chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu vaccine administered approximate 15 min prior to 12N on 10/24/12. Client returned to nurse reporting his right arm sore at injection site. Assessed area noted redness out 3 inch diameter from injection. At 3pm returned the site was red, hot with induration and soreness. No difficulty breathing or other complaints.
Headache, light headed, stomach ache. Felt like I might faint and vomit. Headache started a little later
Following injection I had a red spot in my arm, yesterday (1/16/21) I noticed the spot had increased in size, about 5 inches long, 2 inches wide. The spot was hot to touch and began to itch. A knot was felt at the end of the mark, 5 inches from injection site.
Intussusception: Taken to the ER due to screaming pain that was not subsiding. The ER diagnosed her with intussusception that was determined using an ultrasound machine. Around two hours later a follow up ultrasound was performed, and it was determined the intussusception had a spontaneous reduction. After an overnight stay to be monitored, she was released the following evening after an additional ultrasound showed the intussusception had a spontaneous reduction.
3 year old girl came into ED -Emergency Department on 9/1/19 due to right upper thigh swelling and redness for the past 3 days.  Prior to coming into our ED, the girl was also seen in urgent care  for the same swelling and started on antibiotic- Cephalexin.   Mother stated that her daughter received flu vaccination in pediatrician's office 3 days ago (on 8/29/19).      Swelling involved anterior right thigh, circle of erythema, and additional symptoms also include abdominal pain. Patient was admitted to our pediatric unit for IV antibiotic and close observation.    Patient rec'd IV fluid,  Rocephin IVPB,  oral Benadryl,    Patient discharged the following day on 9/2/19  and to follow up with her pediatrician Dr.
9 inch diameter redness w/blisters filled w/clear fluid. Started 7/28 and went to ER on 7/30 - given 1gm of ROCEPHIN IM. Then ROCEPHIN 1gm on 7/31. Also on oral antibiotics.
Spoke to patient's mom, Patience, to provide a routine follow-up consultation for patient's Humira, but mom was very frustrated and began inquiring why a prescription would be given to her son that would cause him to have high blood pressure.  Mom noted that her son was perfectly normal before and never had any blood pressure issues, but now his blood pressure is very high, his heart is racing, and he has occasional headaches.  Patient began taking Humira 1/29/21 and did well on the first few doses, but later in May 2021, mom noticed that patient?s heart was racing when he came to her bed to give her a hug after school one day.  Mom checked his pulse the next day and again noted it was racing, so she checked his blood pressure, which was 175/80.  Mom continued to take multiple readings daily and continued to get high and similar readings.  Mom took patient to MD, who noted that EKG looked okay and referred her to take her son to a Cardiologist.  Mom is distraught wondering if there is another medication that GI doctor can give patient since he never had high blood pressure before and it?s ?not okay? for this to be happening to her son and does not understand what has caused him to now have high blood pressure and heart problems.  After further questioning about medical history, mom noted that patient received the COVID-19 vaccinations at school and began having the heart and high blood pressure symptoms about two weeks following the first dose.
This spontaneous prospective pregnancy report as received from a registered nurse refers to a 28 year old female patient without drug allergies. On 02-SEP-2014 the patient was vaccinated with GARDASIL, dose 4 (dose, lot # and route of administration were not reported). There was no concomitant medication. The patient became pregnant with last menstrual period (LMP) of 08-FEB-2014 and estimated date of delivery (EDD) of 15-NOV-2014. Initial exposure to GARDASIL was at 29 week(s). The pregnancy outcome was outcome pending. It was reported that on 02-SEP-2014 the pregnant patient received GARDASIL during pregnancy instead of Tdap. On 02-SEP-2014 the patient received Tdap after it was realized that patient received GARDASIL instead of Tdap on the same day (02-SEP-2014). The patient stated that she completed a 3 doses series of GARDASIL on specified dates in 2008. The patient did not receive any treatment. There were not laboratory diagnostics performed. No adverse effects were reported. Additional information has been requested.
