chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart attack; This case was reported by a consumer via call center representative and described the occurrence of heart attack in a 94-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2018, the patient received the 1st dose of Shingrix. In March 2018, between 1 and 3 months after receiving Shingrix, the patient experienced heart attack (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the heart attack was recovered/resolved.   The reporter considered the heart attack to be unrelated to Shingrix.  Additional details were provided as follows: The case was reported by the reporter for the mother. The age at the vaccination was not reported.  The patient had a heart attack in March 2018 and now was out of hospice and doing well.  Heart attack and hospice stay was not related to Shingrix. Till the time of the reporting, the patient did not receive the second dose of Shingrix because of heart attack. The reporter did not consent to follow-up
Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 9 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 9 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Foods" (unspecified if ongoing), notes: known allergies: Foods. The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101577003 same reporter/drug/event, different patient
From initial information received on 22Jun04 from a health care professional regarding an adverse event occurring it was reported that a two year old female pt received a dose of Diphtheria tetanus and acellular pertussis vaccine possibly administered on 13Apr01. Lot number, route and site of administration were not reported. Within 24 hrs of vaccination, the pt developed hives on her face and neck. The pt was seen in the ER on 16Apr04. Reportedly, the pt recovered from these events. From additional information received on 23Aug04 from a health care professional, it was reported, the immunization given to the pt on 13Apr01 was given at health dept. Reportedly the pt received TriHibit (Acthib, lot R1021) and Tripedia, lot U0299AA) administered IM in the deltoid. No further information reported. Further information will need to be obtained from the health dept. From additional information received on 03Sep04 from the health dept, the correct date of the ER visit was 14Apr01 and product and lot numbers confirmed. No other information is available. No additional information is anticipated this case is considered closed.
patient complained of dizziness after vaccination. AT 9:40 AM 02 was 92 at first and blood pressure 64/44. Patient sweating profusely , ice pack was applied and patient was advised to take deep breath and reassured patient. patient denied shortness of breath . re evaluation vital: BP102/70    02:99
Extreme headaches-came in waves-started one or two hours after injection. Woke me  up in the middle of the night. Also developed right ear pain, almost that it was closed.  Over the next few days had shortness of breath, got a cough that tiny bits of flim came up, fatigue, malaise, continued to feel worse, developed more chest pain, by Friday night September 3rd and unbearable right leg pain, in tears, icing multiple areas in my body. Also felt as though I could not think straight.  Called the doctor for an appointment. It was holiday weekend he saw me the following Tuesday.
Patient received pfizer 1 st dose at some other facility. She register online for 2nd dose appointment at this location thinking we offer pfizer. She instead received moderna
Patient woke up at 0200 with the room spinning, she felt dizzy, and nauseated. Was able to get into the rest room where she vomited.  Patient received meclizine and ondansetron in the ED. Neurology consult requested stroke/TIA work up.
On 6/6/01, the pt received her 3rd left deltoid adult dose of Engerix-B. On 6/7/01, the vaccinee experienced headache, stiff neck, dizziness, vomiting, chills and fatigue. All symptoms resolved except for fatigue and stiff neck. As of 6/8/01, the adverse events were resolving "slowly".
2x1cm from erythematous nodule of lt thigh that devel p/vax;is healing-no tx required;
Hospitalized 04/23/2022-04/26/2022; OCVID-19 positive 04/23/2022; fully vaccinated plus booster  Discharge Provider: DO  Primary Care Provider at Discharge:  Admission Date: 4/23/2022 Discharge Date: 04/26/2022 Discharge disposition: Home Condition on discharge: Stable DETAILS OF HOSPITAL STAY:   AKI (acute kidney injury) (HCC) [N17.9] Pneumonia due to COVID-19 virus [U07.1, J12.82]   ADMISSION AND DISCHARGE DIAGNOSES:  HOSPITAL COURSE:   COVID-19 pneumonia CXR shows subtle patchy airspace disease at the lung bases laterally. This is nonspecific but is compatible with Covid 19 pneumonia.  COVID-19 PCR was positive Cont. Decadron , Rx for 3 more days, pt did well and on room air quickly, do not feel need full course of Decadron considering onset of symptoms is less than 10 days ago  Supportive care    AKI on CKD stage 3. Resolved  History of renal cancer status post left nephrectomy Creatinine is 2.33 on admit  Creatinine was 1.74 on 10/20       Lab Results Component Value Date   CREATININE 1.74 (H) 04/26/2022   CREATININE 1.64 (H) 11/01/2017   CREATININE 1.60 (H) 11/01/2017     Coronary artery disease Hyperlipidemia Will continue aspirin and statin   Hypertension Cont. losartan and hydrochlorothiazide  Will continue amlodipine   Right lower extremity edema US negative for DVT      USV Venous Lower Extremity Duplex Right Final Result   There is no deep venous thrombosis in the visualized deep veins of the right lower extremity.   *   DR CHEST 2 VIEWS FRONTAL AND LATERAL Final Result   There is subtle patchy airspace disease at the lung bases laterally. This is nonspecific but is compatible with Covid 19 pneumonia.   The cardiac silhouette is within normal limits. No pneumothorax or significant pleural effusion. No other change.             Physical exam on discharge:   BP 152/74  | Pulse 50  | Temp 36.6 °C (Oral)  | Resp 16  | Ht 1.778 m  | Wt 102.3 kg  | SpO2 97%  | BMI 32.36 kg/m²  Physical Exam   Alert  No distress Non toxic appearing  No scleral lesions  Oral mucosa moist  Neck supple  RRR No respiratory distress.  No wheezing Abdomen soft  No lower extremity edema No gross neuro deficits appreciated  Skin is warm, no diaphoresis  Affect normal. Calm. No agitation     I spent 35 minutes performing this hospital discharge.   I have reviewed the instructions with the patient and/or surrogate decision maker, answering all questions to his satisfaction. Patient verbalized understanding.
