chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-Jun-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient was the reporters mother. The reporter stated that the patient did get shingles after the Shingles shot and that the patient never had shingles until she got the Shingles vaccine. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
I had a deep burning pain in my biceps, it came 3/4 times a day lasting a min - hour each time. When I went to the doctor and got a ultra sound they found a lot of fluid so I got sent to orthopedics. Went from burning to aching, after MRI initial pain came back and lasted for a week and now its back to being a aching muscle again.
Muscle ache and joint ache starting 2 days after first injection and lasting for the next 9 days.
Temp. of 100, rash started on (R) leg, and spread to (B) legs and diaper area.
Pt's face and neck on (L) side had rash. Later in day was covered with red raised dots-went to urgent care-all within 22 hours of receiving DTaP #5 on 3/11/08 at clinic.
Over two days developed 12 x 15cm area of induration, warm, redness.
major issue since getting vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (major issue since getting vaccine) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 VACCINATION COMPLICATION (major issue since getting vaccine). At the time of the report, VACCINATION COMPLICATION (major issue since getting vaccine) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Treatment information was not provided. Concomitant medication was not reported.
18-20 hrs after injection, pt developed redness, swelling, hot to touch on Rt arm. Seen in office on 8-19-09, recommend apply ice, use BENADRYL.
Information has been received from a physician concerning a 14 month old male patient who on 12/17/2002 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 641878/0182M).  On 12/25/2002 the patient developed a measles-like rash.  It was noted that the patient was afebrile and did not require hospitalization.  Unspecified medical attention was sought.  The physician also reported another patient that developed a severe measles rash and swelling in hands and feet (WAES # 0301USA00833).  "MD concerned since probably from the same lot since given in her office on the same day".  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information has been requested.
This spontaneous report as received from a physician refers to a female patient of unknown age with anxiety, arthritis, Gastrooesophageal reflux disease (GERD),  polio in 1948 and dysplasia on her right side. On 13-MAY-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H017759, expiry date on 04-JUL-2014, standard dose and route). Concomitant Medication: Unspecified medications for treatment of GERD, Anxiety, Arthritis, and Dysplasia on her right side. The patient developed swelling similar to Cellulitis in her arm after receiving PNEUMOVAX23. The patient went to the emergency room(ER) for treatment and received ice before being released. The patient re-presented to the doctor's office on 15-MAY-2013 and was given ROCEPHIN for treatment. The swelling was about 7 inches across the injection site and 7 1/4 inches along the length of the arm and possibly spreading. The outcome of event was reported as recovering/resolving. The physician considered the event was significant disability or incapacity as patient was still in pain. Additional information has been requested.
First dose moderna: 3/18/21 Second dose moderna: 4/15/21 Conceived: 4/14/21 Miscarriage at 7.5 weeks pregnant. Baby stopped growing at size 6 weeks pregnant.  Due date: January 17 2022 Pregnancy confirmed 5/24/21. gestation age: 8 weeks 1 day based on LMP.  Baby only measured 6 weeks 0 days on this date.
CLIENT CALLED ON 5-9-06 TO REPORT L ARM SYMPTOMS THAT BEGAN 5-5-06. STATED THAT L ARM GOES NUMB FROM FINGERS UP WITH SHARP PAINS WHEN BENDING/LEANING ON ELBOW. SYMPTOMS WERE WORSE ON 5-8-06 BUT BETTER TODAY.
This spontaneous prospective pregnancy report was received from a nurse reporting on herself, a 29 year old female patient. The patient had none pertinent medical history, concomitant medications, drug reactions, or allergies. Approximately on 26-FEB-2018 (reported as "2 weeks ago"), the patient was vaccinated with a 0.5 ml dose of VARIVAX injection (route of administration, lot #, expiration date were not reported) for prevention of chickenpox. Approximately on 10-MAR-2018 (reported as "2 days ago"), the patient discovered, that she was pregnant through a pregnancy test. Therefore, the vaccine exposure was in the first trimester of pregnancy. Pregnancy gestation was reported as "maybe a month". Last menstrual period was calculated as 12-FEB-2018 and Estimated Date of Delivery as 19-NOV-2018. The pregnancy outcome was pending and the fetal outcome was unknown. It was reported, that no adverse event (AE) was reported. No treatment was given for adverse event. The patient did not seek a medical attention.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Severe, Additional Details: patient left after about 45 minutes  called patient about 2 hous later and was much better
Hives and itchiness all over body. Originated around waist, but seemed to spread to anywhere pressure was commonly applied. swelling of the palms as well.
