chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax 2FEB95 & later in AM pt awoke & vomited several times;did not cry;unresponsive following episode;according to paramedics, event characterized as hypotonic-hyporesponsive episode;hosp 2 days;lab & x-rays nl;
Redness and swelling right upper arm and shoulder. Seen at office 4 days following vaccine. Treated with Medrol dose pack and Amoxil. Questionable early celluitis vs. immune system reaction to vaccine. No fever.
ActHIB lyophilized vaccine reconsituted with "sterile diluent" that they use for other vaccines, such as varicella, rather than the accompanying ActHIB diluent, no AE; Initial information received on 28-Apr-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 4 months old male patient who was vaccinated with 0.5 ml second dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number UJ135AB and expiration date 26-Feb-2021) lyophilized vaccine which was reconstituted with sterile diluent that they use for other vaccines, such as varicella, rather than the accompanying acthib diluent (lot U6477AA, expiration date 26-Nov-2020) on 27-Apr-2020 intramuscularly in the left thigh for prophylactic vaccination.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  t was an actual medication error case due to wrong solution used in drug reconstitution.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
A report has been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning a female patient who had been receiving FLUMIST (Intranasal). FLUMIST started on an unknown date. The patient received FLUMIST while she was pregnant, vomiting and diarrhea. The outcome of the event of pregnant patient received LAIV3, vomiting and diarrhea is unknown. The outcome of pregnancy was unknown. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the events of vomiting and diarrhea to be not related to the suspect drug FLUMIST. The company causality was implied to be no for the event of pregnant patient received LAIV3. The reporter's description of the event(s) was as follows: There was one report of nausea and vomiting after receiving QLAIV3 during pregnancy.
Patient presented on 12/20/04 with bruising and petechiae. Parents thought her symptoms had occurred for a least 1 week. She had a gastrointestinal virus (vomiting/diarrhea) per parental report 1.5 weeks before. She had thrombocytopenia (platelet count down to 8,000). Received MMR 11/5/04. 60 Day Follow Up: She has had normal platelet counts twice 1/25/05 and 2/25/05. Appears to have recovered.
Mother reported vomiting, screaming and red rash. Mother was advised by this nurse to call Pediatric office and/or take child to Emergency Dept.
This case was reported by a nurse via call center representative and described the occurrence of headache in a 60-year-old female patient who received Flu vaccine for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to Flu vaccine. Additional details were reported as follows: This case was reported by the patient who herself was the Nurse. The age at vaccination was not reported. In the past, the patient received flu vaccines and she normally gets headaches. The patient did not know the brand of the vaccine. The patient did not want to provide her address. The reporter told that, the representative could call her if needed. The reporter consented to follow up. This is 1 of the 2 cases reported by same reporter.
VZV given 09/24/2001. Shingles rash develop early December 2001. Seen 12/07/2001.
Chills followed by fever, rash and swollen glands in armpit near where shot given, back of neck.
8-9-10 Fever & rash saw Dr. 8-11-10. Had breathing treatments for wheezing Dr. referred patients mom to HD to report possible reaction to vaccines.
Pt recvd Hep B & shortly p/ began to c/o systemic pruritus & upon PE no sx of local rxn @ site of inject noted; Pt tx meds which failed to relieve pruritus; steroids relieved pruritus but d/c pruritus back;
Information has been received from a healthcare worker referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 23-NOV-2015 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot # K004281, expiration date 22-MAR-2015; strength, dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Patient answered yes on passing out on consent form.  When questioned, patient stated she frequently hyperventilates and passes out following vaccine. We made the decision to move forward with vaccine with additional monitoring. Upone being vaccinated, patient needed to vomit about 5 minutes after administration. Patient then appeared go into absence seizures every 15 or 20 seconds (aware of surroundings but unable respond to stimuli). Patient stated this had happened before at different times but was the first time after a vaccine. She stated that this stte usually lasted for an hour+ and doctors were trying to determine the cause. The patient was monitored for 30 minutes until her twin sister came and took her home to rest.
Vaccine excursion; This spontaneous report has been received from a medical assistant referring to a 5-year-old male patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 14-JUL-2022, a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin, rHA) (PROQUAD), experienced a temperature excursion and on an unknown date in 2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin, rHA) (PROQUAD), at the dose of 0,5 milliliter (ml), once, (lot number reported and validated as W016358, expiration date reported and validated as on 16-NOV-2023) (dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error).  This case is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA004135: US-009507513-2208USA003812: US-009507513-2208USA004011: US-009507513-2208USA004012: US-009507513-2208USA004255: US-009507513-2208USA004086: US-009507513-2208USA004105: US-009507513-2208USA004223: US-009507513-2208USA004255:
This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus/baby. This is a fetus/baby report. A 39-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 02Apr2021 11:00 (Batch/Lot Number: Ep7833) for COVID-19 immunization. Last Menstrual Date: 15Aug2020. Deliver due date was on 22May2021. Medical history included allergies Penicillin. Concomitant medication(s) included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP). The mother was hospitalized for delivered baby at 33 weeks 5 days on 08Apr2021 (premature baby) for 7 days. The mother reported she became pregnant while taking BNT162B2. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021514102 same report, mother/fetus case.; US-PFIZER INC-2021516155 same report, mother/fetus case.
body rash; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number and Expiry date: not provided), via unspecified route on 29Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. On 17Apr2021, the patient had body rash before getting the second dose on 19Apr2021. The outcome of the event was unknown.  No follow-up attempts were needed; information about lot/batch number cannot be obtained.
