chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; vision loss; Information was received from a lawyer regarding a case in litigation concerning a 67-year-old female patient (pt). The pt's medical history, concurrent conditions, or concomitant medication were not provided. On an unspecified day in January 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date not provided) for prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), on an unspecified day in June 2016, the pt suffered vision loss (blindness) including any and all its sequelae. As a result, the pt suffered serious and dangerous side effects including shingles (herpes zoster), as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt suffered severe personal injuries, pain, suffering, and emotional distress, as well as to incurred substantial economic damages. As a result, the pt required and/or would require more health care and services and incurred medical, health, incidental and related expenses. The pt informed and believed and further alleged that she would, in the future, be required to obtain further medical and/or hospital care, attention, and services. Outcome of blindness and herpes zoster was reported as not resolved. The causal relationship between these events was reported as related to zoster vaccine live (ZOSTAVAX).  The reporter considered blindness and herpes zoster to be disabling events.  Upon internal review, blindness was determined to be a medically significant event.
Patient felt burning sensation to tongue and lips within minutes. Patient has had fever, chills, fatigue, left side of face drooping, muscle ache, headache, blisters to lip and tongue
Rash onset 5/27 am, both legs, scrotum, trunk, pt fussy, rash warm to touch, afebrile. Rash papular in appearance.
I woke up at 02:00A with a bad headache, I took some Tylenol. On Thursday April 8th, 2021 around 02:00pm I had flu-like symptoms with body aches, fever, chills. The next day April 9th, 2021, I experienced fatigue, headaches and ringing in the ears. On the 4/10/2021, fatigue, headache and noise or ringing in the ears. On the 4/11/2021, fatigue, ringing in the ears. On 04/12/2021, dizzy spells which has continued. Feeling of lightheadedness and on the 04/14/2021 I went to see my doctor. Feeling of pressure in my ears with the ringing. For two weeks I struggled with the dizziness and lightheadedness. I also developed Tinnitus. I also had low back pain and pelvic pain.
04/12/2022  DEVELOPED A LARGE PAINFUL KNOT IN HIS LEFT AXILLA. 04/13/2022 WAS SEEN IN OUR OFFICE. 04/15/2022 SWELLING WAS WORSE AND NOW DOWN HIS LEFT CHEST AREA UNDER HIS BREAST AND NIPPLE. WAS PRESCRIBED STEROIDS FOR THE PAIN AND SWELLING.
intermittent loss of smell, loss of taste since 2/6/2022, also with nasal congestion and runny nose
Pt got lightheaded and dizzy 30 to 60 seconds after getting immunization. Blurred vision, pale, nausea. Had stay seated leaning back and gave OJ and water, observed for about 30 minutes. Pt walked away after rest and fluids.
This spontaneous report as received from a physician via company representative refers to a patient of unknown age (gender not reported). On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX for immunization (route and lot not provided). On an unknown date, the patient experienced shingles (mild case). The outcome of shingles was reported as recovered (date unspecified). The patient sought medical attention (office visit). Relatedness between the patient's event and ZOSTAVAX was not provided. This is one of several reports from the same source (MARRS # 1310USA007717). Additional information has been requested.
Lab employee was vaccinated on March 12.Developed chest pain on Friday 3/21 which lasted for three days. Described as sharp, mild to moderate, came and went. Did usual activities and did not seek medical care. When received letter about cardiac complications called the health department. Saw her health care provider on 3/28 and had EKG which was read as normal. Cardiac enzymes done that day: CKMB 2.4 and Troponin I 0.2. Is recovered now.