Cellulitis at injection site; erythema/warmth and swelling increasing, per Mom, since day following injection. Rx'd w/Abx & cold pack.
Patient is a 84 y.o. female patient of, MD with history of dementia, COPD, and mood disorder who presented to  Hospital with altered mental status, dyspnea on exertion and diagnosed with COVID-19 infection and MSSA bacteremia   Assessment and Plan   Sepsis due to unknown source, POA MSSA bacteremia Blood cultures 2 out of 2 grew MSSA No obvious source of infection, denies back or neck pain Son states patient had dental abscess with root canal done end of January 2023. CT maxillofacial without contrast-periapical lucencies sugestive of dental abscess, ? Right source CT Chest and abdominal  negative Echo with no vegetation and normal LVEF On Ancef 2 g IV every 8 hours day #2, repeat blood cultures on 4/24 NGTD Afebrile, WBC normalized Check WBC scan-results noted and discussed with son no further imaging planned as it does not alter the ongoing management. Discussed about need for clinical monitoring  after completion of IV antibiotics and son verbalized understanding. D/w ID and felt stable for discharge home on IV rocephin 2g daily for two weeks F/u discharge protocol for labs monitoring while on antibiotic and repeat blood culture one week after IV antibiotic as instructed     Acute respiratory failure with hypoxia- resolved COVID-19 virus infection with potential bacterial superinfection Date of onset of symptoms: Unable to determine from patient, but declining mental status over the last several days Symptoms present on admission: Confusion, chronic cough without change Date of covid positive test: 4/21/2023 Vaccination status: vaccinated Imaging: CXR showed no acute findings. CTPA chest and abdomen showed no PE, bibasilar atelectasis, possible trace pleural effusion Oxygen requirements on admission: 2 L Current oxygen requirements: O2 sats in low 90s on room air Medical therapy: not indicated Anticipated special isolation end date: 4/27/23 per ID Inflammatory markers; CRP 122 To maintain dry lung strategy we will give Lasix 20 mg x 1 Procalcitonin elevated secondary to MSSA Antibiotics changed to Ancef as mentioned above     Acute UTI Abnormal urine analysis with urine cultures positive for Staphylococcus Monitor PVR, straight cath as needed if bladder scan greater than 300 mL On Ancef as mentioned above   COPD Not in acute exacerbation As needed bronchodilators Resumed outpatient Advair (changed to Symbicort per formulary)   Dementia Continue home Aricept, Namenda, and Remeron   Acute metabolic encephalopathy Suspect secondary to infection in setting of baseline dementia Started on Seroquel 25 mg at bedtime, wean as able Continue to monitor with treatment of above issues Frequent orientations and avoid sedation Hypokalemia Received 1 dose of Lasix on 4/22 for dry lung strategy Check mag level Supplement oral potassium again and  recheck in a.m.   Moderate Malnutrition Poor appetite over the last several days Augment nutrition
At 11:30am patient complained of "feeling dizzy" and a "numb tongue". We advised staying another 15 minutes after the initial 15 minutes. Patient agreed. Pt was able to stand without issue after 30 minutes. Denied numbness before she left.  She didn't drive here, but walked from home. She refused to go to hospital and said she was fine to walk home.
Arm swelled became hard and painful.  Erythema tender left upper arm around vaccine site and some swelling 9 1/2 x 8cm.  Doctor visit for evaluation on 07/23/2005.
