chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Liver Cirrhosis; Urined turned very yellow/ yellowish bright almost orange-ish; Soft/ loose stools; A spontaneous report, was received from a consumer concerning a 82 year old male patient (race unknown, ethnic group unknown) who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced his urine colour changing to yellow and then to orange-ish (chromaturia), his stools were loose and soft (diarrhoea) and later he was diagnosed with liver cirrhosis (hepatic cirrhosis).  The patient had no medical history. Concomitant medications reported included are metformin, atorvastatin and multivitamins.  On 11 Jan 2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (Batch number: 013L20A), intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 07 Feb 2021, after administering the vaccine, the consumer experienced his stools turned very yellow and his stools were soft.  On 08 Feb 2021, the patient received second of his two planned doses of mRNA-1273 (Batch number: 013M20A), intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Approximately after two days of the second dose, the consumer again experienced his stools turned bright yellow to almost orange-ish and loose stools. His primary physician got him bloodwork done and the laboratory results showed signs of liver cirrhosis.   On 26 Feb 2021, he got ultrasound scan and few more blood tests done and the results showed possible liver cirrhosis. The patient was booked for another CT scan for 27 Feb 2021. No treatment information was provided.   The outcome of the events, chromaturia and diarrhea was unknown. The outcome of the event hepatic cirrhosis was considered not recovered.; Reporter's Comments: Based on the 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.
3/22/19 admin time 1515 - noticed @ 0200 on 3/23/19 small hard knot, progressed to 70 mm x 130 mm round, raised, swollen, warm to touch area. Also noticed fatigue and headache for at least 24 hours after vaccine admin.
SOME SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced some side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of some side effects was not reported. This report was non-serious.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since 11-MAY-2016, the patients were vaccinated with the improperly stored doses of VAQTA (lot #, expiration date, dose and route were not reported). No adverse effects were reported. VAQTA was supported until the labeled expiry. This is one of several reports received from the same reporter. Additional information has been requested.
A consumer report has been received. The report concerns a 2 year old, Male consumer, who had been receiving Nasal FLUMIST. FLUMIST started on 20-Sep-2012. The patient experienced FLU-LIKE SYMPTOMS which started on 21-Sep-2012. There was experienced, that the storage unit reached 50 degrees F. That was outside the temperature stability range. At the time of reporting, the event of FLU-LIKE SYMPTOMS was improving. The report was considered to be non-serious.
2 days after MMR-V, Hep A, pt has an episode when suddenly she screamed from sleep, shaking of extremities, stiffening and eye rolling with purple face followed by period of somnolence, duration ?, Parent called 911 and taken to ER. Admitted overnight for observation.  6/19/07 Received hospital medical records which reveal 2 days s/p vax patient experienced irritability, shaking, high pitched screaming, stiffness, eyes rolling back & cyanosis lasting approx 1 min, then went limp & unresponsive.  Began emesis, crying & was irritable after that.  Patient was post ictal in ER.  Admitted 6/9/07 for monitoring & peds neuro consult done.  No d/c summary available.  T/C to med recs for d/c date. ADMIT DX: ALTE, r/o new onset seizures vx breath holding vs reflux.   8/10/07 Received v/m that no d/c summary dictated.  Case will be closed & reopened should it become available.
Pain extending down arm from injection site to hand, fingers. Bumps/rash also appeared. Started day of injection (6/1/16) and continuing through today. Patient has been icing/taking ibuprofen. Saw a doctor and was prescribed antibiotic.
he experienced a sore arm after his first dose of the Covid-19 vaccine on 23Mar2021.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: ER2613, Expiry Date: 31Jul2021) on 23Mar2021 15:30 in left arm as single dose for COVID-19 immunization. Medical history included ongoing hypertrophic cardiomyopathy which diagnosed probably 8 years ago; family medical history included mother and father are diabetic. Concomitant medications were none. No additional administered vaccines. No prior vaccinations (within 4 weeks).  Patient experienced a sore arm after his first dose of the Covid-19 vaccine on 23Mar2021. Patient reported that he recovered completely from the sore arm following the first dose. No emergency room visit required. No physician office visit. No relevant tests. Outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Generalized pruritic papular rash (not urticarial) started. Seen yesterday
Pt experienced swelling around injection site 4.5 cm X 4 cm with erythema in serpiginous pattern.
Urinary frequency Narrative:  Per nursing report: "took 2nd dose of Moderna on Friday March, 12th. States within 24 hours developed urinary frequency the whole weekend [3/13-14]. States not sure if it had anything to do with the vaccine. Requested urinalysus with c&s. Denies any fever or pain."  Other Relevant History:
Headache, body ache, flu like symptoms, shortness of breath   All within an hour afterwards and remaining still. Taking aspirin with no relief
arm still hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: arm still hurts).  The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt date: 23-SEP-2023 This case was reported by patient via (social media) interactive digital media. The patient got his/her, and arm still hurts 5 days later. Follow up was not possible as no contact details were available.
