chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; incorrect product storage; This spontaneous report was received from an unspecified report and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 18-DEC-2020, the patient was vaccinated with improperly stored doses of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T007790 with expiration date 03-DEC-2021, 0.5 milliliter for prophylaxis. No other adverse event (AE) was reported. The vaccine experimented Temperature of 31.2 F for 30 minutes. No Previous temperature excursión. Digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This is a 21-year-old who had been in his usual health until 02/11/04. He received his primary smallpox vaccination on 02 February 2004. On 11 February 2004, awoke @ 0800 hours with "really really bad chest pain". Walked around and "shook it off" and the pain subsided. Went to beach after spending ~2-3 hours at beach. Went home went to bed. After lying down developed chest pain (8-9/10) and shortness of breath. Could only get comfortable when "sitting in fetal position in corner of his room". Did not seek medical attention. However chest pain did not resolve.  On 13 February 2004, client went on mandatory run, however after completing ~1/8 of a mile had to stopped because of severe (10+/10) chest pain and severe shortness of breath. He was instructed to go to the BAS, was sent to Emergency Department and later transferred to another hospital and admitted to the Coronary Care Unit.  As of 02/18/04 client continues to have chest pain and shortness of breath. Client states he cannot lie completely supine or has chest pain (6-7/10) and short of breath. When he walks around the room/ward he develops some mild dizziness and minor pain at cardiac catheter injection site. When he stops walking the chest pain (6/10) and experienced moderate shortness of breath upon returning to a sitting position. Nurse follow up on 06/02/04 states: ADD: Pericarditis/Myocarditis.
Awoke in middle of night 18 hours after injection itching all over. Awake finally 21 hours after vaccine with visible hives on arms and chest. Benadryl taken with relief. 48 hours after injection, whole body hives ensued.  Benadryl, Zyrtec taken. PA ordered Medrol dose pack. Mostly resolved by next morning, 60 hours after injection, but hives intermittently appeared throughout the day in between medrol doses.
Redness, swelling around injection site with hard lump. Pain in armpit. Hot to touch. Diameter about 3 inches. Started to improve 24 Sept 2020 in the afternoon.
Red rash, both itchy and swollen, first noticed to be about 2 inches in diameter and which doubled by Feb. 3.
I had flu like symptoms that morning, my arm was sore., fever and chills The next day I had flu like symthons  and rash started on the 2nd day at let side , left breast in middle. I took pictures and sent to doctors. 10th March 2021 as it Valtrac in case it was shingles. The rash went off 4 days until it completely went away.  and have tropical cream - clotrimazole. Dr. on 3/10/2021
generalize rash - chicken pox lesions, severe itching, it's been 3 month since symptoms began and still ongoing
EXHAUSTED; FELT PAIN ON THE FRONT UPPER CHEST OF THE LEFT SIDE BELOW THE SHOULDER AREA; UNUSUAL BRUISING IN DIFFERENT PLACES; DOUBLE DOSE SHOT OF THE VACCINE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and other pre-existing medical conditions included: Patient did not have medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-AUG-2021, the patient experienced double dose shot of the vaccine. On 18-AUG-2021, the patient experienced bruising in different places. On 19-SEP-2021, the patient experienced felt pain on the front upper chest of the left side below the shoulder area. On an unspecified date, the patient experienced exhausted. Laboratory data included: Blood pressure (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruising in different places, and the outcome of double dose shot of the vaccine and felt pain on the front upper chest of the left side below the shoulder area was not reported. This report was non-serious.
- Rash that looks like measles all over the body. - Not itchy - 2 knots (lymph nodes) in Bilateral inguinal areas. - No fevers.  - Tx - supportive care - Avoid close contact with Immunocompromised individuals
G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, MILD 4/14/2023 ADULT OBSTRUCTIVE SLEEP APNEA, MILD CERVICAL RADICULOPATHY
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 30-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot number N015624 and expiration date of 15-NOV-2018 for prophylaxis (dose, route of administration, lot number and expiration date were not reported) reconstituted with sterile water diluent lot number N007932 and expiration date of 06-MAY-2018. No adverse effects were reported. The vaccine was exposed to a temperature excursion of 15°F to 46°F with a time frame of 15 hours and 50 minutes, while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved. There was not product quality complaint involved. This is one of the two reports received from the same reporter.; Sender's Comments: US-009507513-1801USA001046:
On May 3rd, severe joint pain started to my fingers and feet, the pain was getting worse and extended to my knees and shoulders. Then I started not to be able to walk longer because of shortness of breath. My SPO2 dropped to 70 if I climb stairs. I got many blood tests, CT scans, X rays at hospital but they could not explain my condition. Finally I reached out at the hospital in December, 2021, and finally, on February 4th, 2022, they diagnosed me for intravascular lymphoma (stage 4). My doctors think my illness is connected to the vaccine.