On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 23-Aug-22; No adverse event; The patient received dose after 30 day use date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 23-Aug-22) and NO ADVERSE EVENT (No adverse event) in an 86-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Unspecified vaccine, Dose 1), COVID-19 Vaccine (Unspecified vaccine, Dose 3 (First booster dose).), COVID-19 Vaccine (Unspecified vaccine and Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine, COVID-19 Vaccine and COVID-19 Vaccine.    On 23-Aug-2022 at 11:36 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Aug-2022 at 11:36 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 23-Aug-22) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 23-Aug-22) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 23-Aug-22).    No concomitant medications was reported.  On 18-Apr-2022 the vial was delivered and stored in the refrigerator on same date. The vial size is of 5.5mL. The vial did not undergo any temperature excursions. Vaccines were only offered on Tuesdays from March-2022 forward to the patient. For each Tuesday vaccine date, only removed one vial from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator).  No treatment medication was reported.
Swelling and erythema to site; extended to all arm - Hot to palpation - Dx: Cellulitis to (L) arm.
Information has been received from a physician concerning a 5 year old male who was vaccinated with a dose of Varivax. Subsequently the patient broke out with chickenpox. The patient's 3 brothers experienced chickenpox following vaccination with Varivax (WAES# 0605USA04858, 0606USA01456, 0606USA01458). Additional information has been requested.
same day as vax-became sl red-next AM has circular rash 1 1/2 inch diameter w/tapering rash down arm-area reddened-swelled & warm to touch;taking Nuprin instructed to take APAP for pain, apply cold moist pack, & call MD if no improvement
I woke up Tuesday morning with a scratchy throat and congestion and thought it was allergies, I woke up the next day I had the sore throat but it was worse, headache, body aches, and so then it progressed to my chest and started with a cough on the Thursday and on Sunday or Monday I was feeling much much better and then yesterday everything took a turn backwards. I was prescribed Paxlovid from the telemedicine RNP and have been taking that. I am still sick as of today.
Narrative:  pt had a covid vaccine within 42 days of death. unknown cause of death.
This spontaneous report as received from a father's and mother's consumer refers to a 8 years 6 month old male patient with autism, who on 05-OCT-2012, was vaccinated mistakenly with a dose of GARDASIL (dose, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The reporters' consumer reported that the patient had an appointment with his pediatrician to receive the second series of Hepatitis A vaccine (manufacturer unspecified), however the pediatrician's office mistakenly administered the GARDASIL vaccine. No treatment information was reported. Additional information has been requested.
6/22/05, 11:30 AM, mom calls and says pt has a temp of 105, rectally. Asked about if she had given Tylenol. States she had Motrin throughout the night for fever and fussiness but ran out by 05:00 AM. Primary MD has informed her to alternate Tylenol with Motrin. Ok, 6/23.
Tested positive on 11/04/21  while conducting testing for all of the residents.  Patient claims to feel tired.
This case was considered medically important. Information regarding PREVENAR was received from a healthcare professional regarding a 7-month-old patient who experienced strep pneumoniae meningitis. The patient received a dose on an unspecified date. On an unknown date, the patient developed strep pneumoniae meningitis. The child reportedly had received all required vaccinations. The outcome was not provided. No additional information was available at the time of this report.
Patient is a six-month old healthy male who has been followed in our practice. he was most recently seen on Wednesday, September 4 of 2002 for his routine six-month well check. At that time he was noted to be healthy with excellent growth parameters, and the physical exam notned mainly for some mild seborrhea. he was given his third does of DPT, hemophilus influenzae and Prevnar injections. He was noted to be formula-feeding well, and on the night prior to admission he was noted to be somewhat fussy. On the morning of admission, the parents, upon changing the diaper noticed a significant swelling in the right groin area. In addition, he was noted to have a fever, mainly to touch. There was been no vomiting, no diarrhea. He has had no upper respiratory illnesses of note, and he has had good urine and stool output. The parents have also noted a slight redness at the meatus of the penis, but there have been no open sores or diaper rash noted. The patient was brought to our office, and upon examination he was found to have a rectal temperature of 101. His other vital signs were normal. He was found to be active and alert to exam, but did demonstrate a rather large 4cm by 2.5cm mass lesion in the right groin area. Overlying skin appeared to be red and tender upon examination, and slightly warm to the touch. His GU exam was otherwise remarkable for slight erythema at the meatus, however his testicles were descended bilaterally and did not show any evidence of any swelling or erythema of the scrotal area. Because of a suspicious for cellulitis/lymphadenitis, a peripheral CBC was done in the office, which demonstraed a white cell count of 24.2, normal hemoglobin and hematocrit, and differential of about 36 lymphs and 64 polys. Because of possible bacterial lymphadenitis/cellulitis, and possible bactermia, patient was referred to facility for admission and IV antibiotics.
