chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a female consumer of unknown age referring to herself. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 18-OCT-2017 (reported as yesterday) the patient was vaccinated with ZOSTAVAX for prophylaxis (strength, route, dose, units or lot number were not reported). On an unspecified day of October 2017 the patient experienced redness and itchiness at the injection site. At the time of the report the patient was still experiencing redness and itchiness at the injection site. Causality assessment was not provided.
1  Extensive left upper extremity venous thromboembolism-nonocclusive in the left subclavian, left axillary, brachial and basilic veins 2  Right lower lobe subsegmental PE 3  Mechanical thrombectomy of the left subclavian and axillary veins  4 Bruising all over body
A 60 year old male, was admitted from the Clinic on 17Dec09 for progressively-worsening upper and lower extremity weakness. The patient has a glomus tumor at the base of the skull and a history of non-Hodgkins lymphoma in the past.  He received seasonal influenza immunization 10/02/2009: Vaccine:  Influenza  0.5 ml (IM)          Site: Left deltoid         Manufacturer:    CSL Biotherapie          Lot #:     08049111A          Expiration Date:     Jun 30,2010  No evidence that the patient received the H1N1 novel or "swine" flu vaccine.  We are currently attempting to determine whether or not the patient received the H1N1 vaccine from a community source.  He was subsequently admitted on 28Oct09 with history of possible TIA.  At that time, he reported shooting pains in the right lower extremity for 6 weeks' duration, with acute onset of numbness in the right upper extremity, particularly the medial forearm and 4/5 digits.  In addition, he stated he noted numbness in the right face and right thigh, but denied dysarthria, weakness otherwise, or gait disturbance.  He was discharged on 28Oct09 without a definitive diagnosis having been made.    The patient had symptoms in the interval from 28Oct to 17Dec.  The symptoms gradually worsened and on admission he had right-sided paresis with reflexes brisk on the right and normal on left.  A lumbar puncture revealed significantly elevated cerebrospinal fluid protein, which is typically indicative of an inflammatory/immunologic reaction in the spinal meninges or spinal nerves which can be consistent with several conditions.  The clinical picture in this case includes Guillain-Barre Syndrome which has been reported as a rare adverse reaction from the seasonal and the "swine" H1N1 influenza or vaccination for those conditions, and also as a parA-neoplastic syndrome associated with the immunologic disorders related to ongoing cancerous processes or the direct physical effects of tumor masses on the nervous system.   The non-Hodgkins lymphoma, the glomus tumor, and/or either the seasonal or the H1N1 vaccine could be etiologic to a GBS-like syndrome.
Patient well at visit; received vaccines. Was fine when leaving office and at home. Was put in for a nap in early afternoon. Found 30 minutes later, was blue and nonresponsive. Received CPR and taken to ER.  Nurse follow up on 09/28/04 states: "No new information." Medical records reviewed state patient COD was cardia arrest.
High heart rate/panic attack. Patient reported feeling high blood pressure and panic after 10 minutes of administration. Upon talking to patient and monitoring patient for an additional 20 minutes heart rate was at 70 and patient was feeling better and felt good enough to leave with his adult children for lunch. Water, deep breathing, and time were the only treatments administered, no epinephrine or diphenhydramine were administered. Followed up with the patient later that day, approximately 4 hours later and he was felling better. During monitoring patient did mention that he had a similar reaction to Miralax in the past but not Go Litely. Upon looking at the screening form this was not noted in the allergy field. This patient may have a concentration dependent sensitivity to polyethylene glycol, suspending agent or major component in the moderna vaccine is not diluted in any volume. Talked to supervisor to add a potential field of propylene glycol for the screening from.
A report has been received from a non-medically confirmed source concerning a 13 year old female patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. On 03-Jan-2014 the patient received nasal FLUMIST QUADRIVALENT, but the vaccine was expired (Preferred Term: expired drug administered) on 02-Dec-2013. At the time of reporting, the outcome of the event of gave expired FLUMIST QUADRIVALENT was unknown. The report was considered to be non-serious by the reporter.
Severe pain, worst I have ever felt. Huge lump about the size of a large marble, have not been able to sleep on that arm for 4 days. Called Dr. was told that is normal and to massage the area. I tried but it hurt too bad. was advised to call Dr. back Monday if pain still persists.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 32 years for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 24Dec2022 to 28Dec2022.
