chrisvoncsefalvay/vaers-outcomes huggingface dataset:
drowsiness; weakness; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (drowsiness), ASTHENIA (weakness) and DIZZINESS (dizziness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   '4  On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced SOMNOLENCE (drowsiness), ASTHENIA (weakness) and DIZZINESS (dizziness). At the time of the report, SOMNOLENCE (drowsiness), ASTHENIA (weakness) and DIZZINESS (dizziness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received and contains significant information updated event outcome and patient denied further follow-up.
Accidentally administered a Pfizer Monovalent when she was due for a Pfizer Bivalen booster. Previously had 3 doses of Moderna and was due for a bivalent booster.
This spontaneous report as received from a registered nurse refers to an 8month old patient. On 31-OCT-2013, the patient was inadvertently vaccinated with HAEMOPHIUS B CONJUGATE VACCINE (MENINGOCOCCAL PROTEIN CONJ)) (dosages and routes of administration not reported) that had been improperly stored. No adverse effects were reported. Nurse informed incorrectly stored vaccine had been disposed of and she did not have lot numbers or expiration dates. She confirmed that no patient had been vaccinated with GARDASIL. The case is linked to 1311USA000343 and 1311USA011719 due to same reporter link. Additional information is not expected.
Boostrix and Engerix-B have very similar shades of green / could lead to confusing the products; This case was reported by a pharmacist via call center representative and described the occurrence of product label confusion in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix, Boostrix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix, Boostrix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced product label confusion. On an unknown date, the outcome of the product label confusion was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The age at vaccination was not reported. Pharmacist reported that Boostrix and Engerix-B have very similar shades of green, it led to confusing the products, which led to product label confusion. No other information was reported.
TONIC- CLONIC SEIZURES; LOW BLOOD PRESSURE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced tonic- clonic seizures for 3 minutes and the patient's blood pressure was low 94/72 and then the Emergency medical services (EMS) was called and the patient was transported for evaluation the same day. The patient visited emergency room or department/urgent care facility for treatment of the events. On APR-2021, Laboratory data included: Blood glucose (NR: not provided) 97, CT scan (NR: not provided) Negative (units unspecified) and Blood pressure (NR: not provided) 94/72. On 08-APR-2021, patient was discharged from emergency room/urgent care facility and followed up with neurology. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tonic- clonic seizures and low blood pressure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210417256, 20210417209, 20210417456 and 20210417122.; Sender's Comments: V0:20210417620-Covid-19 vaccine ad26.cov2.s-Tonic-clonic seizures. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Patient stated she started itching shortly after receiving the Covid vaccine. The next day she started itching all over her body. No rash noted. Nurse recommended that patient follows up with her doctor and go to the emergency room if she experiences any shortness of breath, throat swelling, or fever.
the physician has had no side affects; physician was accidently given VARlVAX vaccine instead of the Shingrix vaccine; This spontaneous report was received from a registered nurse refers to a 66-year-old patients of unknown gender, reported as physician. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On 01-SEP-2021, the patient was accidently given 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) vaccine, 0.5 ml, subcutaneously (lot # T012551 and expiration date: 10-APR-2022) instead of varicella zoster vaccine rge (cho)(SHINGRIX) vaccine by a new nurse (wrong vaccine administered). The patient has had no side affects.
Red, blotchy, itchy hives appeared on the sides and back of my neck and up into my scalp.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 22-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Apr2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Known allergies: Narcotic pain medication" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral product for COVID 19 Treatment was Pfizer brand Paxlovid from 15Jun2022 to 20Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 1 day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported that sometime between 24th September 2018 to 28th of September 2018, the patient received SHINGRIX. The patient experienced soreness, swelling, redness and tenderness at the injection site the next day of vaccination. The patient was still experiencing pain at the injection site as of the day of reporting. The healthcare professional contacted MI and would like the efficacy and immunity after receiving just 1 dose. No additional information provided.
2 days after receiving the first does of Pfizer's covid vaccine I started my period.  My period has not stopped since and I have now had my period for 2 weeks.  My cycles are always regular with a 28 day cycle and lasting 4 days.  This is very abnormal for me.
Rash on her arm since then only been spreading and getting worst. Over her full body.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her arm since then only been spreading and getting worst. Over her full body.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced RASH (Rash on her arm since then only been spreading and getting worst. Over her full body.). At the time of the report, RASH (Rash on her arm since then only been spreading and getting worst. Over her full body.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I received my 2nd shot 1/12 @3:30pm. 1/13 @5:00 I started having severe stomach cramps, a migraine, and vomiting that is still occurring 1/14 @ 8:10 am.
sore throat; mild pain the left ear; Headache; chills; fever; fatigue; weakness; arm soreness started same day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness started same day), ASTHENIA (weakness), HEADACHE (Headache), OROPHARYNGEAL PAIN (sore throat) and EAR PAIN (mild pain the left ear) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020. Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE;VALSARTAN, VITAMINS NOS (DAILY MULTIVITAMIN), CALCIUM and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness started same day). On 01-Feb-2021, the patient experienced ASTHENIA (weakness), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue). On 02-Feb-2021, the patient experienced HEADACHE (Headache), OROPHARYNGEAL PAIN (sore throat) and EAR PAIN (mild pain the left ear). The patient was treated with PARACETAMOL (TYLENOL) in February 2021 at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (arm soreness started same day), ASTHENIA (weakness), HEADACHE (Headache), OROPHARYNGEAL PAIN (sore throat), EAR PAIN (mild pain the left ear), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment included Tylenol, then the patient stopped as she found from friend to not take anything.
Arm is red and warm to touch. Nausea, vomiting - all started the day after injection. ZOFRAN called in. Advised to put ice on injection area.
Vx given @ 2pm. Child given Motrin that eve.  Sat. a.m. child's R. leg aching. Early afternoon, mild swelling on R. thigh.  By eve., thigh twice normal size. Swelling extended fr. hip to knee.  Child unable to bend knee.  Skin hot, red and very hard. Dx cellulitis @ E.R. & placed on augmentin for 10 days.
Information has been received from a Licensed Practical Nurse referring to unspecified amount of patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the patients were vaccinated with improperly stored oral ROTATEQ (lot # L022447, expiration date February 2017) (dosage and strength unknown) (temperature fridge 0.1 degree centigrade, time frame 2 hours and 59 minutes) orally. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
8 days after vaccination a palm sized red spot appeared at point of injection, and from that time until four days later I suffered frequent chills, sweating, aches, headaches culminating in a migraine. Also extreme fatigue, lack of appetite.
because she had a cold; This is a spontaneous report received from non-contactable reporter(s) (Other HCP and Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "because she had a cold".  Additional information: 'Age/Date of Birth: 0-9 years'   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Stomach Muscles Turning; tight chest; Hip muscles were not working and could not stand up; Walking by holding on to the wall; Soaked Pajamas and Sheets; Red Entire Upper Left Arm; Headache; Chills; Fever,; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach Muscles Turning), CHEST DISCOMFORT (tight chest), MUSCULAR WEAKNESS (Hip muscles were not working and could not stand up), GAIT DISTURBANCE (Walking by holding on to the wall) and NIGHT SWEATS (Soaked Pajamas and Sheets) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach Muscles Turning), CHEST DISCOMFORT (tight chest), MUSCULAR WEAKNESS (Hip muscles were not working and could not stand up), GAIT DISTURBANCE (Walking by holding on to the wall), NIGHT SWEATS (Soaked Pajamas and Sheets), ERYTHEMA (Red Entire Upper Left Arm), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever,). On 10-Feb-2021, ABDOMINAL DISCOMFORT (Stomach Muscles Turning), CHEST DISCOMFORT (tight chest), MUSCULAR WEAKNESS (Hip muscles were not working and could not stand up), GAIT DISTURBANCE (Walking by holding on to the wall), NIGHT SWEATS (Soaked Pajamas and Sheets), ERYTHEMA (Red Entire Upper Left Arm), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Initial case was received from a none healthcare professional on 20 January 2014. A 30-year-old female patient whose medical history and concomitant medication was not reported had received an intramuscular FLUZONE, batch number, dose and anatomical site of administration not reported) on 18 January 2014. The patient was allergic to Ciprofloxacin. The next morn. On 19 January 2014, in the morning after receiving FLUZONE, she developed itchy, red raised rash, on back under arms and a tiny bit on chest sides. On 19 January 2014, the patient took an antibiotic that was completed two days before the flu vaccine. She consulted MD. No treatment was prescribed. The event was not recovered. List of documents held by sender: none.
