chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller: patient's mother.  4:20 pm.  Patient had local reaction to varicella.  Left arm swollen to baseball size yesterday, pain and rash at site as well.  Resolving today (day 2) about 1/3 of the size it was yesterday and more "lumpy, not a solid mass like yesterday". Mother states patient has had no painkillers or antihistamines.  Advised of what to watch for in anaphalaxis (breathing, swallowing difficulties) would warrant emergency medical care (ER) and otherwise can use a cold compress (bagged frozen peas or something similar) for short times to ease the swelling and discomfort. Advised VAERS will be filed and she may receive a call from CDC r/t this.  Mom states older brother was vaccinated at same visit in our office with no reaction other than "a little soreness" but no redness or swelling.  I checked and same lot number of varicella vaccine was used for both siblings. Nurse who vaccinated both boys states no difference other than the 2 boys are built differently-one more muscular and thinner than the other. Patient also received HPV9 and hepatitis A in the right arm at this visit on 12/16. Mom states he had no reaction to it whatsoever. Not even complaint of soreness.
mild swelling/warmth/redness & tenderness over site of immun lt deltoid 1wk later;tx local heat, pain reliever;
Had the shingles shot and I got shingles/ suspected vaccination failure; Gastroperesis; Got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included chickenpox (patient's 4 boys and granddaughter had chickenpox).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shingles shot and I got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), gastroparesis (Verbatim: Gastroperesis) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles). The outcome of the vaccination failure was unknown and the outcome of the gastroparesis and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, gastroparesis and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, gastroparesis and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 2-Mar-2023 The case was received from the patient via interactive digital media.  The patient had the shingles shot 2 and half years ago and got shingles while in the hospital for gastroperisis. The patient asked that he/she was supposed to get 2 shots or something and he/she never had chickenpox, even after taking care of his/her 4 boys and granddaughter while they had it. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As it was not clear whether the patient was hospitalized for gastroperisis or not was just visit for follow-up, therefore, only emergency visit was tick considering that the patient was not hospitalized.
Information has been received from a registered nurse referring to patient of unknown age and gender. Information about pertinent medical history, concurrent conditions, concomitant medication, and drug reactions/allergies was not provided. On 06-FEB-2019, the patient was administered an expired dose of ROTATEQ (lot #: N01645, expiration date: 08-DEC-2018, strength, dose, and route were not reported) for prophylaxis (expired product administrated). No adverse effect was reported.
RASH, WARM, INDURATED, REDNESS. KEFLEX WAS USED AS TREATMENT.
pt recvd vax 15SEP92 had severe h/a, sleepiness, numbness in both legs; seen by MD treated w/APAP, fluids, bedrest for 2 days; resolved;
Mother refers her child began to have pain, swelling, redness and discomfort in injection site (left arm) at 7pm the same day. she was vaccinated. She was taken to ER the following day for evaluation.
Next day flu-like symptoms, achy, low grade temp, fatigue, HEADACHE.    Headache continues through today, November 2, 2019.  24 hours per day.  Sometimes more painful than other days.  Sense of being in a fog.  Headache is mostly right-sided, top of head, behind right eye, right side of nose/cheek.
Death. Found unresponsive and blue on 05/18/01. CPR attempted but unsuccessful. Autopsy lists cause of death as "undetermined" as the differential diagnosis of SIDS vs parental caregiver overlay cannot be determined on autopsy findings alone.
6 year old, administered full adult dose; 6 year old, administered full adult dose; This case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 6-year-old female patient who received HAV (Havrix adult) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 7th October 2022, the patient received the 2nd dose of Havrix adult. On 7th October 2022, unknown after receiving Havrix adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.   Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the 6 years old patient inadvertently received full dose of Havrix vaccine. The reporter stated that this was the 2nd dose of the patient series. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional Supportive Information: The child patient was administered a full dose of Havrix, which led to overdose and adult product administered to child.
Patient received a COVID-19 Vaccine on 04Mar21 @ 1140.  She called our onsite nurse on 05MAR21 @ 0735 to report the following adverse reactions:  hives, headache, muscle pain, chills and fever.  On 04MAR21, she took Benadryl 50mg po at home at 1600 and again at 2000.  On 05MAR21 at 0735, she reported that her hives were almost gone.
Rapid heart rate the next morning upon waking, heart rate up to 124 BPM while doing nothing, also felt light headed for a couple minutes when sitting down on the toilet.  I took a propranolol 10mg around 8:55 am. I went to the urgent care to make sure I wasn't having an allergic reaction. I ended up taking my propranolol at the urgent care and waited to make sure I felt better after taking it. I left about 9:30. My heart rate went back down to mid 80's.  So they let me leave. My heart rate went back up for a little bit while driving home, 113bpm. Then back down when I got home. My heart rate went up upon waking  each day until Sunday, but the episodes were not as bad as each day went by. I took a propranolol pill each day it happened. When my heart rate goes up like that I also feel abnormal, and I'll get sort of a headache, and sometimes light headed.
Myself and three (3) other ladies in my office got the J&J vaccine on the same date, at the same location on 4/2/21.  All four of us, beginning roughly around 8/17 began having several shoulder/neck pains, with no one having done any injury.  All of us continue to experience pain and have been to our respective doctors.  Mine and one other's doctors diagnosed with inflamed muscles, possibly affecting nerves and prescribed anfi-inflammatory and muscle relaxer meds.  One was told could be rotator cuff and nerves and referred to an Orthopedic.  One reports nerve issues and referred to a Neurologist.    In my case, medication not helping, nor is heat, ice, icy  hot, or electronic pulse massager.  Was told NOT to go get a message for a few weeks.
Have a low to medium grade fever; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 12Mar2021 at 10:00 as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 12Mar2021 patient stated "had my Pfizer Vaccine (Covid-19 Vaccine) today in the morning and just want to know that is it normal to have a low to medium grade fever, patient had it around 10:00 AM. So, is it normal for me to have fever like at night, started feeling this around at 08:30 or 9:00 I guess." In response to further probing, consumer stated, "No, I am at the bed right now and I need to sleep." The patient underwent lab tests and procedures which included body temperature with result low to medium grade fever on 12Mar2021. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT REPORTED SWELLING AT INJECTION SITE, SLIGHT WARMTH, AND SORENESS IN TRYING TO RAISE ARM ABOVE HEAD.
Area below the injection site is swollen; Area below the injection site is hot; Area below the injection site is itchy; Area below the injection site is stings; Area below the injection site is red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Area below the injection site is swollen), INJECTION SITE WARMTH (Area below the injection site is hot), INJECTION SITE PRURITUS (Area below the injection site is itchy), INJECTION SITE PAIN (Area below the injection site is stings) and INJECTION SITE ERYTHEMA (Area below the injection site is red) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced INJECTION SITE SWELLING (Area below the injection site is swollen), INJECTION SITE WARMTH (Area below the injection site is hot), INJECTION SITE PRURITUS (Area below the injection site is itchy), INJECTION SITE PAIN (Area below the injection site is stings) and INJECTION SITE ERYTHEMA (Area below the injection site is red). At the time of the report, INJECTION SITE SWELLING (Area below the injection site is swollen), INJECTION SITE WARMTH (Area below the injection site is hot), INJECTION SITE PRURITUS (Area below the injection site is itchy), INJECTION SITE PAIN (Area below the injection site is stings) and INJECTION SITE ERYTHEMA (Area below the injection site is red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Initial report received from a health care professional on 22 May 2014. A male patient (age and date of birth not reported), had received intramuscular dose of TYPHIM VI vaccine (lot number: not reported, dose number and site of administration not reported) on an unspecified date and also received a dose of HEPATITIS A VACCINE (Manufacturer- unknown, lot number: not reported, dose number, route and site of administration not reported) on an unspecified date. The patient had no illness at the time of vaccination. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was not provided. It was reported that Patient received vaccines prior to traveling to another country and upon return began experienced facial and hand swelling. Swelling appears and subsides, not lasting very long. Corrective treatments details were not reported. Laboratory details included - Blood work-normal result. At the time of this report, outcome of the event was not recovered. Documents held by sender: None. Follow-up received from healthcare professional on 26 June 2014. It was reported that the patient was not medicated by the reporter. It was reported that the patient was came for allergy test and reporter was only gathering patient history. No new information was reported. Documents held by sender: None.
Patient reports right arm and shoulder pain starting about one week after receiving the PREVNAR 13 injection. Symptoms progressed to difficulty in raising arm to comb hair or touch head. Methocarbamol 1500 mg QID, diclofenac 75 mg BID.
patient receiving 2nd shingrix dose, defective syringe, approximately half of the product leaked out of the syringe between the barrel and the syringe and down the patient's arm.  the ndc for the syringe is 08290-3052-70 lot 0027028 exp 2025-01-31.  patient will need to be revaccinated.
This case was reported by a nurse and described the occurrence of hives in a 4 year old male pt who received Infanrix. On 2/10/04, the pt received the 5th dose of Infanrix in the left arm. On the same day, the pt received injections of MMRII and IPOL. The sites of administration for MMRII and IPOL were not provided. Approximately 7 days later, on 2/17/04, the pt experienced hives at the injection site of Infanrix and irritability. At an unspecified time following the injection site hives, on an unspecified date in 2/04, the pt experienced "hives all over the body". The hives and irritability resolved after "several months". The nurse reported that the pt had a biopsy of the skin; however, the biopsy was not performed in the physician's office and the results were not known. In the nurse's opinion, the events were possibly related to vaccination with Infanrix.
Patient received second dose of ZOSTAVAX on 7/30/17. First dose given 9/14/16. Patient had no reaction to either as of 7/30/17.
she is experiencing mild fever now.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient (reporter's wife) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 01Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 11Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. It was reported that, patient got the 2nd dose of COVID-19 vaccine and currently she was experiencing mild fever on an unspecified date in Apr2021. Caller was asking if his wife could take Tylenol for her fever. The outcome of event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
pt recv vax 6DEC96 330PM w/inconsolable crying, temp elevation, ? apnea, flushed skin @ 930PM;seen @ hosp T102.5;
productive cough x 3 weeks, similar to cough that he had prior to vaccination Narrative:
This spontaneous report was received from a nurse and refers to a patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, approximately in September 2017 (reported as "about 2 weeks ago"), the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). On 04-OCT-2017, the patient was vaccinated with the second dose of PNEUMOVAX 23 via intramuscular route, lot# N014188, expiration date: 22-JAN-2019 (dose and route of administration were not reported). No side effects were reported.
Patient felt dizzy/faint after administration of vaccine. Assisted by staff to lie down. No signs or symptoms of respiratory distress. Blood pressure 122/60, pulse 93, pulse ox 97%. About 5 minutes after adverse event began, patient stated she was feeling better. Raised to sitting position and juice given. Blood pressure 112/68, pulse 71, pulse ox 99%, blood glucose 107. 2 minutes later, patient to standing position. Denied dizziness or symptoms of distress. Patient awake and alert. Pulse 83, pulse ox 98%.  12 minutes after event began, patient able to walk to personal vehicle driven by mother. Accompanied to parking lot by nurse and physician.
Dizziness and vertigo that continues since the day of the vaccine through today.   Pain and swelling throughout internal body organs continues  since the day of the vaccine through today.  Migraine headache lasted approximately 2 weeks.
ACTHIB was reconstituted with sterile water diluent instead of 0.4% saline with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via physician via the Medical Information (Reference number- 00628765) and transmitted to Sanofi on 04-Jun-2021.  This case involves a 4 months old male patient who received 0.5 ml second dose of HIB (PRP/T) VACCINE [ACT-HIB] reconstituted with sterile water diluent instead of 0.4% saline (lot UJ426AAB, expiry: 03-Jul-2022, Injection) via intramuscular route in the right thigh for prophylactic vaccination on 24-May-2021 (Product preparation error)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for prophylactic vaccination.  It was a case of an actual medication error due to Wrong diluent used (latency same day)  At the time of report, no adverse event was reported  The caller reported that he was reviewing their vaccine log and noted that on 24-May-2021, a male child was administered a dose of ACT-HIB incorrectly. The caller wanted to know what to do now. The vaccine will be repeated.  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 the 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.
Did the adverse event start after the first or second vaccination?  both Date and time of vaccination: (list both if they received both shots):   12-30-2020 11AM  Moderna LOT # 025120A 1-26-2021 11AM  Moderna LOT # : didnt have a LOT # written in Pain in arm 1-26-2021 pain at injection site immediately and now achy . pi point prick like pain that wakes her up while sleeping/laying down. used cold compresses and warm compresses. took OTC pain reliever and states that helped. also reports a possible lymph node swollen above/anterior the collar bone
Information has been received from a physician concerning an 18 year old female with no medical history or allergies who on 03-SEP-2009 and 24-JUN-2010, was vaccinated IM with the first (lot# 661046/0381X, expiration date 01-DEC-2010) and the second (lot# 662529/1317Y, expiration date 30-MAY-2011) doses of GARDASIL, 0.5 mL, respectively. There was no concomitant medication. The patient did not have any problems after the first dose of GARDASIL. On 24-JUN-2010, 5-10 minutes after standing up and ready to go, the patient got dizzy, fell, and half minute later stiffened and hand clenched. The patient was diaphoretic and pale. The patient's blood pressure was 110/70 with a pulse of 80. On 24-JUN-2010, the patient recovered from the events. The patient sought medical attention in the office. In follow up, the physician indicated that 10 minutes post the second dose of GARDASIL, the patient stated she "felt dizzy", then went limp and lost consciousness. The patient also experienced stiffening of extremities and eye rolling. The events lasted about 1.5 minutes, was not past one day. This is an amended report. "Vaccinated at Private doctor's office/hospital" and "Vaccine purchased with private funds" had been selected for the second dose of GARDASIL. Additional information is not expected.
pt recvd flu vax & 16 to 24 hrs later, pt devel pain, swelling, redness, induration, warmth @ the inject site; reaction lasted 4 days;
spontaneous bruising with acute pain in right buttock awakening pt from sleep and unable to sit for more than 20 minutes due to pain for the past3 days,
A friend who received a expired dose; 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 EXPIRED PRODUCT ADMINISTERED (A friend who received a expired dose) 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 EXPIRED PRODUCT ADMINISTERED (A friend who received a expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A friend who received a expired dose) had resolved.            No concomitant medications were provided. No treatment medications were reported.
Enuresis; This spontaneous case was reported by a consumer and describes the occurrence of ENURESIS (Enuresis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported ).   On 05-Feb-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 an unknown date, the patient experienced ENURESIS (Enuresis). At the time of the report, ENURESIS (Enuresis) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported   No treatment medication reported
LEFT ARM INITIALLY PAINFUL WITH ROM, NUMBNESS STARTING IN PM ON 27TH, 28TH AM SWELLING STARTED. CURRENTLY ROM IMPROVED, SWELLING OF ARM/HANDS STILL EVIDENT, PAIN PERSISTS AT SAME LEVEL.
Decompensated heart failure. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 12-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). On 10-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.