chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA298667, 2018SA298673, 2018SA298674, 2018SA298679, 2018SA298676, 2018SA298677, 2018SA298678, 2018SA298675, 2018SA298672, 2018SA300038, 2018SA300042 and 2018SA300042, same reporter. This case involves an unknown gender patient (age ranging from 32-50) who received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. On 25-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ039AA, expiry date 15-May-2019 via intramuscular route on unknown site of administration. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that patient with age ranging from 32-50, was inadvertently administered FLUZONE HIGH DOSE. The patient did not experience any adverse reaction after the injection. 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. List of documents held by sender- none.
Case previously recorded as MA2009-4237. Initial case report received from a nurse, via agency, on 11 NOV 2009. A 3-year-old female patient was vaccinated with 0.5 ml with FLUVIRIN 2009/2010 (batch no. 101041P1, expiration date 30 MAR 2010) i.m. on 11 NOV 2009, an off-label indication. No adverse event was reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to foreign and local label: Vaccination in children younger than 4 year-old is an off-label and unexpected for FLUVIRIN (2009/2010). No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-007964.
Hives (Face and trunkal); Itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives (Face and trunkal)) and PRURITUS (Itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives (Face and trunkal)) and PRURITUS (Itching). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives (Face and trunkal)) and PRURITUS (Itching) outcome was unknown.            No concomitant medication was provided.
No additional AE; A patient was inadvertently administered an expired dose of MMR-II; This spontaneous report was received from a nurse and refers to a patient of unspecified age and gender. The patient's pertinent medical history, drug allergies and concurrent conditions were not reported. Concomitant medications included sterile diluent.   On 30-AUG-2022, the patient was inadvertently administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human Albumin (rHA) (M-M-R II) lot # T027936, expiration date: 18-AUG-2022, (dose, anatomical location and route of administration were not provided) as prophylaxis (expired product administered).  No additional adverse events were reported.
7cm x 8cm area of induration. 4cm x 4cm area of erythema.
thrombocytopenia purpura day 8 p/MMR, day 5 of URI sx;
Pt's grandmother reported red fine rash over face and neck seven days after vaccine administration. Taken to private physician and diagnosed with measles-like rash, probable reaction to MMR given on 4/16/03. Pt also reported temperature of 102 degrees. Pt to return to physician if further problems.
Please note that I am a primary care physician and that cases of coronavirus were very high in my geographical area during the time in question.  I received coronavirus vaccine (Pfeizer) #1 on December 23rd.  During the late afternoon to evening of December 29th, I began having fatigue and sore throat.  On December 30th, I underwent a nasopharyngeal swab for coronavirus test that returned positive.  My symptoms remained very mild and lasted for 3 to 4 days.  My close contacts did not get sick and remained negative on their coronavirus tests.  I am not concerned about this given the available literature and do not think this was caused by the vaccine.  I thought that this may just be beneficial information in case you are tracking vaccine results.
Pt. has received Inflluenza vaccine on 10/21/14 and PNEUMOVAX on 10/22 and after about 40 days of getting these vaccine complaining of having muscle pain at the site of injection.
Went to ER due to vomiting and bloody stools, also lethargic on 12-12-13 was admitted. Abd. ultrasound and barium enema was done. Was diagnosed with intussusception. Was taken to surgery where he had 2 inches of colon removed.
hives of arms, pruritis arms/trunk/scalp/ears.  It resolved for the timebeing  w/i 1.5 hours w/ 50 mg oral diphenhydramine and dose of oral famotidine
Initial unsolicited report received from a consumer via social media (on 10 Oct 2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (Same reporter source, same vaccine). This case involves a patient (age and gender are not reported) who was vaccinated with a dose of Flu shot (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date in 2010. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced Guillain Barre Syndrome. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. Upon medical review, the case was considered as serious due to important medical event: Guillain Barre Syndrome. List of documents held by sender: none. Sender's Comments: In this case Guillain Barre syndrome was reported following INFLUENZA VACCINE, in this poorly documented social media case where manufacturer of INFLUENZA VACCINE is not provided. Further information on patient's medical history, concomitant medications, previous immunization and tolerance information are needed to complete assessment of the case.
