chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine was kept in refrigerator/HCP did not know but states that vaccines are usually put in refrigerator a week before administration; No adverse event; Expired vaccine administered to patients; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients), PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator/HCP did not know but states that vaccines are usually put in refrigerator a week before administration) and NO ADVERSE EVENT (No adverse event) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator/HCP did not know but states that vaccines are usually put in refrigerator a week before administration) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients), PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator/HCP did not know but states that vaccines are usually put in refrigerator a week before administration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients) and PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator/HCP did not know but states that vaccines are usually put in refrigerator a week before administration).    No concomitant drug was reported. It was reported that patient was administered to 7 patients past the expiration date, from Moderna lot number 033K21-2A with an expiration date of 20MAY2022. The patients not reported any adverse reactions. HCP did not know but stated that vaccines were usually put in refrigerator a week before administration. Vial did not undergoes temperature excursion. No Treatment medications were reported.
Received the flu vaccine on 11/12/06. About a week after she began to have "crampy type sensation in her lower chest and epigastrium". SOB, Temp 100.5.  1/9/07 Received medical records from hospital which reveal patient admitted 11/28-11/30/06 with chest pain which increased with lying down & breathing, dyspnea, night sweats & fever/chills for approx 1 wk.  She was d/c to home on steroids & was to f/u with cardiologist & rheumatologist as well as have a repeat CT of chest in 1 mo.  FINAL DX: Pleural pericarditis, probably viral, with left effusion, question of mediastinal adenopathy; HTN; depression; & Grave's disease, thyroidectomy & parathyroidectomy./ss
NO ADVERSE EVENTS REPORTED BY PATIENT. Patient presented on for a 2nd dose of Moderna COVID Vaccine on 10/11/21. Upon doing a routine database check, saw a posted dose of Janssen on 3/5/21 @ different pharmacy. Confirmed with patient they had received JSN. Patient stated they thought it was okay to get the vaccine since it is a "different technology." Notified patient he should not be receiving this dose today or have received the first one, as it is not needed and has completed a series based on CDC guidelines.
Feels like she has the flu; Aches all over; Arm hurt very bad; Nauseas; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feels like she has the flu), MYALGIA (Aches all over), VACCINATION SITE PAIN (Arm hurt very bad), NAUSEA (Nauseas) and CHILLS (Chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 11-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feels like she has the flu), MYALGIA (Aches all over), VACCINATION SITE PAIN (Arm hurt very bad), NAUSEA (Nauseas), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, INFLUENZA LIKE ILLNESS (Feels like she has the flu), MYALGIA (Aches all over), VACCINATION SITE PAIN (Arm hurt very bad), NAUSEA (Nauseas), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication reported  No treatment information was provided    This case was linked to US-MODERNATX, INC.-MOD-2021-049527 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049527:Patient case for first dose
Patient was given 0.5ml instead of correct dose of 0.3ml. Patient experienced fever up to 101F, chills, headache, body aches, joint pain, fatigue, generally feeling unwell, and injection site pain into left deltoid. EE then reports that a cough and congestion.
Symptomatic with cough, congestion with yellow sputum, sore throat, and body aches.  Tested positive on 12/26/21 and isolated with her other son. Husband tested negative and her other son's result is pending. Isolation period ends on 1/2/22, she will callback the hotline for f/u. She also participated in the Quasar studay, antibody testing after isolation is completed.
large red hot spot at injection site; large red hot spot at injection site; severe sinus congestion; severe sinus congestion achy, sore throat and ache around ears; sore throat; ache around ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 28Feb2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for immunisation. The patient's relevant medical history included: "cancer", start date: 2011 (unspecified if ongoing), notes: X cancer patient diagnosed and treated 2011.; "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Oct2016. The following information was reported: EAR PAIN (non-serious) with onset 01Mar2023 at 13:00, outcome "recovering", described as "ache around ears"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 01Mar2023 at 13:00, outcome "recovering" and all described as "large red hot spot at injection site"; SINUS CONGESTION (non-serious) with onset 01Mar2023 at 13:00, outcome "recovering", described as "severe sinus congestion"; PAIN (non-serious) with onset 01Mar2023 at 13:00, outcome "recovering", described as "severe sinus congestion achy, sore throat and ache around ears"; OROPHARYNGEAL PAIN (non-serious) with onset 01Mar2023 at 13:00, outcome "recovering", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site warmth, sinus congestion, pain, oropharyngeal pain, ear pain. Additional information: Initially large red hot spot at injection site, severe sinus congestion achy, sore throat and ache around ears. No fever tested 2 times for Covid, both negative.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Moderna COVID-19 Vaccine EUA Headache about 13 hours after the shot; nausea, body aches, chills, tiredness, sore arm about 16 hours after the injection.  After taking a Tylenol, most symptoms were gone after a few hours, except the tiredness, which lasted about 10 days.
p/vax pt exp a red, raised rash @ inj site that was hot to touch;
Child became less responsive within 4 hrs of vaccine but by the next morning, baby was lethargic with marked decrease in interaction with others. Seemed 'drugged'.
