chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from nurse on 05-Oct-2018. This case is linked to cases 2018SA279275, 2018SA279268, 2018SA279274 and 2018SA279276 (same reporter and same suspect). This case involves a eight years old patient was vaccinated with a 0.25 ml dose of FLUZONE QUADRIVALENT (Batch number: UT6259KA, expiration date: 30-Jun-2019, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to vaccine underdose (gave the FLUZONE QUADRIVALENT of 0.25ml that needed the 0.5ml and gave incorrect dose /No AE). No Adverse Events have been noted at time of the call. 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. List of documents held by sender: none.
Itchy; It is really turned red; I got irritated and itchy; really turned red; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 14Feb2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14Feb2021, from CDC or an organization, patient got the shot and it was done by Pfizer. Patient was fine all week and the following Sunday, the 23Feb2021, patient stated that it was getting really itchy and it really turned red. So, patient called the primary doctor and went there and the nurse practitioner took a magic marker and circled it and said, let us see if it gets any bigger and that did. So, patient still have the red mark and doesn't know what to use on it, it is not a exactly mark, it is a little saucer like a small circle like the size of cantaloupe and while the doctor chose to give Benadryl but it didn't work. So, then he gave me a hydro cream, it got the hydrocortisone in it (treatment). Patient tried the Benadryl first but couldn't mix the Benadryl with the allergy tablet that physician gave the patient. So, patient still got it and wanted to know if it was normal. Following that, patient got irritated and itchy. The outcome of the event 'really turned red' was not recovered; while for the other events, it was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At injection site, my arm became numb. The numbness spread to the whole right side of my body withing an hour, including my neck, ear, and cheek, as well as my side, breast, leg and foot. During the remainder of the day, the numbness would come in waves, followed by sharp pains on the right side of my body. The numbness would spread further during each wave and eventually made my tongue and throat numb.
5" Febrile seizure. Taken by ambulance to Hospital and at facility had extensive work-up.
Fever around 100.7 for more than 24 hours, puffy and swollen eyes and splitting headache
fever started within 24 hours.  cough, wheezing and shortness of breath temperature up to 101
fever 17NOV96 took to MD has ear infect & put on ATB;20JAN96 fever 104;not eating or swallowing own saliva;taken to ER;had epiglottis in intensive care 2 days w/ ER tube
Approximately 35 minutes after her 1st dose of Pfizer COVID vaccine,  patient's head started hurting and her eyes got really hot.   She said the symptoms worsened that evening as her eyelids were both really swollen.  Patient said she took a picture in case that was a reaction (I do not have that picture).  She said it took about two days for her eye symptoms to resolve.   Other reported side effects: being super sore and tired, however, the swelling was the concerning symptom for patient.  Patient  did not go to the ER or PCP or have to take time off.
Pain and soroness; Fatigue; 2 doses on the same day; This case was reported by a other health professional via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2022, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 20th November 2022, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced overdose. On an unknown date, the patient experienced pain and fatigue. On an unknown date, the outcome of the pain and fatigue were not recovered/not resolved and the outcome of the overdose was unknown.   It was unknown if the reporter considered the pain and fatigue to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comment: The reporter was a medical liaison for redacted with limited details. The reporter stated that a patient was administered with 2 doses of Shingrix on the same day and was now experiencing pain and soreness and fatigue. The reporter consent to follow up. Additional Supportive Information: The patient received two doses of Shingrix on the same day, which led to overdose.
I have hives all over my body. Sometimes itchy and they are warm. I went to the doctor on October 30th. They give me steroids that did not help. I went to the doctor today, Nov. 15th. They did blood work. They are checking for allergies. They think it might be from my third dose.
This spontaneous report was received from a registered nurse refers to 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 16-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M009378, dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/Insurance. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments:  US-009507513-1612USA003706.