About 5 min. After shot, we walked to lab waiting room, sat down, within 3 min. He began to seize up and shake, causing him to fall out of the chair, hitting his cheek. I screamed something was wrong. I was told he passed out and would be fine. He laid down and got a cold compress and fan, as well as some juice. 10 min later he finished his eye and ear test and we left. The dr.  Said as I was checking out, next dose we would have him stay laying down for 15 min. But I worry it was a seizure and he shouldn't have the 2nd!
PATIENT REPORTING 07/32/2021 that since recieving 2nd covid19 vaccine, folowing 2 weeks post administration started having chest pains, discomforts and pressure.  no treatment sought until today.  no treatment ie antiinflammatory, etc at home either.
The patient received an adult dose of Hepatitis A Vaccine when she should have had a pediatric dose. The patient did not experience an adverse reaction to the vaccine.
Information has been received from a nurse concerning an "approximately 5 month old" male who on "11-MAY-2007" was vaccinated with a second dose of Rotateq (Lot # not provided). Concomitant therapy included PREVNAR, PEDIARIX and ACTHIB. Subsequently the patient experienced intussusception. Unspecified medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. Upon internal review, intussusception is considered an other important medical event. Additional information has been requested. 10/02/07-records received for DOS 7/26-7/31/07-DC DX: Terminal ileum resection with cecal resection, appendix removal, partial right colon resection. lymphoid hyperplasia of the iliococal valve with intussusception and ulceration of overlying mucosa. Seen in ER for abdominal pain and discomfort for 3 days and started vomiting 2 days prior. Multiple episodes of bilious emesis. Evaluated for pyloric stenosis in June with upper GI that was normal.  Had currant jelly stool.
In May, 99 the pt received her first dose of Lymerix. Subsequently in May, 99, she experienced a severe rash from head to toe which was extremely itchy. She treated herself with Benadryl. The rash resolved in five days.  The most recent information received on 11/15/99 reports the condition of the pt is resolved.
eyes are all red; eyes are swollen; her cheeks are flushed; there is a red dot on skin under her eyes; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 68-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Batch/ Lot number: Not available) via an unspecified route of administration on unspecified date as dose 3 (BOOSTER), single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Historical vaccine included the patient previously received BNT162B2 (COMIRNATY, solution for injection, Batch/ Lot number: Not available) via an unspecified route of administration on unspecified date as dose 1, and dose 2, single for COVID-19 immunization. On unspecified date the patient experienced her eyes are all red, there is a red dot on skin under her eyes, eyes are swollen, and her cheeks are flushed. She wants to know if anyone has reported similar experience. She stated that it could be coincidental but she has never woken up with that eyes before. She said she is putting ice on, like a cold cloth which is easing up the discomfort and is planning on taking half of a Benadryl. The outcome of events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
24 HRS AFTER TDAP INJECTION TO LEFT DELTOID, DONOR NOTICED WARMTH AND REDDNESS IN CIRCULAR AREA OF INJECTION WITH PAIN . NO TREATMENT DONE. 8 HR LATER REDDENED WAS LARGER WITHOUT TREATMENT PERFORMED. 5 DAYS LATER DONOR RETURNED TO CENTER WITH REDDNESS AND PAIN FROM UPPER ARM TO ELBOW WITH SWELLING NOTED IN INNER ELBOW AREA. DONOR STATES HE ONLY TOOK IBUPROFEN LAST EVENING.
4hrs after vaccine, extreme weakness, difficult to walk/move.  During night difficult breathing. Slept on 2 pillow. In am noted left side of face swollen and tight.
I got first shingrix yesterday evening. Today I feel like crap. I've had a fever growing all day. I am fully vaxed with Moderna and also in an abundance of caution took a rapid test for COVID today (negative)
Woke up in A.M. for church went to take shower - walked around bed and collapsed - legs wouldn't work - was paralyzed - husband called ambulance and sent to hospital and had numerous tests done. Pt. became paralyzed following vaccine - only thing it could be attributed to - nothing else changed - reporting now because per patient request - she doesn't think it was ever reported by MD. Patient diagnosed with transverse myelitis. Was not able to walk once episode occurred. After copious amounts of physical therapy she now needs the support of a cane to walk but still suffers pain and cannot participate many activities as she once did.
