chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/ not resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received all the shots and still had shingles and they were very painful. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Initial unsolicited report received from a nurse on 12 March 2015. A 60-year-old female patient, had medical history of hyperglycemia, hypertension, asthma and concomitant medications were not reported, had received a dose of ADACEL (Batch number C4714AA, expiry date and dose number was not reported) on 09 March 2015. On 09 March 2015, the patient had experienced body aches, chills, headache and soreness and redness and swelling and warm to touch at injection site on left deltoid. Laboratory investigations were not reported and corrective treatment included ibuprofen and ice pack. The patient had no illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects included allergy to ELAVIL and ZYRTEC. The event of body aches, chills and headache was resolved on an unspecified date. The event of soreness and redness and swelling and warm to touch at injection site was not resolved. List of documents held by sender: none. Follow-up information received from a nurses on 16 April 2015. The expiry date of ADACEL was reported as 08 April 2017. At the time of this report, the outcome of all the events was reported as resolved within 1 week of vaccination. Documents held by sender: none.
On 4/9/2021 started with left sided pleuritic CP and went to ED and found to have bilateral pulmonary emboli. On Eliquis 5mg BID No underlying chronic conditions for increased risk of PE Extensive work up without a direct cause found, no underlying malignancy noted
Patient called on 7/2 stating that 5 days after receiving vaccination started to have trouble walking and has had numb fingers. Patient states this has continued until now. Patient is going to follow up with doctor.
girl giving the vaccines  was rolling the vials back in forth in her hands/Received the vaccine from a vial that had been manually warmed by the woman who was administering the product; girl giving the vaccines  was rolling the vials back in forth in her hands/Received the vaccine from a vial that had been manually warmed by the woman who was administering the product; veins in my right hand started popping out; flush; temperature was but she told me it was very high; right arm is numb/complete numbness from my shoulder where my shot was put on and till my fingers/no feeling in my right arm; right arm is numb/she can raise it slowly.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in arm right on 28Feb2021 15:00 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization. Medical history included breast cancer for over 30 years. The patient also had left sided mastectomy and 11 lumpectomies on the right side. She had large tumor removed from her abdomen with stoma creation on 30Sep2020. There were no concomitant medications.  The patient described that she noticed the girl who was giving the vaccines was rolling the vials back in forth in her hands. She read that vaccines were kept in extreme cold. She received the vaccine from a vial that had been manually warmed by the woman who was administering the product on 28Feb2021. On that same day of 28Feb2021, the veins in her right hand were almost wanting to pop out of her hand (looked like when pregnant which the veins come completely out). The patient also asked them to take her temperature and the woman who gave the vaccine told her that she looked flush and asked her to drink a bottle of water as fast as she can. The vaccinating woman also mentioned that her temperature was very high as she looked flush. The patient also mentioned that her right arm was numb on that same day on 28Feb2021. She elaborated it as a complete numbness from her shoulder where her shot was put on until fingers. She has no feeling in her right arm while putting her sweater on it using her left arm. She can raise it slowly and was trying to hold a pencil and to try to exercise it. She put warm water in her hands as she no feeling with her right hand. The patient did not receive any treatment for the events of mobility decreased, flushing, body temperature increased, and vein disorder. The patient did not recover from numbness of upper extremities while unknown for the remaining events.
BLOOD VESSEL BURST IN RIGHT EYE; PAIN IN ARM; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: unknown) frequency 1 total, dose was not reported, administered at left arm on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, Patient's arm was also sore after getting the vaccine and resolved within a few days. On 31-MAY-2021, the patient looked in the mirror and noticed one of the blood vessels in the right eye had burst. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm on MAY-2021, and the outcome of blood vessel burst in right eye was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210600178- covid-19 vaccine ad26.cov2.s- blood vessels burst in the right eye. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Several hours after injection, patient noted rash, pain, redness, warm and swollen upper left arm. Patient seen in follow-up 8/13, 8/14, and 8/15 and 8/18/14. Treatment: 5 day course of clindamycin, probiotics. Resolved.
About 2 hours after receiving the H1N1 shot in my right arm, I began experiencing intermittent numbness and tingling in my right shoulder blade. This is still continuing as of 12/27/09.