Myalgia, Fever, NauseaVomiting, Arm soreness, fatigue, chills, mental "fog" Narrative:  Arm soreness, fatigue, chills, mental "fog", fever, myalgia, nausea; some relief with Tylenol
Received 1st dose Pfizer-BioNTech vaccine Lot EN9899 exp 03/2021 on 01/18/2021 during CVS onsite clinic for Assisted Living Facility. Received 2nd dose Pfizer-BioNTech vaccine Lot EN5318 Exp 05/2021 on 02/08/2021 during CVS onsite clinic for Assisted Living Facility.  On 02/10/2021 during routine employment screening, tested positive for COVID-19. On 02/12/2021 reported generalized malaise, otherwise denied symptoms.  On 02/21/2021 employer notified by family friend that patient was treated at Medical Center on 02/20/2021 secondary to sudden onset difficulty swallowing, impaired speech, and facial droop. Employer later notified patient was then admitted to the ICU at aforementioned hospital secondary to dx of CVA.
Atrial Fibrillation; Low WBC; Low RBC; Low Neutrophils/Low Neutrophils Absolute; High Monocytes; This is a spontaneous report from a non-contactable consumer (patient). A 75-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on Feb2021 (Lot Number: EP6955) as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on Feb2021 at 13:00 (Lot Number: en6198) as single dose for covid-19 immunization. On 30Mar2021, the patient experienced atrial fibrillation, low white blood cell (WBC), low Red blood cell (RBC), low neutrophils, high monocytes, low neutrophils absolute. The events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
During the patient's admission to the hospital on 04/15/2011 she received PNEUMOVAX, 0.5 mL in left deltoid, and was discharged without complications. On 05/01/2011 she was admitted to the hospital and began intravenous vancomycin hydrochloride to treat the presence of enterococcal bacteremia. She was then discharged on 05/06/2011 with a PICC line. On 05/11/2011, she woke up with blisters present on her left arm at the PNEUMOVAX site and in her mouth.
Large amnt of swelling, redness and pain in right deltoid area where shot was administered.
vaccination failure; mumps parotitis; This literature marketed report has been received from authors of published article. The incidence of parotitis and mumps in children was increasing nationwide. Retrospective chart reviews were conducted using ICD9/10-codes for parotitis and mumps from January 2007 to December 2017. Data on demographics, vaccination status, labs, management and disposition were collected. The patients had mumps immunoglobulin (IgM) and/or buccal swab for mumps reverse transcription polymerase chain reaction (RT-PCR) or viral culture to test mumps. 1017 parotitis cases were diagnosed, an upward trend in incidence occurred over time. Of the 1017 children with parotitis evaluated over the decade in the Healthcare  emergency departments (EDs), 47 (4.6%) were tested for mumps and 9 (19%) of those tested were positive for mumps either by serology and/or PCR. Five of those cases were considered probable mumps and 4 were confirmed mumps. Of the 9 patients identified with probable or confirmed mumps, 7 (78%) were fully immunized, one was incompletely immunized (one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)) and 1 child was unvaccinated. The most likely explanation for mumps cases in previously immunized persons may be secondary vaccine failure, or waning immunity.  This report referring to a 7 years old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On unknown dates, the patient was vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose detial, route, lot #, expiration date and anatomical location were not provided).   In 2014, the patient was tested mumps IgM. The results were postive for mumps at right site. It was cnsidered probable mumps parotitis. On an unknown date, the patient experienced vaccination failure. The outcome of the events was unknown. The reporter considered the events to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown).  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-2011USA009173:
sx 6/20/22  ,to hosp 7/12/22 found unresponsive in his car at a medical center where he works.  CPR initiated, ems called.  VFIB on arrival. ACLS drugs given including epi, lidocaine, amiodarone  and failed to have ROSC.  Deceased 7-12-22.
Tenderness, localized edema/ erythema approx. 8cm, decreased ROM, warm to touch.
