chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial misuse report receied from a healthcare professional on 18 June 2013. A 16-year-old patient, whose age and concomitant medications were not reported, had received a dose of Tdap (manufacturer unknown, Lot number, route and administration of vaccination was not reported) on an unspecified date. It was reported that, the patient had received previous dose of Tdap on 04th April 2012. On 18 June 2013, it was reported that yesterday patient had received a dose of Tdap. Thus extra dose administered. As of 18 June 2013, there is no mention of adverse events. List of documents held by the sender: None.
states felt feverish achy muscles, h/a;laid around & didn't feel lke doing work;did not take temp;sx complicated because of back (low)problems & allergies preexisting;states felt better on 1NOV97;recovered;
just got shingles today / Suspected Vaccination Failure; just got shingles today; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had before). Concurrent medical conditions included diabetes mellitus.   In OCT-2022, the patient received Shingles vaccine. On 28-FEB-2023, between 4 and 5 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: just got shingles today / Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: just got shingles today). The outcome of the vaccination failure was not reported and the outcome of the shingles was not recovered/not resolved.   It was not reported if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was not reported if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 28-Feb-2023 This case was reported by a patient via interactive digital media. The patient got the Shingles shot a few months ago from reporting.  The patient just got shingles on the day of reporting.  The patient had type two diabetes and could not had steroids.  The patient hope it did not last too long. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
On 3/18/21  was providing vaccinations for its employees  I was asked if I wanted to take advantage of the extra vaccine. I did and got the 1st vaccination Pfizer EN6208. On 3/19/21 Shortly after arrival at work 08:00 I began to feel numbness/ tingling of both my feet. The numbness/tingling had moved up to my knee?s by Noon and once at home at approximately 6:00pm while at home the numbness/ tingling had moved up to my waist. The numbness/ tingling remained from the waist down. In addition my groin and rectum region also have the numbness/ tingling. When I sit down it feels like I am sitting on a gel pad, kind of squishy. On 3/22/21 had an appointment my vitals were checked a couple of physical tests were done and he recommended a full panel of blood work.
Patient admitted to hospital on 06/29/2021 with non COVID reasons (compression fractures). Was (-) on admission. Discharged and readmitted on 07/03/2021 with admission screen of COVID (+). Asymptomatic. Hospital admission for non COVID reasons (back pain due to compression fractures). Had 2 subsequent (-) COVID tests on 7/4 & 7/6. Per WI DHS patient still considered a (+) case but does not have to isolate. Being discharged on 7/7/21 to the rehab unit.
Beginning approx. 08/21/2020 I started having bladder infection or kidney stone symptoms which lasted straight thru until I saw the doctor finally on  09/07/2021.  I was treated for an injection with sulfamethoxazole-trimethoprim 800-160 mg tablet for 3 days and that seems to have cleared up the problem.  Was only tested for infection, not kidney stones at that time.
It seemed to have greatly amplified the adverse effects of Cipro, resulting in extreme brain fog, confusion, disorientation, nausea, uncontrolable diarrhea, and I could not walk because my legs were not working. EMS had to wheel me out of my house. I was hospitalized for four days.
Some redness/tenderness at injection site about a few hours after recieving vaccine, which resolved over next couple days. a couple days later, developed red, warm, tender, golfball size, very firm area around where vaccine was injected. This persisted for several days, with the middle of the area blanching to a pale color with a red ring around it. Hot compresses, cold compresses, oral benadryl and topical benadryl seemed to have no effect on area. Contacted my doctor in case this was something that needed to be treated with antibiotics. They recommended Claritin which I did take and it seemed to help, or else it was resolving on its own at that point as the area had been there for four days already.