Initial report received from a healthcare professional (nurse) on 30 May 2013. An 11 year old male patient was vaccinated on 06 May 2013 with MENACTRA intramuscularly into the right deltoid, batch # U4079AA and ADACEL intramuscularly into the left deltoid, batch C3922AA. The patient experienced a syncopal episode post vaccination at an unspecified time. The episode occurred after he left the office and was standing near the elevator. The patient did not have an acute or chronic illness or medical history. Concomitant medications and laboratory tests were not reported. The patient was observed for 15 minutes. The patient outcome was recovered at an unreported date. Documents held by sender: None.
Pericarditis; couldn't breathe; with every dose of the vaccine caller has had muscle problems; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received bnt162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (ongoing), notes: in her late 30s. Doctor tried to figure out if it was rheumatoid arthritis or Lupus.; "Rheumatoid arthritis" (ongoing), notes: Patient's aunt had rheumatoid arthritis; "Hashimoto's" (ongoing); "Fibromyalgia" (ongoing); "Sjogren's" (ongoing). There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE , Batch/lot number: EN6205 , Anatomical location: Upper left arm), administration date: 02Mar2021, for Covid-19 immunization, reaction(s): "polymyalgia rheumatica", "had muscle problems", "arm irritation", "arm tenderness"; bnt162b2 (DOSE 2, SINGLE , Batch/lot number: ER8727 , Anatomical location: Upper left arm), administration date: 23Mar2021, for Covid-19 immunization, reaction(s): "polymyalgia rheumatica", "arm sensitive/ had tenderness", "every muscle in body was bothering patient/ muscle problems", "leg cramps", "very tired"; bnt162b2 (DOSE 2, SINGLE , Batch/lot number: ER8727 , Anatomical location: Upper left arm), administration date: 23Mar2021, for COVID-19 immunization, reaction(s): "headache", "sore throat". The following information was reported: MUSCLE DISORDER (non-serious) with onset 21Oct2021, outcome "unknown", described as "with every dose of the vaccine caller has had muscle problems"; DYSPNOEA (hospitalization) with onset Mar2022, outcome "unknown", described as "couldn't breathe"; PERICARDITIS (hospitalization) with onset 26Mar2022, outcome "unknown". The patient was hospitalized for pericarditis, dyspnoea (start date: 31Mar2022, discharge date: 04Apr2022, hospitalization duration: 5 day(s)). The events "pericarditis" and "couldn't breathe" required emergency room visit. The patient underwent the following laboratory tests and procedures: did lots of tests: unknown results. Therapeutic measures were taken as a result of muscle disorder. Clinical course: In 2022 patient had an emergency visit to hospital, had pericarditis, was in late Mar2022, in between vaccines, does not know if connected, was very odd. Patient had no idea, thought it was her bra causing the pain caller was experiencing. The patient had chest pain under rib on left side. It was clarified and confirmed that when the patient went to the emergency room, was admitted into the hospital, did lots of tests. Clarified the reason for admission was that the patient could not breathe.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300337361 same patient/vaccine, different doses/event;
Case number PHEH2014US024298 is an initial spontaneous report from a nurse received on 02DEC2014 and with a follow-up from a nurse received on 21JAN2015. This report refers to a 49 year old female patient. Past medical history was not reported. Concomitant medications were none. The patient had tolerated vaccines well in the past. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) intramuscularly into the right deltoid at a dose of 0.5 ml on 05NOV2014. The nurse reported that FLUVIRIN 2014/2015 was stored at 49F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). Follow up received from the nurse on 21JAN2015: updated site of vaccination and reporter comment.