Pt states within seconds of receiving flu shot, she felt flushed, dizziness and nausea. Had one prior flu shot few years before with no problem. Since then states health has deteriorated. Has intermittent episodes of a variety of ? Fibromyalgia, headache, wt. loss (50 lbs.), memory loss, blurred vision, jerking facial muscles and other muscles. Has seen MD with no particular diagnosis other than the flu and fibromyalgia. Was hospitalized in March 2003 for 7 1/2 days with dehydration and fatigue. Believes her health problems  began after receiving flu shot and was healthy before.
pt given vax 20OCT 1 day later fever of 103-persistent irritability x 4 days;
Within two hours of administration, burning sensation felt in roof of mouth, left side only. Within 12 hours, pain felt on left side of head from top of forehead along side of face down to halfway down throat, left side only, including but not limited to shots of pain in ear, back of tongue, jaw. Severe pain upon movement of tongue from side to side or extension. Pain continued for two weeks. Additionally, soreness at site of vaccination for approximately four days.
?Moderna COVID-19 Vaccine EUA Severe Flu-Like symptoms. Bed ridden for two days. So bad that I took an at home rapid test which proved negative.
woke next morning feelin off then fever took Tylenol fever still increased went to bed and felt my hear in A-Fib.  I took a fast acting metoprolol tartare went to a clinic for exam had an EKG performed went home and after 3 hours was back in normal rhythm. I no longer have A-Fib but now 3 days later still am experience lightheadedness and dizziness and occasional nausea.
Patient presented to ED after sustained VT at home with ICD shock. EMS gave him diltiazem upon seeing the rhythm, and due to the resulting hypotension he was observed inpatient post amiodarone IV load.  Switched to oral; seen by EP and joint decision to defer invasive re-evaluation in favor of amiodarone load and f/u with his ongoing outpt EP.
I woke up the morning after dose #1 unable to see out of my right eye. It was tho someone had placed a large amount of vaseline in my right ee. My left eye was blurred and extremely sensitive to light. The right eye began to clear up but took many days. Opthamalogist appoint was made.  Now seeing a Retinal specialist. Vitreous Hemmorhage in the right eye and an Aneurysm sitting on the optic nerve in the left eye.
INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; This spontaneous report received from a pharmacist concerned a 17 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced inappropriate age at vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inappropriate age at vaccine administration was not reported. This report was non-serious.
Asthma like symptoms - wheezing when laying down - throat itching, eyes red and face slightly puffy, slight rash on abdomen.
high fever, swollen inj site, redness of inj site Per follow up report-Autistic like syndrome. Pervasive developmental delay. Evaluation and rehab are in progress.
Tingling in the arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling in the arm). At the time of the report, PARAESTHESIA (Tingling in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided
Tinnitus in both ears, migraine, both unresolved.  Extreme irritability with 1st dose, not as bad with second.
I received the first covid-19 Pfizer vaccine after being encouraged by my obgyn on 8/4/2021. Up until this point I had a normal pregnancy with an EDD January 19, 2022. I was 16 weeks pregnant when I received my first dose of the vaccine. At my anatomy ultrasound at 18 weeks on 8/19/2021 my baby had no fetal heart tones and edema around her head and abdomen. Fetal femur length was consistent with 16 weeks. I underwent a dilation and evacuation. My baby was sent for genetic testing and found to have no abnormalities. Consequently I was worked up for a multitude of disorders, all came back negative.
