chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PALLOR, REPORTS OF UNEASINESS, FEELINGS OF SYNCOPE - DID NOT LOSE CONSCIOUSNESS, BLOOD PRESSURE 116/73mmHg BPM 64.  HAD PATIENT LIE ON SIDE ON FLOOR FOR 10 MINUTES THEN SIT UPRIGHT FOR 5 MINUTES.  PATIENT RECOVERED AFTER 15 MINUTES.
prolonged crying-high pitched w/o comforting for approx 1 1/2hrs;
Hives flare up began once initial side effects faded (pains in back, throat, fatigue.) Hives lasted until next dose. CIU was well-controlled with a single allegra everyday for 12 years. No flare ups in 12 years until Covid vaccine. Upon receiving 2nd dose on May 13, 2021, hives flare up worsed greatly. Increased antihistamines but did not resolve. Went dermatologist on July 21, 2021. Began prednisone and received steroid cream which helped greatly. After prednisone wore off, hives are back daily. Flare up again on Sep. 5, 2021. On prednisone again, not as effective.
mom reports had high pitched cry for 5 hr same day as shots; also t103 & 104 w/APAP; called ER-not seen @ ER; talked w/mom on 20APR95 & states is fine now;
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VAQTA lot # L015460 for prophylaxis.    Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage. No adverse effect was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. Additional information has been requested. Sender's Comments: US-009507513-1708USA005191.
started with a red rash on and around injection site about 12 hours after injection.  Over the next two days she developed clear fluid filled pustules over her trunk and arms.  Patient reports that they resemble chicken pox.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 5 (booster), single (Lot number: GJ6742) at the age of 51 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), on 24Mar2021 as dose 2, single (Lot number: EP6955), on 18Oct2021 as dose 3 (booster), single (Lot number: 320308D) and on 14Apr2022 as dose 4 (booster), single (Lot number: FL3197) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient received Paxlovid for treatment of COVID-19 from 20Oct2023 to 24Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350598 Same reporter/patient, different drug/events;
pt recvd vax APR93 & w/in 72 hrs of vax pt devel urticaria & a fever;
Pt had a positive COVID test 6/13/22; was hospitalized for COVID infection; dc'd to home; began to have worsening SOB, syncope; back to the hospital; admitted with severe sepsis secondary to bilateral pneumonia; IV steroids and ABX; required mechanical ventilation; failed attempts to wean off mechanical ventilation; tracheostomy created; bradyarrhythmia; poor prognosis; pt's condition declined; family transitioned pt to DNR but continued on full therapeutic regimen; pt's condition deteriorated; worsening respiratory failure; PEA arrest; pt passed away in the hospital
This case was reproted by a consumer and described the occurrence of loss of appetite in an adult male subject who was vaccinated with TWINRIX, (GlaxoSmithKline) as part of a program to cure Hepatitis C. A physician or health care professional has not verified this report. Concurrent medical conditions included Hepatitis C. On an unspecified date, the subject received an unspecified dose of TWINRIX (unknown route and injection site, batch number not provided) to cure Hepatitis C. At an unspecified time after vaccination with TWINRIX, the subject experienced loss of appetite. At the time of reporting, the outcome of the event was unspecified. The reporter would not provide any additional information about this case. Case was closed. The reporter also reported his own case of appetite loss after vaccination with TWINRIX (see case A1079811A).
This case was reported by a pharmacist via call center representative and described the occurrence of general malaise in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patients experienced general malaise. On an unknown date, the outcome of the general malaise was recovered/resolved. It was unknown if the reporter considered the general malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that she had many reports of general malaise for 1-2 days after receiving initial dose of SHINGRIX.