Jittery; Allergic reaction - minor; left sided numbness; shortness of breath; chest pain; blood pressure elevated/ greater than 200; This is a spontaneous report from a contactable consumer (patient) and a physician. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Apr2021 (Batch/Lot Number: EW0172; Expiration Date: Aug2021) as 1st dose, single for Covid-19 immunization. Medical history included lung cancer from Aug2008 (in remission), surgery to remove half of the upper lung (where the cancer mass was and also all of lymph nodes in upper left lung area), and allergies to pollen, bee sting, dust and dust mites. Concomitant medications included levocetirizine dihydrochloride (LEVOCETIRIZIN); losartan potassium; montelukast sodium. On 22Apr2021, the patient experienced jittery (1 hour after vaccination) and allergic reaction - minor, left sided numbness, shortness of breath, and chest pain. EMS was called vitals shown blood pressure elevated and greater than 200. patient was given famotidine (PEPCID) (oral, 20 mg, 2x/day for 3 days), diphenhydramine hydrochloride (BENADRYL) (oral, 25 mg, 1x/day every 6 hours for 5 days) and prednisone (oral, 20 mg, single for 2 days) for these vaccine reactions. Events required visit to Emergency Room. Patient got the vaccine because she was high risk for Covid 19 but now she does not plan on getting the 2nd vaccine for fear it would kill her. The outcome of events was unknown.
itch; gets red; swells; pain all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch), ERYTHEMA (gets red), SWELLING (swells) and MYALGIA (pain all over body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itch), ERYTHEMA (gets red), SWELLING (swells) and MYALGIA (pain all over body). At the time of the report, PRURITUS (itch), ERYTHEMA (gets red), SWELLING (swells) and MYALGIA (pain all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Extremely painful right upper arm, with mild erythema, warmth and marked decreased range of motion.
Patient's husband contacted the pharmacy on 09/25/2021 around 11:15 am and reported that patient was experiencing a rash, itchiness, and redness around injection site. He was referred to contacting the patient's medical doctor for further instruction. He was notified that the pharmacy would be filling out a VAERS.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-OCT-2016, the patient was vaccinated with an expired dose of PEDVAXHIB 0.5 ml, once, intramuscularly, lot # J015437 with an expiration date 09-OCT-2016 (anatomical location was not reported). No adverse effects were reported. Additional information has been requested.
I had EKG on May 1st (Prior to the shots EKGs were always normal). On May 2nd (I had a massage the day prior) when I bent down my head felt fuzzy/weird. (That never happened following a massage) My left arm still has a small sore section near the injection site and a sore spot under my arm (probably a lymph node) please investigate.
pt had sz disorder had sz 4-6 days following immun; t101; MD suspects MMR is responsible; consultation w/MD-neurologist;
urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced URINARY TRACT INFECTION (urinary tract infection). At the time of the report, URINARY TRACT INFECTION (urinary tract infection) outcome was unknown.            no concomitant medications are provided. treatment to the events not reported. patient wants to get the booster on 1-sep-2021.   This case was linked to MOD-2021-302521 (Patient Link).; Sender's Comments: Based on pathophysiology of the event urinary tract infection, the event is assessed as unlikely related to mRNA-1273.
pt recvd vax; pt exp'd nausea, fever, vomiting, diarrhea, a headache, a feeling of hot & cold, & aching muscles;
Second arm felt sore Sunday. Six days later pt states felt tightness around muscle. Pt describes light red circle around muscle 10 day later. Pt also states pain extended down arm and into back and neck. Pt states will see private MD on 11/17/2001 for evaluation. Red circle nickel size around injection site today. Pt took 5 days of Amoxicillin.
