chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ocular myasthenia gravis left eye. Immune system over acting attacking signal to eye muscles. Currently prescribed Mestinon to increase strength of nerve signal which is not helping much. Next step will be an immune depressant.  Symptoms and treatment ongoing.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11May2021 as dose 2, single (Lot number: Ew0168), in left arm and on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid treatment from 11Sep2022 to 16Sep2022. Patient has not received any 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.
fatigue, nasal congestion, sore throat, cough, sneezing. starting on 9/11/21
This initial report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the unspecified patients were vaccinated with improperly stored ROTATEQ, oral route, lot number M014318 with expiration date 30-SEP-2017 (dose and strength were not reported). The temperature was 50.7 F with a time frame of 30.5 hours and data logger was involved. No adverse experience was reported. This is one of two reports from the same reported (MARRS 1611USA010654). Additional information has been requested.
Patient was administered an outdated (likely less potent) Moderna vaccine. The vial was left out from the day before and not discarded after 12 hours. Pharmacy technician thought the vial was recently pulled and administered the vaccine after pharmacist verified the Moderna Booster. Patient did not report any issues with receiving this vaccine; however, wanted to report to VAERs for proper record keeping. Our team will follow-up with clinical to assess what are the next steps for this patient's immunization schedule.
The monthly temperature logs were not done for the Month of October for both the manual temp logs and digital logs. Due to no temperature log not being done all vaccines are considered and deemed unviable.
Mom called at 8:00 am this am that she noticed that the baby is stiffening her arms and legs with staring look 4-5 times this am, brought the patient to the office. Patient examined, episodes never happened in the office. Patient has history of dysplastic pulmonic valve.
Patient received vaccine after its expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) 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 EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date).    No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided. This case contains information for the 7th of 7 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727965 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727965:Master Case of Patient 1
Patient presented to the adverse reaction nurse at 12:00PM complaining of a dry throat and cough. Patient has a history of allergic reaction to Latex and Kiwis. Patient was carrying her epi pen with her. Patient stated she did not feel any difficulty breathing. Examination of her throat did not show any signs of swelling.  Patient stated after 15 minutes that she continued to have a itchy/scratchy throat.    The physician was consulted at 12:30PM and ordered 10mg of Cetirizine which was administered at 12:45PM and that the patient could be discharged if her symptoms did not worsen and to advise the patient to call 911 and administer her epi pain if she experienced swelling of the throat or difficulty breathing.   At 1300 the patient stated that her symptoms had slightly improved and she was then discharged   Patient was advised that if she experienced any difficulty breathing, dizziness, weakness, swelling of the throat or tongue, hives or rash all over the body to call 911.
This spontaneous report was received from a medical assistant referring to 12 unspecified patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot number N004945 and expiration date of 09-OCT-2018 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. The patients received the vaccines after a prior temperature excursion of 32°F to 35°F (32.3°F), that occurred on 21-SEP-2017 with a time frame of 1 hour. There was no previous temperature excursion. A "data logger" was involved. There was not product quality complaint involved.
Body aches 4/6/2021, Migraine 4/7/2021, Head aches off and off since 4/8/2021
Around 9 o'clock at night on 04/26/2021, I started to feel not great. I woke up at 2 in the morning on 4/27/21 and I ran into the bathroom with diarrhea and started to violently vomit. I was in the bathroom for at least two and a half hours. The next day, I just had tea and water and tried not to aggravate my stomach anymore. By 4/28/21, I started to feel a little better and was not throwing up anymore. I gradually started to feel better.  I did not go to a doctor.
Initial report received from health authority (121801) on 11 Aug 2010: This patient with previous history of seasonal vaccination in Nov 2009 was vaccinated with S-OIV FOCETRIA (batch number: 090802) on 15 Dec 2009. Fifteen days after the vaccination, the patient experienced dizziness and bleeding from teeth. One week later, the patient experienced hemorrhage from an eye. In the beginning of Jan 2010, the patient experienced again bleeding from teeth and went to a dentist who prescribed an unspecified antibiotic. After that, the patient was hospitalized on an unspecified date. Again in Jan 2010, the patient experienced bleeding from teeth, pain in superior limb, red eyes and dark arms. A blood test was performed which indicated partial thromboplastin time of 58 and the patient was diagnosed with acquired hemophilia. As corrective measure, the patient was treated with cortisone and ENDOXAN. Final outcome of the events was reported as complete recovery on 01 Mar 2010. This report combines follow-up information received from the Health Authority on 18 Aug 2010 and Internal review done on 23 Aug 2010 of the information received on 11 Aug 2010: In the end of Jan 2010, the patient presented with clinical and laboratory findings of acquired hemophilia, characterized by the acute onset of cutaneous hemorrhagic manifestations and coagulation alterations which included APTT prolongation of 50 seconds, clotting factor VII reduced to less than 1% and presence of a high inhibitor titre (128 Bethesda Units). For this reason, the patient was hospitalized and was treated with activated recombinant factor VII and also received an immunosuppressive therapy with cortisone and cyclophosphamide. Subsequently, no major hemorrhagic events occurred and 2 months after therapy start, coagulative state became normal. During hospitalization, the principal cause of acquired hemophilia including neoplasia and systemic autoimmune diseases were excluded. The absence of underlying causes and the quick resolution of the patient's laboratory findings, as well as the temporal relationship suggested a possible correlation with vaccination previously performed. After internal review, the seasonal flu vaccine (manufacturer unknown) received in Nov 2009 was also considered as co-suspect drug as it might have contributed to the event.
Vaccination was given on Friday - May 7th. Started having 104.5 fevers on Friday - May 14th and continued through Monday - May 17th (fever broke on this eveing @ 8:00 PM). Behavior changes started on Monday - May 10th and have continued to this date - not sleeping, possibly in pain - waking all night every night, especially noticeable since fevers started on Friday - May 14th. No other vaccinations were given on this date.  I have been giving my children 1 vaccination a month.
experienced having sore throat; difficulty swallowing after receiving the vaccine; Initial information received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA288656(CLUSTER).  This case involves patient of unknown demographics who is having sore throat and difficulty swallowing after receiving the vaccine influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection strength, dose, expiry date: not reported lot UT8055NA via unknown route in unknown administration site for Immunization.  On an unknown date the patient experienced having sore throat (oropharyngeal pain) and difficulty swallowing after receiving the vaccine (dysphagia) (unknown latency) following the administration of Influenza Quadrival A-B Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events experienced having sore throat, difficulty swallowing after receiving the vaccine.  At time of reporting, the outcome was Unknown for the event experienced having sore throat and difficulty swallowing after receiving the vaccine.
received second dose of Shingrix / shingles but not a fully fledged case; Shingles; Rash; shivering; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and shivering. On an unknown date, the outcome of the vaccination failure and shivering were unknown and the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shivering to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and developed shivering that night, and had a rash.  The physician said the rash was shingles but not a fully fledged case. It was reported the rash/ shingles was not itchy or painful but it did appear to be spreading. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
reaction to the vaccine that was received about 10 days ago; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction to the vaccine that was received about 10 days ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (reaction to the vaccine that was received about 10 days ago). At the time of the report, VACCINATION SITE REACTION (reaction to the vaccine that was received about 10 days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
patient reported developing  urticaria on left arm 48 hours after he  received the does which also moved to other parts of body (leg, buttocks) The patient reported that it lasted for a few days and was usually worse at night and better during the day.  He took antihistamines by direction of his doctor and symptoms improved
Pain in left arm at injection site.  Started out as a dull ache about 8 hours after the administering of the vaccine.  It gradually worsened for the next two days to the point I could not lift my arm if it was bent at a 90 degree angle, which additionally caused excruciating  sharp pain bringing unwanted tearing.  I took one dose of 81 mg St Joseph low dose baby aspirin and within 30 minutes the pain went away and I have had no further aching or serious pain.  It remains slightly sore at the injection site if pressed.
Headache the evening of the vaccination. The next day I had headache, chills, whole body ache, stomach upset. I took Tylenol, as directed, for two days.
pt recv vax 22JAN97 & 28FEB97 pt devel a low grade fever assoc w/a mild case of chickenpox comprised of an unk number of lesions;
I have been extremely fatigued and Major Brain Fog , making it difficult to function as I have before.   No matter how much I sleep and even with my Adderall I am not the same and its difficult to function and , I have major confusion at times .  I feel  like my Adderall is not working at all now.
Severe joint pain and nausea.  The patient went to the ER.  They found nothing. No treatment was given.  Patient began to feel better.
Feverish, painful joints, headache, fatigue 12 hours after injection lasting until 48 hours after injection
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 19-APR-2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles (herpes zoster). On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Systemic: Weakness-Mild
Patient arrived at vaccine site at approximately 1520 reporting that she had received dose 1 of the AstraZeneca COVID vaccine (lot 77673) in Mexico on 7/23/2021. She requested to receive the Pfizer COVID vaccine. PHN called PHN supervisor and the medical team. Dr from the medical team approved Pfizer vaccine series for the patient. Patient received dose 1 of the Pfizer COVID vaccine (lot 30145BA) at 1530. Patient waited in observation area, no report of adverse symptoms. Patient left walking at approximately 1548 with steady gait.
I just spent 14 hrs in the ER trying to treat, what I was sure to be, an ovarian cyst. The pain had been building over the past mo. I procrastinated going to the ER, because I wanted my 2nd dose b4 going, which was yesterday.    I had exams, pelvic, ultrasounds, Cat scans, labs, etc & they found nothing. I can barely walk without doubling over.  4 wks ago I had an L-5 block & trigger point injections with steroids, due to inflamed nerve roots, & inflamed L thigh. 1 wk later, I had my 1st shot, L arm. Within days my abdomen began hurting mildly, but I thot it'd subside. It never occurred to me that it could be related to the vaccine. 2 wks later, it was unbearable & I thot it an ovarian cyst. I waited for my 2nd shot appt, b4 going to ER, in case I was hospitalized. I didn't want to ruin my 2nd dose, as I have lung issues.   ER Dr said, I had "undetermined inguinal pain". Then, I found a study about women, hormonal changes & the vaccine. I saw that lymph nodes can get inflamed after a vaccine.   Now, I think I had a vulnerable area on my L side, then rec'd steroids L side, which lowered my immune system. Next, I rec'd my 1st shot L side, & my "inguinal lymph node" on L side became inflamed. It got progressively worse, & now my 2nd dose was yesterday, also on my L side, & has aggrivated it even more.   Tomorrow I see my pcp.  It feels exactly like my ovary's swollen, & the inguinal lymph node's located right in the same place, so after all tests have been negative, I suspect a connection & I'll discuss with pcp for more testing & treatment.
Initial unsolicited report received from a nurse on 14 June 2016. This case involves a 39-year-old female patient who was vaccinated with a dose of ADACEL (batch number: UI568AA, expiration date 16 June 2018 and dose were not reported) by intramuscular route in the left deltoid and dose of TUBERCULIN PPD (M) 5 TU (Tubersol) (Batch number: C4866A, expiration date 22 January 2018 and dose were not reported) by intradermal route in left forearm on 07 June 2016. Patient had no illness at time of vaccination. Pre-existing physician diagnosed allergies, birth defects included allergy to Keflex, penicillin, phenergan and medical conditions included hypertension. Concomitant medications were not reported. 08 June 2016, one day following the vaccination experienced mild symptoms of headache, nausea, vomiting and body aches. Patient went to emergency room on 12 July 2016. Laboratory investigations included Tuberculin skin tests which was positive. Corrective treatment were not reported. Patient was not recovered from event. It was reported that physician told that it was a reaction to the vaccine. List of documents held by sender: none.
Pt complained of possible SOB last night. Has hard hot puff red area around injection site approximately 4 inch in diameter today.
Patient came into office to receive 1st COVID vaccine at 10:40, our office typically has never done pediatric patient COVID vaccines. I talked to my lead MD, she said we do them, I was still unsure. She then looked up dosage to make sure. She then still said yes to doing the vaccine. I administered Moderna with a red cape and light blue border NDC: 80777-273-10 to patient. Patient did not have any reaction at this time. I then tried to input into vaccination tracking system and was unable to, the system was saying that the vial was for 12+/ I then started to report to my Supervisor, Health Department, Moderna and VAERS.
a 71 year old was administered  kinrix; was administered  kinrix instead of boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 71-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. In November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Kinrix couple weeks ago from the date of reporting instead of Boostrix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
severe chills, fever, body ache, fatigue, head ache, nausea during slee