chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; MEDICATION ERROR; This spontaneous report was received from literature. This report concerned a 67 year old male of unspecified ethnicity. The objective of this study was to describe the impact of rituximab on humoral response to COVID-19 booster vaccine and antibody kinetics in patients with ANCA vasculitis. The patient's height, and weight were not reported. The patient's concurrent conditions included: microscopic polyangiitis phenotype, and anca (anti-neutrophil cytoplasmic antibody) vasculitis. The patient was previously (4 month before vaccine first dose) treated with steroids for microscopic polyangiitis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and batch number were not reported , expiry: unknown) one total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included rituximab for microscopic polyangiitis, and bnt (pfizer vaccine)162 for prophylactic vaccination..  On an unspecified date, the patient experienced confirmed immunological vaccination failure, and medication error. Laboratory data (dates unspecified) included: ANCA (NR: not provided) proteinase 30.8 u/mL, Estimated GFR (NR: not provided) 68 mL/min (1.73 x m2, Proteinuria (NR: not provided) 91 mg, and SARS-CoV-2 IgG antibody test (NR: not provided) More than 12 AU. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccination failure and medication error was not reported. The author has provided data for the first demonstration of antibody development post booster dose of the COVID-19 vaccine in associated vasculitis (AAV) patients on rituximab maintenance therapy. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20210927182. This case associated with product quality complaint.; Sender's Comments: V0: 20210935336-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS, CONMEDS-OTHER SUSPECT DRUGS
L upper arm is sore, a #2 on scale of 1-10. Most of the time even when not in use since received 11/4/03 vaccine. 12/29/03-states arm continues sore without swelling. She is to see chiropractor to see if back related.
rash on chest; This case was reported by a consumer via call center representative and described the occurrence of rash in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. In June 2019, 7 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. About 3 weeks ago, the patient received 1st shot of Shingrix..  About a week or so after receiving the shot, the patient experienced rash on chest. At first, the patient thought it was a bunch of bug bites, but have not been out since and it was spreading.  The patient asked could it be a reaction to the shot.
High blood pressure, premature ventricular contraction both quite high; High blood pressure, premature ventricular contraction both quite high; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 10May2021 12:45 (at 46-year-old) (Lot Number: EW0167) as 2nd dose, single in arm left for COVID-19 immunisation. Medical history included ongoing sulfonamide allergy. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) as 1st dose, single for COVID-19 immunisation. The patient experienced high blood pressure, premature ventricular contraction both quite high after 2nd dose on 13May2021 13:00. No treatment received. Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events was resolving.  Additional information has been requested.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccine on 2/03/21 and 2/24/21. Admitted 2/6/22 Covid+ for acute on chronic hypoxic respiratory failure 2/2 COVID PNA. Code status DNR on admission. Advanced pulmonary fibrosis on 9L O2 at baseline. O2 requirements continued to increase needing Airvo. Became less responsive, hypotensive, febrile and showed signs of distress. TX'd w/remdesivir, baricitinib, solumedrol, nystatin, bactrim, and Zosyn. Transitioned to comfort care and expired 2/26/2022.
Patient complained of sharp pain in the back of her left eye for a couple days (starting Monday 8/17/20). Went into her eye doctor where he checked the back of her eye and noticed the start of a virus attacking her retina. She was prescribed erythromycin ointment and Valtrex 1 gram orally.
Muscle and joint aches; low grade temperature on 9-16-11, general fatigue and malaise, not sleeping well at night muscle & joint aches specifically lasting 2 plus weeks that kept me awake at night.
High fever (103), extreme dehydration and thirst; chills; nausea; extreme fatigue; general malaise all started at 14 hours after injection. At 16 hours post injection, symptoms of inability to communicate or get up from bed, out-of-body sensations. All symptoms persisted for 6 hours. After this, fever and chills subsided, but general malaise, inability to focus mentally, nausea and extreme fatigue persisted and continue even today (11 days post vaccination).
Patient was due for their 2nd Moderna dose. The patient was navigated to a station in the vaccine clinic who was only provided Janssen vaccine. Per the administrating nurse, the patient consent form was reviewed by the immunizing nurse with the patient. Per the nurse, the patient was advised she would be receiving her J&J vaccine which pt agreed to. Vaccine was given to patient and they were observed for 15 minutes. No adverse reactions noted. The immunizing nurse reported to supervising nurse (reporter) of error after the fact when the immunizing nurse had gone to document the administration on EHR. RCA performed and identified patient was incorrectly seated in wrong station, the patient's consent was not fully reviewed as it did identify patient was due for Moderna #2.
