chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 21-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported.    This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
a female child age 5 months 22 days old on 12-Nov-2019 received a Fluzone Quadrivalent, no AE; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 month 22 day old female patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6656NA and expiry date: 30-Jun-2020) not reported via intramuscular route in the right thigh on 12-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was an actual medication error due inappropriate age at vaccine administration. It was reported that a female child age 5 months 22 days old on 12-Nov-2019 received a Fluzone Quadrivalent.  At the time of reporting, the patient had no adverse event.  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 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.
Pt received varicella vaccine 7/21/1999 was seen on 10/23/2006 and diagnosed with varicella, pruritic rash starting on back-chest.
Dose administered more than 24 hours after the vial initially punctured; 2 doses of the Moderna Covid-19 Vaccine were administered more than 24 hours after the vial was initially punctured; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Covid-19 Vaccine were administered more than 24 hours after the vial was initially punctured) and PRODUCT STORAGE ERROR (Dose administered more than 24 hours after the vial initially punctured) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Covid-19 Vaccine were administered more than 24 hours after the vial was initially punctured). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered more than 24 hours after the vial initially punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Covid-19 Vaccine were administered more than 24 hours after the vial was initially punctured) and PRODUCT STORAGE ERROR (Dose administered more than 24 hours after the vial initially punctured) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Dose was administered more than 12 hours post puncture,the vial was initially stored in the refrigerator on 27-May-2022, the vial was first punctured on 8-Jun-2022 at 1:10 PM. The vaccines were administered on 9-Jun-2022 at 2 PM and  2:01 PM. The vial did not undergo any temperature excursion. Treatment information was not provided.   This case was linked to MOD-2022-587397 (Patient Link).
Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 12:00 (Lot number: ER8730) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid reflux and seasonal allergies to pollen" (unspecified if ongoing); "Acid reflux and seasonal allergies to pollen" (unspecified if ongoing). Concomitant medication(s) included: ALEVE; VITAMIN C ACID; BIOTIN; TURMERIC +; GINGERCALM; COLLAGEN. Vaccination history included: Bnt162b2 (Dose 1, lot number: ER8730, administration time: 14:30,, vaccine location; Left arm,, ), administration date: 25Mar2021, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 15Apr2021, outcome "recovering", described as "Dizziness". Therapeutic measures were taken as a result of dizziness with ALEVE.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, has the patient did not tested for COVID-19. Patient had no allergies to medications, food, or other products  No follow-up attempts are possible. No further information is expected.
Received vaccines on 10/6/20. Rash appeared on face beginning 10/19/20, then spread to entire body. Thought to be an amoxicillin allergy but his twin brother who did not receive amoxicillin developed the same rash 2 days later (twin brother's case was milder). Treated with antihistamine and steroids (Propranolol). Extreme itching and fussiness in both boys. Skin was 90% covered by the rash on and extremely inflamed, approximately 60% on his twin. Applied thick layers of 40% zinc oxide because calamine lotion and oatmeal did not appear to help. Rash faded from the face first on 10/20/20. Now on 10/22/20, the rash has mostly faded but appears like small off color dots on the skin.
Information has been received from a nurse practitioner concerning a 5 year old male patient who on 09-AUG-2010 was accidentally vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not provided) instead of a dose of VARIVAX (Merck). The patient had not relevant medical history, concomitant medications, and past drug history. On 09-AUG-2010, the patient was scheduled to received a VARIVAX (Merck) dose, but was accidentally given ZOSTAVAX (Merck). It was unknown if there was any relevant laboratory data. As of 09-AUG-2010, the patient would no longer receive the ZOSTAVAX (Merck) and he had not experienced any adverse events from the accidental administration. No further information is available.
03/15/22 presents to EC ED for "Diarrhea with abdominal pain". PMHx of "CAD, atrial fibrillation (not on AC), hypertension, kidney stones  and chron's disease"
Booster shot - only reaction after shots 1 and 2 were sore arm which weren't reported.   Shots 1 and 2 were Moderna  & booster was Moderna.  Booster was 7 months after 2nd shot. Fever; chills, body aches & severe headache and brain fog.  Sore arm at injection site.  Tylenol taken and only addressed symptoms partially for about 2 hours.  The time in between Tylenol doses was just as if I hadn't taken anything.  Symptoms started within 3 - 4 hours of shot and 36 hours later were still strong.  Symptoms then started to taper off 40 or so hours later; however headache and brain fog persisted to the point of not being able to concentrate to work for more than small periods of time.