pt reports swelling in neck lt side 9 days p/vax;pt did not take temp but describes feeling yukky for 3 days;swelling inc to both sides of neck as well as under both jaws;swelling also occured in front of rt ear;swelling lt side of neck
Renal conditions leading to hospital stay; Fainted due to low Blood Pressure; low Blood Pressure; Missed Second dose Beyond day 36; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RENAL DISORDER (Renal conditions leading to hospital stay), SYNCOPE (Fainted due to low Blood Pressure) and HYPOTENSION (low Blood Pressure) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Kidney disorder and Blood pressure abnormal.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RENAL DISORDER (Renal conditions leading to hospital stay) (seriousness criterion hospitalization), SYNCOPE (Fainted due to low Blood Pressure) (seriousness criteria hospitalization and medically significant), HYPOTENSION (low Blood Pressure) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Missed Second dose Beyond day 36). At the time of the report, RENAL DISORDER (Renal conditions leading to hospital stay), SYNCOPE (Fainted due to low Blood Pressure) and HYPOTENSION (low Blood Pressure) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed Second dose Beyond day 36) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medications as blood thinners, for High Blood Pressure, Insulin and for renal conditions . Treatment information was not provided. Caller also mentioned that her grand mother fainted recently due to low blood pressure.  Company comment:Causality for the event Missed Second dose is not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events Renal disorder, Syncope and Hypotension,  a causal relationship cannot be excluded.; Sender's Comments: Causality for the event Missed Second dose is not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events Renal disorder, Syncope and Hypotension,  a causal relationship cannot be excluded.
What the mother thought was going to be a fainting episode, it actually turned into what looked like a seizure which lasted about 15 seconds.
Information has been received from a pharmacist referring to 7 patients of unknown age and gender. Information about concurrent conditions and medical history were not provided. Pharmacist reported that the 7 patients received their second and third doses of RECOMBIVAX HB (strength 2.5mcg/0.5ml, dose, lot# and route not reported) at not the recommended schedule on an unspecified days described as "the second dose was given after 1 month and the 3rd dose was given after 6 months" (Inappropriate schedule of vaccine administered). No adverse effects reported. The outcome of the event was not reported. This is one of several reports received from the same source. Additional information has been requested.
Developed chest pain two weeks after first shot. Developed severe and debilitating heart palpitations a week after the second shot. They were intermittent for 3 months. They spontaneously resolved in February 2022.
pt received a 3rd dose of Hep A vaccine and 5th dose of Dtap at 2 years old.
This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with MMR II (lot # H018949. expiry date: 18-OCT-2014, therapy type, dose, route were unknown), which was improperly stored vaccine. The outcome of the event was unknown. This is one of several reports that received from the same source. Additional information is not expected.
administered tenivac that has expired on 24Sep2023 to a patient with no reported adverse event; Initial information was received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac] that has expired on 24sep2023 to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Sep-2023, the patient received a unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT (Suspension for injection) (lot U7183AA, strength, expiry date unknown) via unknown route in unknown administration site for Immunization.  On 28-Sep-2023 the patient was administered tenivac that has expired on 24sep2023 to a patient with no reported adverse event (expired product administered) (latency : same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered tenivac that has expired on 24sep2023 to a patient with no reported adverse event.  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.