chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient appeared to have a change in mental status, appeared lethargic, speech slowed down, and stated she felt dizzy and nauseous, at that time her daughter was contacted reported to the pharmacy.  While waiting for patient's daughter we contacted the doctor's office to report incident and have her seen.  Meanwhile the patient's daughter arrived and preferred us to call an ambulance rather than take her herself as doctor had suggested.  Within 30 to 40 minutes of patients first report of reaction paramedics arrived and took patient to the hospital.
PATIENT REPORTED WAKING UP WITH SEVERE MUSCLE PAIN, HEADACHE, SHIVERING, FEVER, PAIN AND NAUSEA THE DAY AFTER THE ADMINISTRATION- PATIENT CALLED PRIMARY TO REPORT SYMPTOMS. PATIENT WAS UNABLE TO PERFORM DAILY FUNCTIONS FOR 5 DAYS. REPORTED FEELING BETTER 2/10/21
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium.
I experienced constant high pitched ringing in both ears that has not abated since receiving my booster. I am under the care of my PCP and it is being monitored at the time and it has not resolved.
doses less than one month apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO).   On 31st January 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 31st January 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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. The patient recently received two doses of Bexsero less than one month apart, which led to shortening of vaccination schedule. No other information available. The reporter did not consent to follow-up.
This spontaneous report was received from an office manager concerning a 4 month old male patient. ON an unspecified date, the patient was vaccinated with the first dose of ROTATEQ, (dose, route and lot # not provided). On 04-NOV-2013, the patient was vaccinated with the second dose of ROTATEQ, 2 ml, oral (lot # 0741AE; expiration date 03-OCT-2012). Concomitant therapies included diptheria toxoid, pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine inactivated (unspecified), hib conj vaccine (unspecified carrier) and PREVNAR13. It was reproted that the second dose of ROTATEQ, was expired. Patients outcome was unknown. Additional information has been requested.
ACCORDING TO THE PATIENT'S AND SON'S NARRATIVE, SHE EXPERIENCED BRAIN FOG AND NAUSEA AND VOMITTING IMMEDIATELY AFTER HER FIRST DOSE.   SHE CAME BACK FOR HER 2ND DOSE AND SAID HER SYMPTOMS JUST GOT WORSE. THE IMMUNIZING RPH SAID THAT SHE ASKED THE PT HOW WAS HER FIRST DOSE AND SHE SAID THAT EVERYTHING WAS OK AND DIDN'T HAVE ANY PROBLEMS.  WHEN SHE CAME TODAY, SHE SAID THAT SHE WAS JUST DISCHARGED FROM THE HOSPITAL AND STAYED THERE FOR 2 MONTHS. THEY TOOK OUT HER GALL BLADDER AND SAID IT STILL DIDN'T FIX THE PROBLEM. THE SON SAID THAT NOW SHE CAN'T EAT NORMAL NOW AND CAN ONLY EAT A TABLESPOON OR SO NOWADAYS AND STILL FEEL VERY SICK.
administered the expired Fluzone; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received by non-healthcare professional via consumer (under Agency Inquiry Number-00814605) .  This case involves an unknown age female patient who administered the expired fluzone (expired product administered) while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On 03-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2017, expiry-30-jun-2021) via unknown route in unknown administration site.  On 03-Sep-2021 the patient administered the expired fluzone (expired product administered) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "There were 16 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available."  Relevant lab data was not reported.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered the expired Fluzone).  At time of reporting, the outcome was Unknown for the event administered the expired fluzone.  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.
Bladder diverticulum cancer; This spontaneous case was reported by a consumer and describes the occurrence of BLADDER CANCER (Bladder diverticulum cancer) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced BLADDER CANCER (Bladder diverticulum cancer) (seriousness criterion medically significant). At the time of the report, BLADDER CANCER (Bladder diverticulum cancer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Biopsy: abnormal (abnormal) Diagnosis of bladder diverticulum cancer..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided.  Company comment: This case concerns a 68-year-old male patient with no relevant medical history, who experienced the unexpected event of Bladder Cancer. The event the same month after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since the event only happened after the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-378125 (Patient Link).; Sender's Comments: This case concerns a 68-year-old male patient with no relevant medical history, who experienced the unexpected event of Bladder Cancer. The event the same month after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since the event only happened after the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Joint Pain, Sleep Apnea, HBP, Palpitations, Difficult breathing, mood change.
101.3 Fahrenheit fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (101.3 Fahrenheit fever) 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, the patient experienced PYREXIA (101.3 Fahrenheit fever). At the time of the report, PYREXIA (101.3 Fahrenheit fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 (High) 101.3 Fahrenheit fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was reported by reporter
This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 67 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 11-FEB-2014 (also reported as 11-FEB-2013), the patient was vaccinated with M-M-R II (Lot number reported as J008882; expiry date, dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the M-M-R II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Rash at the injectio nsite, left leg swollen, hot to the touch, 3 days of rash and 1 day of swelling. No treatment needed. Noted as a side effect of DTaP.
