chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 15-MAR-2021, the patient was vaccinated with one Hepatitis A Vaccine, Inactivated (VAQTA) (lot number T014589, which has been verified to be valid, the expiration date was reported and validated as 25-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: T014589; expirationdate: 25-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA001297:
Hiv.es  relentless itching burning. took benadryl 1  /2 pill partial relief. for 4 or 5 hours. after researching antihistamines I tried  zyrtec. i take 1/2 pill- 5mg relief lasts 48 hours. but if idont take another one itching returns after 48 hours. its been 3 weeks since hives first started.
32mins post vaccination pt reported chest tightness and tachycardia.  However, vitals showed the following: Vitals: 14:07 192/87, 50, 18, SpO2 98% -- > 14:09 178/83, 50, 17, 99% Recommended that pt f/u w/ healthcare provider.  Pt declined ambulance and left for the ED via private car @14:15.  In the ED:  57 y.o. female who has history of hypertension, and prediabetes presents to the ED for evaluation of generalized chest tightness.  Onset started at around 2 PM after patient was getting Moderna booster shot at 1:30 PM today.  Patient describes the chest pain as "tightness".  Patient did have similar reaction after the first Moderna shot. She denies trauma, fever, vomiting, sore throat, coughing, shortness of breath, difficulty breathing, abdominal pain, or uti symptoms.  No drooling or stridor.  Patient is alert, awake, and oriented x4. Physical examination unremarkable.  Patient does have marked bradycardia upon arrival to the emergency department.  Current heart rate is 48 bpm on the bed monitor.  We will continue to monitor.  Her lungs are clear bilaterally.  Abdomen soft and nontender.  No acute distress noted.   Patient complaining of frontal headache and nausea.  Tylenol, Reglan, and antihistamine given for symptom control.  BEFAST negative.  No neurological deficit.  Patient is not in acute distress. Laboratory workups unrevealing. No electrolytes or cardiac enzymes abnormalities. Of note patient had at presentation early in the year and she had a cardiac stress test which was negative for ischemia.  Cardiology recommended observation overnight.  This is likely bradycardia induced by vasovagal response in the setting of vaccine charts today and possible component of medication induced bradycardia (Pt may be on atenolol).  Pt was admitted and later found to have asymptomatic persistent Mobitz Type 2 Second degree 2:1 AV block with transient asymptomatic complete AV block in a patient whose initial presentation with dizziness post vaccination possibly related to vagally induced worsening heart block. Pt also found to have atypical non cardiac chest pain with recent coronary angiogram showing insignificant coronary artery disease and responding to PPI suggestive for reflux esophagitis.  Pt had a pacemaker placed 11/3/21 and was discharged 11/4.  Pt presented to the ED again on 11/6 c/o chest tenderness to palpation to the left breast region has been ongoing all day today.  Pain is most likely muscular skeletal in nature.  Pt discharged home.
blood pressure was taken before I had it was fine it was normal and now ever since I have taken it, ever since I have it is been high; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number was not reported), via an unspecified route of administration on 13Sep2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's blood pressure was taken before patient had it was fine it was normal and then ever since patient had taken it, ever since patient had it had been high in Sep2021. Patient just got the vaccine yesterday, the Pfizer vaccine. The patient underwent lab test and procedure of blood pressure measurement, and it was fine on unspecified date, and it was high on unspecified date in Sep2021. The outcome of event was unknown.  Follow-up attempts were completed. No further information was expected.
Injection site swelling, redness, warmth.  Entire body aching and muscle pain and weakness lower limbs.  Nurse hardly able to ambulate.  Nurse Called her physician X 2 and rested with resolution of symptoms.
Information has been received from a health professional concerning an adult male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). It was reported that the patient developed injection site reactions to include redness, warmth, swelling and pain. The patient was treated with antibiotics. Subsequently the patient was recovering. Unspecified medical attention was sought, No product quality complaint was involved. No other information was provided. Additional information has been requested.
MILD HEADACHE; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic headache, allergy with latex penicillin, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 vaccinated at right arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, Laboratory data included: Headache (NR: not provided) 2 (units unspecified). On 24-MAR-2021 20:00, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild headache. This report was non-serious.
Vaccination given in error.  Patient had already received fourth dose of Prevnar on 6/24/2010 at 15 months of age.
Dizziness, Headache, Fever & NauseaVomiting Narrative:  missed work following second dose due to symptoms
DEVELOPED FEVER GREATER THAN 102, JOINT PAIN AND EXTREME FATIGUE THAT LASTED 2 DAYS.
COVID-19 Vaccine: COVID-19; COVID-19 Vaccine: COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ2524) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "COVID-19", start date: Feb2021 (unspecified if ongoing), notes: all got COVID-19 at the same time in Feb2021. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Dec2022, outcome "unknown" and all described as "COVID-19 Vaccine: COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2022) Positive, notes: tested positive for COVID-19, he thinks on 29Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300011224 same patient, different product and event;
PATIENT COMPLAINED THAT 24 HOURS AFTER INJECTION, SOME SWELLING AND REDNESS OCCURRED AND SPREADED DOWN ON HER LEFT ARM. HER ARM WAS SORED AND FELT WARM TO THE TOUCH.