Discharge Provider: DO Primary Care Provider at Discharge:  DO  Admission Date: 3/13/2023 Discharge Date: 3/14/2023  PRESENTING PROBLEM: Sepsis (HCC) [A41.9]   HOSPITAL COURSE: A 69 y.o. male with past medical history significant for hypertension post-polio syndrome with left lower extremity weakness, atrial fibrillation on Eliquis, obstructive sleep apnea on CPAP, chronic obstructive pulmonary disease, type 2 diabetes mellitus, hyperlipidemia, abdominal aortic aneurysm, gout, arthritis, alpha-1 antitrypsin deficiency, initially presenting to Hospital Emergency Department accompanied by his wife with chief complaint of altered mental status and disorientation.  Symptoms started yesterday.  Patient also reports that he has had a cough for a day or 2.  Patient reports chills. Patient denies any nausea vomiting, no shortness of breath or chest pain, no abdominal pain.  Patient has a history of urinary incontinence and had a Foley catheter placed in the emergency department.  Patient reports chronic left lower extremity weakness secondary to post-polio syndrome.  Patient states that he spends most of his day in a recliner.  Patient is able to ambulate but uses a cane or a walker if he is going outside the house.  Patient denies any numbness or tingling.  No diarrhea constipation.  Patient reports that he is vaccinated for COVID.   In the emergency department, patient was found to be tachycardic and febrile.  Patient was oxygenating 94% on room air.  Patient had no evidence of leukocytosis or pneumonia on chest x-ray, no evidence of urinary tract infection.  Patient tested positive for COVID 19 by PCR.  Patient did have an elevated lactic acid of 2.5 that improved to 1.9 after fluid resuscitation.  Glucose was elevated at 186, patient did have slight bump in liver enzymes with AST of 115 and ALT of 51. EKG with evidence of sinus tachycardia with no acute ischemic process.    In the emergency department, patient as mentioned above was fluid resuscitated with 3 L of normal saline per sepsis protocol.  Patient also received IV antibiotics in the form of IV ceftriaxone and IV azithromycin.    Given patient's altered mental status with evidence of severe sepsis without septic shock, patient was admitted to Hospital for further treatment.   Upon examination after arrival to the medical unit, patient is alert and oriented to person place, time, and situation.  Patient is afebrile, oxygenating 96% on room air, blood pressure within acceptable.  Patient was admitted and monitored.  Sepsis symptoms resolved readily.  Laboratory studies came back mildly elevated CRP normal D-dimer and stable chemistries and complete blood count.  He had no respiratory symptoms.  He was tolerating oral nutrition.  He was able to complete his ADLs without assistance.  He was otherwise stable and deemed ready for discharge.  He was subsequently discharged home to follow-up outpatient with primary care provider.  He was to resume his regular medications as previously ordered.  He could return to his diabetic diet and activity as tolerated.  He understood all these instructions and was discharged home in stable condition.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 24-DEC-2014 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, dosage and route unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
redness at injection site; pain ay injection site; received the first dose of Shingrix via subcutaneous route; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number DJ3FL, expiry date 5th March 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional information was provided as follows: The nurse reported that 17 patients received the first dose of Shingrix via subcutaneous route, which led to intramuscular formulation administered by other route. Some of them were female patients. Nurse did not provide initials, date of birth, lot number and expiration dates of the vaccines. She did not said how many patients were male and how many were female. This is 1 of the 17 cases, reported by same reporter.   Follow up information received from the nurse on 3rd April 2020: The patient's demographic details were updated. Concurrent medical conditions included asthma (started on 4th December 2014), hypertension (started on 9th May 2016) and hyperlipidemia (started on 9th May 2016).  On 24th January 2020, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. The batch number and expiry date details were updated. On 24th January 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site pain. The reporter considered the injection site erythema and injection site pain to be unrelated to Shingrix. The VAERS details were updated.  Upon internal review, the classification exclude was removed.
Immunizations 06/16/06 - Seen in another clinic 06/17/06 with febrile seizures.
Pt. reported throat and ears burning as well as burning at the injection site. Pt. has history of anxiety, vital signs checked and WNL. Pt's symptoms began to improve over time. Pt. released home after being evaluated for additional 10 minutes.
about 4 days after receiving the vaccine I began to observe hives in a variety of locations.  No hives ever appeared near the injection site itself.  Locations most affected are neck, head/face, hands, groin,  and lower legs/feet.  The hives seem to be reactive to touching and heat.  If I draw a line lightly on my skin with my finger, 30 secons later the entire line will be raised and colored deep red.  If the area is overly warm or exposed to any kind of friction it will result in a hive reaction.  Benadryl helps a little bit.  Primary care physician administered two steroid injections a week apart and prescribed steroid pills.  This kept the itching and hives at bay until the steroids left my system.  Hives immediately returned.
Status migraine lasting at least 6 days, nausea without vomiting, treatment with NSAIDS, acetaminophen, & Prednisone
Drowsy for 24 hours after the vaccine was given. April 17th - around 1:00 PM, I fixed myself some lunch. It felt like I burned my mouth but it didn't go away in a day or two. It felt like my tongue was blistered on underside and side of tongue and rough like  a cat's tongue. It felt like I had had hot soup in my mouth. I went to a dentist. Referred to Oral Surgeon and he didn't know and he referred me to a new Oral Surgeon and he said they aren't taking new patients. I went to my regular doctor and they didn't know where it was and they said I needed to see a specialist. I called the and went on June 3rd - saw specialty DR - He looked at it and knew within 5 minutes-  Burning mouth/Tongue Syndrome  was the diagnosis. I  had found a wonderful natural mouthwash with Aloe in it and used that - and that helped me a lot before I found the Diagnosis. I was fit with a stent - a mouth guard and it covers the rough of my mouth and my teeth so that my tongue doesn't touch the roof of my mouth so those nerve symptoms are not awakened. My tongue had deep grooves in it and I had very very dry mouth. Biotine mouthwash  - I used too. Friday, July 9th, is follow up appt with this Dental Surgeon. On my own, I have been doing acupuncture once a week and they've said that this diagnosis is in their protocol and they are using the acupuncture protocol for that.
This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 18-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (therapy type rHA) lot # N019253 and expiration date 20-DEC-2018 (dose, frequency and route of administration were not provided) for prophylaxis which was reconstituted with sterile diluent, lot # M036841 and expiration date 17-APR-2019. The vaccine was stored at a temperature of 6 Fahrenheit degree to 14 Fahrenheit degree, time frame of 63 minutes and previous temperature excursion of 6 degree Fahrenheit to 14 Fahrenheit for 240 minutes. Digital Data logger was involved.
Unresponsive for 15 mins 2days after dtap. Also moaned tossed and turned all night.
A non-serious spontaneous report of administration to immune compromised and administered the vaccine using a cotton swab was received from a wife/consumer concerning her 37-year-old husband. The patient history and concomitant medication was not reported for this patient. At the time of event the patient was immune compromised. On 09-Jan-2010, the patient received H1N1, Intranasal, for unknown indication, via nasal route. The vaccine was placed on a cotton swab and then nasally applied. There was no adverse event associated with this medication errors therefore, treatment and reporter causality assessments were not applicable, and the events were considered resolved.
This spontaneous report as received from a nurse refers to a 14 year old female patient. Patient's medical history, concurrent condition and concomitant medications were reported as none. On 30-AUG-2018, the patient was vaccinated with MENACTRA (dosing details unknown) for prophylaxis, and shortly after on 30-AUG-2018, the patient was vaccinated with GARDASIL 9, intramuscularly (dosing details unknown) for prevention of Human Papilloma Virus. On 30-AUG-2018, about 5 minutes after GARDASIL 9, was administered the patient slid off the chair and fell on the ground. The nurse was unable to provide a reason why the patient slid off the chair and the nurse did not define this as syncope. On 30-AUG-2018, the patient also experienced rash on both arms, but not at the injection site. The patient stated her throat felt funny on 30-AUG-2018, but nurse reports there was no swelling of throat. Patient sought medical attention and received treatment for the event. Lab diagnostics/ studies performed was reported as none. The outcome of fall, oropharyngeal discomfort and rash was reported as recovered/resolved. Causality assessment was not provided. No product quality complaint was present.
Lethargy began the day of vaccine and shortness of breath along with abdominal and chest pain followed the next day.  Decedent was found deceased the next evening.
Received 4th dose on 4/29/2022. On 5/4/2022 developed significant pain at injection site.  It's now 6 weeks later and have pain with movement and activities involving right arm.
stroke; Bells palsy; postherpetic neuralgia; herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. The pt's concurrent conditions, medical history an concomitant medications were not reported.  On 24-AUG-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) in a pharmacy (exact dose, site and route of administration, lot# and expiration date were not reported) for the long term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated for the following injuries, resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster, post herpetic neuralgia, Bell's palsy and stroke.  The outcome of the events was unknown. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was reported as related.  Upon internal review, the events of Bell's palsy and stroke were determined to be medically significant.
Doses administered out a vial which experienced excursion for 4 hours; Doses administered out a vial which experienced excursion for 4 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered out a vial which experienced excursion for 4 hours) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered out a vial which experienced excursion for 4 hours) in a 30-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 001J21-2A and 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered out a vial which experienced excursion for 4 hours). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered out a vial which experienced excursion for 4 hours). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered out a vial which experienced excursion for 4 hours) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered out a vial which experienced excursion for 4 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  The vials were returned to stable refrigerator temperature after 4 hours.   This case was linked to MOD-2022-525469, MOD-2022-525791 (Patient Link).
No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 25-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U029319, expiration date: 19-MAR-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes; Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.     No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Left arm still sore, it hurts worse if he moves; Soreness for 2 days; This case was reported by a consumer via call center representative and described the occurrence of pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 20th July 2022 and experienced pain, refer case US2023AMR018900).   On 22nd September 2022, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain and pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR018900   Additional Information: GSK Receipt Date: 06-FEB-2023 Reporter's Comment: The case was self reported by the patient. The patient received second dose of Shingrix into left arm and experienced soreness for 2 days but did not clarified which dose this referring to. The patient reported that although no super painful, the back of his upper left arm was still sore on the day of reporting and stated it hurts worse if he moves a certain way, and that the arm was not swollen. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2023AMR018900:Same reporter
had initially slight feelings of bronchitis and full chest; had initially slight feelings of bronchitis and full chest; chest congestion; injection site pain; swelling; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 25Mar2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date in Mar2021, after second vaccination, the patient had initially slight feelings of bronchitis and full chest, chest congestion and injection site pain and swelling but it was going away today (at the time of report). Patient wanted to know if there was going to be booster doses. Outcome of the events was recovering at the time of report.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Information has been received on 13-APR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 13-JAN-2011, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a medical center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 09-MAY-2016, the patient was treated by a physician at a medical center for the onset of a severe vesicular rash, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed acyclovir, cephalexin (KEFLEX) and bacitracin for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX, 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.