Patient was  holding hand of his spouse after getting his shot and he pass out while holding his spouse's hand and fall on display and then on the floor. He came back to sense in about 30 seconds. He scratched his hands and bumped his head on the floor. His scratch was cleaned with antiseptic wipes and applied antibiotic ointment. He had redness on his head from collapse but his refluxes were completely normal. They both went to shopping after 15 minutes of monitoring.
IPSILATERAL TRAPEZIUS MUSCLE SPASM TREATED WITH IBUPROFEN AND HEAT STARTING ON 1/1/21 AND WORSENED ON 1/2/21
pt stopped breathing & unresponsive for unk period prior to arrival @ ER;cyanotic;comatose, conjugate gaze;BP 23/13;limp, cold, pupils fixed, dilated;on respirator;hypotonic;cardio pulm arrest r/o sepsis r/o CNS bleed;
Pt. felt extremely week and her legs gave out. She fell, the daughter put her in bed and she slept. She woke up around midnight to urinate and she felt better, still week but better.
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 24-APR-2014, the patient was vaccinated with an unspecified improperly stored dose of PNEUMOVAX 23 with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported). On unspecified dates, the PNEUMOVAX 23 had four temperature excursions of 32 Fahrenheit (F) Degrees (0 Celsius) for 152 hours, 31 Fahrenheit (F) Degrees (-0.555555556 Celsius) for 32 hours, 33 Fahrenheit (F) Degrees (0.555555556 Celsius) for 88 hours, and 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for 40 hours (lowest recorded temperatures). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor was product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Patient was unable to move arm in which vaccine was given (left). Called doctor, but did not go in. Was able to feel a little relief the next morning.
Burning where injected and through chest and neck for 4 days strong; hurts to move left arm or my neck; hurts to move left arm or my neck; nausea; tiredness; fever; chills; sweats; This is a spontaneous report from a contactable consumer (Patient, self-reported).  A 36-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8736 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 19May2021 at 03:45 PM, as DOSE 1, SINGLE for COVID-19 immunization (age at vaccination: 36 year). The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included gabapentin (GABAPENTIN). The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 19May2021 at 20:00, the patient experienced burning where injected and through chest and neck for 4 days strong now hurts to move left arm or my neck, nausea, tiredness, fever, chills, sweats. The AE did not result in emergency room or physician office visit. The patient did not receive any treatment for the events. Outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Nausea-Medium, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe
Headache, Myalgia,  lips tingling/12/26 had cold sore , RT ear pain went walk-in stated both eardrums bulging rt side face numbness
Myalgia FATIGUE, L SUPRACLVICULAR LYMPHADEMA Narrative:
On April 06,2021 I took the Johnson and Johnson vaccine the next day I threw up  and my leg would fall asleep I advised my doctor she sent me  to the emergency room I went to the hospital. They did a ultrasound they didn?t find and blood clots I also advised them that I had been having headaches and they told me take over the counter pills. The head aches continued I was with the pain for a month in half my doctor sent me for a MRI and to a neurologist. The headaches still continue finally my neurologist sent me to the hospital. They conducted MRI MRV MRA I was admitted to the hospital for 14 days I haven?t been able to return to work I am not 100% I am on blood thinners.  They ended up finding a blood clot on the right side of my head I am still not able to return to work still having headaches and still having to go to follow ups.
On Wednesday, July 6, 2022, I had some sinus drainage in the back of my throat and my throat was scratchy. I started developing a cough on Thursday and more head congestion. I took HALLS and MUCINEX to help with congestion. Friday I was coughing worse. I thought it was just a normal head cold. On Thursday I also had a bit of body aches but Friday they were gone. I felt better but still had congestion and cough and went fishing for 8 hours. When I returned home I tested at home and was positive for COVID-19 on Friday July 8, 2022. On Friday I reached out to my doctor to inquire about PAXLOVID and I began taking it that evening. I was exhausted and stayed in bed for three to four days. I continued to have fatigue and a cough. As of today I am doing better regarding my fatigue. My cough is not gone completely. It returns when I exert myself or laugh or talk too much.
Intense body aches, +4 degree F fever.  Took 2 rounds of Tylenol.  Felt fine the morning of 04/18/2021
Started at 2 PM with Scratchy, hoarse, swollen throat, itchy watery eyes with discharge, headache, dizziness... By 4pm body aches by 6pm chills by 8 pm low grade fever 100 degrees. Symptoms were gone the next morning.
SOB, tachycardia, palpitations. Treated with IV fluids, Solumedrol 125 mg, Benadryl IV 50 mg, Pepcid 20 mg IV.
This spontaneous report was received from a registered nurse via a sales representative concerning a 6 year old male patient. The concurrent conditions included immunodeficiency (type unspecified). In approximately 2014 (reported as "last year"), the patient was vaccinated with a first dose of PNEUMOVAX 23. (Dose and route were not reported). In 2014, after vaccination the patient had titers drawn (unspecified date), and then the titers came back as "negative". The nurse stated the patient was hospitalized (unspecified location and date), "6 times last year" due to developing pneumonia. The patient's immunologist had a written order for the patient to receive the vaccine according to his "record of a treatment plan that was supposed to draw out the patient's titers". On 14-MAY-2015, the patient was vaccinated with another (second dose) of PNEUMOVAX 23 and had titers drawn. Receiving the PNEUMOVAX 23, was outside of the recommended dosing instructions. The patient did not seek medical attention. The outcome of pneumonia was unknown. Additional information has been requested.
Admitted to unknown hospital on 10/13/2021-Patient was not interviewed for COVID.  No other info is available. Outcome is unknown
This case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 29-year-old female subject who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 25 August 2014, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, intramuscular, unknown injection site). The subject's gestational age at that time was 26 1/2 weeks. Her last menstrual period was on an unspecified date and estimated date of delivery was on 26 November 2014. The subject was exposed to the vaccine during the 2nd trimester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 08 October 2014 from the nurse (patient). The patient received BOOSTRIX (batch number 3HG7R, expiry date 8th November 2016). Concurrent medical conditions included anemia. Concomitant products included IRON, docusate sodium, Vitamin C, prenatal multivitamin (tablet, oral from 01 January 2014) and fiber. On 3rd September 2014, the patient received BOOSTRIX (intramuscular) .5 ml. The subject's last menstrual period was on 19th February 2014. The subject received BOOSTRIX at week 28 of the pregnancy and during the 3rd trimester of pregnancy. On an unknown date, an unknown time after receiving Flu Seasonal QIV, the patient experienced vaccine exposure during pregnancy and multiple allergies for which she was treated with loratadine. At the time of the follow-up reporting, the outcome of multiple allergies was unknown. It was unknown if the reporter considered the multiple allergies to be related to Flu Seasonal QIV.
Patient developed some soreness and redness at the site that she describes as being about a quarter size.  She reports that night after getting the vaccine she felt somewhat generalized illness with mild headache and body aches.
uncomfortable; my upper Right lip began to swell, slowly; This is a spontaneous report from a contactable consumer. A 63-years-old male patient received second dose BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EN6203), via an unspecified route of administration, administered in Left arm on 04Mar2021 16:45 as 2nd dose, single dose; and previously took 1st dose of BNT162B2 for COVID-19 immunization. No covid prior vaccination and no known allergies. The patient medical history and concomitant medications were not reported. No vaccines within 4weeks. On 04Mar2021 17:00, 18 minutes after vaccination, patient upper Right lip began to swell, slowly. 30 minutes later when home it was very noticeable and uncomfortable. patient reported it was only point of concern. 6 hours later after 2 Tylenols, the swelling has decreased, Somewhat. No covid tested post vaccination. Patient reported no treatment was received. Patient was not recovered from events.  No follow-up attempts are possible. No further information is expected.
Dull Headache 4/14/21 at 6pm, Headache 4/15/21 at 9:30am, Migraine 4/15/21 at 11:30pm, Migraine 4/16/21 All Day - All were given 2 Tylenol at 500 mg to equal 1000 at approved intervals between 5-6 hrs apart. Migraines had light and sound sensitivity. Vertigo 4/16/21 All Day - No treatment provided other than resting with assistance to and from bathroom. Low grade fever of 99.9 4/15/21 and 4/16/21 - treatment was used the Tylenol used for the migraines, ice packs on forehead, cool showers and eating pop sickles. Lump on injection site 4/15/21, 4/16/21 and 4/17/21 - ice packs applied onto injection site to help with pain.
Her tongue cracked; her throat was itchy; the roof of her mouth had ulcers; her chest did also get tight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) at the age of 55 years 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: TONGUE DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "Her tongue cracked"; THROAT IRRITATION (non-serious) with onset Mar2021, outcome "unknown", described as "her throat was itchy"; MOUTH ULCERATION (non-serious) with onset Mar2021, outcome "unknown", described as "the roof of her mouth had ulcers"; CHEST DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "her chest did also get tight".  Additional information: Reporter calling about the Covid 19 vaccine. Stated that she had a reaction last March (Mar2021), within 8 minutes of getting her first dose of the vaccine. Stated that her reaction was all in her mouth. Her tongue cracked, her throat was itchy, and the roof of her mouth had ulcers. Caller then clarified that her chest did also get tight. States that her doctor recommended that she not get the 2nd dose. So she was still unprotected in this very scary time. She was calling to ask about the new pill that was just approved; what are the ingredients? Stated that she would like the list of the ingredients just in case she needs it, so she can give it to her doctor. Stated that she had mast cell, so she has a lot of allergies to different things, and she was just trying to be prepared in case she ever needs to take the new pill. Patient took the covid vaccine back in Mar2021 and had an adverse reaction to it, so patient's doctors advised to patient against the second and booster. Patient was so scared of getting this virus even though patient was very careful. So now that the pill created for covid has given me hope, patient would like to know what the ingredients are since patient had serve allergies to many medicines.  The lot number for bnt162b2 was not provided and will be requested during follow up.