chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called office on 7/10 describing vomiting that started on 7/9/20, associated w being fed and possibly bilious based on description. None bloody. No blood in stool. No fever. Mom says had become somewhat fussy, not lethargic. Referred to ED for evaluation (Hospital at Medical Center) where ultrasound demonstrated intussusception. Unable to be reduced via enema, was taken to OR for surgical resection and was admitted from 7/10-7/13/20.
Local redness, swelling and heat around injection site. Approx. size-10cm X 10cm.
24 hrs. after Dose 2  on 09/02/2021  had left arm was numb and lymph nodes swollen and  neck stiffness, gave Motrin. Took a week to feel better but the lymph node  has remained consistent.  Three weeks 09/20/2021 Patient awoke with   lymph on left side of body and arm felt discomfort in his left side of neck and body and three weeks still lymph Monday morning sharp pain before 6am could not move and not able to take deep breaths and had EMT come to the house took to  Hospital  and check with heart issue and full ex-ray and major inflammation in his body and hour later he has been feeling better and still not recovered.
administered improperly stored vaccine; No advesre effect; This spontaneous report as received from a other health professional refers to unspecified patients of unknown age and gender. The patients pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown dates, the patients were vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose, route of administration were not reported, lot # S008729 has been verified to be a valid lot number for (haemophilus b conjugate vaccine (meningococcal protein conjugate)), expiration date reported as 21-JAN-2020) for prophylaxis (product storage error). No additional adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 1.0 degree Celsius for a time frame 3 hours 30 minutes. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report. The outcome of product storage error and no adverse event were  unknown. Causality was not provided.  This is a non-valid case due to lack of patient identifiers.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unspecified date in January 2018, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M041085, expiration date 03-JAN-2018, 0.65 mL once (strength was not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) lot # M035268 expiration date 19-APR-2019. The reporter denied any adverse effect reported by the patient.
This spontaneous report was received on 10-JUL-2017 from a pharmacist and refers to 38-year-old unspecified patient of unknown gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The pharmacist reported that an unspecified patient received the first dose of RECOMBIVAX HB (Dose, route of administration, site of administration, Lot number and expiration date were not reported) on 13-MAY-2016 and second dose of RECOMBIVAX HB (Dose, route of administration, site of administration, Lot number and expiration date were not reported) on 13-JUL-2016. No side effects reported. Additional information has been requested.
60 yr old pt received Fluzone HD - should have received regular flu shot. Patient aware & dr's office also notified
Chronic hives break out ALL over body, and swelling of my lips and eyes. The hives have been occurring every single day since about three weeks after my second dose. They present worse at night, but will be present all day. I received a 5 day steroid treatment from urgent care which helped for a few days, but was ineffective once the steroids were off. I've since been prescribed Famotidine 2x daily, which keeps them at bay, but if I forget a dose the hives immediately reappear. I have never in my life had an allergic reaction to anything besides mild hay fever symptoms in the spring. I've changed the diet and body products I use to eliminate those as potential causes.
PT received Td shot on 6/13/02. PT developed fever (103 deg F) and pain at inject site. The symptoms lasted about 1 week. PT was found to have a tick borne disease.
injection site pain; feeling unwell; lost weight; joint pain; fever; very thirsty after 2 hr; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318) via intramuscular route of administration, administered in left deltoid (at age of vaccination 74) on 28Jan2021 as dose 1, single for COVID-19 immunization (School/ Student Health clinic). The patient medical history included baker cyst bunion and simple renal cyst from 01Jun2010, osteoarthritis and nocturia from 04May2012, hypertensive disorder and hyperlipidemia from 11Jun2010, chronic prostatitis and interstitial cystitis from 23Nov2013, degenerative arthritis of knee from 05May2012. The patient concomitant medications included acetylsalicylic acid (ASPIRIN 81), Atorvastatin, Cholecalciferol, Hydrochlorothiazide, Losartan and Tamsulosin taken for unspecified indication and start date and stop date was not reported. On an unspecified date, the patient experienced injection site pain, feeling unwell, lost weight, joint pain, fever and very thirsty after 2 hr. The patient underwent lab tests and procedures which included body temperature 99.7F (29Jan2021, 11:45), 98.3F (30Jan2021, 7:15), 99.4F (30Jan2021, 01:45), 98.8F (30Jan2021, 4:30), 98.4F (30Jan2021, 9:30), 98.5F (31Jan2021, 04:15), 95.7F (31Jan2021, 06:30), 99.8F (01Feb2021, 13:15), 98.7 (01Feb2021,06:00), 98F (02Feb2021, 04:00). The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Swollen, red, itching, burning skin around eyes.  Broken blood vessels on upper and lower eye lids.  Symptoms started around 4pm day of vaccine.  Woke up on AM of 4/17/2021 with severe swelling around eyes and increased redness.  Took Benadryl and applied hydrocortisone cream and received small amounts of relief.
