chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 13-FEB-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10 PK 0.5 mcg/0.5ml SDLLolCap Ped" and lot number K008986 with expiration date of 01-APR-2016 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 684 hours with a lowest recorded temperature of -3 Fahrenheit (F) (-3 Celsius (C)) and other one of 336 hours with a highest recorded temperature of (-3 C). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Moderna Covid-19 Vaccine .  Raised red area size of half dollar very mild pain little itchy at first.  I tried to put in my birthday but kept going back to today?s date.
Pt recvd vax & was adm to hosp 27JAAN94 for periodic breathing & apnea; given 2 breaths & a compression a/coming to PMH; PMH did complete sepsis-all neg; did sleep study w/dual PH probe; all nl; no obstruction; no apnea repeated no reflux;
"I don't know what's wrong with e today, I had that Covid vaccine that's what's wrong; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patient).   A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation and estrogens conjugated (PREMARIN) vaginal cream, route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced "I don't know what's wrong with a today, I had that covid vaccine that's what's wrong (feeling abnormal)" (non-serious) on an unspecified date with outcome of unknown.   Information on the lot/batch number has been requested.
This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included shingrix (received 1st dose in November 2020). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details provided were as follows: The reporter was patient's husband. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not get the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. No additional details were provided by the reporter.
Patient stated she went home and 4 hours later she became very sleepy. She then took a nap. When she woke up she felt dizzy, feverish, confused, itchy, and could not walk. All side effects have subsided except the itchiness at this point. She has been treating herself with Benadryl and a topical anti itch lotion.
Patient received the wrong TDap for his age. He should have received the Vaccine for ages 11yrs and up.
I received my vaccine 3/18/2021 around 5/24/2021 I started getting swollen glands, nausea, diarrhea and headaches.  I called my Dr. on 6/2/2021 because I started having symptoms of  Pneumonia, it's the first time I had pneumonia and it was very different from anything I had ever had.  I did not go into the office and I was prescribed Azithromycin and Prednisone.  The next 3 weeks were really bad with a unproductive cough, headaches and diarrhea off and on, nausea, body aches.  After 2 weeks I was sent to Urgent care to get a Covid test and then they sent me to the Emergency room. and they did an EKG, which showed  Pericarditis and chest pains.  that was 2 weeks ago and I was told to rest, I'm still having chest pains, headaches and waiting to feel better. No Covid results reported because Urgent care thought ER was doing a test and ER did not do a test because Urgent care did, but Urgent care disposed of their test.  Still now well at all.
25 year old otherwise healthy female who presented with chest pain 1 week after her March 4, 2021 PFizer-BioNTech COVID-19 vaccine. Chest pain was initially constant and severe, alleviated with leaning forward, worsened with lying supine. She visited her local Emergency Department 4 times and has had 1 outpatient cardiologist visit. Labs, including troponin, ESR, CRP, EKG, echo and echo stress test were negative. Naproxen and colchicine started empirically which alleviated her pain. Patient's chest pain is still persisting daily 4 months later, although no longer constant. Chest pain now lasts few minutes at a time without clear trigger.  Pt is not pregnant, no history of drug allergy, no medical history of other illness.
I have an IUD so I do not have regular periods. If anything I have very rare spotting that lasts a day or so, but no more. However, I have been spotting more heavily than ever before, and it has lasted 3 days already. I'm also experiencing cramps, which is very highly unusual for me.
Pt is a male who received his primary smallpox vaccination on March 10, 2004 on his right calf. The vaccination was placed on his calf secondary to tattoos. He also received anthrax#1 on that date. On March 15, 2004, he reported to immunization to have his site checked and he noted that it could barely be seen. On Thursday March 18, 2004, he noted redness around the site and the site was sore. On Friday March 19, 2004, he went to medical to have an evaluation. He measured the redness and made several phone calls. the patient was assured that his vaccination site was normal. At the end of his shift the site looked worse, the color had turned purple, the area had increased in size and was extremely pruritic. He was also experiencing pain 4/10. He does mostly standing while on the job. After leaving work that evening, he reported to emergency room. The area was noted to be 4X6 cm, indurated and painful to palpation. He was given Motrin and told to return for reevaluation the following day. When he returned on March 20, 2004, the size had increased to 9X14 cms. He was given Ancef 1 gram IV and discharged home on Dicloxicillin 500MG by mouth four times a day for 10 days. He was instructed to return the following day (March 21) and the site was found to be improving. He was given crutches and told to rest, elevate his leg, and to continue the medication. He remained afebrile.