Immediate onset of uncontrollable chills and fever of 100.8.  Muscle aches and major malaise.  Later chills/hot flashes occurred.
No Adverse event; Extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022 at 6:18 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Dec-2022 at 6:18 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medications were reported.  Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.   No treatment drugs were reported.  This case contains the information for 3 out of 13 elderly patient who received the vaccine as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-688372 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-688372:master case 1 of 13
Information has been received from a nurse concerning a 6 year old female with an allergy to amoxicillin who on 4/14/03 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 644571/1160M). There was no illness at the time of vaccination. Concomitant medications include cetirizine hydrochloride. The patient presented to the physician's office on 6/2/03 with a varicella break through described as 10 lesions. No other details were provided. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that on 6/29/03 the patient developed a varicella-like rash on her back and neck with approximately 16 lesions. The outcome was reported as recovered. The reporter also indicated that 2 other patients experienced breakthrough varicella. No further information is expected.
expired dose of ACTHIB that was administered, with no reported adverse event; Initial information was received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case a patient with unknown demographics who administered expired dose of HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Sep-2022, the patient received a dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (with unknown with unknown strength, dose, route, batch number, expiration date and administration site) for Immunization. Information on the batch number was requested.  On 27-Sep-2022 the patient administered expired dose of acthib with no reported adverse event (expired product administered) (latency: same day).  No lab data was reported.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.  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 the 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.
Information has been received from a pharmacy technician concerning a multiple unspecified patients (unknown ages and genders). The patients' pertinent medical history and concurrent conditions were not informed. It was reported that on multiple unspecified dates, the patients received improperly stored doses of GARDASIL 9 (lot # L037554, expiration date 25-DEC-2017, dosage and therapy route were not provided). Concomitant therapies were not informed. The temperature was 48F and the time frame 12 hours 20 minutes. There was no previous temperature excursion or call because of a data logger. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of two reports from the same source (MARRS#1609USA009609).
I had chest pains off and on for three days. It was an aching pain that had went through painfully from my chest, ribs and back. The pain was so bad I went to the ER. They performed testing I had to wait until my cardiologist came, and said things weren't any different from his last visit with me. He did not feel it was heart related. I feel better now it did take a couple of days. They do not know what caused this.
This study case was received from the investigator on 12 November 2012. A 28 year-old male subject with no significant past medical history was found to have Acute pericarditis, unspecified, 18 days after the subject had received the following vaccines on 05 July 2012: an injection of ACAM2000 (lot number, route and site of administration not reported), an injection of TYPHIM VI (lot number, route and site of administration not reported), and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory tests included an abnormal ECG on 11 July 2012 and a normal echocardiogram on 13 July 2012. Troponin I, MRI (brain, spinal cord and heart) and lumbar puncture results were not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
The cases were received on 21 March 2014 at agency. Initial misuse report received from a healthcare professional on 18 December 2013. A 9-month-old patient had received 0.5 ml of FLUZONE. It was an overdose. No adverse event was reported. List of documents held by sender: none.
A day after my shot I got my menstrual cycle 7 days early . I usually start on the 28th and my period lasted 2 weeks . My period was dark and thick . Not the usually pattern and it was abnormally long
Information has been received from a nurse referring to a patient of unknown age and gender. On 19-FEB-2016 the patient was inadvertently vaccinated with an expired dose of (Oka/Merck) PROQUAD (lot # K010211, expiration 17-JAN-2016, dose and route were not reported) (expired product administered). No adverse effects were reported. Additional information has been requested.
This report describes the occurrence of autism in a male child of unspecified age who was vaccinated with hep B vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received an unspecified number of Hib-Titer "in or about 1992 and 1993," diphtheria and tetanus toxoids and pertussis vaccine "in 1992 and 1993," and Tri-Immunol "in or about 1993." The subject's attorney alleged that "As a result of the mercury in the thimerosal-containing vaccinations received during these developmental years, the subject now suffers and in the future will continue to suffer, from the toxic neurological effects of his mercury poisoning, including but not limited to autism." The autism and mercury poisoning in this report are considered medically serious (OMIC).  Follow up on 12/08/03: "The most recent information, received on 11/21/03 did not provide the outcomes of the alleged events.  The autism and mercury poisoning in this report are considered to be medically serious by GSK."
Started with a temperature on Sautrday 7-26-03.  Was as high as 101 degrees. Fever broke on Monday 7-28-03.  Rash apperared on 7-30-03 on neck and chest that is described as tiny red dots and remains the same today 7-31-03.  chid is active today and tolerating fluids and food, but is having loose stools.  Mom is treating symptoms with Tylenol and Motrin.
