chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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. On or about 27-OCT-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. On or about 28-MAY-2015, the patient was treated at an Urgent Care and Family Practice facility, for a burning vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient was prescribed famciclovir (FAMVIR) and capsaicin cream 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.
extensive longitudinal acute transverse myelitis, there is a possible argument that can be made of the link between the patient's acute transverse myelitis (ATM) and the Shingles vaccine; pulseless ventricular tachycardia, it is possible that our patient's ventricular tachycardia could also be related to the Shingles vaccine; This literature marketed report has been received from the authors of a published article, titled as stated below, and refers to a 50-year-old male patient. His concurrent conditions included psoriatic arthritis. Concomitant medications included methotrexate.  On an unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) subcutaneous injection (exact dose, route of administration, anatomical site, lot # and expiration date were not provided) as prophylaxis.  On an unknown date (reported as "one week following a shingles vaccine"), the patient presented to the emergency room (ER) with complaint of ascending bilateral lower extremity paresthesia. The paresthesia progressed from his feet to groin with associated loss of sensation with urination, incomplete bladder emptying, and ambulatory dysfunction due to difficulty with proprioception of both his legs. Examination was significant for diminished light touch, vibration, and temperature sensation of the bilateral lower extremities. Urinary retention was noted and was treated with a foley catheter. Magnetic resonance imaging (MRI) of the patient's spine revealed longitudinally extensive T2 hyperintensity from the lower cervical spine to the upper thoracic spine. The patient's ER course was complicated by acute onset of diaphoresis and lightheadedness followed by a syncopal episode. The patient was unresponsive and pulseless, and the telemetry was consistent ventricular tachycardia which was quickly self-limiting with return of mental awareness and normal sinus rhythm. Amiodarone was initiated and the patient remained in normal sinus rhythm. He was treated with 1 g of intravenous (IV) solumedrol for suspected extensive longitudinal acute transverse myelitis (ATM) based on clinical presentation and spinal cord appearance on MRI. After 5 days of IV steroid treatment, there was no clinical improvement and the decision was made to initiate plasmapheresis, which was well tolerated and the patient's symptoms gradually improved. Extensive blood work and cerebrospinal fluid (CSF) studies failed to determine the etiology of the ATM. The patient's symptoms continued to progress (not recovered), and on an unknown date, he was discharged to a rehab facility with long-term cardiac event monitoring.  The reporter considered myelitis transverse and ventricular tachycardia to be possibly related to zoster vaccine live (manufacturer unknown).  Upon internal review, the events of myelitis transverse and ventricular tachycardia were determined to be medically significant.  Literature Report:
Patient is a 53 year old male who presented to Medical Center Emergency Department on 5/12/2021 with the chief complaint of fever.  He is not under the care of a primary care provider and does not take any regular medications. On May 4th patient received his second Moderna COVID vaccine. Several hours later he developed a subjective fever with chills, body aches and a headache. These symptoms have been ongoing since onset. Since this time he has also developed a dry cough, generalized weakness and burning with urination. Denies any shortness of breath, chest pain, nausea, vomiting, or diarrhea. No bloody/dark stools. Wife is at the bedside who states that patient has recently developed "little red bumps" all over his body.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 05-APR-2017, the patient was vaccinated with an improperly stored dose of PROQUAD injection, lot # L051102, expiration date 17-JUN-2017 (dose, route and site of administration were not reported) for prophylaxis. The administered dose of PROQUAD was stored in the temperature between 15 and 46 degrees Fahrenheit for 25 hours. Data logger was involved. There were no previous temperature excursions reported. The administered dose of vaccine was reconstituted with a sterile water diluent (manufacturer unknown), which did not undergo a temperature excursion. No adverse effects were reported. No additional information was provided. Additional information has been requested.
pt recv vax 7JAN99 & 10JAN99 pt devel a fever of 99.7 to 100.2 7 twisting, turning & positioning suggestive of abd cramps;11JAn99 pt devel dec oral intake, vomiting & dec urination which persisted as of 12JAN99;
I had very bad diarrhea , accompanied by no other symptoms- no nausea, cramping, or any bad feelings like I would normally expect w/ such dreadful runny bowels. This lasted for 6 weeks, then got a little better, but still very runny for another week and a half. Today  is the first day it is ALMOST normal. I did not tell anyone but my husband, and then last week I had an acupuncture treatment (not for this)and she told me I should tell the clinic. I have not yet, because it is so embarrassing. Then I looked at the paper I was given at the time of the vaccination, and saw there was this forum to report on. It was like nearly pure water with small little chunks of food; after the 1st 6 weeks it was more like thick soup. It did not make my anus sore like I would expect from regular diarrhea either. I have no idea if it was caused by the vaccination, but I can think of nothing else.
Initial misuse report received from a healthcare professional on 15 April 2013. A 42-year-old male patient was inadvertently administered a dose of DAPTACEL instead of ADACEL. No adverse event was reported. List of documents held by sender: none.
Information has been received from a nurse practitioner concerning a 56 year old female health employee, smoker, who on 05-OCT-2010 was vaccinated with a first dose of PNEUMOVAX 23 (Lot # 667418/0978Z), 0.5 mL SC in the left upper arm. There was no concomitant medication. On 05-OCT-2010 the patient developed erythema, soreness and mild inflammation at the injection site. The patient was seen on 06-OCT-2010 and she had no elevated temperature. Patient was told to put cold compresses on her arm and to elevate it. She was re-evaluated on 07-OCT-2010 and she had almost complete resolution. Follow up information has been received from an advanced practical nurse. It was reported that on 05-OCT-2010 afternoon the female patient was vaccinated with the first dose of PNEUMOVAX 23 (Lot # 667418/0978Z) SC in the left arm and with the second dose of AFLURIA (lot number 11049121A) IM in the left arm. On 06-OCT-2010 morning the patient presented and complained of soreness at the injection site. The patient experienced localized erythema and swelling without posterior aspect. Oral temperature was 99.4. The patient was given TYLENOL and cold compresses with relief. On 07-OCT-2010 the patient presented decreased soreness, erythema and swelling. At the time of the report the patient had recovered. No further information is expected.
This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown age. The patients were vaccinated with improperly stored ROTATEQ lot # L000568, expiry date 10-JUL-2016, on multiple unspecified dates following an excursion that occurred on 13-JAN-2016. No adverse effects were reported. The temperature was 50.7 with a time frame of 1 hour and 30 minutes. This is one of the several reports received from the same reporter. Additional information has been requested.
mom of pt contracted shingles w/in 1wk of pt being given vax;mom had chickenpox at age 10mo;pt had T102 x 2 days;shingles was mild case;
1) Pt history by urgent care tongue swelling occurred 11/7/09 8am. 2) Pt history to PCP 11-16-09- symptoms began 11-3-09. (note had mild URI 11-2-09 day of vaccine).
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type II Diabetes" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "recent foot fracture resulted in surgery" (unspecified if ongoing); "recent foot fracture resulted in surgery" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested Positive; Positive, notes: positive Covid test 4 days after final dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Fever; urinary incontinence; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number K735H, expiry date 13th September 2022) for prophylaxis.   On 28th September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In September 2020, less than a day after receiving Shingrix, the patient experienced urinary incontinence. On 28th September 2020, the patient experienced fever. On 30th September 2020, the outcome of the fever and urinary incontinence were recovered/resolved.   It was unknown if the reporter considered the fever and urinary incontinence to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the vaccine later that night, she began to experience a fever. When she stood up to go to the bathroom, she had an episode of urinary incontinence. She also had a second episode of incontinence around 3 am the next morning.  As of 1st October 2020, her symptoms have resolved. The reporter did not consent to follow up.
Headache Narrative: At time of second COVID vaccine employee reported that she had a headache since dose 1. She took Advil on the 3rd and 4th day and it was gone. Reported HA was nagging in nature, tolerable and was back again. Reported that she had the headache before the second shot and is not new .
10/25 (2 days post vaccine administration) patient presents with increased swelling, increased redness, increased warmth, increased pain, decreased range of motion in left shoulder - site of Flu vaccine 10/23/07
On 02/08/2021 patient noticed her arm at the site of injection was getting red, itchy, and hot to the touch.  Over the next couple of days the redness and itching spread down her arm, over to her back, and down the front of her chest.  She visited her primary care provider, on 02/12/2021 where she was diagnosed with cellulitis and prescribed antibiotic treatment.  As of today, 02/15/2021, the redness and itchiness has fully subsided.  Dr. advised her not to return for her second dose that was scheduled for 02/24/2021.
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patient were vaccinated with improperly stored GARDASIL 9 lot # L043214 and expiration date: 30-AUG-2017; lot # M004116 and expiration date: 12-OCT_2017; lot # M007764 and expiration date: 30-JAN-2017; (route and dosage unspecified). No adverse effects were reported. It was reported that therapy was not discontinued. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse event; Someone had given a patient of ours an expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Someone had given a patient of ours an expired Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Someone had given a patient of ours an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Someone had given a patient of ours an expired Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Someone had given a patient of ours an expired Moderna vaccine).    The concomitant medication was not reported by reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No reported symptoms. The treatment medication was not reported by reporter.
Had to be observed for 30 minutes following the vaccine due to her allergies.  She had the expected arm tenderness, but 10 hours later she started experiencing severe pain to the point that she could hardly walk.  The pain was in her legs, thighs, hips, shoulders, ankles, it was pretty bad.  She also had a sense of malaise, and tiredness.  She was frightened due to the pain.  She was also having memory issues, could not remember things within 10 minutes.  She went to bed and got up the next morning with the same pain and could not sleep due to that pain.  Nine days after the vaccine she is still experiencing the pain, but the fatigue and memory issues were still present.   She called the Covid 19 hotline who transferred her to a pharmacist, who told her that the reaction.   He advised her to get blood work to get RA factors checked, and they were very very low and did not trigger that, but still experiencing the pain.  it is less than it was, but still experiencing the pain.  She is still also experiencing itching from the injection site.   Has not slept due to the pain, and scared to get the 2nd vaccine.
This spontaneous report was received from a registered nurse refers to 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 19-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M009378, dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/Insurance. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Felt like passing out around 12:30p the day after my first dose of the vaccine. Internal temperature of 95 degrees at that time. Fatigue, headaches, minor chest pain, and shortness of breath since that event.
Developed pain, redness, and swelling at L deltoid injection site. Worsening over 48 hours.
Vial was initially stored in refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022; No adverse event; bivalent Moderna COVID19 vaccine given after the beyond use date BUD 17-Nov-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine given after the beyond use date BUD 17-Nov-2022), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051d22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-2022, 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 18-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine given after the beyond use date BUD 17-Nov-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine given after the beyond use date BUD 17-Nov-2022), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022) 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 EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine given after the beyond use date BUD 17-Nov-2022) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022).    Concomitant drugs were not reported. It was reported that the individual vials of 2.5 ml size did not underwent any temperature excursion. Treatment medications were not provided. This case was reported for Adult patient 5.   This case was linked to US-MODERNATX, INC.-MOD-2022-675260, US-MODERNATX, INC.-MOD-2022-675264, US-MODERNATX, INC.-MOD-2022-675268, US-MODERNATX, INC.-MOD-2022-675259, US-MODERNATX, INC.-MOD-2022-675269, US-MODERNATX, INC.-MOD-2022-675270 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675260:Patient 5 US-MODERNATX, INC.-MOD-2022-675264:same reporter US-MODERNATX, INC.-MOD-2022-675268:Patient 5 US-MODERNATX, INC.-MOD-2022-675269: US-MODERNATX, INC.-MOD-2022-675270: US-MODERNATX, INC.-MOD-2022-675259:Patient 5
Since first shot having very mild temperature; flu like symptoms; Since first shot having chills on the evenings; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Since first shot having very mild temperature), INFLUENZA LIKE ILLNESS (flu like symptoms) and CHILLS (Since first shot having chills on the evenings) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D3 for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced BODY TEMPERATURE INCREASED (Since first shot having very mild temperature), INFLUENZA LIKE ILLNESS (flu like symptoms) and CHILLS (Since first shot having chills on the evenings). The patient was treated with IBUPROFEN for Fever and Pain, at an unspecified dose and frequency. At the time of the report, BODY TEMPERATURE INCREASED (Since first shot having very mild temperature), INFLUENZA LIKE ILLNESS (flu like symptoms) and CHILLS (Since first shot having chills on the evenings) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included 5 pills for blood pressure, gaud medication, stomach pills.   This case was linked to US-MODERNATX, INC.-MOD-2021-056373 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056373:Case for second dose
developed shingles around 8/9 days after vaccination. shingles on right lower back. currently still have.
large, local reaction-redness, swelling, warmth, firmness reaction is 4.5 by 2.5 inches in size
I had a cough, congestion, headache, pain in my lung, chest heaviness, shortness of breath. I was at home and over the weekend was using over the counter medication trying to get relief. On Monday I had a fever of 101F, I called work they told me not to come in and my doctor called in a Medrol dose pack. I immediately started taking ibuprofen to get my fever down and taking the dose. By Tuesday, I wasn't getting any better, I went to the emergency room of the hospital I work at thinking I would just get a nebulizer treatment and go home. They ran PCR COVID-19 test, bloodwork, EKG. echocardiogram, chest x-ray, CT scan. The chest x-ray showed that I had a bacterial infection in my lung and I was admitted into the hospital. All other test were negative.