chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMErix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMErix (unknown). On an unspecified date after vaccination with LYMErix, the subject experienced joint pain, fatigue, memory loss, flu-like symptoms, headaches, cognitive dysfunction, visual problems, rashes, decreased activities of daily life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 22 June 2007 via medical records. The subject was a male in his forties with a history of tick bites in June 1999. Medical history also included bilateral arthroscopic knee surgeries due to meniscal tears. the subject was vaccinated with LYMErix on 14 June 1999, 12 July 1999, and 25 July 2000. Approximately one year following immunization, the subject was reportedly evaluated for arthritis of the knees. In December 2001 underwent knee surgery, followed by recurrent knee pain. On 06 May 2003 he was evaluated for a second opinion regarding knee pain. He noted "some catching" in the knee without swelling, and he was diagnosed with 1) possible lateral compartment early arthritis and/or 2) possible lateral meniscus tear. On 28 October 2003, he was seen for a diagnosis of degenerative arthritis, and complained of knee, hip, and leg pain described as a "burning pain that travels down the lateral aspects of his leg into his foot". The symptoms were treated with cortisone injection. In May 2004, he reported experiencing occasional knee pain treated with Aleve, but was not receiving daily arthritis medication. On 26 April 2001, the subject complained of right leg pain and was diagnosed with thrombophlebitis. On 11 July 2001 he complained of chest pain and a "questionable nodule" was identified from x-ray; he was diagnosed with pleurisy. These were considered to be incidental findings upon review of medical records.
Immediately after vaccination pain in arm and some redness at vaccination site and swelling; welt began to appear after 1 hour after vaccination, pain in arm and some redness at vaccination site and swelling increased with welt. Welt has progressed in size 2 in x 4in. Pt is now experiencing tingling in fingers.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored COMVAX (dose, frequency, route of administration and indication were not reported). No adverse effects reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No additional information provided. This is one of several reports received from the same reporter. Additional information has been requested.
BLOOD CLOT IN RIGHT ARM; ARM SWOLLEN; This spontaneous report received from a patient concerned a 56 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, alcohol use (beer at home), and smoker. The patient experienced drug allergy when treated with acetylsalicylic acid.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 05-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient did not feel sick after vaccination. On an unspecified date in 2021, the patient believed that, she had a blood clot in right arm. In past 2-3 weeks, it had been getting bigger and was moving up in her arm. She probably had the clot for longer but started noticing it more 2-3 weeks ago. Clot was moving from her elbow to the shoulder blade and arm was getting big. Patient did not have any pain but her arm was swollen and due to dark skinned she could not tell if her arm was red. Patient called emergency medical service and told them that she had a blood clot, she could feel and see the blood clot and it was told that she needs to go to the doctor but she did not bother. The blood clot kept moving up. Patient had a regular doctor but she did not inform her doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in right arm and arm swollen was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210547027-covid-19 vaccine ad26.cov2.s- blood clot in right arm. This event 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.
I received the shot and waited there about 15-20 minutes after before returning home.  No issues at that time.  About an hour after the vaccination, I began to lose my mental function.  My brain/mind were not functioning properly - to the point that I could hardly remember my name, let alone do anything on the computer that I was attempting to do.  At about that same time, I had a feeling of near complete exhaustion come over me, to the point of thinking I might faint at any moment. I went to my bedroom and laid down.  I fell asleep shortly there after and woke up approx 2.5 hours later.  After waking, I felt normal again.  I was able to process my thoughts and did not feel faint or exhausted any more.  It has been 1 month today since having the shot.  I have not felt any additional adverse affects to this point, other than the several hours after the shot. On a side note, I had not been sick prior to the shot or in the several months leading up to the shot.  I have also not been sick since the shot.  It was only the several hours on the day of the shot.
2.5 months later I experienced partial right facial paralysis, tingling into the right upper and lower extremity as well as weakness with flexion of the right lower extremity. I was placed on prednisone  immediately for possible Bells Palsy without much immediate relief of symptoms. MRI of the brain did demonstrate demylenating condition, on the same side of the brain where the vaccination was given, which was later determined to be Multiple Sclerosis.
First started with lots of muscle soreness of arm where vaccine was placed, a few bumps that were itchy developed that same afternoon, more bumps appeared next day accompanied by malaise and itching sporadically. By 24 hours, rash and bumps were more prevalent and lots of itching which progressed rapidly through night and hives developed even with antihistamine.
Date the vial was initially stored in the refrigerator on 22 May 2023, BUD was 21 Jun 2023, Date of administration of vaccine 27 Jun 2023; No adverse event; A dose was administered on 27 Jun 2023 and the BUD was 21 Jun 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose was administered on 27 Jun 2023 and the BUD was 21 Jun 2023), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22 May 2023, BUD was 21 Jun 2023, Date of administration of vaccine 27 Jun 2023) and NO ADVERSE EVENT (No adverse event) in a 75-year-old 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. AS7184B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 2.5 milliliter. On 27-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose was administered on 27 Jun 2023 and the BUD was 21 Jun 2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22 May 2023, BUD was 21 Jun 2023, Date of administration of vaccine 27 Jun 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose was administered on 27 Jun 2023 and the BUD was 21 Jun 2023), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22 May 2023, BUD was 21 Jun 2023, Date of administration of vaccine 27 Jun 2023) 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 (A dose was administered on 27 Jun 2023 and the BUD was 21 Jun 2023) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22 May 2023, BUD was 21 Jun 2023, Date of administration of vaccine 27 Jun 2023).    The vial did not undergo temperature excursions. Concomitant medication details not reported by the reporter. Dosage text was reported as unknown. Treatment details was not reported by the reporter.
not feeling well with diarrhea; not feeling well with diarrhea; nausea; hot/cold flashes (was unable to take temperature); hair follicles to be achy; severe migraine; mentioned a slight sore throat that lasted a few hours; By Sunday 8:30pm started feeling better with just a small headache; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This 44-year-old Female consumer reported for herself that: A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Friday 26Mar2021 (age at vaccination 44-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunization. On 28Mar2021 after the second dose of vaccination, the patient experienced not feeling well with diarrhea, nausea, hot/cold flashes (was unable to take temperature), hair follicles to be achy, severe migraine, mentioned a slight sore throat that lasted a few hours and by Sunday 8:30pm started feeling better with just a small headache. It was reported that, the patient on Sunday 28Mar2021 was woken up early 5ish am not feeling well with diarrhea. Started experiencing nausea, hot/cold flashes (was unable to take temperature) and described hair follicles to be achy. Started to experience severe migraine. The migraine escalated hour later and described it almost as unbearable at one point. Also, mentioned a slight sore throat that lasted a few hours. By Sunday 8:30pm started feeling better with just a small headache. Patient mentioned the only medication she taken for her migraines. Her Dr. prescribed a few migraine medications as it's ongoing problem. She also mentioned that she did not have a reaction to the first dose of Pfizer covid vaccine. Patient indicated she was taking many migraine medication. Only meds she taken. Her migraines was easily triggered by stress. Event took place after use of product. The outcome of event headache was reported unknown, while outcome other events was recovering at the time of last observation.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
No symptoms the first 12 hours. Upon waking up for work, I had severe fatigue, chills, and severe arm pain, no fever.. At 3:30pm, 24 hours after the vaccine, I noticed a large red spot on my arm that appears as though the liquid spread out under my skin (best way to describe it). About 3 inches by 2 inches in size. It could have been there since I woke up, but I didn't notice until later today.
Pt is experiencing headache, sore throat, fever (101.7) and cough.
Under arm pain; Noticeable swelling under armpit when palpated; received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via unspecified route of administration in left arm on 05Mar2021 at 18:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior vaccination. The patient received other medications (unspecified) within two weeks of the vaccination. On 09Mar2021 at 08:30, the patient experienced under arm pain that occurred few days after the vaccination, went away and came back, for total of almost two weeks now. The patient noticed swelling under armpit when palpated. The events not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events under arm pain and swelling under armpit when palpated was not recovered. No follow-up attempts are needed. No further information is expected.
Returned for TB test reading 6-14-18 (L) antero-lateral thigh with a 3 inches x 2 inches (approx.) red oral of skin with mild thickening and mildly tender to touch. No treatment and resolved after incident, next 7 days.
Got COVID; Got COVID; Compromised immune system; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; cilgavimab, tixagevimab (EVUSHELD), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Got COVID"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Compromised immune system". The action taken for cilgavimab, tixagevimab was unknown. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Patient had 3 Pfizer vaccines as part of initial treatment, 2 Pfizer Boosters, and the current bivalent Booster along with cilgavimab, tixagevimab. When patient got COVID this fall patient was able to be treated with monoclonal antibodies and stayed home. Patient had a very compromised immune system.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
I have broken out into hives.  It started approximately 7 days after being vaccinated and increased daily so that by today they cover most of my body.  It is the first time I have experienced this. Nothing unusual in my routine or diet. It may or may not be related to the vaccine. My doctor prompted me to report.
Patient came in the pharmacy on 11/7/23 and stated he has had a mark/bruise ever since day of administration on 10/11/23. He stated the mark is not causing any pain and is not getting any bigger, but that it still hasn't faded. Patient advised to contact the pharmacy if mark spreads or starts to hurt.
