chrisvoncsefalvay/vaers-outcomes huggingface dataset:
paraplegic; This spontaneous case was reported by a patient and describes the occurrence of PARAPLEGIA (paraplegic) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAPLEGIA (paraplegic) (seriousness criterion medically significant). The patient was treated with OXYGEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PARAPLEGIA (paraplegic) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the patient was a paraplegic and was on Oxygen. After vaccination the patient had a lot of problems and the doctors reported it to Moderna. No treatment medication was reported. Company comment: This spontaneous case concerns a 48-year-old female patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of PARAPLEGIA. The event was reported with no onset date; hence latency could not be properly assessed to the first or the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). She reported having had problems after vaccination and that she was on oxygen. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
temperature dropped down to -30 degrees outside causing the building temperature and refrigerators to drop, temperature reached was 32.2F for a total excursion time of 39 hours, with no reported adverse event; patient to receive menquadfi post-excursion with no reported adverse event; Initial information received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an 18-year-old female patient who receives MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] post-excursion and temperature dropped down to -30 degrees outside causing the building temperature and refrigerators to drop, temperature reached was 32.2f for a total excursion time of 39 hours, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Feb-2023, the patient received dose 1, at 0.5ml total dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength: standard) (lot number: U7576AB and expiry date: 28-Feb-2025) via intramuscular route in the left deltoid for Immunization and on the same day patient received menquadfi post-excursion with no reported adverse event (poor quality product administered).  On an unknown date, a non-serious event reported, temperature dropped down to -30 degrees outside causing the building temperature and refrigerators to drop, temperature reached was 32.2f for a total excursion time of 39 hours, with no reported adverse event (product storage error).  It was reported, Caller reporting a temperature excursion at their facility. The caller requested stability data. Extended stability data covers the excursion with the exception of the MENQUADFI.    Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  At time of reporting, the outcome was Unknown for both events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case was reported by an employee of a healthcare facility via a sales representative and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject experienced injection site redness and swelling injection site. At the time of reporting the outcome of the events was unspecified. The sales representative had limited information. The sales representative was told that the adverse events were noticed with three separate subjects on different dates. The injections were given by different nurses. Please see A0877765A and A0877779A for the two additional reports of injection site redness and swelling injection site.
If vaccine received Yes/vaccine brand: Pfizer / BioNTech/product: COVID 19 Treatment, brand: Paxlovid; If vaccine received Yes/vaccine brand: Pfizer / BioNTech/product: COVID 19 Treatment, brand: Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLUOXETINE; WELLBUTRIN; FINASTERIDE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for covid 19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "If vaccine received Yes/vaccine brand: Pfizer / BioNTech/product: COVID 19 Treatment, brand: Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:Metallic taste in mouth during treatment. Cold like symptoms (running nose, cough) returned 4 days after stopped treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
parents noted swelling, hard lump @ inj site 2 days p/inj when examined by PHN, still hard w/black & blue bruising on 10DEC96;
Patient was over 12 and should have gotten dosage of Pfizer Covid-19 vaccine for 12 and up. Was mistakenly given 5-11 year dosage of Pfizer vaccine by RN. MD and parent were notified, note was put in chart, will get correct dosage when coming back for 2nd dose.
Quick onset of numbness in fingertips on left and right hands, primarily left. Thumb, forefinger and middle fingers most affected. General numbness in arms from shoulders down. Over the past two years, I had expected the symptoms to improve, but they have not, although they have not gotten worse. I underwent 10 weeks of physical therapy which continues at home to maintain strength. There were no other events to which I could attribute the onset of symptoms. No injury or trauma. During this same period, I also received Zoster vaccine for shingles (October 29, 2020). A separate Adverse Effect report will be filed for that as well, as I cannot determine which vaccine (or both) may have caused the symptoms.
Shortness of breath occasionally and a rapid resting heart rate fluctuating between 98-125 BPM Lasting for almost 2 1/2 weeks!
unbalanced / issues with balance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BALANCE DISORDER (non-serious), outcome "unknown", described as "unbalanced / issues with balance". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a licensed nurse practitioner referring to unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # K016005, expiration date 27-AUG-2016, route and dose not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Pt experienced a vasovagal syncope episode 10 minutes post vaccine. Pt had never experienced a similar episode according to mother. Pt also had a mild upper extremity tremor briefly.
Melena and hematochezia with associated nausea, fatigue and abdominal discomfort. Symptoms began that evening and continued for 3 more days. Stool was initially watery but became more formed each day.
Pt presented to Medical Center on 11/27/10 at 11:30 am. Pt woke that morning with L sided facial droop and difficulty opening L eye. Pt was diagnosed with Bell's Palsy and treated with a prednisone taper and valacyclovir. Pt still reported mild L sided facial numbness on 3/3/11.