vaccine were exposed to negative 7.7 degree celsius for 30 days /no AE; Initial information received on 18-Nov-2021 regarding an unsolicited valid  non-serious case received from a other health professional and non health care professional via Medical Information (MI) number: 00864804.  This case involves an unknown age and unknown gender patient who was administered  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (product storage error).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number: UJ702AC and expiry date: 30-JUN-2022 via unknown route in unknown administration site, a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number: U7055BA and expiry date: 03-JUN-2023 via unknown route in unknown administration site, a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number: C5774BA and expiry date: 18-SEP-2022 via unknown route in unknown administration site, a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number: U6831AA and expiry date: 08-OCT-2022 via unknown route in unknown administration site and a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number: QFAA2110 and expiry date: 01-JUN-2022 via unknown route in unknown administration site for prophylactic vaccination respectively.  It was case of an actual medication error due to Product storage error temperature too low (latency: same day).  At the time of reporting, 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.
arm soreness; fever; chills; unwell; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm, fever, chills and unwell. On an unknown date, the outcome of the pain in arm, fever, chills and unwell were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fever, chills and unwell to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The reporter reported that her husband got his first dose of Shingrix at the end of May 2019, in the left arm.  For about two days the patient experienced fever and chills, and just unwell for three days. He also experienced a very sore arm for about a week.  The patient still plan to get the second dose. The patient had not reported these events to his physician.
This case was reported by a healthcare professional and described the occurrence of diarrhea in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB, (non-gsk) PREVNAR, ROTATEQ (non-gsk) and seasonal  (non-gsk) FLUZONE. On 6 January 2009 the subject received 3rd dose of PEDIARIX (.5 ml, unknown, right thigh), 2nd dose of ACTHIB, 3rd dose of PREVENAR, 3rd dose of ROTATEQ, and 1st dose of FLUZONE. On 6 January 2009, within hours of vaccination with PEDIARIX and after an unspecified amount of time within the same day of vaccination with PREVNAR, ACTHIB, FLUZONE and ROTATEQ, the subject experienced diarrhea, infant feeding problems, fever, vomiting and inability to eat. The nurse reported that a subject developed a severe reaction after her third vaccination with PEDIARIX. The subject developed a fever of 101.6, diarrhea, vomiting, eating only once every 24 hours, and unable to eat. These symptoms developed a few hours after the vaccination and are worsening. The subject has been seen by emergency rooms, urgent care centers and doctor's office without any improvement. The nurse stated that the subject also received several other vaccines that same day and she is not sure which was related or if the vaccines are involved in the adverse events. The healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were worse.
Vaccine used past its 30 day expiry date; patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccine used past its 30 day expiry date) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022 at 3:45 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022 at 3:45 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine used past its 30 day expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccine used past its 30 day expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Ethnicity was reported as Multiethnic and dose number was reported as Booster It was reported that vaccines went into 2-8 C thaw state on or above 24-Dec-2021 and were administered up until the MFG expiry date of 04-Apr-2022. No treatments were reported.   This case was linked to MOD-2022-542869 (Patient Link).
Pt was given a dose from vial that had been at room temperature for 23 hours.
Swelling/edema under left arm.; Swelling/edema under left arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Oct2021 18:15 (Lot number: FF2590) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for immunisation, administration date 15Sep2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 05Mar2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 25Mar2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: SWELLING (non-serious), OEDEMA (non-serious) all with onset 14Oct2021, outcome "recovering" and all described as "Swelling/edema under left arm.". Therapeutic measures were not taken as a result of swelling, oedema.  Additional information: The patient did not realize the extent of the AE until 16Oct2021 at this point she noticed that swelling progressed significantly to the point she wanted to report it. Initial swelling was not significant enough for her to be clear that it may have been associated with the vaccine. The patient was not a pregnant at the time of vaccination. The patient did not receive any other medication within two weeks of vaccine. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
I have a bump or lump on my left elbow and that was the site where I received the vaccination and it is about a size of half of a golf ball; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL9263) on 24Jan2021 at single dose in left arm for COVID-19 immunization.  Medical history included enlarged prostate, high blood pressure and high cholesterol. Concomitant medication included alfuzosin for Enlarged prostate, finasteride for Enlarged prostate, amlodipine for High Blood Pressure and atorvastatin for High cholesterol.  Patient had a bump or lump on his left elbow and that was the site where he received the vaccination and it was about a size of half of a golf ball on an unknown date in 2021. Patient had unspecified physical lab test in Nov2020 (reported as two months before) with unknown result. The second dose of the vaccine is scheduled for 14Feb2021.The final outcome of the event was unknown.