The patient experienced some neck pain about 2 hours after getting the shot. Patient went to primary doctor. The today 7 days later patient began to have sciatica pain in left hip.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent condition and medical history. On 10-JUL-2015, the patient was inadvertently vaccinated with a dose of M-M-R II (lot # J007930, expiration date: 28-JUN-2015, strength, dose and route unknown) (expired product administered). At the time of reporting, no adverse event was reported. Additional information is not expected.
chest, back underarm pain; chest, back underarm pain; back pain; adhesions; Inflammation numbers were high; Clotting numbers were way high over 2000; pneumonia; This is a spontaneous report received from a contactable consumer. A 76-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration in right arm on 01Jan2021 11:45 at single dose for COVID-19 immunisation. Medical history included thyroid, pancreas, and known allergies: Sulfa, k-flex, macrobid, statins, and pork. Concomitant medications included levothyroxine sodium (L-THYROXINE CAMPUS), vitamin B3, magnesium sulfate, and unspecified blood thinners. The patient experienced chest, back underarm pain two week later and did not get better. Patient had some adhesions and thought maybe from that. Patient had surgery and did not help. Pain kept getting worse. ED visit. On 04Mar2021, patient was diagnosed with pneumonia and sent home. After antibiotic, patient was no better. Another ED visit on 08Mar2021, clotting numbers were way high over 2000. Inflammation numbers were high. Patient was admitted every test available. 3 days in hospital. Patient was no better. Pain was terrible. Chest underarms and upper back. Patient was in serious pain and afraid to get second shot. Patient had cancelled. These adverse events were result in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. This case was reported as serious with seriousness criteria-caused/prolonged hospitalization. The patient underwent lab tests and procedures which included several computerised tomogram (CT scan): unknown results on an unspecified date, COVID test (nasal swab): negative on 08Mar2021, and X-ray: unknown results on an unspecified date. Patient was treatment for the adverse events. Outcome of the events was not resolved.  Information on the lot/batch number has been requested.
chills; fever; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), GABAPENTIN, TOPIRAMATE (TOPAMAX), DULOXETINE HYDROCHLORIDE (CYMBALTA), METOPROLOL SUCCINATE, ATORVASTATIN CALCIUM (LIPITOR), Low-Dose Aspirin and ALPRAZOLAM (XANAX) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On 14-Mar-2021, CHILLS (chills), PYREXIA (fever) and INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Norco, Gabapentin, Topamax, Cymbalta,Metoprolol Succinate, Lipitor, Low-Dose Aspirin, Xanax.   Reporter did not allow further contact
Pt brought to facility as transfer from another facility one day after receiving 2mo vaccinations c/o fever, stiffness, weakness, and loss of appetite. Pt found to have clinical sepsis of uknown etiology (all cultures have been negative to date and MRI showed no evidence of encephalopathy or meningitis) with end organ toxicity (transaminitis, AKI, anemia, and hypoglycemia to 20). Pt was admitted to PICU and placed on 7 day course of IV ceftriaxone, vancomycin, and acyclovir. Pt afebrile for last 5 days of admission, improved clinically, tolerated PO feeds, and activity back to baseline. Discharged on 12/1/16 with f/u appt with pediatrician on 12/5/16.
Erythema; Raised rash; Soreness; Tenderness; unable to workout; This case was reported by a physician via call center representative and described the occurrence of erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number GH455, expiry date 29th January 2022) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced erythema, raised rash, pain, tenderness and activities of daily living impaired. The patient was treated with methylprednisolone (Medrol) and antiinflammatory/antirheumatic products (Anti Inflammatory Drug (Nos)). On an unknown date, the outcome of the erythema, raised rash, tenderness and activities of daily living impaired were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the erythema, raised rash, pain, tenderness and activities of daily living impaired to be related to Shingrix.  Additional case details were reported as follows: The patient was unable to workout. The patent had Medrol pack on another anti inflammatory. The reporter consented to follow up. This case has been linked with case US2020015854, reported by same reporter.
patient experienced pre-syncope reaction: nausea, sweating, dizziness, palor/paleness, feeling as if going to pass out. SHE however, DID NOT faint.
Fever, rash (widespread). Alternate TYLENOL and ibuprofen; BENADRYL; epinephrine injection; ZANTAC; ORAPRED.
Widespread papular eruption, pruitic, covering most of torso. Extremities and face spared. No signs of illness. Treated with prednisone and Atarax. REsolved.
This spontaneous report was received from a pharmacist regarding a unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 04-JUN-2018, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 intramuscular route, lot# M038359 and 13-MAY-2018 expiration date for prophylaxis (strength and frequency were not reported). No adverse effects were reported. No product quality complain was involved.
