chrisvoncsefalvay/vaers-outcomes huggingface dataset:
general malaise; All experienced similar symptoms, primarily the next day, including injection site soreness; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (general malaise), VACCINATION SITE PAIN (All experienced similar symptoms, primarily the next day, including injection site soreness) and FATIGUE (fatigue) in a 16-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On 04-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 05-Nov-2023, the patient experienced MALAISE (general malaise), VACCINATION SITE PAIN (All experienced similar symptoms, primarily the next day, including injection site soreness) and FATIGUE (fatigue). At the time of the report, MALAISE (general malaise), VACCINATION SITE PAIN (All experienced similar symptoms, primarily the next day, including injection site soreness) and FATIGUE (fatigue) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  Patient was vaccinated with COVID booster 2023 on 04-Nov-2023 and received a Flu vaccine at the same time.    Primarily the next day experienced injection site soreness, fatigue and general malaise. All symptoms were resolved within the following 24-48 hours.  It was reported that administered at a pharmacy without a treating physician.  Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-749068, US-MODERNATX, INC.-MOD-2023-749070, US-MODERNATX, INC.-MOD-2023-749071 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749068:Same Reporter  US-MODERNATX, INC.-MOD-2023-749070:Same reporter  US-MODERNATX, INC.-MOD-2023-749071:Same reporter
Patient was on continuous TPN and preparing for discharge before she developed COVID-19 pneumonia, started to have acute respiratory failure with MRSA bacteremia. Patient started on IV vancomycin and cefepime and then switched to IV daptomycin. Patient started on IV Decadron with continuous AVAPS and anti-bowel treatment but the patient's condition continued to be deteriorating. The patient was on continuous AVAPS and the family opted for the patient to be on DNR comfort and started on comfort medications on 1/19/2022.
I26.99 ACUTE PULMONARY EMBOLISM 5/24/2022 HX OF COLON CANCER I26.99 ACUTE PULMONARY EMBOLISM 5/24/2022 ATHEROSCLEROSIS OF AORTA
10/20/14 Injection given slowly in the left deltoid approx. 3.6 in below the acromion process. Patient does not have a thin arm. No pain noted at the time but soreness did develop at the injection site within hours. Five hours following the injection pain extended to the entire arm. The following AM (10/21/14) noted loss of most mobility of arm. Following days continued lack of movement and guarding of the arm. At this time also noted a jelly/numbness feeling in thigh muscles, this has since resolved. 11/18/14-Visited the ER x 1 due to left arm pain and limited mobility. The patient has tried shoulder acupuncture, multiple massages, laser treatment to relieve discomfort and promote mobility. Currently she is receiving OT ROM and strength has improved but notes decreased ROM when not participating in routine OT. Patient has had MRI (attached) and pain mgt consult.
Patient was given her 2nd Moderna vaccine 7 days before the recommended time between the 1st and 2nd dose.
The vaccine was not mixed, only the adjuvant suspension component was administered to the patient. Patient did not experience any adverse symptoms. Patient was made aware.
Sensation of globus (lump in throat) within 10 minutes of receiving HPV#1, Meningococcal, and TdaP.
3 days sustained fever over 102, cardiac arrest Thursday night, back & chest pain, vomiting, difficulty breathing. Went to ER, admitted to ICU, currently in ICU at hospital.
The vaccine was administered too high in her arm/deltoid.  It was near the bursa and may have been injected in the joint.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Information has been received from a Medical Assistant concerning a 58 year old patient who on an unknown date, was vaccinated with a dose of ZOSTAVAX (Merck) that had expired. It was unknown if the patient sought medical attention. Follow up information has been received from a Nurse Practitioner (N.P.) concerning the 58 year old male patient with stage 4 prostate cancer who on 10-OCT-2011 was vaccinated subcutaneously with a 0.65mL dose of ZOSTAVAX (Merck) (lot # 664319/0562Y) that had expired on 17-OCT-2010. The nurse reported that ordinarily, she would not give the ZOSTAVAX (Merck) to this patient, but the patient stated that his oncologist recommended the flu vaccine and ZOSTAVAX (Merck) vaccine. The day after ZOSTAVAX (Merck) was administered, he was vomiting a lot. He was admitted to the hospital for fluids because of the vomiting. At the time of the report, outcome of vomiting was unknown. Additional information has been requested.
UrticariaPruritus Narrative: Developed scattered pruritus over b/l lower extremities and b/l forearms. No associated rash, scratched until petechiae developed. Not described as hot, swollen, sloughing. No hives or swelling. Stated 2 days after vaccination and lasted for another 1-2 days. Took unknown OTC allergy medication. No other adverse effects noted.
Chills, fever (100.1) Saturday, November 3, 2007 2:00pm rash on buttocks Sunday, November 4, 2007 9:00am (at October 27 injection site) low grade temperature (99.7) Sunday, November 4, 2007 9:00am and aches worsening rash on buttocks - Monday, November 5 and Tuesday, November 6 Took aspirin and Tylenol Saturday - Monday.
