chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received expired ACT-HIB with no reported adverse event; Initial information received on 05-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient received expired act-hib with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Dec-2022, the patient received a  dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection, (Dose number :1)Dose: 0.5 ML (millilitre) 1X and Drug Treatment Duration: ONCE lot UJ635AAB , Expiry date : 30-NOV-2022 ( strength, dose site, route: unknown, ) for Immunisation  On 01-DEC-2022 the patient received expired act-hib with no reported adverse event (expired product administered) same day following the administration of HIB (PRP/T) VACCINE.  Reportedly "Vaccine Coordinator reporting a patient received expired ACT-HIB. The caller advised the product expired on 30Nov2022 and a patient received the vaccine on 01Dec2022. Should the patient be revaccinated or was the product viable"  Action taken was not applicable..  At time of reporting, the outcome was Unknown for the event   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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
A red circular hard rash appeared at the injection site of my left arm.  The diameter of the rash was approximately 4 inches.  The edges were distinct. The rash was not raised but it felt hot and hard to the touch (compared to the skin outside of the radius).  It was painful to touch.  After four days, the rash has substantially subsided, but I still have lingering soreness and a smaller red patch at injection site.  The diameter of the rash is now an inch.
No additional AEs were reported; patient received improperly stored vaccine.; This spontaneous report was received from the healthcare worker and referred to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-AUG-2022, the patient received improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot #W003118, expiration date: 13-JUL-2023; lot #W015191, expiration date: 27-OCT-2023; dose, strength and route were unknown) for prophylaxis (Product storage error). The patient received only one dose but the healthcare worker did not specify which actual lot the patient received the vaccine. The temperature was 11.3C and time frame was 34 minutes. No previous temperature excursion. No additional AEs were reported, no further information provided (No adverse event).
Pain where shot was giving with swelling.  Pain in both arms and back and neck.  Fever, chills body aches, sore joints bad headaches.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 02-MAR-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-AUG-2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Headache, Myalgia, Fever, SkinRash, NauaseaVomiting, Fatigue, chills Narrative: Reported chills, fever, HA, body aches, nausea and fatigue. symptoms resolved. On 2.6 developed shingles. PCP stated that pt. immune system was stressed which caused outbreak. Reported chills, fever, HA body aches and fatigue with 1st vaccine.
12/11/2019 The child was accidently given 0.25CC of Tuberculin PPD into the right lateral thigh instead of Influenza Vaccine on 12/07/19. The parents were informed as soon as the mistake was realized and were advised to monitor the child. I discussed with pediatric infectious disease (DR.) regarding the error. He stated that the child may not have any problems besides a small bump at the injection site. I rechecked the child on 12/09/19. The child had a small bump (Less that a pea size) in the right lateral thigh. Parents had more questions, so I referred to the pediatrics infectious disease group. Parents will make the appointment. Also, CDC was contacted and appropriate forms filled out.
Swollen lip; Droppy lip; This spontaneous case was reported by a pharmacist and describes the occurrence of LIP DISORDER (Droppy lip) and LIP SWELLING (Swollen lip) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 016821A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 01-Nov-2020 and Lip augmentation (Lip fillers.).   On 19-Mar-2021 at 2:11 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced LIP DISORDER (Droppy lip). On 20-Mar-2021 at 8:00 PM, the patient experienced LIP SWELLING (Swollen lip). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 22-Mar-2021, LIP DISORDER (Droppy lip) and LIP SWELLING (Swollen lip) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive,  rapid test.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. Patient did not experience any adverse effects for the second dose and did not take any medications.    Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Reporter address and patient demographics added. Medical history was added. Lab data was added. Updated first dose date, batch number and anatomical location along with second dose details. Updated start date of events, stop date and outcome. Added treatment medication.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 60-year-old male patient who received SHINGRIX (batch number J4D5J, expiry date unknown) for prophylaxis. The patient's past medical history included shingles (1 to 2 times every year for the past 30 years from the reporting date). On 29th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were received as follows: The healthcare professional stated that the patient had a history of reoccurring shingles. After vaccination with the dose of SHINGRIX the patient developed shingles. No further details provided regarding the event. The reporter consented to follow up.
pt recvd vax & approx 6 hrs after vax, devel total body myalgia; lasted for 24 hrs;
administration of Menquadfi today, as per past immunization record patient had his initial dose when he was 12 years old and booster dose when he was 16 years old with no reported adverse event; Initial information on 29-Aug-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 18 years old male patient who got administration of meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] today, as per past immunization record patient had his initial dose when he was 12 years old and booster dose when he was 16 years old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine B for Prophylactic vaccination.  On 29-Aug-2023, the patient received 0.5 ml (TOTAL) dose 3 of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection (lot U7675CA and expiration date- 01-Oct-2025) via intramuscular route in the right deltoid (strength: not provided) for Immunization (inappropriate schedule of product administration) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
On 4-3-13 mother brought her son age 1 yr into Health Dept for immunizations. Nurse administered a KINRIX instead of a Hib vaccine.
Information has been received from a female consumer of unknown age reporting on herself. On unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, lot #, expiration date and route were not reported). On unknown date after receiving PNEUMOVAX 23 her arm swelled and she had to carry it on a pillow for 3 days, before she was able to drive. The patient was treated with BENADRYL. The patient sought unspecified medical attention. The outcome of the event was unknown. Additional information is not expected because there is not reporter's contact information.
While at recovery pt complained of dizziness, became pale and diaphoretic. Immediately sat pt on floor( refused to elevate feet). leaned against wall with ice pack to back of neck , water for hydration.  no LOC no SOB no N/V.   VS taken 130/72, HR 98 reg strong, resp 16 reg non labored, SopO2 97% Pt stated this happened before with tetanus shot a long time ago.  Monitored  30 minutes.  Provided reassurance  pt stated I feel fine now. OKd to exit
The end of July I noticed a dry scaly patch on my upper cheek. I did not pay much attention to it. When we got to (Privacy) it got worse. It was in the folds of my cheeks and was peeling down those fold. That is when I went to the Clinic. I saw a PA and she diagnosed it as atopic dermatitis and she prescribed corticosteroid cream. It did not help. It was getting worse. I called the doctor, she diagnosed it as atopic dermatitis and prescribed me another steroid cream and that did not seem to be helping and I went back, and she said I would need to have the patch test on my back. In the beginning of December, I had the patch test. That was 80 different items they tested for. I have gone fragrance free, different detergents. It is just strange that it just popped up all of a sudden. I would say no, I have not recovered from AE because I still have it on my face and on my eyelids and now I have it behind my knees and inside my upper thighs. I just started a new ointment this morning, Tacrolimus ointment 30 mg. I should apply it for 7 days and stop it if it has not gotten better.
PATIENT REPORTING LINGERING PAIN AND TINGLING AT INJECTION SITE (06/23/2017).
Mild illness; Tested positive for COVID; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Mild illness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced ILLNESS (Mild illness). At the time of the report, ILLNESS (Mild illness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She tested positive for COVID on 1/6/2021 via nasal swab PCR. Concomitant medications were not reported. Treatment information were not provided.
Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 17 year old female patient with attention deficit/hyperactivity disorder and penicillin allergy who on 27-NOV-2007 was vaccinated with the first dose of GARDASIL (lot# 659437/1266U) 0.5 ml intramuscularly. On 31-JAN-2008, the patient received the second dose of GARDASIL (lot# 659055/1522U) 0.5 ml intramuscularly. The patient received the third dose of GARDASIL (lot# 659182/1757U) 0.5 ml intramuscularly on 12-MAY-2008. Concomitant therapy included methylphenidate hydrochloride. The patient was pregnant after receiving the three doses of GARDASIL. No adverse effect was reported. The patient sought unspecified medical attention. Estimated last menstrual period: 19-MAY-2008, Estimated delivery date: 23-FEB-2008. Follow up information has been received from the physician, who reported that on 26-JAN-2009, the female patient delivered a normal and healthy male baby weighing 3062g and apgar score 7/9. There were no congenital anomalies and complications or abnormalities. No complications during the labor/delivery and diagnostic tests during pregnancy were not performed. No infections or illnesses during the pregnancy. The patient had hypertension, eclampsia and seizure during her pregnancy. The patient did not have prenatal care. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
I got sick to my stomach within 15 of vaccine. I was unable to throw up - I did a little but it was just bile in my stomach. They monitored for about an hour and a half. They gave me some motion sickness medicine. I went home after that. I had upset stomach for the rest of the day - went to bed early. The second symptom came one week and one day later. I woke up that Saturday morning, and my arm was itching and then I noticed there was a small lump under the skin - about the size of a quarter. I called the doctor and they said to draw a circle around the lump. My arm was really itchy and the lump was red. It changed shape and grew and by the next day it was pretty much my whole upper arm that was red and swollen and itchy.  I saw a doctor then on  Monday, I saw the doctor and she said she had the same experience after her vaccine but it hadn't taken so long for her to get her symptoms. She was sure it was an allergy at the injection site. Prescribed me an ointment to relieve itching - a prescription cortisone or something. By late Tuesday or Wednesday it was completely gone.
Experienced irregular, shortened, and lighter periods beginning 8/4. Pattern occured in Aug, Sept, and Oct. 3rd booster and ovulation experienced nausea. Reported symptoms to doctor. Was diagnosed with subclinical hypothyroidism after 5-8 years of taking no medication from Graves Disease hyperthyroidism once disease went into remission. My numbers have fluctuated toward hypothyroid without medication and stress events also more likely to make me hyperthyroid. For this reason, hypothyroidism feels rare and could possibly be linked to vaccine.
Within 3 hours of the event, started having expected side effects of headache, bodyaches. That night had difficulty sleeping and new onset neck pain as well. Finally took tylenol at 3AM. Woke up at 9:15 and walked from bedroom to kitchen at which time had severe orthostatic hypotension with near sycope that did not progress to full syncope due to lying down quickly.  Continued with tachycardia for several days and mild shortness of breath for two days.   That evening, had  new onset RUQ abdominal pain for 2-3 hours that resolved.
FLARE UP VERY OCCASIONALLY; Fatigue; BODY ACHES; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (FLARE UP VERY OCCASIONALLY), FATIGUE (Fatigue) and PAIN (BODY ACHES) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (FLARE UP VERY OCCASIONALLY), FATIGUE (Fatigue) and PAIN (BODY ACHES). At the time of the report, CONDITION AGGRAVATED (FLARE UP VERY OCCASIONALLY) had resolved and FATIGUE (Fatigue) and PAIN (BODY ACHES) was resolving.      This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Reporter causality with Humira was provided as Not Related to all the events.
Information has been received from a health professional concerning a female patient who was vaccinated with a first dose of Gardasil. Subsequently the patient passed out after receiving the vaccine. Therapy with Gardasil was discontinued. Additional information has been requested.
Seven days after Flu vaccine, ascending pain and paralysis occurred up to mid-face. Inability to swallow, breath and function. Six days out, went into respiratory failure, EMG and spinal tap confirmed Guillain Barre Syndrome. *Plasma Pheresis- trtmt at least 95%. 10/17/07-records received for DOS 11/26-1/5/07-DX: Guillain-Barre syndrome. Initially presented to transferring facility on 11/21/06- with C/O paresthesia of hand and lower extremities up to her knees. Sunday prior to admission was suddenly unable to walk. Recently had hip surgery. Flu shot prior to surgery in early 11/2006. Progessively weakened and developed respiratory failure requiring intubation, ventilation and tracheostomy and PEG were inserted. Eventually weaned off of CPAP. Problems with abdominal pain and reflux and nausea. Abdominal laparoscopy revealed a dislocated hip replacement and hip arthroplasty was performed. Transferred for rehab.
c/o sneezing, pt eyes edematous;lungs clear;VS 100/60, HR 120, R28;pt c/o eyes burning, red purple color around eyes;DPH given;no breathing difficulty;
Headache, backpain, fever, joint and swelling in arm where the vaccine where inyected. Inflamation under the arm. Rash in the vaccinated arm. Tireness. Urge to drink water.
Non irritating rash that appeared at injection site 1 week later and resolved after 5 days.
Erythema nodosum. Bright red rash about 20x10cm in diameter located at the anterior left lower ext. Warm and tender to touch. Clear demarcated. Redder papula within the rash area. No scratch marks. Most likely cellulitis: start pt on doxycycline, oxycodone for pain, and monitor vitals closely. Affected area is marked. Will f/u tomorrow. DDx is erythema nodosum due to the location, redness, and tenderness of the rash. Pt had hep B vaccine back on Jan 26th. Possible cause of erythema nodosum.
I went home and took my daily nap. I was really tired and not feeling well. The next morning, I woke up with a fever and I had fatigue. I was also coughing and had SOB. The doctor said I needed to go to urgent care. I had a breathing tx and a steroid injection. I was told I also had a respiratory infection. I was also given steroid pills, antibiotics and pump. Still have a lingering cough.
A week after receiving an influenza vaccine, reports feeling pain and weakness developing in L deltoid. Pain/weakness has not subsided or decreased as of 10/24/16. Also reports pain in L neck and jaw. Describes pain as dull aching that is unrelieved after 2 weeks.
About a month after the 2nd dose, I started having a pain in my chest. The doctor thought it might be anxiety so it was treated as such but it kept getting worse. Around Thanksgiving I thought I was having an attack of some kind even though I?d never had heart problems in the past. I called the doctor and was scheduled immediately for a gallbladder ultrasound, EKG, and lab work. The EKG revealed a right bundle branch block that has a known cause of myocarditis. I am under the care of a cardiologist currently and have more tests scheduled this week.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 21-NOV-2013, the patient was vaccinated with an expired second dose of GARDASIL (Lot # reported as 030GAA, expiration date 10-MAY-2013) (route not reported). No adverse symptoms were reported. Additional information has been requested.
About 10 minutes after receiving Tdap, the patient c/o itchy rashes all over both under arms spreading to upper arms.
Patient complained of itching all over, not specific to just the injection site.  Described as creepy-crawly itching sensation.  Relieved by some Benadryl.
HEADACHE,WEAKNESS, NAUSEA, CHEST PRESSURE LASTING 4 DAYS UP TO AND INCLUDING TIME OF ER VISIT. ALSO COMPLAINED OF DYSPNEA ON EXERTION.