Fever, headache, chills, body aches.  Took Tylenol pretty much every four hours and fever and all other symptom's were gone by 8:30 am on 01/27/2021.
1 week after the vaccine, an itchy, red, swollen patch of skin appeared at the injection site (left arm). It is warm to the touch and significantly itchy. It is currently the size of a golf ball but appears to be growing.
Received Dtap 08/25/04 in left deltoid, had severe local reaction, now has recurrent hives at injection site whenever she is warm (after baths, etc).
a day after vaccination, felt fatigue and "under the weather". 2 days after injection, experienced sharp pain in left ear radiating down to jawline and left shoulder and upper arm. Pain also caused severe headache relieved with high dose Tylenol. Symptoms lasted 24hrs. Headaches became mild lasted thru day of report reaction (1/4).
A report has been received from a Health Professional concerning a 6 year old, Female subject, Height: 44.0 IN; Weight 49.0 Pounds, who had received FLUMIST quadrivalent, (intranasal), 0.2 Millilitres, Once/Single administration. The patient's medical history included wheezing. FLUMIST quadrivalent, (intranasal) started on 16-Nov-2015. It was reported that the patient received FLUMIST quadrivalent on 16-Nov-2015 after a temperature excursion of 34.7 degrees Fahrenheit for 20 hours. FLUMSIT quadrivalent (intranasal) was discontinued on 16-Nov-2015. The outcome of the event of consumer received FLUMIST quadrivalent on 16Nov2015 after a temperature excursion of 34.7 degrees Fahrenheit for 20 hours is unknown. The report was considered to be non-serious.
This spontaneous report as received from a registered nurse, concerning an unspecified number of patients (patient's demographics not provided). Registered nurse first, requested temperature stability data for several vaccines. Then, stated that she believed that an unspecified number of patients may have received improperly stored GARDASIL. No symptoms reported. This is one of two reports from the same source (MARRS; 1402USA001214). Additional information has been requested.
Patient developed diarrhea, leg cramps x 6 weeks, insomnia, tremors x 3 days, swelling of wrist on the arm injection was given, fever, microscopic hematuria x 11 months, and numbness over entire body x 11 months. Pt follows with neurology, urology, and internal medicine for these issues.
Fever 102.7 for 24 hours, body aches and pain, headache, chills, metallic taste in mouth, large lump and painful swelling at injection site.  All resolved in 24 hours except the metallic taste and lump at injection site which still exist 72 hours post injection.
I have noticed since I have had the covid vaccine my period symptoms are different. Now it lasts from 6 to 7 days, previously it was a maximum of 5 days. The blood flow is much heavier since the shot. My period was on time at the beginning of the month for over a year, and since the vaccine it changed. My period will start at any time. Also in the past 3 weeks I have had my period in the beginning and now I am bleeding again. The workflow is enough to change tampons twice in the day. This bleeding is going on the third day.
