chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient describes no immediate adverse event after vaccine receipt to suggest IgE reaction (e.g. oral/facial/throat/tongue edema, SOB, wheeze, CP, urticaria, pruritis, etc.) . He reports he felt ill the following day with weakness, cough, increased nasal drainage,  decreased exercise tolerance resulting in SOB and elevated HR. He was seen in ER 29 APR (day 8) and diagnosis was URI vs. vaccine reaction. He states these symptoms have resolved.  He reports 2 weeks ago (day 7) he was then in the field training  and exposed to poison ivy. On day 14 he  developed  dermatitis to arms, abdomen and groin. He self treated with topical benadryl cream, which made symptoms much worse and produced a large plaque. He switched to calamine,  and witch hazel. On day 17 he developed a targetoid erythematous dermatitis to his hands and arms. He was seen in ER and diagnosed with EM and contact dermatitis and treated with oral prednisone, and cetrizine and Bactroban for sites of secondary infection. He reports lesions to hands and arms are mostly resolved, and abdominal plaque is much improved. He is using cetrizine and pruritis is not significant. He had no oral lesions, oral pain, vesicles, vision changes.
Injection site was painful for several months (previously, no injection had ever been painful for more than a day). After several months, the pain began spreading from the injection to other portions of the upper arm and into the shoulder. Tendinitis was setting in, but was relieved through ibuprofen and physical therapy (scraping). While the tendinitis ceased after a few weeks, the upper arm was still painful enough to limit movement to about 50% of prior span of motion. This same arm received an annual flu shot over 6 months later which immediately returned the arm to tendinitis (reported in a separate VAERS).
Fever started spiking about 12 hours after vaccine. Fever & chills. Fever was 103.9 before I took ibuprofen. Took Ibprufofen every 4 to 6 hours from about 12 hours after vaccine to about 36 hours after vaccine- and fever never went below 100. Fever was gone about 45 hours after vaccine. On day 2 to 3 after vaccine, developed hives all over stomach. Also itchy on legs and arms.
MMR given 5/2/03, 13 days later developed rash dx'd petechiae/bruising platelet count 3,000. Dr at hospital as ITP not treated or hospitalized counts recovered to 201K by 5/29/03. No bleeding.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant drug and drug reactions/allergies were not reported. On 04-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route was not reported) lot # r024023, expiration date of 22-AUG-2019 for prophylaxis (product storage error). Other suspect therapies included sterile diluent (strength, dose, route of administration, lot/batch# and expiry date were not reported). No adverse effects were reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
Pt c/o redness and swelling to right arm with itching, States it is better than yesterday, Did have some fever and chills last night, No SOB, 12/14/01 Right arm swelling decrease also went to work, No more fever chills, Feeling better per his friend.
Large, somewhat circular rash appeared on upper left arm, around the injection site, a week after receiving first dose of the Moderna vaccine. Initially the area was raised, itchy, and inflamed; the next day it was red and slightly itchy. Day three it is still the same size, but redness is fading in the middle and concentrated in a ring around the perimeter. Day four it looks similar, with the exception of some darker red marks appearing near the center of the rash. Size is around 2-3 inches in diameter. Antihistamines, both oral and topical, have been tried.
11/19/2021 I woke up at 0430 am with a severely sore arm. I got up to take Tylenol, I felt a little dizzy. At 1230pm I began to have a bad headache , severe chills, low grade temperature  I was very weak and my eyes were feeling like I had the flu. I took Tylenol every 6 jours These symptoms lasted until 6 pm When I finally began to warm up I still felt very tired headache an dizzy
Early, heavy period with clots.  Cycle went from 25-26 days to 14 days.  First period after second shot came 1 week early and was very heavy and lasted 2 days longer than normal.  Experienced 3 periods in April the month following the second dose.  After that, 2 periods per month and bleeding through super tampons and overnight maxi pads every 2-3 hours with gelatinous blood clots.  Experienced lethargy 1-2 days before cycle and during the cycle.  Now 7 months after my second dose, My cycle length is back to normal 25-26 days, but the heaviness of the period is still very extreme and heavy with clots.   My Obgyn performed an ultrasound and endometrial biopsy to rule out any complications causing the heavy bleeding, that biopsy and ultrasound was normal.
Day one: rash on chest and back, left side of face tingling that was transient/intermittent; day 2/about 16 hours after the vaccine: severe abdominal pain and nausea x 17hours with inability to get out of bed or tolerate any po's, not even ice; headache (as expected) x 18hrs, 48hrs later fatigue only with dizziness; day 3 after vaccine: moderate consistent vertigo x next 5 days through Friday February 5th, hypertension with BP 169/92 and range of 160's/90's x 3; right side face tingling, right eye tingling or unlcear vision and right side of mouth/lip tingling with swelling feeling but not visible;  day 3 or 72 hours after vaccine I had a sudden onset break out in cold sweats, lightheadedness, nausea and inability to concentrate x 60 minutes or more without any exertion, sitting did not relieve sensation of impending doom or incoherence, slowly improved after 60 minutes to return to vertigo and right upper body numb tingling sensations from eye to finger tips. Full 7 days of feeling "unwell" and not safe.
I had a scratchy throat that felt like I had cat fur in the back of my throat.   This was from the time I got up (0730) until I went to bed (2300) I started to experience a rapid HR (110-150 BPM) for approximately 6 hours which started around 11 am.
funny feeling in arms 7/6/2021, Acute bronchitis/Pneumonia, Afib, CHF, Stroke front, middle and back right side  as of 7/7/21.
PATIENT 16 YEARS OLD HAD THE FLU SHOT AT 235 ON 11082018 AND SHE FAINTED SHE DID NOT LOSE CONSCIOUS.
From mailed correspondence received from manufacturer (EB2001017049) regarding events in California. It was reported on 7/9/01, an adult female with no known allergies received her second injection of Engerix B. She also received an injection of Yellow Fever vaccine. Approximately 45 minutes post immunization, she experienced numbness and tingling of the palate. These sensations reportedly came in waves of decreasing intensity. The numbness and tingling resolved that night, hours later.
This case was reported by a nurse via call center representative and described the occurrence of flushing in a 56-year-old female patient who received FLUARIX QUADRIVALENT (batch number 2RG54, expiry date 30th June 2017). On 13th October 2016, the patient received FLUARIX QUADRIVALENT 0.5 ml. On 13th October 2016, several hours after FLUARIX QUADRIVALENT, the patient experienced flushing, burning lips, burning skin and feeling abnormal. The patient was treated with BENADRYL and PREDNISONE. On an unknown date, the outcome of the flushing, burning lips, burning skin and feeling abnormal were recovering/resolving. The reporter considered the flushing, burning lips, burning skin and feeling abnormal to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: Director of Quality Assurance and Staff Development reported that patient received a flu vaccine at 9:00 am and when she arrived home she was flushing, rushing feeling, complained of burning lips and burning of the skin. The patient required emergency room visit. Reporter did not have full details and will email with lot number or expiry date, date of birth and any other details which she did not have today.
feeling tired; had like flu-like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "feeling tired"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "had like flu-like symptoms". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021526486 same reporter/vaccine/event, different patient
expired vaccines that are administered inadvertently; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves Child male patient who experienced  received expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  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 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5202AA via unknown route.  It was of actual medication error due to  expired vaccine used..  No adverse event was reported.  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.
Developed skin rash 6-7 days after the vaccine. It started with 2 small red bumps on the legs (near the knee caps) on the 6th day after vaccine. On the 7th day, a large, swollen, hot rash was visible on arm where the vaccine had been administered. In addition, the small red bumps increased in number and spread to the other knee, feet, elbows and torso. After another 3 days, the arm rash went away. However, now 14 days after the vaccine and 8 days after the first symptoms, the rash is persistent on knees and elbows. They are painful and itchy and do not appear to be reducing.
Information has been received from a consumer who contacted a representative to report that after vaccination with ZOSTAVAX the patient had experienced adverse event (unspecified). The consumer was advised to initiate further communication to provide additional information. Additional information is expected.
Patient came in c/o rash to left deltoid. Pt states she had a pneumonia shot on 6/4/15 and now has a knot that keeps getting bigger.
I started to have a runny nose, head congestion and a dry cough. I did not have a fever but I had mild body aches. For the last two days I've been experiencing dizzy spells, and I my cough has loosened up. I took two home COVID-19 test on 6/30/2022 that came back negative. I went to urgent care to have a COVID-19 test done there because both of my sons were positive for COVID-19. On 7/1/2022 my COVID-19 test came back positive. My symptoms have gotten a lot better and I feel almost back to normal.
Nasal Swab: positive; Nasal Swab: positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 17 years for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 21May2022, outcome "unknown", COVID-19 (medically significant) with onset 21May2022, outcome "recovered" and all described as "Nasal Swab: positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical course: Facility type vaccine: Doctor's office/urgent care, The patient did not take any other vaccine in four weeks. The patient took other medications in two weeks. Adverse event: cough, congestion, sinus pressure, fatigue, headache, body ache. Adverse event start date: 21May2022. If patient recovered: Recovered. If treatment AE: Unknown. The patient did not had Covid prior vaccination. The patient tested Covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200792393 Same patient and drug, different event separated in time
Once I?d gone to bed on 3/25 about 10:30 pm. I woke up later that night feeling uncomfortable and restless. Had cold chills and headache  when I woke up the next day I was extremely tired and felt like I had flu like symptoms The following day(Saturday) I felt like normal again myself again
Patient received pneumonia vaccine on 10/25/11. Reported arm swelled up like a balloon & very painful could not sleep all night. Wen to MD to get checked next day.
Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 20-Apr-2022; Patient received an expired vaccine on 20-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 20-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 20-Apr-2022) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 001B21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 20-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 20-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 20-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that they initially called on 12-May-2022 and reported a total of 18 patients received expired doses after the 30 days Use by Date. On 17-May-2022, the reporter reported after doing further research, that the actual total number of patients that received expired doses after the 30 days use by date was 82 patients total and not 18 patients. The date the vial initially stored in the refrigerator was 11-Jan-2022 which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. Reportedly, the vial didn't undergo any temperature excursions.   The patient had not reported adverse reaction to the reporter's knowledge.  No treatment information was provided
Syncope - patient experienced lightheadedness, sweating, paleness, blurred vision and cold extremities. I reassure patient that he will be okay and this is the body's response to pain/anxiety. I also provided patient with water and make sure he was seated so he does not fall. His vision return to normal after 5 minutes or so and he started recovering within 15 minutes.
1st time shot - after 5 minutes I had disoriented issues, hot flushes for about 5 minutes where I took my shoes off in the car and mentally felt like I was having an anxiety attack so the ?attendant lady? said it was normal to have a #panicattack . Two weeks later I went to my 2nd shot, and thinking it was a previous ?anxiety attack? this time would be better.  Same timing, same feelings happened that lasted about 3 minutes and it was extremely  scary.
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from an other health professional via The Agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310354, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310464, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310559, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310708, 2020SA310769, 2020SA310770 and 2020SA277871 (same reporter).  This case involved a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (Product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  At the time of report, no adverse event was reported.  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.
On 5/17/02, right leg started feeling weak; on 5/18/02, both legs weak and fell 3 different times and noted weakness of hands; on 5/19/02, legs were getting weaker and grip was getting weaker and fell 4 times. On 5/20/02, weakness increased. Saw company physician and was referred to a Neurologist. Saw the Neurologist on 5/22/02 and was dx'd with Guillain-Barre.  Received on 06/11/2003: "Not at this time.  The recipient contines to have weakness in all extremities and the treating physician anticipates the recipient will be at maximum medical improvement in May 2005.  Due to company police (6 months of leave and 6 months of light duty) the recipient has a possibility of losing his job.  He has been with this company for 26 years."
This report describes the occurrence of mercury poisoning in a 12 month old male who was vaccinated with hepatitis B vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The subject was allegedly born a perfectly normal, healthy boy whose Apgar scores at birth were well within the normal range. Developmentally, neurologically and socially, he achieved every developmental milestone anticipated of all normally developing children until the age of 12 months. The subject received injections of Engerix-B on 1/9/95 and 9/18/95. He also received injections of combination diphtheria and tetanus toxoids and pertussis vaccine/Haemophilus influenzae type B conjugate vaccine, diphtheria and tetanus toxoids and pertussis vaccine, and diphtheria and tetanus toxoids and acellular pertussis vaccine. The subject's attorney alleged that at approximately 12 months of age, the subject was neurologically devastated by the accumulation of Mercury in his body, having been exposed via IM vaccinations, and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to  becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior and the loss of language skills, motor skills and affect. Treatment and outcomes of these events were not specified. The mercury poisoning and developmental regression in this report are considered medically serious.
All symptoms appeared within 18 hours of receiving vaccine Back pain that gradually began and increased in severity for 2 weeks. It then developed into painful spasms on left side of spine near kidney, which lasted for 4 more days. Ankle joint pain - lasted 2 weeks Elbow  joint pain - lasted 1 week Appearance of two cold sores, which lasted 3 days Exhaustion - lasted 3 days Headache - lasted 1 day
Evening of vaccine, developed high fever, uncontrollable shaking. Swollen glands, and severe headache only on left side. Next day, symptoms reappeared with a painful circular rash (3 inches across) on left arm well below injection site, rash was hot to touch and very painful. Fever, neck and head pain resolved on 3rd day but rash continued for a few days, then started to lighten but still has the sensation of discomfort when touched. Please note all symptoms, except fever, were all on the side that vaccine was given.