chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262; Expiration date was not reported) on 03Feb2021 (12:15) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the physician's office. Medical history included vulvodynia; back issues; sulfa allergy; penicillin (PCN) allergy; and allergy to "mycins". Concomitant medication included estrogens conjugated (PREMARIN) and propranolol. The patient previously took morphine sulfate, and had drug allergy; lansoprazole (ZOLANAS), and had drug allergy; and tetanus vaccine, and had allergy to the vaccine. The patient was not pregnant at the time of vaccination. On 11Feb2021 (16:30), the patient had induration/3-inch diameter raised injection site that was hot, very red, itchy and hard around it. The reported events resulted into physician's office visit. The patient did not receive any treatment for the reported events. The outcome of the events, 'induration/3-inch diameter raised injection site that was hot, very red, itchy and hard around it', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
Shingles symptoms arose on top of head and on eye. On 11/29, was diagnosed to be Shingles and treatment for Shingles began. Still recovering from Shingles on 12/05/2021.
10 year old patient received 0.3 ml (30 mcg) 12 & older dose instead of 0.2mL (10 mcg) dose. Patient had no adverse reaction or side effects from receiving this dose.
Rash all over the body; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2022NVX-US-000003862).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "Rash all over the body". Additional information: On 13Oct2022, it was reported that the patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine booster shot dose for an unknown indication. It was reported the patient had rash all over the body after receiving the Pfizer COVID-19 booster shot. No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Ear infection; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (Ear infection) and INJECTION SITE PAIN (Soreness at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness at injection site). On 03-Mar-2021, the patient experienced EAR INFECTION (Ear infection). At the time of the report, EAR INFECTION (Ear infection) and INJECTION SITE PAIN (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Terrible chills and shivering with a massive headache. Headache lasted two days.....shivering for a few hours.
No adverse events have been reported.  The vaccine was given before the minimum interval of 2 months was reached.
flu like; lots of muscle pain in biceps, calfs, thighs; light headed; Dizzy; This is a spontaneous from a contactable consumer (patient) A 70-year-old male patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, on arm right on 08Feb21 as a single dose for Covid-19 immunization. The patient historic vaccine included first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EK9231), 11 hh:30 mm (24 hour clock) via an unspecified route of administration, on 08Jan21 at single dose for Covid-19 immunization .Ongoing concomitant medication included Crestor 5 mg 3 days WK Date Started 2008,Amitriptyline 10 mg 7 days WK Date Started 2005,Fluticasone propionate 7 days WK Date Started 2010, Amlodipine Besylate 215 mg 7 Days WK Date Started 2010.Patient experienced after second day of vaccination Flu Like with lots of muscles pain in bicps, Calfs, thighs, on day three most of event recovering. Still a little, light headed/ dizzy, Day 4 all but gone little left but seems it'll go soon. Vaccination Facility Type: Hospital  The outcome of event was Recovering.
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Expiration Date for the lot 070H21A was reported as 07-Apr-2021 with total of 173 doses. The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was reported as unknown. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received contains non-significant information.
started to bother him and his arm; lymph node under his left arm is was swollen; terribly sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 (Lot number: EN6202) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (The first one we got was the 27Feb), administration date: 27Feb2021, for Covid-19 immunization. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "started to bother him and his arm"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered", described as "lymph node under his left arm is was swollen"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "terribly sick". Therapeutic measures (Tylenol and it has gone down to medicines) were taken as a result of lymphadenopathy. No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 01-MAY-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax 2NOV94 & 3NOV94 pts reported to MD that upper arm around the inj site was painful, red & swollen since evening of 2NOV94;pt otherwise felt fine;no fever;tx ice;recovered
Headache, Myalgia, Fever, NauseaVomiting, inj site tender/red/itchy; fatigue, chills,  Narrative: inj site tenderness for 5 days; fatigue, fever, chills, myalgia, nausea for 4 days
Coughing and wheezing 2 days after vaccine. Lasting 6 months. Death from Cardiogenic shock. Patient never suffered from wheezing before vaccine but didn?t not have it have it until he died.
frozen vaccines temperature excursion that occurred last night; This spontaneous report was received from a clinical lead referring to a patient of unknown age and gender. The patient's medical history and concomitant therapy were not provided. Concomitant therapy included sterile diluent.      On 28-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# S021326, expiration date 05-JAN-2021, therapy type rHA; dose detail, strength and route were not provided) for prophylaxis (product storage error). The temperature excursions included 10.56 Fahrenheit degree to for 50 minutes. Temperature previously excursion was 8.47 Fahrenheit degree for 30 minutes (on 26-AUG-2020). There was a data logger involved.