Fever, fully body aches, headache, sinus pressure and pain, blackout vision, dizziness, weakness, fatigue, cough to inability to breathe, shortness of breathe, chest pressure and pain, mild left side facial swelling and numbness. Scared to contact emergency services due to cost. Took otc ibuprofen and suffered through night and next day. Slept on and off many hours over weekend. Some improvement but most symptoms still linger.
A couple/few days post-vaccination, I noticed a minor skin irritation on my lower-right back.  It was barely a rash; I thought it might have been due to exercising outside with a lot of layers on and sweating into those clothes and chafing/irritation from that.  So, I didn't think anything of it.  Then after a couple days, it developed into a more pronounced rash.  Then, yesterday (six days post-vaccination), it started itching.  Upon touch, I could feel that the rash was raised above nearby skin, and I could feel defined vesicles or papules.  At this point, I grew concerned, and sent a portal message to my PCP.  Midday today (seven days post-vaccination), a nurse and two internal medicine physicians examined me, and I was diagnosed with Shingles.    I have never had Shingles before in my life.  At age 5, I had Chickenpox, but I have had no presentation of the underlying virus in 30 years.  I can't speak to there being a causal or correlational relationship with being administered the Covid-19 vaccine -- I leave that you all -- but it does seem quite oddly coincidental given the rash appearing within perhaps 48hrs after the first injection.  I began a regimen of oral Valacyclovir a few hours ago and will see how this illness and rash progress.
Right underarm lymphadema; Dose 3 administration: 07Oct2021; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 27-year-old non-pregnant female patient received the third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the right arm on 07Oct2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration in the right arm on 14Dec2020 (at the age of 26-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 01Jan2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 07Oct2021, the patient experienced right underarm lymphadema less than 24 hours after getting the third vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right underarm lymphadema was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient became violently nauseated, developed severe diarrhea and abdominal cramping. Also experienced total body itching as well as tongue swelling.
Its as if I hear my heartbeat in my left ear ALL THE TIME.  It almost sounds like a constant rushing sound.  Makes it very difficult to hear and try to fall asleep.  I get very little sleep now and it effects the way I interact with others. FYI... my age is listed as 66 when in actuality it is 68.  The form would not be accepted until I revised this information square.  My date of birth is correct on the form.
bump on my arm after taking the vaccine; arm hurts after 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (bump on my arm after taking the vaccine) and MYALGIA (arm hurts after 4 days) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, the patient experienced PERIPHERAL SWELLING (bump on my arm after taking the vaccine) and MYALGIA (arm hurts after 4 days). At the time of the report, PERIPHERAL SWELLING (bump on my arm after taking the vaccine) and MYALGIA (arm hurts after 4 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
The night of my vaccine, my ears swelled from the inside of the ear canal. I lost all hearing in both ears for about a week and a half. I was in excruciating pain, I could not touch my ears, with horrific migraines and deep pain down my neck and jaw. I was given amoxicillin which did nothing, then I was prescribed a heavier antibiotic which I no longer have the bottle of to write the name, which opened my ears. I was given steroid drops and a pain killer. I still am in excruciating pain with the exact same symptoms in the exact same places, but at least I can hear in a tunnel-like fashion.
Patient came to pharmacy to receive the second Moderna vaccine. She received the incorrect dose in April. Our pharmacy was just completing the Moderna series based on the guidance of the manufacture and guidelines. Again, we completed the series and did not give the initial incorrect dose.
The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. In 2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, patient was treated by a healthcare provider for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
Pt developed an inflammatory reaction in upper arm extending distally to beyond elbow. He was also noted to have a possible small amount of periorbital edema.
