chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant concerning a 4 year old male patient who on 09-MAY-2007 was vaccinated SC with a dose of Zostavax (Merck) (Lot #656412/1476F) instead of varicella virus vaccine (Merck). It was reported that there was no product confusion just a medical error. It was also noted that the patient received a previous dose of varicella virus vaccine (Merck) on 18-FEB-2004. No problems were reported. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2007. Additional information has been received from the certified medical assistant who stated that patient did not experience any adverse reaction. He was checked for couple of days. The patient did not have bumps or swelling. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 01Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; fluoxetine hydrochloride (PROZAC), (Batch/Lot number: unknown) at 20 mg. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: TOVIAZ, start date: 01Nov2020; ESTRADIOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 20Aug2023 to 24Aug2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a consumer refers her son, a 15 year old male patient. On 20-JAN-2013 the patient was vaccinated with GARDASIL dose 1, intramuscular for prophylaxis, the patient is foreign but he received the vaccine in another country. The reporter informed that the vaccine which was administered to the patient was stored under incorrectly temperature (not under refrigeration). Additional information is not expected, because the reporter refused to provide more details.
Pain at injection site; This is a spontaneous report from a non-contactable other hcp (patient). A 28-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jan2021 13:30 (Batch/Lot Number: unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown that the patient tested for COVID-19. The patient experienced pain at injection site on an unspecified date in Jan2021. The seriousness of the event was reported as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
pt recv vax SEP97 & pt devel GBS 1mo p/vax;approx 14OCT97 pt exp rt leg weakness that progressed to profound rt leg weakness;sx persist as of the time of report 6NOV97;reportedly pt had no prior hx of GBS;
This spontaneous report was received from a medical assistant, refers to a 20 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 01-SEP-2016, the patient was inadvertently vaccinated with a dose of PROQUAD, lot # L016394, expiry date 08-NOV-2016, subcutaneously. No adverse effect reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further details provided. Additional information has been requested.
About two weeks and two days after I had the second vaccine, I felt a little chill  and had a very slight scratchy throat and a very slight cough on and off for about five days and I was wondering if what I had experienced was a delayed reaction to the vaccine even though it was two weeks and two days after I had received it?  I had associated the reaction to being ?better? than having a cold because when I get colds, it would start with a very bad sore throat and then would become a full-blown cold with very bad coughing and sometimes I would develop bronchitis. I thought that the reaction that I had was quite mild.
Pulmonary embolism in Right lung.  Subsequent finding was multiple blood clots throughout both lungs.  Gave blood 3 weeks after second Moderna injection, blood clotting would not allow a full donation (right arm).  Upon checking in to the ER for chest pain on April 17, blood clotting would not allow IV hook up in right arm.
Tender arm for a couple of days, then 2nd day after shot two fingers on right hand were extremely achy, felt arthritic.  About 5 days after shot began itchy rash on my stomach and back.  Rash and itchiness still continues and I'm currently at 2 weeks.  Started antihistamine two days ago and it's better but still there.
Moderna COVID 19 vaccine administered to 12 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID 19 vaccine administered to 12 year old) in a 12-year-old patient of an unknown 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID 19 vaccine administered to 12 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID 19 vaccine administered to 12 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.    Reporter did not allow further contact
Patient is a 61 y.o. female patient of MD with history of HTN, CAD, HFrEF, COPD who presented with dyspnea.   