During 5 week field exercise, patient was administered anthrax and smallpox vaccine, 05MAR09. Patient did follow-up note on 12MAR09 with no problems noted.  ~ 23MAR09, patient's rank collar insignia punctured skin in upper left chest.  Patient developed rash at that site.  Over next 2-3 days, patient developed a generalized pox appearing rash over most of body to include torso, face, extremities, genitalia.  Rash spared palms and soles.  Rash was itchy, but felt different from pain of vaccination site.  Patient presented to medical on 26MAR09.  Rash appeared like chickenpox, but mostly in same stage of development.  Patient had chickenpox between age 4-6.  There was no fever, chills, or systemic symptoms (other than pruritis.)  Medical Officer contacted vaccine manufacturer and MILVAX representatives.  Photos were sent to MILVAX via camera phone.  MILVAX felt that the patient's reaction was non-viral pustulosis.  Afterwards, the patient's rash was treated with benadryl.  It resolved over the next 3 days without complications.
Injection site reddened, slightly raised, area baseball size, warm to touch, caused itching to area. Injection site back to normal w/in 24-48 hrs.
Severe underarm and left breast swelling that lasted 5 days with pain, chills, fever, body aches and fatigue still present 7 days later
Teammate had vaccine on 9/21/23, initially site was sore and experienced bad headache. Whole Body redness reaction began couple hours after vaccine administration.Itchiness intially experienced. Does not feel needs to be seen at this time. Pt took Ibuprofen and relieved symptoms of headache.
C/O feeling warm x few days, fussy, followed by red bumps apprx. 50-60 scattered over body and limbs.
Information has been received from a new article via an journalist in a website referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of GARDASIL (dose, dose number, lot number, application and route were not reported). According to the research of Centers for Disease Control and Prevention, the researchers looked at problems reported to the Vaccine Adverse Events Reporting System in the 2.5 years since GARDASIL was licensed. There were 8.2 reports of fainting per 100,000 cases. The outcome of event fainting was not reported. The causality was unknown. This is one of several reports received from the same source. Additional information is not expected since there was no contact details provided.
Per patient's request Moderna Covid19 vaccine first dose administered by APhA IMZ certified Pharmacy Technician. After receiving the shot and while being observed for 15 minutes in waiting area, patient started to complain of being hot and gradually slouch over chair. I rushed to support up patient then his head involuntarily rocked back abruptly and his eyes rolled back. Technician told to dial 911 emergency. Patient gradually moved to the floor on his back with legs raised. Blood pressure taken (201/97). While on floor patient started to choke and struggle to breathe so 1 dose of Epipen Autoinjector 0.3mg administer into left thigh at 1:45pm. Patient then was placed in recovery position with breathing improving. Blood pressure check again at 1:55pm at 193/75. Patient was not completely responsive or coherent. Store's defibrillator retrieved while continued to monitor patient's pulse and airways until paramedics arrived. Paramedics apply EKG patches and sat patient up then decided to transported patient to hospital for continue observation.
Strange thoughts, neck pain, dyspepsia, esophageal spasms, hives, itching, itchy nose, runny nose, sore joints, irritability, anxiety, fatigue, tingly head.
3-29-04 immunization given. 3-30-04 1AM woke crying. Left thigh warm. Child crying. 9pm more swollen, firm red- went to ER area marked top margin below diaper lower margin just above knee. Was given Benadryl in ER. 3-31-04 brought to clinic. Child running, playing--area of redness about 1.5 inches smaller in diameter than earlier area marked. Reports no fever.
Muscle spasm and tightness in shoulders, neck and back. Dizziness, Diaphoresis, elevate heart rate, nausea.
Pt complained of inflammation at the injection site and gradually moving down to her arm. Area is hot to touch and pain.
Patient received second dose on 5/9/2021 when they were supposed to receive second dose on 5/16/2021 (21 days after first dose)
Swollen arm very red at site heartbeat rapid woke up in eve taken to emergency room by pharmacist.
Body aches; Painful sinuses; Fatigue; Arm pain; Fever; Chills; Headache; Dose 1: 27Apr2021;Dose 2: 11May2021; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11May2021 at 11:00 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. Medical history included shellfish allergy and latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included iron (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 11:00 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. On 11May2021 at 23:00, the patient experienced fever, chills, body aches, headache, fatigue, painful sinuses and arm pain. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, body aches, headache, fatigue, painful sinuses and arm pain were resolving at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Ax T 102 4Dec90, 1 day only, emesis of formula/table food given 7-Up, seen by MD had Ax T 98. Fine rash abd/back
Feeling pain at the injection site on the right arm; Achy; Overall sick feeling; This case was reported by a consumer and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th August 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, pain and feeling unwell. On an unknown date, the outcome of the injection site pain, pain and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the injection site pain, pain and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of Shingrix on right arm and within 1 day patient felt pain at the injection site on the right arm also achy and felt sick. The the pain at the injection site, achy and sick felt resolved in 7 days. The reporter did not consent to follow up. The caller did not willing to share patient's complete DOB and street address.