Client had a varicella vaccine on 10-20-17 that was recommended by her MD. States she had no Hx of chicken pox disease. 12-8-17 she called to report she was allergic to the vaccine. She had the reaction over the weekend of 10-21 or 10-22-17. Started as a sore throat. Then had some problems swallowing and a swollen tongue and swollen lymph nodes. Self-treated with BENADRYL. Went to the emergency room in November for the same symptoms. Got antibiotics and saw an ENT specialist who she stated advised her that her symptoms were from the varicella vaccine. She had a CT on 11/20/17. Then saw her primary MD on 11/29/17.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a adult male patient who received HAV (Havrix) (batch number 72T95, expiry date 9th August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd August 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 23rd August 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comments: The registered nurse called to report that patient received an expired Havrix vaccine which was expired on 9th August 2022. No more patient´s details provided. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Mother of the minor indicates left eye getting red and hot. Paramedics indicate of mother refusing to transfer patient to the hospital. She said she will keep him in observation.
Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of currently 76 year old. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. In 2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Herpes zoster and she was treated by a physician for the event. The outcome of the event herpes zoster was not reported. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Information has been received from an LPN concerning a 12 month old male with no past medical history who on 4/3/01 was vaccinated SC with a 1st dose in the right arm of varicella virus vaccine live (lot 636363/1337K), a 1st dose SC in the left arm of MMRII (lot 635921/1181K) and a 2nd dose IM in the right arm of Prevnar (lot 472050). Subsequently, on 4/14/01, the pt developed spots and hives. The pt was treated with diphenhydramine (Benadryl) and subsequently recovered from the spots and hives. Unspecified medical attention was sought. Additional information is not expected.
Developed hives approximately 3-4 hours after Hep A given. Resolved with BENADRYL. Seen in office 3/14 to evaluate. Hives continued to recur. Rapid Strep (+) however throat c/s (-) strep. Recheck in office 3/15 & Dx erythema multiforme by Dr, as well as hives. DECADRON 12 mg orally given. To take ZYRTEC q am, BENADRYL q pm & recheck in 2 days. Also on 3 days of ORAPRED -> pt improving with decreased rash & decreased edema 3/19.
Very sore arm (painful to move), Nausea, diarrhea, headache.
From last Saturday pt was fussy and crying a lot. Sunday night  pt had fever a little over 100 degrees. Over night very fussy, next day while bathing dad noticed redness and swelling of the right arm. He has been having high fevers (103-104). Due to fever, restlessness and arm swelling pt was taken to PCP. At PCP's office pt was diagnosed with cellulitis and was sent to clinic for further evaluation. In hospital swelling/erythema initially worsened despite being placed on ancef. Switched to clindamycin and patient's condition began to improve after 24 hours. Erythema localized to injection site, swelling persisted. Following 48hrs of clindamycin 10-15 small white pustules developed at site. Ultrasound showed no abcess but did show muscle irregularities suggestive of myositis. 5/26/09-records received-DX:MRSA wound infection at the site of vaccine. Infection localized no abscess with incision and drainage after developing erythema and was diagnosed with cellulitis.
Contracted pneumonia following administration of the vaccine.  Symptoms began about 10 days following injection.  Thought is was a cold at first.   Symptoms became worse in the following days.  Consulted a Urgent Care Clinic on April 21st.   Pneumonia was diagnosed at this visit by chest x-ray.  Consulted my regular doctor on April 22nd.  A second chest x-ray confirmed prior diagnosis.   Took prescription antibiotics for 10 days.  Symptoms of coughing, chest congestion, blowing nose, nasal congestion, and fatigue began to improve.  Still have some coughing and chest congestion today, May 20, 2019.
Information has been received from a nurse practitioner for GARDASIL, a Pregnancy Registry product, concerning a 24 years old female with no drug allergies and no pertinent medical history who on 06-NOV-2008 was vaccinated with the first dose of GARDASIL (lot number unknown). On 23-JAN-2009 the patient was vaccinated with the second dose of GARDASIL (lot number 661703/0651X). On 12-JUN-2009 the patient was vaccinated with the third dose of GARDASIL (lot number 661703/0651X). The patient became pregnant around the time of the 3rd dose GARDASIL. Pregnancy is normal to date. The patient's LMP was reported as 24-MAY-2009. The estimated delivered date would be on 28-FEB-2010. Follow-up information was received from the consumer via a completed outcome pregnancy questionnaire. It was reported that the patient did not have any previous pregnancies, pre-term deliveries, spontaneous abortions, elective terminations or fetal deaths. The estimated conception date was 11-MAY-2009. On 16-FEB-2010, the patient delivered a normal female baby with no congenital anomalies weighing 8 pounds, 7 ounces, length 20 inches. The patient had no complication and no infections or illnesses during pregnancy. It was reported that the baby was stuck, so the patient had to have a C-section. The patient had no concurrent medical conditions. Upon internal review, C-Section was determined to be an other important medical event. Subsequently, the baby experienced heart murmur. The baby's experience was captured in WAES#0907USA01322B1. Additional information has been requested.
