chrisvoncsefalvay/vaers-outcomes huggingface dataset:
UNABLE TO STAND UP; HEAVINESS IN BOTH LEGS; PAIN IN LEFT UPPER THIGH; HEADACHE; BACK ACHE; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported.  The patient's past medical history included back pain, and concurrent conditions included irritable bowel syndrome (ibsd) with major constipation, abstains alcohol, and cigarette smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of report.  The patient experienced cannot breath when treated with tetanus vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced back ache, pain in left upper thigh, headache. On 01-MAY-2021 and heaviness in both legs.  On 02-MAY-2021, the subject experienced unable to stand up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heaviness in both legs, headache, pain in left upper thigh, back ache, and unable to stand up. This report was non-serious.
TRAVELING TO AN ENDEMIC AREA BEFORE COMPLETING VIVOTIF; This spontaneous case report (PVX2019-1671) was received from a pharmacist on 26-Jun-2019. It describes a 27-year-old female consumer who "traveling to an endemic area before completing Vivotif" (Inappropriate schedule of vaccine administered). She was receiving oral Vivotif capsule (one dose every other day; lot number: 3003275 and expiry date: May 2020) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif yesterday (25-Jun-2019) and had a planned travel to an endemic area on Friday (28-Jun-2019).  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "traveling to an endemic area before completing Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "traveling to an endemic area before completing Vivotif" was considered as not applicable.
Patient indicates fatigue, chills, weakness, rash, malaise. This occured the day following the vaccination.
This case was reported by a nurse via call center representative and described the occurrence of meningitis in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced meningitis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the meningitis was unknown. It was unknown if the reporter considered the meningitis to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not applicable for this report. The age group was not provided, but was selected adult as per the vaccine indication. The nurse reported that the person was refusing the 2nd dose of SHINGRIX because he has heard that patients were experiencing severe adverse effects such as meningitis and were ending up in the ICU (intensive care unit). The reported did not consent to follow up. The reporting nurse did not had knowledge of further information concerned the incidents that the patient referenced. The reporter declined to follow up for this reason.
VERTIGO AND RAPID HEART RATE.  REMEBERED HAD NOT EATEN.  ATE NABS.  DISMIISSED TO CARE OF HUSBAND WHO SAID HE WILL TAKE HER DIRECTLY  TO   CLINIC ALTHOUGH SHE STATES SHE IS FEELING BETTER.   RECOVERED  PENDING  F/U WITH PROVIDER.    3/29/2021PROVIDER CALLED BUT UNABLE TO REACH AT THE TELEPHONE NUMBER PROVIDED..  CONSTANT BUSY SIGNAL.
On 30-JUL-2001 the pt received his first injection of Twinrix. When he returned for his second injection of Twinrix he reported that he developed yellow eyes on 01-AUG-2001. He also reported that the yellow eyes resolved on 03-AUG-2001 without treatment. The Twinrix immunization series was discontinued and the pt was referred to a gastroenterologist. the most recent information was received from the vaccine provider on 07-NOV-2001. the vaccine provider considered the event to mild in intensity and possibly related to Twinrix administration. Yellow eyes is considered medically serious.
103R fever that noc;no blood work then;brought to office day after;100.2 fever R 2 days of screaming;appetite OK, breathing okay;blood work done on 5FEB99;CBC, C reactive protein, blood cult;cult ok c-reactive protein elevated;
Headache, Sedation, Arthralgia,  injection site pain Narrative:  ibuprofen prn, drinking extra fluids
short of breath; fatigue; sugar level abnormal; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported)), via an unspecified route of administration on an unspecified date as dose unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced short of breath, fatigue, sugar level abnormal and my sugar has been out of control. The outcome of the events were unknown.  Information on the lot/batch number has been requested.
booster dose; Positive COVID test; Positive COVID test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adolescent male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) as dose 3 (booster),single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster dose"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive COVID test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: shortly after booster dose.  The lot number for BNT162B2 was not provided and will be requested during follow up.
This spontaneous report was received from a physician via company representative regarding a female patient of unknown age. No medical history was reported. On an unknown date the patient was vaccinated with GARDASIL (dose and frequency not provided). No concomitant therapy was provided. On an unknown date the patient was diagnosed with cervical cancer (medically significant). The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Upon internal review the cervical cancer was considered as medically significant. Additional information has been requested.