Acute Respiratory Failure w/Hypoxia - Resolved Multifactorial, including COVID, PNA, sepsis, AECOPD Initially required 4L NC, no baseline requirement CT Chest w/RUL infiltrate Aggressive pulmonary hygiene NIPPV ordered on admission for significant WOB Pulm/CC consulted Now stable on room air   Septic Shock - Resolved Present on admission: yes Etiology: PNA Criteria: tachycardia, tachypnea, fever, leukocytosis, source Evidence of end organ damage:  Initial lactic acid: 1.4 WBC 28, COVID + Resp PCR, Blood/sputum culture, urine AG, MRSA probe pending Given Rocephin/Azithro in ED Current antibiotic regimen: Rocephin Vasopressors/steroids: Levo off by 11/17   Covid-19 Virus Infection Date of onset of symptoms: 11/7 Symptoms present on admission: Cough, fever, malaise Date of covid positive test: 11/7 at MC Vaccination status: vaccinated, booster x2 Imaging: CT w/RUL infiltrate Oxygen requirements on admission: 4L Current oxygen requirements: Room air Medical therapy: Decadron, Cefepime and zithromax Consultants following: Pulm Special isolation end date: 11/18 Complete 10 day course of Decadron on discharge   AKI Likely pre-renal/ATN from shock vs COVID renal injury BUN/Cr 54/3.46, baseline WNL Limit nephrotoxins as able Monitor UOP, strict in/out Improving slowly; 2.54 on 11/17, 2.03 on 11/18 Monitor renal function  Elevated Troponin Asymptomatic, likely demand ischemia Initial trop 39 EKG w/o acute ischemic changes Monitor on tele Negative trend; no further cardiac work up at this time   COPD, w/acute exacerbation Secondary to COVID, PNA Scheduled MDI, tiotropium, Symbicort Steroids, abx as above Aggressive pulmonary hygiene Advair on discharge (based on coverage)   T2DM, non-insulin dependent Chronic, controlled BG 133, A1c 6.7 Home oral agents held on admission Accuchecks and SSI ordered Due to worsening, changed to insulin drip Now with low sugars so changing back to basal bolus insulin Resume home agents on discharge   HFrEF, w/o acute exacerbation NICM s/p dual chamber AICD placement Stable, clinically euvolemic  ECHO 2010: EF 45-50% Holding GDMT given shock Echo with EF 41%, mild MVR and TVR   Obesity BMI 33.01 Weight loss, lifestyle modification encouraged   Tobacco Use Disorder Smokes 1/2 PPD >3 minutes spent counseling cessation NRT while hospitalized
36 hours post administration, had irritability, drowsiness and diarrhea; 36 hours post administration, had irritability, drowsiness and diarrhea; 36 hours post administration, had irritability, drowsiness and diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 9-month-old male patient received BNT162b2 (BNT162B2), on 26Jun2022 at 15:45 as dose 1, single (Lot number: FT9142) at the age of 9 months intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious), IRRITABILITY (non-serious), SOMNOLENCE (non-serious) all with onset 28Jun2022 at 09:30, outcome "recovering" and all described as "36 hours post administration, had irritability, drowsiness and diarrhea". Therapeutic measures were not taken as a result of diarrhoea, irritability, somnolence.  Additional information: No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination, no covid tested post vaccination, no known allergies and no other medical history.
shingles (herpes zoster); Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. In or around April 2018, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster was considered to be disabling.
Clinet reported that about an hour after receiving the vaccine she had chills and body aches and after about 5 hours she noticed a rash to upper thighs.
I had retinal hemorrhage in my left eye. I had no vision in that eye because of the blood covering my retina. I went to the eye doctor in July of 2021. Four months in a row, they did an injection in my eye. They did surgery on my eye but they could not remove all the blood. So, my vision in my left eye will not come back.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN PULMONARY EMBOLISM, UNSPECIFIED.
she had trouble raising my arm, had to make a big effort to raise my arm; She had also trouble swallowing her vitamins; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she had trouble raising my arm, had to make a big effort to raise my arm) and DYSPHAGIA (She had also trouble swallowing her vitamins) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (she had trouble raising my arm, had to make a big effort to raise my arm). On 29-Jan-2021, the patient experienced DYSPHAGIA (She had also trouble swallowing her vitamins). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (she had trouble raising my arm, had to make a big effort to raise my arm) was resolving and DYSPHAGIA (She had also trouble swallowing her vitamins) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant medications included vitamins A, B, C, D.  Patient put ice on arm.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up information received on 05-JUL-2021 and contains non significant information. Race information added.
SEVERE DIARRHEA AND VOMITING X 7 DAYS AND HASN'T STOPPED. HAD TO BE HOSPITALIZED FOR DEHYDRATION AND THEN AGAIN SEEN IN THE ER FOR DEHYDRATION.
several hrs p/shot was given, inject site became hot, raised, red, tender to touch; area was approx 12 cm in diameter per mom; mom applied ice;
I discovered through  a CT scan at the end of April that I have many lump nodules and finally learned that I had nodules in my lungs that was reactive with the none reactive ones with no known cause and now I am  just waiting to see if they will go away on its own.
Redness on neck, tightness in throat, 25 mg diphenhydramine PO, 20 mg pepcid PO, 50 mg diphenhydramine IM
Sudden fatal heart attack. Patient went from a medically well person of 69 and died suddenly of PES within 2 weeks of dose. Patient reported arm pain, fatigue, and coldness to extremities
Severe dizziness, sweating, vomiting upon waking. Symptoms lasted 36 hours- treated w OTC meclizine.