injection site is so painful and it goes down the arm; injection site is so painful and it goes down the arm; experiencing awful headache; joint pain; calf pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site is so painful and it goes down the arm), PAIN (injection site is so painful and it goes down the arm), HEADACHE (experiencing awful headache), ARTHRALGIA (joint pain) and PAIN IN EXTREMITY (calf pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 04-Dec-2020. Concurrent medical conditions included Anxiety, Sulfonamide allergy and Allergic reaction to drug. Concomitant products included LOXAPINE, BUSPIRONE, LEVOTHYROXINE, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), LOVASTATIN, LISINOPRIL, CLONAZEPAM and ESTRADIOL.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection site is so painful and it goes down the arm), PAIN (injection site is so painful and it goes down the arm), HEADACHE (experiencing awful headache), ARTHRALGIA (joint pain) and PAIN IN EXTREMITY (calf pain). At the time of the report, VACCINATION SITE PAIN (injection site is so painful and it goes down the arm), PAIN (injection site is so painful and it goes down the arm), HEADACHE (experiencing awful headache), ARTHRALGIA (joint pain) and PAIN IN EXTREMITY (calf pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: No specific follow-up information recorded.
After the first shot I had nerve pain throughout my body for two days, mainly in the evenings. After the second shot, it was more pronounced. Every time I am really tired or coming down  with something (cold, etc.) the same thing happens. So, it was no surprise and I would choose to get the shots again. I have not taken a flu shot or any kind of vaccine since I had Guillain Barre. I debated this time and watched the recommendations of the CDC and the GBS Assn. and decided to go for it.  I guess it is safe to say that my body reacted in the usual way.
Patient experienced syncope immediately following the vaccine injection.  Patient quickly regained consciousness.  Had patient lay down for observation.  Patient was offered water and a blanket and was able to respond appropriately to questions.  Observed and spoke with patient for 15 minutes with father present.  Patient reported no dizziness or lightheadedness at the end of 15 minutes and was allowed to go home under the care of her father.
contracted c-diff; my female organs were shutting down; my heart was palpitating; my back gave out; had no feelings in my legs / my right foot still has no feelings; ears kept going in and out as in hearing; had nosebleeds never had a nosebleed in my life; my tailbone is killing me; feel like the back of my neck is broken; shoulders are very sore; shoulders are / in a lot of discomfort; the temples of my head hurt; This case was reported by a consumer via interactive digital media and described the occurrence of clostridioides difficile infection in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced clostridioides difficile infection (serious criteria hospitalization and GSK medically significant), vaginal discomfort (serious criteria hospitalization), palpitation (serious criteria hospitalization), back pain (serious criteria hospitalization), loss of sensation (serious criteria hospitalization), ear discomfort (serious criteria hospitalization), epistaxis (serious criteria hospitalization), coccydynia (serious criteria hospitalization), neck discomfort (serious criteria hospitalization), shoulder soreness (serious criteria hospitalization), shoulder discomfort (serious criteria hospitalization) and temporal headache (serious criteria hospitalization). On an unknown date, the outcome of the clostridioides difficile infection, vaginal discomfort, palpitation, back pain, loss of sensation, ear discomfort, epistaxis, coccydynia, neck discomfort, shoulder soreness, shoulder discomfort and temporal headache were unknown.   It was unknown if the reporter considered the clostridioides difficile infection, vaginal discomfort, palpitation, back pain, loss of sensation, ear discomfort, epistaxis, coccydynia, neck discomfort, shoulder soreness, shoulder discomfort and temporal headache to be related to Shingles vaccine.  Additional details were provided as follows: The report was the patient. The age at vaccination was not reported. The reporter stated that, within an hour after receiving Shingles vaccine her female organs were shutting down. Her heart was palpitating, her back gave out, the patient had no feelings in her legs, her right foot still had no feelings which the patient was getting it checked out in a couple days. The patient had an appointment, her ears kept going in and out as in hearing she had nosebleeds never had a nosebleed in her life. The patient's tailbone was killing her. The patient felt like the back of her neck was broken, her shoulders were very sore and in a lot of discomfort, the temples of the patient's head hurt. The patient had been hospitalized three times since the shot and also had contracted c-diff. The reporter stated that, the covid shots were nothing compared to this.