Breakthrough case admission after 2 vaccines Moderna 3/26/21 Lot# 030A21A;  Moderna 4/13/21 Lot# 025B21A
My son passed away on October 30, 2002 approxiametly one month after the second Hepatitis B shot was administered.  He died from a subdural hematoma with out any other evidence of trauma or stroke activity.  My son did display some of the reactions such as low birth weight, prematurity, high blood pressure during pregnancy, labor induction, jaundice, constipation, cold without fever, projectial vomitting.  I was also involved in a car accident four weeks prior to delievery and had some loss of ambiotic fluid associated with the accident.  We had also talked to his pediatrician regarding his hard, clay like stool and he was constipated two days prior to his death. Follow up per autopsy report: Subdural hematoma, abusive head trauma.
This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (more intense reactions) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (more intense reactions). At the time of the report, ADVERSE EVENT (more intense reactions) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD21-033420, MOD21-033319 (E2B Linked Report).; Sender's Comments: MOD21-033420:cross link; MOD21-033319:crosslink.
6 hours post-injection, developed severe chills, dizziness, light-headedness, weakness, headache - to the extent walking across the room was a challenge!  Not sure exactly which quadrivalent I got - who does???
Local inflammatory reaction - no cellulitis.  Treatment: ice, MOTRIN, elevation, recheck 48 hrs.
fever, extreme irritability & sl cough beginning same day as vax 20SEP95; sxs persisted 4 days; adm to hosp 23SEP95;
Patient developed nausea & vomiting the evening of 10/3/22 after receiving COVID booster and flu vaccine earlier that day. He developed chills, weakness, chills, & increasing lethargy over the next 2-3 days, and presented to ER on 10/6/22 where he was diagnosed with severe sepsis, pneumonia, UTI, acute-on-chronic renal insufficiency, & acute hypoxic respiratory failure requiring supplemental O2 by nasal cannula.  He was admitted to the hospital, treated with iv antibiotics & fluids.  He ultimately recovered and was discharged to nursing facility, after a 22-day hospitalization (made prolonged by unrelated urological issues).
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (on an unknown date received 1st dose). On 5th February 2019, the patient received the 2nd dose of SHINGRIX. On 5th February 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient reported had received the 2nd dose of SHINGRIX 5 days past his six month period and experienced soreness at the injection site on his left arm. The reporter consented to follow up.
Administration of only the liquid component; Administration of only the liquid component; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 7th February 2022, the patient received Menveo. On 7th February 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient was inadvertently administrated only the liquid component of (MenCWY) of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No patients identifiers were provided.  No lot number or expiration date was provided. The Vaccine administration facility was the same as Primary reporter. The reporter did not consent to follow up.
3NOV92 10PM t102 R-onset vomiting & diarrhea; 4NOV92 945AM t103 R, vomiting & diarrhea cont called clinic-advised take to Er; adm for fever & dehydration;
swelling with hives, started next day after the shot. Seen 11/11/2021 in the office giver orapred for four days. Follow up next day hives resolved and swelling of left thigh decreased.
Arm swelled, felt real hot, itched. Dr recommended Benadryl. Took till 01/20/2005.
Patient's partner reporting patient is having difficulty with movement 1 day post vaccination. She explains that although patient is limited he is able to move and stand, walk. However, today patient unable to do that. Is having difficulty with movement and is very weak.
Red unraised spots to arms, legs back, buttocks, and stomach. Swelling to Right knee with pain.  Bruising to legs Right knee and right foot.
On 7/21/10 Pt was given Tdap shot in RA deltoid. After shot pt felt warm, face got flush then turned pale BP  at that time was 130/74. Shot given at 1:15 pm. Pt never lost awareness of surrounds and was able to respond. Fanned pt and she began to gain color. After 10 mins escorted to bathroom and tolerated walk well. Then rechecked BP at 1:45pm 110/70. Pt report feeling well. After leaving office felt rush again and then referred to minor med.
w/in a day of receiving 2nd DTP pt started w/an upper resp infect which resulted in a gaggy cough, choking spells & inspiratory noise (whoop) w/cough; pt required hospitalization;
Fever - lasting one week, large, hard lump at injection site - severe swelling of arm, soreness, redness from shoulder to elbow, two large red blisters at injection site.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  An 84-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EL3249), in right arm and on 10Feb2021 as dose 2, single (Lot number: EM9810) at the age of 82 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Congestive heart failure" (unspecified if ongoing), notes: .; "Coronary artery disease." (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Aug2019; METOPROLOL, start date: 01Aug2019; PROTONIX [OMEPRAZOLE]; ATORVASTATIN; ESCITALOPRAM; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had other medication in 2weeks. The patient had COVID 19 Treatment with paxlovid, Treatment start date was 13Dec2022, Treatment start date was 15Dec2022. The patient had no known allergies. No known allergies.
