chrisvoncsefalvay/vaers-outcomes huggingface dataset:
employees that were under the age of 65 were administered fluzone hd qiv instead of the fluzone qiv with no reported adverse event; employees that were under the age of 65 were administered fluzone hd qiv instead of the fluzone qiv with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2022SA446068, 2022SA446195, 2022SA446385, 2022SA447853, 2022SA447822, 2022SA448075, 2022SA447385 and 2022SA448121.  This case involves a 62 years old female patient who was administered Quadrival A-B high dose hv vaccine [Fluzone high-dose quadrivalent] instead of the Fluzone QIV with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2022, the patient received 0.7 ml dose once of suspect Quadrival A-B high dose hv vaccine (lot UT7729CA, exp date: 30-Jun-2022) via intramuscular route in the right deltoid for Immunization at inappropriate age instead of the Fluzone QIV with no reported adverse event (product administered to patient of inappropriate age) (wrong product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
Pt, while sitting after receiving vaccine, started to react negatively after 28 mins. Complains of difficulty breathing and had noticeable hives. Pt was given benadryl to reduce allergic reaction. After a few minutes, pt breathing became better, hives went away. Pt was released to himself at 5:20pm
drug exposure during pregnancy; No adverse event; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205E23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Sep-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Company comment This spontaneous case concerns a female patient of an unknown age with no medical history reported, who experienced the unexpected, non-serious, event of maternal exposure during pregnancy and no adverse event was reported. The patient received a dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS). The event onset date was not provided, thus, exact latency between vaccination and onset of the events could not be assessed. Last menstrual period and estimated date of delivery were not provided. No further clinical information was provided. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) is not affected by this report.
pt recv vax 19NOV97 & 21NOV97 pt exp dry cough & tightening of throat;
Rash started in the vagina area and then spread to torso, legs, arms, and cheeks. No fever.
Headache, body ache, nausea, fever, chills from the onset. Symptoms continued for approx. 24 hours. Also no appetite. All symptoms eventually resolved after 48 hours.
redness, swelling, heat at site of injection beginning hours after vaccine and still present 6 days later
a rash in both legs /a rash in lower back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a rash in both legs /a rash in lower back) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced RASH (a rash in both legs /a rash in lower back). At the time of the report, RASH (a rash in both legs /a rash in lower back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment. Concomitant product included cholesterol medication and high blood pressure medication.  Patient used cream Icy Hot (idiopathic patch) for the treatment.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow-up document was received. Email information and address of reporter was updated.
Pt brought to the emergency department by EMS status post fall 3/8. Pt is on Pradaxa and complains of pain in her forehead and nose.  Reports tingling sensation in her arms.  No chest pain.  No abdominal pain. On 3/9 pt having pain in right arm, but has improved with pain medications. Pt is asymptomatic but has tested positive for COVID 3/10, patient A&Ox4 from the 3rd floor with no complaints of pain and no signs of respiratory distress. On 3/11 pt with elevated blood pressure.  Patient was anxious and complaining of generalized pain.  Xanax and Norco given. Pt discharged 3/12 in stable condition.  No c/o any pain or shortness of breath.  Iv removed.
Patient presented to the vaccination site on 11/07/21. The client notified RN that she received a single dose of Janssen COVID vaccine on 4/07/21. Patient stated to Vaccinator that she was diagnosed with Thrombocytopenia Purpura autoimmune disorder back in 1997.  Vaccinator alerted RN. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID booster vaccine Pfizer. Per Dr., approval to proceed with COVID booster vaccine Pfizer was obtained from medical consult team via text message from RN, Vaccine Operations Lead. Client received COVID vaccine Pfizer Lot# FF8839 on 11/07/21. The client did not report any symptoms during the 15 minute observation period. RN educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site at 1430. Client left vaccination site with her husband unassisted and with a steady gait.