numbness from shoulder to elbow; Sinuses have been an issue too; Pain in my left shoulder  to my elbow; Inject site swelled about 5 inches around, red and itchy; Inject site swelled about 5 inches around, red and itchy; Inject site swelled about 5 inches around, red and itchy; Inject site swelled about 5 inches around, red and itchy; sever itching from left shoulder  to my elbow; Pain in my left shoulder  to my elbow; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jan2022 17:00 (Lot number: fj5682) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfa and narcotics, reaction(s): "Allergy"; Narcotics, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Product=COVID 19, Brand= Pfizer, Lot number=fj5682, administration time=10:30 AM, dose number=1, vaccine location=Left arm), administration date: 03Jan2022, when the patient was 53 years old, for COVID-19 immunization.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Jan2022, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE REACTION (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 19Jan2022 12:00, outcome "not recovered" and all described as "Inject site swelled about 5 inches around, red and itchy"; PRURITUS (non-serious) with onset 19Jan2022 12:00, outcome "not recovered", described as "sever itching from left shoulder to my elbow"; ARTHRALGIA (non-serious), PAIN (non-serious) all with onset 19Jan2022 12:00, outcome "not recovered" and all described as "Pain in my left shoulder to my elbow"; HYPOAESTHESIA (non-serious) with onset 19Jan2022 12:00, outcome "not recovered", described as "numbness from shoulder to elbow"; SINUS DISORDER (non-serious) with onset 19Jan2022 12:00, outcome "not recovered", described as "Sinuses have been an issue too". Therapeutic measures were not taken as a result of inappropriate schedule of product administration, vaccination site swelling, vaccination site reaction, vaccination site erythema, vaccination site pruritus, pruritus, arthralgia, pain, hypoaesthesia. Therapeutic measures were taken as a result of sinus disorder.  Additional Information: The patient was not tested for Covid post vaccination. The patient did not take any other vaccine in four weeks and no other medications in two weeks.   No follow-up attempts are possible. No further information is expected.
Mild Chest Pressure Urgent care and ER visit. Abnormal EKG. Follow ups  with cardiologist still pending. Change diet to eliminate possible acid reflux symptoms.
Patient's husband called to say that the vaccine was given lower than deltoid muscle, that it was a few inches above the elbow.  The arm is sore. He is concerned about long term effects.  I called Pfizer on 5-3-21 11:20am. They gave me guidance by cdc that the dose does not need to be redone.  I gave husband this info 5/3/21 at 5:55pm.  He is still agitated and concerned.
Given a flu shot @ work, felt soreness @ injection site later in evening. Area is firm, red, warm.
pt was asleep & started crying;cried for about 45min;body was jerking like had really bad hiccups;pt would cling to the person holding her;pt just stared when laid won;
Approx 2 hours after vaccination - seizure activity/fever taken to hospital via ambulance - temp 103.3. Nausea/vomiting - arrived in ER at 7:32 p.m. - given MOTRIN for fever. ZOFRAN for vomiting. IV fluids - temp 99.6  ax in ER labs, x-rays done, released to home at 9:20 pm
Bilateral Tinnitus began within a few days post Moderna 1st vaccine given on 02/10/2021, with feeling of Tympanic Membrane pressure, otherwise  no other significant findings
11:45am 10/15, received vaccine in left shoulder. 10/16, had some minor muscles aches, primarily at vaccination site. 10/17 about 1am, woke from sleep with searing pain in right side of neck and shoulder. Took Naproxen Sodium and tried to go back to sleep. Pain continued and worsened throughout the night. Pain moved to both sides of neck and shoulders, temporarily relieved by massage and icy hot. Area of pain expanded to bottom of shoulder blades and ribs, at times making it difficult to breathe. Tried using Tylenol, Icy Hot, and Vicks chest rub to alleviate pain throughout the day. Had a dizzy and near-fainting spell at about 9:30pm. Went to ED at 11pm. Dx pericarditis - treat with Ibuprofen 600mg 3x/day, Colchicine 2x/day, Omeprazole 20mg 2x/day, follow-up within a week with PCP and cardiology.
Patient developed  10 x 5 cm evanescent, warm, firm papule at injection site approx 8 days post vaccination.  Very itchy.,  Not relieved with Benadryl.  We have asked her to take Zyrtec daily, Benadryl q 4-6 h breakthru itch, provided RX clobetasol cream for use BID to site.  She is also advised to follow with ER immediately any itch mouth, lips, airways, any swelling these sites, any SOB, any new rash or worsening symptoms any sort.  Localized immune response/injection site reaction vs true allergy to some component of Covid Vaccine or injector.  We have asked her to discuss with you and PCP whether she should receive 2nd dose vaccine.
sickness; Initial information regarding an unsolicited valid non-serious case received from a consumer via social media  and transmitted on 14-Dec-2020.  This case involved patient with unknown demographic who experienced sickness (Illness), while he/she received influenza vaccine.  The patient's medical history, medical treatment(s), vaccination(s), family history and concomitants were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, following the administration of influenza vaccine, patient developed sickness (Illness).  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for illness.  There will be no information about batch number.
