chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cystitis; Blood in urine; Headache; Fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CYSTITIS (Cystitis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). On 08-Apr-2021, the patient experienced BLOOD URINE PRESENT (Blood in urine). On an unknown date, the patient experienced CYSTITIS (Cystitis) (seriousness criterion medically significant). At the time of the report, CYSTITIS (Cystitis), BLOOD URINE PRESENT (Blood in urine), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Urine analysis: 3+ Blood 3 plus. On an unknown date, Urine analysis: 1+ Blood 1 plus and nitrates (infection).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that they completed the vaccination dose series and experienced events after both the doses. The patient post receiving their second dose of vaccine had headache, fatigue, and had blood in their urine which the patient experienced even after receiving their first dose of vaccine. The patient consulted their Health care professional and was diagnosed with Cystitis.  No Concomitant product use was reported.  Company comment : This case concerns a 66-year-old female with a serious unexpected event of cystitis, and nonserious unexpected Blood urine present, and expected headache and fatigue. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Treatment medication included two rounds of antibiotic Cipro (2 courses).  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-095681 (Patient Link).; Sender's Comments: This case concerns a 66-year-old female with a serious unexpected event of cystitis, and nonserious unexpected Blood urine present, and expected headache and fatigue. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
anaphylactic reaction after receipt of her first dose of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The patient had anaphylactic reaction after receipt of her first dose of Bexsero. The patient's physician wrote a note that she had anaphylaxis after her first dose and needed to be exempt from receipt of a second dose. She had no vaccine details as it was not administered at her facility. The reporter consented to follow up.
Starting about 30 min after receiving the vaccine, she developed a fever of around 101.6 and felt fatigued and had a headache. I gave her TYLENOL and when it wore off her fever returned to above 102. I gave her MOTRIN right before bedtime. She had a fever all day Saturday and it would be above 102. The highest it went was 102.7. I gave her MOTRIN 2x that day and she had trouble sleeping that night. So, Sunday I started giving her FLONASE to help her nasal congestion so that she would be able to sleep better that night. She woke up on Monday without a fever but due to the continued nasal congestion and cough, I kept her home to rest. I was giving her FLONASE through 12/23. She started developing a hoarse voice on 12/21 and by 12/23 I decided to have her stop the FLONASE which resolved her hoarse voice. On 12/26, she saw her pediatrician and they did a rapid strep test and one they send out to a lab (both came back negative). The doctor noticed she had fluid in her left ear and a swollen lymph node on the left side of her neck. So, she told us to start an antihistamine and to monitor the swollen lymph node. When we got home, she started the ZYRTEC and took an at-home COVID-19 test which was negative. The last day she took the ZYRTEC was 12/29 because I forgot to do it on 12/30. She woke up on 12/31 with a full body rash. We took her to urgent care and the doctor said the lymph node was no longer swollen and the fluid in the ear was resolved. They were not sure what was causing the rash but thought it could either be viral or an allergic reaction. So, they told us to increase her ZYRTEC to 2x daily. They said the allergic reaction could have been from something days prior but due to already being on the ZYRTEC it wasn't visible. The rash progressively got better. I took her to her pediatrician on 01/02/2023 and showed her pictures of the rash that was present on Saturday and she said it was hives. She said it was likely an allergic reaction to something but not sure what. She said to continue the ZYRTEC and to bring her to an allergist. Now, she has very few hives and I stopped giving her ZYRTEC on 01/07/2023.
This spontaneous report was received from a medical assistant regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 25-MAY-2016, the patient was vaccinated with one dose of improperly stored VARIVAX (Merck) (lot # L001334 with an expiry date 13-JAN-2017 and dosing details not reported). No other doses were administered. These vaccines were exposed to temperature excursions of 56 degree Fahrenheit for two hours on 12-MAY-2016 and to 28 degree Fahrenheit for 28 hours on 15-AUG-2016. No doses of VARIVAX (lot # L037563, expiry date: 29-SEP-2017) were administered to any patients. There was no prior excursions, the call was because of a data logger. No adverse effects were reported. Additional information has been requested.
Diaphorhesis, abdominal pain, nausea vomiting and diarrhea 8-12 hours.  conservative treatment NPO, followed by clear liquids.   This was followed by 3 weeks of epididymitis and orchitis, with persistent epidydimal  cysts, and impotence.
Throat felt like there was something stuck in it, vomiting, diarrhea, weakness, chills
violent chills which stopped after 6 hours,  a hot bath, and 4 layers of clothes. Weakness. Lack of appetite.
When patient got home from clinic notice red bumps. Returned to clinic with hives to lips, face, chest, back, and legs. Patient monitored and given Benadryl.
1st Vaccine Injection:  I developed small red spots on my arms and hands bilaterally, and also developed a red, rough, dry patch of skin on my left supra-pubic area for which I had continual itching for a period of 2 weeks.     2nd Vaccine Injection:  I developed a cylindrical area on my supra-pubic area approximately 1 week after the injection, which continues intermittently at this time ( over 1 month later) becoming slightly red with a rough, dry patch of skin on the right side of the area.
On 3/16 in the afternoon, I noticed a red, hot to the touch patch on my right arm under the injection site. It has not caused me any pain or discomfort until today when I noticed it was very warm to the touch and a little sore. It is about 3 inches long and is very oddly shaped. Today it almost feels like a bruise on my arm and is a little sore when I lift or move my arm. I have not taken any medication or sought medical treatment in regards to it. It if becomes more painful and swollen, then I will call my doctor right away.
Moderna COVID-10 Vaccine EUA. I had 2nd shot in my left arm.  About 3 hours post injection, I developed a sore arm that lasted for 4 days.  About 10 hours post injection, I had chills that lasted for 6 hours.  About 12 hours post injection, I had intense body aches that lasted for 6 hours.  About 24 hours post injection, I developed a very itchy red rash (size 2" x 4") at the injection site on my left arm, that lasted 3 days.  (I put steroid topical cream on it) I'm fine now.
Patient is a 39 y.o. male nurse employed at a hospital.  Not diagnosed with HTN, but states his diastolic pressure has been in the 90's for the last 2-3 months (from his doctor's records, at one visit his BP ws 132/80 and 144/84), last cholesterol was 256, no diabetes, non-smoker, no family hx of cardiac disease.  He was vaccinated on 5/8/03, on 5/11/03 he developed  SOB with exertion.  On 5/12 during heated union negotiations he developed a few seconds of palpitations and chest tightness.  He then walked up and down stairs and felt quite SOB.  On 5/13 he went to the ER on the suggestion of a colleague. Per patient report, in the ER his BP was 140/110, O2 sat at rest was 94%, ABG showed a "moderate" A-a gradient with a PO2 of 88.  CXR was negative, Chest CT (pulmonary angiogram protocol) was negative for pulmonary embolization, EKG had non-significant ST elevations (per patient), CK and troponin were negative, ECHO was negative.  On 5/15 he had a negative stress thallium.  By 5/20 his SOB was almost resolved, v. slight SOB on exertion only, by 5/28 his symptoms were totally resolved.  He had a similar episode 3 yrs ago with a few seconds of palps/SOB while at court with his mother (feeling stressed/anxious), stress thall at that time was negative. PMD saw him for follow up, did not recommend any further pulmonary work up, for his "borderline" BP and high cholesterol, just recommended weight loss.  I am still waiting for ER records.  Lab results showed ABG: pH 7.44, PaCO2 37.2, PaO2 83, HCO3 25.8, O2Sat 97
I am experiencing numbness and weakness  in my left arm mostly, and somewhat in my leg and face.
Flu like symptoms and soreness at the injection site.  Difficult to raise my left arm..  Fever from 99.1- 101.4.   Symptoms started about 12-13 hours after injection.  My wife experienced similar symptoms but milder.  We both are feeling much better today.  I had tested positive for the COVID antibodies on Nov 23, 2020,2:12 pm SARS-CoV-2 Antibodies (ELISA) - Reactive .
Pfizer 5-11 Orange Cap given to a 4-year-old boy. No adverse reaction was noted.
NAUSEA DIZZY VOMITTING SWEATING ARM PAIN FATIGUE BODY ACHES
Injection site irritation, high fever of 103.6 degrees that lasted 4 days, a Rash has been forming since the fever stopped. The rash is still getting worse as of this time.
Rhinorrhea, fever 102 ax, diffuse maculopapular rash;
June 30th, 9pm, itch, itching, arms, scalp, buttocks, torso, thighs, front and back of torso. Wave in rash, pink in color like hive. Took Allegra, it did relieved itching. Continue with Allegra for 3 days, rash goes away, rash comes back. This continued from June 30th through July 21st.  It would come and go. If I had to be more specific, it would come every two days.  Have not been able to see a dermatologist. But it has now stopped.
fever 101.2 and severe fatigue. 12-15 hours after vaccination of Menomune. Early exam 9/16/04. No fever.
Patient first complained of her normal anxiety and was doing deep breathing exercise. Then she described chest tightness similar to when she had contrast dye. At that time EMT notified and brought to back area 1:18. Chest tightness and tightness in her throat, O2 sat 95%, HR 92, BP 141/89, EMT started an IV 1:23 Benadryl IV given 1:28, 12 Lead EKG for the chest tightness, HR 90- 94, O2 sat 94-95%, BP 142/92, 1:32 chest tightness improved, Now with a Headache 1:36 transport to ER via ambulance
pt recv vax 16JUL96 & was exposed to a varicella breakout @ daycare between 11NOV97 & 25NOV97;6DEC97 pt devel varicella rash, 100-200 small lesions over trunk area w/malaise & fever of 100.4;
pt brought to ED with c/o SOB, fatigue, poor po intake x 5 days; positive for COVID in ED; chest x-ray showed left lower lobe pneumonia; treated with antibiotics, remdesivir, dexamethasone; intubated in the ED and transferred to ICU; condition improved and pt was able to be extubated; BiPAP AVAPS; condition continued to improved and she received O2 supplementation via NC; transferred to medical floor where she was making improvements; pt abruptly went into cardiac arrest; CPR performed but pt died in the hospital
accidentally injected with MENQUADFI instead of a Meningococcal B vaccine, with no reported adverse event; Initial information received on 14-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an 18-year-old female patient to whom accidentally injected with MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] instead of a meningococcal b vaccine, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Feb-2023, the patient received dose 3 at 0.5ml (frequency: once) of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (formulation: unknown) (strength: standard, 0.5ml) (lot number: U7596AB and expiry date: 14-Mar-2025) via intramuscular route in the left deltoid for Immunization and on the same day patient was accidentally injected with menquadfi instead of a meningococcal b vaccine, with no reported adverse event (wrong product administered).  It was reported, the medical assistant (MA) asks if there is an issue with taking MENQUADFI so close together, what to expect, and how long they should wait until they give the Meningococcal B vaccine.   Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  At time of reporting, the outcome was Unknown.  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 the guidelines. 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.
No additional adverse events reported; improperly stored vaccines were potentially administered to unknown patients; This spontaneous report has been received from a licensed practical nurse, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 10-JAN-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot # T033815 with expiration date: 05-OCT-2022, route, strength and dose were unknown) for prophylaxis (Product storage error). No additional adverse events reported.  Administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) experienced the temperature excursion with 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursions were reported as 32.9F for 53 hours 16 minutes; 49.1F for 5 hours 9 minutes; 56.3F for 14 hours 7 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA003592: US-009507513-2203USA003310: US-009507513-2203USA003311: US-009507513-2203USA003312: US-009507513-2203USA003313: US-009507513-2203USA003314: US-009507513-2203USA003315: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003318: US-009507513-2203USA003320: US-009507513-2203USA003321: US-009507513-2203USA003322: US-009507513-2203USA003323: US-009507513-2203USA003324: US-009507513-2203USA003325: US-009507513-2203USA003326: US-009507513-2203USA003327: US-009507513-2203USA003328: US-009507513-2203USA003329: US-009507513-2203USA003330: US-009507513-2203USA003331: US-009507513-2203USA003332: US-009507513-2203USA003333: US-009507513-2203USA003334: US-009507513-2203USA003335:
No adverse event; Patient 6 months-5 years of age received a Moderna Covid19 vaccine from the pink cap vial (10 mcg) instead of blue cap vial (25 mcg; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient 6 months-5 years of age received a Moderna Covid19 vaccine from the pink cap vial (10 mcg) instead of blue cap vial (25 mcg) and NO ADVERSE EVENT (No adverse event) in an infant female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 27-May-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 10 microgram. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient 6 months-5 years of age received a Moderna Covid19 vaccine from the pink cap vial (10 mcg) instead of blue cap vial (25 mcg). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient 6 months-5 years of age received a Moderna Covid19 vaccine from the pink cap vial (10 mcg) instead of blue cap vial (25 mcg) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient 6 months-5 years of age received a Moderna Covid19 vaccine from the pink cap vial (10 mcg) instead of blue cap vial (25 mcg).    The route of administration of suspect Moderna bivalent dose 1 and 2 was reported as BI. Concomitant medication was not reported. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
Severe polyarticular inflammatory arthropathy with active synovitis in hands and knees following second Lymerix dose. No improvement despite over 6 months of triple remittive drug therapy. Also, joints were noticably swollen- legs, ankles and wrists. Pt. has been diagnosed with rheumatoid arthritis.
two ActHIB vaccines were inadvertently administered from a shipment package that experienced a delayed transit time/ no AE; Initial information received on 04-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via phone.  This case is linked to case 2019SA157837 (same reporter).  This case involves a 6 months old male patient who was vaccinated with 0.5 ml third dose of HIB (PRP/T) VACCINE [ACT-HIB] (Batch number: UJ128AAB and expiry date: 08-Nov-2020) via intramuscular route in the left thigh on 31-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE); DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) on an unknown date.  It was a case of actual medication error due to deteriorated drug administered.  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 holders 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 the sender: none.
Information has been received from a 75 year old female patient with drug reaction to CELEBREX who on 16-MAR-2009 was vaccinated with single dose of series of ZOSTAVAX (Merck).  On 25-MAR-2009 the patient noticed at the injection site on her left arm there was a red mark and a "big goose egg".  The patient had not sought medical attention.  At the time of reporting the patient's red mark and "big goose egg" at the injection site on her left arm persisted.  No further information is available.
Severe itching, rashes, fatigue, low grade fevers, lymph node enlargement lasting for 1 year.