No adverse events; Temperature excursion; This spontaneous report was received from a Medical Assistant, refers to a patient of unknown age and gender. Information regrading the patient's pertinent medical history, known allergies, concurrent conditions and concomitant therapies was not provided.      On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (strength, route, dose, lot # and expiration date were not provided) for prophylaxis.         On 16-NOV-2020, it was found that hepatitis b vaccine (recombinant)(RECOMBIVAX HB), experienced a temperature excursion. The reported stated that the patient had no adverse reactions. Information regrading the temperature excursion in which the vaccine was involved was not provided.  This is one of several reports received by the same source.; Sender's Comments:  US-009507513-2011USA010999: US-009507513-2012USA002966:
hot induration entire upper lateral arm w/in 2 days of vax;another pt got same rxn from same vial;
experienced soreness in arm the day after receiving the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 9 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 9 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "experienced soreness in arm the day after receiving the vaccine".  No follow-up attempts are possible. No further information is expected.
Extremity swelling, throat tight, anxiety, rash, fever, headache, short of breath, oxygen saturations at 86%, edema, took benadryl and no relief so went to the ER
Loud tinnitus started day after shot and is still there at day 55 hours. Rest of the symptoms are mostly gone.
upon insertion of needle pt held breath approx 15-20seconds startled & turned red then began shaking & crying vigorously;no cyanosis, rhythmic movements of mouth, extremities noted;no convuls shaking noted;pt quieted when consoled by mom;sz
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 78 years-old female patient (pt). No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On 23-JUN-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) ) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. In or about 2014, the pt experienced shingles, including any and all of it sequelae. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt has and will continue suffer severe and permeant personal injuries including but not limited to shingles, as well as other severe and permanent health consequences; substantial pain and suffering, and emotional distress, as well as to incurred substantial economic damages and loss, significant expenses for medical care and treatment, and will continue to incur such expenses in the future. Plaintiff has lost past earnings and has suffered a loss of earning capacity. The outcome of the event was not reported. The event was considered related to zoster vaccine live (ZOSTAVAX).
Vaccine given on 12/16/2021 had expiration date of 12/14/2021. Pt had no know adverse reaction to this error.
This spontaneous report as received from a healthcare professional refers to unspecified patients of unknown age and gender. On an unknown dates the patients were vaccinated with a doses VAQTA (doses, route and lot numbers were not reported) that were improperly stored. No adverse symptoms reported. The temperature excursions with these vaccines were found to be supported with in-house instability data. This is one of several reports from the same source. Additional information has been requested.
Received flu shot on a Thursday. States on Friday she could not move her body, only her eyes. States she was in a "trance". Eyes also swollen. Lasted all day Friday to Saturday. Gradually got better on Saturday and was able to move. Eyes still swollen - gradually got better - subsided Tuesday. Pt did not seek treatment.
Pt adm to ER about 2030 cardiopulmonary arrest-no fever transferred to another hosp & placed on life support-taken off ventilator 2100 18MAR92 & expired;
Pt had chicken pox the last day of Feb. Vaccinate 11/26/1996.
Patient had an allergic reaction to the first 3 Moderna COVID-19 shots. She had heat over her body.; Patient had an allergic reaction to the first 3 Moderna COVID-19 shots. She had severe rash and heat over her body.; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Patient had an allergic reaction to the first 3 Moderna COVID-19 shots. She had heat over her body.) and HYPERSENSITIVITY (Patient had an allergic reaction to the first 3 Moderna COVID-19 shots. She had severe rash and heat over her body.) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Patient had an allergic reaction to the first 3 Moderna COVID-19 shots. She had heat over her body.) and HYPERSENSITIVITY (Patient had an allergic reaction to the first 3 Moderna COVID-19 shots. She had severe rash and heat over her body.). At the time of the report, FEELING HOT (Patient had an allergic reaction to the first 3 Moderna COVID-19 shots. She had heat over her body.) and HYPERSENSITIVITY (Patient had an allergic reaction to the first 3 Moderna COVID-19 shots. She had severe rash and heat over her body.) outcome was unknown.            No concomitant medication was provided by reporter. No treatment medication was provided by reporter.   This case was linked to MOD-2022-642119 (Patient Link).