lost their babies; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "lost their babies".  Clinical course: The Reporter stated that he is reporting that the Pfizer COVID 19 Vaccine is causing cancer to everyone. The Reporter mentioned there were four girls who got the vaccine, and three of them lost their babies. The Reporter also mentioned that one of his friends took the shot and had a massive heart attack. They also recently found out they have stage 4 cancer of the prostate. The Reporter also mentioned that (withheld), after getting the shot, had COVID twice already. The Reporter also mentioned that a boy got the vaccine and died afterwards. The Reporter states that Pfizer did not put out much, but according to Pfizer's own numbers they killed 110,000 plus people. Reporter states that he has not seen a bottle or label for Comirnaty, but over special weekend it went Bivalent. Reporter says that instead of putting 2 in front of it, they used Bivalent. Most people don't know what the word Bivalent means. Reporter says they say it is for two different variants, but it is not, it is for 5 different variants. Reporter states that bivalent means double the dose and basically Pfizer doubled the dose over special weekend, and then (withheld) started.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11.5 CM x 18 CM reaction site. Red, swollen, and itchy. Reaction began shortly after administration and has worsened over the past two days. Course of treatment includes Ibuprofen, benadryl, and ice packs on reaction site PRN.
Very tired, became lethargic when woken up, the started running fevers of 102 and vomiting.
Expired vaccine was kept in refrigerator a week before administration; No adverse event; Vaccine expired on 20-May-2022 was administered on 16-Jun-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022 was administered on 16-Jun-2022), PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator a week before administration) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022 was administered on 16-Jun-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator a week before administration) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022 was administered on 16-Jun-2022), PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator a week before administration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022 was administered on 16-Jun-2022) and PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator a week before administration).    Concomitant drugs were not reported. The patient received first booster dose. The patients had not reported any adverse reactions. Number of doses/vials were 7 doses/1 vial. It was reported that the reporter did not know when the vial was initially stored but states that vaccines were usually put in refrigerator a week before administration.  The vial did not undergo any temperature excursion. Treatment medications were not provided.
Severe injection site reaction noticed the morning after vaccine received- approximately 2 in. diameter red, hard induration, hot to touch. Diffuse pink, warm rash on entire upper left arm. Improvement in symptoms over the next 48 hours. Patient reported to pharmacy to alert pharmacist of the reaction on 11/28/16 at approximately 8 pm.
The medical records indicate that the pt," has some diffuse facial erythema and edema, no conj injection, mouth and throat normal. Minimal redness, tenderness and swelling at the site of the yellow fever shot right upper arm, the rabies and hep sites look okay. The PPD is nonreactive." She was prescribed with benadryl, hydrocortisone.
Pt had 1) fever x 3 days, 2) itchy, arm bright red & white bump x 2 wks, a couple days later had on both arms, both legs, & feet, & 3) stomach ache pain can't eat & felt like vomiting & dizzy.
3 days post-vax the patient developed a red and sore arm, anorexia, chills, a possible fever, fatigue and a headache. The patient had these symptoms 4-5 days. The patient's headache was severe enough to use medication every 2-4 hours.
TIRED; This spontaneous report received from a male patient of unspecified age, race and ethnicity.  The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On an unspecified date, the patient was tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious. This case, involving the same patient is linked to 20211246124.
Headache, eyes hurt, ears ringing, body aches, cold shivering and night sweats and night. Couldn?t sleep at all first night. Symptoms lasted four days.
Extreme headache which kept increasing. Cough, leading over made it worse Tylenol 650 mg x's 2, Fioricet, Tylenol w Codeine 5 mg taken over 7 hours with no relief ER visit with Demerol IM given.
A report has been received from a Health Professional vai Medical Rep. concerning a 15 year old , Female subject, who had been receiving  FLUMIST (INTRANASAL), 0.2ml, 1/2 in one nostril and the other 1/2 in the other nostril. The patient experienced TESTED POSITIVE FOR THE FLU TYPE B(Preferred Term:Influenza B virus test positive) which started on 04-Jan-2016.  The outcome of the event of TESTED POSITIVE FOR THE FLU TYPE B is unknown. The report was considered to be non-serious.
3-4 hours after taking the 3rd oral typhoid vaccine dose patient experienced itching and a rash around her neck. Rash and itching improved.  Patient took final dose 4 of oral typhoid vaccine on 4.26.10 and within 1 hour had same rash with worse symptoms.