Covid + on 10/26/2021. Received Pfizer vaccine with 1st dose on 02/10/2021 and 2nd dose on 03/04/2021.  Per ED Note:  This is a 78-year-old male past medical history of CKD on dialysis, diabetes, hypertension, chronic anemia is presenting to the emergency department today with generalized weakness that has been progressively worsening over the last several weeks.  He is also complaining of right lower extremity pain.  Apparently he is supposed to have a stent placed at the end of this week by some of his providers at Hospital.  He indicates that he has noticed that the smell has been progressively worsening.  His wife is also drawn a line around some redness that has started extending itself up the patient's leg.  Otherwise, his wife states that she has been having difficulty taking care of him at home because he has been having difficulties ambulating because of not only the pain but the weakness diffusely.  She has had to call the ambulance on multiple occasions throughout the week because she is been unable to get him up off of the toilet.  Otherwise, the patient denies any fevers, chills, shortness of breath, chest pain, diarrhea  ED course:   This is a 78-year-old male presented to the emergency room today with complaints of generalized weakness.  His wife also states that he has had multiple falls over the last several weeks we will obtain a head CT as well as basic labs.  Will obtain blood cultures and start the patient on IV antibiotics as apparently the patient has been on antibiotics for the last 2 weeks.  We will plan for admission and evaluate to ensure that there is no sign of osteomyelitis or gas gangrene of his right foot.  Patient is Covid positive, he is agreeable to be transferred to our Hospital Center if a bed opens.  Will admit him to the emergency department initially.  Either way if the bed opens up the patient will be admitted.  I did speak to the on-call attending here at emergency department who is agreeable and would like infectious disease nephrology and podiatry consulted.  A bed did open up at hospital, patient is agreeable to transfer, an ambulance is called.  Final Impression:
Pt received shot, went home, within 1 hour of having shot he felt extremely high.  The feeling escalated quickly, lasted about a 1/2 hour, and then subsided.   He described his symptoms as feeling paralyzed, as he couldn't move, even to reach his phone to call for help, but his mind was alert.  He felt tired and achy and slept for 3 hours.
Patient reported sudden onset of muscle spasms to her left neck and trapezius. Reports neck feels hot. Reported feeling lightheaded.
Pt received 0.5ml of FLUZONE vaccine instead of 0.25ml on 10/18/18.
Information has been received from a registered nurse concerning an adult female who was vaccinated with a dose of varicella virus vaccine live (Lot #636580/0098L). Subsequently the patient "did not show seroconversion when titered post vaccination". No other information was available. Unspecified medical attention was sought. There was no product quality complaint. The reporter indicated that one other patient "did not show seroconversion" (WAES #0312USA02727). Additional information has been requested.
Onset of symptoms appr 1 hour after vaccination. Bilateral urticarial rash on forearms.  Treated with Benadryl (PO) and topical hydrocortisone cream.
The same day of vaccination, high fever 39 and the next day reaction on the face (swelling and intense itching) 10 days two days of fever 39, 3 and greater reaction on the face.
NAUSEA, VOMITING, DIARRHEA, AND VESICULAR RASH
This spontaneous report was received from a certificated medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M009378 with expiration date of 23-APR-2018 and lot # M016193 with expiration date of 24-APR-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses with the lot # M009378 and expiration date of 23-APR-2018 and with the lot # M016193 and expiration date of 24-APR-2018, experienced a temperature excursion during 119 hours 30 minutes at a temperature between 32 degrees Fahrenheit and 35 degrees Fahrenheit (0 degrees Celsius and 1 degrees Celsius) (# cycles: 30) from 15-DEC-2016 to 13-JAN-2017, and a temperature excursion during 04 hours at a temperature between 32 degrees Fahrenheit and 35 degrees Fahrenheit (0 degrees Celsius and 1 degrees Celsius) (# cycles: 30) from 23-FEB-2017 to 24-MAR-2017. A data logger issue was involved. No previous temperature excursion and no adverse effects were reported. Additional information has been requested.; Sender's Comments: US-009507513-1704USA008690: US-009507513-1704USA008691:
Facility transfer resident to ER due to respiratory failure. Symptoms included decrease oxygen stats, difficulty breathing and chest pains. ER transferred to Hospital with diagnosis of myocardial infraction.  Admitted to ICU on telemetry.  Placed on 50% Bipap for Hypoxia.  Placed on IV Amiodarone and Ceftriaxone.  Resident was stabilized and discharged back to facility on 2/24/2021.
Received quadrivalent flu shot Mon. 11/13/2017. Woke up the next AM with shoulder and arm pain. Felt like a rotator cuff injury but I had not injured or lifted anything. I started on prednisone and saw my doctor who said it was SIRVA.
