chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered Shingrix Diluent only; administered Shingrix Diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The quality assurance specialist called to report that, the patient inadvertently administered shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The specialist was unable to provide any patient or vaccines details. The specialist also declined follow up from safety. The reporter did not consent to follow up. This case was 1 of 41 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170619:same reporter US-GLAXOSMITHKLINE-US2021AMR170931:same reporter US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021AMR170932:same reporter US-GLAXOSMITHKLINE-US2021AMR170933:same reporter US-GLAXOSMITHKLINE-US2021AMR170930:same reporter US-GLAXOSMITHKLINE-US2021AMR170929:same reporter US-GLAXOSMITHKLINE-US2021AMR170928:same reporter US-GLAXOSMITHKLINE-US2021AMR170927:same reporter US-GLAXOSMITHKLINE-US2021AMR170934:same reporter US-GLAXOSMITHKLINE-US2021AMR170926:same reporter US-GLAXOSMITHKLINE-US2021AMR171145:
Dizzyness upon injection, continuing to build for several hours. 35 minutes after injection, severe light headedness, chest pain. Pulse skyrocketed and both arms and upper lip began severely tingling. Difficulty breathing. Nausea and headache. Tingling radiated into feet. Emotional liability. Called 911 but did not require ambulance, a nurse friend picked me up and monitored me for 4 hours. 1 hour after injection, metallic taste in mouth, difficulty breathing, fatigue, intermittent tingling in hands and feet. Muscular pain. High blood pressure. 9.5 hours after injection, tight chest, intermittent metallic taste, ongoing headache, periodic tingles, extreme fatigue.
extreme photosensitivity (partial loss of vision appearing ?sparkly? for 5 hours), fever, body aches, nausea
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot number N010707 with expiration date on 03-DEC-2018, for prophylaxis (dose was not reported). The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F (53.5°F) for 2 hours, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. Sender's Comments: US-009507513-1802USA013718: US-009507513-1802USA013806.
Information has been received from a registered nurse concerning a 23 year old female who in approximately May 2007, was vaccinated with Gardasil. Subsequently the patient experienced a red welt at injection site. Additional information has been requested.
07/05/02 mom called to report that child received shots on 07/03/02 and today she noticed her child's upper left arm was red (approx size of hen's egg) swollen, and had small area of hardness in center. Mom reports no fever, but child was fussy and c/o arm hurting. Gave Tylenol to child-PHN referred to PMD.
Local reaction to flu shot. symptomatic control ice to area, tylenol, and benadryl for pain and swelling. RTC or ER if redness or swelling increases, pain increases, dyspnea or fever.
Patient presents to ED with complaints of worsening shortness or fair, generalized fatigue and malaise, fever, vomiting, loss of sensory taste. Patient stated he received the Pfizer vaccine series + booster "sometime last year."  Unable to provide dates nor manufacturer.
No adverse experiences; Was administered an expired dose of Recombivax HB; This spontaneous report was received from an office manager concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unspecified date in 2021, the patient was vaccinated with an expired dose of hepatitis b vaccine thimerosal-free (recombinant)(RECOMBIVAX HB), lot number S022584 with expiration date  31-OCT-2021, single dose, for prophylaxis (dose, strength, frequency and route of administration were not provided).  At the reporting time, the patient's outcome was unknown.  This is one of several reports from the same source.
On April 8, 2022, I received the first dose of the Shringrix Vaccine at a local Pharmacy. That evening I experienced chills, nausea, body aches, extreme fatigue and a sore arm. Over the next few days, the chills, body aches and sore arm resolved. However, as of the time that I am writing this, I'm still experiencing extreme nausea, upper gastric pain, and general body fatigue and a feeling of not being well.