Shortness of breath, wheezing, cough, sore throat, sinus pressure, headache, runny nose, chills
1NOV93 pt recvd vax & 1 wk p/vax c/o sore throat, bronchial type cough & felt terrible all over;
Received flu shot on 11/30/12, immediately experienced pain. 2 weeks later still in pain with limited mobility. Arm and shoulder affected.
patient is under 18 years old and was giving moderna 1st shot instead of pfizer. no adverse reported by patient, pt contacted to get pfizer for 2nd dose
No additional adverse events reported.; The vaccine coordinator is reporting the patient was administered a dose of VARIVAX on 1/8/2020 , that had been improperly stored.; This spontaneous report was received from the office manager and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 08-jan-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) that had been improperly stored, lot # S021926 with expiration date of 15-JUL-2012, for prophylaxis (route of administration and frequency were not reported). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (DILUENT MRK). No additional adverse events reported.      It was stated that the vaccines underwent a temperature excursion of 1.2°FC (degrees Celsius) for 3 hours 9 minutes. No previous temperature excursion was done. The call was because of a "data logger".
red, swollen, painfull arm tx: ibuprofen, ice and clindamycin
pt states skin rash on body , itching since yesterday after FLU vaccine. ash for 1 day, after flu vaccion. + macular rash scattered to entire body. no erythem, no swelling, + itchy. no cp, no sob, no n/v
Initial case was received on 18 October 2010 from a healthcare provider. An 83 year old male patient received on 27 September 2010 an intramuscular left deltoid injection of FLUZONE (lot number UH182AC). He began having pain throughout the left arm after the vaccine administration. The pain was so intense, the patient had difficulty lifting his arm. No other symptoms were noted. The patient was to have an magnetic resonance imaging (MRI). Pre-existing medical conditions were unknown. Concomitant medications were acetaminophen and Codeine. The patient was "healthy" at the time of the vaccination and had no vaccinations within 4 weeks. At the time of this report the patient had not recovered. Follow-up information was received on 02 November 2010 from a healthcare professional. the results of the MRI (date not reported) showed an inflamed bursa. The patient received an injection of Cortisone and the "symptoms cleared up". The pharmacist stated the "symptoms were not related to the vaccine" the patient received. The outcome status was recovered (date not reported). The reporter for this case (2010-05998) is the same as for case number 2010-05997. Documents held by sender: None.
p/vax pt woke x2 during night due to teething; very pale; clear nasal drainage; T97; diaphoretic; slept all day;
9/23/21 - presented to the emergency department with weakness, dizziness, nausea.  CT showed large pericardial effusion and pleural effusion.  Taken to OR for emergent pericardial window complicated by AF RVR and transient hypotension.  Patient intubated and admitted to ICU.  Further diagnoses:  Cardiac tamponade, obstructive shock, anemia.  9/24: R pleural drain placed.  9/25:  extubated  9/28:  continues to be hospitalized and is improving.
Employee did not dilute the Pediatric Pfizer shot before administering,  therefore child received 0.2mls of undilted vaccine
Joint aches, chills, headache, received shot 8-9-18 at 4:04 pm and symptoms started at 10:00 pm on same day. Treated with Ibuprofen.
leg swollen & red clear down to knee;then is a bright red spot around inj site;pt is able to walk but does c/o pain;also given APAP;lt upper thigh below inj site 6-7cm irregular shape, warm;sl rash;bruise area @ inj site;
Information has been received from an RN concerning a female with sinusitis who on 1/21/02 was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 641027/1051L), in the upper arm. Concomitant therapy included Lorabid. On 1/25/02, the pt had localized bruising, redness, pain, skin warm to touch, tenderness and swelling. The pt sought unspecified medical attention. It was reported that 2 weeks later, the pt was "fully recovered". Two other pts had a similar experience (WAES 0202USA00145 and 0202USA00146). It was also reported that 1 of these 3 pts had "swelling down to her elbow, 6" or more", and as of 1/31/02, is still experiencing tenderness and redness. No further information is expected.
Experienced slight nausea at 8 pm and took Tums.  At 10 pm had a headache and took two Extra-strength Tylenol.  At 12:30 am on 8/20/21, I vomited and then again at 2:30 am.  Felt tired on 8/21/21 and rested during the day.  Had not eaten any meals except for toast, crackers, and fluids until 8/22/21.  Started to feel better on 8/22/21.
This spontaneous report as received from a physician assistant refers to a patient (age unknown) which on 11-FEB-2013, the patient was vaccinated with GARDASIL (lot # not reported) dose 1. On 06-MAY-2013, the patient received the second dose of GARDASIL (lot # not reported) and the patient would like received the third dose. No adverse symptoms reported. Additional information has been requested.
The patient began to feel badly and have a headache the day after the vaccine was given.  This seemed to be normal but then the patient began experiencing blurry vision that lasted around a week.  The patient seems to be feeling much better now.
acute disseminated encephalomyelitis; This case was reported by a lawyer and described the occurrence of acute disseminated encephalomyelitis in a adult patient who received Herpes zoster (Shingrix) for an unknown indication.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced acute disseminated encephalomyelitis (serious criteria GSK medically significant). On an unknown date, the outcome of the acute disseminated encephalomyelitis was unknown.   It was unknown if the reporter considered the acute disseminated encephalomyelitis to be related to Shingrix.  Additional details were provided as follow: The initial information received on 04 December 2019 via legal complaint. The age group was selected as adult as per vaccine indication. As per attorney, indicating he has a client who experienced acute disseminated encephalomyelitis (ADEM) an unspecified amount of time after receiving Shingrix.
Fever to 104 within 24hr. of vaccines. Mild URI symptoms. No vomiting. Clinically stable.
Caller is a nurse reporting that an expired dose of ROTATEQ was administered to the patient on 15SEP2022. Caller confirmed that the ROTATEQ has not been involved in a temperautre excursion through the date of administration. No additional information; No additional AE; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-SEP-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot #1741381, expiration date: 04-SEP-2022, administered orally for prophylaxis (strength was not provided). The reporting nurse stated that the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) has not been involved in a temperature excursion through the date of administration. No additional adverse events were reported.
RED BRUISE TO LEFT ARM; LEFT ARM WARM TO TOUCH; HARD KNOT ON LEFT ARM; PAIN TO LEFT SHOULDER/ARM; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included cyclic vomiting syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 09-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 09-MAY-2021, the subject experienced pain to left shoulder/arm. On 09-MAY-2021, the subject experienced headache. On 09-MAY-2021, the subject experienced nausea. On 10-MAY-2021, the subject experienced hard knot on left arm. On 11-MAY-2021, the subject experienced left arm warm to touch. On 12-MAY-2021, the subject experienced red bruise to left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and nausea, and had not recovered from hard knot on left arm, pain to left shoulder/arm, left arm warm to touch, and red bruise to left arm. This report was non-serious.
Woke up at 2:30 am June 14 itching with a rash from neck down to groin, feeling light headed and dizzy. Did not throw up. Temperature was 98.5 but I was sweating. Went to the ER at Hospital around 3:30am.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of GARDASIL (route, strength, lot# and dose were unknown), which were exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
felt like lump in throat-a lot of phlegm lasted all day; started 2hr p/vax; all sx resolved 10/7/99;
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers to 68th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F. And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event and reporter's comment: Amended narrative accordingly.
This is a spontaneous report from a contactable consumer reporting for himself. This patient of an unspecified age, and gender receive the first single dose of TRUMENBA via an unspecified route of administration on 27Apr2015 at approximately 1:30 PM. The patient medical history and concomitant medications were not reported. While the injection site did not hurt at first, within a few hours (at approximately 4 PM) sharp pain at the injection site and in the surrounding muscle had developed, as well as a moderate headache. The patient took ALEVE for the pain at approximately 5:45 PM. By 9 PM the pain had reduced, and the headache was gone. In the morning of 28Apr2015 she only had a moderate soreness in the arm that received the injection, headache was not present. Follow-up attempts completed. No further information expected.
About 5-10 minutes after vaccine administration, patient reported he felt itchy on his shoulders and vaccination arm. Nurse and pharmacist offered to give diphenhydramine injection 50 mg to opposite arm. Pt refused treatment and signed a note declining treatment. Blood pressure taken 118-70. Pulse 82. We kept patient at pharmacy for 30 minutes. Before patient left, he stated he felt fine and the itching was gone. At 7:07 pm pharmacist called patient to check up on him. No answer. Voicemail left
Fever of 100 degrees F w/ dry cough noted since 9/27/10 (1 day prior to office visit). Mom noted red raised rashes like mosquito bites today scattered all over trunk, few on face & neck. During physical exam in office the lesions showed different stages from papular to vesicular to crusts.
Bad psoriasis flare within 5 days of vaccine. Have not had even 1 little psoriasis spot in over 5 years, psoriasis was well controlled or in remission
PATIENT HAD HPV VACCINE ON 01/14/2014. PATIENT STATES RASHES ALL OVER BODY BEGINNING ON 01/15/2014. PATIENT TOOK BENADRYL AT HOME 01/15/2014. PATIENT CAME 01/29/2014, BENADRYL 50MG IM GIVEN. TREATMENT PLAN INCLUDES: RANITIDINE 150MG PO BID, BENADRYL 50 EVERY 6HRS AS NEEDED. IF PATIENT EXPERIENCE SHORTNESS OF BREATH GO TO ER.