This non-serious spontaneous consumer report (initial receipt 08-Dec-2014) concerns a 4 year-old male patient who previously received and tolerated seasonal influenza vaccine in the past 9se3e 2014047486) and was not taking any other medications, vitamins or herbal supplements. He did not receive any other immunisations in the last 3 months. On 17-Nov-2014, the patient inadvertently received intramuscular AFLURIA vaccine (batch number not provided pre-filled syringe) once, for the protection against seasonal influenza virus. On 21-Nov-2014, the patient experienced a fever of 102 Fahrenheit which lasted for one or two days. The reporter consulted a healthcare provider who informed that it was not likely due to receiving the vaccine. Antipyretic treatment was not administered. Outcome was reported as recovered.
ended up having some issues with his heart; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISCOMFORT (ended up having some issues with his heart) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, 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 experienced CARDIAC DISCOMFORT (ended up having some issues with his heart). At the time of the report, CARDIAC DISCOMFORT (ended up having some issues with his heart) outcome was unknown.            No concomitant medication were reported. Patient had been looking online to see if there were any reported side effects associated with the 2 lot numbers of vaccine had received. He received 2 doses of the Moderna COVID-19 vaccine in August 2021 and September 2021 (lot numbers and expiration dates were unknown). Patient ended up having some issues with his heart.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Pt recv vax on 1/13/99; on 1/14/99 pt exp swollen/hot/ red rt leg (thigh); itchy vax site
Low grade fever; muscle aches; fatigue; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) as first dose for covid-19 immunisation. On an unspecified date, the patient experienced low grade fever, muscle aches and fatigue. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
w/in 7hr site of inj was swollen & reddish for next 12hr pt alternately screamed inconsolably & fell into a deep sleep, next day had diarrhea & tool longer to finish bottles, as day went by skin felt cold to touch;pt later died;constipation
Night of vax my daughter had night terrors every hour throughout the night. Each one involving violent kicking and crying and sitting up in bed but never waking. These continued for 8 nights consecutively but the terrors became more infrequent each night. She has never had night terrors before.
RASH ON FACE AND CHEST. DRAINAGE WAS NOT OBSERVED, SWOLLEN WAS NOT OBSERVED, VITAL SIGNS WERE NORMAL (SEE REFERENCES), STUDENT DENIES ITCHING OR PAIN. HIS MOTHER SAID THAT HE HAVE NOT HAVE ANY RESPIRATORY PROBLEMS, SWOLLEN, ITCHING OR PAIN. Vital Signs  Tympanic membrane temperature 97.8 F RR   18 breaths/min PR   88 bpm BP while sitting 90/70 mmHg Pain level (0-10)   0 Pain level (0-10) - (Re-assessment): 0
Noticed some increased joint pain in knees, shoulders with first dose of Covid19 vaccine.  After second Covid19 vaccine the joint pain increased & involved back & hips.  After booster Covid19 vaccine I have had even more joint pain in areas.  There are days when I rate the pain at a 10.  I take Aleve & Tramadol for normal knee pain for arthritis.  I have had at least 3-4 UTI's since the vaccines began.  Was treated with antibiotics
Mother reports approx. 24 hours after receiving vaccine child reported having SOB, and heart palpitations. Mother picked up child from school then took him to a walk in urgent care clinic and that clinic referred them to the ER due to child c/o SOB. Mother states child was only there approx. 1 hour with 30 minutes of oxygen no other testing was done and child felt fine & was d/c'd.
This spontaneous report refers to one or more of 8 to 10 patients of unknown gender and age. Information was received from the registered nurse. She stated that PROQUAD (Merck) lot # J001052, expiration date: 28-JUL-2014 was stored in refrigerator 36F to 46F up to the middle of August. Improperly stored PROQUAD (Merck) was administered to one or more of 8 to 10 patients on 12-AUG-2013. No symptoms were reported. This case is linked with MARRS # 1310USA000175 MARRS # 1308USA014956 and MARRS # 1310USA000175(Same reporter link). Additional information has been requested.
Case number PHEH2014US017251 is an initial spontaneous report received from the other health care profession on 26 Aug 2014. This report refers to an 18 years old male patient. He did not have any history of allergy to any vaccination, no history of nervous system disorders and severe illness after vaccination. His concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12102) intramuscularly on 22 Aug 2014. It was reported that immediately after vaccination he experienced ringing in ears, clammy skin, nausea and high blood pressure. The nurses and EMTs at the clinic elevated his feet and laid his head back. The vitals improved within 10 minutes. He was feeling much better and did not have any complaints for 25 minutes after the leg elevation and laying head back techniques. He was advised to rest before he left the clinic. He was on his feet and left the clinic approximately one hour after MENVEO vaccination. The final outcome of the events was reported as unknown. The seriousness and causality of the events were not reported.