After 5-10  minutes, experienced tightness and burning in arm; after 15 minutes, inflammation began and heat was radiating off of arm, the doctor massaged arm to distribute medication and discharged me (patient). After 45 minutes entire left arm and hand was swollen, a small knot had developed at the injection site and I had a fever of 99.7 F with profuse sweating. I called the Clinic and was advised to take Tylenol. Over night, temperature increased to 101 F and stayed for the next 24+ hours, 100 mg Tylenol was taken every 6 hours. 72 hours after the injection, I still had a low grade fever and inflammation in my arm.
Immediately following injection the patient stated he was going to pass out. He lost consciousness for approximately 30 seconds. He was confused and disoriented for a few minutes. Radial pulse was present and regular at 66, O2 sat was 96% on room air, BP was 118/77. Skin was warm and diaphoretic. He was monitored for 30 minutes in Observation area. He refused offer of EMS transport, When he left the clinic he was alert and oriented with no complaints.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 26-SEP-2014 the patient was vaccinated with improperly stored PNEUMOVAX 23 (strength, route not reported). The reporter mentioned that temperature excursion involved was found to be an unsupported excursion with in-house stability data. No adverse symptoms reported. The outcome of administered improperly stored PNEUMOVAX and no adverse symptoms reported is unknown. No product quality complaint was involved. This case is linked to the case 1410USA001798 via same reporter link. Additional information has been requested.
Heavy, irregular menstrual cycle; Heavy, irregular menstrual cycle; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 22Apr2021 at 17:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity and bee venom allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included phentermine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 09May2021, the patient experienced heavy, irregular menstrual cycle. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heavy, irregular menstrual cycle were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
No further AE information available.; Caller reporting AE for PROQUAD. Caller states a dose was given today (1/11/2021) that expired on 1/5/2021.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 11-JAN-2021, the patient was vaccinated with an expired dose (expired product administered) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter (ml), as prophylaxis (formulation, strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported, lot number S021328 which has been verified to be valid, expiration date reported and validated as 05-JAN-2021). There was no previous temperature excursion reported. No additional adverse events were reported.
4NOV93 generalized rash large red spots-fever; 5NOV93 cont w/rash-fades & appears periodicly; rash described as hives; ER MD found ear infect;
pt recvd flu vax on 15OCT93; 18OCT93 devel a localized fever in one breast, accompanied by soreness & hardness;
This case was reported by a healthcare professional, via another manufacturer, and described the occurrence of stomach pain in a child subject of unspecified gender who was vaccinated with Dtap (with small D + P), manufacturer unspecified, Menactra. On an unspecified date, the subject received unspecified dose of Dtap (with small D + P) (unknown, unknown arm) and unspecified dose of Menactra (unknown, unknown arm). Two seconds after vaccination with Dtap (with small D + P) and Menactra in the same arm, the subject experienced sharp, burning stomach pain. According to the reporter, four other child subject's experienced the same event (sharp, burning stomach pain) two seconds after administration of Dtap (with small D + P) and Menactra in the same arm (see case id's A0887425A, A0887433A, A0887434A, and A0887436A for the other child subjects reports). After the 5th patient complained, the vaccinations were administered in separate arms and there were no further adverse reactions. At the time of reporting the outcome of the event was unspecified.
light-headedness for about an hour after the injection; woke in the middle of the night with body aches; This is a spontaneous report from a non-contactable other health professional. An adult patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:EM9899) on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced light-headedness for about an hour after the injection on an unspecified date. It was also reported that the patient woke in the middle of the night with body aches on an unspecified date. The patient was treated with ibuprofen (ADVIL) for the events reported. Outcome of events recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Vomiting; dry heaves; difficulty breathing; weakness; shaking; headache; chills; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 18May2021 13:00 (Lot number unknown as not available/provided to reporter at the time of report completion) as 2ND DOSE, SINGLE DOSE for covid-19 immunization, at facility as "pharmacy or drug store".  The patient's medical history included High Blood pressure (BP), Chronic obstructive pulmonary disease (COPD), Prior history of stroke (not ongoing). The patient was diagnosed with COVID-19 prior to vaccination (not further specified). There was no known allergies. Concomitant medications (other medications received within 2 weeks of vaccination) included lisinopril, nicotine pills, blood thinners, and inhaler for COPD. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of bnt162b2 intramuscular on 27Apr2021 (at the age of 70-year-old) (Lot number unknown as not available/provided to reporter at the time of report completion) for covid-19 immunization. On 19May2021 13:00, the patient experienced Vomiting and dry heaves, difficulty breathing, weakness, shaking, headache, chills. Per the patient, the events were serious as requiring hospitalization. No resulting in death, life threatening, disabling/incapacitating, nor congenital anomaly/birth defect. The events resulted in Emergency room/department or urgent care visit. The patient was not sure if treatment was received for the events. The outcome of the events was recovering. It was unknown if the patient has been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; Information about batch number cannot be obtained.
