about the size of a quarter was present.  Now at day 15, the red spot is about the size of the palm of my hand, itches and is warm to the touch.  Firmness to the area as well.
Information has been received from representative reported experience as reported by a nurse concerning a female patient who on 18-MAY-2009 was vaccinated with the first dose of GARDASIL (Lot # 661953/1130X), 0.5ml. After receiving the patient fainted. The outcome was unknown. The patient sought medical attention. Later on 27-MAY-2009, C.M.A. provided the following details: a female patient with past history of fainting with blood draw who on 18-MAY-2009 was vaccinated with the first dose of GARDASIL (Lot # 661953/1130X), 0.5ml in the right arm after receiving VAQTA (Lot#663490/1605X) in the left arm. Concomitant therapy is YAZ. After receiving the first dose of GARDASIL (Lot # 661953/1130X) , the patient fainted. When she came to, her B/P was 115/68, she was given something to eat and drink and then fully recovered. Additional information has been requested.
Case number PHEH2013US019158, is an initial spontaneous report received from a lawyer on 10 Sep 2013: This case refers to a female patient of unspecified age. Past medical history and concomitant medications of the patient were not reported. She was vaccinated with MENVEO (batch number: A12097 and expiry date: Aug 2014), on an unspecified date. Right after vaccination, she lost consciousness, falling sustaining a laceration to her right hand which required ten stitches and sustained a head injury. The seriousness, outcome and causality of the events were not reported. No more information was provided.
patient was given fluad for 65 and older pt is only 63 immunizing technician called patients name and patient said that is me and went in vaccine room technician then state which vaccines patient was getting and patient agreed immediately after vaccinated pharmacist realized she had answered to the wrong name being called (that patient had stepped out of the waiting room and was not present at the time.  Asked patient why she stated she was getting those vaccines and answered to other name she said she figured she needed both vaccines anyway.  Patient was not upset and not harmed incident report completed immunizing technician reminded to always verify identity of patient and vaccines they are getting with open ended questions in the future
Patient developed a red oblong mark near the injection site that was about 1.5in x 1in.  It does not itch, hurt, feel hot, and it is not raised.  She noticed this the next morning when she woke up.
On the day after 2nd pfizer vaccine, I had the typical flu like symptoms. On the second day after I started experiencing very strong heart palpitations from the time I woke up until the time I went to bed. Nearly constant all day long. They were very strong and frequent for about 2 weeks and I got put on Verapamil to try and help calm them. They lasted for another 2 months slowly decreasing over time.
A spontaneous report has been received from a health professional concerning a, patient of unknown gender, who had been receiving FLUMIST, 0.2 millilitres, unknown. FLUMIST started on 25-Mar-2016. It was reported the patient received FLUMIST that expired on 25-Mar-2016. The outcome of the event of received expired FLUMIST was unknown. The reporter's description of the event was as follows: None Reported. The report was considered to be non-serious.
Systemic: Allergic: Itch Generalized-Medium, Systemic: Headache-Medium, Additional Details: patient has had issues with vaccines in the past. felt itchy pretty quick , used her own epipen. paramedics offered multiple times but her husband drove her to the er
On the 23rd of June, I had a sore throat and congestion, I did a at home COVID-19 Test and it was positive. I had a very low temp and was having body aches. I was extremely fatigue, I did a telehealth visit with a doctor. I was told I could not get the Paxlovid, because they said I was not at risk at first. I was extremely exhausted and lots of sweating. I did not have a fever, I started having headaches and a really bad cough. On 25th  of June, I developed a cough and called back to the doctor to ask for the Paxlovid. I started taking the prescription on the 26th of June,
Patient stated his neck felt weird after being cleared in the 15 minute lot.  Benadryl 25 po given.  VS taken.  Stable at discharge with no s/s
thought  it was my tooth bleeding because that's what it looked like if you cut yourself; the phlegm she spitted up this morning had blood in it; she started to bleed/nose bleed coming out of my mouth; achy; tired; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) via an unspecified route of administration on 28Jan2021 08:05 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included an unspecified sinus disorder, unspecified allergies and reflux usually after eating, all from unknown dates and unknown if ongoing. The patient's historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) on 06Jan2021 with no specified side effects. The patient's concomitant medications were reported as unspecified medications for sinus problems and allergies. The patient stated that she got the second dose on "Thursday."  She experienced side effects "that everybody has like achy and tired for two days." She continued to say that she normally spits up phlegm in the morning from sleeping overnight because she has sinus issues and she snores. This morning ("Saturday") it was pinched with blood and she was bleeding, just bleeding. She's not bleeding anymore because she has a mouthwash medication to make gargles and also with salty water. She thought it was her tooth bleeding because that's what it looked like if you cut yourself. It has stopped. She also noted that it was more like a nose bleed coming out of her mouth. She gargled with warm salted water. Treatment of the events blood in sputum, nose bleed and tooth disorder included using a mouthwash medication to make gargles and also warm salt water. The clinical outcomes of achey and tired for two days were reported as unknown. The clinical outcomes of blood in sputum, nose bleed and tooth disorder were reported as recovered on an unspecified date in Jan2021.
Systemic: Fainting/Unresponsive-Mild, Additional Details: Patient had previous fainting issues with needle encounters in the past. He was also nervous and scared of shots. Patient woke up within less than 10 seconds (once his name was called and tapped lightly for response). Pulse was fine. He felt fine after the shot but suddenly fainted about 5-6 minutes after. ER team came checked vitals. Patient was fine. Patient didn't go to hospital but stayed and sat for about 45 min to be safe. Patient called 3 hours later to say he was fine and thanked us for taking care of him.