Aches/pain; Took next day off work. Had fever; Headache; whole body constricted including throat closing; whole body constricted including throat closing; This is a spontaneous report from a contactable consumer. A 68-year-old contactable consumer(patient) reported herself.  A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER2613 and Expiration date was not reported), via intramuscular route, administered in Arm Left on 17Mar2021 15:50 as single dose for COVID-19 immunization. The patient's Medical history included colon cancer, sigmoidectomy, allergic to chemo from Mar2016 to Aug2016, normal blood pressure was normal is 120/80. Familial history includes father side heart disease and diabetes, mother side crohn's disease and colon cancer. Concomitant medications included ibuprofen per oral daily for arthralgia and arthritis and still ongoing. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202 and Expiration date was not reported), via intramuscular route, administered in Arm Left on 24Feb2021 15:50, as single dose for COVID-19 immunization. At the time of 2d Pfizer the patient experienced vaccination numbness and tingling on left arm that was vaccinated, went to urgent case- blood pressure increased 153/95, patient normal blood pressure was 120/80, urgent case did not just suggested to observe and come back if needed as go to emergency room or call. whole body constricted including throat closing at time of vaccination went to urgent care blood pressure increase 153/94. On 17Mar2021, patient had fever and took next day off work. On an unknown date in Mar2021, the patient experienced aches, pain and headache. Therapeutic measures were taken as a result of adverse events and patient received treatment with Tylenol from 19Mar2021 to 21Mar2021 for Fever, aches, headache pain 2 days after second shot. The patient underwent COVID test on 15May2020 and the result was negative. The patient was scheduled for CT scan abdomen in Jun2021. The outcome of the event was reported as unknown.   No follow-up attempts are needed. No further information is expected.
right upper back pain radiating to right shoulder and down right arm shortness of breath Pulmonary Embolism
Information has been received from a registered nurse (RN) concerning a 4-month-old male with no medical history or allergies who on 24-OCT-2007 was vaccinated PO with the second dose of ROTATEQ vaccine live (human-bovine). There was no concomitant therapy. The RN reported that on 27-OCT-2007, the patient vomited. The patient was seen in the physician's office. No laboratory/diagnostic tests were performed. On that same day, the patient recovered. Additional information has been requested.
Diaphoresis. Sensation of cold. Generalized aches and pains. Cutaneous hypersensitivity. Increased body temperature.
Narrative: 68 y/o female presented to ED on 1/12/22 with sob for past 12 days. Recent visit to ED 12 days prior diagnosed with influenza A and treated with Tamiflu, prednisone and azithromycin. Worsening sob over last 12 days, cough with yellow and brown sputum production reported. COVID positive on 1/12/22. CXR showed no evidence of COVID PNA on 1/12/22. Admitted to hospital and treated for acute hypoxic respiratory failure secondary to Covid 19 infection, COPD exacerbation and influenza A. Treated with supplemental oxygen to keep SPO2 > 89%, dexamethasone and Remdesivir, Advair, duonebs, albuterol, guaifenesin and flutter valve. Status improved and pt discharged to home on 1/18/22. PMH includes COPD, PVD, HTN, nicotine dependence, obesity, female stress incontinence, alcohol dependence, peripheral neuropathy, allergic rhinitis, bipolar disorder, anxiety, amphetamine dependence in remission, dysthmia, vitamin D deficiency, hematuria, chronic pain and osteoporosis.
Malestar en el cuerpo/ discomfort in the body; Dolor en el brazo/ pain in the arm; Dolor en el cuerpo /pain in the body; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Malestar en el cuerpo/ discomfort in the body), PAIN IN EXTREMITY (Dolor en el brazo/ pain in the arm) and MYALGIA (Dolor en el cuerpo /pain in the body) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included PRAVASTATIN for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Dolor en el brazo/ pain in the arm) and MYALGIA (Dolor en el cuerpo /pain in the body). On 05-Apr-2021, the patient experienced DISCOMFORT (Malestar en el cuerpo/ discomfort in the body). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 04-Apr-2021, PAIN IN EXTREMITY (Dolor en el brazo/ pain in the arm) and MYALGIA (Dolor en el cuerpo /pain in the body) had resolved. At the time of the report, DISCOMFORT (Malestar en el cuerpo/ discomfort in the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was a Spanish speaker and received their first dose of Moderna vaccine on 01-Apr-2021. At night, the patient's daughter had symptoms and on Friday their daughter tested positive for COVID-19. On 02-Apr-2021, Friday, the patient began to have symptoms, such as pain in their body and in their arm. These symptoms continued on Saturday but on Sunday the patient felt fine. On 05-Apr-2021, the patient again experienced discomfort in their body.