The patient received an injection of ACTHIB using a diluent of 0.9% nebulized saline, no AE; A 63 year old patient was vaccinated with ACT-HIB, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00704024) and transmitted to Sanofi on 30-Jul-2021.  This case involves a 63-year-old male patient who was vaccinated HIB (PRP/T) VACCINE [ACT-HIB] using a diluent of 0.9% nebulized saline (Product administered to patient of inappropriate age and Product preparation error)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE and MENINGOCOCCAL VACCINE for prophylactic vaccination and RABIES VACCINE (RABIES) used for an unknown indication.  On 29-Jul-2021, the patient received a 0.5 ml booster dose of suspect HIB (PRP/T) VACCINE (lot number not reported) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong diluent used and inappropriate age at vaccine administration (latency same day).  It was reported that "Pharmacist stated that a patient received an injection of ACTHIB on 29JUL2021 using a diluent of 0.9% nebulized saline and asked about adverse event data regarding the use of alternative diluents. Pharmacist states that the product was sent from a satellite office without the diluent and that a new nurse used the 0.9% nebulized saline as an alternative"  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.  There will be no information available on the batch number for this case.
pt recv vax 6JAN99 & presented w/diplopia that started very distal, seeing two lines, not one;this progressed to double vision for almost everything x/reading;this was considered to be a disabling event;Annual follow-up dated 11/27/00 provided no additional data.
The following morning;  soreness at injection sight, extreme joint pain, low grade fever, and slight headache, swollen armpit on side of injection and cough.  All of the same symptoms I had while sick with COVID on Christmas, 2020.  Spent that entire day in bed. With all the questions asked beforehand, why doesn't anyone ask if you already had COVID, and tell you you are more likely than others to have severe side effects?
Information has been received from a 23 year old female medical assistant with sulfonamide allergy, who on 26-AUG-2008 was vaccinated with the first dose of GARDASIL, HAVRIX, and meningococcal vaccine (unspecified).  On 02-SEP-2008 she started to have frequent urination.  The medical assistant reported that she did see an urologist who did a "cysto test" in which they stretched her urethra, which relieved some of the pressure, but on 03-NOV-2008 the frequent urination started again.  The medical assistant stated that she is not sure is the HPV vaccine has caused this, but she is due to receive the second dose on 11-NOV-2008.  At the time of the reporting, the patient had not recovered.  Additional information has been requested.
Significant body aches severe migraine at front of head and base of neck rash/inflammation at injection site
Pain in left arm, left arm swelling, itching all over body, hives, fatigue.
More tired than normal; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid vaccine (Dose number:1), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "More tired than normal".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 13 days post expiry) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 13 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
persistent runny nose; Pain in joints; left arm joint and deep tendon pain extends from the shoulder to the arm and hand.; left arm joint and deep tendon pain extends from the shoulder to the arm and hand.; Also joint pain in left hip, right hip. both knees.; Also joint pain in left hip, right hip. both knees.; This is a spontaneous report from a contactable Nurse(patient). A 64-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL3302), via an unspecified route of administration on 28Jan2021 at 07:15 (at the ag e of 64-years-old) as dose number unknown, single for COVID-19 immunisation. The medical history of the patient included osteoporosis and arthritis. The know allergies were reported as Sulfa. The concomitant medications of the patient were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had been tested negative with covid-19. On 06Feb2021 at 12:00, the patient experienced persistent runny nose, pain in joints, left arm joint and deep tendon pain extends from the shoulder to the arm and hand, also joint pain in left hip, right hip. both knees. The patient underwent lab tests and procedures which included Nasal Swab sars-cov-2 test: negative on 01Feb2021. The outcome of the events was reported as not resolved.  Follow-up attempts completed. No further information expected.
Pt was given both PEDIARIX and PENTACEL today at appointment. Instead of HIB grabbed PENTACEL.
Patient given immunization on 01-29-2015. As per patient she started having (R) leg pain approximately 2 weeks later, has difficulty walking due to pain. Vaccination given in the arm seen orthopedics and had multiple ER visits. Now (R) side better c/o pain (L) leg.
Difficulty swallowing (getting worse over 1 hour), diarrhea (8 pm), chills (8:15 pm), fever (9 pm),  aches (9:30 pm).  After 10 hours, back to normal.
Extremely sore vax arm, left side for 2 weeks straight after first shot; Slight swelling and occasional itch around vax site; Slight swelling and occasional itch around vax site; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included scoliosis. The patient was allergic to soft shell crab. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 09Apr2021, the patient experienced extremely sore vax arm, left side for 2 weeks straight after first shot. Started to fade at 14 days with regular ice treatment, slight swelling and occasional itch around vax site, as well, but no rash or dermal issues. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event extremely sore vax arm and included treatment with regular ice. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely sore vax arm, left side for 2 weeks straight after first shot, slight swelling and occasional itch around vax site was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
On 03/24/17 at 3:50 pm. Pt was administered vaccines GARDASIL, BEXSERO and MENACTRA. Pt. started to get hives around neck and chest area. Pt. was very anxious after vaccines.