Per mother client became fussy and developed nasal congestion at approx 0100. On 02/05/10. At approx 06:45 his mother used a bulb syringe and withdrew "large amounts of blood clots mixed with mucous" from child's naries. No s/s of active bleeding. Took child to daycare 02/04/2010. Child awake in am covered in fine rash. Mother called MD who ordered Benadryl. Rash resolved.
A report has been received from a Health Professional concerning a 19 months old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The reporter stated that they accidentally gave FLUMIST to a 19 month old patient on 17-Oct-2012 and the patient had not experienced any adverse events. The outcome of the event of ACCIDENTALLY GAVE FLUMIST TO 19 MONTH-OLD was unknown. The report was considered to be non-serious.
pt recv vax & 2hr later pt exp a h/a & chills & devel diarrhea;15FEB97 felt ill all day w/cont h/a , diarrhea & gen body aches;pt felt that event were coincidental w/onset of gastrointestinal flu;
pt recv vax & 10hr later pt exp hives on trunk & under breasts;hives were described as small, itchy blisters;tx w/DPH & pt recovered;
The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 23-MAY-2014 was vaccinated with (Oka/Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and does schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
DTP vax given 2PM;Inconsolable high pitched scream for 50min then cont to fuss off & on for 3-4hrs a/falling asleep
General fatigue; sleepiness; malaise; head fog; tightness and sensitivity to heat. Extreme tightness in neck/throat (dryness). Nausea and diarrhea (5 days). Dizziness (off & on). Shoulders muscles painful. Hard to use arms. 1st dose in right arm. 2nd in left arm 37 days later.
This case was reported by a physician and described the occurrence of Hepatitis B surface antigen positive in a subject of unspecified age and gender who was vaccinated with ENGERIX B. Concurrent medical conditions included dialysis. On an unspecified date the subject received unspecified dose of ENGERIX B. At an unspecified time after vaccination with ENGERIX B, the subject experienced Hepatitis B surface antigen positive. Relevant test results included Hepatitis B surface antigen positive. At the time of reporting the outcome of the event was unspecified.
Developed fever on evening following vaccinations followed by generalized rash all over body. Examined on 10/20/04: no treatment recommended.
The Pfizer (maroon cap) vaccine was administered to this patient who is 3 years old. However, the nurse used the incorrect volume of diluent to reconstitute the vaccine vial. 1.3ml of sodium chloride was used for reconstitution instead of the required 2.2mL for the maroon cap vaccine. The patient was given the vaccine and monitored during the observational phase. No adverse event was seen. Contacted Pfizer representative for more information regarding future vaccination schedule. Pfizer representative stated that the patient should just continue the vaccination schedule normally as indicated by the CDC guidelines.
Itchy throat and ear canals. Itchy red patches/hives on skin. Began approximately 24 hours after vaccine administration and continues now, approximately 48 hours after.
This spontaneous report as received from a licensed practical nurse refers to an approximately 5-week-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-NOV-2017, which was one day shy of the patient's 6 week recommended first dose schedule, the patient was vaccinated with a dose of ROTATEQ, orally, lot # N005618, expiration date 04-OCT-2018, for prophylaxis. No adverse effects were reported. The reporter stated that ROTATEQ did not undergo a temperature excursion.
Inadvertently given Pfizer Peds dose instead of Pfizer age 12 and older dose. Dose 2 will be Pfizer 12 and older.
This solicited report was received from the patient's mother concerning to her daughter of unknown age who was enrolled in a marketed research program. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the subject was vaccinated with the third dose of GARDASIL (lot #, expiration date, dose, frequency and route were not provided). On an unknown date, after vaccination with the third dose of GARDASIL, the patient got lightheaded and almost passed out. The outcome of the events and the causality between them and GARDASIL were unknown. Additional information is not expected as no contact details were provided.