chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states she developed an itchy rash on her back along her bra line and on some other areas of her body that resembles the zoster rash
Within 1 hour of administration patient became nauseated, fatigued and light headed. Nausea increased to vomiting & inability to keep food or liquid down. Treated with fluids & phenergan PRN over following 3 days.
This spontaneous report was received from a physician, via a company representative, concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 07-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2018, 0.5 ml (route and anatomical location of administration were not reported). On unspecified dates, the PNEUMOVAX 23 vaccine had two temperature excursions of 1 Celsius Degree for 168 hours and -1 Celsius Degree for 96 hours, respectively. The vaccine status was reported as "in excursion" and the type of excursion and storage criteria were reported as "refrigerator (R)". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Initial report received on 14 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 14-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3783AA received on 21 July 2011, C3912AA received on 22 September 2011 and C3818AA received on 22 November 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 21 July 2012, approximately 8 months after the last dose. On 23 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 24 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 24 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
30 minutes after injection rash on the backs of both arms and throat - sent to PMD. At arrival to PMD office rash covered entire body and tongue "felt thick". Per patient, "doctor said it was definitely a reaction to the H1N1 shot. Given shot of antihistamine and shot of steroids and sent home".
Mild edema and erythema right arm decreasing MOC history. Using Tylenol and cool soaks.
1 hr  p/vax began vomiting frequently (4-6 times per hr); also became listless, cold & clammy; 4 hrs later was taken to ER & was given Tigan suppository;
Patient presented back to the mass vaccination complaining of headache and dizziness. Patient directed to the emergency department in no acute distress.
Nausea, fever, bodyaches, chills, lethargy, headache, cognitive difficulty
Patient started to have seizure-like episodes that last for an average of 5 seconds within 20 minute intervals of less. His entire body became tense and his breath ceased during the episode.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 16-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally (lot # R034700, expiry date 16-JUN-2020) for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000895:
inconsolable crying for more than 6hr when returned to office;sl swelling @ inj site lt thigh;
Caller notes no symptoms were reported. No additional AE's/PQC's reported; a temperature excursion that occurred on 5/27/2021 and notes (1) patient was given VARlAX on 6/10/2021; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 10-JUN-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route of administration were not reported, 1 dose, lot # T027299, expiration date was 12-AUG-2022) for prophylaxis (product storage error).   It was reported that the suspect vaccine was exposed to a temperature of minus 11.8 degree Celsius for a time frame of 30 minutes, as recorded by the digital data logger (on 27-MAY-2021). There were no previous temperature excursions. No additional adverse event reported.
While driving home experienced sudden numbness on right side of face/ear. Numbness of tongue and tingling of tongue and throat along with a metallic taste in mouth. Took Benadryl around clock and symptoms improved, but still mildly present this morning.
12/25/21: Patient presents to the ED with weakness and loss of appetite for several days. Patient's son, who lives with patient, reports for the past few days, his father has not been eating much. he reports generalized weakness, resulting in multiple falls. Patient complains of bilateral hip and bilateral knee pain but states it is manageable. He did have a low grade fever a couple days ago but none since. He also has an increased non productive cough and chronic post-nasal drip. His son did have COVID about 1 month ago, but had done his best to stay away from the patient. Upon arrival to the ED, pt VS are stable, labs show Na 133, k 3.4, BG 280, BUN 32 and creatinine 1.69. CXR shows partial groundglass opacity. Patient received first dose Pfizer vaccine on 2/23/2021 Lot # EL9265 and the second dose on 3/16/2021 Lot # EN6205
Vaccinated at 11 years of age;   Client registration indicated incorrect Date of Birth (12 years).  Registration and consent to vaccinate completed by parent with verification of Correct Age to Receive COVID-19 Pfizer BioNTech vaccine and verification that child belongs to vaccine eligibility group.   Client age verified at clinic twice, in registration and at vaccination station.  Client (child) stated date of birth both times to separate nurses at the clinic.  Client vaccinated as a 12 year old.