TYPHOID INJECTION 0.5ML GIVEN INTRAMUSCULAR IN RT DELTOID @ APPROX 1000HRS. APPROX 1100-1115HRS PT. EXPERIENCED STRONG THROBBING TO THE RT 2ND,3RD AND 4TH FINGERNAILS WITH MILD RT NECK PAIN
This case was reported by a healthcare professional and described the occurrence of crying in an infant of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Dtpa, manf unspecified) for prophylaxis. On an unspecified date before 19Sep05, the subject received a dose of Dtpa (dose number and lot number not provided). At an unspecified time after vaccination with Dtpa, the subject experienced crying. The crying resolved after seven hours. The vaccination course with Dtpa was discontinued.
Started with mild diarrhea which kept getting worse.  Eventually called doctor and he ordered stool culture and c difficile cultures to be done.  I took Cipro and eventually diarrhea stopped
Information has been received from a registered nurse concerning a 13 year old female patient who on 13-JUL-2007 was vaccinated with the first dose of GARDASIL, on 07-JAN-2009 was administered the second dose of GARDASIL and on 15-DEC-2009 received 2 doses of GARDASIL accidentally. According to the nurse the patient was not experiencing any known symptom. At the time of the report the patient's outcome was not specified. Follow up information has been received from the registered nurse who indicated that the patient was a 14 year old (previously reported as 13) student with disorder with speech delay who on 15-DEC-2009 was given her third dose of GARDASIL (Lot # 663454/0672Y) into her left deltoid at 17:25 PM and was given another dose of GARDASIL at the same time. Concomitant therapy included influenza virus A (antigen type unspecified) vaccine (H1N1). There were no illnesses at the time of vaccination. It was reported that the registered nurse and the physician notified immediately. No adverse reaction was noted other than pain at injection site on 16-DEC-2009 at 16:20PM. The patient recovered on 17-DEC-2009. No further information is available.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
The patient started vomiting about an hour after her second dose of Moderna.  She then got hives and took Benadryl.  Then she got short of breath and came to the ED.  She was in respiratory distress on arrival but not clear that this was asthma or anaphylaxis.  She was treated aggreassively with epi, solumedrol, albuterol, and epinephrine
An RN reported that an unidentified pt received Flu Shield (2001-2002 formula) (influenza virus vaccine, trivalent, types A & B/2001-2002 formula) and subsequently, developed an injection site reaction characterized by redness and swelling. This is 1 of 5 pts from this facility who experienced these events following receipt of (Flu Shield 2001-2002 formula) lot 4088052. One pt (not identified) developed an injection site reaction that measured 4 to 5 inches in diameter. No additional information was available as of the date of this report.
This spontaneous report as received from a nurse refers to a 16 year old patient of unknown gender. on 13-OCT-2014, the patient was inadvertently vaccinated with a dose of PROQUAD, 0.5 ml, subcutaneous (lot#, expiration date and strength not reported). No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of two reports received from the same source. Additional information has been requested.
?Covid arm?. Bright red softball size mark at injection site that lasted 7-10 days.
Two days after receiving the vaccine, it triggered acid reflux for me which was previously under control. Since getting the first vaccine, this symptom has not gone away. I have chronic burping, throat irritation, and a gurgling sensation in my throat.
Patient got Hiberix after expiration date; 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 12-month-old male patient who received Hib (Hiberix) (batch number J7CS5, expiry date 01-APR-2023) for prophylaxis.   In APR-2023, the patient received Hiberix. In APR-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Patient got Hiberix after expiration date). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-APR-2023. On 21 April 2023, health care professional reported that a 12 months old male baby received Hiberix vaccine after the expiration date with lot number J7CS5, expiration date 1 April 2023. The approximated administration date of the vaccines was 8 April 2023 but health care professional was not sure about it. The reporter reported that suspect vaccine start date was 2 weeks after expiration date, The reporter consented to follow up. The patient was administered an expired dose of Hiberix, which led to expired vaccine used.
LEFT ANTERIOR THIGH SKIN SWOLLEN, ERYTHEMATOUS, WITH BLISTERS THAT VANISHED AFTER 24 HOURS, NO TENDERNESS, INCREASED LOCAL TEMPERATURE, SALMON PINK ELEVATED BORDERS THAT VANISH, NO MASSES PALPABLE, REDNESS BLANCHES, CENTER LASTS UP TO 2 SECONDS TO GET COLOR AGAIN. aREA OF 3 X 3 INCHES. 1 cm ROUND PALE AREA AROUND NEEDLE ENTRANCE SITE WITH NO DISCHARGE. THIS WAS THE VZV SHOT SITE.