chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Random smells not associated with environment / Typically a funky smell like body odor; smelly feet; Administration date: 26Nov2021; dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 14:45 (Lot number: FM8030) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Ehlers Danlos Syn" (unspecified if ongoing); "depression" (unspecified if ongoing); "PTSD" (unspecified if ongoing), notes: PTSD; "GAD" (unspecified if ongoing), notes: GAD. Concomitant medication(s) included: PROZAC; GABAPENTIN; TRAZODONE. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Dose Number: 2, Batch/Lot No: ER8737, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 09Apr2021, when the patient was 30 years old, for COVID-19 immunization; Bnt162b2 (Product: COVID 19, Brand: Pfizer, Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 12Mar2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 14:45, outcome "unknown", described as "Administration date: 26Nov2021; dose number: 3"; PAROSMIA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Random smells not associated with environment / Typically a funky smell like body odor"; SKIN ODOUR ABNORMAL (non-serious) with onset 27Nov2021, outcome "not recovered", described as "smelly feet". Therapeutic measures were not taken as a result of parosmia, skin odour abnormal.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Did not reported any allergies. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient received Prozac, gabapentin and trazodone within 2 weeks of vaccination. It was reported that Random smells not associated with environment for several seconds to several minutes (30 min or longer) at each event. At least 100 instances of strange scent experiences in a day. Typically a funky smell like body odor, smelly feet. Seriousness was no.Seriousness criteria-Results in death,Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect was  reported as no.  Follow-Up (07Dec2021): Follow-up attempts are completed. No further information is expected.
Less than 10 minutes after getting the flu vaccine, my entire left side of my head and face went completely numb. It lasted for a few hours. I called the pharmacist, who called another pharmacist. She called me back, and said it was a rare possible side effect.   I do not have the details of the lot # of the vaccine, etc. Here is my appointment information:   Date: 9/24/2021 Time: 1 pm Vaccine: Flu
Day Of vax felt fine. Woke up next day with major headache that lasted 5 days. I suffer from headaches/migraines but this was not that and was the strangest headache I?ve ever experienced.
One day prior to the clinic on 5/18/22, an email was sent to the pharmacy with a list of patients that needed boosters. At the start of the clinic on 5/19/22, copies of vaccine cards for these patients were given to the pharmacy staff. All cards were checked by the pharmacy to ensure eligibility for boosters. Vaccine administration started at 1pm. At approximately 1:20pm, after 14 vaccines were given, the facility alerted the pharmacy that the copies of vaccine cards and emailed list were not up-to-date. After consulting with the facility, who had an updated list of vaccine records, it was determined that six patients were given a booster shot when not eligible. Consulted with the pharmacy team on how to follow-up and proceed with the clinic. Going forward, each patient vaccinated had their records verified on the system and online. Emailed list was cross-checked with the updated list given by the facility. Even with updated list from facility, errors were found with vaccine records not being up-to-date and inconsistencies. Photos of covid vaccination cards were taken for records and vaccination cards were sorted.
pt recv vax 25JUL97 & 2 days later 27JUL97 pt exp h/a & myalgia;17FEB98 pt still noticed retro-orbital h/a on 30JUL97 but no myalgias then;
103 fever x3 weeks, welts developed all over body mostly on the legs but some on abdomen and back - general flu like symptoms
burning in her face, arms and legs; Initial information received on 16-Dec-2020 regarding an unsolicited valid non-serious case received from a patient.  This case involves an 80-year-old female patient who had burning in her face, arms and legs (burning sensation) while she was treated with Influenza Quadrival A-B High Dose Hv Vaccine (FLUZONE HIGH-DOSE QUADRIVALENT).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date in 2012, the patient received a dose of suspect quadrivalent influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose and frequency via unknown route and unknown site for prophylactic vaccination.  On -SEP-2012, (latency unknown) after starting the suspect vaccine therapy, the patient had burning in her face, arms and legs (burning sensation).  No laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
The first day I was sore in the arm. The next day I woke up with uncontrollable vomiting and diarrhea. I also was feeling numbness. After two days I went to the hospital and I was given fluids and was give medications to try to reserve the reactions. This lasted for about four to five days. After about a week I felt better , but felt sore on the right side of my body. The left side of my face had a major droop.