reactions 7 days after initial dose; Redness; Fatigue; Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reactions 7 days after initial dose), ERYTHEMA (Redness), FATIGUE (Fatigue) and RASH (Rash) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION COMPLICATION (reactions 7 days after initial dose), ERYTHEMA (Redness), FATIGUE (Fatigue) and RASH (Rash). At the time of the report, VACCINATION COMPLICATION (reactions 7 days after initial dose), ERYTHEMA (Redness), FATIGUE (Fatigue) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: Follow up received on 09-FEB-2021: Phone Number & e-mail of primary reporter, secondary reporter, Report media, Suspect drug-route, date, batch, Patient DOB and events start date were added
Information has been received from a woman working in a physician's office concerning a child who was vaccinated with a dose of Varivax. "Very recently" in 2006, the patient experienced breakthrough chickenpox. It was reported that the child was being boostered. It was also noted that the child was in an unspecified stage of breaking out with lesions. It was reported that the patient's experience was currently ongoing. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a physician indicated that he was aware of the breakthrough of chickenpox at the local school, but had "no idea" about any additional information. Additional information is not expected.
This spontaneous case reported by a consumer, describes the occurrence of myalgia (sore arm) and headaches in a male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. March 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. March 2021, patient experienced myalgia (sore arm). On an unknown date, patient experienced headaches. At the time of the report, myalgia (sore arm) and headaches outcome: unknown. No concomitant medication or treatment information provided. Reporter did not allow further contact.
Admitted to  hospital on 12/24/08 for intussusception; ROTATEQ vaccine was given on 11/3/08.  1/21/09 Reviewed hospital medical records of 12/23-12/24/2008. FINAL DX: Intussusception, enema reduced Records reveal patient experienced irritability, vomiting & bloody diarrhea.  Seen by PCP & dx w/viral gastroenteritis.  Emesis became bilious & bloody diarrhea continued.  Went to ER where IS diagnosed & reduced w/BE.  Admitted overnight for observation, did well & d/c to home.
Sore throat; Some cold; Sneezing; Face swelling; Swelled eyelids; Swelled area around the nose; Fatigue; Arm sore; Pain on injection site; Headache; Some muscle pain on left leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Some cold), SNEEZING (Sneezing) and SWELLING FACE (Face swelling) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included RIZATRIPTAN for Migraine.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), VACCINATION SITE PAIN (Pain on injection site), HEADACHE (Headache) and MYALGIA (Some muscle pain on left leg). On 06-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Some cold), SNEEZING (Sneezing), SWELLING FACE (Face swelling), SWELLING OF EYELID (Swelled eyelids), NASAL OEDEMA (Swelled area around the nose) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 06-Mar-2021 for Headache, at a dose of 600 mg. At the time of the report, PAIN IN EXTREMITY (Arm sore), OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Some cold), SNEEZING (Sneezing), SWELLING FACE (Face swelling), SWELLING OF EYELID (Swelled eyelids), NASAL OEDEMA (Swelled area around the nose), VACCINATION SITE PAIN (Pain on injection site), HEADACHE (Headache), MYALGIA (Some muscle pain on left leg) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I woke up at 4:30 a.m. this morning with chills. I was running a fever and am still extremely nauseated. My body is sore all over.
Patient returned to pharmacy at 12:00 noon stating he felt woozy, slight headache, and unable to drive. I asked him to sit in pharmacy privacy area. I checked his BP 139/83 and pulse 62. I checked the injection sight which was not red, swollen and no hives. His skin was warm to touch but not hot or moist. He denied SOB or tightness in chest. He did complain of slight pain in injection arm. I called Dr. and informed him of reaction. Patient did state he had not eaten since breakfast but did have a peanut butter cup before returning to pharmacy. I gave him a cup of water and he continued to rest for 15 minutes. He stated he felt ready to go home as his wife was driving. I called him at 5:00pm and spoke to his wife who stated he felt better and was outside in his truck. I asked that he call if any other reaction to report.
09/04/22 presents to ED for "abdominal pain". PMHx of "Anemia, Fistula of vagina to small intestine (03/2022), History of blood transfusion (03/2022), Hypertension, Osteoporosis, Ovarian mass, Pneumonia (03/2022), SBO (small bowel obstruction) (CMS/HCC), and Small bowel perforation (CMS/HCC) (03/2022)"
Injection site swelled across several inches, was bright red, painful and itching like a "bad bee sting".
Hive like rash head to toe. Sporadic an arms legs and face confluent or chest.