Case number PHEH2015US020603, is an initial spontaneous report received from a nurse on 13 Oct 2015. This report refers to a 24 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with an expired dose of FLUVIRIN (batch number: 1412701) intramuscularly at a dose of 0.5 ml on 08 Oct 2015. No adverse event was reported following this maladministration.
put her to sleep. She slept for a full day and night; Adverse reaction; This case was reported by a consumer via call center representative and described the occurrence of sleepiness in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hip discomfort and sulfonamide allergy.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sleepiness and adverse reaction. On an unknown date, the outcome of the sleepiness and adverse reaction were recovered/resolved.   It was unknown if the reporter considered the sleepiness and adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced slight reaction on the 1st doseof Shingrix.  The first dose put her to sleep. She slept for a full day and night. Consent to follow up was provided. For tolerance with 2nd dose of Shingrix refer case US2020AMR012125.
Pt reported 11/1/16 to Medical Assistant that she experienced a rash, and itching at the site of injection - one day after injection given 10/3/16 - Pt said SX started 10/4/16. Reported 11/1/16.
1st day (12.27.21)  rash at injection site, rash progressing to arms and torso,  headache, fatigue 2nd day (12.28.21)- headache, body aches, fatigue 3rd day (12.29)- milder headache, hives intensified  3th day (12.30)- intense hives, headache, body aches
For the first time in my life I started hearing a constant ringing in my ear.  (Tinnitus - Bilateral). My primary care physician referred me to an ENT specialist.
Patient came in for her first flu shot and was given Influenza immunization. The recommendation is to administer 0.25ml to a patient 6m-8 years old that has never received a flu shot. Patient was given a full 0.5ml dose.
Information has been received from a physician concerning a memo from their cooperate office regarding a nine year old patient who had received a varicella virus vaccine live (Oka/Merck) booster. It was reported that he developed a possible anaphylaxis reaction with wheezing, shortness of breath, facial edema, facial mottling, was stabilized, and transported to the hospital. It was not reported if the patient was admitted. Current patient status was not reported. No product quality complaint was reported. Further information was not available. This is one of three reports from the same source. Additional information has been requested.
11OCT98 sore throat & later morning rt ear ache-fluid in rt ear (started ATB 18OCT) x 8 days;13OCT generalized weakness, stomach pain, nausea;14OCT cont weakness/stomach pain;
Since receiving my original vaccine in December 2020; I have had several labs develop as abnormal. My lupus labs also became positive including anti phospholipid antibody and Beta 2 glycoprotein which have to do with clotting. I had never had these labs be abnormal in the time I have had lupus - since age 5 years old.  Since the 2nd dose of Pfizer Covid 19 vaccine I have become severely debilitated with increased HTN out of control. Was hospitalized once for this while at work. Also as of today I have so little energy as my lupus has flared and not back to baseline since. I have also developed painful lymphadenopathy in my jaw that continues to persist today and now having neck spasms due to this. I also developed pre-syncope and orthostatic hypotension since this last vaccine. The pre-syncope sent me to 2 Emergency rooms after the vaccine in October 2021.
Swollen, bruised and warm to touch at injection site. Small red papules on arm, sides and back. Tx w/MEDRIL dose pak, 4 mg tablets.
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. On an unknown date the patient experienced paranoia and mental status changes. The outcome of paranoia and mental status changes is unknown.
Fever, headache, left side hurt, hands hurt.  Felt like everything is inflamed.
