chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt very dizzy for 2 following days; I got vertigo attacks next day after vaccination; This is a spontaneous report from a contactable other healthcare professional (patient). A 68-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER2613), via an unspecified route of administration in the right arm on 06Jul2021 at 10:30 as dose number unknown, single for COVID-19 immunization (at the age of 68-years-old). Medical history included meniere's disease from an unknown date and unknown if ongoing. Concomitant medication was not reported. The patient previously took ampicillin and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient stated that she got vertigo attacks next day after vaccination (07Jul2021) and she felt very dizzy for 2 following days. The events were assessed as non-serious as per reporter. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal swab): negative on 12Jul2021 and 21Jul2021. The patient received meclizine 25mg X 3/day and hydrochlorothiazide 12.5mg within 2 weeks of vaccination. The clinical outcome for the events was recovering.  Follow-up attempts are completed. No further information is expected.
After the standard soreness after injection lasting approx 3 days, symptoms dissipated. At around 7 days post injection, acute onset of profound redness, swelling and pain was noted to the injection site.   Now at 10 days, redness and swelling still present, however symptoms have decreased in severity. Now I have muscle twitching at the injection site as well.
infected with COVID and fully vaccinated; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (infected with COVID and fully vaccinated) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2021, the patient experienced COVID-19 (infected with COVID and fully vaccinated). At the time of the report, COVID-19 (infected with COVID and fully vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Positive.         No Concomitant and  treatment medications were provided.
Information has been received from a physician concerning a 20 year old female who on 30-MAR-2009 was vaccinated with her first dose of GARDASIL.  Concomitant therapy included YAZ.  On 03-APR-2009 the patient developed 102.5 degree F fever, nausea and body aches.  The outcome was not recovered.  The patient sought medical attention by phone at office.
Pain at injection site, diffuse myalgia and 3 x 4 cm supraclavicular swelling adenopathy.
12/08/21 presents to EC ED for "Cough, dyspnea, fever". PMHx of "MVP, asthma, IBS, htn"
After Week 1 of my 1st Moderna vaccince, I have experienced heavy menstrual bleeding.  I had a full period 1 week after 1 dose on 4/15 when I was still 2 weeks away from my expected period start date ( and I have been consisitent of 23-26 day cycle)  Now this has continued that I am experiencing my periods on a about a 15 day cylce (so almost close to twice a month) and heavier than normal.  Ive had consistent periods since the birth of 2nd daughter 4 years ago until 4/21/21
tested positive for covid; tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EP6955), on 07Apr2021 as dose 2, single (Lot number: EP6955) and on 22Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 44 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 25Apr2022, outcome "not recovered" and all described as "tested positive for covid". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive, notes: COVID test post vaccination COVID test type post vaccination=Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Device timestamp: 26Apr2022, no COVID prior vaccination. COVID was tested post vaccination.
Information has been received from a physician concerning a 12 year old (reported as 11 years old) female who was vaccinated with two doses of MMR II (lot#s not reported) respectively on 17-DEC-1998 and 28-MAR-2001. On 13-DEC-2009 the patient developed mumps. The patient also has a fever of 101F and left parotitis. On 15-DEC-2009 the patient was diagnosed with mumps. On 15-DEC-2009 the first blood work was performed. IgM was <1:10 (normal range <1:10), IgG was 7.04 (normal range > 1:10), serum amylase was 73. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-3977168-00.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (hospitalization), outcome "unknown", described as "Flu like symptoms". The patient underwent the following laboratory tests and procedures: Ultrasound kidney: Unknown Results, notes: For Kidney stones.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received 1st dose of vaccine and within 5 minutes felt very light headed and became disoriented.  Patient was laid on back with knees elevated and given an ice pack to rest on her head.  After 5-10 minutes patient was sat up in a chair and given some cold water.  Patient never lost consciousness and was able to communicate to a degree.  Patient felt better after sitting in chair for another 10-15 minutes.  Patient left on own accord.
booster given greater than 12 hours post vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster given greater than 12 hours post vial puncture) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Drug allergy (Remeron), Drug allergy (Restyl), Latex allergy, Dementia, Chronic kidney disease, Insomnia and Hypertension. Concomitant products included AMLODIPINE BESILATE (NORVASC), DRONEDARONE HYDROCHLORIDE (MULTAQ) and MEMANTINE HYDROCHLORIDE (NAMENDA) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (booster given greater than 12 hours post vial puncture). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (booster given greater than 12 hours post vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication includes Senna.  No treatment drugs were reported.   This case was linked to MOD-2021-416295.
This patient received both his Influenza shot and Pneumonia shot on the same day. The arm became swollen, red, and hot. The swelling extended down the arm.
Severe bruising approx 2 inch in diameter; pt states no heat or redness, does not hurt arm with pressure.
this was the first vaccine and it left me with a stiff neck and overall muscle pain that went away with the administration of the second dose.