Initial report received from a healthcare professional on 09 October 2012. The patient (No information about number of patient), whose age, gender, medical history and concomitant medications were not reported, had received intradermal dose of FLUZONE intradermal vaccine (lot number: UT4467BA, site of vaccination was not reported) on an unspecified date. It was reported that, the patient experiences soreness, redness and swelling up to 1 week after injection, date was not reported. It was also reported the physicians' here in office no longer want to administer the intradermal due to the side effects and patient complaints. The patient corrective treatment and lab detail were not reported. The patient's outcome was not reported. List of documents held by sender: None.
Rash developed, some that were vesicular in nature, within a few days of vaccine.  When I saw the patient, no vesicles were present, just small papules.
Vet was administered 0.5ml of Moderna dose instead of 0.25ml.    PCP and Veteran were made aware. Vet was monitored for ~45 minutes. V/S 15 min post injection 136/59 HR 47 RR 18 Temp 97.8 SP02 98%. ......30 minutes post injection 133/56 HR 50, RR 18, Temp 97.9, SP02 98%. Vet has no complaints. No distress noted. States "I feel fine".
neck pain, gran-mal seizure. Convulsions for 5 minutes or more.
Patient states she woke up at her usual time and on the way to the kitchen blacked out.  She woke up and crawled to the kitchen then blacked out and and peed herself.
Heart started feeling like it was racing on Friday night and has not stopped since.; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old non-pregnant female patient received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in right arm on 23Mar2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The medical history and concomitant medications were reported as no. The patient was not aware if she had any allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. On 26Mar2021, at 21:00, the patient had experienced heart racing. The patient reported that she had the vaccine on Tuesday and her heart started feeling like it was racing on Friday night and had not stopped since. No treatment was received for the adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of heart racing was not recovered at the time of report.   No follow-up attempts are needed; No further information is expected.
Cough started 2 days before vaccination but now more in her a day after vaccination, it got worse; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough started 2 days before vaccination but now more in her a day after vaccination, it got worse) and OROPHARYNGEAL PAIN (Sore throat) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.  The patient's past medical history included Cough since an unknown date.  On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced COUGH (Cough started 2 days before vaccination but now more in her a day after vaccination, it got worse) and OROPHARYNGEAL PAIN (Sore throat). The patient was treated with SILVER (COLLOIDAL SILVER) for Cough, at an unspecified dose and frequency. At the time of the report, COUGH (Cough started 2 days before vaccination but now more in her a day after vaccination, it got worse) and OROPHARYNGEAL PAIN (Sore throat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
This case was reported by a nurse via sales rep and described the occurrence of laceration in a adult patient who received ROTARIX lyophilized formulation (batch number A41CB558A, expiry date 5th September 2017) and (batch number A41CB573A, expiry date 17th October 2017). This case was associated with a product complaint. On an unknown date, the patient received ROTARIX lyophilized formulation. On an unknown date, the dose was an unknown dose. On an unknown date, immediately after receiving ROTARIX lyophilized formulation, the patient experienced laceration and pharmaceutical product complaint. On an unknown date, the outcome of the laceration and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the laceration to be related to ROTARIX lyophilized formulation. Additional details were reported as follows: The age at vaccination was not reported. The first incidence involves vial breaking when transfer adaptor attached (during preparation of vial). The other three incidences involve vials snapping at the neck when cap is removed (during preparation of vials). It was confirmed that no product given to the patients. As per GlaxoSmithKline employee, package condition not damaged or open. It was unknown who opened the box. Medical Assistants administered product, unknown if experienced. It was unknown how stored. It was unknown if purchased directly from GlaxoSmithKline. It was unknown if carton was damaged, unknown if leakage was there in carton, unknown if glass pieces were till in vial, unknown if holes or pieces missing from vial and it was unknown if med still in vial. It was attempted to reach out to health care professional for further details. Voicemail was left with serial number. It was unknown if product was available for return, unknown if credit needed. It was unable to verify lot numbers. One of the staff members experienced the product exploding in face and got into eyes. It was unknown which of the four incidences is related to this adverse event. This case was linked to case US2017130511 and US2017130509, reported by the same reporter.
Inadvertently administered Menactra-Meningitis and Gardasil HPV to 7 year old - supposed to have been given to 15 year old. No immediate reaction. Pediatrician informed mother of error. Tylenol prescribed along with allergy medication. After visit summary provided with summary of all immunizations given on date of service.
Extreme swelling and erythema at vaccination site, mild pain, multiple episodes of diarrhea.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA057733 (CLUSTER) and 2023SA057309 (CLUSTER).  This case involves a child of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.   Action taken: Not applicable.  Outcome:  Unknown for both the reported events.  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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
At around 12:50, patient was seen on the ground in front of chair he was sitting in. Got patient back into chair and said he felt light headed, his vision "got all weird," he was very warm, clamey and nauseous. Gave patient a bottle of water and encouraged him to have a snack that we keep on hand and he declined.