Shingles in their system; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles in their system). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she was told by his or her physician that from the second dose he or she might get shingles in his or her system and that the reason he or she did not received second dose yet. Follow-up would not possible as no contact details were available.
Redness of left deltoid seen by Mother on 08/30/2005, child had received 2 vaccines this day, area some 70 mm length wise - Mom giving Tylenol or Motrin, cool packs - provider gave this advise also- to be see again if having problems.
Severe headache with fullness and discomfort in both ears. Took Advil, little relief. Symptoms slowly improved over 1 week.
Almost one month after my second Moderna Covid 19 vaccination I had what I can describe as prickling sensations in my right side of the face. It resolved in a few days. About two days February 21st 2021,later my head started to hurt towards the front, both sides. Within a day this resolved. The next day a very sensitive tender sensation arrived underneath the arch of my right eye. Blinking, talking or touching this general area was very uncomfortable. I could not lie comfortably on that side of my face given it?s sensitivity  to fabric against it.  On a scale of 1-10 most painful it was a 2 or 2.5 most of the time. Advil did not really help much. I figured it would just resolve on it?s own.  The pain was stable at no time completely going away. Mid April I decided to see my PCP who referred me to a neurologist. I also started Accupuncture to assist wondering if it was stress related. In fact I?ve intuitively thought it was a side effect of the inoculation. The neurologist gave me comparing at night I could not take after second night due to pain in my muscles it created. Then he gave me a trial on nortryptaline (pamelor) older SSRI to see if that would help it reduce. I am a week into this medication and it?s not really doing much yet. However, I have had history of neuropathy in gyn region when lower receptor site gets triggered/inflamed. Nortryptaline has helped that in many years past. Have also used amytryptaline for same many years prior to that successfully. My neuro had me do a brain MRI also. No problems. My eye doc also saw no problems.
joint pain-arthralgia since summer 1991;tachycardia, n;cont tx has included dx undiff connective tissue disease, +ANA, fibromyalgia, trigeminal neuralgia, conjunctivitis, hypotension;paresthesia,vertigo,memory/concentration diff;
stomach pain; fever; chills; Also mentioned burning eyes; pain in ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 05Dec2021 15:30 (Lot number: FK5618) at the age of 11 years as dose 2 (tris), single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "allergic to dust and pets" (unspecified if ongoing); "allergic to dust and pets" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Time: 15:30, anatomical site: right arm, route of administration: intramuscular, batch/lot number: FK5127), administration date: 14Nov2021, when the patient was 11 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 06Dec2021 03:00, outcome "recovered" (07Dec2021), described as "stomach pain"; PYREXIA (non-serious) with onset 06Dec2021 03:00, outcome "recovered" (07Dec2021), described as "fever"; CHILLS (non-serious) with onset 06Dec2021 03:00, outcome "recovered" (07Dec2021), described as "chills"; EYE IRRITATION (non-serious) with onset 06Dec2021 03:00, outcome "recovered" (07Dec2021), described as "Also mentioned burning eyes"; EAR PAIN (non-serious) with onset 06Dec2021 03:00, outcome "recovered" (07Dec2021), described as "pain in ear". The patient underwent the following laboratory tests and procedures: body temperature: (06Dec2021) unknown results; sars-cov-2 test: (06Dec2021) negative, notes: home Covid test. Therapeutic measures were taken as a result of abdominal pain upper, pyrexia, chills, eye irritation, ear pain.  Additional Information: Patient medical history was reported as none. It was reported that, early next morning (3 am) post second dose patient experienced stomach pain, fever and chills. Also mentioned burning eyes and pain in ear. Lasted entire day. The patient was reported to be physically active11 year old female. No medications. The events reported as non-serious. The patient received Advil as treatment for events. Awareness date was reported as 06Dec2021.  Follow-up attempts are completed. No further information is expected.
A 4 year old had her shots given on 02/04/2002. Following day mom noted swelling, redness, tenderness of right upper extremity from shoulder to wrist and part of front chest. Crying and irritability.