Chills; cold sweat; he experienced a fainting spell/ Micturition syncope; fainting spell after getting the second dose and had a prior history of fainting 3 times in his life time; dizziness/Lightheaded; weakness; This is a spontaneous report from a contactable physician (patient). A male patient of 73-year-old received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on Mar2021 (at the age of 72-year-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included history of fainting 3 times in his lifetime prior to getting the vaccine in years past. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: not reported), an unspecified date (at the age of 72-year-old) as DOSE 1, SINGLE for covid-19 immunization and had no reaction. On an unspecified date, 36 hours after getting the second dose, the patient experienced fainting spell. The patient had also experienced dizziness and weakness. The patient felt chills and put on flannel shirt which is unusual in withheld. The next day, patient felt good, but by evening, he had chills again and put flannel shirt on and felt fine.  The patient went to sleep.  Sometime early in the morning around 06:00, he woke up and did not feel bad and decided to go to the bathroom.  The patient urinated and while standing there, the patient felt a cold sweat and felt lightheaded.  The whole thing came about while he was urinating.  There is something called Micturition syncope.  It is not common, but for people who faint, sometimes peeing will make them faint.  The patient wants to know should he get a third dose, or does he disqualify since he fainted. The patient is  not immunocompromised but looking forward to getting the booster dose. The outcome of the event chills was recovered on an unspecified date in 2021, while outcome of all other events was unknown at time of report.   The lot number for the BNT162B2, was not provided and will be requested during follow up; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This case was reported by a consumer via call center representative and described the occurrence of complete blood count abnormal in a 71-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included knee arthritis, inflammation, tooth infection and dental cavity. On 17th December 2018, the patient received SHINGRIX. On 18th December 2018, 1 days after receiving SHINGRIX, the patient experienced complete blood count abnormal. On an unknown date, the outcome of the complete blood count abnormal was not recovered/not resolved. It was unknown if the reporter considered the complete blood count abnormal to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on right arm. On 18th December 2018, the patient had blood work performed. The patient's levels were within the normal range, but all levels were slightly out of normal range. White blood cells 12.3, red blood cell 4.36, mean corpuscular volume 98.2, mean corpuscular hemoglobin concentration 31.3, hemoglobin 13.4, neutrophils 8.67 and monocytes 1.02. The patient has arthritis in his knee that has some inflammation. The patient also mentioned the possibility that he has an infection in his tooth, although he thinks it was probably a cavity. These symptoms were present prior to the vaccination. The reporter consented to follow up.
P Joint paint in left and right wrists and fingers. Visited primary care Dr. His diagnosis suggested arthritis. Treatment suggested was warm water in am, cold water in pm. Have had stiffness in hands prior to booster, but after booster was much worse with no relief.
After lunch, patient developed nausea, fatigue, elevated B/P, blood shot eyes, facial edema. EPI PEN administered and instructed to go to ER. Husband came and transported to hospital.
Patient received dose of Moderna vaccine post excursion; Patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion).    This case contains information for the 11th patient out of 19 patients as described by the reporter.  Concomitant medications were not reported.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:
Information has been received from a physician concerning a 14 year old female on unknown date was vaccinated intramuscularly with the first dose of GARDASIL (LOT # was not provided) and fainted. The patient eventually came to and left the office, however, the physician was unsure if she had recovered. She sought medical attention and was seen in office. Follow-up information has been received from the physician concerning the female patient with no known drug allergies or pertinent medical history. It was reported that there was no illness at the time of vaccination. The physician reported that the patient fainted after vaccination for a few seconds. It was noted that the patient did not have any breakfast that day and was practicing field hockey for one hour prior to coming to the office. There were no laboratory studies performed. Subsequently, the patient recovered. No further information is available.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 11-APR-2016, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately 2016 (reported as shortly after receiving ZOSTAVAX), the patient suffered macular edema left eye (OS), neuroretinitis OS, distortion of vision both eyes (OU), and nuclear sclerosis OU. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of ZOSTAVAX, the patient suffered severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events were considered not resolved. Causality assessment was related. Upon internal review, macular edema OS and neuroretinitis OS were considered to be medically significant events. The lawyer considered macular edema OS, neuroretinitis OS, distortion of vision OU, and nuclear sclerosis OU to be disabling. Additional information has been requested.
This spontaneous report as received from a Medical assistant via sales representative refers to an unspecified number of patients. No medical history or concurrent conditions reported. On an unknown date, an unspecified number of patients have been administered a second dose of GARDASIL (dose, and route not reported) (confirmed not GARDASIL 9) 2 years after the first dose of GARDASIL. No adverse effects reported nor PQC involved. No concomitant therapy reported. Additional information has been requested.
PRODUCT STORED AT INAPPROPRIATE STORAGE CONDITION; VACCINE SYRINGES WERE DRAWN AT AN UNKNOWN TIME AND WERE ADMINISTERED; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced product stored at inappropriate storage condition. On 26-MAY-2021, the subject experienced vaccine syringes were drawn at an unknown time and were administered. The action taken with covid-19 vaccine was not applicable. The outcome of the product stored at inappropriate storage condition and vaccine syringes were drawn at an unknown time and were administered was not reported. This report was non-serious.
10/27/2001 Parents seen with child at clinic. Parent report child had temp of 105 and seizure last night. Was taken to ER. No report avaiable. Seizure related to immunizations of viral illness.
JOINT PAIN; FEVER; This spontaneous report received from a patient concerned a 34-year-old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s the patient experienced joint pain, and fever (Dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and joint pain was not reported. On an unspecified date, the patient received booster dose of covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported (dose number in series: 2) to left arm for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series: 2). This report was non-serious.
Pt recv vax on 2/12/99; on 2/13/99 pt exp red/ swollen/ tender vax site-rt arm; tx=steroid shot & antibiotics
With seconds after injection, at about 5:15 pm, there was a rush to my head. My nose became immediately and intensely congested to the point there was pressure, I felt heated and as I communicated that I may be having a reaction my throat started to swell. Then it suddenly released. A heat ban moved down my body to my abdomen.  I waited for about 20-25 minutes and felt fine. Then about 45 minutes later, I experienced tingling in my lips and very mild congestion. The tingling and mild congestion would perhaps come on and subside with less intensity over the next hour.  Very mild congestion continued on and off until the next afternoon.
Abdominal Pain     times 3 days o Altered Mental Status     hx of elevated amnonia levels o Nausea And Vomiting  She reports a sore throat which is new      ROS:  General: No fevers, pos for tremor, chills             CV: No chest pain, palpitations             Pulm: No cough, pos for SOB  Exam: General: awake and alert, No acute distress, appears stated age HENT:  Normocephalic, atraumatic, moist mucous membranes, oropharynx clear, no rhinorrhea Eyes:  Pupils equally round and reactive to light and accomodation, conjunctiva/corneas clear Neck:  Supple,  no adenopathy; no thyromegally, trachea midline Lungs:   Clear to auscultation bilaterally, no crackles/wheezes/rhonchi.  No increased work of breathing  Exam: Heart:  Regular rate and rhythm, S1, S2, no murmurs, rubs, or gallops, no jugular venous distention, no extremity edema Abdomen:  Soft, positive right-sided tenderness to palpation, mild distention Neurologic:   cranial nerves intact, no sensory deficit Psych: Alert and oriented x 4, normal affect   WBC 4.77 12/30/2021   HGB 9.8 (L) 12/30/2021   HCT 32.0 (L) 12/30/2021   MCV 86.3 12/30/2021   PLATELETCT 174 12/30/2021 1/7/22 Sodium 133              Postassium 3.5             Total Bilirubin  1.9             Chloride  102                 AST/SGOT  183             Carbon Dioxide 25        ALT/SGPT  64            Glucose 88                      Alkaline Phosphatase  322             BUN 14             Creatinine-Blood  0.69            Total Protein 6.4             Albumin  2.2            Calcium 7.9  Hospital discharge note: 1/7/22  The patient is a 58-year-old female with history of Nash cirrhosis and gastroparesis status post gastrectomy with recurrent admissions for hepatic encephalopathy.  She presented to the hospital with worsening confusion as reported by her husband.  She had not had any bowel movements in a couple of days.  She was admitted for further care.  She was seen by the GI service.  She was treated with lactulose enema initially and then oral lactulose.  She is not able to afford rifaximin outpatient due to cost.  Her mental status improved back to baseline.  She did had some issues with nausea and vomiting, reportedly history of gastroparesis.  She was started on a trial of erythromycin and her nausea improved.  The patient worked with physical therapy and subacute rehab was recommended.  She is stable to discharge to subacute rehab today.  Her volume status is stable.  There is no significant ascites or extremity edema.  It is very important that she has at least 2-3 soft bowel movements every day.  She should follow-up with her primary care and gastroenterology as outpatient.
Pt reported Head ache in occipital area, dizziness, and light headedness. Gave pt juice and water. Pt denied history of diabetes. Pt reported improvement and felt well to leave. Pt was given education or when to call doctor or go to ER if symptoms worsen.
Red rash, warm to the touch, slightly painful started day after vaccine, has progressively gotten worse over the last 24 hours.