Product temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Non-significant follow up received on 15-Nov-2021, Contact information updated.
arms start swelling was red, and right below the reaction site and very sore; arm was red right below the reaction site; arms start swelling right below the reaction site; arm was very sore right below the reaction site; Hard time sleep due to every time she rolled over it hurt; Initial information received on 16-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves female patient of an unknown age who experienced arms start swelling was red, and right below the reaction site and very sore (inflammation), (erythema), (swelling), (pain in extremity) and hard time sleep due to every time she rolled over it hurt (sleep disorder), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION 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 in morning at 11:30 AM, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ245AA via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious arms start swelling was red, and right below the reaction site and very sore (inflammation), (erythema), (swelling), (pain in extremity) and hard time sleep due to every time she rolled over it hurt (sleep disorder) on same day by that afternoon following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was hard time sleep due to every time she rolled over it hurt and arms start swelling was red, and right below the reaction site and very sore.  It was not reported if the patient received a corrective treatment.  The patient was Recovering from inflammation, erythema, swelling and outcome of the other events was unknown.  Documents held by sender: none.
I had flu like symptoms, slight fever, body aches, felt clammy. My symptom persisted for about 3 days.
Pt. felt numbness on the arm of injection when got home and wasn't relief until next day. The sensation comes on and off sporadically since the day of vaccination. No treatment so far.
Vaccine Friday PM, rash started Saturday PM. No previous allergic reaction to medication, insects, food. Had headache Sat/Sun, took aspirin but no other medication since. Moved into dorm room Saturday but everything same as previous. (Today is Wedsnesday, Day 5).
contracting covid post 1st dose of the Pfizer Covid vaccine; contracting covid post 1st dose of the Pfizer Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 34-year-old male patient received bnt162b2 (BNT162B2), administration date 23Aug2021 (Batch/Lot number: unknown) as dose 1, single 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) all with onset 2021, outcome "unknown" and all described as "contracting covid post 1st dose of the Pfizer Covid vaccine". Therapeutic measures were taken as a result of covid-19. Additional information: The reporter was looking for information about dosing a 34-year-old patient who acquired COVID-19 after the 1st dose of the Pfizer Covid vaccine on 23Aug2021 and received Regeneron treatment. The reporter stated how long could he wait between the first and second dose of the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) in 2021, and contracted COVID-19 on an unspecified date in 2021. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.
side effects; 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 VACCINATION COMPLICATION (side effects) 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 VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Treatment information not provided.
No adverse effects. Vaccine re-dose was administered at 32 days rather than at 60 days like it is supposed to be
itching; small bumps like mild hives on the lower back and at the injection site in the left arm; small bumps like mild hives on the lower back and at the injection site in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), URTICARIA (small bumps like mild hives on the lower back and at the injection site in the left arm) and VACCINATION SITE URTICARIA (small bumps like mild hives on the lower back and at the injection site in the left arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PRURITUS (itching), URTICARIA (small bumps like mild hives on the lower back and at the injection site in the left arm) and VACCINATION SITE URTICARIA (small bumps like mild hives on the lower back and at the injection site in the left arm). At the time of the report, PRURITUS (itching), URTICARIA (small bumps like mild hives on the lower back and at the injection site in the left arm) and VACCINATION SITE URTICARIA (small bumps like mild hives on the lower back and at the injection site in the left arm) outcome was unknown. Not Provided          No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Red swollen leg area at site of injection, Rt thigh hardness felt at site, question of abscess, mother to apply warm compresses, antibiotic given. 2 1/2 x 2 1/2 cm septic looking at site area, appt scheduled for follow up with MD.
when checking out the patient fainted; was attended to by Dr after the incident and was placed in an exam room for about 30 min until she felt better
Patient experienced a headache that lasted for a few days prior to admission, relieved with ibuprofen. On 4/17/21, patient had two seizures at home and subsequently brought to the ER, started on levetiracetam. CT brain on admission showed dural venous sinus thrombosis, heparin drip initiated. Hypercoagulable workup was negative.
A physician reported that a female patient received an injection of TD Absorbed, and subsequently developed fatigue, chest pain, and an injection site reaction characterized by redness and swelling. She was seen in the emergency room, where cardiac enzym levels, complete blooe count, and lung scan were performed, the results were reportedly normal. As of 09-MAR-1999, the injection site reaction and chest pain abated; however, the fatigue persisted.