PT RECEIVED MONOVALENT INSTEAD OF BIVALNT, NO ADVERESE EVENTS AT ALL, PT WILL GET VACCINATED WITH BIVALENT IN 8 WEEKS
43 days since first dose and hasn't received second one; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL DOSE OMISSION (43 days since first dose and hasn't received second one) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ex-smoker and Blood pressure high.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced INTENTIONAL DOSE OMISSION (43 days since first dose and hasn't received second one). On 01-Mar-2021, INTENTIONAL DOSE OMISSION (43 days since first dose and hasn't received second one) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium
11am day after shot/ uneasy wanted to lie down. 1pm went home from work. 2pm. extreme dizziness, fever -pressure in head and chest. 230pm slept until 430pm. dizziness lessened and I could walk again but closing eyes/ opening them again (on purpose) re-adjustment holding of wall / chair required. sat at computer checking to see symptoms / whether I needed to call an ambulance. 6pm pressure and fever relented dizziness dropped to mildly dizzy. went to bed at 11:30pm. Mild dizziness has been consistent since awake now all day friday. Still not feeling well enough to drive. called out sick at 530am. mobile in house but feeling see-sick like dizzy still at 1pm. Still have mild pressure in head and wobbly.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Pt's chest pain resolved prior to transport to hospital
Patient stated he had an adverse reaction following 2 nd dose of Pfizer COVID-19 vaccine. Symptoms included headache, dizziness, abdominal discomfort, and chest pain. Patient visited ER where he was cleared and no further treatment was advised at this time.
9pm had chills then a hot flash, slight stomach ache. Went to go use the restroom and passed out and fell.  Woke up and was stood up by friends and passed out again.  I do have a history of vasovagel syncopy but it hasn?t happened in over 10years
Patient is a 76 y.o. male patient of DO with history of type 2 diabetes with previous diabetic foot wound, paroxysmal atrial fibrillation, OSA intolerant to CPAP presented to Hospital with acute shortness of breath.   Acute respiratory failure with hypoxia secondary to COVID-19 pneumonia Acute renal failure, possibly due to COVID-19 Metabolic acidosis, likely due to renal failure, resolved OSA, untreated Patient presented after developing shortness of breath and generalized fatigue yesterday On presentation oxygen was in the 60s and did respond well to nonrebreather Chest x-ray reviewed that shows diffuse bilateral interstitial infiltrate CT of the chest abdomen pelvis showed multifocal patchy opacities within the chest bilaterally concerning for viral pneumonia, no hydronephrosis or other abnormality noted within the abdomen or pelvis Positive for COVID-19 on admission Continue dexamethasone 6 mg daily Completed course of Remdesivir  Continue supplemental oxygen to maintain oxygen saturation greater than 88%, will use BiPAP if necessary on 3L O2.  Continue to wean off as tolerated  Acute renal failure requiring hemodialysis Unclear etiology of acute renal failure CT of the abdomen pelvis not show evidence of hydronephrosis Creatinine significantly elevated at 7.65 on presentation UA unremarkable S/p tunneled catheter placement and kidney biopsy per IR 3/27 Undergoing hemodialysis per nephrology FU pathology report   Type 2 diabetes with diabetic foot wound and long-term insulin use History of osteomyelitis of the foot currently on outpatient IV antibiotics Known history of type 2 diabetes with most recent A1c of 7.7 Blood sugars have been under adequate control at home Was hypoglycemic on arrival so we held basal insulin and started sliding scale insulin Basal insulin increased to 40 units last night Blood sugar at goal Continue sliding scale insulin Continue to monitor blood sugars and adjust regimen as necessary He is currently on cefepime and vancomycin for recent diabetic foot wound No evidence of worsening infection, appreciate ID recommendations, completed cefepime 3/24.  Continue wound care and wound VAC management but budipine.  Outpatient follow-up with primary podiatrist   Paroxysmal atrial fibrillation Patient has history of paroxysmal atrial fibrillation, likely stress-induced Currently in normal sinus rhythm with rate controlled Not currently on anticoagulation as it was a one-time episode   OSA Known history of OSA and has been able to tolerate CPAP so he is not on CPAP at home Is having acute respiratory failure with concerns for COVID-pneumonia as discussed above Continue supplemental oxygen to maintain oxygen saturation greater than 88% but if unable to maintain saturation he may require BiPAP given his acute respiratory failure and COVID-pneumonia
Information has been received from a billing manager concerning a 14 year old female who on 25-SEP-2007 was vaccinated with a 1st dose of GARDASIL (lot# 658282/0929U).  On 10-DEC-2007 the patient was vaccinated with a 2nd dose of GARDASIL (lot# 656372/0243U).  On 14-APR-2008 the patient was vaccinated with a 3rd dose of GARDASIL (lot# 659441/1446U).  Concomitant therapy included HAVRIX, lot# AVB223AA).  Subsequently, on 14-APR-2008 the patient fainted 5 minutes after receiving her 3rd dose.  The nurse held the patient.  The patient felt weak so she laid down for 10-15 minutes.  The patient was given water and after 15 minutes, she was fine.  The patient had no symptoms following the previous 2 doses.  Additional information has been requested.