Pain in armpit that turned into pain in arm and back. The next day, swelling, redness, and warmth appeared.  Treated for cellulitis
Pleasant 73-year-old obese lady who was diagnosed with COVID-19 infection on 26 July 2021.  Since then she has had on and off cough which is nonproductive.  She is over the last couple of days been getting increasing shortness of breath.  Today she was noted to be needing 5 L of oxygen via nasal cannula.  She was subsequently transferred from the outside facility.  She is fully vaccinated for COVID-19 taking more than vaccine.  She denies any nausea vomiting or diarrhea.  No recent travels.  No sick contacts
One hour after receiving the vaccine patient had sever arm pain, chills, and cold sweats. On  06/04/2021 @ 9:36 PM patient had a high fever of 103.8 with stomach ache and chest pain patient passed out while in the Emergency room.
He came to the hospital with a chief complaint of left-sided chest pain.  Patient also reported some dizziness associated with that.  Pain is less in the left lateral chest wall.  Patient reports that recently his wife passed away so he is feeling very down and anxious.  He reports that his chest pain may have something to do with that.  He denies any fevers, chills, cough, shortness of breath, palpitations, abdominal pain, nausea, vomiting, burning or painful urination, diarrhea.  Patient however denies any severe depressive symptoms or suicidal ideations.  Tested positive on 01/16/2022
It was reported that a 42 year old male received a Fluzone SV '99-'00 vaccination on 10/27/99 and reportedly, 45 minutes, post vax, the pt developed generalized hives, no respiratory distress. From additional information received on 12/6/99, it was reported that the pt recovered from this experience.
contracted covid; contracted covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FFG1620) at the age of 30 years as dose 2, single and (Lot number: PG8762) as dose 1, single 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 "contracted covid". Clinical information: Caller was a patient/nonHCP. She reported having received the first dose of the Pfizer covid 19 vaccine, then contracted covid, and had received the second dose of the vaccine after recovering from covid. The first dose LOT is FFG1620, the second dose lot is PG8762. Caller asked to schedule her next dose. Caller transferred to for report filing. Transferring agent stated, "I was calling with a patient on the other line who was reporting a safety event with the Pfizer COVID-19 Vaccine. She was 30 years old (Further not appropriately clarified hence not captured), she was a patient. She have had the first two doses of the Pfizer COVID-19 Vaccine and got COVID after her first dose () and I have their LOT.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Pt has documentation of receiving varicella vaccine 12/10/1997. Pt diagnosed with varicella disease 9/12/2003.
Miscarriage (chemical pregnancy). I didn?t test positive for pregnancy until a week after my vaccine so I put ?unknown? for pregnant at the time of vaccine. I then tested negative a couple days later and had the miscarriage 2 weeks and 2 days after my vaccine
Patient presented to office on 1/2. 2 days after receiving PPSV 23 vaccination because she is a smoker with throbbing pain to the right upper arm, unable to lay on the right side and hold her baby with arm. Crying with pain at times. Feels sweaty/cold at times since yesterday and very run down since vaccine given. Right upper arm with large area of splotchy redness, warm and tender to touch to lateral portion of upper arm. Afebrile at visit.
No side effects reported at this time. Pt was only 64 years old at the time of administration. Fluad is indicated for people aged 65 years old and older.
received the full series of the GARDASIL-9 vaccine after the age of 45; no adverse event; This spontaneous report was received from a female patient who was currently in her 50's, who was reporting on herself, via a company representative. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. She had previously received series of human papillomavirus vaccine (HPV) manufactured by GSK.  On an unknown date (after the age of 45), the patient received the full series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (Product administered to patient of inappropriate age). No additional adverse event was reported.
It was found that the pt likely received an undiluted peds dose of Pfizer vaccine.
Fatigue, weakness, Guillain-Barre syndrome. Hospitalized for 9 days - IVIG x 5 days. PT/OT/PM and R f/u continues.