Information has been received from a public health nurse concerning her daughter a 19 year old female patient with no known allergies who on last summer (2007), was vaccinated with the first dose of GARDASIL vaccine (yeast). On last fall (2007), was vaccinated with the second dose of GARDASIL vaccine (yeast). In February 2008, was vaccinated with the third dose of GARDASIL vaccine (yeast). In January 2008, the patient was diagnosed with mononucleosis and was treated with (3 MEDROL dose pack). The patient's mononucleosis persisted. Nurse states that her daughter was not on any medication when the third dose of GARDASIL vaccine (yeast) was administered. The patient had muscle aches and pains on both arms and legs, had been tired, fatigued and generally feels unwell. Nurse states she thought these symptoms were lingering due to mononucleosis, but is not sure now. At the time of reporting the patient had not recovered. Additional information has been requested.
73-year-old male who was sent to our emergency room by ambulance for shortness of breath.  The patient has an extensive past medical history multiple medical problems.  He was recently admitted to this facility from 172022-1112022 for hypotension and sepsis.  Patient has a history of paraplegia.  He has a history of heart failure with reduced ejection fraction with a EF of 20%. , coronary artery disease, chronic pain syndrome, hypothyroid, and diabetes mellitus.  The patient relates the history that he had a positive COVID test at his primary care physician's office 6 days ago.  He has not been hypoxic.  He has not had any fever.  No treatment was recommended.  Patient has had his initial 2 COVID immunizations.  states he was scheduled to get the booster next week.  Workup in the emergency room tonight is essentially unrevealing.  He is not hypoxic.  His chest x-ray actually looks improved from when he was here previously.  He does have a mild hypokalemia and hypomagnesemia for which replacement has been ordered.  His main reason for admission is that he lives quite a distance away and has no ride home.  DISCHARGED 01242022: 73-year-old male who was sent to our emergency room by ambulance for shortness of breath.  The patient has an extensive past medical history multiple medical problems.  He was recently discharged on 1/11/2022 for hypotension and sepsis.  Patient has a history of paraplegia.  He has a history of heart failure with reduced ejection fraction with a EF of 20%. , coronary artery disease, chronic pain syndrome, hypothyroid, and diabetes mellitus.  The patient relates the history that he had a positive COVID test at his primary care physician's office 6 days ago.  He has not been hypoxic.  He has not had any fever.  No treatment was recommended.  Patient has had his initial 2 COVID immunizations.  He states he was scheduled to get the booster next week.  Workup in the emergency room tonight is essentially unrevealing.  He is not hypoxic.  His chest x-ray actually looks improved from when he was here previously.  He does have a mild hypokalemia and hypomagnesemia for which replacement has been ordered.  His main reason for admission is that he lives quite a distance away and has no ride home.   The morning he finally procured a ride home and wanted to leave.  His ride arrived prior to me seeing him and he left AMA.  His vitals appeared stable at that time.
Headache MUSCLES/JOINT and BACK OF NECK SORENESS ,FATIGUE, Narrative:  Other Relevant History:
Abnormally high level Fatigue, Muscle and Joint Aches, slight headache. Injection site tenderness/soreness.  After effects beginning approximately 18 hours after injection and lasting approximately 36+ hours.
Cold chills, shock all over (started 6-7 hours after shot was given). Episode last 1-2 hours. Headache, body aches, feverish w/o temperature. Lasted 36 hrs. (approx). Redness in eyes & joints achy.
63-year-old patient inadvertently administered the Fluzone High-Dose Quadrivalent rather than Fluzone Quadrivalent vaccine, no AE; 63-year-old patient inadvertently administered the Fluzone High-Dose Quadrivalent rather than Fluzone Quadrivalent vaccine, no AE; 63-year-old patient inadvertently administered the Fluzone High-Dose Quadrivalent rather than Fluzone Quadrivalent vaccine, no AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a other care health professional.  This case involves a 63 year old female patient who was vaccinated with a 0.5 ml once dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringe, lot UJ478AA and expiration date 30-Jun-2021) via an intramuscular route in the left deltoid for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 22-Sep-2020.   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   The patient did not receive concomitant vaccines.  It was an actual medication error case due to wrong vaccine administered, inappropriate age at vaccine administration and overdose (latency was same day).  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. No medical history, concurrent conditions or concomitant therapies were reported. On unknown dates, ,the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot #, dose, route of administration and anatomical location were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as the reporter did not wish to be contacted.