Patient has experienced NOCTURNAL ENURESIS for 2 evenings at this point. She received the vaccine on Monday (4/12), and it's Saturday (4/17) as I type this as it was reported to me.
Body rash, aches, fever, localized swelling, cotton mouth, swelling up to right side of neck. 3cm x 4cm area of induration on right upper deltoid area. Pain in area of vaccine.
Severe nausea and burning in stomach that has persisted since the day after I was vaccinated.
Infection at injection site, swelling, tender, hot, 2 1/2 inch diameter redness - Dr prescribed Doxycycline 100 mg BID for 10 days. Fluconazole 150 mg 1 now repeat in 7 days.
Severe irritability with fever X 48 hours. RSV + 2 days, post vaccines by NP wash.
Vaccine given beyond-use-date. Vaccine received in refrigerator on 01/11/2022 and kept in appropriate temperature (2-8 Celsius). Vaccine administered to patient 14 days past the 30-day time in refrigerator.
24hrs p/shot devel hives around the inj site rt leg;hives spreading to the entire body;MD rx DPH
Case number PHEH2014US016215, is an initial spontaneous report received from a pharmacist on 11 Aug 2014. This report refers to a 70 year old patient of unknown gender. The patient received FLUVIRIN, (batch number: unknown) 0.5 ml intramuscularly on 09 Aug 2014. The pharmacist reported that the patient received FLUVIRIN from either an unopened MDV or an opened MDV after it reached 74.3F for 4-6 hours on 08 Aug 2014. No adverse event was reported. No further information was provided.
Was given a flu mist on 10/10/06.  This was her very first flu shot.  Two days later, she travelled with her parents.  She started blowing her nose on the plane and upon arrival, her cold got really bad that her nose was constantly running and sneezing.  Mother gave her 5 mg of Singulair thinking she had allergy but it got worse.  Before she slept that night, mother gave her a dose of cold meds at around 8+ pm.  Around 2+ AM, woke up to go to the bathroom.  When she got back to her bed, she started shaking violently facing down on the bed with limbs going up and down.  Her eyes were rolled up and mother could hear her chest congestion and she was having a hard time breathing or seemed to be not breathing.  This lasted about 2 mins.  EMS was called and she was brought to the ER.  She was monitored and sent home after 5 hours.  A Cat Scan was done and result was normal.  6 days later, she and her parents flew back home.  That night, she woke up at 10+ and started walking around.  Mother took her back to her bed.  As she was going down to her bed, she suddenly had a fright and was all stiffen up and shaking and her eyes rolled back again.  This episode also lasted for 2 mins.  EMS was called and she was brought to the ER to be monitored.  A contrast Cat Scan was done and was normal.  All other tests done appeared normal.  She was sent home after 7 hours.  The following week, an EEG was done and was reported normal.  On both occasions of travelling, she did not have much sleep prior to the flight and during the flight.  She has travelled numerous times a year since an infant, and has never had seizures in her life before now.  The seizure happened after she was given a flu shot.
expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date 22-APR-2023) for prophylaxis.   On 01-MAY-2023, the patient received Boostrix. On 01-MAY-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 01-MAY-2023 The reporter was practice manager. The reporter reported that the patient received an expired dose of Boostrix at the time of reporting No symptoms were reported.  The vaccine administration facility was same as the primary reporter.  The healthcare professional (HCP) did not have any patient details.  The reporter consented to follow up via email. The patient received an expired dose of Boostrix, which led to expired vaccine used.
Fatigue; red rash; Diarrhea; aches and pains; cancer through the liver; This is a spontaneous report from a contactable consumer (patient's husband). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on 11Jun2021 18:27 (age at vaccination: 62 years) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route on 21May2021 as Dose 1, 0.3ml, SINGLE for COVID-19 immunisation. There were no prior vaccinations within 4 weeks. It was reported that the patient got the second shot on 11Jun2021. The patient experienced fatigue, diarrhea, rashes starting to form on her body that looked like prickly heat a red rash and bumps, aches and pains. On 20Jun2021, the patient experienced fatigue and diarrhea. On an unknown date in June2021, the patient had rashes starting to form on her body that looked like prickly heat a red rash and bumps, cancer through the liver, aches and pains. The patient was hospitalized for fatigue (fatigue) from an unknown date to 09Jul2021. The patient required emergency and physician's office visit. Therapeutic measures were taken as a result of fatigue, red rash and diarrhea. The patient was treated in the nursing home put her in rehab facility under prednisone 60mg for rash, unspecified treatment for fatigue and Mucilex for diarrhea. The patient was hospitalized for red rash from an unknown date to 09Jul2021. On 12Jul2021, the patient underwent biopsy but results were unknown on an unknown date, magnetic resonance imaging showed cancer through the liver. They are saying this is in relation to a malignancy in the body. They do not feel it has to do with what happen. It all came up within a week of getting shot. The outcome of the events hepatic cancer, aches and pain was unknown; fatigue, diarrhoea was not recovered, rash erythematous was recovering.  Information about lot and batch number was requested.