Swelling redness soreness the size of a half dollar at injection site cried for 20 minutes straight in the middle of the night for 2+ days fever of 101 for 2 days.
pt recvd vax 28JUL93 & on 29JUL93 parent reported sore rt leg on pt-hard & tender-pt not walking on that rt leg since PM 28JUL93;
After about 30minutes of shot l had feeling of fullness on my face and slightly warm ears for maybe 30seconds and immediately after that I had feeling of sinking as if l am going to die for 30 seconds and I was alright after.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient(herself). Other Case identifier(s): 21K-163-4157183-00 (AbbVie).  A 69-year-old female patient received bnt162b2 (BNT162B2, Solution for injection,Batch/Lot number: unknown), intramuscular route as dose 1, single and intramuscular (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation; ibrutinib (IMBRUVICA), oral since Jan2020 (ongoing) (Batch/Lot number: unknown) at 420 mg for chronic lymphocytic leukaemia. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. NO KNOWN ALLERGIES . The following information was reported: CARDIAC FLUTTER (medically significant) with onset Oct2021, outcome "unknown", described as "Heart Flutter"; BLOOD PRESSURE INCREASED (non-serious) with onset Oct2021, outcome "unknown", described as "Blood Pressure Shoot Up".The patient underwent the following laboratory tests and procedures: blood pressure measurement: (Oct2021) shoot up; heart rate: (Oct2021) 136 bpm; sars-cov-2 antibody test: (unspecified date) negative. The action taken for ibrutinib was dosage not changed.  The reporter considered "heart flutter" and "blood pressure shoot up" not associated to bnt162b2.   Additional information:It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of heart flutter, blood pressure shoot up and had third covid  Pfizer vaccine as she didn't have antibodies was not provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Left arm sore at injection site within five hours.  I woke up with chills at 2am on 4/16/21 and kept waking up because I was so cold even though I had three blankets on me and the house thermostat was set to 75. I continued waking up from being so cold and started to have muscle aches in my buttocks, hamstring, and quads in the middle of the night. Got up at 8am on 4/16/21 and still have goosebumps/chills and aches in the above mentioned areas.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPERSENSITIVITY REACTION, SEQUELA
9 days after injection, pt began to develop erythema, warmth and tenderness around the injection site. It spread from a quarter size on 1/19/2021 to approximately  12 cm x 6 cm today, with increase pain, warmth and stiffness.
Her tongue felt like it was swelling & she said it was getting difficult to swallow.  Liquid Diphenhydramine 25 mg was given immediately.  About 10 minutes later, another dose was given.  About 5 minutes after the 2nd dose of Diphenhydramine was given, she stated her tongue was getting worse & she was having a more difficult time swallowing.  Epi 0.3 mg given IM.  Within about 3-4 minutes, she stated she was feeling better.  Then, about 5 minutes later, she stated her tongue was beginning to swell again.  She was immediately taken to the ED for treatment.  Steroids were given.  Pt was discharged from the hospital.  She is feeling much better today (the day after the event).
fever; body still sore; arm still hurts; Back pain; Neck pain; This case was reported by a consumer via and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th August 2021, the patient received the 1st dose of Shingles vaccine. In August 2021, less than a day after receiving Shingles vaccine, the patient experienced fever, general body pain, pain in arm, back pain and neck pain. On an unknown date, the outcome of the fever, general body pain, pain in arm, back pain and neck pain were unknown.   It was unknown if the reporter considered the fever, general body pain, pain in arm, back pain and neck pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient stated that, he/she got first Shingles shot a day before reporting date. The patient woke up at 3:00 with a fever, his/her body was still sore from it, including neck and back. The patient arm still hurts, but the patient guess it was better than getting the shingles. The patient would get his/her next shot in October.
Rash started and is covering my body, welts with itching and burning appears to be hives.
a swollen lymph node on my left clavicle; other vaccine same date vaccine date 12Apr2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 (Lot number: EW0173) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "migraines due to traumatic brain injury (TBI)", start date: 2014 (unspecified if ongoing), notes: migraines due to traumatic brain injury, (TBI) in 2014; "hypertension" (unspecified if ongoing), notes: hypertension. Concomitant medication(s) included: DEPAKOTE; LAMICTAL; OXYTROL FOR WOMEN; LISINOPRIL; CHANTIX. Vaccination history included: Bnt162b2 (lot number=EW0151, lot unknown=False, administration date=12Apr2021 administration time=04:15 PM, dose number=1, Vaccine location=Left arm), administration date: 12Apr2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 08May2021, outcome "not recovered", described as "a swollen lymph node on my left clavicle"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08May2021, outcome "not recovered", described as "other vaccine same date vaccine date 12Apr2021". The events "a swollen lymph node on my left clavicle" and "other vaccine same date vaccine date 12apr2021" were evaluated at the physician office visit.  Additional information:  It was reported that after second dose, noticed a swollen lymph node on my left clavicle (08May21). Have seen a doctor (05May21), and are still keeping track of my ongoing symptoms. Patient did not receive other vaccine in four weeks. Did not have covid prior vaccination and not tested covid post vaccination. No allergies were reported.  No follow-up attempts are possible. No further information is expected.
Golf ball size raised on right arm, warm, red, hot, rash, very itchy.
After receiving the vaccine, I was told to sit out in the waiting area right after. About a couple minutes pass I started to feel hot and sweaty. I went to look at my phone but only could see a blur. When I went to look up, I made eye contact with the person working behind the pharmacy counter. I told him I didn't feel well. By the time he came over, I saw black. By the time I came to, people were around me. I immediately threw up. I was still hot, and felt a tingling feeling all through out my body. I was told to sit there longer. I sat there for about 45 minutes before the feeling went away. Once that happened I left.
Right eye turned blood red; the eye ball itself was swollen; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient).  A 59-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: ER8730, expiry date: not reported) via an unspecified route of administration in the left arm on Apr2021 at 12:30 (at the age of 59-years old) as dose number unknown, single for covid-19 immunisation. Medical history included prediabetes. Concomitant medication(s) included berberine (BERBERINE), cinnamomum verum (CINNAMON), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), zinc (ZINC) taken for an unspecified indications. The patient previously took tetracycline, terramycin and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Apr2021, 01:00, the patient experienced right eye turned blood red, no pain though. Next day the eye ball itself was swollen, especially at the interior corner of eye. Still no pain. No discharge. Eye doctor could find no indication of anything in eye. Not allergies. Left eye was fine. This occurred 2 weeks past 1st vaccine. Doctor finally put patient on Prednisone which helped. Therapeutic measures were taken as a result of the events (Fluorometholone and then Prednisone). The outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are required. No further information is expected.
Fever, cough, wheeze, syncope and serum sickness. Prednisone 60 mg every day and taper as directed.
J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/2/2022 CHRONIC POSTTHORACOTOMY PAIN J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/2/2022 DRUG INDUCED DM J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/2/2022 CHRONIC POSTTHORACOTOMY PAIN J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/2/2022 HYPOXIA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/2/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse) from Regulatory Authority. The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Feb2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 20Sep2021 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01May2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Elevated cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 20Apr2022, stop date: 04May2022. The following information was reported: COVID-19 (medically significant) with onset 15May2022 at 08:00, outcome "not recovered", VACCINATION FAILURE (medically significant) with onset 15May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Negative; (15May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course- After feeling fully recovered and testing negative on 12May2022, The patient developed headache, runny nose, sore throat, fatigue and tested positive on rapid anti-gen test 15May2022. The patient did not have any Known allergies. The patient received other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt received HAVRIX, TYPHIM, BOOSTRIX on 3/11/18. Right after his vaccines, patient complained of dizziness, sat down and lost consciousness. Patient was lowered to the floor. Paramedics were called. Pt regained consciousness about a minute later before paramedics arrived. Vitals were normal and pt walked out by himself.
His whole upper arm almost triple in size. Swollen, red, very painful. Low grade fever. Tylenol, Ibuprofen, Ice. This was the 3rd year he reacted on flu vaccine.
I was awakened at 2:30 A.m on 4-18-21 with severe pain all over my body, fever, chills, headache, bodyaches, nausea and urinating every 30 minutes until 6:00 a.m when I got out of bed and started drinking water with electrolytes. I am in the medical profession and I knew something was wrong. These symptoms (except the urinating every 30 minutes) continued for 3 days+. I took Advil and Tylenol and nothing helped. I was in a fog for about 3 months after this. I did let my primary doctor know of these symptoms