23MAR95 soreness, swelling @ vax site, fever; 24MAR95 red, itchy rash both axillae; 25MAR95 headache, earache-took Talwin; nausea, vomiting for 4.5 hr; 27APR95 red papular rash, hands & arms; 29MAR95 felt fine;
I ended up getting COVID-19. I had very sore scratchy and swollen throat, extreme fatigue, headache. Sinus pressure, and muscle aches. I took TYLENOL for my symptoms. This lasted for about a week. I still have fatigue.
LEFT TESTICULAR PAIN; SPINAL PAIN; LEFT KIDNEY PAIN; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes type 2, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043AZA expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced left testicular pain. On 11-APR-2021, the subject experienced spinal pain. On 11-APR-2021, the subject experienced left kidney pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left testicular pain, spinal pain, and left kidney pain. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard operating procedures.
Chills, Fever, Headache, Fatigue, Joint Soreness for 24 hours
Left upper arm, elbow to injection site (deltoid), entire circumference of upper arm: red, swollen, hot and hard to touch. Benadryl PO q 4 days, started 1 hr after onset of swelling. 3 hrs after injection.
Patient is a 46 year old female who was admitted on 4/27/2021 for ACUTE DVT, UNSPECIFIED VEIN.   46 year old female with past medical history of POTS and on chronic hormonal oral contraceptive medication, and reported history of recurrent renal stones. Patient presented to ED after several days of left upper quadrant pain and tenderness, that worsened and became associated with nausea and vomiting. Initial evaluation by imaging demonstrated left renal stone in left renal pelvis with associated mild hydronephrosis. Incidentally on imaging, patient had DVT noted in right illiac vein with continuation into IVC. Subsequently admitted and started on heparin drip and pain control.
had hives since the 1st shot; This is a spontaneous report from a contactable consumer (patient). A 50-years-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0161 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 11Apr2021 at 10:45 hours as dose 1, single (at the age of 50 years old) for COVID-19 immunization. The patient medical history included low thyroid (Hashimoto's) and anxiety (both from an unknown date and unknown if ongoing). Patient previously took penicillin for unknown indication and stated that penicillin gives her diarrhea not allergic, just intolerant. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient concomitant medications/other medications within 2 weeks of vaccination included levothyroxine, escitalopram oxalate (Lexapro), progesterone and estrogen not otherwise specified (NOS) (all taken for an unspecified indication, start and stop dates were not reported). Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 18Apr2021 at 10:45 hours, patient had hives since the first shot, it got a bit better in the 3 weeks in between shots. Patient had no prolonged hospitalization for the event. Patient had doctor or other healthcare professional office/clinic visit for the event. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
10/14/05 2:00PM pt given HBV #2 - 2 hrs later whelps appeared on body. Called here at clinic. Advised to go to ER. Sent home. At 9:00PM face and neck began to swell. Pt stated a little hard to breathe. Taken back to ER - given prednisone and epinephrine. Mother states sent home and did better. Saturday night had some swelling to return. Given Benadryl and sx subsided. (Had HBV series completed in 1992. This was revax in 2005 due to freezer kept too cold and had to be repeated.
This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A patient of unknown age, gender and ethnicity received TURMENBA at single dose in the arm on an unspecified date. Concomitant medications and medical history were not reported. On an unspecified date after use of product, the patient experienced hives of arm injected. Outcome was not reported. Follow (20MAY2016): Follow-up attempts completed. No further information expected.
Patient presenting today with concerns for chest and back discomfort.  States she got her second Covid shot today and thereafter*developing some aching pain and heaviness type sensation in her chest especially in someone in her back muscles.  States she got a rash after the first shot that never completely went away.  Has a history of asthma and noted some mild shortness of breath as well.  No fevers or chills.  No cough.  No leg swelling.  Never had anything like this before. History appears more consistent with a vaccine reaction. ED visit the same day as COVID vaccine second dose
Redness; Arm swelling; Severe Pain; Unable to use Left arm for a couple of days; This case was reported by a physician via call center representative and described the occurrence of erythema of extremities in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included measles virus vaccine live attenuated (Measles Vaccine) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Measles Vaccine at an unknown dose and frequency. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced erythema of extremities, swelling arm, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the erythema of extremities, swelling arm, pain in arm and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm, pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The reporter asked how to proceed with the 2nd dose. The patient after receiving 1st dose experienced local reaction of redness, swelling, severe pain and unable to use her Left Arm for a couple days. The patient 2 weeks prior received a measles vaccination. The reporter asked for any information available to continue series or any drug interaction with the measles vaccination. The reporter consented to follow up. This case has been linked with case US2019165633, reported by the same reporter.
This spontaneous report was received from a physician refers to a 92 year old female patient. No concurrent condition or medical history was reported. On an unknown date in 2007, also reported as 8 years ago, the patient was vaccinated with ZOSTAVAX (standard dosage, dose and route of administration not provided). No concomitant therapy was reported. On an unknown date in 2015, also reported as this past summer, the patient developed a very mild rash and severe post herpetic neuralgia. The patient sought medical attention and saw physician. The patient was treated with 300 units of Neurontin 3 times daily. No lab diagnostics were performed. The outcome of the event was reported as recovering. The patient was doing better and the physician would be tapering her off of the Neuroontin shortly. No product quality issued was involved. Additional information is not expected as the reporter did not wish further contact.
Received GARDASIL #3-within 30 minutes has headache, vomiting x1, and hot/cold flashes.  No prior reaction to vaccine.
Extreme fatigue, headache, body aches, rash not at injection site. It is a rash that has in the past  been diagnosed as shingles but an visit with doctor diagnosed as contact dermatitis.
09/03/22 presents to ED for "coronavirus concern". PMHx of "A. fib on Eliquis, hypertension, CAD"
At around bedtime on 6/23/2022, I began to feel like I might be getting a head cold, because I had phlegm in my throat. When I woke up the morning of 6/24/2022, I had fatigue, more phlegm in the throat, and a strange discomfort in my neck. I didn't have a sore throat, but my throat did feel very dry. I was on a trip out of state when I developed these symptoms. I flew back home on 6/26/2022. When I got home that night, I still had all the above mentioned symptoms, plus a very stuffy nose. I began to wonder if I had COVID-19 instead of a head cold. On the morning of 6/27/2022, I took two at-home tests for COVID-19, and both yielded a positive result. I called my doctor's office and spoke to one of the nurses, and the doctor prescribed me PAXLOVID, which I took for the following 5 days. During the week I was taking the PAXLOVID, I developed conjunctivitis in both eyes. Not only was I blowing out mucus from my nose and mouth, I also had it oozing from my eyes. I was prescribed ciprofloxacin hydrochloride to treat the conjunctivitis. I saw my doctor in person on 7/5/2022, because I've been having trouble sleeping on account of the fact that my stuffy nose is keeping me from breathing. The doctor discovered that both of my ears are infected, so she prescribed a 7-day course of amoxicillin to treat the infection. The fatigue has diminished a bit, but the head cold symptoms still persist at the time of this writing; I still have nasal congestion and phlegm in the throat. Whenever I blow my nose, the expulsions are not clear or transparent. However, on a more positive note, my doctor says that my lungs are clear. Since I have been sick, I have checked my oxygen levels, and they have never dropped. The ciprofloxacin hydrochloride seems to have helped with the conjunctivitis, as I also have no more oozing from the eyes.
Vaccine was given one day after it was deauthorized. Patient has not complained of any adverse events.
Approximately 12 hours after vaccination with SHINGRIX, at bedtime, I experienced severe chills, flatulence, headache in temples, sinus congestion/headache and muscle aches. I had to find a sleeping bag to toss on top of bed and curl up in fetal position to keep warm. The chills were something I don't recall experiencing before.
a patient received a dose of VARIVAX after a temperature excursion; No other adverse effects were reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) after temperature excursion, lot # S038177, expiry date 26-NOV-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine experienced temperature excursion of -1.3 Celsius degrees (temperature range -9 to 8 Celsius degrees) for 44 minutes. There were previous temperature excursions of -10.4 Celsius degrees (temperature range -14 to -10 Celsius degrees) for 29 minutes, -13 Celsius degrees (temperature range - 14 to -10 Celsius degrees) for 24 minutes and -5.6 Celsius degrees (temperature range -9 to 8 Celsius degrees) for 39 minutes. Digital data logger was involved. The vaccine was reconstituted with 0.5 ml of sterile diluent. No additional adverse effects were reported.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2010, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2013, the patient was treated in the center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, 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 had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This case was reported by a consumer (spouse of subject) and described the occurrence of cancer in a 59-year-old male subject who was vaccinated with Hepatitis A vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of Hepatitis A vaccine (unknown details). At an unspecified time after vaccination with Hepatitis A vaccine, the subject experienced hepatitis A infection, cancer and possible vaccination failure. The subject died from cancer in September 2013. It was unknown whether an autopsy was performed. The reporter had previously reported another case with HAVRIX. See A0993321A for details on the other case. The cases have been noted as potentially legally significant.
both feet are itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (both feet are itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included LOVASTATIN for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PRURITUS (both feet are itchy). At the time of the report, PRURITUS (both feet are itchy) outcome was unknown.            Treatment details included diphenhydramine.   Reporter did not allow further contact
patient incorrectly given moderna.   17 yrs old.  no ill or side effects.