Staff described having the chills, headache, and body aches throughout the day, 1 day after receiving the vaccination. She also had injection site pain in her arm that made it difficult to perform lifting movements. Adverse event was severe enough the staff felt she could not attend work the day after vaccination.
Flu vaccine given intradermal on 1/26/15: 1/27/15 = about 50 mm x 50 mm erythema with slight edema to (L) deltoid c/o #2-3/no tenderness on palpation: Tx= TYLENOL 325-650 mg po wtih 8hs PRN for pain. Warm compress on site x 15 mts. Application, TID.
Initial information received on 11-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 72 years old male patient who received vaccine FLUZONE HIGH DOSE 0.5ml dose, lot UI885AA, expiry date 29-May-2018 via unknown route in unknown administration site on 10-Sep-2018. The patient's past medical history, concomitant medication and family history were not provided. No other vaccines given at the time. It was an actual medication error due to expired vaccine used. It was reported that patient received FLUZONE HIGH DOSE from 2017-2018 season on 10-Sep-2018 that had expired on 29-May-2018. The patient did not experience any adverse reaction after the injection. 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. List of documents held by sender- none.
1005-Flu vaccine given. 1330-hives noted 1400-Benadryl given Benadryl repeated at 2000 and 0800, 1400, and 2000 on 10/29/2008
I received the first shot on January 6th. I had minor side effects that were expected. On approximately January 13th, I noticed that my arm was swelling and red and felt warm to the touch. I went to a doctor on January 14 and I was diagnosed with cellulitis secondary to the vaccine and prescribed antibiotics for 10 days.
This spontaneous report was received from a Registered Nurse concerning a 16 year old female patient. The patient's concurrent conditions and medical history were reported as none. On 30-JUL-2014, the patient was vaccinated with GARDASIL (lot # J013324, exp.: 12-FEB-2016) (dose, route and anatomical location were not provided). Then, on 03-MAR-2016, the patient was vaccinated with GARDASIL 9 (lot # L027282, exp.: 21-SEP-2015) (dose, route and anatomical location were not provided). Concomitant medications were not reported. On 09-MAR-2016, the patient went to a emergency department and was diagnosed with Bell's Palsy (with nerve paralysis). CYCLOVIR and prednisone were given for treatment. No laboratory tests were performed. At the reporting time, the outcome of Bell's Palsy was reported as not recovered. The relatedness between the event and suspect therapy was not provided. Lot # J013324 has been verified to be a valid lot number for GARDASIL. Additional information has been requested.
Could not move. Diarrhea & nausea. Could not drink or eat, felt very hot 2 days after flu shot.
Pallor,dufficult to arouse 5 hrs post injection.This occurred /p a crying episode.1 hr /p spell taken to ER.Not admitted.Is doing fine now.1st injection.No family hx of allergies
Pt reported pain in neck the night of vaccine. She reports receiving neck adjustment from chiropractor - 10/14 and had history of arthritis in neck. The pain was worsen and she put heating pad on it. 10/18 left thumb to wrist was sore and hard to use - went to urgent care 10/19. Received ibuprofen/VICODIN/TORADOL; Pt reports better 10/21.
Patient presented to Urgent Care clinic for evaluation of injected arm with entire bicep circumferentially red and itching, 24 hours post-vaccine. Affected area extends from shoulder to elbow.
Bronchitis; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via unspecified route of administration, on an unknown date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced bronchitis when patient received COVID-19 vaccine. The patient was prescribed xeljanz 5mg. The outcome of the event was unknown.   Information about batch/lot number has been requested.