Received a red, non-itchy rash ontop of both feet 5 days following vaccinations.  By 6th day, Rash covered all lower extremeties.  On 6th day, I started to feel very tired and only wanted to sleep.  On day 8, I felt exhausted with no energy and noticed rash moved up into hairline and into corner of eyes.  Evening of day 8 I was extremely restless and did not sleep.  Morning of day 9 rash moved onto bridge of nose, cheeks and inside of mouth. Severe bruising was apparent on my arms and I had a bloody discharge from my penis. Had difficulty stopping discharge.  Drove to the ER and was admitted on 9/23/04.  Diagnosis: Severe iodiopathic thrombocytopenic purpura. Admitted with blood platelet count 0 and physical exam findings of wet purpura and diffuse petechiae.  Procedures performed: Bone marrow aspiration performed showed normal cellular marrow with adequate megacaryocytes.  Bone marrow otherwise normal except slightly increased myeloid to erythroid ratio.  Received a single donar platelet phoresis pack, leuki-reduced and irradiated transfusion. Started high dose of Solu-Medrol.  Started intravenous IVIG and he received IVIG four days in a row with good response in platelet count.  I had O Negative blood, so WinRho was not administered.  I received four days of IVIG at a dose of 28 grams a day.  His petechiae improved and he remained free of fever or headaches during his stay.  He was ready for dismissal on 9/27/04.  Post follow up care included Prednisone 10mg six tablets daily while slowly being tapered off each week.  On the sixth week I will finish Prednisone.  In addition, I receive one blood CVC draw weekly until the sixth week.  Medline search for vaccinations he received was conducted.  It's noted my condition was a side-effect of Anthrax. Discharge Summary received on 1/10/2005 states final diagnosis confirmed as idiopathic thrombocytopenic purpura. Add symptoms of pain in hips and elbows, frontal headache, non-productive cough, and generalized achiness.
a dose of Shingrix while was having an active case of shingles / trying to get shingles treatment instead; This case was reported by a pharmacist via call center representative and described the occurrence of drug use for unapproved indication in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 7Z9H3, expiry date 7th October 2022) for prophylaxis.   Concurrent medical conditions included shingles.   On 30th January 2021, the patient received the 1st dose of Shingrix. On 30th January 2021, unknown after receiving Shingrix, the patient experienced drug use for unapproved indication. On an unknown date, the outcome of the drug use for unapproved indication was unknown.  Additional details were reported as follows: The received the dose of Shingrix while was having the active case of shingles and trying to get the shingles treatment instead, which led to drug use for unapproved indication. The reporter consented to follow up.
during prolonged neutropenia; development of a dermatome rash; Contraindicated product; This spontaneous report was received from physician and referred to a child of unknown gender. The patient was enrolled in the Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine strain. The patient's medical history included varicella zoster virus serology positive, and skin lesion. Information about the patient's concurrent conditions, concomitant medications and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccine with varicella virus vaccine live (oka/merck) (VARIVAX) injection; or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (reported as VZV Oka vaccine) for prophylaxis (strength, dose description, lot #, expiry date, anatomical site of vaccination and route of administration were not provided) (Contraindicated product administered).  On an unknown date, the patient developed a dermatome rash during prolonged neutropenia. At the time of reporting, the outcome of the event dermatome rash, prolonged neutropenia was not known. The causal relationship between dermatome rash, prolonged neutropenia and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown. The causal relationship between dermatome rash, prolonged neutropenia and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.   Upon internal review, the event prolonged neutropenia was determined to be medically significant.
When she received Dtap and Hib on 5/30/23 she was tired after her vaccine. Within 12 hours- right hand scratching her chest and this occurred for 2 weeks. After 2 weeks the episodes were slowing down and then had resolved after 1 month. This was occurring all of the time, but they did not see it while she was sleeping.  No rashes or dryness at the time on her chest or anywhere else on her body. No redness anywhere on the body. She was more fussy the first night.   The 2nd night her father went to pick her up and was walking with her and she was staring at a wall and had her eyes wide open and her father could not bring her out of that.  He tried talking to her and getting her attention, but she continued to stare at the wall. She had small head movements back and forth. Father reported that she looked scared.  Then the father brought her in to breast feed and she was biting on mother's nipple and the breast feeding calmed her down.  She felt tired and fussy for a few days.  No tonic clonic movements noted.  No deviation of her eyes. She did not have as good eye contact the next couple days after the vaccine per parents.  No concerns around the injection site. No viral illnesses reported. No other symptoms noted. She was waking up every 2 hours for 5 weeks at night, which was different for her
W/in 1-2 min of vaccination pt had syncope episode < 1 min. Some nausea x 15-20 minutes. Observed x 30-40 min. Back to baseline x 15-20 min prior to discharge home.
Case previously recorded as MA2009-3972. Initial case report received from a nurse via MedCom on 06 NOV 2009. A 08 month-old female patient was vaccinated with 0.5 mL i.m. S-OIV FLUVIRIN (batch no. 102044P1) on 06 NOV 2009. It was an out off label use because the patient was younger than 4 years. No adverse events were reported. MedCom reference no.: NA09-007775.
Pt states that she has had pain in her left shoulder x 2 wks following immunization. Pain started decreasing after immunization, but then increased last week. Pt denies shoulder being swollen. Pt plans to see PMD for this problem.
Initial sore injection site 6 hours after injection, slight headache 12 hours after,  slight chills 16 hours after, tiredness and muscle pain 20 hours after and lasting 24 hours, red rash on front torso just below the breasts running in a 2-3 inch wide strip from left side to right side 36 hours after and lasting for 24 hours.
Intense pain in upper arm and shoulder,  staying about an hour after injection and laying for approximately 36 hours.   Also fatigue that continues to now.
having problems swallowing, she kept getting choked when drinking water; she said the fatigue was ridiculous, and the fatigue knocked her off her feet; feeling jittery and irritable; feeling jittery and irritable; This is a spontaneous report from a contactable consumer. This 66-Year-old female consumer (patient) reported for herself that she received the second dose of BNT162B2 (Pfizer-Biontech COVID 19 vaccine, Lot number EN6200) at single dose for COVID-19 immunisation on 26-FEB-2021 at 11:30. Relevant history was unknown. The patient previously received Pfizer-Biontech COVID 19 vaccine on 05Feb2021 for COVID-19 immunisation. Past drug included mild blood pressure medication. Relevant concomitant drug was unknown. The patient has fatigue, she kept getting choked when drinking water, feeling jittery and irritable since 28Feb2021. She said the fatigue was ridiculous, and the fatigue knocked her off her feet.  The patient asked if there was something she could do for the fatigue she was experiencing. This reaction was really not good. She was having problems swallowing. She said the swallowing problem started at the same time as the fatigue on Sunday, 28Feb2021. No treatment was received for the events. The outcome of event having problems swallowing was not resolved. The outcome of other events was unknown.
Day 1 - Body aches/fatigue. Day 2-3 - Fatigue. Day 4-5 - sore throat; sinus congestion; fever 100; H/A. Seen by PCP and treated with 10 days of ABx.
Nausea, vomiting, dizziness within 1 hour of receiving hepatitis B vaccine.  Also headache, light sensitive.  Symptoms lasted approximately 24 hrs.  1/4/08 Reviewed hospital medical records which reveal patient experienced nausea, vomiting & dizziness within an hour of receiving vax.  Was on antibiotic for URI at time of vax.  TMs were clear.  Admitted 12/17-12/18/2007.  Improved w/IVF.  Had mild dizziness & nystagmus  w/moving head to the right.  D/C home w/antivert.   FINAL DX: acute labyrinthitis & adverse reaction to Hep B immunization.
Patient complained of itching dermatitis throughout torso and face with visible hives. Patient complained of throat "feeling funny". Patient immediately transported by wheelchair 300 ft to ED.
Initial report received from a health care professional on 30 March 2007.  A 2 month old, female patient was fussy, crying, with redness, 10 cm diameter swelling and pain at the injection site on the left thigh after she received Act-HIB (lot number UF015AA which corresponds to sanofi pasteur SA lot# Z08140-2), intramuscularly in the left thigh; Prevnar (Wyeth, lot number B36258F) intramuscularly in the left thigh; Pediarix (GSK, lot number AC21B096CA) intramuscularly in the right thigh and Rotateq (Merck, lot number 0023U) orally, on 28 March 2007.  She was treated with oral (po) Benadryl and cold compresses.  On 29 March 2007, she was taken to the Emergency Room (ER) with a fever 103F.  Prior to the vaccinations, on 19 March, she had a runny nose, cough and congestion - taking an antihistamine Rx.  She had no illness at the time of the vaccinations.  It was reported that the patient recovered.
Severe pain in my left shoulder. Can not sleep on left side, having difficulty lifting my arm, don't have much strength in left arm.
2 -3 hours after receiving DTaP, patient became lethargic, not wanting to move, acting stiff and in pain, needed to be carried. Went to ER - no tx resolved 6-8 hours.
Influenza vaccine recd 10-31-12. Began 11-2-12 w/ sore throat, loss of hearing (L) ear, redness & soreness at site of injection.
injection missed Deltoid muscle and entered shoulder joint hitting bursae sac. vaccine administered into bursae.
Initial report received on 14/Aug/2006 from a health care professional.  A 33-year old female patient with an allergy to sulfa, and no current illnesses had received intramuscular dose of Adacel, lot number C2492BA, in the right arm on 08/Aug/2006.  Two days post immunization, the patient experienced injection site swelling and pain.  She had pain in her joints, right shoulder and arm.  Treatments given were not reported.  Two days later, the patient was seen in an urgent care facility with complaints of a right swollen red arm, and malaise.  The patient was treated with KEFLEX and MOTRIN.  Laboratory testing was not reported.  The recovery status of the patient was reported as recovered.
vaccine was administered outside of source - reported by patient  G47.33 ADULT OBSTRUCTIVE SLEEP APNEA 4/7/2022 DM 2 WO COMPLICATIONS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/1/2022 DM 2 WO COMPLICATIONS J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/19/2022 DM 2 WO COMPLICATIONS J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 4/19/2022 DM 2 WO COMPLICATIONS