Pt recvd vax & pt exp adverse effects following vax w/Hep B; No further details were provided;
Anxiety; Energy with 24 hour of extreme tired; Neck and shoulder pain for few hours; Neck and shoulder pain for few hours; Left arm tingling around wrist at times; Increased appetite; Weight gain; Two vaccines administered on the same day lot no EW0185, lot WW185; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left on 18May2021 at 01:00 PM (Batch/Lot Number: EW0185) and another dose via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot Number: WW185) both as a single dose for covid-19 immunization at Pharmacy or Drug Store.  Patient relevant medical history included fast heart rate, HBP (high blood pressure), low thyroid, and meneres. The concomitant medications included Atenolol 25mg, fish oil (OMEGA 3), cetirizine hydrochloride (ZYRTEC), colecalciferol, menadione (VITAMIN K+D) all received within 2 weeks of vaccination. The 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, the patient has not been tested for COVID-19. The patient previously took cefdinir and had allergy. Patient had known allergies to penicillin and Steroids. On 18May2021, the patient experienced anxiety, energy with 24 hour of extreme tired, neck and shoulder pain for few hours, left arm tingling around wrist at times. Weeks after anxiety and increased appetite and weight gain. Patient was administered with two vaccines on the same day (lot no: EW0185 and WW185). Patient received no treatment for the reported events. The events were considered as non-serious. The outcome of event for neck and shoulder pain for few hours was recovered and for the rest of events was unknown.
This spontaneous report as received from a nurse practitioner refers to a 6 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. No information on patient's concomitant medication was provided. On 19-DEC-2014, the patient was vaccinated with the dose of LIQUID PEDVAXHIB, lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). This is one of several reports from the same reporter. Additional information has been requested.
strep throat, T104, dx aseptic spinal meningitis-enlarged liver, MS-dx-suffers w/severe pain-dx fibromyalgia;
pimples started next day from elbow down to hand;no pain , no itch;still has pimples 3JUL96
PARENT PROVIDED WRONG BIRTH YEAR SO THAT CHILD COULD RECIEVE VACCINE. NO ADVERSE EVENTS REPORTED.
Patient came into emergency department with sudden shortness of breath, found to have bilateral pulmonary emboli.
Developed rash starting day after and continued to 2nd day. Rash is up and down arms and legs and on back; This is a spontaneous report from a contactable consumer, the patient. A 61-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 arm left on 01Apr2021 at 12:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included knee surgery. The patient had no known allergies. Concomitant medications included aspirin (MANUFACTURER UNKNOWN) twice daily, received after knee surgery. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 12:15 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 (day after vaccine), the patient experienced rash which continued to second day (03Apr2021). It was stated that the rash was up and down arms and legs and on back. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event rash was not recovered at the time of this report.   No follow-up attempts are needed; information about lot or batch number cannot be obtained.
STIFF NECK ON BODY SIDE OF SHOT BASE OF NECK, SMALL BRUISE AT INJECTION SITE, SHOULDER STIFFNESS ON SIDE OF SHOT.
2nd day after vaccine; shoulder in severe pain on same arm as injection; pain caused nausea, dizziness, and buckling over; woke up with pain that never went away; concentrated around past surgery site
headache; chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: headache) and chills (Verbatim: chills). The outcome of the headache and chills were resolved.   It was unknown if the reporter considered the headache and chills to be related to Shingrix.   It was unknown if the company considered the headache and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-OCT-2023 The reporter was the patient who received his Shingrix 6 months ago from the day of reporting.  He stated that after the dose, he had headache and chills which lasted 2-3 days. The reporter did not consent to follow-up.
Left arm from shot site to elbow very red, itchy, hot to touch and slightly swollen. Started day 8
Narrative:  Patient seen in ED 1-17-21 with c/c of "bloated with epigastric pain". Patient with complicated medical history including stage 1B pancreatic cancer (was currently on chemotherapy mFOLFIRINOX), and a leadless permanent pacemaker implantation on 1-11-21 for long episodes of SR with complete heart block following symptoms of syncope (other cardiac history: CAD s/p CABG 2009, PAF, and HTN). Regarding ER visit for epigastric pain, nothing notable was found on workup and patient was to discharge home to rest. There were available doses of COVID-19 Vaccine following a vaccine clinic that same day, and patient was offered and agreed to a dose of vaccine. Patient was monitored for 15 minutes post vaccine with no notable issues. The following day, Monday 1-18-21, patient's caregiver called facility at 22:30 to report he had a fever of 102.8 degrees and that he had been "feeling kind of bad all day". Patient was advise to seek urgent medical care and reported back to ED on 1-19-21 at 00:55. Patient wasd admitted for SIRS (tachycardia and febrile) -- patient also reported diffuse myalgia. WBC WNL, CXR unremarkable for infection, UA neg for bacteria, LFTs WNL, blood cultures negative. Procalcitonin elevated at 17.8 -- suggesting inflammatory response. Patient initially reported feeling better on the morning of 1-19-21, but around 13:00 began rapidly declining (confusion, unable to walk) and started experiencing EKG changes (9 beats of SVT). Patient then coded and resuscitation was attempted for approximately 30 minutes. Patient did not survive the code. Coroner has been notified and family is considering autopsy at time of this report.