Shingles outbreak on her right back and torso that began within 6 hours of the injection
Patient is a 68 y.o. male patient of DO with history of afib, lymphoma presented to Medical Center with generalized weakness, found to have sepsis 2/2 COVID and afib with RVR.   Sepsis - resolved Covid-19 Virus Infection Date of onset of symptoms: 5/13/23 Symptoms present on admission: weakness, dyspnea Date of covid positive test: 05/15/23  Vaccination status: vaccinated Imaging: CXR nonacute Oxygen requirements on admission: none Current oxygen requirements: 2LNC Pulm/CC consulted ID consulted, plan for 3 days of Remdesivir, cannot get paxlovid due to interactions with Xarelto.    Afib with RVR - resolved HR 140s on presentation Transitioned off of Cardizem gtt Resume home Xarelt Resume home Xarelto, Toprol, ASA Cardiology consulted, have signed off Currently on oral metoprolol Rate controlled.   DM2 Holding home metformin, glipizide A1c 6.4 in 3/2023, below goal for age Can likely DC glipizide on discharge and just continue metformin Afib with RVR - resolved HR 140s on presentation Transitioned off of Cardizem gtt Resume home Xarelto, Toprol, ASA Cardiology consulted, have signed off Currently on oral metoprolol Rate controlled.   DM2 Holding home metformin, glipizide A1c 6.4 in 3/2023, below goal for age Can likely DC glipizide on discharge and just continue metformin   Lymphoma Thrombocytopenia Next chemo due 5/16 Continue home Bactrim and acyclovir for infection ppx Consult oncology, follows with Dr - no further workup or therapy until after COVID.    HTN Home lisinopril, metoprolol BP low normal May be able to DC lisinopril on discharge   Lactic acidosis, POA.  3.6 on admission Trended down to 2.0
Throat tightening. He took 10mg Zyrtec himself in his vehicle. No airway swelling on exam. Clear lungs. No skin symptoms. HR 68, O2 99%
Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 664478/1191Y). Subsequently the patient experienced injection site reaction after vaccination. The patient came to the office. The size of the reaction was approximately "50 cents" and consisted of the area of warmth, redness, and swollen. There were no lab studies were performed. At the time of the report, the patient had recovered (date unspecified). The reporter requested a lot check for lot # 664478/1191Y due to the patient's adverse experiences. This is one of several reports from the same source. A lot check was initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Diarrhea, lightheadedness/dizzy, tired, erythema, injection-site pain. Symptoms resolved 3-4 days following vaccination
painfully red acute rash/dermatitis on his left arm diagnosed as an adverse effect to shingles vaccine; Information has been received from a lawyer referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 09-OCT-2017, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for the prevention of shingles (herpes zoster) and routine health maintenance.   On or about 11-OCT-2017 (reported as 2 days after received the vaccine), the patient experienced painfully red acute rash/dermatitis on his left arm diagnosed as an adverse effect to shingles vaccine. The patient did not recover from the event. As per the reporter, the patient sustained severe and permanent personal injuries. The event was disabling.  The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
lt arm has a lump according to husband c/o aching & tightening of muscles in arm & hand;hand wants to cramp up hurting real bad;
muscle ache; joint pain; suffering terrible; bones ache; legs hurt; back hurts; 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 66-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscle ache"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; MALAISE (non-serious), outcome "unknown", described as "suffering terrible"; BONE PAIN (non-serious), outcome "unknown", described as "bones ache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "legs hurt"; BACK PAIN (non-serious), outcome "unknown", described as "back hurts".  Additional Information: She got the Prevnar 20 shot and she was suffering terrible, she had muscle ache and joint pain and stuff, she want to know if this was normal and what can we do about it. She was having a terrible time with side effects  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 14 hrs later Severe dizziness , chills, some nausea They persisted for about 18 hrs. I don't know if I passed out the next morning but I was dizzy fell and sprained my ankle.
This spontaneous report as received from a health care worker refers to a 34 year old patient. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (919400 PFU) and was not given for prevention (dose, route, lot number and expiration date were not provided). The health care worker reported that a patient was administered a ZOSTAVAX at younger than recommended age. She also stated that ZOSTAVAX was not given for the prevention but that the patient "had already had something". Additional information is not expected.
Starting 6/21/2021 started experiencing intermittent diarrhea.  After several days of diarrhea, doctor was contacted and Imodium was ordered.  Several lab tests were ordered.  Colonoscopy was ordered (performed 10/13/2021)  Diarrhea continued intermittently, and still occurs.  Between 6/21/2021 and 3/3/2023 there were 70 days that diarrhea was experienced, plus many days of loose stool or no bowel movement at all.  On 1/24/2023 there was blood in the diarrhea.  Doctor visited again.  Lab tests ordered again, and an appointment with gastroenterologist is pending.  All lab tests were negative.
This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route of administration, lot# and expiration date were not reported) instead of receiving PROQUAD. At the same time, the patient was vaccinated with a dose of VARIVAX (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Medical Assistant gave two patients the liquid portion of PENTACEL only on 01AUG2022 without re-constituting the powder portion with no reported adverse event; Medical Assistant gave two patients the liquid portion of PENTACEL only on 01AUG2022 without re-constituting the powder portion with no reported adverse event; Initial information was received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a Nurse Practitioner.   This case involves a 9 months old male patient who experienced medical assistant gave two patients the liquid portion of pentacel only on 01aug2022 without re-constituting the powder portion with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination.  On 01-Aug-2022, the patient received single 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot U7197BA, expiry 28-jan-2024) (strength: unknown) via intramuscular route in the right thigh for routine prophylactic vaccination.    On 01-AUG-2022 the patient developed a non-serious medical assistant gave two patients the liquid portion of pentacel only on 01aug2022 without re-constituting the powder portion with no reported adverse event (product preparation error and single component of a two-component product administered) (latency same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  It was reported that "This situation is reported as a medication error due to the liquid portion of PENTACEL being administered without re-constituting the powder portion'.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event medical assistant gave two patients the liquid portion of pentacel only on 01aug2022 without re-constituting the powder portion with no reported adverse event (product preparation error and single component of a two-component product administered)  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 guidelines. 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.; Sender's Comments:  01220255: