chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt developed Guillain-Barre' Syndrome approx. 6 weeks, post vax. He received plasma-phoresis. He has developed Bell's Palsy which began about 1/3/01. He has some paralysis in progress. Per F/U 6/19/01: Pt speech is thick and he has dizziness. He awoke with numbness to bilateral fingers, mouth and slowly progressing now to bilateral feet, too. He also has double vision. He has no reflexes on all 4 extremities. Seen earlier that day for same symptoms but is progressively worsening. 800mg Motrin/ibuprofen. Addendum: Did not have flu vaccine this year (historically, some reports of association of GBS with anticedent vaccinations); would not give flu vaccine at this point. Hospitalized. He has ataxia. Palate paralysis with nasal voice (hoarseness) ; has swallowing difficulty and respiratory insufficiency. Follow-up with Neurology and speech pathology.  Follow up on 06/19/2001: "Patient has had a history of cough for about a week and had an episode of diarrhea last week prior to admisison.  Chronic illnesses before onset of GBS: 2.5 years ago had back surgery 2* to pain in left leg.  Ruptured disc. Another time patient received influenza was two years ago."
Patient received Pfizer COVID vaccine on 1/23/21 and 2/28/21 and has been living in adult family home resident with recent COVID-19 outbreak. Patient developed symptoms and tested positive for COVID-19 on 9/3/21. On 9/7/21, patient's had rapidly progressive shortness of breath, was found to be hypoxic, and was admitted to our facility for acute hypoxic respiratory due to COVID-19. As of 9/9/21, patient is still admitted in the med/surg unit.
A physician reported that a 17 month old child received a 3rd dose of Prevnar. On 02/12/2002, the child developed a septic elbow. the organism identified was streptococcus pneumoniae. As of the date of this report the child has not recovered. This case was considered serious since "streptococcus pneumoniae septic elbow" required intervention to prevent a more serious medical event. No additional information was available as of the date of this report. Follow-up info received 3/12/02, from physician. The pt was hospitalized for four days and she recovered. Lab data was included. On 2/9/02, an x-ray was administered with the following results: four views of the left elbow were done and this was compared with four views of the left elbow done 2/8/02. There is again demonstration of slight soft tissue swelling at medial distal arm adjacent to elbow. No bony abnormalities are seen. There is no periosteal reaction and no joint effusion is seen. Impression: There is again demonstration of slight soft tissue prominence and edema or infiltrate subcutaneous fat layer distal medial arm. The elbow is intact. On 2/9/02, a gram stain resulted in many segmented neutrophils, few mononuclear leukocytes, few red blood cells and Gram positive diplococti. On 2/9/02, an anerobe culture of elbow aspirate was negative. On 2/9/02, a blood culture revealed no growth for five days. On 2/10/02, an antimicrobial susceptibility test was sensitive to the following: Ceftriaxone .032 (MIC), S (Int); Glindamycin S (KB); Erythromycin S (KB); Ofloxacin S (KB); Penicillin .032 (MIC), S (Int); Tetracycline and Vencomycin. On 2/10/02, a gram stain resulted in few segmented neutrophils and rate Gram positive diplococoi. On 2/11/02, an aerobe culture of elbow aspirate revealed streptococcus pneumoniae (moderate). In Feb 2002, a mean cell hemoglobin and mean cell volume revealed were WNL. Hematocrit was administered with the following results: 31.8 (2/9/02) to 28.9 (2/18/02). Hemoglobin results were 11.1 (2/9/02) to 9.8 (2/18/02). In Feb 2002, a monocyte count, red blood cell count and mean cell hemoglobin concentration were noraml. Neutrophil count results were as follows: Band Neutrophils 13 (2/9/02) to 2 (2/18/02). Segnented neutrophils 61 (2/9/02) to 18 (2/18/02) and Absolute neutrophil count 25.2 (2/9/02) to 1.9 (2/18/02). White blood cell count results were 34 (2/9/02) to 9.4 (2/18/02). Platelet count results were 450 (2/9/02) to 865 (2/18/02). Lymphocyte count results were 22 (2/9/02) to 71 (2/18/02) and atypical lymphocytes were WNL. Mean cell hemoglobin concentration and blood basophils were normal. Eosinophil count results were 3 (2/12/02) to 4 (2/18/02). C-reactive protein results were 21.2 (2/9/02) to 4 (2/18/02). Follow-up info received from physician. He has not received a hospital discharge summary as of this time. The concern is of either "failure of vaccination or strep pneumo septic elbow due to a subtype not covered by the vaccine." The pt is doing well now. Dates of immunization and lot numbers of Prevnar vaccine were also included.
Delayed cutaneous hypersensitivity at injection site:  8 days following vaccination, red, itchy, and hot-to-the touch rash (approximately 3 inches long) appeared at injection site; still present today (24 hours later).  Took one tablet of Benadryl and applied 1% hydrocortisone cream to provide relief of itchy, burning sensation.  This has helped somewhat.  Note:  This delayed injection-site reaction has been reported in the Moderna clinical trial, both after the first and second doses.
On July 12, I had severe pelvic pain. That continued until the morning of July 14th. I went to Urgent Care - to get checked for UTI. I didn't have UTI but went to Labor and delivery triage. They swabbed me - I had bacterial vaginosis. The next morning, I had a bleed at 09:00 am. I called an ambulance - was taken to Medical Center. They determined that I have placenta previa and fibroids  - (high risk) that I should be airlifted to hospital. They have a better NICU. That day they gave me magnesium IV to protect baby's brain. They checked - Group B Strep-  vaginal and anal swab  -  and gave me penicillin in case it was positive - and that was received by IV also. The test came back negative. They also gave me IV fluids for hydration. I was having contractions. They determined my cervix was closed so it was not active labor. By that afternoon, both my bleeding and contractions stopped. They kept me in hospital until July 18 for observation. I was released from hospital - no medications upon release.  Pregnancy history: first pregnancy; Estimated due date - October 5, 2021.
There?s a swollen area between my neck and top of my shoulder. Is uncomfortable when moving a specific way.
Positive HBsAg; This case was reported by a pharmacist via call center representative and described the occurrence of hepatitis b surface antigen positive in a male patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HBV (Engerix B).   On 31st August 2021, the patient received the 2nd dose of Engerix B. On 7th September 2021, 7 days after receiving Engerix B, the patient experienced hepatitis b surface antigen positive. On an unknown date, the outcome of the hepatitis b surface antigen positive was unknown.  Additional details were provided as follows: The age at vaccination was not reported. 1st vaccination was done in the end of July 2021 (no further data provided) about lot number and expiry date. The patient presented positive hepatitis B surface antigens after 2nd dose of Engerix-B. No further data provided regarding lot number or expiry date of either doses was available. The reporter did not consent to follow-up.
I had a drink of coffee and asked my husband if he brunt it because it tasted odd, then since then my taste on several food and drink items has changed.  It's a gross taste in my mouth upon smell the item and even while eating.; I can't really smell bleach, my toothpaste (2 different brands) and other food all taste/smell the same.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ew0150), via an unspecified route of administration in the left arm on 07Apr2021 at 18:30 (at the age of 38-years-old) as single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medication taken within two weeks included ethinylestradiol; norgestimate (SPRINTEC) from an unknown date for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 11Apr2021 at 08:00, the patient experienced taste change and smell loss. The patient had a drink of coffee and asked her husband if he had brunt it because it tasted odd, then since then her taste on several food and drink items had changed. It was gross taste in her mouth upon smell the item and even while eating. There were several things the patient just couldn't eat because it was gross but she used to highly enjoy them. The patient couldn't really smell bleach, her toothpaste (2 different brands) and other food all tasted/smelled the same. The clinical outcome of the event taste change and smell change was not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ew0179), via an unspecified route of administration in the left arm on 28Apr2021 at 18:30 (at the age of 38-years-old) as single dose for COVID-19 immunisation and the adverse events for the second dose were not reported.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a medical assistant refers to a 12 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 23-JUN-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2014) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. Addtional information has been requested.
Whole-body hives began approximately one week after receiving the Modern COVID-19 booster vaccine. Hives began suddenly around 7 PM, and frequently moved locations. Accompanying the hives was severe itching, swelling of the hands, loss of appetite, headache, muscle stiffness and aches, heartburn, chest pain, discomfort swallowing, shortness of breath, diarrhea, and tiredness. Visited the doctor after three days when it became impossible to sleep or type/write. Prescribed four Zyrtec and two Pepcid daily, have been taking this dose for four weeks now. Currently, the only symptoms present are hives and itchiness when medication is stopped, heartburn, some chest discomfort, short daily periods of shortness of breath (30 min max), and muscle soreness.
She got her vaccine, she had no symptoms at all.   The next day she had some body aches and fatigue, a headache that lasted for about a week.  Then on day #8 she started with a low grade fever that lasted for 8/9 days.  The highest temp was 101.3.  Most of the time went from 99.9 to 100.6.  Two of those days also had night sweats, headache for a few of those days, body aches and fatigue.  Then week #3 was mostly fatigue, a rash started on her buttocks and was covered, not itchy, but raised in nature that lasted for about #2 weeks.   Then she got a fever back again for a day.   On week 4 she got left lower quadrant pain that lasted for a week.  Then that was end of her symptoms.   She had a telehealth APT for her to return to work, this was during the low grade fever time.  She was then told to come in for blood work.  She had raised eosinophils which they were not concerned about.  They then sent her to hospital and gave her a COVID test, urinalysis, more blood work, chest x-ray.  She had two COVID and flu tests which were all negative.  The eosinophils were raised again during this visit.  She also had a positive Lyme test and then was told that she had either recovered from Lyme disease or that she was fighting something else.    She had a telehealth visit, two hospital visits and also sent for an ultrasound of her left lower quadrant which was negative.
Vertigo/dizziness and nausea for 1-2 days ? 3 weeks after receipt of vaccine first dose.  Tinnitus louder.
Onset of menstruation on day 11 of cycle, heavy bleeding for 12 days. Previous decade of cycles had been regular/26-28 days, bleeding lasting 3-4 days.   Onset of chronic general anxiety, and almost daily panic attacks for the next 3 weeks.  Jaw clenching and shaky feelings continue still at 6 weeks
Patient received smallpox vaccination on 08/05/2005 and reported to clinic on 08/17/2005 after developing blisters and redness around the site of innoculation.  The doctor has diagnosed the patient with self innoculation.
stated today 11/21/19 during phone call that right arm has continued to hurt since day of vaccination.  she did notice that when she tried to lift up an item that she felt she could not do so. she stated she took Ibuprofen for first few nights after vaccination, but has not done so since or other pain relieving therapies.
Patient with a PMH significant for ASCVD, hyperlipidemia, paroxysmal A. fib with anticoagulation on hold due to thrombocytopenia, tobacco use, COPD, CLL with recent progression and initiation of ibrutinib with associated anemia and thrombocytopenia. His prognosis is poor and he is unable to engage in any treatment options given his cytopenias and performance status.  Patient passed away on 11/27/2021. ED visit, hospital admission and death within 6 weeks of receiving the COVID vaccine.
This spontaneous report was received from an epidemiologist who was also the patient's mother and refers to a female child patient (reported as the patient had "about 9 or 10 years old"). The patient's medical history included drug hypersensitivity (fever and nausea) following administration of unspecified vaccine (therapy unspecified) (MARRS case 1601USA006994). On an unknown date, the patient was vaccinated with MMR (manufacturer unknown) (lot number, expiration date, dose and route of administration were not reported). There was no concomitant medication reported. On an unknown date, following administration of the MMR (manufacturer unknown), the patient experienced pyrexia (result and units were not reported). The patient did not seek medical attention. At the reporting time, the outcome of pyrexia was recovered on an unspecified date. This is one of several reports from the same patient. Additional information has been requested.
No additional AE.; Caller reported that GARDASIL 9 that underwent a temperature excursion was administered; This spontaneous report has been received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown date in December 2022 (reported as between 06-DEC-2022 and 22-DEC-2022), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot # W009829 confirmed to be valid for formulation syringe with expiration date 19-OCT-2024 (exact dose, dose number, route of administration, and anatomical location were not reported) for prophylaxis. On an unknown date before administration, the vaccine underwent a temperature excursion of 32.7 Fahrenheit degrees for 118 hours and 45 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age or gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot # K016275, expiration date 20-APR-2016) (route, dose, strength and frequency were not reported). Concomitant medication was not reported. The reporter stated that the vaccine was exposed to 33 degrees F for 24 hours. No adverse effects were reported. Additional information has been requested.
Red spot on arm, left.  Seen in ED 10/26/2003. Treated with antibiotics and improved in a few days.
got COVID vaccine doses on 12/18/20 and 1/8/21. My wife tested (+) for COVID on 1/4/21, so I stayed home for about a week to take care of her. I went back to work on 1/13/21, tested (+) for COVID at work (I work at a hospital). Was sent home for quarantine.   I had no symptoms.
Pfizer #3 9/29/2021 Next day was thurs and tired and temp 101.9 fri enlarged LNs in left axilla fri fingers started tingling Lat three fingers numb Saturday, spoke with MD she knows who thought normal Ice, advil, pit ar up Then lower left ext fell weak yesterday Can walk but feels tingling on bottom of foot Feels yesterday like right hand might be tingling Left cheek focal numb area Sat numbness digits 4-5 left hand, feels weaker although full grip strenght, but tired holding phone yesterday, today is normal LLE felt weak yesterday but still full strenth on exam, pt states was a feeling of weakness but was able to walk normalluy Feels tingling on bottom of fot sensation tight hand tingling possibly started this AM
TEN DAYS AFTER SECOND MODERNA INJECTION THE PATIENT DEVELOPED INTERMITTENT SSCP ASSOCIATED WITH SOB. THE SSCP WAS NOT ASSOCIATED WITH POSITION OR ANY OTHER FEATURES.  THE SOB IS EXERTIONAL.
I21.4 ACUTE NON ST ELEVATION MI 8/13/2022 HOSPITAL ACQUIRED PNEUMONIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/13/2022 HOSPITAL ACQUIRED PNEUMONIA R09.02 HYPOXIA 11/2/2022 HOSPITAL ACQUIRED PNEUMONIA I21.4 ACUTE NON ST ELEVATION MI 8/13/2022 BULLOUS PEMPHIGOID J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/13/2022 BULLOUS PEMPHIGOID R09.02 HYPOXIA 11/2/2022 BULLOUS PEMPHIGOID I21.4 ACUTE NON ST ELEVATION MI 8/13/2022 CHF EXACERBATION, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/13/2022 CHF EXACERBATION, UNSPECIFIED R09.02 HYPOXIA 11/2/2022 CHF EXACERBATION, UNSPECIFIED I21.4 ACUTE NON ST ELEVATION MI 8/13/2022 BULLOUS PEMPHIGOID J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/13/2022 BULLOUS PEMPHIGOID R09.02 HYPOXIA 11/2/2022 BULLOUS PEMPHIGOID I21.4 ACUTE NON ST ELEVATION MI 8/13/2022 CHF EXACERBATION, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/13/2022 CHF EXACERBATION, UNSPECIFIED R09.02 HYPOXIA 11/2/2022 CHF EXACERBATION, UNSPECIFIED I21.4 ACUTE NON ST ELEVATION MI 8/13/2022 RASH J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/13/2022 RASH R09.02 HYPOXIA 11/2/2022 RASH
Sudden congestion in throat, racing heart, nausea, feeling of something stuck in throat, floating feeling, mental fog, fingers tingling
Initial information received on 17-Jun-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 64-year-old male patient who received a dose of FLUZONE HIGH DOSE and he was not yet 65 years old. This is an actual medication error case due to inappropriate age at vaccine administration. No medical history was reported. No details of concomitant therapy were reported. On 16-Jan-2018, the patient received a dose of 0.5 ml FLUZONE HD (batch number: UI883AA, expiry date: 25-May-2018 route and site of administration not reported). Caller states that the patient indicated on his paperwork that he was 65 years old but he was actually only 64 at the time. Caller asking about safety/efficacy of the vaccine if given prior to age 65 and is also asking for reimbursement for the vaccine. It was not reported if the patient experienced any adverse event. Lab data and corrective treatment: not applicable. 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. Documents held by sender: none.
Around 1.30 pm the same day as injection I started with low grade temperature, by 4 pm fever was 102 and my muscles weakened. I had to be helped to bathroom.  By that night my husband said I had a 103.5 and I didn't know where I was and why I was shaking.  He said I would be lucid for awhile then my fever would go back up and again was delusional.  This went on for 3 days, then down to 3 more days with just a temp of 100 and then slowly I was able to walk again by myself and it took me about 2 weeks to feel better.  I never went to see a doctor, just had Advil and water and juice.
Client reports that she had a softball size knot on left arm the day after her last TWINRIX on 2/11/09. It "had local fever and I itched and was very sore. The local fever was reduced by 2/15; The size went down to a quarter (still is that size) by 2/17. Ibuprofen (600 mg) was taken 3x daily for 2-3 days. It was slightly helpful. The ice pack was slightly helpful. Recommended that her next injection be placed in Rt. deltoid.
Information has been received from a 18 year old female student nurse with bipolar disorder, allergic reaction to CECLOR, PROZAC and SEPTRA concerning herself who on 14-AUG-2008 was vaccinated IM with the first dose of RECOMBIVAX HB 1ml (LOT# not reported), on 15-SEP-2008, was vaccinated IM with the second dose of RECOMBIVAX HB 1ml (LOT# not reported), on 16-FEB-2009, was vaccinated SQ with the third dose of RECOMBIVAX HB 1ml (LOT# not reported). Concomitant therapy included LAMICTAL, metformin (manufacturer unknown), SEROQUEL, CLOZARIL, atenolol (manufacturer unknown) and LOESTRIN. Several hours after administered the third dose of RECOMBIVAX HB, on 16-FEB-2009, the patient developed soreness of the right upper arm. No treatment had been recommended. The patient was not recovered from adverse events. It was reported that the patient sought medical attention: office visit. Additional information has been requested.
Duplicate administration of FLUZONE 2015 Hi-Dose vaccine. Pt given FLUZONE 2015 Hi-Dose vaccine on 9/22/15 and again on 10/22/15.
had covid for three weeks/with symptoms like head achs, being light headed and coughing up stuff; had covid for three weeks/with symptoms like head achs, being light headed and coughing up stuff; 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 number unknown (booster),single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization), COVID-19 (hospitalization) all with onset 2023, outcome "not recovered" and all described as "had covid for three weeks/with symptoms like head achs, being light headed and coughing up stuff". The events "had covid for three weeks/with symptoms like head achs, being light headed and coughing up stuff" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Treatment of covid-19; (2023) Positive, notes: still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient have had Covid twice now. And have had shots And boosters. The first time was not to bad. But now patient have had covid for three weeks now. And was bad enough to where patient had to go to the hospital and was given a I.V. and oxygen. Patient have taken pills three times now. One called Paxlovid and one called Azithromycin twice. coughing up stuff. It first started off being a yellowish color then a tan color.  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.