Vertigo, extreme loss of balance, deafening tinnitus, numbness in hands and feet that radiate up arms and legs, nausea, visual disturbances, moments of intermittent cognitive impairment. Tx: contacted PCP, went to the ER, also consulted an ENT and a Neurologist Outcomes: symptoms still persist
This spontaneous report was received from a currently a 57 year old male patient referring to himself. The patient's concurrent conditions included high blood pressure. His medical history was not reported. In approximately 2008, reported as about 9 years ago, the patient started therapy with REMERON 30 mg tablets, 30 mg once a day, orally (lot number and expiration date were not provided) for help him with sleep, which was other than indicated in the prescribing information (product use issue). Other suspect therapies included losartan (manufacturer unknown) 100 mg tablets, orally; ZOCOR 20 mg tablets, orally (dose, frequency, lot, numbers, expiration dates and indication of both therapies were not reported) and on an unknown date, while he was on those therapies, he received a dose of pneumococcal vaccine (manufacturer unknown) (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient had a reaction to the pneumococcal vaccine (manufacturer unknown); he developed sepsis at the site of the injection. The patient was treated by his physician with an unspecified treatment and recovered on an unknown date. The patient stated that after 9 years, he attempted to slowly take himself off REMERON. So, he started cutting the tablets in half and then stopped taking the medication completely (unknown dates). Thereafter, on an unspecified date, the patient experienced blood pressure being all over the place, wanting to pass out, his heart was racing and nausea. On approximately 05-APR-2017, reported as about two weeks ago, he was admitted to the hospital due to the events. The patient received unspecified treatment for the events and was discharged on an unspecified date in April 2017. No laboratory diagnostic studies were performed. At the time of the report, therapy with REMERON was continued and the patient was recovering from the events. However; he stated that he needed to be "off" REMERON as per his physician. The action taken with losartan (manufacturer unknown) and ZOCOR was unknown. The action taken with REMERON, losartan (manufacturer unknown) and ZOCOR regarding sepsis at the injection was unknown. The reporter considered the injection site infection to be related to pneumococcal vaccine (manufacturer unknown). The causal relationship between the other events and the suspect therapies was not reported. Upon internal review, the sepsis was considered to be a medically significant event. Additional information is not expected because there was no consent to contact the physician.
This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 18th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than 2 months after receiving SHINGRIX, the patient experienced upset stomach and feeling unwell. On an unknown date, the outcome of the upset stomach and feeling unwell were recovered/resolved.  It was unknown if the reporter considered the upset stomach and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. After receiving SHINGRIX, the patient had some side effects that lasted about a day. The reporter did not have a lot of information about the symptoms.
Like the 1st dose, the injection sight was sore that evening and the next day. But, that was all for the first injection. For the second injection, I had chills and muscle aches over the body for the day.  Everything disappeared on day 3.   I did not see a doctor and did not take any medication. I just let nature work its way through it.
4 y.o. Male received Pfizer Covid-19 (12+) Vaccine dose. No adverse reactions noted or reported by patient and parents to date.
The first hour and days after receiving the flu vaccine had a red area with swelling  burning and rash on arm that received flu vaccine. The area was hot but she never had fever.  Several days later experiencing muscle, back, knee, and ankle pain and tingling.
Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA256189 (same reporter). This case involves five patients (gender not reported), who were vaccinated with a dose of FLUZONE QUADRIVALENT (lot number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date that was in a shipping excursion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PENTACEL for Immunisation; ROTATEQ for Immunisation; HEPATITIS B VACCINE for Immunisation; and PREVNAR 13 for Immunisation on an unknown date. It was a case of actual medication error due to incorrect product storage. No known reported symptoms. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
6 1/ 2 X 2 1/2 cm reaction on right deltoid.
2/1 woke up with severe/stabbing  upper right back/scapular pain. took NSAIDs and comfort measures. Had an X-ray.  2/7  developed a rash in the same area in a line.
Right after administration of the vaccine. Patient became dizzy and fainted for a few seconds and then regained consciousness. She stated that she was nervous before the vaccine was administered. No other adverse reactions and the patient felt fine soon after. No treatment was needed
Patients received the vaccine after the expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after the expiry date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after the expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after the expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Reporter stated that the date on packing slip that comes with the vaccine was not a correct expiration date and reporter also used the CIR (City Immunization registry) portal, where they store their documentation inventory and find out that the date on the portal is also not accurate, after that reporter used the Look up tool on the Moderna website, the tools told her the vaccine was expired.  Reporter wanted to know the lot number 042J21A have been extended and reporter thought the expiration date was 31-Dec-2069.  The vial didn't undergone temperature excursions.  No treatment information was provided.
pt recvd vx 30AUG94; pt noted itching, head, swelling in area where inj was given on 31AUG94 & later had onset of h/a & vomiting; seen 1SEP94 by PMD