pt recvd vax & had respiratory dis;dx w/ hyperkalemia; sepsis;slight depression on breathing;fussy;gagging;had heaves; difficulty in breathing; was pale;cyanosis;weak pulse & unobtainable BP;grunting in acute respiratory distress;1 100.7;v
complainted itchy rashes over body and discomfort feeling inside the throat three and half hours after receiving immunizations.  Mom gave client Benadryl.  Symptoms resolve at evening per mom on next day phone call.
This case was reported by a healthcare professional and described the occurrence of injection site stinging in a 40-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 14 October 2008 at 11:30, the subject received a dose of FLUARIX (.5 ml, unknown, left arm). On 14 October 2008, immediately after vaccination with FLUARIX, the subject experienced injection site stinging, injection site pruritus and intramuscular formulation administered by other route. The healthcare professional reported that she was vaccinated with FLUARIX via deep subcutaneous injection. She also reported some tissue stinging "that comes and goes" and some itching. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLUARIX.
Developed herpes zoster at vaccine site immediately after injection -- rash with vesicles, pain, tingling.
Chest pains, arrhythmias, and headaches started the day after vaccination. The symptoms continued through the weekend  after the vaccination.
This spontaneous report received from a patient concerned a patient of unspecified age and sex (local case ID# Unknown). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 03-DEC-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced severe side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe side effects was not reported. This report was non-serious. Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Fever, chills, fatigue starting ~4 hrs after 2nd dose. Diarrhea began next morning.
Enable to make sleep headaches ,GI,elevated temp.and extreme fatigue ,rapid heartbeat
caller states she and her husband both had a sore arm for 2 days; This is a spontaneous report from a contactable other hcp. A 71-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 26Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on un specified date (at the age of: 71-years-old) as dose 1, single for covid-19 immunisation. It was reported that the reporter states that she and her husband both had a sore arm for 2 days after the vaccine was administered. She states that she also had a sore arm after her flu shot. She takes B12 injections every 30 days and is wondering if it would be safe for her to take the B12 injections before the vaccine or should she wait. she wanted to know if it's ok to take pain/fever reducing medication after receiving the Pfizer vaccine. Outcome of the events was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223134 same drug/reporter/event, different patient
1wk p/vax pt devel 2 blotches on lt upper arm;the top blotch was 4" x 2" beginning @ the top of shoulder then space w/the bottom blotch 3" x 3" a  little above the elbow;described as bright red & warm to touch;
10 Minutes after received the vaccine, felt like my throat was going to close, like it was hard to swallow.  I started to feel lightheaded and nausea as well.   I broke out in a sweat as well.
Pain in the right upper arm that has since moved into the shoulder and the right shoulder blade. Pain is still there after 2 weeks.
Hospitalized due to weakness, fatigue, dehydration, myalgia, sore throat and cough in the setting of positive COVID-19 (diagnosed 3/21). Uses wheelchair and walker for mobility at home. Due to weakness unable to care for self. Mild COVID-19 (no treatment prescribed). Received monoclonal antibodies 3/23/2022.
Following 1st dose administration of Pfizer vaccine patient was noted to be falling out of chair. Staff was able to catch her. Patient noted to be having involuntary "jerking" motions, diaphoretic, with pupils dilated. Patient assisted to lying position and assessed airway, breathing, and circulation. Staff contacted 911 to assess patient. This nurse spoke with patient sister who states patient does not have a history of seizures or any other medical history. Paramedics arrived and assessed patient. Patient verbal and responsive and able to verbalize name, location and year. Facial redness noted at this time. Airway patent. Patient transferred from cot to stretcher with minimal assistance. Patient transported via EMS to hospital. All patient belonging sent with her via EMS.