Hollow of heat behind her head; Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Hollow of heat behind her head) and VACCINATION SITE PAIN (Soreness of arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEAD DISCOMFORT (Hollow of heat behind her head) and VACCINATION SITE PAIN (Soreness of arm). On 04-Feb-2021, HEAD DISCOMFORT (Hollow of heat behind her head) and VACCINATION SITE PAIN (Soreness of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a physician concerning a 5 year old female who on 24-JAN-2012 was vaccinated with a dose of MMR II (Lot#, dose and route not reported). Secondary suspect therapy included VARIVAX (Lot#, dose and route not reported) and influenza vaccine (manufacturer unknown). At the time of vaccination (prior to administration) the patient complained of dysuria and was found to have hematuria on urine analysis. Patient was given KEFLEX on 24-JAN-2012 ("the same day") for presumptive urinary tract infection (UTI). Urine culture was negative and KEFLEX discontinued after 4 days. On approximately 29-JAN-2012 ("about 5 days after vaccination") the patient experienced fever and the patient experienced red maculopapular rash on 31-JAN-2012 ("about 7 days after vaccination"). The patient also had exudative pharyngitis, palpebral conjunctival injection. Renal ultrasound, liver and renal function test and renal ultrasound were normal. C-reactive protein and red blood cell sedimentation rate elevated. The patient was hospitalized on approximately 01-FEB-2012 and remained hospitalized on the time of report. Additional information has been requested.
Administration error:  patient received the 2nd Moderna dose too soon.  Patient arrived at our drive-thru vaccine clinic.  The vaccine was administered before the staff was able to properly check the patient into the computer and validate 1st dose timing.  No adverse effects were noted.  Per cdc guidance, 2nd dose will be considered valid.
Immediately after receiving second shot individual's arm became sore and has been constantly sore since the injection
the patient experienced no symptoms; shipment of PNEUMOVAX 23 was dueto be delivered on 2/26/2020 but was not delivered until 2/27/2020; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. This case concerns 1 patient and 1 combination product. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 10-MAR-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029542, expiration date 10-JUN-2021 (dose and route of administration were not reported) for prophylaxis that was due to be delivered on 26-FEB-2020, but the vaccine was not delivered until 27-FEB-2020. The patient experienced no symptoms.
At 8:35 AM Pacific Time on 1/6/2021, I removed my long-sleeve shirt and noticed redness and swelling on my upper left arm.  This is the site where I received my first dose of the COVID19 (Moderna) vaccine.  This is the first time seeing any redness and swelling on the injection site.   Before experiencing redness, swelling and slight warm feeling on my upper left arm, I only experienced mild pain and soreness.  Mild pain and soreness went away on 1/5/2021.  In addition to redness and swelling, my upper left arm feels slightly warm.   After taking a shower, I made sure to not put any lotion on my upper left arm.   I got dressed, and I took one tablet of Diphenhydramine HCl 25 mg to help reduce redness and swelling.  I went to bed at approximately 10:50 AM.  I woke up at approximately 6:50 PM and checked my upper left arm.   The redness and swelling went down on my upper left arm, but it still feels slightly warm.  I will continue to monitor it for the next several days.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 23-APR-2018, 25-JUN-2018 and 29-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N024295 and expiration date 24-MAR-2019; lot# N028258 and expiration date 30-MAY-2019; lot# N030175 and expiration date 16-JUN-2019) orally for prophylaxis, respectively. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Fever of 102 degrees, arm pain, swelling in arm, back pain, muscle pain, headache
Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No Adverse Event (No reported medical history).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.; Sender's Comments: Based on reporter's causality (and any other explanation worth adding) the event is assessed as unlikely related to mRNA-1273.