Information has been received from a female consumer with genital warts and herpes virus infection who on 24-MAR-2008 was vaccinated in the left arm with a first dose of GARDASIL (lot # not reported).  The patient states that "sometimes her menstrual cycle is late and at the beginning of each menstrual cycle she has a light flow for 2 or 3 days."  The patient reported that "her menstrual cycle has stopped, she was supposed to get her menstrual period on 25-MAR-2008 and she still has not gotten it" (as of 27-Mar-2008).  The patient confirmed that she is not pregnant because she has "not been sexually active."  She stated that she would like to conceive.  Her last menstrual period was 21-FEB-2008.  Also, the patient stated that she has been experiencing some stomach pains, and some dizziness.  The patient stated she will seek medical attention in a follow-up visit with a doctor this afternoon (27-MAR-2008) and she will discuss her symptoms with her physician.  There was no concomitant medication and the patient has no known allergies.  There was no product quality complaint involved.  Additional information has been requested.
A LITTLE OVER 3 HRS AFTER THE SHOT I DEVELOPED BLISTERING ON MY LIPS, IN MY MOUTH AND SOME BACK BY MY THROAT WITH SORENESS, BURNING AND DISCOMFORT.  THIS LASTED ABOUT 72 HRS.  IN LATE DECEMBER '21 THE LIP IRRITATIONS RETURNED FOR A FEW DAYS.  IN LATE JANUARY THE IRRITATIONS RETURNED FOR ABOUT A WEEK.  ON 3/2/22 THE IRRITATIONS RETURNED AND HAVE LASTED FOR 3 WKS.  I SAW A DERMATOLOGIST TODAY AND IT IS DIAGNOSED AS ORAL LICHEN PLANUS AND I AM BEGINNING TREATMENT FOR IT.
Localized irritation (redness, rash like appearance), agitation upon contact causes itching, dilation approx. size about that of a silver dollar.
Narrative:  Pruritus, dizziness 30 min after getting vaccine. Patient observed in ED and given diphenhydramine.
Received smallpox vaccine 10/24/03; reading 10/31/03 - previous response. 11/1/03: fever chills, night sweats rash, LA axilla cellulitis 2 hours smallpox vaccine; off work 11/3-11/5. RTC 11/6 cellulitis somewhat improved but still feeling achey, pain left axilla 2nd course of c pack, off work 11/6-11/7, RTC 11/10 for re-evaluation. Cellulitis resolved 11/10/03.
My arm was sore for a few hours after the first second dose, then got tingling sensation in fingers, which went away.  The soreness and weakness got worse after the second dose - I cannot lift my arm over shoulder height without assistance and every time I move it there is some pain - similar to a deep bone bruise.  After the first dose, the symptoms improved within a day; after the second dose they were worse and have not changed since I got the shot on March 15.
102 fever for four days, fatigue, weakness, not able to even care my myself - our sweet neighbors helped us with the basics.
pt recv vax & 2hr later pt exp gen hives-possible erythema mult;
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's age was reported as 42  years and 05 months. No concomitant medication was provided. It was reported that vaccine was administered beyond use date to the patients. There was no adverse reaction noted or reported regarding these administrations. Vaccine NDC code. No treatment medication was provided.
BRIEF OVERVIEW: Admission Date: 8/5/2023 Discharge Date: Aug 7, 2023 Discharge Disposition:  home or self care   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Shortness of breath [R06.02] Dyspnea [R06.00] Fever, unspecified fever cause [R50.9] Chest pain, unspecified type [R07.9]   HOSPITAL COURSE: 62-year-old with past medical history of chronic diastolic congestive heart failure, type 1 diabetes, diabetic neuropathy, history of coronary artery disease with CABG in 2023, hypertension, blindness, depression, chronic short-term memory loss, OSA not on CPAP, who presented with dyspnea and cough.  In ED febrile, mildly hypertensive, tachypneic to 30. ProBNP elevated to 7649 which is significantly elevated from her last few readings.  White blood cell count within normal limits.  COVID-19 positive.   Discharge from the ED discussed with the patient, however she was not comfortable with this and so decision made to admit under observation status.   On admission patient is placed on IV Lasix 40 mg 2 times a day.  Noted last discharge weight 93.1 kg.  Noted last echocardiogram 07/24/2023 ejection fraction 60% assessment for diastolic indeterminate.  By 8/6 standing weight was 92.7 kg.  Discussed with patient torsemide dose had been decreased from 60 mg daily to 20 mg 2 times a day.  Patient felt she did not have significant urine output from the lower dose.  On discharge patient will be given 40 mg once daily and advised to monitor daily weights and call physician if significant weight gain. Patient also noted positivity for COVID-19 on admission.  Patient received 1 day of remdesivir given risk for progression with underlying multiple medical comorbidities.  Patient was able to remain on room air including with ambulation.  Fevers improved.  Patient will be prescribed paxlovid at the reduced renal dosing on discharge.  Urinalysis and urine culture obtained in emergency department grew Klebsiella however patient has absolutely no dysuria or abdominal discomfort and fevers can be attributed to the COVID-19 infection.  Discussed with patient if she develops any urinary symptoms she will need to discuss with her PCP and start antibiotics however does not appear indicated at this time as patient asymptomatic.