Lt arm swollen,T 102, rash @ inject site,ER Dr's Dx: ear infection, tonsillitis & placed pt on ear drops,Tylenol 10Jan91, Lt arm stayed swelled for 7 days,coughed & vomited X 2 days,had general rash 7 days /p inject,tonsills out now per mom
Numbness and tingling sensation in hands and feet. Loss of strength. Pain. Difficulty walking. Diagnosed with Guillain Barre Syndrome. Recieved 5 days of Immunoglobulin therapy.
Ipol was given on 09-Oct-2019, later discovered that it had expired on 05Oct2019, no AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 39 yerars old female patient who was inadvertently vaccinated with an expired dose of IPV (VERO) [IPOL] (frequency once) lot N1J451M, expiry date: 05-Oct-2019 unknown route in the left deltoid on 09-Oct-2019.   The patient's past vaccination(s) included IPOl which she recieved as child.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included TYPHOID VACCINE (TYPHOID VACCINE); and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR).  It is an actual medication error case due to expired vaccine used.  It was reported that Ipol was given as a booster dose for a patient with unknown childhood immunization history, but who stated that she did receive vaccination for polio as a child. The nurse said that she would therefore consider this dose as 3 and the patient was administered on 10/09/2019 with IIPOL that expired 10/05/2019.  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 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.
Information has been received from a healthcare worker concerning her daughter who on an unspecified date was vaccinated with a dose of MMR II. In approximately 1993 ("15 years ago") the patient experienced deafness after receiving MMR II. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. The adverse event, deafness, was considered disabling by the reporter. Additional information has been requested.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210611858, 20210612779 and 20210614876.
A nurse reported that a 47 year old male did not respond to immunization with hepatitis B vaccine recombinant (Engerix-B).  The subject's medical history, concurrent conditions, and concurrent medications were unknown.  The subject received injections of Engerix-B on 08/13/01 (Lot # ENG5179A6), 09/13/01 (Lot # ENG5179A6) and 02/01/02 (Lot # ENG5255D6).  An unspecified titer measured on 05/28/02 was "negative".  The subject then received another series of Engerix-B on 06/19/02 (Lot # ENG5260A6), 08/22/02 (ENG5257A4), and 01/30/03 (Lot # ENG5305C6).  An unspecified titer measured in "late" March 2003 was again "negative".
Breakthrough COVID-19 case; hospitalization at Hospital 9/2/2021 for unknown duration
Mom states child with father at 6 PM child was OK on 9/5/12 on 9/6/12 10 AM father noticed red area & rash at site of KINRIX that PM had vomiting / fever on 9/7/12 child was OK redness of arm only.
BODY ACHES; COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET; COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET; MUSCLE ACHES; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (BODY ACHES), RASH PRURITIC (COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET), BURNING SENSATION (COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET), MYALGIA (MUSCLE ACHES) and PYREXIA (FEVER) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (BODY ACHES), RASH PRURITIC (COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET), BURNING SENSATION (COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET), MYALGIA (MUSCLE ACHES) and PYREXIA (FEVER). At the time of the report, PAIN (BODY ACHES), RASH PRURITIC (COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET), BURNING SENSATION (COVERED IN ITCHY BURNING RASH ON HAND ARM AND FEET), MYALGIA (MUSCLE ACHES) and PYREXIA (FEVER) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Right arm and hand are feeling weak, hurts to lift,complains of pain at the site of injection to just below the elbow on the right arm. Pain when lifting. Has seen PMD who reports grips are equal.
Patient fainted approx 10 minutes post vaccination, he was unresponsive for approx 30 seconds, awoke slightly confused.  We elevated feet and applied ice pack to back of neck.  we called 911, arrived within 3-5 minutes, they took over and transported pt out of store
Narrative:  Wife reported that patient passed away in sleep at his house on 04/17/2022. Patient received EUA J&J COVID vaccination on 04/01/2021 and a Moderna booster 0.25 ml (11/18/2021). Patient called the triage nurse on 04/08/2022, one week prior to death, with complaints of loose stools, bowel urgency, and vomiting. Patient noted that since ankle surgery at Hospital on 03/15/2021, he has had intermittent LE swelling, and the swelling was also notable with the GI symptoms. Patient missed group therapy session and wife reported his death.