A physician reported that an adult received an injection of TD and subsequently, developed an injection site reaction characterized by redness, swelling and pain. No further information was available at the date of this report. Additional reports will be generated when identifying information is provided.
Pt recvd Hep B vax 4OCT91 & approx 8OCT91 pt devel a temp which lasted 3 days, body aches & flank pain; lab eval revealed ketonuria & bilirubinuria;
flush feeling; when I clean my house, it's not hot it's cold and I just get really hot; night sweats; lightheaded, dizzy; feels weird in her head; if feels like an off balance feeling; like under her arm feels sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 27Sep2021 16:00 (Lot number: 30155BA) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose Covid-19 vaccine, Lot No. FC3183, Anatomical location: Right deltoid), administration date: 04Sep2021, when the patient was 48 years old, for Covid-19 Immunization, reaction(s): "feels like she sweats all the time", "got really hot and is hot all the time". The following information was reported: HOT FLUSH (non-serious) with onset Sep2021, outcome "not recovered", described as "flush feeling; when I clean my house, it's not hot it's cold and I just get really hot"; NIGHT SWEATS (non-serious) with onset Sep2021, outcome "not recovered", described as "night sweats"; DIZZINESS (non-serious) with onset Sep2021, outcome "not recovered", described as "lightheaded, dizzy"; FEELING ABNORMAL (non-serious) with onset Sep2021, outcome "not recovered", described as "feels weird in her head"; BALANCE DISORDER (non-serious) with onset Sep2021, outcome "not recovered", described as "if feels like an off balance feeling"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "not recovered", described as "like under her arm feels sore".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101341415 same reporter/drug, similar events, different patient
first dose 60 days ago/ did not receive his second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT PRODUCT ADMINISTRATION DURATION (first dose 60 days ago/ did not receive his second dose yet) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced INCORRECT PRODUCT ADMINISTRATION DURATION (first dose 60 days ago/ did not receive his second dose yet). At the time of the report, INCORRECT PRODUCT ADMINISTRATION DURATION (first dose 60 days ago/ did not receive his second dose yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided. Consent given for safety to contact the patient and declined consent to contact his HCP
pain in neck with a lump started at 2:30 patient was brought to clinic at 3:30 was asessed by PA and dx with lymphadneopathy on left side
This spontaneous report was received from a pharmacist refers to a 63 year old female patient. Patient got the first dose of RECOMBIVAX HB in 2009 (reported as "5 years ago"), and the second dose of RECOMBIVAX HB (1.0 ml, intramuscular, right deltoid) on 14-JUL-2014 (reported as "today"). No adverse effects reported. Additional information is not expected.
15OCT93 pain @ site; lt brachial plexus neuropathy; 17OCT93 pain in lt arm, neck, tips of fingers;
pt recv vax 22SEP95 & devel shingles that were described as located on center of back, large cluster of vesicles, scattered vesiculopustular lesions on axilla & lt arm & mid chest;
4 month old patient receiving the Fluzone HD; fever upto 99.4  degree Celsius; patient had experience vomiting; Initial information received on 05-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old female patient who experienced fever up to 99.4 degree celsius (pyrexia) and vomiting (vomiting), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL); and HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]).  On 04-Feb-2020, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ307AB  and expiry date: 29-Jun-2020) via unknown route in the left thigh.  On 04-Feb-2020, the patient a non-serious experienced fever up to 99.4 degree Celsius (pyrexia) and vomiting (vomiting), same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that, the patient was kept for 15 minutes observation.  Relevant laboratory test results included: Body temperature - On an unknown date: 99.4 Cel  Final diagnosis was vomiting and pyrexia.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for both events.  It was actual medication error due to Inappropriate age at vaccine administration .  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.
pt recvd vax & 24 hrs p/2nd dose exp lymphadenopathy, malaise, blurred vision, & weakness;
Patient presented to ED this evening with shortness of breath, troponin elevated at 0.154 and transferred to local hospital to start heparin bolus with drip. Started on 5 day prednisone course for COPD exacerbation, reports improvement of SOB but not back to baseline. Had RN perform walking saturations, 95% on room air therefore not meeting criteria for home O2. Prescribed Spiriva on discharge to add to her Qvar, albuterol, DuoNeb. Recommend Pulmonology consultation, outpatient PFTs, and close follow up with PCP. Patient hemodynamically and clinically stable and ready for discharge home. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Within 15 minutes of receiving Varivax, developed nausea & extreme pruritus of feet, then entire body.  P facial swelling (redness), no airway compromise or SOB.  P mild wheeze, 10x94.  Received Benadryl, Orapred & Epinephrin 0.15 mg IM.  Normal BP's.  Sent to ER after Epi given for observation.