Patient felt a102 degree fever, he experienced fatigue, chills, pain in the injection site
Vaccine was reconstituted the hib with sterile water, instead of the diluent, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Agency (Reference number- 00585910) and transmitted to Sanofi on 03-May-2021.  This case involves a two-month-old female patient who received 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ390AAA and expiry date: 29-Oct-2021) via an unknown route in the left thigh for prophylactic vaccination, which was reconstituted the hib part with sterile water, instead of the diluent on 03-May-2021 (product preparation issue).   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  The reporter wanted to know that the revaccination should be needed or not.  This was a case of actual medication error due to inappropriate reconstitution technique (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good 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.
On 12/14/15, 78 yo F presented to clinic for a follow up appointment. During visit, pt was ordered to receive pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13). At 1158, pt was administered 0.5 mL in left deltoid (lot #M27554; exp: 4/30/2017). Soon after the injection, pt developed a pruritic rash around the injection site. Pt denied any SOB, fever or other symptoms. Pt reported event to the MD and was instructed to take over the counter diphenhydramine for itching and/or use hydrocortisone cream as needed. On 12/22, pt reported symptom improvement.
My niece, an RN, felt it could be a side effect.  After 15 minute wait went to my car and was on phone 10 - 15 minutes.  Left to go to the dry cleaners.  No problem leaving and taking the correct direction but first couldn't remember the name of the road I was on. Couldn't remember where the dry cleaners was located.  I drove slow and a few minutes later I remembered the location.  I have not had an episode like this sense.  I was really scared but at the time didn't think of it as a side effect.  Did not report elsewhere.
3min tonic clonic activity-10min postictal period 18 hrs p/vax; also hx of febrile convuls in past p/MMR
Patient was given vaccines by a medical assistant in the clinic on 8/28/2020. It is charted that all vaccines were given in left deltoid.  It was not documented about which vaccine was given first or what part of left deltoid they were given in.  Patient came into clinic on 9/1/2020 with reports of redness, swelling, warmth and itching to left arm.  The provider who examined the patient believed that she had a reaction to one of the vaccines.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant medication was not provided. It was unknown if patient received any other vaccinations 4 weeks prior to the COVID-19 vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Inj given on Monday 5/6/13 - in left upper arm - area is red / swollen / hot itching all the way to elbow.
Mom sent email along with picture of site.  States that 2 days after vaccine they noticed a rash on patient thigh.  Rash is located only on the left thigh.  Does not seem to bother the patient.  Area is not hot to the touch, patient is afebrile.  Parents have not tried any OTC creams or lotions.  They were encouraged to try Benadryl cream to the area and see if that helps.
Had mild to severe brain fog for the first month.  This seems to be subsiding.  Have developed persistent ringing in my ears that has become more frequent in the last four weeks.  It is more noticeable in the hours between 6:30 p.m. and 12:00 a.m.  This may be because I am too busy to notice it at work prior to 6:30 p.m. and am asleep after 12:00 a.m.  Also, my first menstrual cycle after the vaccine was highly irregular.  The next one seemed normal.
This spontaneous report was received from a healthcare professional referring to a 12 months old male patient. Information about the patient's medical history or concurrent conditions was not reported. On 18-SEP-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
The patient's left arm was red and swollen. The Dr advised warm soaks. On 11/29/2001 the patient's mother states the patient's arm is improved.
Slugged in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Slugged in the arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PANTOPRAZOLE and ZOLPIDEM for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Slugged in the arm). At the time of the report, PAIN IN EXTREMITY (Slugged in the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.   This case was linked to MOD-2021-245523, MOD-2021-245523 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Significant FU: Second dose details and Outcome provided.
Blister; Boil; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced blister and boil. On an unknown date, the outcome of the blister and boil were unknown.   It was unknown if the reporter considered the blister and boil to be related to Shingrix.  Additional case details were reported as follows: The patient had the first dose of Shingrix in last week. The patient developed a blister or a boil on his behind.  The reporter did not want to provide any further details at the time of the call. The reporter called to ask if it could be related. The reporter consent to follow up.
HAND WAS NUMB, LOSS A BALANCE, COULD NOT HOLD OBJECTS IN LEFT HAND.
Pt presented to hospital for confusion and UTI, but also was COVID positive and had acute hypoxic respiratory failure.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the unknown number of patients were vaccinated with (Oka/Merck) VARIVAX (lot # and expiration date not provided) (dose not reported).   It was reported that GARDASIL and ROTATEQ were exposed to 34F for 48 hours and (Oka/Merck) VARIVAX was exposed to 32F for 48 hours. The reporter stated that she did not have access to specific patient or vaccine information but she was able to state that all products had been administered post excursion. No adverse effects have been reported by any patient.  It was reported that the unknown number of patients did not seek medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Pfizer on 4/14 and 5/5. Positive on 9/29
OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis, torn meniscus, and lupus. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown) dose was not reported, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. On an unspecified date, the patient experienced pain in ankle and vaccination site pain (dose number in series 1). The outcome of pain in ankle and vaccination site pain was not reported (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown) dose was not reported, 1 total, on an unspecified date in 2021 for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered (dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 29-OCT-2021, the patient received additional covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, intramuscular, and batch number was not reported) dose was not reported, 1 total, administered for prophylactic vaccination. It was unknown if patient experienced any adverse reactions following administration of vaccine (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220246857 (dose number in series 1).
Was performing a COVID vaccine clinic at a skilled nursing facility.  The patient states that at approximately 5 minutes after admin of her second shot, she started feeling short of breath. The nurse ran over to monitor her and take her BP. I arrived as well to monitor. Her breathing appeared fast and labored but patient was alert and oriented. She had no localized reaction to the vaccine. The patient's lungs were auscultated and were clear. Her glucose was checked, it was "low" for the patient at 80.  She stated the center of her chest was radiating pain and her hands went numb. Her BP was 161/93 and HR 65 and OSAT was 94 but this was close to her normal range. Epinephrine was not administered - but instead diphenhydramine 25 mg. The patient reported feeling better at 12 minutes post immunization and her breathing improved. Her chest pain went away and numbness went away. The patient also ate a donut and drank a glass of water at this time and stated she felt much better. Her BP again at 15 minutes post immunization was 158/96 and HR was 61 and OSAT was 100. Monitored patient for 20 more minutes and no other issues were experienced. The patient is being paired with a nurse from the facility to monitor the rest of the day.   After discussing with the pharmacist who reviewed the consent forms, it was noted that the patient marked yes on the portion that asks the patient if they've received a blood transfusion in the last year.
A report has been received from a Health Professional concerning a 6 year old, Female subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. The patient reported that FLUMIST administered in one nostril which started on 16-Oct-2013. The outcome of the event of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
A physician reported that a 15 month old child received an injection of HIB vaccine on 10/14/00, and the vial was inadvertently reconstituted with Prevnar. On 10/16/00, the child had redness at the injection site. The reporter declined to provide additional information and declined to grant permission for follow-up investigation.
Swollen eyes, ? stridor the following morning after vaccine administration. Resolved spontaneously.
2-2 1/2 inch area around injection site is warm, swollen and red with nodule. Painful. Difficulty raising arm and lifting arm. Recommended medical evaluation due to limited use of arm. Has used TYLENOL.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2022 at 3:59 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Feb-2022 at 3:59 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Patient ethnicity reported as white. Patient received booster dose vaccination time was reported as 15:59:46.  The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. We no longer possess this lot number. Treatment medications were not reported.
knows a lot of patients who received the Pfizer Covid-19 vaccine and caught Covid-19; knows a lot of patients who received the Pfizer Covid-19 vaccine and caught Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-019702 (Agency).  A male 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "knows a lot of patients who received the Pfizer Covid-19 vaccine and caught Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Caller says that he knows a lot of patients who received the Pfizer Covid-19 vaccine and caught Covid-19.  Clinical information: It was reported that, the reporter had no other information on these patients. No dates of administration, not lot numbers, no other adverse reactions or side effects of the Moderna Covid-19 vaccine were reported. There was no product complaint associated with this case and there was no concomitant list.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Cellulitic reaction to arm, began with chills, fever, arm redness and swelling.