vision and anxiety; fever; permanent ringing on her head, intense headaches; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (vision and anxiety), HEADACHE (permanent ringing on her head, intense headaches) and PYREXIA (fever) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031a21a and 008b21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced HEADACHE (permanent ringing on her head, intense headaches). On 12-Apr-2021, the patient experienced ANXIETY (vision and anxiety) and PYREXIA (fever). At the time of the report, ANXIETY (vision and anxiety), HEADACHE (permanent ringing on her head, intense headaches) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other Concomitant Medication provided was Cholesterol medication and Gastritis medication. No treatment  was provided.   This case was linked to MOD-2021-092382 (Patient Link).
Severe body aches - inflamed my fibromyalgia; headache; violent / flowing nose bleeds lasting up to 1 1/2 hours (went to ER due to the consistent flowing of blood and unable to stop it).
SHORTLY FOLLOWING VACCINE MEMBER DEVELOPED FATIGUE, NAUSEA, VOMMITING, DIAHRRHEA, HEAD ACHE AND CHILLS
Information has been received from a registered nurse concerning a 49 year old male with drug allergies to ALTACE and high blood pressure and high cholesterol who on 02-NOV-2010 was vaccinated IM with a first dose of PNEUMOVAX 23 (lot # 665917/1311Y, expired date 06-JUN-2011) to prevent pneumococcal disease. Concomitant therapy included AZOR, metoprolol and LIPITOR. On 02-NOV-2010 night, the patient began "to not feel well". The next morning, on 03-NOV-2010, the patient developed a red, swollen area that covered the entire deltoid where he received the injection. The patient also "developed a fever of 101". No lab diagnostics studies performed. The patient had not recovered. The patient sought unspecified medical attention. Follow up information received from a registered nurse concerning a 49 year old male with hypertension, obstructive sleep apnoea and fatty liver who on 02-NOV-2010 at 9:00 AM was vaccinated IM with a first dose of PNEUMOVAX 23 (lot # 665917/1341Y) in the left arm. It was reported that the patient showed up complaining of redness and swelling of the left arm. It was not infected and the patient was instructed to just keep an eye on it, no further complaints were received from the patient. The patient recovered. It was reported that the patient did not require emergency room/doctor visit. Additional information is not expected.
received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 934NJ, expiry date 10th December 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th December 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 13th December 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   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 provided as follows: The reporter was a certified medical assistant. The age at vaccination was not reported. The patient received an expired dose of Pediarix today (day of reporting), which led to expired vaccine used. The reporter consented to follow-up.
Started out as red nodule on Friday, 8.5 and then grew to 4-6 cm lump appeared, size of walnut on Sat, Aug 6.  Tender and hot to touch; mild fever.
Blood-tinged stool (specks) started 2 days after receiving routine 2 month old vaccines, including Rotarix (RV1).  By 3/27/14 (today), still present.  No vomiting, no current-jelly stools, feeding well, no pain or fussiness, otherwise normal exam. Clinically not acting like intussusception -- just blood-specked stools.  (This could very well be cows-milk sensitivity, so will restrict cow and soy products from mom's diet [nursing] and change to elemental formula.)
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; MEMORY HAD BEEN WORSE; This spontaneous report received from a patient concerned a 77 year old male, unspecified race and ethnicity. 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, intramuscular, batch number: unknown expiry date: unknown) dose was not reported, 01 total, administered on 01-MAR-2021 for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number: unknown expiry date: unknown) dose, frequency, and therapy dates were not reported, used for moderate to severe adult Crohn's disease, and moderate to severe ulcerative colitis. No concomitant medications were reported at the time of reporting.  On unspecified date in SEP-2021, the patient had suspected covid-19 infection (suspected clinical vaccination failure) and memory had been worse since Covid-19. He was hospitalized for 3 weeks. The hospital discharge date was not reported. He was better as of 15-OCT-2021, but he did physical therapy two to three times a week. It was unknown if patient was enrolled in a Covid-19 vaccine trial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and memory had been worse, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint:90000199305.; Sender's Comments: V0: 20211050446- Covid-19 vaccine ad26.cov2.s- Suspected covid-19 infection, Memory had been worse. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211050446-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination 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
High fever with chills, body aches starting with right toes, joint pain and intense headache, nausea, vomiting, diarrhea.  (Lasting at least 24 hours) Low grade fever for 2 more days.  Fatigue and feeling that all my strength was drained from my muscles lasted off and on for several weeks.