DEVELOPED CROUP, RUNNY NOSE, DECREASED APPETITE AND IRRITABILITY; PATIENT WAS SEEN AT THE ER AND GIVEN RACEMIC EPI AND DEXAMETHASONE THEN SENT HOME
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72-year-old female patient. No information was provided regarding medical history, concurrent conditions or concomitant medications. On or about 29-APR-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of shingles was not reported. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
Case number PHEH2013US023749 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 74-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with an expired dose of FLUVIRIN 2012/2013 (batch number: 123303, expiry date: JUN 2013) at a dose of 0.5 ml intramuscularly on 18 OCT 2013. No adverse event was reported following the maladministration.
HOSPITAL COURSE: Patient is a 88 y.o. female with a past medical history of CAD s/p MI 1986 (medically managed), s/p PCI LAD 9/1999 and subsequently s/p 2V CABG 10/2000 (LIMA-LAD, SVG-OM), DM2, HTN, HLP, and atrial tachycardia with tachy-brady syndrome s/p BSCi  dual-chamber PPM placement 10/2007 presented for ED for evaluation of falls. Incidentally, she was found to be COVID-19 positive. UA with mild pyuria but no other clear signs of infection. Urine culture pending. She was given Rocephin in the ED for prophylaxis. Otherwise, lab workup was generally unremarkable without any electrolyte abnormalities. Creatinine at baseline for patient. Neurologically intact and vitally stable. She did not require supplemental O2 throughout this admission. Patient was evaluated by physical and occupational therapy who recommended home with home cares. Patient and family are in agreement with this plan. Home care orders sent and patient was educated on current CDC quarantine guidelines PCP Recommendations:- INR check this week - F/U on COVID recovery. HOSPITAL COURSE BY PROBLEM: Generalized weakness, Right leg pain s/p fall, COVID-19 PNA UA pyuria with small clear signs of infection. Chest x-ray with some mild vascular congestion/interstitial infiltrate otherwise no consolidation.  Incidentally, she was found to be COVID-19 positive. UA with mild pyuria but no other clear signs of infection. Urine culture pending. She was given Rocephin in the ED for prophylaxis. Otherwise, lab workup was generally unremarkable without any electrolyte abnormalities. Creatinine at baseline for patient. Right leg XR without fracture. Neurologically intact and vitally stable. She did not require supplemental O2 throughout this admission. PT/OT recommending home with home cares. - Pain control prn - home PT/OT orders sent - Follow-up on urine culture - Follow CDC guidelines for quarantine   h/o paroxysmal Afib/h/o sick sinus syndrome s/p dual chamber PPM / CAD/h/o MI s/p CABG x3 - on warfarin with pacemaker in place -- continue PTA aspirin, statin -- continue PTA furosemide 40 mg daily -- continue PTA metoprolol succinate 25 mg daily - recheck INR with PCP this week   DM II - chart review basaglar 30 units daily and novolog 5 units TID. She was given Basaglar 20 units qhs and medium SSI while admitted.  - resume home insulin dosing   HTN - post-op BP 150s/80s, no acute issues.  -- continue PTA clonidine   CKD - Cr 1.35 on admission, at baseline. Remained stable with repeat    GERD - no acute issues -- continue PTA omeprazole   HX S/p removal of partial L knee replacement with left total knee arthroplasty on 6/18/18 - Pain control with tylenol as needed
09/27/13-GARDASIL #3; Hepatitis A #2, Typhoid vaccine VI capsular Polysaccharide IM- Rash.
Injection site was soaked in blood and fluid, with a ring under the skin around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Injection site was soaked in blood and fluid, with a ring under the skin around the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    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) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Injection site was soaked in blood and fluid, with a ring under the skin around the injection site). At the time of the report, VACCINATION SITE HAEMORRHAGE (Injection site was soaked in blood and fluid, with a ring under the skin around the injection site) outcome was unknown. Not Provided       Concomitant medications were not reported. The patient did not received treatment medications.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-084818 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Migraine headache, nausea, hot flashes, rapid heartbeat, dizziness, vomiting. It took a few hours for the symptoms to present themselves. I vomited multiple times the next morning, then I started feeling better.