Within 24 hours developed eczema on thighs and lower legs. Became ill and congested with a low grade fever. Symptoms lasted for about a week. Eczema is still on going.
Vaccine received Expired on 4-17-22, report to Moderna, findings from internal review of vaccine:  "Analysis of the vials associated with your storage excursion is complete. The vaccine administered on April 19, 20, 21, 2022 from lot number 016J21-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."
Hives beginning in upper torso (not at injection site) that initially subsided with Benadryl. Returned with more severity two days later. Plaque hives covering 95% of body and on face and mouth. Patient continued Benadryl but was eventually seen by a doctor who prescribed Zyrtec, Pepcid, and hydooxy
Information was received on 19-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions, or concomitant medication was not provided. On or about 01-OCT-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 05-JAN-2016 the patient was treated by a physician for blistering vesicular outbreak accompanied by weakened immune symptoms and severe discomfort and distress, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of these malfunctions, 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, pain and suffering and other damages. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In January 2017, a physician administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In January 2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
ADACEL (Tdap) vaccine that was given instead of DAPTACEL (DTap) with no reported adverse event; Initial information received on 01-Sep-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 5-year-old female patient, diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] vaccine that was given instead of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] (dtap) with no reported adverse event and.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine for Prophylactic vaccination; and polio vaccine for Prophylactic vaccination.  On an unknown date, the patient received an unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (strength, lot number, expiry date: unknown) not reported via unknown route in unknown administration site for Prophylactic Vaccination (immunization).  On 21-Aug-2023, the patient received dose 1 of 0.5 ml total dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (lot: U7870AB, Expiry date: 23-Aug-2023) via intramuscular route in the left thigh for for Prophylactic Vaccination (immunization) and adacel (tdap) vaccine that was given instead of daptacel (dtap) with no reported adverse event (wrong product administered) (latency: same day)  Action taken with diphtheria, tetanus and acellular pertussis vaccine (Adacel) and diphtheria, tetanus and acellular pertussis vaccine (Daptacel) was not applicable.  Outcome: Unknown  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.
Sore arm; Real tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and FATIGUE (Real tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), FLUOXETINE HYDROCHLORIDE (PROZAC), VITAMIN B12 [VITAMIN B12 NOS], MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], VITAMIN D NOS, MAGNESIUM and IRON for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and FATIGUE (Real tired). At the time of the report, VACCINATION SITE PAIN (Sore arm) and FATIGUE (Real tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication also included acid reflux pill when she has acid reflux. Treatment information was not provided.   This case was linked to MOD-2021-320212 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Updated patient date of birth.
Lethargy x 3 days then vomiting requiring visit to ER and physician office.
Pt has developed a fever, red spots, vomiting, and an abscess on the left thigh. Pt was diagnosed with cellulitis of left lower limb.
experienced shingles rash; experienced shingles rash; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2020, the patient received the 1st dose of Shingrix. On 4th August 2020, 8 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced shingles rash on L 10-11th rib cage. The adverse event was collected. The HCP unable to provide vaccine details. The reporter did not consent to follow up.