Anthrax Lot# FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per milvax direction.
Initial information received on 29-Aug-2018 regarding an unsolicited valid serious case received from a physician. This case involves a 71 years old female patient who was passed out, weak and felt overheated, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number UJ004AA and route of administration not reported). On an unknown date, the patient developed a serious overheated (pyrexia), weak (asthenia) and passed out (loss of consciousness) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event. No clear etiology for syncopal event. Relevant tests were not reported. Final diagnosis was felt overheated, passed out and weak. It was not reported if the patient received the corrective treatment. The patient was recovering from the events. List of documents held by sender: none.; Sender's Comments: This case involves a 71 years old patient who developed weakness, felt overheated and passed out post vaccination with FLUZONE HIGH DOSE. Time to onset is unknown. Additional information including patient's medical history, condition at the time of vaccination, latency information, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 59 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 01-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
I have had a variety of symptoms starting on the night of the vaccination with a soreness and bruising at the vaccination site. I have had headache, body aches and tiredness on various days. Now 8 days after the shot, my arm around the vaccination site is itchy, red and blotchy, emanating heat, and is still bruised.
Bottle of PFIZER Pediatric 5-11 years was not diluted and 0.2ML was administered to the patient undiluted. The patients mother was called to evaluate the patient and indicates that she does not have any symptoms at the moment. It is recommended to put ice on it, give Panadol or TYLENOL and observe her. Adverse effects are expected to be major. Mom stated she will keep her in observation.
Information has been received from a registered nurse concerning an approximately 69 year old female with haemodialysis, hypertension and diabetes and no known allergies who in 2003 was vaccinated with 3 dose series of RECOMBIVAX HB and failed to seroconvert. The registered nurse reported that the patient's antibody blood test result that was drawn on 05-FEB-2007 was 7 but should be 10. Unspecified attention was sought. No product quality complaint was involved. Further information has been received from the nurse who reported that the patient received four doses of RECOMBIVAX HB in 2003. The patient had been vaccinated with hep b NOV 04, 2002 Lot # 0036M, on 06-DEC-2006 Lot#/0036M, on 06-JAN-2003, Lot # 0036 and on 07-MAY-2003 Lot # 0918M. The nurse noted that she did not known if these doses were for the first or second series for RECOMBIVAX HB. The patient was vaccinated on 24-JUL-2002 with pneumococcal vaccine lot # 1051L and vaccinated against influenza 22-OCT-2002, 03-OCT-2003 ( Lot # 765413), 08- Nov-2004, 10-OCT-2005 (Lot # U1777AA) and on 06-NOV-2006 with lot 2F601211. Additional information not expected.
16 out of 29 pts recvd vax in opposite arm 19OCT94 & all exp inj site rxn @ pnu-immune site (erythema, tenderness, swelling, adenitis)-size from quarter to shoulder/elbow;MD visit rx:ice pack/Motrin;pt recovered;
After receiving my second dose on 5-3-21 I have continued to experience soreness in my shoulder muscle in the arm that the injection went into.  The initial soreness subsided somewhat and now it still feels somewhat bruised when I try to move my arm in certain ways.
Extreme weakness not experienced previously. Could not stand up first night.  Rapid heart rate 125-105 still today. Slight fever. Normal blood pressure.
Error: unauthorized age group (13-year-old, Pfizer EUA approved only for  persons 16 years and older at time of administration. Patient signed consent form with incorrect DOB indicating age greater than 16 years). Event discovered and forwarded for reporting. Signs and symptoms: None known. Diagnosis and treatment: None known. Outcome: No adverse reaction reported.
Information has been received from a female consumer who posted her daughter's experience on internet. She reported that her healthy 13 year old daughter started having her first of several seizures after she had received her second dose of GARDASIL (lot# not reported) in March 2007. She was now 15 year old and still having random seizures. On 21-OCT-2010, the patient had a seizure and she fell to the ground and had minimal injuries. The outcome was not reported. Upon internal review, seizures was considered to be an other important medical event. No further information is available.
Site: Bruising at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: called 911 for pt. who had chest tightness after getting the covid shot. pt recovered after being seen by paramadics