At almost 10 hours after receiving my covid vaccine I experienced extreme chills and weakness. I had a tough time moving throughout my room and could barely get up from bed. It felt similar to having a severe fever. However, these symptoms diminished throughout the night and I only felt a slight weakness going into the next day. The severity of these symptoms decreased throughout the day but remained in the background for a while.
Patient was vaccinated on 01MAR21 @ 0830.  She called our onsite nurse on 11MAR21 to report that on 10MAR21, patient noticed raised, red, warm to touch, itchy injection site (left deltoid).  She reported that she has already spoken to her primary care provider and is using a prescription cream on the area.
Eyes became very scratchy and matter began to build up; Eyes became very scratchy and matter began to build up; Nauseous; Threw up; Chills; Pfizer Covid bivalent vaccine and flu shot received on the same day; Pfizer Covid bivalent vaccine and flu shot received on the same day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 14:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 71 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 11Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster); manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster); manufacturer unknown), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 11Oct2022 at 14:00, outcome "unknown" and all described as "Pfizer Covid bivalent vaccine and flu shot received on the same day"; CHILLS (non-serious) with onset 11Oct2022 at 18:00, outcome "recovered"; EYE IRRITATION (non-serious), EYE DISCHARGE (non-serious) all with onset 11Oct2022 at 18:00, outcome "recovered" and all described as "Eyes became very scratchy and matter began to build up"; NAUSEA (non-serious) with onset 11Oct2022 at 18:00, outcome "recovered", described as "Nauseous"; VOMITING (non-serious) with onset 11Oct2022 at 18:00, outcome "recovered", described as "Threw up". Therapeutic measures were not taken as a result of eye irritation, eye discharge, nausea, vomiting, chills.  Additional information: Patient has no known allergies. She did not receive any other vaccines within 4 week prior vaccination. She had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since vaccination.  Follow-up attempts are completed. No further information is expected.
Red rash and heat in large area around vaccination site and on left elbow for 3 days. Hives and rash on chest and left side of neck - still a few left that are red, itchy, swollen and painful. Using benadryl and pain relievers to treat.
Information has been received from a medical assistant(also reported as office manager) referring to a 2 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 09-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis(Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1704USA014784:
administered the vaccine before realizing that the vaccine had expired/ no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00760288).  This case involves a 74-year-old female patient who vaccinated with a 0.7 mL (once) dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ549AB and expiry date 30-Jun-2021) via intramuscular route in the left deltoid on 08-Sep-2021 for prophylactic vaccination while nurse administered the vaccine before realizing that the vaccine had expired (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  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. 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.
Respiratory therapist received flu vaccine as part of our hospital's flu program where we give flu shots to staff on our unit. I am the representative for our unit and my assistant administered employee with a non-refrigerated dose. Earlier that week on Tuesday, Oct 18, I accidentally left a box of three doses out for a few days in my box of supplies (because it looks very similar to our band aid box), and was unsure what to do with it. I didn't hear back until several days later from the coordinator, so I left them with the supplies. I was giving them out that day on the 23rd and was aware that they were not to be used until I heard back from Occupational Health. However, my assistant, jumped in and gave the doses to the respiratory therapist. I should have labeled the box as "do not use" and so I take responsibility for the error. I reported the incident immediately and we offered to revaccinate. This individual chose not to revaccinate. We did provide full education from the pharmacist recommending re-vaccination since the former dose was out of the refrigerator for > 72 hours and was considered ineffective. However, she still chose not to be revaccinated. I spoke with her following the injection and she did not report any symptoms.
Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment medications were not provided by the reporter.   This case was linked to MOD21-070451 (E2B Linked Report).; Sender's Comments:  MOD21-070451:Crossed linked as per source doc
first dose/ August 5th 2019.; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 5th August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter wanted to know if the patient needs to restart series or if they should administer the 2nd dose now. The follow up would not be possible as no contact details were available.
Sore Throat; Aches and Body Pain; Low Grade Fever; Hoarseness; Cough; Low Grade Fever
5-10 minutes after vaccine pt stated her throat was itchy, similar to her experience with nuts.  Pt observed for 15 more minutes with continued itchy throat and growing axiety.  25 mg of Benadryl were administered and pt began to feel improvement within 10 minutes.  Pt observed for 1 hr with resolution of symptoms and BP stable.  Transported home by family member.