Rash two days post injection. Starting on neck then spread to arms and legs. Blotchy, non raised, reddened rash that itched and burned when scratched. Benadryl and cortisone cream used with little help. Oral antihistamine such as Benadryl was effective. Rash would go away and return after 1 or a few hours and show in a different area than previously. In the morning and in the evening worse. Rash would show on eye lids and face as well. Lasted about 2 weeks then resolved on its own. Now skin is more photosensitive  and blotchy rash will develop with certain creams or sun exposure without specific sunscreen reapplication
Extra booster administered; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra booster administered) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension, Coronary artery disease, Congestive heart failure, Hypothyroidism, Dementia, COPD and Drug allergy (Allergy to simvastatin).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Extra booster administered). At the time of the report, EXTRA DOSE ADMINISTERED (Extra booster administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No prior vaccine allergy reaction reported. No treatment medication were provided.
A rash appeared on my upper right hip that itched quite severely at first, but no longer does. Still, the red dots remain.
2/24/2021 2/26/2021: High Fever and body ache till 2/26 early morning. 2/26/2021: Became very dizzy and FAINTED/PASSED OUT in Restaurant after eating dinner and had 1 beer/1 smoke.  Went and sat in a chair when dizzy and passed out in the chair.  Created panic in the restaurant.  Was Fever free since morning.  PASSED OUT FOR about 5 minutes.  Woke up and profuse sweating for about 3 minutes after which felt normal.
Swelling of eyelids, left lower lip. Hives and itching on thighs, arms, around breasts, hips, upper lateral back, side of left eye.  Severity decreased, but I don't know what to expect tomorrow.  Usually It starts again every morning since the first dose. However it was mild after first dose, more severe after second dose. Hives stayed whole day this time.
Information has been received from a consumer concerning her 17 year old daughter with allergies to amoxicillin and sulfonamide and no pertinent medical history reported, who in June 2008, was vaccinated with her first dose of GARDASIL. Subsequently the patient experienced hair loss. In August 2008, the patient was vaccinated with her second dose of GARDASIL. The hair loss became worse after the second dose of vaccination and she was "recently" diagnosed with anemia. No further information was given. Concomitant therapy included ALLEGRA. Lab diagnostics studies performed included routine blood work. The patient had not recovered at the time of the report. The patient was seen by a physician. Additional information has been requested.
I am having debilitating migraines for over a week almost every day. This is effecting my every day life.
Patient reports swelling and redness on left arm at a location below the injection site. Noticed at about 24 hours after the shot was administered. Reports tenderness and inflammation (heat), not related to injection site pain. Has tried icing and benadryl but nothing has relieved the symptoms.
It was reported that a patient (1of 6) received a Fluzone SV '01-02 vaccination, Lot Number UO590AA administered IM on 09/26/01.  Reportedly, the patient developed a local reaction consisting of pain, redness and warmth at the injection site.  Patient was treated symptomatically and the symptoms resolved. Linked cases U2001-01195, U2001-01196, U2001-01197, U2001-01198 & U2001-01199.
This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 15:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure, cholesterol, fusion surgery on c6/c7, known allergy to cantaloupe and known seasonal allergies. Concomitant medications included lisinopril 10mg (MANUFACTURER UNKNOWN), rosuvastatin 5mg (MANUFACTURER UNKNOWN), and cyclobenzaprine (MANUFACTURER UNKNOWN); all for unknown indication from unknown dates. The patient previously took azithromycin (MANUFACTURER UNKNOWN) for unknown indication from unknown date and experienced drug allergy.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 18Mar2021 the patient experienced mild headache for the first 2 days. On 21Mar2021, on the third day, the patient experienced severe migraine. On an unknown date in 2021 the patient experienced vertigo periodically. The patient reported to have had hazy and mild headache lasting since the vaccine. The headache "comes and goes" as reported. The patient had no fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events headache, migraine, and vertigo were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.