1st dose 05/13/10, 2nd dose 05/27/11; This case was reported by a other health professional and described the occurrence of drug dose administration interval too long in a 11-year-old male patient who received Hepatitis A vaccine for prophylaxis.   Previously administered products included Hepatitis A (received first dose on 13th May 2010).   On 27th May 2011, the patient received Hepatitis A vaccine. On 27th May 2011, unknown after receiving Hepatitis A vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age  at vaccination was not reported. The patient also received 2nd dose of Hepatitis A, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up. This case was linked with US2021165573, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165573:same reporter
DIED; This spontaneous report received from a consumer via a company representative concerned 4 patients of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, and batch number: unknown expiry: unknown) dose, start therapy date were not reported dose number in series was 1, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was reported that, "4 people died after vaccination" (dose number in was series 1). On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).  Version created to amend previously reported information on 15-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V2: Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event. 20220127913 -covid-19 vaccine ad26.cov2.s- 4 people died after vaccination. This event(s) is considered unassessable. The event(s) 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(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/21/2023 Discharge Date: 2/27/23 PRESENTING PROBLEM: Weakness Fall, initial encounter Chronic kidney disease, unspecified CKD stage COVID COVID-19   HOSPITAL COURSE: Patient is a 74-year-old male with a past medical history of ankylosing spondylitis, chronic pain, hypertension, prostate cancer, decubitus ulcer stage IV, diabetes mellitus type 2 and dyslipidemia who presented with a chief complaint of fever, recent falls with a positive COVID test at home.  Patient was feeling ill 2 days prior to admission with a temperature up to 103°.  He recently had been weaning off of gabapentin and on to Lyrica per his nephrologist an outpatient PCP.  His pain had increased with these adjustments.  He had been started on Norco.  He also had been noting constipation.  He already was taking tramadol and p.r.n. morphine, but had significant side effects of nausea from his morphine and only took it for breakthrough pain.  He had fallen multiple times prior to admission. His daughter noted he was 88% on room air on a home monitor.  He was afebrile.  His creatinine was elevated from baseline with AKI on CKD stage IV.  Labs were otherwise stable.  He was admitted to the hospitalist service for COVID-19 infection and generalized weakness with AKI.   He was initially treated with gentle fluids without improvement of his kidney function.  Renal ultrasound showed no obstruction, but showed bilateral medical renal disease.  He was continued on fluids with eventual improvement of his kidney function towards his baseline.  Nephrology was consulted and recommended continuing fluids and adding sodium bicarb.  In regards to COVID-19,  he required up to 3 L nasal cannul and received 5 days of Decadron therapy while inpatient, discharged on room air with mild dry cough.    Palliative care was consulted to help with adjustments in his pain medication,  His gabapentin was weaned down with plans to completely replace with Lyrica by March 3rd with prescription given on discharge. Final pain plan includes intermittent norco with low dose oxycodone for severe pain available, due to kidney dysfunction morphine was discontinued along with tramadol.    PT/OT recommended subacute rehab but patient improved enough during stay to qualify for HHC for PT/OT, and RN for wound care. DC in stable condition on 2/27.
They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and 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) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    Case corresponds patient 3 out of 24 patients reported by the reporter.  Concomitant products were not reported. Patient age was between 6 months to 5-years. The vaccination clinic received incorrect guidance from the Department of Health in regards to the vaccination, who instructed to order and administer the vials with pink top to 6month-5year previously unvaccinated patients when the switch from monovalent to bivalent happened. This resulted in 24 patients being under vaccinated. It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were being contacted and revaccinated with the correct dose. Treatment medications were not reported.     This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Pulse is around 117 beats per minute; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Pulse is around 117 beats per minute) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included AMLODIPINE, HCTZ and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 09-Feb-2021, the patient experienced HEART RATE INCREASED (Pulse is around 117 beats per minute). At the time of the report, HEART RATE INCREASED (Pulse is around 117 beats per minute) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 117 117.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.