A red lump and a rash on the injection site; Didn't had any fever, nor anything, just the rash and it's very itchy; Rash on the injection site; A bad rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (A red lump and a rash on the injection site), VACCINATION SITE RASH (Rash on the injection site), RASH PRURITIC (Didn't had any fever, nor anything, just the rash and it's very itchy) and RASH (A bad rash all over the body) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Hypertension and Osteoporosis. Concomitant products included LOSARTAN and HYDROCHLOROTHIAZID for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (A red lump and a rash on the injection site), VACCINATION SITE RASH (Rash on the injection site), RASH PRURITIC (Didn't had any fever, nor anything, just the rash and it's very itchy) and RASH (A bad rash all over the body). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (A red lump and a rash on the injection site), VACCINATION SITE RASH (Rash on the injection site), RASH PRURITIC (Didn't had any fever, nor anything, just the rash and it's very itchy) and RASH (A bad rash all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: ADR Form.
Painful injection site, sick stomach, fever, earache, headache,  After 24 hours from injection I developed a bloody taste in mouth, severe bloody nose.
After patient received  vaccines informed patient to wait 20 minutes when patient was sitting patient informed me he felt like fainting and his eyes started turning back and his face tuned pale
Immediate bleeding and swelling of injection site after injection. Bleeding stopped in 2min but the swelling did not go down and the site bruised. Had patient sit for 15mins to make sure she was fine. Shes had flu shots in the past with no issues. This was her first reaction.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's concurrent conditions included "sulfa" (unspecified) allergy. There was no information about the patient' s concomitant therapies or medical history provided. On 19-SEP-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # N012492, expiry date 17-MAR-2018 (exact dose and route of administration were not reported) for prophylaxis. Other suspect therapies included sterile diluent lot# reported as N0079321, expiry date 06-MAY-2018. On 21-SEP-2017, the patient came to the pharmacy and she had a lump at the injection site, redness, itching, warmth and pain. The pharmacist called the patient on 22-SEP-2017 and lump and pain had decreased but the redness had gotten larger, the size of a softball, and was very itchy. No treatment was given for the events. The outcome of the events was reported as not recovered. Causality assessment was not provided by the reporter.
Pt exposed to Pertussis - 6/18/03. Tried erthromycin 250 mgm/5cc 3/4 tsp po qid. Took 6 doses - gagging with meds - spit out meds. 8 1/2 cm round circular area warm to touch mildly elevated.
WEAK; EXTREME TIREDNESS; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 125 pounds, and height was 64 inches. The patient's concurrent conditions included high blood pressure, non alcohol user, smoking, penicillin allergy, and sleep disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on left arm on 14-MAR-2021 09:30 for prophylactic vaccination. Concomitant medications included trazodone for for sleep, furosemide, and potassium. On 15-MAR-2021, the subject experienced weak. On 15-MAR-2021, the subject experienced extreme tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme tiredness, and weak. This report was non-serious.
w/in 24 hrs p/vax pt exp an inject site reaction @ DTP site (4x5" in diameter which included induration, erythema, warmth, swelling & raised borders); dx erysipelas; afebrile; pt exp sharp pain on rt side w/hematuria; r/o kidney stone;
This spontaneous report was received from a medical assistant referring to a patient of unknown age (currently 1 year old). Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with PROQUAD (therapy type: rHA, lot # R008206, expiration date: 16-SEP-2019; 1 dosage form, subcutaneous for prophylaxis) following two temperature excursions. No adverse effects were reported in the patient. Temperature/Time frame 15 degrees F to 46 degrees F (-9 degrees C to 8 degrees C) (15.2F) for 2 hours 30 minutes. Previous temperature excursion 6 degrees F to 14 degrees F (-14 degrees C to -10 degrees C) (13.2F) for 9 hours 5 minutes.
Patient had a headache, flu-like symptoms, achiness, redness/warmth around injection site approximately 2 inches in diameter starting day after vaccination. 2 days post vaccination she doesn't have the headache or flu-like symptoms anymore but the redness/warmth around the injection site is still there. Recommended to ice the area.
Pt, received vaccine at 4:15 PM and at 4:20 PM started to get hives on (R) upper arm spreading across her face and back. Informed Dr. and had her evaluated. Administered 2.5 mls of CLARITIN per Dr. Informed pt. we will keep her for another 30 minutes to monitor her. Pt. cleared hives and was released to go home after 30 minutes.
Information has been received from a certified medical assistant concerning an 11 year old female with asthma and allergy to sulfa who on 14-DEC-2006 was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 14-DEC-2006 the patient experienced fever. The patient outcome was not reported. On 14-MAR-2007 the patient was vaccinated with a second dose of dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 653937/0637F) and experienced local reaction at the injection site and arm swelling. The patient outcome was not reported. Additional information has been requested.