tinnitus; anxiety feeling; Typical fatigue; strange headache; constant eye twitching and dryness which started 1/2 hr after shot; constant eye twitching and dryness which started 1/2 hr after shot; Random muscle twitches; tunnel hearing and vision; tunnel hearing and vision; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 16:45 (Lot number: ER8729) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "mitral valve prolapse" (unspecified if ongoing), notes: Other medical history: None/mitral valve prolapse. Concomitant medication(s) included: PROBIOTICS NOS; MAGNESIUM; ZINC; B12 [CYANOCOBALAMIN]; VIT D [COLECALCIFEROL]. The following information was reported: FATIGUE (non-serious) with onset 06Apr2021 17:15, outcome "not recovered", described as "Typical fatigue"; HEADACHE (non-serious) with onset 06Apr2021 17:15, outcome "not recovered", described as "strange headache"; DRY EYE (non-serious), BLEPHAROSPASM (non-serious) all with onset 06Apr2021, outcome "not recovered" and all described as "constant eye twitching and dryness which started 1/2 hr after shot"; MUSCLE TWITCHING (non-serious) with onset 06Apr2021, outcome "not recovered", described as "Random muscle twitches"; HYPOACUSIS (non-serious), VISUAL IMPAIRMENT (non-serious) all with onset 06Apr2021, outcome "not recovered" and all described as "tunnel hearing and vision"; ANXIETY (non-serious) with onset 06Apr2021 17:15, outcome "recovered" (2021), described as "anxiety feeling"; TINNITUS (non-serious) with onset 10Apr2021, outcome "not recovered", described as "tinnitus". The events "typical fatigue", "strange headache", "constant eye twitching and dryness which started 1/2 hr after shot", "constant eye twitching and dryness which started 1/2 hr after shot", "random muscle twitches", "tunnel hearing and vision", "anxiety feeling" and "tinnitus" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of fatigue, headache, dry eye, blepharospasm, muscle twitching, hypoacusis, anxiety, tinnitus.  Additional information: Typical fatigue, strange headache lasted about week 1/2, constant eye twitching and dryness which started1/2 hr after shot. Random muscle twitches, tunnel hearing and vision, anxiety feeling right after shot - subsided in a couple weeks. 4 days after shot developed tinnitus which has not subsided! Overall still not feeling 100%. Patient did not take any other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination: Unknown. No known allergies.  No follow-up attempts are possible. No further information is expected.
exacerbated her Arthritis; This is a spontaneous report from a contactable other hcp (patient) via Medical Information Team.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. it was unknown that patient was pregnant at the time of vaccination. The patient's medical history and concomitant medications were unknown. On an unspecified date, after first dose the patient experienced exacerbated her arthritis. the event was no Life threatening, no Disabling/Incapacitating, no Intervention/Medically Important, no Congenital Anomaly/Birth Defect. The event was non serious. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
mild rash; stiff joints; lump on his arm; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (stiff joints), PERIPHERAL SWELLING (lump on his arm) and RASH (mild rash) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.    Co-suspect product included non-company product ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Thrombosis.    The patient's past medical history included COVID-19. Concurrent medical conditions included Allergy to antibiotic, Ragweed allergy, Drug allergy (Novocaine), Diabetes since 2006, Venous ulcer NOS since 2018 and Hypertension since 1998. Concomitant products included INSULIN for Blood glucose abnormal, ATENOLOL for Blood pressure management, MULTIVITAMINS [VITAMINS NOS], COLECALCIFEROL (VIT D [COLECALCIFEROL]), HYDROCHLOROTHIAZIDE, SPIRONOLACTONE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE), ACETYLSALICYLIC ACID (BABY ASPIRIN) and CYANOCOBALAMIN (VIT B12) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) (unknown route) 83 mg. On 02-Feb-2021, the patient experienced JOINT STIFFNESS (stiff joints) and PERIPHERAL SWELLING (lump on his arm). On 07-Feb-2021, the patient experienced RASH (mild rash). The patient was treated with BETAMETHASONE at an unspecified dose and frequency. At the time of the report, JOINT STIFFNESS (stiff joints), PERIPHERAL SWELLING (lump on his arm) and RASH (mild rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient received second dose on 02-MAR-2021.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Added relevant history, updated concomitant medications, updated second dose details.
Swelling, Redness, and patient claimed injection site was hot to the touch. Patient received Pneumococcal 23 vaccination (indicated on following screen )at same time.
Site of injections feels hot and hard, very red 3in wide in diameter, pt states it is sore. Pt notice it later on that evening of shot.
NO ADVERSE REACTION. PT 17 AT TIME OF VACCINATION. DOSE NUMBER 2 GIVEN PER PROTOCOL TO FINISH SERIES AFTER FIRST DOSE GIVEN.