Pain at injection site, feelings of weakness. Paleness unresolved after laying down elevation of legs/feet. Complaint of irritation in throat (no stridor heard, lungs clear bilateral) respirations non-labored, no distress. EMS activated, treated by EMS. EMS recommended transport to ER, parent refused ambulance.
Information has been received from a physician concerning an 11 week old male who on 27-Dec-2006 was vaccinated with an oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot# 655405/1113F). On 05-Jan-2007 the patient experienced mucous like stool with a red dot in it. It was reported that the medical attention was sought. No product quality complaint was involved. No other information was provided, Upon internal review, stool with a red in it was considered to be an other important medical event (OMIC). Additional information has been requested.
Right anterior thigh (erythema and edema of thigh) color changes. Use and dosing of analgesics. Apply ice for 20 min every hour for 24-48 hours. Follow-up if no improvement or worsens.
Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023; Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023).    No concomitant medications were reported. It was reported that Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023. They were to be used within 24 hours but administered to 24 patients on unknown dates. Vaccine administration dates and patient information were unknown.  Excursion Timeframe, on 21-Feb-2023, Max 8.60C for 10 hours and 57 minutes, on 22-Feb-2023 Max 8.5 C for 24 hours, on 23-Feb-2023 Max 8.5 C min 7.4 C for 17 hours and 56 minutes. No treatment information was provided by the reporter. This case was reported for patient 24 th out of 24.   This case was linked to US-MODERNATX, INC.-MOD-2023-713467, US-MODERNATX, INC.-MOD-2023-713484, US-MODERNATX, INC.-MOD-2023-713485, US-MODERNATX, INC.-MOD-2023-713504 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713467:Patient 1 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713485:Same Reporter US-MODERNATX, INC.-MOD-2023-713484:Same Reporter US-MODERNATX, INC.-MOD-2023-713504:Same Reporter
102-103* fever and chills beginning 12-13 hours after vaccination. Chills continuing for 12 hours with fever subsiding gradually. Muscle soreness in both arms and upper back, neck.
Information has been received from a consumer concerning her 14 year old daughter with a seasonal allergies and a medical history of an appendicectomy (date not reported), who on 19-OCT-2007 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included cetirizine hydrochloride (ZYRTEC) and an influenza virus vaccine (unspecified).  Subsequently, in October 2007, within two weeks after receiving her first dose of GARDASIL, the patient began to experience headaches that lasted all day.  The patient went to her pediatrician, whose name was unspecified, and told the patient to get more sleep and become more hydrated.  The patient also went to a chiropractor.  After following the pediatrician's recommendations the headaches still persisted and the patient then sought the medical attention of a neurologist.  The neurologist scheduled an MRI, performed a complete physical and diagnosed the patient with "NDPH, which stands for New Daily Persistent Headache."  The consumer also reported that the neurologist stated, "these headaches could come from a virus."  The consumer contacted the pediatrician to see if the patient had any previous illness, which she had not.  The consumer informed the neurologist that her daughter had the GARDASIL vaccine and a flu shot.  The neurologist was not sure if this could be the cause of the headaches.  The consumer stated that if the headaches keep persisting, she may have to take the patient to the hospital.  At the time of this report the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Information has been received from a registered nurse concerning a female patient (age and gender not provided) who on unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 650331/0749P). Subsequently, the patient developed injection site reaction which was uncomfortable and very painful. The patient required treatment with an antibiotic PO (unspecified) and methylprednisolone. The patient was reported as recovered. Injection site reaction was considered to be an other important medical event by the registered nurse. There was no product quality complaint involved. Additional information has been requested.
Emotional distress; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EMOTIONAL DISTRESS (Emotional distress) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EMOTIONAL DISTRESS (Emotional distress). At the time of the report, EMOTIONAL DISTRESS (Emotional distress) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.
intermittent low grade fever for 3 days Chills for 3 days Fatigue for 3 days Headache for 3 days Muscle pain for 3 days
Right hand numbness. Refused TRANSPORT BP 183/102 88 16. Has an appt with Cardiologist
pt recv 2 doses of vax 15APR96 & 17MAY96 & 18JUL96 pt titer was tested & did not register;it remained negative & pt exp no other adverse events;