My arm is injured; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 11Oct2021 at 01:00 (Lot number: 301558A) at the age of 62 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). The patient received unspecified concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: N6200, Anatomical location: Left arm, Time of administration: 00:15), administration date: 24Feb2021, when the patient was 62 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: ER8727, Anatomical location: Left arm, Time of administration: 01:00), administration date: 18Mar2021, when the patient was 62 years old, for COVID-19 immunisation. The following information was reported: LIMB INJURY (non-serious) with onset 11Oct2021 at 01:00, outcome "not recovered", described as "My arm is injured". The event "My arm is injured" was evaluated at the physician's office visit. Therapeutic measures were taken as a result of limb injury.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Treatment included pain medications (unspecified) and cortisone shot for LIMB INJURY.  Since the vaccination, the patient had not been tested for COVID-19.
DOSE #3 MODERNA COVID VACCINE GIVEN 11/19/21, LOT #065F21A; pt to ED with worsening SOB and cough; found to be positive for COVID; O2 supplementation; placed in ICU; on BiPAP; pt improved and then significantly deteriorated; family transitioned pt to DNR/DNI and opted for inpatient hospice care; pt passed away in the hospital
Sore arm, EXTREME FATIGUE x 1 week, swollen underarm/breast lymph node, Headache, nausea, chills.
Tingling in feet the ascended over a period of 1 week to include legs and hands. Burning dysthesia. Crawling sensations. This plateaued around 2-3 weeks but took over 6 months to resolve.  I never had sensory loss or motor loss. This was  extremely uncomfortable and miserable for 6 months, making it very difficult to work/function.  It should be noted that a month prior to vaccination I had unexplained vertigo for 2 months.
patient was administered higher than recommended dose because of error in mixing the vaccine with the diluent. the vaccine was only mixed with 0.8ml of the diluent instead of 1.8ml of the diluent resulting in the concentrated form of the vaccine
Complaints of redness/tenderness/swelling/warmth to left upper arm, fatigue and nausea. Cellulitis - treated with AUGMENTIN.
Initial and follow-up information has been received from a physician's assistant concerning a patient's family member who on an unspecified date was vaccinated with a dose of GARDASIL. The physician's assistant mentioned that the patient experienced paralysis waist down. She also stated she did not know the patient's name or any information concerning the patient. The physician's assistant stated her patient had reported that the patient's cousin had heard that there was a patient who received GARDASIL and had paralysis from the waist down. The physician's assistant did not remember the patient's name that had reported the incident to her. Upon internal review paralysis is considered to be other important medical event. No further information is available.
Received vaccine at 1115, passenger in front seat of van,  at 1121 pt told daughter she felt funny, daughter hit the car horn.  1122 - pt found sitting upright, tripoding in front passenger seat of van, resp distress, using accessory muscles, wheezes auscultated in upper fields, speaking in 1-2 word sentences, skin pink warm and dry. 911 called  1123 - O2 sat 93%, resp rate is 34   1125 EpiPen used right thigh.  Diminished breath sounds in bases, rare wheezing in apexes,  Pulse ox shows HR 134, 98% RA, BP 190/100 RA,  1127 - GPFD arrives, pt breathing easier - no longer tripoding, speaking in 4-5 word sentences. Report given to GPFD Paramedic.  AA HHN started - tolerating well. 1148 AMR arrives - report given and care assumed.
ACUTE COR PULMONALE 7/3/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA  HYPOTENSION 4/28/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA  ACUTE COR PULMONALE 7/3/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA  HYPOTENSION 4/28/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA  ACUTE COR PULMONALE 7/3/2022 CHF EXACERBATION, UNSPECIFIED  HYPOTENSION 4/28/2022 CHF EXACERBATION, UNSPECIFIED  ACUTE COR PULMONALE 7/3/2022 MITRAL VALVE REGURGITATION  HYPOTENSION 4/28/2022 MITRAL VALVE REGURGITATION  ACUTE COR PULMONALE 7/3/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  HYPOTENSION 4/28/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED