chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited misuse report received from a consumer on 04 November 2015. This case involves a 53-year-old female patient who was vaccinated with a dose of FLUZONE ID (batch number, expiry date, dose, dose in series, were not reported) intramuscularly in right deltoid on 03 November 2015. Illness at time of vaccination was reported as no illness, pre-existing physician diagnosed allergies included history of allergies, sensitivity to many items. Birth defects, and medical conditions were not reported. Concomitant medications were not reported. On 13 November 2015, few minutes following the vaccination, the patients lips became itchy, she had an increased heart rate, felt faint, nauseous, had diarrhea, stomach upset, right deltoid developed swelling that looked like a mosquito bite, it was the size of a dime, itchy and painful to touch. Under the skin surface, at the injection site swelled up 2x the size of a quarter, which could not be seen, but could be felt. Same day few hours, following the vaccination (once home), the patient fell asleep for 2.5 hours, after she woke up she still had stomach upset, was not able to eat anything all day, but did take in fluids. During the night, the patient woke up with up from pain in her right arm. On an unknown date, (next day) following the vaccination most symptoms were alleviated. The patient was given the vaccine via intramuscular route which led to wrong route of administration. The patient's laboratory data was reported as none. The patient treated with BENADRYL which eased most of the symptoms. It was reported that, the patient still had some swelling at the injection site about the size of a dime, the area is still itchy. The patient was not recovered from the events. List of documents held by sender: none.
Increased heart rate since vaccine, normal was ~70, post-vaccine my rate hovers at ~80bpm.  Chronic fatigue. Trouble concentrating. Some difficulty catching breath. Difficulty recovering from infections. Unusually dry sinuses. Vertigo. Muscle weakness.
This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding her son who she described as borderline autistic. The patient received the Prevnar vaccine on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunisation. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. The child's mother described her son as borderline autistic (autism). The reporter declined to grant permission for follow up No additional information was available at the time of this report.
Swelling at injection site; Redness at injection site; Itching at injection site; Injection site Pain; Injection site Warm to Touch; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site itching, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site itching, injection site pain and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site itching, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter husband received 1st dose Shingrix late February. The patient experienced swelling, redness, itching, pain, and warm to touch all at the injection site for approximately 2 days following both doses. By the third day, all symptoms reported as resolved. For tolerance to the 2nd dose of Shingrix, refer case US2019127857.
BRIEF OVERVIEW: Discharge Provider: , MD Primary Care Provider at Discharge:  DO Admission Date: 7/20/2023 Discharge Date: 7/22/203   DISCHARGE DIAGNOSES 1. COVID 2. L1 compression fracture 3. Mild hyponatremia 4. Chronic obstructive pulmonary disease 5. BPH 6. Chronic atrial flutter 7. Chronic diastolic congestive heart failure 8. Obstructive sleep apnea 9. Depression 10. Dyslipidemia 11. Essential hypertension 12. Sick sinus syndrome 13. Coronary artery disease  DETAILS OF HOSPITAL STAY: HOSPITAL COURSE: Patient is a 63 y.o. male who presented on 7/20 with cough, congestion and fatigue for 3 days, initially hypoxic to 88% with ambulation, found to be COVID+. Admitted for treatment. Patient also had a recent fall, and CT showed acute compression fracture at L1. Back pain controlled with tylenol and motrin. Patient's COVID symptoms improved with decadron for 3 doses, satting well on room air.  Upon discharge patient's back pain is improved.  Of note patient's blood pressure was elevated in the hospital.  Should be monitored by PCP and Cardiology outpatient.  Discharge with out-patient PT referral due to recent falls and balance deficits.    Prescribed 3 day course Decadron 6 mg on discharge, start taking 7/23, total steroid treatment will be 6 days.
Injection site within normal limits -not red or swollen 2-3 inches below injection site, arm is red and swollen and warm to touch. KEFLEX 500mg, QIDx10 days ordered for cellulitis Dx.
In July, 2021, my son started experiencing partial complex seizures.  He would have anywhere from one to three seizures every day.  He was diagnosed with non-lesional left frontotemporal epilepsy on 10/21/2021
On the 9th day after the vaccine injection, the area around the injection site had become newly hard, rec, hot in an area approximately 2-1/2?x2?. It became irchy and somewhat larger over the next several days.  Today is day 14 after the vaccine. The site is still a little red and itchy but the swelling has pretty much subsided. I have taken photos if these would help.   Previously I had no other symptoms except some soreness at the site over the first 3 days.
About two days after the vaccine I fainted and was very dizzy for a couple of hours. Had a couple minor dizzy spells in that week.
Approximately 1 hour after injection of DTaP/Hib, the pt developed Diffuse Erythema, Periorbital Edema and Urticaria on cheeks.  Patient was seen in ED and given Benadryl.
Administration past beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration past beyond use date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration past beyond use date). On 02-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Administration past beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details not provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-348416, MOD-2021-337336, MOD-2021-348447, MOD-2021-336767, MOD-2021-335024 (Patient Link).
No adverse outcomes reported to the HD at time of filing report. Reporting d/t administration error. Administered 3 days past expiration date.
Patient received flu vaccine during the flu clinic. Patient said that his right arm started hurting around 2-2:30 AM on Nov. 9, 2011. His wife was the witness. The pain spray to his shoulder (right side) and his right arm and his neck, back. He had numbness of right arm as well. Patient went to the ER in Hospital.
Guillain-Barre Syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter stated that the possible side effects of the Shingrix vaccine, Guillain-Barre Syndrome was listed, and reporter want to know one experiences that side effect, was it permanent. Additional Supportive Information: The follow up would not possible as no contact details were available.
Pt developed a raised red rash from sternum to spine on left side of body, underneath left breast, no pain or itching associated with rash. Pt received Flu and Td vaccine on Monday, 10/13/03, noticed rash on Wednesday, 10/15/03. States did not do anything different except worked in yard and looked for hickory nuts. No rash on arms. Right arm (tetanus) slight swelling (local reaction), suspect Herpes Zoster/see attached pictures. Sent pt to family physician. Physician confirmed Herpes Zoster and treated with Acyclovir. Does not appear to be vaccine reaction.
My 4 month old son was given only the HiB vaccine. When it was administered into his leg I noticed that approximately 4 drops of the vaccine was on his leg and the table. Within 18 hours the left side of his face was red, hot and swollen. The hives subsided in about 2 hours. I have the vaccine insert and pictures and welcome questions.
rashes after receiving the SHINGRIX vaccine; This case was reported by a consumer via other manufacturer and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and  experienced rashes. The reporter declined to provide additional information about the patient.
last PM started crying around 10:00;lasted until 2AM started breaking out this AM;has scattered pustule-appearing lesions on trunk (back & front) & neck;
Headache, Myalgia, Fever, NauseaVomiting, drowsiness, chills Narrative:  Other Relevant History:
L deltoid area "knot" about 2 inches wide, no redness, a little warm to touch stiffness to elbow, can raise arm, but it hurts on scale 1-10 5 1-19-10 referred to PMD.
Fatigue, nausea, and headache beginning day after the second vaccination shot (5/21/21). Treated by patient --- rest, fluids.
Elevated blood pressure; arm/shoulder soreness on 12/11/21 Death on 12/13/21.
pt stated that he got the covid vax he developed head ache and fatigue.  Around the 4th day he started having a tickling  and numbness around the mouth area.  On 3/1/2021 he felt a difference and could tell something was going.  He went to see his PCP on 3/2/2021.  He was diagnosed w/ Bells Palsy.  He did not give him any meds that day.  When he got home his symptoms got worse.  He contacted his PCP which then prescribed steroids and baclofen.  Pt is applying warm compresses and messages.  He has also had acupuncture.  His left eyebrow is downward and the left side of his mouth is drooping.  He feels like he has sand in left eye.
mild fever (99 degrees to 100 degrees); chills, headache, fatigue, nausea
Patient fully vaccinated with Pfizer (3/9/21, 4/6/21,8/25/21)  Patient admitted to hospital after testing COVID+
Received intranasal live influenza vaccine at flu clinic on 10-15-08 at 1515.  1/2 hour later, she started to get welts on her cheeks then it progressed to her hands and feet which were red et edematous.  To the PA at the clinic.  Takes Benadryl 12.5mg PO q 4 hours until rash is gone.  Rash is all over her body.
After administration of Janssen vaccine 0.5mL, pt reported arm was hurting and he began moving arm.  CMA noticed that continued to shake arm after 5 minutes but patient was alert and oriented x 3.  CMA thought the way he was shaking his arm seemed irregular so she advised pt he would be taken to an observation area for further observation.  Half way to the observation area, pt reported to CMA that he was seeing spots and felt like he was going to get sick.  CMA called for help.  Patient experienced a syncopal event just as he made it to the chair.  Several staff was helping to support patient.  Legs were lifted to another chair.  Patient was not responsive for a short time, very diaphoretic, breathing regular and unlabored.  Patients eyes then rolled upward toward the ceiling and patient's entire body began shaking uncontrollably while staff managed to keep patient from falling to floor from the chair.  Once patient was conscious, he was able to state his name but reported he was very confused and could not think clearly.  He was able to sit upright.  In the meantime while patient was shaking uncontrollably, staff sought urgent care provider to come and see patient.  Patient was then taken over to the urgent care side of the building to evaluate and treat patient.
Around 04/18 I had a sore throat and I let it go for a couple days. I talked to the doctor and asked him if it was possible that I had ingested glass. There were nodules in my throat and the doctor told my they were my tonsils and I explained they have been removed for some years now. I never tested myself until 04/27 and, I was positive. I isolated for about 5 days. I had a open sore on my face that I notices around the 05/01 and I called the doctor and they confirmed it was skin cancer 05/30. I will say I did have some issues with memory its still a little foggy but not as bad.
Rash upper left arm. Fever, stomach ache, headache, wheezing.
Extreme fever (102 degrees) & very intense shooting pains in my legs, especially my knees.
had mild seizures; This serious case was reported by a consumer via call center representative and described the occurrence of seizure in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Lamictal (had been on Lamictal for several years).   In SEP-2023, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced seizure (Verbatim: had mild seizures) (serious criteria GSK medically significant). The outcome of the seizure was resolved.   It was unknown if the reporter considered the seizure to be related to Arexvy.     It was unknown if the company considered the seizure to be related to Arexvy.   Additional Information: GSK receipt date: 1-Nov-2023 The case was received from the patient's sister. According to the reporter the patient received Arexvy vaccine in September 2023 and recently had mild seizures for a couple of days, one seizure last Saturday and two the following day on Sunday.  Reporter would talk to the physician before providing consent to them to contact him. Reporter refused to provide zip code, address, initials for the patient and date of birth. Reporter provided consent to be contacted by GlaxoSmithKline.
16 year old received Flublok/no AE; Initial information received on 03-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 16 years old patient who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age). It was reported that the error occurred possibly due to a knowledge gap and just grabbing a flu-vaccine.   Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of report 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 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.  There will be no information available on batch number for this case.
Initial unsolicited report received from a nurse on 15 October 2015 and additional information received from nurse in the United States on 17 October 2015. This case is linked with case number: 2015SA164148 (same reporter, same vaccine, same lot number). This case involves 10 patients (age not reported and gender reported as both males and females) who were vaccinated with a dose of Fluzone QIV (batch number: U5319AA, expiration date: 30 June 2016, dose and dose number were not reported) subcutaneously in deltoid (left or right arm below) on October 2015 (reported as "12 October 2015 and 13 October 2015"). Pre-existing physician diagnosed allergies, birth defects, medical conditions and Illness at time of vaccination were not reported. On October 2015 (reported as "12 October 2015 and 13 October 2015") following the vaccination, the patients developed site redness swelling, and lump at site some with softball sized lump. It was reported that all patients who developed reactions were heavier set. Patients required ER or doctor visit whereas, two patients seen by medical group for observation. Laboratory investigation was not reported. The patient did not receive any corrective treatment. The patient was not recovered from events. Follow up information received from a Nurse in on 22 January 2016. This case involves a 45 years old female patient (reported as in her mid-forties) who was vaccinated with Fluzone QIV vaccine on 12 October 2015. The patient had experienced discomfort, swelling, redness and felt shaky on an unspecified date. The patient had received Ibuprofen as corrective treatment for event discomfort. The patient was seen by physician on 14 October 2015. The physician reported that, the patient had moderately severe reaction to the flu immunization. List of documents held by sender: none.
This spontaneous report as received from a certified medical assistant refers to a 1 year old patient of unknown gender. No information on medical history, concurrent conditions or concomitant medications was provided. On an unknown date the patient was vaccinated with MMR II dose, site and route of administration, lot#, expiration date not reported. On an unknown date the patient developed fever of 103.3 F, and was seen in the physician's office six days after vaccination. The patient was diagnosed with an "illness", but did not specify any diagnosis or treatment. No further information on the diagnosis or treatment provided. The outcome of illness and fever was reported as not recovered/not resolved. Relatedness between the adverse events and the use of the vaccine was not reported. Additional information has been requested.
I tested positive for COVID on 1/11/2022, almost one month after my booster (12/2/21).  I tested positive again for COVID on 4/29/2022.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.      In 2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced herpes zoster (date unspecified), was treated by a health care provider and was hospitalized due to the event (date unspecified).  As a direct and proximate result of patient use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
This case was reported by a healthcare professional and described the occurrence of facial flushing in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 28 October 2009 at 14:00 the subject received unspecified dose of FLULAVAL (0.5 cc, left arm). On 28 October 2009 in the evening, within hours of vaccination with FLULAVAL, the subject experienced facial flushing, red face, bad feeling and malaise. It was reported that the injection site "looked fine". The subject was treated with BENADRYL without improvement. At the time of reporting the events were unresolved. The subject was not experiencing any shortness of breath or fever at the time of reporting. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.
FLU LIKE SYMPTOMS; This spontaneous report received from a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported.  On an unspecified date, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms was not reported. This report was non-serious.
Severe muscle pain and stiffness with fever in area surrounding injection site within 12 hours. Raised welts, itching in area surrounding injection within 24 hours. Pain in underarm to breast of left arm. Symptoms treated with over the counter pain relievers and over the counter allergy medicine. Symptoms resolved by 4 days.
Pt recvd 1st dose Hep B 7OCT91 & on 13OCT91, exp severe h/a, achiness, chills, fever, nausea, anorexia & sl jaundice; sx lasted 2 wks; pt tested neg for mononucleosis, hep & on 30OCT91 was neg; shaking, chills, muscle & joint pain;
Information has been received from a nurse concerning a patient born on 25-JUN-1922, who on 31-JAN-2008 was vaccinated with a 0.5 mL dose of PNEUMOAX 23. Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed a fever of 102 Fahrenheit lasting for two days. The patient sought unspecified medical attention. The patient was treated with aspirin. The patient has also received pneumococcal 23v polysaccharide vaccine in the past. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.