A report has been received from a nurse practitioner, concerning a 32 year old, female patient. The patient's medical  history, concurrent diseases and concomitant medications has not been reported. The patient received nasal FLUMIST on 16-NOV-2012. She received full dose in one nostril. The outcome of the event of full dose in one nostril was unknown. The report was considered to be non-serious by company physician. Corrected report on 14-APR-2014: occupation added for first reporter; reporter order corrected: occupation deleted from patient, action taken and de/rechallenge set to not applicable. associated cas ID added; narrative updated. The case has been updated with full data due to KUR term additions for FLUMIST/Q/Laiv.
arm got sore in the spot of the injection; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm got sore in the spot of the injection) and DIARRHOEA (diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm got sore in the spot of the injection) and DIARRHOEA (diarrhea). At the time of the report, VACCINATION SITE PAIN (arm got sore in the spot of the injection) and DIARRHOEA (diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications reported. no treatment details reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Followup received on 28-apr-2021. Second dose was taken. Events outcome were updated
This is a spontaneous report from a contactable Health Care Professional (medical assistant) who was calling on behalf of a physician. A 62-year-old female patient received, on 30Jan2015 at 08:52 in the morning, the first dose of PREVNAR 13 (Lot. J20346, Expiration Date: 31May2016) intramuscular on left arm, 0.5 ml, single dose. The medical assistant mentioned tat the patient received PREVNAR 13 because her medical history included chronic cardiac disease, chronic pulmonary disease, renal disorder, diabetes, chronic liver disease. The medical assistant mentioned that no other vaccines was given four weeks prior to the day of suspected vaccine. On an unspecified date (in 2015), the patient experienced rash, swelling redness, itching and tenderness at the site of injection. The medical assistant mentioned that no emergency room visit was required. Clinical outcome of the events was unknown at time of this report.
About 1 hour post flu shot administration, patient experienced hot sensation starting from injection site radiating throughout the rest of the body. Other symptoms included blurry vision, eye pain, severe headache, nausea, upset stomach, diarrhea. BP elevated to 174/105.
Hospitalized 01/28/2022; COVID-19 positive 01/28/2022; fully vaccinated  Discharge Provider: MD Primary Care Provider : MD   Admission Date: 1/28/2022 Admitting Diagnoses: Pyelonephritis Discharge Date: 1/31/2022 Details of Hospital Stay PRESENTING PROBLEM: Pyelonephritis   HOSPITAL COURSE: Patient is a 47 y.o. female with a past medical history significant for TIA who presented with left sided flank pain. The patient under a CT abdomen/pelvis which showed cystitis and left sided pyelonephritis as well as hepatic steatosis. The patient was started on ceftriaxone. Urine cultures grew e coli that is pan sensitive. Secondary to allergy to cipro the patient is being discharged on cefdinir to complete a total of 14 days of antibiotics. The patient is instructed to continue tylenol for pain management.    The patient also presented with COVID, her symptom onset was 1/24 with a positive at home test 1/25. The patient is vaccinated but not boosted. She has a known close contact. She mostly had upper respiratory symptoms and remained on room air. Because of this the patient was not started on steroids or remdesivir. Inflammatory markers were trended and with a mildly up trending ddimer the patient will be placed on eliquis 2.5mg PO bid for five days to continue to act as a prophylactic while the patient is in the acute phase of infection and risk for blood clot. Presently the patient does not show signs or symptoms of a PE or DVT.  The patient remained hemodynamically stable at time of discharge. All questions were answered. She should follow up with her PCP in 5-7 days for post hospitalization follow
pt recv vax 3JUN96 & during 4mo well check pt seemed fine per mom until 1AM 4JUN96 when pt woke w/t104-104.5, fussy;fever dec w/APAP;pt went to daycare w/low grade fever cont to be fussy;5JUN96 pt is fine w/o any ill sx