Fever, joint pain, muscle pain, sinus pain, injection site soreness, mild itchy rash
fever - shaking arm still bothers bothers me large (about 3" knot) & red & swollen & warm & throbbing sick to stomach  week later out break fever blisters & caucor sores lasted over a month
Pelvic pain, pressure, discomfort, frequent urge to urinate especially at night. Swollen, throbbing lymph node right armpit with shooting pains.
2:00 PM: Sudden onset of confusion, severe Headache, vomiting, diarrhea, inability toto stand or w/c transfer from chair to bed. Incontinent. Low grade fever - 6 days Headache - 5 days Muscle Aches - 5 days unrelenting Nauses - 7 days Vomiting - 4 days Protracted Diarrhea - 7 days
First dose / on 12/09/2020 / still did not receive second dose; Had a sore arm / after first dose; Had trouble sleeping for about 8 days after first dose; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, difficulty sleeping and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm and difficulty sleeping were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The age at vaccination was not applicable for this report for 2nd dose. The patient received Shingrix had sore arm and trouble sleeping for about 8 days. The patient still did not receive second dose, which led to incomplete course of vaccination. The reporter did not consent to follow up. The reporter was referred to the health care professional. Limited information obtained.
Rash on face; A spontaneous report was received from a consumer, concerning himself, a male patient of unspecified age, who received Moderna's COVID-19 vaccine and developed a rash on face.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number unknown) via unknown route for prophylaxis of COVID-19 infection.   On an unspecified date, after vaccination, the patient experienced rash on his face. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, rash on face was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
I recently tested positive for COVID-19, even though I am fully vaccinated; I recently tested positive for COVID-19, even though I am fully vaccinated; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I recently tested positive for COVID-19, even though I am fully vaccinated". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I recently tested positive for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm got very red and swollen, very painful. It was not at the injection site, it was further down probably 5 inches away from injection site. Oval shape red mark on the arm.
Chills began 8 days after 2nd vaccine.  With both vaccine did get headache, migraine, fatigue within the 1st few days.  Although, after 2nd vaccine on day 8 began chills and low grade fever, fatigue, nausea, and headache has continued.   Earlier in the week had a migraine.
This spontaneous report was received from a physician, via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 31-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", lot # L007720 with expiration date of 08-JUL-2016, (strength, dose and route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 192 hours, with a lowest recorded temperature of 1 F (also reported as 1 Celsius degree). There were also another excursions on unknown dates which lasted 96 and 24 hours with lowest recorded temperatures of -1 F (-1 Celsius degree) and 0 (0 Celsius degrees), respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases received from the same reporter. Additional information has been requested.
Cold Chills Sunday night. Fever during that night and woke up to be covered in sweat like my fever broke. Extreme tiredness all day yesterday. Joint pain down my entire left side. Headache completely around my head like no other. Fever again yesterday which broke a few hours later.  As of now at 7:08pm on the 13th of September, minor headache and just joint pain in left hip area.
Initial pregnancy report received from a healthcare professional on 10 June 2013. A 34-year-old female patient had received an intramuscular 0.5 ml dose of ADACEL vaccine (Lot number: U4612AA, dose number not reported) in right deltoid region on 10 June 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 07 November 2012. The estimated date of delivery was reported as 14 August 2013. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. At the time of this report, the patient had not experienced any adverse event. Documents held by sender: none.
Patient received COVID-19 Moderna 2 or 2 in series yesterday; then neck pain began next morning. Neck and back stiff and tender with doll ache severe at 10 out of 10 associated symptoms nausea headache fatigue and malaise chills.  Treatment includes 1000 mg of Tylenol every six hours PRN, nonpharmacological methods including heating pad, rest in adequate fluid intake, instructed to return to clinic if symptoms worsen or become stagnant, if not resolved in one week, obtain x-ray and refer to oncology for history of pleomorphic adenoma tumor in neck
after 1st dose of vaccine given in left arm, patient experience some arm soreness and noticed lump under her left armpit with some swelling to area.
Flu vaccine given at 8:30 am. client developed shortness of breath and back pain around 11 am.Took Advil for relief and soon developed lip swelling and itchy mouth. Went to local ER and was given Benadryl and ibuprofen.Sent home on Prenisone by mouth for 4 days.
Patient inadvertently received vaccine after published expiration date. Moderna analyzed batch/lot# 007B21A and indicated vaccine maintained activity necessary to protect against COVID-19 at time vaccine administered. Also patient did not call in to complain of adverse event.
About 5.5 hrs after Comirnaty & Fluad simultaneous injection, along with notable myalgias and malaise, a 6-10 second full visual field oblique, colored wavy lines perception occurred. It was present equally with one or the other eye closed, implying cortical event. It fully resolved and has not recurred.  2 days later a long scheduled annual bloodwork testing returned normal except for lowest platelet count seen down to 120,000.  Repeat blood work is scheduled in several months per routine testing. No excessive bleeding or other events occurred.  Presumably this was a very brief TIA?